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DMF submissions in 2021: India, China continue to top filings

The year 2021 was eclipsed by the Covid-19 pandemic. In our update for the first half of 2020, we had mentioned that Covid-19 has not slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). That trend continued in 2021, when the speed of DMF submissions to the agency remained similar to that witnessed in the previous years. In fact, Type II DMFs, or DMFs for active pharmaceutical ingredients (APIs), were higher in 2021 as compared to previous years. In the first quarter, FDA received 164 Type II DMF submissions, which rose to 165, 166 and 172 submissions over the next three quarters. In all, 667 Type II DMFs were filed in 2021, as opposed to 662 in 2020, 633 in 2019 and 644 in 2018. DMFs are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes or articles used in manufacturing, processing, packaging and storing of human drug products. Overall, 2021 saw a total of 913 DMFs (Type II, III, IV and V) being submitted. In comparison, FDA had received 931 DMF submissions in 2020, 894 in 2019 and 979 in 2018. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) India continues to lead DMF filings, followed by China Country-wise data on DMF filings at the FDA tells us the potential of a country in the field of pharmaceuticals. At the company-level, with each DMF filing, a firm commits itself to manufacturing drugs in a facility that is aligned to the FDA’s rules and regulations. This year too, DMFs filed from India and China were significantly higher than those from other countries. Expectedly, India continued to lead with 376 DMF filings. Submissions from India were over twice that of DMF filings from China (at 159). This is not surprising since the two countries have the maximum number of API manufacturing facilities registered with the FDA. As compared to this, the United States had 52 DMF filings, Italy had 10, Spain and Taiwan had 9 each, and countries like Canada, Israel, Japan and UK had five DMF filings each. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) India’s MSN Labs leads DMF count As in the past, India's MSN Laboratories continued to lead the DMF filings by a single company with 43 submissions. MSN was followed by five other Indian companies — Dr. Reddy’s Laboratories filed 15 submissions, Hetero Group and Aurobindo Pharma 14, Metrochem API 13 and Aurore Life Sciences filed 12 DMF submissions. The only Chinese company in the top 10 by DMF count was Brightgene Bio-Medical Technology Limited with nine DMF submissions. The maximum number of DMF filings were for semaglutide (eight), followed by favipiravir (seven), apalutamide (six), sitagliptin phosphate (six) and tofacitinib citrate (six). Others like acalabrutinib, elagolix sodium, lenalidomide, liraglutide and pantoprazole sodium had five DMF filings each. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) Slow assessment review, higher GDUFA fee Although there were 667 Type II DMFs filed with the FDA, only 194 (or 29 percent) had their review completed. The GDUFA (short for Generic Drug User Fee Amendments) fee associated with a DMF assessment review for 2021 was considerably higher — at US$ 69,921 — as opposed to US$ 57,795 for 2020. For FY 2022, the GDUFA fee has been revised upward to US$ 74,952 (an increase of US$ 5,031). There are 42 products for which a DMF was filed for the first time. Among the patented products which should expect generic competition are avatrombopag, encorafenib, esketamine hydrochloride, siponimod fumaric acid, tedizolid phosphate and vorapaxar sulfate. In fact, DMFs were also filed for products that are yet to receive an FDA approval. Some of these products are imeglimin, aviptadil, gimeracil, linzagolix choline, meglumine antimoniate, roluperidone hydrochloride and teneligliptin. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) Our view The Covid-19 pandemic revealed how the global supply chain for pharmaceuticals is excessively dependent on India and China. As a result, many countries across the world are making investments into expanding their API production capacities. This should translate into more Type II DMF filings from countries other than India and China. Moreover, as the pandemic begins to wane and the FDA increases its inspections — both domestic and international — compliance issues are bound to increase. The US is planning to run a pilot program soon that will test a system of unannounced inspections in India and China. Companies in both India and China will need to increase their focus on compliance if they wish to continue to be major contributors to the global supply chain for pharmaceuticals. We can certainly expect more regulatory news in 2022.View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)

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17 Feb 2022

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Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

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29 Apr 2020

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DMF submissions in 2019: India maintains bulk drug supply supremacy to US

At PharmaCompass, we highlighted the significance of India in the global active pharmaceutical ingredient (API) supply chain last week with our list of generic drug facilities registered with the US Food and Drug Administration (FDA). Our compilation revealed that India had 182 generic drug facilities registered with the FDA and this number was nearly as much as the corresponding numbers for China (100) and United States (84) put together. These 182 facilities paid a fee of US$ 59,400 each to the FDA. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) This week, we review the API Drug Master Files (DMFs) submitted to the FDA in 2019. Expectedly, India also led the DMF submission list. In 2019, there were 616 active DMF submissions to the FDA with Indian companies submitting more than half (331) of them. Submissions from India were a little less than double the number of DMF submissions made by Chinese (113) and the US (57) firms put together. Drug master files (DMFs) are submissions made to the FDA by manufacturers by providing the agency with confidential, detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of human drug products. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) MSN Labs leads total count of DMF filings The 616 active DMF filings to the FDA were quite diverse — they covered over 400 products, and over half (322) the filings were for unique products. Among the products with multiple DMF filings, Sugammadex Sodium topped the list as it had 18 DMF filings. Sugammadex is the API used in Merck’s Bridion for the reversal of neuromuscular blockade induced by rocuronium and vecuronium in general anesthesia. The other products with over five DMF filings were for the APIs of Lundbeck and Otsuka’s antipsychotic drug Brexpiprazole, Novartis, Gilead and Intercept’s blockbuster products Sacubitril-Valsartan, Tenofovir Alafenamide Fumarate and Obeticholic Acid. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) The year 2019 also witnessed continued DMF filings for Rivaroxaban, Sitagliptin Phosphate, Ticagrelor and Tipiracil Hydrochloride. These filings indicate that the companies currently developing these products should brace themselves for intense competition in the near future. India’s MSN Labs continued to lead the count of total DMF filings with 42, of which it had 17 filings where it was the only one submitting a DMF for a specific product in 2019. The leading Chinese company filing DMFs was Fuxin Long Rui Pharmaceutical with nine DMFs, followed by Brightgene Bio-Medical Technology Co with five. The API DMF is part of the final generic drug product submission to the FDA. Therefore, the owner of a DMF incurs a one-time fee (US$ 55,013 for FY2019, US$ 57, 795 for FY2020) the first time the generic drug submission references that DMF. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) DMF holders may also pay the fee in advance in order to have their DMF subjected to an initial completeness assessment by the FDA. This would allow their DMF to be included on a publicly-available list of DMFs that have paid their fee and not failed the initial completeness assessment. Aurobindo, Sun, Lupin lead DMF assessments While reviewing the DMF submissions made in 2019, we found that a third (209 out of 621) of the DMFs were listed on FDA’s publicly-available list of DMFs that have paid their fee and whose initial assessment had been completed. This indicates that either companies may have been unwilling to pay the fee or the FDA’s review process found shortcomings in their applications. Major Indian generic drug companies like Aurobindo (16), Sun Pharmaceuticals (13), MSN Labs (12), Lupin (7) and Macleods (7) led the list of companies that had the maximum DMF assessments completed for their 2019 submissions. There are also DMF submissions for products which can sometimes indicate future drug approvals. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) Sanyo Chemicals submitted a DMF for Ibudilast, an anti-inflammatory drug whose oral capsules are used in Japan for the treatment of asthma and its ophthalmic solution is used to treat allergic conjunctivitis. The product is currently not approved in the United States. New drug approvals in the future can also be expected for Tertomotide, Omarigliptin, Estetrol Monohydrate, Abametapir, Pirenzepine, Cortexolone Proprionate, Lurbinectedin, Terlipressin, Ethyl Olivetolate, Remimazolam and Triapine. These products are currently under clinical trials for a variety of indications. Our view After compiling the list of companies that have submitted DMFs to the FDA as well as the generic facilities that paid their user fees, it’s clear that the API industry is beginning to find a new equilibrium. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available) Our compilations of the previous years have shown that there is a steady decline in facility registrations and DMF filings. Given the increasing costs involved, as well as scaled up regulatory requirements, it seems that companies are becoming more selective in their product development decisions and also their willingness to do business in the United States. While the number of Indian API facilities registered with the FDA has remained relatively unchanged, the number of Chinese sites that registered with the US has reduced by 35 percent over the past five years. Several factors are changing the landscape of the generic drug industry. For instance, environmental regulations in China are driving up the cost of raw materials. Quality issues — such as the valsartan impurities case — have increased regulatory scrutiny. Moreover, passing inspections continues to remain a challenge for many manufacturers. And generic drug product manufacturers are also facing margin pressures, which in turn is driving a lot of M&A activity. Given this scenario, the generic industry should brace itself for more challenges in 2020. View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)

