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New Drugs Approvals by FDA and EMA: 2020 Recap

The year 2020 was an eventful year for the pharmaceutical industry, with several companies across the world working at a feverish pace to find a treatment or a vaccine for the raging Covid-19, which has so far taken over 1.79 million lives worldwide. With countries imposing lockdowns and regulators putting on-site inspections on hold, we were expecting far lower new drug approvals in mid-2020. But our mid-2020 recap published in July, which looked at new drug approvals by the US Food and Drug Administration (FDA) and European Medical Agency (EMA), found that the FDA had approved 33 new drugs by the end of June. This put the approvals within the ballpark of the past two years. This week, we bring you a roundup of 2020, a tumultuous year when 58 drugs (53 approvals by the Center for Drug Evaluation and Research and 5 by the Center for Biologics Evaluation and Research) bagged FDA’s new drug approvals. While this number is lower than the number of drugs approved in 2018 (62), it is higher than the number for 2019 (54). Out of this, while 23 approvals were in the field of oncology, 9 were for infectious diseases and infections, 8 for genetic diseases, 7 for neurology, 3 for immunology and 2 for gastroenterology. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) A year marked by EUA With the pandemic raging across the world, emergency use authorizations (EUAs) dominated news headlines in 2020 — the FDA issued 10 EUAs, with the most prominent being those issued to Pfizer-BioNTech and Moderna for their Covid-19 vaccines. EMA was busy as well since they issued 75 positive opinions with Novartis leading the pack with 8, followed by Pfizer and Sanofi which received 4 each. The EUAs came with their own set of controversies. In March, the FDA had issued an EUA “for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of” Covid-19. However, by June, FDA had revoked the EUA, as the agency determined that chloroquine and hydroxychloroquine were not likely to be effective in treating Covid-19 for the authorized uses in the EUA. Amongst treatments for Covid-19, in May the FDA authorized the emergency use of Gilead’s antiviral drug remdesivir. In our mid-2020 recap, Gilead’s remdesivir was on top of our list of top-selling drugs after it received an EUA from the FDA. In October, remdesivir became the first drug to be approved by the FDA for treatment of Covid-19 patients requiring hospitalization. While analysts predicted US$ 3.5 billion in revenue in early October, the future of this drug as a treatment for Covid-19 in hospitalized patients remains uncertain, especially in wake of results from the World Health Organization (WHO)-led Solidarity Trial that said Gilead’s remdesivir had little or no effect on the 28-day mortality or length of hospital stays for Covid-19 patients. The FDA approved remdesivir for hospitalized patients a week after the WHO results. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Gilead US$ 21 billion Immunomedics acquisition Immunomedics' antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA in April this year for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for the disease. Such tumor types account for 15 to 20 percent of breast cancers. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026. In September, Gilead made a big move and acquired biotech company Immunomedics Inc for US$ 21 billion. The transaction, which was completed in October, will strengthen Gilead’s cancer portfolio and add another potential blockbuster to it. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the US over the next quarter. According to a statement, Immunomedics is also on track to file for regulatory approval of the drug in Europe in the first half of 2021. Moreover, ongoing studies are also evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other types of solid tumors. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Roche-PTC Therapeutics’ risdiplam bags approval Following Troveldy in sales potential for drugs approved by the FDA is Roche and PTC Therapeutics’ drug Evrysdi (risdiplam), the first oral medicine approved for the rare genetic disease, spinal muscular atrophy, which until four years ago had no available treatments. The approval of Evrysdi presents patients and their families with a unique choice between a one-time gene therapy, an RNA-based drug infused three times a year at the doctor’s office and a daily medicine taken at home. Roche priced the drug by patient weight, with a maximum cost of US$ 340,000 per year — substantially lesser than the competing (and approved) therapies from Biogen and Novartis. