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GSK hits back at Elliot, supports CEO; Israel says Pfizer jab only 64% effective against delta variant
This week, Phispers brings you an update on the GSK-Elliot Management saga, as the activist investor issued a 17-page open letter questioning the British company’s performance last week. GSK hit back at Elliot Management by supporting CEO Emma Walmsley and rejecting several of its demands, such as the sale of the consumer health franchise.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced its new guidance on good practices for data management and integrity for drug manufacturers and distributors.
In Covid vaccine news, Israel said the effectiveness of the Pfizer-BioNTech vaccine against the fast-spreading delta variant is only 64 percent in preventing infection. The vaccine had proved to be 94.3 percent effective in May, as per Israel’s own data. After Sanofi, Novartis is now contemplating an entry into messenger RNA technology.
In cardiovascular news, Eli Lilly and Boehringer Ingelheim’s diabetes drug — Jardiance — has shown to reduce death or hospitalization in heart failure patients with a preserved ejection fraction (HFpEF). The companies have already applied for FDA approval for treating heart failure patients with a reduced ejection fraction (HFrEF), and the agency is reviewing their application.
Mylan has filed a lawsuit against Teva for blocking the entry of generic Copaxone. And a class-action lawsuit was filed against Takeda and Endo for a pay-for-delay deal around constipation drug Amitiza.
GSK supports Walmsley in fight with Elliot; inks US$ 2.2 billion deal with Alector
A fortnight ago, we had reported on how GlaxoSmithKline (GSK) CEO, Emma Walmsley, had announced plans to turn its consumer healthcare arm into a separate listed company. The move is expected to generate US$ 11 billion (£ 8 billion) and other financial benefits for GSK’s underperforming drugs business.
Walmsley has been under pressure from activist investor Elliott Management since it increased its stake in GSK in April this year. Last week, Elliot attacked Walmsley once again through a 17-page open letter questioning the company’s performance. In the open letter to GSK Chairman Jonathan Symonds, Elliot called for drastic changes to salvage GSK from what it called “years of under-management.” Elliott also called for an overhaul of the GSK board to include directors with biopharma and consumer health experience, while suggesting a sale of GSK’s consumer health franchise, instead of de-merging it into a standalone firm, as spelt out by Walmsley. Elliot said the proceeds from this sale can be used to fund R&D, reduce debt and buy back shares. Elliott also implied that it may have already lined up potential buyers.
The next day, GSK hit back at Elliott Management. Backed by “widespread and strong” investor support, GSK responded to Elliott’s open letter by rejecting its demands to change its board and sell its consumer healthcare arm after separating it from its drug business.
In a statement, the British pharma giant said GSK’s board “strongly believes” Walmsley is the “right leader” for the company after the upcoming consumer health spinoff. The board “fully supports” the steps she’s taking to improve performance, it said. GSK noted that it had already appointed two new non-executive directors to the board in the last 18 months. The company intends to add new faces to the team ahead of the separation “to increase biopharmaceuticals and scientific experience.”
Meanwhile, the board is already close to appointing a CEO designate for the consumer health unit after “an extensive search and selection process,” GSK said. Elliott had also demanded complete autonomy for GSK’s vaccines business, and the drugmaker rejected this idea as well.
GSK pens US$ 2.2 billion deal with Alector: Under pressure to perform, GSK has inked a US$ 2.2 billion deal with Alector. GSK is paying Alector US$ 700 million upfront to co-develop two drugs for neurodegenerative diseases. The British company will pay Alector US$ 1.5 billion in milestone payments.
Under the terms of the deal, the two drugmakers will co-develop and sell two “next generation” drugs for major neurodegenerative diseases including Parkinson’s and Alzheimer’s.
Covid update: Israel says Pfizer jab only 64 percent effective against delta variant
This week, Israel’s Health Ministry said the effectiveness of the Pfizer-BioNTech coronavirus vaccine has dropped to 64 percent in preventing infection as the delta variant continues to spread across the country. The delta variant is believed to be twice as contagious as the original strain of Covid-19 and is thought to be responsible for 90 percent of new cases in Israel over the past two weeks.
The data shows that in May, when the delta strain was less prevalent, the vaccine was 94.3 percent effective — implying a 30 percent drop in efficacy against the delta variant, which was first identified in India.
Pfizer’s vaccine has been less effective at keeping people from getting Covid-19. However, the vaccine continues to protect against severe Covid. The ministry said the vaccine is still 93 percent effective in preventing hospitalizations and severe symptoms (as compared to 97 percent in an earlier government study).
According to Israeli data published in March, two weeks after the vaccine was given, it had 99 percent efficacy in preventing symptomatic Covid-19 and 91.2 percent in preventing infection.
Third shot for people with impaired immune system: Last week, we had reported on how vaccine manufacturers like Pfizer and Moderna were differing from the United States Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) on the need for an extra shot. This week, there is news that Israel is examining a third dose for people with an impaired immune system. According to social media posts, the Israel Health Ministry met on July 4 to debate offering a third dose of the Pfizer vaccine to people with weakened immune systems. The ministry has refrained from recommending administering a third dose of the vaccine at this stage.
Delta already a dominant variant in US: According to the US Centers for Disease Control and Prevention (CDC), the delta variant is already the dominant strain of Covid-19 in the United States. The agency said the delta variant became dominant in the country over the two weeks ended July 3, with 51.7 percent cases linked to the variant. The proportion of cases linked to the alpha variant, which was first identified in Britain, have fallen to 28.7 percent.
Similarly, in France, the highly contagious delta variant now represents around 40 percent of new Covid infections and could ruin the summer if a fourth wave of infections is allowed to build, government spokesman Gabriel Attal said.