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23 Jan 2020

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US market offers niche opportunities, reveals manufacturer sales data from Medicare Part D

This week, PharmaCompass reviews the recently released data of the Medicare Part D Prescription Drug Program in the United States for calendar year 2017. The US market is the world’s largest and most important pharmaceutical market, accounting around 45 percent of the global share of drugs, and was valued at US$ 466 billion in 2017. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) What is Medicare? Medicare is the federal health insurance program in the US which covered 58.4 million people in 2017 — 49.5 million aged 65 and older, and 8.9 million disabled. The National Health Expenditure (NHE) in the US grew 3.9 percent to US$ 3.5 trillion in 2017 and accounted for 17.9 percent of the gross domestic product (GDP). As a result, Medicare spending grew 4.2 percent to US$ 705.9 billion in 2017, or 20 percent of the total NHE. Prescription drug spending in the US increased to US$ 333.4 billion in 2017 while prescription drug coverage under the Medicare program, known as Medicare Part D, reached US$ 151.6 billion in 2017, a little less than half of the total prescription drug spending in the United States. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) Why has Medicare been in news? The Medicare Part D drug benefit is delivered by private drug plans, which are mostly chosen by the program’s participants. Under Part D, drug prices are determined primarily through negotiations between Part D plans and providers (such as pharmacies and drug manufacturers). A key factor that helps Part D plans lower drug costs are rebate payments that the plans negotiate with drug manufacturers. With drug pricing debate raging in the United States, these rebate payments have come under a lot of scrutiny. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) During the hearing of Big Pharma executives summoned by the Senate Financing Committee last month, Sanofi’s CEO Olivier Brandicourt detailed a chart showing Sanofi and Genzyme's US sales from 2018, explaining how as much as 55 percent of Sanofi’s gross sales were given back to payers as rebates. The chart showed how out of Sanofi’s US$ 21.6 billion in gross sales in 2018, US$ 4.5 billion was given back in mandatory rebates to government payers and US$ 7.3 billion in discretionary rebates. Earlier this month, the Trump administration unveiled a budget that would reduce spending in Medicare as well as Medicaid by hundreds of billions of dollars compared to the current law. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) What are the insights available from the 2017 US Medicare Part D data? The Medicare Drug Spending dashboards were updated earlier this month to include data for 2017, providing more data and transparency to better identify trends and track consumption and price changes over time. Using the available data, PharmaCompass has developed its own dashboard to show recent trends in consumption of prescription drugs under Medicare D. Our dashboard also helps identify drugs with limited to no competition. The data reveals that while almost 60 percent of the Medicare spend (nearly US$ 90 billion) is for drugs with only one manufacturer, i.e. mostly patented drugs, there is another US$ 12 billion spend on drugs which have only two manufacturers. The next highest spend — of US$ 4 billion — is on drugs with as many as five manufacturers. This clearly indicates that if the market can support up to five manufacturers for established products, increased generic competition will significantly help Medicare reduce its Part D prescription drug spending. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available) Medicare’s highest spend was on Insulin Glargine (US$ 4.7 billion) followed by patented drugs Celgene’s Revlimid (lenalidomide), Bristol-Myers Squibb’s Eliquis (apixaban), Merck’s Januvia (sitagliptin phosphate) and AbbVie’s Humira (adalimumab). Drugs with limited to no competition can be identified using the dashboard by sorting for drugs with few manufacturers. Information is also provided on drug uses and clinical indications, thereby enabling comparison between different medications for a given condition. View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)

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28 Mar 2019

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Mylan’s President, Emcure’s CEO named in US drug price-fixing probe; Novartis buys French biotech for US$ 3.9 billion

This week in Phispers, we look at how Mylan’s president Rajiv Malik and Emcure’s CEO Satish Mehta, along with 12 major generic drug players, got added to an expanded investigation into the drug price-fixing case in the US. While Trump declared the opioid crisis a health emergency, pharma companies Celgene and Gilead saw their third quarter results and guidance get impacted by a drug trial failure and competition. Meanwhile, there was news on Novartis buying AAA, CVS Health showing interest in buying health insurer Aetna and Merck cutting jobs and withdrawing its application for Keytruda as treatment for advanced lung cancer. Mylan’s president, Emcure’s CEO, 12 firms to be probed in price-fixing case This week, attorneys general from 45 US states named Mylan’s president Rajiv Malik and Emcure’s billionaire CEO Satish Mehta as they expanded their three-year old investigation into price-fixing in the generic pharmaceuticals industry. In addition to the two individuals, 12 major generic drug companies and 13 drugs were added to the expanded investigation. This week’s filing alleges collusion of 18 defendant companies, as well as two individual executives, involving a total of 15 drugs. (To view the complete list of companies and drugs, click here) The states allege multiple conspiracies that restrained trade, artificially inflated and/or maintained prices and reduced competition in the generic drug industry. According to the expanded complaint, Mehta and Malik were “directly involved in conceiving an illegal agreement and taking affirmative steps to ensure it was executed by their subordinates.” Earlier this year, a federal criminal investigation resulted in the convictions of former Heritage Pharmaceuticals CEO Jeffrey Glazer and former Heritage President Jason Malek. Heritage is a wholly-owned subsidiary of Emcure. Both Glazer and Malek pleaded guilty and have been cooperating in the anti-trust investigations being conducted by federal and state prosecutors. PharmaCompass had covered the illegal practices at Heritage Pharmaceuticals that had come to light when Emcure had filed a lawsuit against Glazer. It now remains to be seen if Glazer acted on his own or colluded with his bosses in India to fix generic drug prices in the United States. As Trump declares opioid crisis an emergency, Insys founder gets arrested Last week, the US President Donald Trump hardened his stand on the opioid crisis, blaming it on factors like criminals, drug companies, Mexico and China. In the US, the crisis claimed over 30,000 lives in 2015. He termed abuse of opioids a public health emergency and outlined steps to fight it — such as new efforts to curb prescription abuse, reduction in import of certain drugs and educating children on the risks. “We must stop the flow of all types of illegal drugs into our communities,” Trump said. Blaming pharmaceutical companies for over-prescribing pain medications, he said the US Food and Drug Administration (FDA) will provide more training to doctors who prescribe drugs to prevent abuse. Moreover, he has requested that one opioid drug, Opana ER, no longer be sold. According to Trump, a border wall with Mexico will “greatly help” reduce this problem. He also talked about China’s role in the production of fentanyl. Meanwhile, John Kapoor, the founder of Insys Therapeutics, was arrested last week on charges of participating in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug. Kapoor has resigned from the company’s board of directors, and his arrest is being seen as a step towards fighting the opioid epidemic. The charges against Kapoor marked a major escalation of probes into Subsys, an under-the-tongue spray that contains fentanyl, an addictive synthetic opioid. Celgene’s Crohn’s disease drug fails trial; Gilead reports weak Hep C sales Two companies have not had a good going — Celgene and Gilead. The former announced that its drug mongersen — a potential treatment for Crohn’s disease — had failed. Celgene had purchased the drug four years ago for US$ 710 million from a private company in Dublin — Nogra Pharma Limited. The New Jersey-headquartered biotech firm had promised that if mongersen gets approved, Nogra would get another US$ 815 million. But that was not to be. What was worse, Celgene’s third-quarter financial announced last week spooked its investors. The company missed analysts’ sales projections for the third quarter by 4 percent, cut its guidance for 2020 by 5 to 10 percent, and announced that sales of a key (plaque psoriasis) drug — Otezla — had missed forecasts by US$ 100 million. In a note, Geoffrey Porges, a biotech analyst at Leerink, said: “Investors are likely to ask whether the company’s good fortune has run out, with disappointments (mongersen) and negative revisions (Otezla) left and right.” Gilead, on the other hand, is trying hard to move away from hepatitis C. Its hepatitis C drugs generated US$ 2 billion during the last quarter — just US$ 300 million short of Wall Street’s projections. However, investors were cautioned about AbbVie’s new launch —Mavyret — which is expected to have a “big impact” on Gilead’s fourth-quarter results. Gilead’s hepatitis C drugs have been facing competition from new rivals who have eaten into its market share and driven down prices over the last few quarters. However, we could expect some M&A action soon. “Gilead noted that it is in a ‘constant state of valuation and opportunities’ and that it is very, very active,” said an analyst. Novartis buys radiopharmaceutical firm AAA for US$ 3.9 billion In July, PharmaCompass had covered news on how Lutathera — a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs — got a nod from the European Medicines Agency (EMA), boosting prospects for its developer Advanced Accelerator Applications (AAA). Well, last week the French biotech — AAA — got bought over by Novartis for US$ 3.9 billion. Novartis is paying a 44 percent premium over AAA’s market valuation from September 28. The deal further strengthens Novartis’ oncology business, which had got a shot in the arm in 2015, when it acquired GlaxoSmithKline’s marketed cancer drugs. And in August, its gene-modifying leukemia treatment (a chimeric antigen receptor T-cell therapy or CAR-T therapy) — Kymriah — got approved. This was the first CAR-T therapy to bag an FDA approval. With AAA, Novartis will now have a technology that deploys trace amounts of radioactive compounds to not only diagnose a disease (by creating images of organs and lesions), but also to fight cancer. Lutathera is a radiopharmaceutical — it uses radioisotopes to target neuroendocrine tumors. Along with Lutathera, Novartis also gets a pipeline of drugs from AAA with some near-term potential. US Merck to cut 1,800 jobs, withdraws EU application of cancer wonder drug Late last week, Merck announced it had withdrawn its application for Keytruda (pembrolizumab) as a combination treatment for an advanced stage of non-small cell lung cancer (NSCLC) from the European Medicines Agency (EMA). An analyst with Evercore ISI, Umer Raffat, said in a note that EMA was reluctant to approve drugs based on Phase II data, even though the FDA regularly does so in oncology. The company is also moving to a new sales team structure in the US, and plans to cut 1,800 sales positions, while adding 960 jobs to a new chronic care salesforce. According to a Fox Business report, three of Merck’s US sales teams will be cut: primary care, disease-focused endocrinology and hospital chronic care. This is “to better support changes in our business in the United States,” Merck’s spokeswoman said. Merck’s new chronic care team will focus on Januvia (a diabetes drug), other primary care products such as sleep medication Belsomra, and products for respiratory conditions and women's health, she added. Releasing its third quarter numbers in the US, Merck was also forced to concede that the NotPetya cyber attack had cost the company US$ 135 million in lost sales along with US$ 175 million in related costs. That extra US$ 310 million in costs will be repeated in Q4 as overall damages inch up to the US$ 1 billion mark, the company said. As Amazon threat looms over US pharmacy biz, CVS eyes health insurer Aetna Amazon has been trying to get into the US$ 412 billion pharmacy business in the US. Every year, pharmacies in the US dispense about 4.5 billion prescriptions. Patients pick up about 9 out of 10 prescriptions at a retail pharmacy. Amazon’s entry into online prescription drug sales, therefore, poses an existential threat to brick-and-mortar pharmacies. And that’s the reason why news about US pharmacy operator CVS Health Corp reportedly evincing interest in buying health insurer Aetna Inc is important. This potential acquisition could trigger another round of deal making in an industry that is fearing Amazon’s arrival. According to news reports, CVS Health is expected to buy Aetna for US$ 66 billion in what would be the biggest deal of the year. If the deal goes through, it would also be the biggest of its kind ever in healthcare. “A potential combination would diversify CVS profit streams ahead of an Amazon entry and set the stage for a new healthcare-retail delivery model,” Morgan Stanley analysts wrote in a note. A deal would make CVS-Aetna a one-stop shop for customers’ healthcare needs — which could range from employer healthcare and government plans to managing benefits and running drug stores.