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Vertex’s Kaftrio bags EMA approval Earlier this year, PharmaCompass had published its compilation of sales forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic fibrosis treatment — Trikafta — which was expected to have sales of US$ 3.935 billion by 2024. Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor and its stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date. In June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Vertex’s combination, which will be marketed as Kaftrio. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) A year of multiple setbacks Not everything went smoothly in 2020. In fact, the year saw several setbacks — almost 44 drugs were not granted approval by the FDA. Bristol Myers Squibb was one such company that received setbacks. As part of Bristol’s US$ 74 billion acquisition of Celgene, the New York-headquartered drug company offered Celgene shareholders Contingent Value Rights or CVRs. But to realize the US$ 9-a piece payment, approvals for three ex-Celgene drugs must meet their pre-specified deadlines. While in March, the FDA approved Bristol’s ozanimod, a sphingosine-1-phosphate receptor agonist for the treatment of relapsing multiple sclerosis, well ahead of the December 31, 2020 deadline, in May, Bristol Myers Squibb and bluebird bio, Inc announced that they have received a Refusal to File letter from FDA regarding the Biologics License Application (BLA) for their CAR-T therapy — idecabtagene vicleucel (ide-cel) — for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further details to complete the review. This was followed by Bristol Myers announcing that the FDA has extended the action date by three months for the BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR-T therapy for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA had then set the new Prescription Drug User Fee Act (PDUFA) action date as November 16, 2020. However, on that day, FDA informed the company that its review of the BLA for liso-cel will not be completed by November 16. The FDA approval of liso-cel by December 31, 2020 is one of the required remaining milestones of the CVRs issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is FDA approval of ide-cel by March 31, 2021. FDA declines approval to Novartis’ inclisiran: Recently, there was news that the FDA declined to approve Swiss drugmaker Novartis AG’s lipid-lowering therapy, inclisiran (branded as Leqvio). The drug came to Novartis' fold through the US$ 9.7 billion acquisition of The Medicines Company last year. The drug has been cleared by the European Commission. In a statement, Novartis said the FDA has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter (CRL) is due to unresolved facility inspection-related conditions. No onsite inspection was conducted by the FDA, the company said. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available) Our view Like the drug companies, regulators across the world also worked at a frenetic pace in order to accelerate EUAs and drug approvals, especially for treatments and vaccines for Covid-19. Apart from Covid-19, the year saw wider adoption and approvals for cell and gene therapies along with approvals of several innovative medicines like relugolix (the first oral gonadotropin-releasing hormone receptor antagonist for the treatment of adult patients with advanced prostate cancer), berotralstat the first oral once daily plasma kallikrein inhibitor to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older, lumasiran (an HAO1-directed small interfering ribonucleic acid indicated for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult patients) and osilodrostat for the treatment of adults with Cushing’s disease). Moreover, there were several interesting ‘non-Covid’ medical breakthroughs that took place during 2020. One such breakthrough is a single pill that combines four medications meant to lower blood pressure and cholesterol and aspirin that was found to cut the risk of heart disease. While the agility shown by pharma companies and regulators was undoubtedly quite impressive, with many countries granting EUA to vaccines for Covid-19, the ongoing pandemic did put mankind in a bind for several months. And if the words of the WHO director general Tedros Adhanom Ghebreyesus are to be believed, the coronavirus crisis will not be the last pandemic and attempts to improve human health are “doomed” without tackling climate change and animal welfare. If that really proves to be the case, the pharma industry has a lot to learn from this pandemic, and science has a lot to demonstrate if mankind is to emerge unscathed from such adversities. View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available)

