Aspirin
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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#PharmaFlow by PHARMACOMPASS
29 Apr 2020
FDA announces generic drug user fees for FY18; Gilead acquires Kite for US$ 12 billion
This week, Phispers brings you the FY18 user fee schedule under GDUFA II, posted by the USFDA, with significantly higher fee for several applications.  There is news on an old drug getting approved for treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, and a new study revealed benefits of blood thinners — Xarelto and Brilinta. Meanwhile, Gilead acquired Kite Pharma to access a new kind of cancer therapy. Read on. USFDA announces generic user fees for FY18; ANDAs, APIs, devices to pay higher fee   This week, the US Food and Drug Administration (FDA) posted the FY18 user fee schedule for the Generic Drug User Fee Amendments. Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) applications to market generic drugs, known as abbreviated new drug applications (ANDAs), will see fee increases of more than US$ 100,000 —  from US$ 70,480 in 2017 to US$ 171,823 in 2018. The fees were set based on negotiations between the pharmaceutical industry and the USFDA as part of a new five-year reauthorization of the FDA user fee programs signed into law earlier this month. In the fee schedule, a US$ 15,000 foreign differential applies to all non-US facilities, for both finished dosage form (FDF) and active pharmaceutical ingredients (API). This is the first year when pure CMO (contract manufacturing organization) facilities will pay a ‘reduced’ facility fee — one-third of the fee for a non-CMO. This year an ANDA holder fee, also known as program fee, was introduced. This fee has three tiers: entities that hold 20+ approved ANDAs, entities that hold six-19 approved ANDAs, and entities that hold one to five approved ANDAs. ANDAs pending approval are not added to this count, just as facilities that are only referenced in pending ANDAs are not subject to a facility fee. GDUFA II fee for FY 2018 in US dollar One-time application fee   ANDA 171,823 DMF 47,829 Recurring fee for facilities   Domestic API facility 45,367 Foreign API facility 60,367 Domestic FDF facility 211,087 Foreign FDF facility 226,087 Domestic CMO facility 70,362 Foreign CMO facility 85,362 Recurring GDUFA program fee   (20+ANDAs) Large size operation generic drug applicant program 1,590,792 (6-19 ANDAs) Medium size operation drug applicant program 636,317 (1-5 ANDAs) Small business generic drug applicant program 159,079 The fee is applicable from October 1, 2017, until September 30, 2018. Decades old drug — amantadine — wins FDA approval to treat dyskinesia in Parkinson’s   Adamas Pharmaceutical got the nod from the USFDA last week to sell its therapy ADS-5102 — an extended-release version of the generic amantadine. The agency approved it for treatment of a side effect (dyskinesia) caused by a commonly prescribed Parkinson’s drug — levodopa. Amantadine was able to beat a placebo in significantly reducing the side effects of levodopa. This generic drug is already used off label for dyskinesia. This is the first drug cleared by the FDA to control levodopa-induced dyskinesia (LID). According to Adamas, around 200,000 people in the US suffer from LID. LID leads to involuntary movements, mostly non-rhythmic, purposeless and unpredictable, making life all the more difficult for a patient of Parkinson’s disease. The disease is progressive and debilitating, causing tremors, rigidity, extreme slowness of movement, impaired balance, and difficulties in swallowing and speaking.   After GSK, Novartis picks its chief digital officer from retail; Pfizer’s swanky new HQ Last month, GlaxoSmithKline appointed former Walmart chief information officer — Karenann Terrell — as its chief digital and technology officer. And last week, Swiss drug major Novartis followed suit — it appointed Bertrand Bodson, who is currently the chief digital and marketing officer for Sainsbury’s Argos retail chain, as its new chief digital officer. Bodson will assume office on January 1, 2018. These two appointments point to the growing challenges drug companies face from the digital world. For instance, mobile applications offer patients new ways to monitor their health. And clinicians increasingly communicate with their patients using the digital media. Bodson’s appointment is also an indication that Novartis intends to use technology for nearly everything — from drug discovery to interactions between clinicians and patients around the world. Bodson’s job also entails automating business processes. Bodson holds a degree from the Harvard Business School. He has also co-founded the social network site — bragster.com. Pfizer’s new HQ in New York: Pharma giant Pfizer has chosen the skyscraper — The Spiral — for its new headquarters in New York. The Spiral is a 1,005-foot-tall office tower in the Hudson Yards district of Manhattan’s Midtown West. According to New York Post, Pfizer has taken up nearly 800,000 square feet of space in this building. The 65-story, 2.85-million square-foot building is designed by Danish architect Bjarke Ingels. FDA approves first CAR-T therapy for cancer; Gilead bets big on it by acquiring Kite   California-headquartered biopharma company Gilead Sciences is acquiring Kite Pharma for US$ 11.9 billion. The acquisition points to Gilead’s increased focus on a new kind of cancer therapy, known as chimeric antegen receptor (CAR) T-cell therapy (or CAR-T) According to Gilead, Kite is an industry leader in cell therapy — a treatment that uses the patient’s own immune cells to fight cancer. Kite’s most advanced CAR-T therapy candidate, axicabtagene ciloleucel (axi-cel), is currently under priority review by the USFDA. The FDA has set a target action date of November 29, 2017 under the Prescription Drug User Fee Act (PDUFA). For Gilead, Kite could bring in the much-needed growth. Gilead has been witnessing falling sales of its hepatitis C treatments. It generates most of its sales from anti-infective therapies. Therefore, the acquisition will diversify Gilead’s portfolio. It will also boost Gilead’s emerging oncology drug franchise. For the biotech sector, this acquisition is a big endorsement of the immuno-oncology segment. CAR-T inhibitors allow doctors to create a “personalized” drug tailored to each cancer patient by harvesting their T-cells and modifying them in a laboratory to make them more efficient at combating and killing cancer cells. Though critics say Gilead has overpaid for Kite, Gilead’s CEO, John Milligan, justified the purchase. “It is certainly our hope that as we are able to drive down manufacturing costs, and as or if these indications broaden to larger patient populations, that we would be able to drive down the prices over time through manufacturing efficiency,” he said. “CAR-T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers,” Arie Belldegrun, president and CEO of Kite, said. Just days after Gilead’s announcement of its acquisition, the FDA approved Novartis’ Kymriah (tisagenlecleucel), the first CAR-T gene therapy, for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). The list price of Kymriah is US$ 475,000 for a one-time treatment. Bayer-J&J, AZ post promising data on their blood thinners; AZ to expand UK operations   At the annual meeting of the European Society of Cardiology held in Barcelona this week, studies brought to fore several benefits of blood thinners like Johnson & Johnson and Bayer’s Xarelto, and AstraZeneca’s Brilinta. A study published in the New England Journal of Medicine revealed that the combination of a low dose of Xarelto and aspirin cut the risk of heart attacks by 14 percent, strokes by 42 percent, and death by 18 percent. Forty-one out of every 1,000 people who took the Xarelto-and-aspirin combo would be expected to have a heart attack, stroke, or heart-related death compared to 54 among those who got aspirin alone. Next generation anticoagulants, such as Eliquis, had been giving Xarelto a run for its money. Similarly, a sub-analysis from the Pegasus clinical trial, which first reported positive results in 2015, showed that AstraZeneca’s blood-thinner Brilinta cuts the risk of cardiovascular death by 29 percent in patients with a history of heart attacks who keep taking it beyond the standard 12-month initial period. The sub-analysis also showed a risk reduction of 20 percent in all causes of death. The finding comes as a shot in the arm for AstraZeneca, which had suffered several clinical failures last year. AstraZeneca to invest in UK facility: Meanwhile, AstraZeneca is making huge investments into its Macclesfield campus in England in order to ramp up production. This is Astra’s biggest manufacturing site. The investment — expected to run into tens of millions of pounds – is set to be announced soon. This investment is likely to take investors by surprise. A month back, Astra’s CEO Pascal Soriot had said he is putting all capital investment decisions on hold due to the uncertainty around Brexit. The decision comes amid calls for the UK government to do more to support the sector ahead of Brexit. Recently, drugmakers, including AstraZeneca, published a paper calling on the public sector to invest up to US$ 181 million (£140 million) in three new drug manufacturing “centers of excellence” to stimulate the industry and help reverse a long-term decline in UK’s drug exports.    