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02 Nov 2017

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India-China border tension may impact billion dollar pharma deal; AZ’s investors worry as key cancer drug fails trial

This week in Phispers, we analyze the situation at AstraZeneca, where its much anticipated lung cancer drug failed in clinical trials. In the US, there are reports that various generic players are looking to enter into M&A deals in order to safeguard themselves against regulatory crackdown on prices. The tension along the India-China border may lead to cancellation of the Fosun-Gland deal by the Indian government and in the US, the FDA is looking to cut nicotine in cigarettes to ensure they are non-addictive. AstraZeneca’s key lung cancer drug fails in first stage trial; gets investors worried The year 2017 was supposed to be a pivotal year for AstraZeneca. The firm was supposed to display new marvels from its laboratories and march towards annual revenues of US$ 45 billion by 2023. This target was set when Pfizer’s takeover offer was rejected in 2014. But so far, the year has turned out horribly for AstraZeneca. Its key lung cancer drug — Imfinzi — flopped in clinical trials. Known as the ‘Mystic’ study, this was the most anticipated clinical experiment in the pharmaceutical industry this year. The study was key to proving the value of the group’s new drug pipeline, after it rejected a US$ 118 billion takeover bid by Pfizer in 2014.The news crashed the share price of AstraZeneca by 15 percent. Imfinzi, an immuno-oncology drug, was said to be a potential replacement for chemotherapy. However, all is not lost yet. The first stage of the trial merely measured the drug’s ability to prevent a cancer from becoming worse. The second stage, which looks at survival rates, is said to be more important. But for Pascal Soriot, AstraZeneca’s CEO, this came as an embarrassment. He faced a barrage of questions from analysts about future payouts of the company. He was forced to defend the company’s dividend strategies at post-result meets last week. Fears for AstraZeneca’s dividend were driven by the failure of the lung cancer. But there is hope for Astra in the future — another lung cancer pill, Tagrisso, has produced good data. And AstraZeneca is partnering with Merck on another immuno-oncology drug, Lynparza. Another downside for Astra in 2017 has been the uncertainties faced by the company regarding its top executives. It began in January this year, when Luke Miels, the head of AstraZeneca’s European operations, announced he is quitting the company to join GlaxoSmithKline. Recently, there were speculations regarding Soriot considering an offer to join Israeli drugmaker Teva as its head. He is learnt to have turned down the offer. Bleak US generics market forecast has drug makers scrambling for deals In the US, generic drug makers are turning to M&As in order to safeguard themselves against a concerted effort by regulators to crack down on the steep prices of drugs. According to a Reuters report, Impax Laboratories, Perrigo and Alvogen have been talking to advisers about various strategic options for their generics businesses. These options range from acquisitions, as well as outright sale. Earlier, Reuters had reported that Mallinckrodt, one of the largest producers of the generic opioid painkiller oxycodone, has been exploring a sale of its specialty generics unit. In May, the CEO of Impax, which makes a generic version of the EpiPen allergy injection, said it was looking at deals. The US generics market is getting increasingly competitive. Last month, Novartis reported that sales at its Sandoz generics unit were down 4 percent. Generic drugs are cheaper versions of brand-name drugs. In the US, the government is targeting generics to cut the cost of prescription drugs. According to a 2016 report by the Journal of the American Medical Association, US consumers spend more than twice as much on drugs per capita compared to other industrialized nations. In order to bring down the prices of drugs, the US Food and Drug Administration (US FDA) has committed to eliminating the backlog of drug applications awaiting its approval. This could mean nearly 4,000 new drugs will come onto the market over the next few years, based on FDA estimates. Even today, small and mid-sized drug makers are under pressure as consolidation among generic drug distributors has made it less profitable for them to sell their drugs. India-China border skirmish may impact Fosun-Gland deal The heightened tensions along the India-China border are likely to impact business. In the pharmaceutical industry, the Cabinet Committee on Economic Affairs (CCEA) in India is likely to reject Shanghai Fosun Pharmaceutical Group’s US$ 1.3 billion acquisition of Hyderabad-based Gland Pharma Ltd, says a Bloomberg report. However, a report in The Economic Times says the proposal was listed for CCEA’s consideration two weeks back. But the CCEA is yet to take a call on the Gland Pharma-Fosun deal. “It is wrong to say that the deal has been rejected,” the official said. The Gland Pharma-Fosun deal had been approved by the now-abolished Foreign Investment Promotion Board (FIPB) in March this year. And Fosun was to acquire 86 per cent stake in the injectable drugmaker. According to IndiaSpend, China is today the 17th largest foreign direct investor in India, an improvement on the 36th rank it held in 2010. CRO Consolidation: LabCorp buys Chiltern, Evotec acquires Aptuit Consolidation in the CRO industry continued unabated last week. LabCorp bought Chiltern for US$ 1.2 billion last week. Two years back, LabCorp had bought Covance for US$ 6.1 billion. The acquisition of Chiltern will add another 4,500 clinical outsourcing workers around the globe to its employee roster. Another CRO that made an acquisition last week was Germany’s Evotec. It bought out its rival Aptuit for US$ 300 million in cash. And the deal will add hundreds of scientists to its organization along with facilities in Basel, Oxford and Verona. Evotec has earned a large number of clients on both sides of the Atlantic. Evotec says most of Aptuit’s 750 employees are scientists. Last year, Aptuit reportedly handled 1,000 projects for some 400 companies. The CRO business has been consolidating for years, with private equity groups leading the way to build up these global organizations. Leading the pack is Thermo Fisher, which had made acquisitions worth US$ 22 billion in the last five years. Three months back, Thermo Fisher Scientific acquired Patheon NV for US$ 5.2 billion while INC Research Holdings merged with private-equity owned CRO — inVentiv Health. FDA to cut nicotine in cigarettes to non-addictive levels Last week, the US government proposed cutting nicotine in cigarettes to “non-addictive” levels in order to move smokers towards potentially less harmful e-cigarettes. The FDA Commissioner Scott Gottlieb said the agency will study regulating nicotine levels with a view towards the “FDA’s potential to render cigarettes minimally addictive or non-addictive.” “Nicotine itself is not responsible for the cancer, the lung disease and heart disease that kill hundreds of thousands of Americans each year,” Gottlieb said. “It's the other chemical compounds in tobacco and in the smoke created by setting tobacco on fire that directly cause illness and death,” he added. The FDA cannot reduce nicotine levels to zero, nor can it ban cigarettes. However, after this announcement by Gottlieb, shares of major tobacco firms in the US and UK slumped. Analysts said they expect regulators in Europe to study similar actions on nicotine products. This action shakes up a public health debate on whether e-cigarettes represent a health risk or a potential benefit. NotPetya cyber attack hits Merck’s profits Merck is the latest in a string of companies that have disclosed that their operations were significantly disrupted by the NotPetya attack, which devastated businesses and government agencies in Ukraine in June and has gradually spread around the globe. According to a Reuters report, Merck said it had been a victim of an international cyber attack in June 2017, due to which the company had to halt production of drugs. As a result, its profits for the rest of the year have been hit. The company, however, said it is yet to know the magnitude of the impact as it is in the process of restoring manufacturing operations. Merck had disclosed the attack last month, but did not disclose the manufacturing shutdown at the time. The company said it was confident that it will be able to maintain a continuous supply of its top-selling and life-saving drugs, such as cancer drug Keytruda, diabetes drug Januvia and hepatitis C drug Zepatier. However, there maybe temporary delays in delivering some other products, which the company did not identify. “Full recovery from the cyber-attack will take some time, but we are making steady progress,” CEO Ken Frazier said. At least four other major US and European firms have also experienced massive outages due to NotPetya.