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31 Dec 2020

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New Drug Approvals by FDA & EMA (Mid-2020 Recap)

In case you thought Covid-19 had slowed down US Food and Drug Administration’s New Drug Approvals, you’re in for a pleasant surprise — the FDA appears to be more active than ever before. By the end of June, the FDA had already approved 33 new drugs which put the approval activities within the ballpark of the past two years — 62 novel drugs were approved in 2018, while 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 25 new molecular entities and new therapeutic biological products, of which almost half — 12 out of 25 — were oncology drugs, while the rest of the novel therapies were approved by the Center for Biologics Evaluation and Research. The European Medical Agency (EMA) was also busy as the regulator issued a positive opinion for 41 drugs, of which 27 were classified as novel treatments. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Conditional Approval for Gilead’s Remdesivir Gilead’s Remdesivir has certainly been one of the most talked about drugs this year. While it is still under clinical evaluation, the FDA, EMA and the Japanese Ministry of Health, Labour and Welfare (MHLW) found ways of providing market access to this drug as a treatment against Covid-19. On May 1, 2020, based on the totality of scientific evidence available to the FDA, the agency issued an Emergency Use Authorization (EUA), as it believed that remdesivir may be effective in treating Covid-19 and that the known and potential benefits of remdesivir, when used to treat Covid-19, outweigh the known and potential risks of such products. On June 25, 2020, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of conditional marketing authorization for Veklury (remdesivir). The demand for remdesivir is such that the US bought more than 500,000 doses, which is all of Gilead’s production for July and 90 percent of production for August and September, leaving almost no stock of remdesivir for the UK and Europe. In 127 poor or middle-income countries, Gilead is allowing generic drugmakers to supply remdesivir. It has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand the supply of the antiviral drug. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Vertex’s Kaftrio bags EMA approval Earlier this year, PharmaCompass published its compilation of the sales forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic fibrosis treatment — Trikafta — which is expected to have sales of US$ 3.935 billion by 2024. Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor and its stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date. In June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for Vertex’s combination which will be marketed as Kaftrio. EMA also adopted positive opinions on other drugs which were previously approved by the FDA in 2019, such as Novartis’ Zolgensma and Piqray, Pfizer’s Staquis and Daurismo among many others. Immunomedic’s antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026. FDA’s approval of Lundbeck’s Vyepti (eptinezumab) and Biohaven’s Nurtec ODT (rimegepant) for migraine headaches brought additional CGRP-targeted products to the market. It will be interesting to see how Nurtec ODT is accepted given it is a small molecule drug, which makes administration easier. It was recently promoted on social media by Khloe Kardashian. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Covid-19 impacts drug launches The pandemic has, however, started taking a toll on drug launches. One of the most anticipated drug approvals of the year, Bristol-Myers Squibb’s multiple sclerosis (MS) treatment — Zeposia (ozanimod) — was approved in both the US and Europe. However, the launch of the drug would be delayed due to the coronavirus outbreak. The drug was added to BMS’s portfolio through its US$ 74 billion acquisition of Celgene last year. Its approval was one of the three conditions set for a potentially higher payout for Celgene investors. Analysts have high hopes from ozanimod. Its average peak sales for 2024 have been predicted to be at US$ 1.62 billion by Cortellis, though the Covid-19 pandemic may weigh in there as well. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) First non-statin cholesterol drug bags FDA approval This year also witnessed the first non-statin treatment to be cleared for sale in the US in nearly 20 years. The drug, bempedoic acid, is made by Esperion Therapeutics Inc. This cholesterol-lowering drug is aimed at helping millions of people who can’t tolerate or don’t get enough help from widely used statin pills like Lipitor and Crestor. This new drug is to be used as an add-on treatment with statins. It lowers bad cholesterol or low-density lipoprotein (LDL) by inhibiting its synthesis in the liver. It targets patients with high cardiovascular risk. Esperion also won approval of bempedoic acid in combination with ezetimibe, another cholesterol-lowering drug. In January last year, Daiichi Sankyo Europe had entered into an exclusive licensing agreement with Esperion Therapeutics for Daiichi Sankyo Europe to market bempedoic acid and bempedoic acid/ezetimibe combination tablet in the European Economic Area and Switzerland. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Approvals not granted to almost 20 drugs There were setbacks too, and not everything rolled smoothly. This year, almost 20 drug approvals were not granted. Among the major setbacks were Bristol Myers Squibb and bluebird bio, Inc announcing that they have received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for their CAR-T therapy, idecabtagene vicleucel (ide-cel), for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Two years after Intarcia Therapeutics received a CRL for its matchstick-sized, long-term drug implant for type 2 diabetes, the FDA issued a second CRL to the company for its ITCA-650 implant. The implant is designed to be a small, osmotic pump which can be slipped under the skin and deliver a continuous, six-month dose of the GLP-1 agonist exenatide. The FDA also did not approve Intercept Pharmaceuticals’ obeticholic acid to treat NASH (or nonalcoholic steatohepatitis, a liver condition in which the buildup of fat progressively scars the organ), as it wasn’t convinced that its benefits outweighed the potential risks. After acquiring Allergan for US$ 63 billion, one of the first drugs which AbbVie was expecting approval for was Abicipar pegol, their experimental DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). However, FDA’s review indicated the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of wet AMD. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available) Our view While everyone’s attention is on the Covid-19 pandemic, the industry is certainly busy working towards getting new drugs to market. At the halfway mark, the FDA and EMA seem to be on track to set approval records this year, since the number of drugs approved by June are almost twice the number that were approved at the same time last year. However, it remains to be seen how companies adapt their sales and marketing strategies in a world where mobility is likely to get restricted and interpersonal contact is set to reduce dramatically. View New Drug Approvals by June 2020 with Estimated Sales (Free Excel Available)

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23 Jul 2020

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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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Novartis leads in new drug approvals; Vertex’s cystic fibrosis med holds highest sales potential