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#PharmaFlow by PHARMACOMPASS
31 Aug 2017
Chemical entities SHINE in the top 10 fastest-growing drugs of 2016
Global pharmaceutical companies are increasingly focusing on the development of new biologics. In fact, in 2016, nine out of the top 15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder what the future holds for manufacturers specializing in drugs that originate from chemical synthesis. This week, PharmaCompass continued its analysis of the top pharma drugs by sales to evaluate the drugs that registered large sales growth in 2016. Click here to Access All the 2016 Data (Excel version available) for FREE! Please note that these are not the top-selling drugs, but are the top 10 drugs that registered the maximum growth in global sales over 2015. Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.  Here’s a list of drugs that witnessed the largest sales growth in 2016: 1. Opdivo (nivolumab) – Bristol-Myers Squibb   2016 sales: US$ 3,774 million 2015 sales: US$ 942 million Sales growth: US$ 2,832 million First approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer. With a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth of any single drug in 2016. However, Bristol-Myers Squibb received a nasty surprise last year when Opdivo did not demonstrate the desired slowdown in the progress of advanced lung cancer in a trial, as compared to conventional chemotherapy. While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million. Click here to Access All the 2016 Data (Excel version available) for FREE! 2. Humira (adalimumab) – AbbVie   2016 sales: US$ 16,078 million 2015 sales: US$ 14,012 million Sales growth: US$ 2,066 million Abbvie’s Humira (adalimumab) juggernaut continued as it not only remained the best-selling drug in the world, but also added another US$ 2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016. Last year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. 3. Epclusa (sofosbuvir and velpatasvir) – Gilead   2016 sales: US$ 1,752 million (new launch) Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion. Click here to Access All the 2016 Data (Excel version available) for FREE! 4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie   2016 sales: US$ 3,083 million 2015 sales: US$ 1,443 million Sales growth: US$ 1,640 million Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally. 5. Eliquis (apixaban) - Bristol-Myers Squibb / Pfizer   2016 sales: US$ 3,342 million 2015 sales: US$ 1,860 million Sales growth: US$ 1,483 million Although apixaban was the third-to-market novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its class based on total prescriptions. Rivaroxaban's total 2016 sales were US$ 5.392 billion. While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban. 6. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) — Gilead   2016 sales: US$ 1,484 million 2015 sales: US$ 45 million Sales growth: US$ 1,439 million Genvoya has been the most successful HIV treatment launch since the introduction of Atripla (the first single-tablet regimen launched a decade ago). Gilead is the dominant HIV player in the US market and has the top three most-prescribed HIV regimens in the US.  Genvoya adds Tenofovir Alafenamide (TAF) to already known treatments. TAF based drugs have demonstrated a better safety profile. They would also allow Gilead to maintain its dominance in the HIV market. Click here to Access All the 2016 Data (Excel version available) for FREE! 7. Ibrance (palbociclib) — Pfizer   2016 sales: US$ 2,135 million 2015 sales: US$ 723 million Sales growth: US$ 1,412 million Discovered in Pfizer laboratories and approved by the US FDA in February 2015, Ibrance is used in combination with Letrozole as a first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. 8. Triumeq (abacavir, dolutegravir, lamivudine) – GlaxoSmithKline   2016 sales:US$ 2,151 million 2015 sales: US$ 905 million Sales growth: US$ 1,246 million GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine. 9. Revlimid (lenalidomide) – Celgene   2016 sales: US$ 6,974 million 2015 sales: US$ 5,801 million Sales growth: US$ 1,173 million Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion. 10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer   2016 sales: US$ 5,392 million 2015 sales: US$ 4,255 million Sales growth: US$ 1,137 million Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the class lead in indications. Xarelto recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the blood thinner in preventing major adverse cardiac events (MACE). The trial was stopped a year early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE (which includes cardiovascular death, myocardial infarction and stroke) reached its pre-specified criteria for superiority over aspirin.  Click here to Access All the 2016 Data (Excel version available) for FREE! Our view   In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that over the coming five years the industry should continue to receive 40 to 45 new drug approvals every year. A quarter of all the drugs in late-stage development are now focused on oncology. The rate of oncology drug development has hit such a rapid pace that new drugs are superseding old ones in a matter of a few years. It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore. Sign up, stay ahead    In order to stay informed, and receive industry updates along with our data compilations, 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 2016 Data (Excel version available) for FREE!  