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03 Aug 2017

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Ghosts of GSK’s billion dollar mistake return; New date for electronic submissions of DMFs

This week, Phispers tells us why David Hung’s taking charge as CEO of Axovant could signal the revival of an Alzheimer’s compound shelved by GSK. While, the FDA has extended compliance date for submitting DMFs in electronic format, there are also indications that there will be more FDA inspections in India. Plus, there is news on companies like Fresenius, Stada, Ajanta Pharma, Merck and Teva. Read on. FDA extends compliance date for electronic DMF submissions to May, 2018 On April 7, the US Food and Drug Administration (FDA) announced it is extending the compliance date for submitting DMFs in Electronic Common Technical Document (eCTD) format to May 5, 2018. “DMF submissions that are not submitted in eCTD format after this date will be rejected,” the FDA website said. “Presentations on submitting in eCTD format created prior to April 7, 2017 will have the incorrect compliance date for DMFs,” it added. Electronic submissions of Drug Master Files (DMFs) were supposed to become mandatory from May 5, 2017. The news coincides with the US Senate’s confirmation hearing for Scott Gottlieb, on April 7. Gottlieb was President Trump’s nominee to be the next Commissioner of the FDA. Gottlieb was with the FDA when the regulator launched its Pharmaceutical cGMPs for the 21st Century initiative. Out of five guidance documents listed as part of this initiative, only one has been finalized. With Gottlieb heading back, Ajaz Hussain, (former FDA deputy office director and president of the National Institute for Pharmaceutical Technology and Education of NIPTE), Vadim Gurvich (executive director of NIPTE) and Peter J. Pitts (president of the Center for Medicine in the Public Interest and a former FDA associate commissioner) shared their perspective on how Trump and the FDA can create a pharmaceutical manufacturing renaissance in a blog posted on Morning Consult. Axovant appoints new CEO and revives ghosts of GSK’s billion dollar mistake After selling Medivation to Pfizer for US $ 14 billion and exiting with US $ 354 million for himself, David Hung is now the CEO of Axovant, the company which we wrote about two years ago, as we asked the question — Did a 29-year old show GSK that it made a billion dollar mistake? Back in December 2014,Vivek Ramaswamy, CEO and Founder of Roivant Neurosciences and Axovant, had bought an old Alzheimer’s drug that GSK had dropped for US $ 5 million. In October 2014, Roivant had spun off a subsidiary by the name of Axovant, which then bought the GSK drug. GSK had shelved the compound — 5HT6 — after testing it in 13 trials and on 1,250 patients. Six months after purchasing the compound from GSK, and without doing any clinical development, the drug resulted in the biggest biotech IPO ever for Axovant, which got valued at US $ 2 billion. Since then, Ramaswamy has been setting up more companies. Throughout, Ramaswamy has recruited high-profile executives to run his companies. And who could be more high profile than Hung? The stock market cheered his appointment — Axovant’s stock was up 28 percent earlier this week after Hung was announced its CEO. Axovant is looking for positive data that GSK had gathered for its 5HT6 Alzheimer’s drug. And a number of senior players in the industry say Axovant has a decent shot at taking the successful dose back into the clinic. With Hung joining, it seems the drug discarded by GSK does indeed have merit. Fresenius in talks to buy Akorn; Stada sold for US $5.6 billion Fresenius SE said it is in talks to buy US generic drugmaker - Akorn Inc. Though discussions are underway, there is no certainty of a deal, Fresenius said. A spokeswoman for Akorn declined to comment. The CEO of Fresenius, Stephan Sturm, who took charge in July 2016, has been expanding the group’s global reach through acquisitions. Last year, the company bought Spanish hospital group IDC Salud Holding SLU, also known as Quironsalud, for US $ 6.11 billion (Euro 5.76 billion) in the company’s largest-ever acquisition. Akorn could complement Fresenius’ Kabi medicines division, which specializes in intravenous drugs, and accounts for about a fifth of the company’s revenue. Stada sell-off: Stada Arzneimittel AG has been sold to Bain Capital and Cinven for US $ 5.6 billion (Euros 5.3 billion), after a long-fought takeover contest. The sell-off will give the equity firms control of one of the last independent generic-drug businesses in Europe. The deal would give buyers access to German and Russian markets for OTC and copycat medicines. It marks another step in the consolidation of the generics industry. FDA inspections in India to rise, says Edelweiss Securities India’s pharmaceutical sector is the largest supplier of drugs to the US. However, “quality issues are an ongoing challenge for the Indian pharmaceutical industry,” Mary Lou Valdez, FDA’s associate commissioner for international programs wrote in a blog. Of the 42 warning letters sent out by FDA’s office of manufacturing quality last year, about one-fifth (9) were addressed to Indian facilities. The number could rise over the next three years as the FDA would inspect 190 facilities that it could not inspect in the past five years, wrote Edelweiss Securities. FDA inspections in India and China have doubled since 2012. This has led to a spurt in warning letters as well. GSK to withdraw 600,000 inhalers; no observations for Ajanta GSK would be voluntarily recalling close to 600,000 Ventolin asthma inhalers across the US, says the FDA. The recall is due to a leak observed in some of the products. The exact number of inhalers to be recalled, as reported by the FDA, is 593,088. These were produced in GSK’s Zebulon, North Carolina manufacturing facility. This is the second time in just over a year that the plant has faced problems with leaking inhalers. Ajanta Pharma: On Monday this week, shares of India-based Ajanta Pharma soared by over 5 percent in intraday trading as investors cheered the fact that no observations were issued during a regulatory inspection at its unit. “Our formulation facility at Dahej (in Gujarat) was inspected by US Food and Drug Administration (FDA) from April 3 to April 7, 2017. At the end of the inspection, no Form 483 was issued to us,” Ajanta Pharma said in a notification to the stock exchanges. FDA delivers a blow to Merck’s Januvia marketing plan In 2015, Merck had come out with a massive 14,724-patient study where the data demonstrated that Type 2 diabetes patients could take its flagship DPP-4 drug — Januvia — without increasing their risk for cardio complications. DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin. Merck wanted to use the findings of this survey in a label to help distinguish themselves from same-class rivals like Onglyza, which has risks. However, the FDA recently nixed the idea, handing the pharma giant a complete response letter (CRL). The CRL covered Merck’s blockbuster Januvia as well as its combos with metformin. However, Merck says it is reviewing the letter and will discuss next steps with the FDA. Teva’s US $ 3.5 billion buy pays off with FDA approval of Austedo Last week, the FDA gave its nod for Teva’s promising drug deutetrabenazine, after putting it on hold ten months back due to certain suspicions regarding some metabolites found in patients. Teva had paid US $ 3.5 billion to acquire Auspex two years back. Teva’s deutetrabenazine is the first deuterated drug to bag an FDA approval. A deuterated drug is a drug where hydrogen has been replaced by deuterium. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine or SD-809 (which had been developed by Auspex). The drug will be sold as Austedo. Due to the presence of deuterium, the drug breaks down more slowly in patients. This way physicians can give the drug less often and at lower doses and still manage great results. The drug is designed to regulate the levels of dopamine in the brain.