Lilly, Boehringer’s diabetes drug shows more gains for patients with heart failure
Chronic heart failure did not have a single approved therapy until recently, when Novartis’ Entresto bagged a US Food and Drug Administration (FDA) approval in February this year. And now, there is new data for Eli Lilly and Boehringer Ingelheim’s diabetes drug — Jardiance — that shows major wins for heart failure patients with a preserved ejection fraction (HFpEF) with or without Type 2 diabetes.
The SGLT2 inhibitor cut the composite risk of cardiovascular death or hospitalization compared to a placebo. According to Lilly, the results are the first time a medicine has met its main goal in a late-stage study of adults with HFpEF, which indicates the heart is still able to contract normally but doesn’t fill with enough blood. The two companies did not disclose specific details.
In a tweet, cardiologist Sekar Kathiresan hailed this as “huge news” in the cardiovascular space.
The FDA is currently reviewing the drug as a treatment for heart failure patients with a reduced ejection fraction (HFrEF) with or without Type 2 diabetes based on results from the Emperor-Reserved phase 3 study. Lilly expects a decision later this year. The company also plans to apply for an approval in HFpEF in 2021.
The immediate challenger for HFpEF is Entresto. But Jardiance isn’t only chasing Entresto. It’s also hoping to get ahead of AstraZeneca’s SGLT2 rival Farxiga, which already sports an approval in HFrEF patients with or without Type 2 diabetes and is hoping for an expansion into HFpEF. AstraZeneca is running its phase 3 Deliver study in HFpEF with over 6,200 patients. The study is expected to be completed in early 2022.
Mylan files lawsuit against Teva for blocking entry of generic Copaxone
Teva Pharmaceutical has been embroiled in several lawsuits. Just last month, Teva reached a US$ 925,000 settlement with the state of Mississippi over a high-profile price-fixing case that dates back to 2019. And now, Mylan just added another case to the list of court cases against Teva.
The Pennsylvania-headquartered generic drugmaker is taking Teva to court over claims that it used anticompetitive practices to guard its branded drug Copaxone from generics. Mylan, which has merged with Pfizer’s Upjohn to form Viatris, charged the Israeli drugmaker of orchestrating a “comprehensive and sophisticated scheme” to stop the entry of generic versions of the multiple sclerosis drug.
The suit claims Teva accomplished this by misleading doctors about the efficacy of Copaxone generics, shifting the market to a higher-dose formulation and forging deals with specialty pharmacies and pharmacy benefit managers (PBMs) to keep Copaxone generics off prescribing lists. Mylan filed the suit this week in a New Jersey federal court.
According to the lawsuit, in 2014 Teva had sought approval for a three-times-a-week 40 mg version of Copaxone in anticipation of onslaught from 20 mg generics. The company priced the 40 mg formula lower than the 20 mg version in a move that would have been “irrational” were it not meant to subvert generic competition, the court documents claim.
Mylan further claims Teva paid PBMs to cover only the 40 mg Copaxone and put certain conditions over its rebate payments. By December 2015, Teva had switched nearly 77 percent of Copaxone patients over to the 40 mg dose, the suit says.
Antitrust suit against Takeda, Endo over pay-for-delay deal: Takeda and Endo are facing scrutiny for a pay-for-delay deal. A patent settlement between Takeda and Par Pharmaceutical (now part of Endo) in 2014 delayed the launch of generics to Takeda’s constipation drug Amitiza. According to a new proposed class-action lawsuit, this broke antitrust laws.
The plaintiff alleged in the Massachusetts federal court that the deal allowed the two companies to “maintain a monopoly” for Amitiza and effectively put off generic competition to the drug by several years. The two reaped “many hundreds of millions of dollars” in profits during the period, while patients paid “far more” than they should because of high prices, the lawsuit says.
PIC/S announces new guidance on good practices for data management, integrity
Last week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors. PIC/S is a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use.
Defining data integrity as “the degree to which data are complete, consistent, accurate, trustworthy, and reliable and that these characteristics of the data are maintained throughout the data life cycle,” the guidance notes that manufacturers and distributors have a duty to seek out vulnerabilities in data systems, and to “design and implement good data governance practices to ensure data integrity is maintained.”
The guidance has come into effect and the final document is meant to guide inspectorates in “planning a risk-based inspection relating to good data management practices,” without imposing an additional regulatory burden. Rather, the final guidance is meant to help regulators clarify how current GMP/GDP requirements relate to “current industry data management practices.”
The scope of the guidance includes all activities pertaining to the handling of data, “including but not limited to data policy, documentation, quality and security.” The primary focus of the guidance is data management as it is related to GMP/GDP considerations, but the general principles also apply to data in the registration dossier. Both on-site and remote, or desktop, inspections are included within the scope of the guidance.
After Sanofi, Novartis weighs entry into mRNA technology
Last week, we had carried news that French drugmaker Sanofi plans to invest US$ 476 million (€400 million) a year in a dedicated vaccines mRNA Center of Excellence. This week, there is news that Novartis could also get into the field of messenger ribonucleic acid (mRNA) technology, which has come to the fore in vaccine development during the pandemic, Chairman Joerg Reinhardt said.
“The mRNA technology has proven to be an attractive option in this situation and of course every research company is questioning whether they should invest more in this area,” he said.
“Novartis is doing the same and we are having the discussion this week in the executive committee and then in August in the board of directors,” Reinhardt added.
He also highlighted that the Swiss drugmaker’s resurgent interest in anti-infective products is driven by the pandemic. In 2018, Novartis had abandoned its anti-viral and anti-bacterial research at a facility in California, as it concluded that the probability of success was relatively low and wanted to re-direct resources to other areas like gene therapy. “We are now reassessing that,” Reinhardt said.
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