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#PharmaFlow by PHARMACOMPASS
17 May 2017
Teva CEO steps down; FDA Warning Letters to firms in Japan, India & China
This week, Phispers highlights more bad news for Israeli drugmaker Teva, along with news on the ‘overwhelming efficacy’ of blood thinner Rivaroxaban over Aspirin, Sanofi’s plans to resubmit its application for Sarilumab, Denmark’s entry into the tug of war for hosting the EMA headquarters and are routine round up of global non-compliance concerns.   Teva CEO steps down, as another bribery probe emerges and discussions of a split start   The chief executive of Teva Pharmaceutical Industries, Erez Vigodman, stepped down after serving for three years. He has been replaced by Chairman Yitzhak Peterburg for the interim period. Teva is the world's biggest maker of generic drugs. In the last five years, he is the third CEO to vacate the position. A sudden change in the company’s leadership came just two months after the resignation of Sigurdur Olafsson, the former head of Teva’s main business unit — generic medicines. Both the executives played an important role in Teva’s US $ 40.5 billion purchase of Actavis Generics last year, touting it as a move that would provide growth. Instead, the acquisition led to more bad news. In a short statement after leaving, Vigodman stated: “I believe that now is the right time for me to step down. It has been a privilege to lead Teva, and I am proud of all we have accomplished. I am confident that the company’s future is bright.” A lot of bad news has already piled up for Teva’s investors since the New Year. This includes the following negative events: The market is criticizing Teva’s acquisition of Actavis (Allergan’s generics division) for US $ 40 billion in cash and shares.   Teva’s acquisition of Mexican company Rimsa proved to be a catastrophe. Rimsa's plants are now shut down.   Apart from the bad decisions over acquisitions, Teva is also involved in two legal wrangles. One was a case of bribery in developing countries, in which Teva agreed to pay US $ 519 million to US authorities after paying bribes to officials in Mexico, Ukraine and Russia to boost sales. Another legal issue involves the investigation of Teva over bribe allegations by Israeli authorities which came up a day after Vigodman stepped down.   A US district court ruling invalidated four patents out of five on its top seller — the multiple sclerosis drug Copaxone. The ruling, issued in late January, may open the door to generic competition (Novartis and Mylan) for thr drug that generates a fifth of Teva’s US $ 20 billion in annual sales.   In the company’s own words: “New products stemming from that asset (Copaxone) would be unexpectedly delayed, while prices of its copycat medicines are likely to remain under pressure in the US, prompting a cut to its 2017 profit forecast.” Following the resignation, at the company's earnings call earlier this week, analysts started asking if Teva would consider a split-up? FDA issues Warning Letters to Indian, Japanese & Chinese firms   Sato Pharmaceutical, a company established in 1939 in Japan, received a warning letter from the FDA as it failed to establish an adequate system for monitoring the conditions of its cleanroom environments. Following the inspection, the firm revised its standard operating procedure related to the “Aseptic Production Area”, however, the FDA found the response to be deficient. FDA inspectors also uncovered that the company had not performed the necessary smoke studies to evaluate air flow characteristics of its open Restricted Access Barrier System (RABS). The company released sterile products manufactured on the aseptic processing line, without studies to demonstrate unidirectional airflow over the exposed sterile product during processing. Although, Sato renovated its RABS to use a closed design and conducted validation studies, the response was found deficient as it does not address the quality of the products which had already been released to the