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13 Apr 2017

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Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017. Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers). The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed. Top Ten Drugs by Cost, 2014 [Most expensive for Medicare] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13 $1,224,835 $94,218 Elaprase 100 $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60 $2,901,115 $48,352 Naglazyme 129 $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15 $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services. Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!

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05 Jan 2017

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Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

This week, the biggest news in the world of pharmaceuticals was the termination of the Pfizer-Allergan mega-merger due to new measures taken by the US government. Post that, Allergan signed a US $ 3 billion licensing deal with UK’s Heptares for a portfolio of neurological drugs. But a lot more happened last week – for instance, Pfizer and Celltrion won approval for a biosimilar of J&J’s Remicade, GSK said it wants to make it easier for manufacturers in least-developed countries to make its drugs and Valeant terminated the salesforce for its female libido pill. Pharmaceutical Whispers (Phispers) brings you the latest news from across the world. Pfizer-Allergan terminate merger; Allergan signs licensing deal with HeptaresOn Monday, the US Treasury announced new measures to curb tax-inversion deals. The measures seemed to specifically target the Pfizer-Allergan US $ 160 billion mega deal. And, by Wednesday, the US government had achieved its desired objective – Pfizer and Allergan announced their decision to mutually terminate the deal. Allergan, which is run from New Jersey but has a legal domicile in Dublin, last year agreed to merge with Pfizer. This mega-merger would have moved the Pfizer headquarters from New York to Dublin, saving the pharma behemoth billions of dollars in taxes. As per news reports, Pfizer will need to pay a US $ 400 million fee to Allergan for expenses relating to the deal. Though the US Treasury decision and the termination of the Pfizer-Allergan deal represents a victory for President Barack Obama, whose administration proposed tougher rules aimed at curbing tax inversions, Allergan is not wasting time. Just hours after Allergan backed away from the US $ 160 billion-merger with Pfizer, the company bounced back with a US $ 3.3 billion licensing deal for global rights to a portfolio of drugs for neurological disorders from the UK's Heptares. The deal sends a clear signal that Allergan CEO Brent Saunders plans to barrel ahead with new pacts to bolster the company's pipeline. Pfizer, Celltrion win approval for biosimilar of J&J’s RemicadeNot all news this week was negative for Pfizer as the FDA approved Celltrion’s biosimilar application of Johnson & Johnson’s Remicade. The product will be co-marketed by Pfizer in the United States, a relationship Pfizer accessed through its acquisition of Hospira last year. Celltrion’s application is only the second biosimilar approved by the FDA. However, unlike generic medicines, biosimilars which have been currently approved are not interchangeable with the reference drug. The European Medicines Agency also issued a positive opinion to the Bioepis copy of Remicade. Samsung Bioepis, a joint venture between a unit of the Samsung group and Biogen, has become a force in the biosimilar drugs industry. In fact, South Korea too is emerging as a hub for biosimilar production. Last week, Bioepis filed a lawsuit against AbbVie Inc., makers of the world’s best-selling rheumatoid arthritis drug – Humira – which generated sales of US $ 14 billion last year. In 2015, Johnson & Johnson’s Remicade sales were US $ 6.5 billion. Glaxo not to patent drugs in poorer countriesIn an unusual step, GlaxoSmithKline said it wants to make it easier for manufacturers in the world's 48 least-developed countries to copy its medicines. The company said it would not file patents in these countries in the hope that by removing the fear of patent litigation and by allowing independent companies to make and sell versions of its drugs in those areas, it would widen public access to these drugs. In countries classified as lower middle income countries by GSK, it will continue to file patents, but will grant licenses to generic manufacturers in exchange for a “small royalty”. Gilead has adopted a similar model, of granting generic licensing agreements in developing countries, for its blockbuster Hepatitis C treatment, Sovaldi. The end of the female Viagra?Valeant Pharmaceutical, still reeling from all its accounting and price-gouging problems, has terminated the sales force for the female libido pill that it acquired last year for US $ 1 billion. The drug – Addyi (flibanserin) – failed to gain traction in its first six months on the market. Valeant’s stock has plunged 90 percent since its peak in August last year. Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months, says a Bloomberg news report. In the meantime, the drug will still be available. Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit. Valeant has about 22,000 employees. Alkem, Rusan and Anuh Pharma – data-integrity issues raise its ugly head yet again in India Inspection at Alkem: In July 2015, the European Union banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. And this year, another laboratory is under the lens of EU regulators.A routine inspection by the European Medicines Agency in March 2015 of the Department of Bioequivalence of Alkem Laboratories, a major generic drugs manufacturer in India, raised concerns regarding study data used to support the marketing authorization applications of some drugs in the EU. Rusan Pharma back in news: In an inspection conducted in 2010 at Rusan Pharma’s facility in Gandhidham (India), the UK’s Medicines and Healthcare Regulatory Agency (MHRA) uncovered “evidence of fraudulent presentation of data” and determined that the site did not comply with Good Manufacturing Practices (GMPs). The same year, another unit of Rusan, located in Ankleshwar (India), did not meet GMP compliance standards during an inspection conducted by Romania’s National Agency for Medicines and Medical Devices. This week, Rusan was back in news. In January 2016, re-inspection by UK’s MHRA of the Gandhidham site found the Pharmaceutical Quality System “not operating in an adequate manner”. In addition, the inspection report mentions “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.” Non-compliant sourcing of drugs by Anuh Pharma: The French Health Agency’s inspection at Anuh Pharma’s facility in Boisar (India) revealed the firm was sourcing commonly used Azithromycin from a non-EU GMP compliant source (Hebei Dongfeng Pharmaceutical Company Limited, China), micronizing the product and then directly exporting it to Europe under the manufacturer name, Anuh Pharma. In addition, several documents were found within a pile of rubble which included an original batch repacking record. A large number of active substances were manufactured at the site, such as chloramphenicol, chloramphenicol palmitate, erythromycin, erythromycin ethylsuccinate, roxithromycin, ciprofloxacin HCl etc. Catalent’s compliance problems delay OPKO’s new drug launchWith more than 40 manufacturing facilities around the world, Catalent is a preferred manufacturing partner for several major pharmaceutical companies across the world. OPKO Health, Inc., one of Catalent’s customers submitted its application for RAYALDEE® (calcifediol) to the FDA. In the complete response letter (CRL) issued to the company, the FDA indicated observations of deficiencies at Catalent’s St. Petersberg, Florida, facility as a result of an FDA field inspection initiated on March 14, 2016, and had held up the new drug approval. According to a news report, OPKO revealed the deficiencies occurred at Catalent’s primary softgel development and manufacturing at St Petersburg, Florida, which was hit with a Form 483 being issued on March 25. Meanwhile, Catalent began production of essential drugs at its French plant, which had been suspended by France’s health regulator in November last year due to occurrence of out-of-place capsules in several product batches. Safety warnings for new age diabetes drugs -- saxagliptin and alogliptin Last year, the FDA had issued safety warnings on new age diabetes drugs called SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) and PharmaCompass had asked the question, “Diabetes: Which new drug is the safest?”. At the time Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other products in the same categrory such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). This week the FDA issued a safety warning on Onglyza® (saxagliptin) and Nesina® (alogliptin) as the evaluation of two clinical trials determined that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo. Blockbuster drug approval expected soon for non-alcoholic fatty liver The FDA reviewed the application of Intercept Pharmaceuticals Inc's liver drug, Obeticholic Acid (OCA) and did not raise any major red flags indicating a high likelihood that it will get approved. While the drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease, late-stage studies are underway on the same drug to treat non-alcoholic steatohepatitis (NASH), which has no approved treatment. Obeticholic acid (OCA) is listed as one of the top 10 possible blockbuster drugs by FierceBiotech with an expected sales in 2020 of US $ 1.6 billion. Gilead is also actively building its liver disease pipeline and this week, the company paid US $ 400 million upfront to acquire an early-stage pipeline of liver disease drugs from privately held Nimbus Therapeutics. Heart-disease science turns over its headScience is supposed to be simple – for instance, LDL is bad cholesterol and HDL is good cholesterol. If a drug lowers the bad cholesterol and increases the good one, the risk of heart disease should reduce significantly. Specialists were stunned by the results of a study of 12,000 patients, announced on Sunday at the American College of Cardiology’s annual meeting: “There was no benefit from taking the drug, Evacetrapib.” The drug’s maker, Eli Lilly, stopped the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision. As per the study, participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 mg per deciliter from 46. Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo.