The US Food and Drug Administration’s (FDA) momentum of new drug approvals dropped marginally in 2019 — while 62 novel drugs were approved in 2018, 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 48 drugs while another six were approved by the Center for Biologics Evaluation and Research (CBER). Novartis dominated new drug approvals as CDER approved five of its new drugs across five different therapeutic areas. But then, it also made headlines when the FDA raised data accuracy issues over the Swiss drugmaker’s gene therapy — Zolgensma — which sent the company into a crisis management mode. View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available) The gene therapy drug came into the fold of Novartis in April 2018 through the US$ 8.7 billion acquisition of Illinois-based AveXis Inc. Zolgensma — the world’s most expensive drug — was approved as a one-time treatment for spinal muscular atrophy (SMA) in May 2019. However, in March 2019, Novartis learnt of manipulation in the raw data derived from a mice assay used at the time to test Zolgensma samples, but only alerted the FDA in June — about a month after the drug gained US approval. Post that, Novartis came under fire from US lawmakers who said the company should have informed the regulators about the data irregularities before the drug’s approval in May, instead of waiting to conclude an internal investigation. Novartis’ other approvals were brolucizumab (for treatment of macular degeneration), siponimod (to treat multiple sclerosis), alpelisib (breast cancer), crizanlizumab (sickle cell disease) and triclabendazole (fascioliasis, a tropical disease). View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available) Vertex’s Trikafta leads in estimated sales potential At PharmaCompass, we compiled the sales forecasts for the new drugs approved by the FDA in 2019. Vertex’s cystic fibrosis treatment — Trikafta — with expected sales of US$ 3.935 billion by 2024, leads our list. Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor. Vertex already has three cystic fibrosis drugs on the market — Kalydeco (a standalone ivacaftor treatment), Symdeko (a combination of ivacaftor and tezacaftor) and Orkambi (which contains ivacaftor and lumacaftor). Trikafta’s stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date. Abbvie’s Humira, the top-selling drug in the world, is beginning to face generic competition in certain parts of the world and two new drug approvals in 2019 — Skyrizi (risankizumab for plaque psoriasis) and Rinvoq (upadacitinib for rheumatoid arthritis) — are critical to AbbVie's plans to grow beyond Humira. The two drugs are expected to contribute over US$ 5.5 billion by 2024 to AbbVie’s top-line. In April, AstraZeneca struck a deal worth US$ 6.9 billion with Japanese drug major Daiichi Sankyo, to jointly develop and commercialize the antibody drug conjugate cancer therapy —trastuzumab deruxtecan. The breast cancer treatment won FDA approval in December and analysts forecast sales of US$ 2.5 billion by 2024 with some believing that the drug could achieve US$ 7 billion in peak sales. View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available) The rise of new drugs from Asia While Daiichi won the FDA nod for its cancer treatment — Turalio (pexidartinib) — new drugs from established Japanese drug makers like Shionogi, Kyowa Kirin and Eisai also bagged the American agency’s approval. Shionogi’s novel antibiotic — Fetroja (cefiderocol) — got approved for complicated urinary tract infections while Kyowa won the nod for its Parkinson’s treatment — Nourianz (istradefylline). Eisai’s insomnia drug — Dayvigo (lemborexant) — was one of the last drugs approved in the year and is expected to generate sales of US$ 329 million. View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available) In 2019, the FDA also approved new drugs from China and Korea. Zanubrutinib (branded as Brukinsa) developed by Chinese biotech BeiGene won accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive and rare form of blood cancer. This was followed, almost immediately, by news that the agency approved a new treatment for partial-onset seizures in adults. The drug — cenobamate — will be sold as Xcopri by SK Life Science, the US subsidiary of the massive Korean conglomerate SK Group. Xcopri will provide another therapeutic option to patients with epilepsy. This approval marked the first time a Korean company independently took a compound from the stage of discovery to FDA approval. Xcopri is SK Life Science’s first commercial product and wraps a decade of quiet growth from SK Life Science, which has been developing its presence in the pharmaceutical industry. The company plans to hire a salesforce to support the drug’s launch, which is expected to generate over US$ 1.5 billion in sales. View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available) Sanofi’s controversial dengue vaccine, cast-off drug get approved The FDA very narrowly approved Sanofi’s controversial dengue vaccine — Dengvaxia. The vaccine, which took 20 years to develop, got embroiled in a controversy when in 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus. In Philippines, 800,000 school-age children had been vaccinated against dengue, the world’s fastest growing infectious disease. The year 2019 had begun with Bristol-Myers Squibb (BMS) and Celgene announcing their US$ 74 billion mega-merger. As the firms worked through the year to get the merger approved, the FDA signed off on Celgene’s myelofibrosis drug Inrebic (fedratinib). Inrebic — the once-daily oral drug — is the first new treatment in nearly a decade approved to treat myelofibrosis. The story of Inrebic’s rise from the dead is a major success for Celgene, which picked up the drug as a part of a US$ 1.1 billion acquisition of Impact Biomedicines in January 2018. Before that, Inrebic had passed through multiple hands. Fedratinib was a flop for Sanofi as patients began to develop a dangerous neurological condition tied to vitamin B deficiency called Wernicke’s encephalopathy. As a result, the FDA put a clinical hold on it in 2013 and Sanofi ultimately shelved the effort. Executives at BMS have said the drug is among a group of potential blockbusters at Celgene. View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available) Our view With over 40 companies from across the world getting new drugs approved in 2019 across 17 therapeutic areas, the horizon for new drug development across the globe continues to widen. Although 2018 was a landmark year for approvals, given all the development activity underway, the day is not far when this record too will get beaten. And 2020 could well witness that day! View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)