U.S. market using the original open RABS design. An active pharmaceutical ingredient (API) manufacturer in India, Resonance Laboratories Private Limited also received a warning letter from the FDA as the inspectors raised concerns over the facilities water systems and cleaning validation methods. The FDA found that the firm’s response to the inspection observations had failed to perform a retrospective review of CGMP deficiencies on the quality of the products which had already been distributed within the United States. PharmaCompass had shared the news about the compliance troubles at Resonance in November, 2016. The FDA also issued warning letters this week to two Chinese firms who had been placed on its Import Alert list last year. The warning letters sent to Ausmetics Daily Chemicals (Guangzhou) Co., Ltd. and Zhejiang Bangli Medical Products Co., Ltd. showed that the companies failed to sufficiently test the batches of the final product they produced and did not adequately confirm the quality of the incoming active raw materials. Bayer’s Rivaroxaban shows 'overwhelming efficacy' over aspirin   Back in 1897, a young scientist at a Bayer laboratory in Wuppertal, Germany — Dr. Felix Hoffmann — synthesized a chemically pure and stable form of acetylsalicylic acid (ASA), which became the active ingredient in Aspirin™.  Since then, Aspirin has been an important medicine due to its remarkable pain relief, as well as cardiovascular (CV) event prevention properties. The medicine has truly stood the test of time. Last week, Bayer AG and its development partner Janssen Research & Development announced the successful outcome of a large-scale Phase 3 study -- COMPASS, involving 27,402 patients, that assessed the effect of blood thinner Xarelto (rivaroxaban) in preventing major adverse cardiac events (MACE). The trial was scheduled to finish next year but was stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE — which includes cardiovascular death, myocardial infarction and stroke —reached its pre-specified criteria for superiority over aspirin.  The drug could potentially be used on 30 million patients with coronary artery disease (CAD) and peripheral artery disease (PAD), in addition to the roughly 25 million patients it sees in the atrial fibrillation market, says Bayer. Xarelto is currently the only non-vitamin K antagonist oral anticoagulant (NOAC) currently under assessment in this high-risk patient population. The drug is already on the market for reducing the risk of stroke and blood clots. Sanofi fixes problems in French plant, to resubmit application for Sarilumab   In 2014 and 2015, while reviewing new drug applications, the US Food and Drug Administration (FDA) had raised manufacturing questions in only one Complete Response Letter (CRL) sent to the applicant. However, by mid-December, 2016 “an astonishing 40 percent were specifically tied to questions the agency raised about the manufacturing capabilities of a drugmaker or its contractor.” Manufacturing issues derailed sales forecasts through new drug approvals of Sanofi, AstraZeneca, Valeant, Bristol-Myers Squibb, Pfizer and many others. In October 2016, Sanofi received the FDA’s Form 483 for it’s Le Trait facility in France since manufacturing deficiencies were discovered during a routine good manufacturing practice (cGMP) inspection where Sarilumab and Dupilumab are manufactured. This plant is involved in one of the last steps in the manufacturing process of Sarilumab — an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderate to severely active rheumatoid arthritis (RA) which is a combined program of Sanofi and Regeneron. Due to the manufacturing issues, FDA issued a CRL  regarding the Biologics License Applications (BLA) for Sarilumab. Sarilumab is said to become a blockbuster after beating the world’s best-selling drug AbbVie's Humira (adalimumab) in a head-to-head trial. Analysts have previously predicted the drug could bring in more than US $ 1 billion by 2020. In response to the letter received from the FDA, the French company has filed a comprehensive corrective action plan with the FDA and is “working towards a timely resolution that addresses these concerns.” Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market. In January 2017, Sanofi and its drug development partner Regeneron Pharmaceuticals said they have resolved manufacturing defects at Le Trait facility, which caused the delay for the approval of Sarilumab drug. Sanofi’s CEO Olivier Brandicourt said: “We worked closely with the US FDA to implement a corrective plan and got positive feedback". Assuming the formal inspection will also play out positively, the companies have decided to resubmit their application for Sarilumab by the end of March. Denmark officially bids for relocation of EMA head office   The future location of the European Medicines Agency (EMA) — one of the regulatory jewels of the EU — has been a consistent topic of conversation since the outcome of the Brexit vote.  The intervention of the Japanese government in early September 2016 brought the EMA issue further into the open when a 15-page letter came up where Japanese officials told their counterparts in the UK that if “the EMA were to transfer to other EU Member States, the appeal of London as an environment for the development of pharmaceuticals would be lost, which could possibly lead to a shift in the flow of R&D funds and personnel to Continental Europe.” And now, Denmark is also in the list of countries that are bidding for EMA headquarters’ relocation. Copenhagen’s candidacy launch on February 8 comes in the wake of similar launches by Amsterdam, Milan, Stockholm, Barcelona and Dublin. Only the Czech Republic and Estonia have ruled themselves out, according to the Financial Times. Therefore, we may see a 20-way tug of war amongst cities that want to host the EMA. The Danish Medicines Agency is excited about the Danish government’s decision. Thomas Senderovitz, Director General of the Danish Medicines Agency, said: “The EMA is the most important European coordination forum in the pharmaceutical field, and Copenhagen offers a visionary and innovative life science cluster. Major international pharmaceutical companies have a presence in Copenhagen, and we offer a strong administration and unique culture for collaboration between the health sector and universities in Denmark and southern Sweden”. As the news came out, healthcare giant Novo Nordisk backed and supported the decision of the Danish Government. India’s Strides plans to spin off API unit   Just two months after Perrigo agreed to sell its entire shareholding in Perrigo API India to Strides for INR 1000 million (US $14.8 million), Strides announced an organizational restructuring plan. As per the plan, Strides has decided to move away from its business-to-business (B2B) model to a business-to-consumer (B2C) model, which includes de-merging and listing its APIs business, exiting probiotics and capping its investment in the biotech business which was also approved by SeQuent Scientific, which bought into Shasun several years ago. SeQuent also has a veterinary drug business. Strides Shasun plans to rename itself as Strides Pharma. Post restructuring, the new Strides Pharma will comprise its retained formulations business having four US FDA-approved plants in India, Europe and Singapore, and three research and development (R&D) centers. This business will have a front-end presence in the regulated markets of Australia, US and the UK and emerging markets of Africa and India. Last year, Strides Shasun had mentioned they plan to hive off its commodity focused API manufacturing unit as a separate business. Strides — with two API manufacturing facilities, one in India and one in the UK — is a global supplier of painkiller (Ibuprofen), anti-epileptic medication (Gabapentin) and anti-acidity medication (Ranitidine). Strides had said that it would retain API capacities required for captive use while setting up a separate company for manufacturing low-margin APIs such as Ibuprofen, Gabapentin and Ranitidine.  