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07 Apr 2016

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Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

The year 2015 has gone down in history as a record year for mergers and acquisitions in the pharmaceutical and biotech space with deals worth US $ 300 billion being announced. The highlight of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion. Pharma Letter tracked transactions through the year and found the number of deals exceeding US $1 billion at 30 in 2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A deals were announced in 2015 (out of which some are yet to be completed), compared to 137 in 2014. This week, PharmaCompass brings you a compilation of the top drugs of 2015 by sales revenue and growth. Sofosbuvir – the outright winner of 2015 2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion. The PharmaCompass prediction that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment of infectious diseases like hepatitis and HIV) would become the best-selling drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864 billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira. Humira retained its place as the best-selling drug with US $ 14.012 billion in sales in 2015. However, with sales growth of US $ 11.737 billion in a single year, Harvoni is poised to become the best-selling drug by the end of 2016. Top 20 Drugs by Sales Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2015 data (Excel version available) for FREE! Product Active Ingredient Main Therapeutic Indication Company 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) AbbVie 12,543 14,012 1,469 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 2,127 13,864 11,737 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen / Pfizer 4,688 8,697 4009 4 Remicade Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson / Merck 6,868 8,355 1487 5 MabThera/Rituxan Rituximab Oncology Roche 5,659 7,115 1,456 6 Lantus Insulin Glargine Diabetes Sanofi 6,978 7,029 51 7 Avastin Bevacizumab Oncology Roche 6,481 6,751 270 8 Herceptin Trastuzumab Oncology Roche 6,338 6,603 265 9 Revlimid Lenalidomide Blood Related Disorders Celgene Corpoartion 4,980 5,801 821 10 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 10,283 5,276 (5,007) 11 Seretide / Advair Salmeterol Respiratory Disorders GlaxoSmithKline 6,005 5,227 (778) 12 Crestor Rosuvastatin Calcium Cardiovascular AstraZeneca 5,512 5,017 (495) 13 Lyrica Pregabalin Neuroscience and Mental Health Pfizer Inc. 5,168 4,839 (329) 14 Neulasta Pegfilgrastim Blood Related Disorders Amgen 4,596 4,715 119 15 Gleevec / Glivec Imatinib Oncology Novartis 4,746 4,658 (88) 16 Xarelto Rivaroxaban Anticoagulants Bayer / Johnson & Johnson 3,369 4,345 976 17 Copaxone Glatiramer Neuroscience and Mental Health Teva 4,237 4,023 (214) 18 Januvia Sitagliptin Diabetes Merck & Co 3,931 3,863 (68) 19 Abilify Aripiprazole Neuroscience and Mental Health Bristol-Myers Squibb/ Otsuka Holdings 6,485 3,804 (2681) 20 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health Biogen 2,909 3,638 729 Click here to access all the 2015 data (Excel version available) for FREE! A year of record FDA approvals 2015 was also the year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information. PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant variation in estimates. However, in our view, drugs that saw highest sales growth in 2015 are likely to do well this year as well. Top 20 drugs by sales growth (in USD, millions) Product Active Ingredient Main Therapeutic Indication 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) 2,127 13,864 11,737 2 Viekira Pak Ombitasvir/Paritaprevir/Ritonavir Infectious Diseases (HIV, Hepatitis etc.) 48 1,639 1,591 3 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) 12,543 14,012 1,469 4 Hepatits C Franchise Daclatasvir and Asunaprevir Infectious Diseases (HIV, Hepatitis etc.) 256 1,603 1,347 5 Imbruvica Ibrutinib Chronic lymphocytic leukemia 200 1,443 1,243 6 Cubicin Daptomycin Anti-bacterial 25 1,127 1,102 7 Eliquis Apixaban Anticoagulants 774 1,860 1,086 8 Triumeq Abacavir, Dolutegravir and Lamivudine Infectious Diseases (HIV, Hepatitis etc.) - 1,037 1,037 9 Xarelto Rivaroxaban Anticoagulants 3,369 4,345 976 10 Opdivo Nivolumab Oncology 6 942 936 11 Revlimid Lenalidomide Blood Related Disorders 4,980 5,801 821 12 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health 2,909 3,638 729 13 Xtandi Enzalutamide Oncology 480 1,207 727 14 Ibrance Palbociclib Oncology - 723 723 15 Invokana / Invokamet Canagliflozin Type 2 diabetes 586 1,308 722 16 Victoza Liraglutide Diabetes 2,014 2,704 690 17 Stribild Cobicistat, Elvitegravir, Emtricitabine and Tenofovir Disoproxil Fumarate Infectious Diseases (HIV, Hepatitis etc.) 1,197 1,825 628 18 Levemir Insulin Diabetes 2,133 2,745 612 19 Votrient Pazopanib Oncology 565 565 20 Perjeta Pertuzumab Oncology 927 1459 532 Hepatitis C products, which had three of the four highest sales growths in 2015, clearly show the impact these revolutionary treatments will have on the global healthcare landscape in time to come. Cancer immunotherapy treatments, a new generation of blood thinners and novel diabetes treatments were some of the others which demonstrated stellar growth in 2015. Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they have not been included in the compilation of drugs. Click here to access all the 2015 data (Excel version available) for FREE! Sign Up, Stay Ahead While some companies like Boehringer and Valeant are yet to release their annual reports. In order to stay informed, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to access all the 2015 data (Excel version available) for FREE! CORRECTION, April 12, 2016: An earlier version of this compilation did not account for cases where the same drug is sold by multiple companies (e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top 20 Drugs by Sales and Sales Growth has been done.