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31 Dec 2019

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Sales Forecast of FDA’s Novel Drugs Approvals in 2018

The year 2018 was a landmark year for the US Food and Drug Administration (FDA) as the agency approved a record number of novel drugs. FDA approved 62 novel drugs in 2018, out of which 34 were orphan drugs. FDA’s Center for Drug Evaluation & Research (CDER) approved 59 drugs while the other three were approved by the Center for Biologics Evaluation and Research (CBER). In a speech towards the end of the year, FDA Commissioner Scott Gottlieb said: “Far more important than the overall quantity of approvals however is the quality of the new drugs”. He went on to add that some “of [the] previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines,” or novel chemical entities that addressed the same common, therapeutic targets. In 2018, FDA reversed three earlier drug rejections, approved the first cannabis-based drug, allowed the first ever RNA interference drug to market and gave the green light to Loxo Oncology/Bayer’s Vitrakvi (larotrectinib) which became the second anti-cancer drug (after Merck’s Keytruda) to bag an approval that treats cancer based on a biomarker across different types of tumors rather than the location in the body where the tumor originated. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Gilead’s Biktarvy tops our list for sales potential PharmaCompass compiled the peak sales estimates of the new drugs approved in 2018 and in our compilation, Gilead’s antiretroviral treatment for HIV — Biktarvy — topped the charts with an estimated sales potential of almost US$ 5.3 billion followed by Vertex’s cystic fibrosis drug Symdeko that is expected to bring in US$ 2.75 billion. Alexion’s Ultomiris, Abbvie’s Orilissa, Novartis’ Lutathera and J&J’s Erleada are all expected to bring in more than US$ 2 billion for their companies at their peaks. Although Loxo’s cancer drug, with an estimated US$ 860 million in peak sales, did not make it to the list of top 15 drugs in 2018 by sales potential, the company got purchased by Eli Lilly earlier this month for US$ 8 billion. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Pfizer won four approvals, Shire won three For 2018, Pfizer led the approvals with four drugs that got the green light, followed by Shire with three drugs. Companies like AstraZeneca, Array Biopharma, Alynlam and Paratek Pharmaceuticals each won two drug approvals. Merck also had two approvals which were in cooperation with other companies. Amgen, Teva and Eli Lilly got their CGRP inhibitors for migraine prevention approved within a few months of each other. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 First cannabis-based drug bagged approval Last year, FDA also approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome. CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. And Epidiolex is the first marijuana-based drug to be approved in the US for epilepsy. It is produced by GW Pharmaceuticals. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 CBD does not cause intoxication. It is one of the hundreds of molecules found in marijuana and has been cited by scientists as a potential treatment for mental health issues. 2018 saw the launch of one-dose flu cure from Shionogi In March 2018, Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose — was approved in Japan. The drug is a treatment for influenza A and influenza B. In October, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil). Xofluza is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 The single dose feature gives Xofluza an edge over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two doses each day for five days. Therefore, there are nine more doses of Tamiflu required, as compared to the single-dose Xofluza. Shionogi aims to double the global market for flu treatment with Xofluza. “While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said last year. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Though the FDA approval for Xofluza has been granted to Shionogi, Genentech (a member of the Roche Group which marketed Tamiflu, which is now a generic) will be marketing the medication in the US. Industry gets far lower returns from its drug launches Gottlieb used Twitter to promote the progress of FDA’s review cycle. “In 2018, CDER met its PDUFA goal for 100 percent of the novel drugs approved – 95 percent of which on the first cycle – reflecting our efficiency in getting new therapies to patients quickly,” he tweeted. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 A ‘cycle’ is the time from when CDER accepts an application for a new drug until the agency decides whether to approve it or not. However, the record number of approvals doesn’t present the complete picture for the pharmaceutical industry. A study published in December by Deloitte highlighted that the industry is getting far lower average returns from its drug launches than ever before. While the costs to bring a drug to market have almost doubled in eight years to over US$ 2 billion, peak sales forecasts have halved to a little over US$ 400 million, the study said. Drug discovery reviews in the scientific publication Nature reached a similar conclusion. “Projected peak annual sales for new therapeutic drugs (NTDs) approved in 2018 total US$ 45 billion — lower than 2017’s US$ 58 billion — and the value of the average peak sales per product has continued to trend down to only US$ 720 million per drug in 2018, the lowest figure in almost a decade,” the publication said. “The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine,” it added. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Our view After suffering brutal losses towards the end of 2018, wherein biotech was among the US stock market’s most oversold sectors and saw a decline of nearly 10 percent, this year the biotech sector has got off to the best start since 2012. Drug companies are continuing to innovate more targeted therapies, and Chinese companies are investing in developing new drugs. While the industry expects to see a lot more mergers and acquisitions in 2019, where smaller biotech companies get acquired by major pharmaceutical corporations, it is unlikely that the general trend of companies bagging more approvals for targeted therapies with a smaller peak sales potential is going to reverse anytime soon. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018