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#PharmaFlow by PHARMACOMPASS
16 Feb 2017
GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal
This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

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#PharmaFlow by PHARMACOMPASS
04 Aug 2016
Teva’s fresh troubles over drug safety, Bollygarchs drug ‘price-gouging’ in Britain, Sun Pharma downsizes U.S. operations
This week’s Phispers takes you through pharmaceutical news from across the globe – from Joe Biden’s computer aided cancer moonshot to AbbVie’s second largest venture capital buyout in history and a lot more. After GMP troubles, migraine patch gives Teva a fresh headacheLast week, Phispers carried news on Teva’s facility in Hungary, which was placed on the US Food and Drug Administration’s import alert list. The FDA inspection had found the plant not conforming to the current good manufacturing practices (GMPs). This week, there is more bad news for Teva Pharmaceuticals. The company had bought NuPathe in early 2014 for about US $ 114 million. Through this acquisition, Teva had got its hands on the only migraine patch approved in the US – known as Zecuity. The patch first hit the market in September 2015. However, in less than a year of its launch, Teva's Zecuity is under the FDA radar for concerns over “serious” adverse events including burning and scarring. Moreover, a large number of users have also reported other problems, such as severe redness, pain, skin discoloration, blistering and cracked skin, the FDA said.  Britain’s Patel brothers do a Martin Shkreli on drugs needed by NHSWhile America’s Martin Shkreli faced additional criminal charges this week of conspiracy to commit securities fraud during his tenure as the CEO of Retrophine (2012 to 2014), Britain saw its own avatars of Shkreli. Millionaire brothers Vijay and Bhikhu Patel, also known as ‘Bollygarchs’ – have been accused of being part of a group of businesses that hike up prices of common drugs needed by the National Health Service (NHS), the publically-funded healthcare system for England. The Patel brothers have allegedly exploited a loophole in NHS’ pricing system. Today the four businesses, including two with past and present links to the Patel siblings, have allegedly hiked the price of common drugs by up to 12,500 per cent. The unreasonably high prices have cost the NHS an additional £ 262 million (US $ 381 million) a year. This sum has conveniently gone into the pockets of the Patel siblings and their associates. Cancer treatment least affordable in India and ChinaWhile we all know that Americans pay the highest prices in the world for cancer drugs, a new study highlights how cancer treatments are least affordable in lower income countries. The study – presented at the annual meeting of the American Society of Clinical Oncology in Chicago – looked at the prices of cancer drugs in seven countries, while not taking into account discounts or rebates. The lowest drug prices were found in India and South Africa. But then, when adjusted for the cost of living, cancer drugs appeared to be least affordable in India and China. The study only strengthens the case for politicians, healthcare providers, doctors, insurers and patients, who have been opposing the high prices commanded by modern cancer drugs. Drug companies justify the high prices, citing the high cost of drug research and the need to make profits to continue spending on research and drug development. Sun Pharma sells two US facilities to Frontida BioPharmaSun Pharmaceuticals – India’s largest drug maker – is selling off two oral solid dosage manufacturing plants in the US to Frontida BioPharm Inc. (a part of Frontage Pharma). The sell-off is part of Sun Pharma’s plans to consolidate its manufacturing facilities in the US. The plants are situated in Philadelphia and Illinois. Sun Pharma earns about half of its total revenues from the US. And this is the drug maker’s second divestment in the US in the last six months. In December, it had divested its manufacturing plant in Ohio to Nostrum Laboratories.  The company is also looking to sell facilities and business units from the Ranbaxy portfolio. In September 2015, it put a plant in Ireland on the block to optimize its overall manufacturing base and also sold the central nervous system business (of erstwhile Ranbaxy) to Strides Shasun for INR 1.65 billion (US $ 24.8 million). China’s Fosun leads the race for India’s Gland Pharma with US $ 1.27 billion bidLast week, Hong Kong-listed Shanghai Fosun (Fosun Pharma) revised its offer to buy KKR-backed Gland Pharma to US $ 1.27 billion, the highest so far. American healthcare company Baxter International and private equity fund Advent made their offers in May. The frontrunner for Gland Pharma, until recently, was Baxter with its bid at US $1.1 billion, a news report said. Fosun Pharma is part of Chinese billionaire Guo Guangchang’s extensive business empire. Fosun is believed to have completed its due diligence on Gland Pharma sometime last we