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10 Mar 2016

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Merck’s top-selling diabetes drug less effective than a match-stick size implant

A tiny match-stick size implant, being developed by Boston-based biopharmaceutical startup – Intarcia Therapeutics – was found more effective in reducing blood sugar and body weight than Merck’s top-selling diabetes drug Januvia (sitagliptin). In a year-long study on 535 patients, Intarcia’s implant – ITCA 650 – led to an average weight loss of 4 kilograms, compared to a loss of 1.3 kilograms in patients taking Januvia. The device reduced blood glucose (measured through HbA1c or glycated haemoglobin test) by 1.5 percentage points, compared with 0.8 percentage point for Januvia. Different drugs and delivery systems for the management of diabetes Initial therapy for the management of type 2 diabetes is almost always metformin and lifestyle interventions. Due to the progressive nature of the disease, pharmacological agents in addition to metformin are required for successful management. There are various treatment options available today. And that’s why choosing the next course of action can be quite challenging for physicians.Two types of drugs – Glucagon-like peptide-1 (GLP-1) receptor agonists and Dipeptidyl peptidase-4 (DPP-4) inhibitors, which act in distinct ways to regulate blood sugar levels – have become the fundamental treatment options before physicians. GLP-1 receptor agonists enjoy the “higher status” due to greater reductions in blood sugar and weight. While DPP-4 inhibitors can be taken in pill-form, GLP-1 receptor agonists have (so far) only been available as injections.Sitagliptin, sold by Merck under the brand names Januvia and Janumet (sitagliptin and metformin), had a combined sales of US $ 6 billion in 2014 and are the top selling drugs in the DPP-4 inhibitors drug class. In comparison, AstraZeneca’s GLP-1 receptor agonist – exenatide – generated total sales of about US $ 767 million in 2014, doubling their 2013 sales. The sales of GLP-1 receptor agonists continue to increase.AstraZeneca sells two version of their GLP-1 receptor agonist – Byetta (exenatide twice a day) and Bydureon (exenatide once a week). ITCA 650, the avant-garde delivery system, could disrupt diabetes management Intarcia’s drug under development – ITCA 650 (continuous subcutaneous delivery of exenatide) – works in a manner similar to AstraZeneca’s Bydureon. The only difference is that unlike an injection, it is released very slowly over time. The high-tech delivery system is a matchstick-sized device consisting of a cylindrical titanium alloy reservoir placed under the skin. Water from the extra-cellular fluid is used to drive an osmotic pump, which is designed to release the drug (exenatide) in small amounts over the course of the year.This means that patients don’t have to worry about forgetting to take their pills!The implant takes under five minutes to be placed in the body at a physician’s clinic. Intarcia has run four final-stage trials covering 5,000 patients. Intarcia plans to apply for the U.S. regulatory approval in the first half of 2016. The Boston-based company has a partnership with French drug-maker, Les Laboratoires Servier SAS, to develop and commercialize the product outside the U.S. and Japan. A new era for drug-device combosTransdermal patches, drug-eluting stents, inhalers, surgical meshes with antibiotic coatings are among the many approved drug-device combinations used in novel ways to deliver medicines. In fact, drug-device combinations have been around for years. As per estimates, the global market for drug-device combos is expected to grow from US $ 66 billion in 2012 to US $ 115 billion by 2019.In 2002, the FDA set up the Office of Combination Products (OCP) specifically to handle the convergence of drug and device technologies. However, since drugs and devices are managed by different regulatory pathways, uncertainty over how the FDA will review the application has made launching a drug-device combination challenging. In order to “eliminate the high level of uncertainty in approval standards”, the Combination Product Regulatory Fairness Act of 2015 was introduced before the U.S. legislators last month. While concerns still remain on how the FDA will approve applications, the government support is an encouraging sign. Our viewWhenever diagnosed with fever or the flu, we don’t think twice before popping a 500 mg pill comprising active pharmaceutical ingredients. In comparison, AstraZeneca’s Bydureon requires patients to inject 2 mg of exenatide once a week to manage type 2 diabetes. With patients requiring only 100mg of the active ingredient on an annual basis, Intarcia’s revolutionary match-stick sized implant offers significant benefits to patients suffering from type 2 diabetes. Factors like an emerging supportive regulatory landscape, increasing incidence of diabetes (29 million Americans aged 20 years and above had type 2 diabetes in 2012) and the effectiveness of the drug when compared with Januvia, prove that you will definitely hear a lot more about Intarcia in times to come.

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03 Sep 2015

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Diabetes: Which New Drug is the Safest? FDA Issues Safety Warning on oral Antidiabetic Blockbusters.

Recently launched type 2 diabetes molecules, canagliflozin, dapagliflozin, and empagliflozin, were served a deadly blow as the FDA recently issued a safety warning regarding their use, leading to a potential life-threatening condition. As almost all diabetes products have some side effect or the other, we are wondering, which next generation diabetes drug is the safest? The recent warning of the U.S. Food and Drug Administration (FDA) says that: “type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition, where the body produces high levels of blood acids called ketones, that may require hospitalization”. The FDA warning is a severe setback as it limits the options available to reduce blood sugar without the need for needles. Ketoacidosis, typically affects type 1 diabetes patients, but patients using these new molecules were type 2 diabetes and have developed ketoacidosis. All of the cases highlighted by the FDA involved people with type 2 diabetes, even if the condition manifested itself slightly differently than in patients with type 1 diabetes. These drugs, are also known as SLGT2 inhibitors. They have been on track for blockbuster sales and are sold under different brand names. Table// Brand names for SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin): Company Name Single Ingredient Fixed-dose Combination Johnson & Johnson Invokana® (canagliflozin) Invokamet® (canagliflozin and metformin) AstraZeneca Farxiga® (dapagliflozin) Xigduo XR® (dapagliflozin and metformin) Boehringer Jardiance® (empagliflozin) Glyxambi® (empagliflozin and linagliptin) Blockbuster sales: Johnson & Johnson, the first to get approval for their SGLT2 inhibitor (canagliflozin) in the United States, reported in 2015 first quarter sales of $278 million, almost triple of their sales for the same period last year. The quarter-on-quarter growth was almost 40%! AstraZeneca, on the other hand, had to contend with a dapagliflozin drug stock out in Canada “due to higher than anticipated demand”. Actually, the overall sales estimates, for this class of drugs, have been variable with some analysts believing the annual sales will be US$2 billion, while others, expect them to reach US$5 billion. Adverse side effects: Despite these success stories, SGLT2 inhibitors have had a bumpy ride in the approval process with potential cancer risk, leading to the rejection of the initial dapaglifloxin application by the FDA. This category of molecules have also been linked to increased rates of genital and urinary tract infections, along with kidney damage and cardiovascular issues. So who will benefit? All this bad news on SGLT2 drugs could be positive for another class of anti-diabetic molecules called DPP4 inhibitors. Merck & Co’s Januvia® (sitagliptin) and Janumet® (sitagliptin and metformin) dominate this category of products with almost $6 billion in 2014 sales. In addition this year, Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other DPP4 inhibitors like AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). While Merck’s Januvia has its own set of concerns (there have been reports of acute pancreatitis), the risks compare mildly when associated with other new anti-diabetes drugs. For Takeda’s other diabetes drug, Actos® (pioglitazone), lawsuits related to cancer risks drove the company to its first annual loss in six decades. They paid a settlement of $2.4 billion last month. While Actos® continues to remain on the market, safety concerns will impact the future sales of diabetes medicines, as they all battle one of the biggest epidemics challenging public health.

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21 May 2015

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Merck vs Merck: A ‘Mercky’ tale