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17 Jan 2019

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FDA’s Drug Approvals in 2015: Novel Drugs & New Versions of Existing Drugs

Each year, the US Food and Drug Administration (FDA) approve hundreds of new medications. A small subset of approvals, classified as novel drugs, are considered to be truly innovative products that often help advance clinical care. In 2015, the FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam). This week, PharmaCompass focuses on the new dosage forms of existing drugs that got approved last year. Modified blockbusters Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015: Jadenu (deferasirox): With almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a tablet for use in a suspension. Novartis, the innovator, got approval in March 2015 for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has simplified daily treatment administration for patients with chronic iron overload. Nexium 24HR (esomeprazole magnesium): Also known as the Purple Pill, Nexium – Astra Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as Nexium 24HR. Last year, the FDA granted approval to the tablet form of the drug. Iressa (gefitinib): AstraZeneca re-introduced Iressa in the US market in 2015. The FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets from the market, as post-marketing studies had failed to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted. Onivyde (irinotecan): Liposomal formulation of anti-cancer drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the treatment of patients with metastatic pancreatic cancer, sold under the brand name Onivyde. Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines because of its high price (more than US $ 300,000 a year). Price concerns aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’. Extended release versions Many of the approvals granted by the FDA last year were to extended release formulations (a pill formulated so that the drug is released slowly) of existing drugs. Kremers Urban’s extended release version of Methylphenidate capsules made headlines last year because of a reclassification of the drug by the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc. In addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus and Morphine Sulphate also received green signals for a market launch. First generic opportunities Last year, PharmaCompass shared the names of some drugs which had no generic competition and were also not protected by patents. (Read: “Litigation Free, first generic opportunities list”). Deferiprone (a drug that chelates iron and is used to treat iron overload in thalassemia major) met the criteria. But it still has no generic competitor and is now available as a new dosage form. Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades without generic competition in the US. Albendazole is a medication used for the treatment of a variety of parasitic worm infestations. In 2015, patients were provided access to chewable tablets of Albendazole. New combinations at work The FDA also approved multiple combination drugs where the individual active ingredients had been brought to market previously. Most of the combination drugs approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc. Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and Tradjenta (linagliptin) approved in 2011, were combined and the combination drug product Glyxambi was approved in 2015. Another combination of empagliflozin, with metformin – Synjardy – was also approved in August last year. Lesser known companies also got combination drugs approved. UK-based development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine polistirex. Similarly, US-based biopharmaceutical startup, Spriaso LLC, also working in the cold and cough therapeutic area, got an extended release tablet containing codeine phosphate and chlorpheniramine maleate approved. Symplmed, a company which is developing various forms of Perindopril, got approval for Prestalia (a combination of perindopril arginine and amlodipine besylate) for the treatment of hypertension. Our view Each year, the FDA approves several pharmaceutical drugs in order to improve patient care; and often versions of these drugs are marketed and distributed across the globe. PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy. Accelerate your drug development PharmaCompass has also launched the Drug Development Assistance tool on its platform. Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate the various drug products approved in the United States.

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