It doesn’t help that the company, which calls itself Merck in the United States isn’t allowed to do so in other parts of the world, because the other Merck is called Merck. Confused? Well you wouldn’t be the only one! Merck is the world’s oldest pharmaceutical and chemical company, which has done business for almost 350 years. Since almost everybody in a chemistry lab has used a Merck product at some point of time, and now that Sigma Aldrich also belongs to Merck, we thought it would be worthwhile to create a simple comparison chart to better understand the two companies: Merck & Co., Inc. Merck KGaA Website www.merck.com www.merckgroup.com Logo Headquarter Kenilworth, New Jersey, United States Darmstadt, Germany Founded 1891, by George Merck, as an American subsidiary of German Merck 1668, by Friedrich Jacob Merck The Split Owing to World War I, Merck & Co. was expropriated by the U.S. government in 1917 Name in the US and Canada Merck EMD Millipore (Emanuel Merck Darmstadt) Name in the rest of the World MSD, Merck Sharp & Dohme or MSD Sharp & Dohme Merck Total Sales (2014) $42 Billion €11.5 Billion Employees 70,000 39,000 Merger & Acquisitions Sharp & Dohme, Inc. Schering-Plough Idenix Pharmaceuticals Cubist Pharmaceuticals OncoEthix Medco Containment Services Inc. Millipore Corporation Serono SA Sigma-Aldrich AZ Electronic Materials SA Major Products Januvia®, Janumet®, Zetia®, Vytorin®, Gardasil®, Remicade® Rebif®, Erbitux®, Gonal-f®, Concor®, Glucophage®, Euthyrox® Recent facts of Confusion: 2011 German Merck KGaA used to have Facebook page:http://www.facebook.com/merck, but one day found U.S. Merck & Co. there instead. As Merck KGaA had an agreement with Facebook, the matter reached the courts . Eventually Facebook admitted their mistake and let the German Merck resume its place at www.facebook.com/merck. U.S. Merck & Co. now sits at http://www.facebook.com/MerckBeWell. 2014 Protestors from the group STOPAIDS (a network working on how to secure an effective global response to HIV and AIDS) reached the offices of Merck KGaA in London, when protesting Merck’s “campaign to delay South Africa’s proposal to allow low-cost copies of patented drugs.” The only problem: the protestors were targeting U.S. based Merck & Co instead of German Merck… 2014 Bloomberg headline “Bayer to Buy Merck Consumer-Health Unit for $14.2 Billion” resulted in Merck KGaA issuing a same day clarification “Merck to Keep Consumer Health Business” since the Bloomberg article was referring to the U.S. Merck & Co! 2015 Even Merck KGaA CEO Karl-Ludwig Kley admits that his company bears some fault in allowing the situation to get to this point: “over many decades we underinvested in our brand,” he told the Financial Times: “we need to make people more aware of the fact there are two Mercks.” RadioCompass just thought it was worth helping Mr Kley out with this complilation!

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13 May 2015

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Who has the biggest one? Sales of the top pharma products by revenue.

We always knew math was fuzzy, but never imagined addition could get so complicated. A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best selling products along with the top therapy areas. The list, based on data published by IMS Health, caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical companies. As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics. Which pharmaceutical company is the largest? Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company. Should divisions like diagnostics, animal health, vaccines, consumer health be counted when determining the size of a pharmaceutical company? FiercePharma, in their analysis, used the total revenue of all divisions of the organizations to determine the largest organization; in their case it is Johnson & Johnson. IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest company. As currency exchange rate fluctuations have their own, big role, in determining the size of organizations, we believed it would be best to share the revenues, as presented, so that you can draw your own conclusions. Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports) Big Pharma IMS Rank IMS Sales (US $Mn) Fierce Pharma Rank Fierce Pharma Sales (US $Mn) Group Sales based on the Annual Report (Currency as reported, Mn) Novartis 1 51,307 2 57,996 USD 57,996 Pfizer 2 44,929 4 49,605 USD 49,605 Sanofi 3 40,037 5 43,070 Euro 33,770 Roche 4 37,607 3 49,866 CHF 49,866 Merck & Co 5 36,550 6 42,237 USD 42,237 Johnson & Johnson 6 36,422 1 74,331 USD 74,331 AstraZeneca 7 33,313 8 26,095 USD 26,095 Glaxo SmithKline 8 31,470 7 37,960 GBP 23,006 Teva 9 26,001 11 20,272 USD 20,272 Gilead Sciences 10 23,673 10 24,474 USD 24,890 Amgen 11 20,473 12 20,063 USD 20,063 Lilly 12 19,909 14 19,615 USD 19,615 AbbVie 13 19,049 13 19,960 USD 19,960 Bayer 14 18,347 9 25,470 Euro 42,239 Bristol-Myers Squibb Not in Top 20 15 15,879 USD 15,879 NB: Mn is million Click here to access and download all the 2014 data (Excel version available) for FREE! Since each group has multiple divisions, we further split the sales for you to brainstorm: Table 2/ Sales comparison of the different divisions of top pharmaceutical companies in 2014 (Annual Reports in Mn) Big Pharma Pharma Division Vaccine Division Generics Consumer Health Other Divisions Medical Devices/ Diagnostics Division Animal Health Division Divestures/ Other adjustments Novartis USD 31,791 Sandoz USD 9,562 Alcon USD 10,827 USD 5,816 Pfizer USD 45,708 USD 3,446 USD 451 Sanofi Euro 22,578 Euro 3,974 Euro 1,805 Euro 3,337 Euro 2,076 Roche CHF 38,969 CHF 10,897 Merck & Co USD 30,740 USD 5,302 USD 6,195 Johnson & Johnson USD 32,313 USD 14,496 USD 27,522 AstraZeneca USD 26,095 Glaxo SmithKline GBP 18,670 GBP 4,336 Teva USD 10,458 USD 9,814 Gilead Sciences USD 24,474 USD 416 Amgen USD 19,327 USD 736 Lilly USD 16,481 USD 788 USD 2,346 AbbVie USD 19,960 Bayer Euro 12,052 Euro 7,923 Euro 22,264 Bristol-Myers Squibb USD 15,879 Click here to access and download all the 2014 data (Excel version available) for FREE! Not sure that it adds any extra clarity on what should define a global pharmaceutical company… Since the various divisions make companies complicated to assess, what about product sales? The good news is that we have a winner! Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason. Unfortunately, things stopped making sense the moment we reached the number-two product on the IMS list. Lantus®, Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%. So unless the Euro/Dollar exchange rate moves back towards the 1.5 range, there seems to be a serious difference in the way the product sales are calculated by companies and by IMS. Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications! Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports) Products IMS Rank IMS Sales (US $Mn) Annual Reports Sales (US $Mn) Pharma Compass Rank Big Pharma Currency Annual Reports Sales in Mn Marketing Partner Marketing Partner Annual Report Sales (US $Mn) Humira® 1 11,844 12,543 1 Abbvie USD 12,543 Lantus® 2 10,331 7,676 5 Sanofi Euro 6,344 Sovaldi® 3 9,375 10,283 2 Gilead Sciences USD 10,283 Abilify® 4 9,285 7,556 6 Bristol Myers-Squibb USD 2,020 Otsuka 5,536 Enbrel® 5 8,707 8,538 4 Amgen USD 4,688 Pfizer 3,850 Seretide® 6 8,652 6,589 8 GSK GBP 4,229 Crestor® 7 8,473 5,512 11 AstraZeneca USD 5,512 Remicade® 8 8,097 9,880 3 Johnson & Johnson USD 6,868 Merck & Co. 2,372 Mitsubishi Tanabe 640 Nexium® 9 7,681 3,655 19 AstraZeneca USD 3,655 Mabthera® 10 6,552 6,936 7 Roche CHF 5,603 Roche 1,305 Avastin® 11 6,070 6,449 9 Roche CHF 6,417 Lyrica® 12 6,002 5,168 12 Pfizer USD 5,168 Herceptin® 13 5,564 6,306 10 Roche CHF 6,275 Spiriva® 14 5,483 3,917 17 Boehringer Euro 3,237 Januvia® 15 4,991 3,931 16 Merck & Co. USD 3,931 Copaxone® 16 4,788 4,237 14 Teva USD 4,237 Novorapid® 17 4,718 2,835 20 Novo Nordisk DKK 17,449 Neulasta® 18 4,627 4,596 13 Amgen USD 4,596 Symbicort® 19 4,535 3,801 18 AstraZeneca USD 3,801 Lucentis® 20 4,437 4,152 15 Novartis USD 2,441 Roche 1,711 Click here to access and download all the 2014 data (Excel version available) for FREE! It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view. Our take: With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing upon and others, which may not be worthwhile to pursue. While the assessment of pharmaceutical sales is far more complicated than what we had originally imaged, the focus of Big Pharma on small molecules is on Hepatitis C drugs (Sofosbuvir, Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments. Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports) Products Big Pharma Sales (US $Mn) 2013 Sales (US $Mn) 2014 Growth (%) Ibrutinib Pharmacyclics, Inc (now AbbVie) 14 492 3414% Dasatinib Bristol-Myers Squibb 1280 1493 17% Trametinib GSK 10 68 580% Nilotinib Novartis 1266 1529 21% Ruxolitinib Novartis 163 279 71% Ceritinib Novartis Not launched 31 Sunitinib Maleate Pfizer 1204 1174 -2% Crizotinib Pfizer 282 438 55% Axitinib Pfizer 319 410 29% Tofacitinib Citrate Pfizer 114 308 170% Click here to access and download all the 2014 data (Excel version available) for FREE! However, Big Pharma is now all about biologics. IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”. The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis). Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!

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