Generics on the way? Top drugs in danger of losing patent protection – Endpoints News

Generic drug entry tends to signal the end of an era — patents expire, competitors reach settlements and prices are cut.
The storyline tends to play out in mostly the same way: patents and exclusivity protections eventually expire, competition swoops in, and within a few months, they’ve transformed the market into a new, less expensive and less marketed landscape.
At least that’s the theory. The reality isn’t always that simple.
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Eli Lilly’s crew is walking into an adcomm tomorrow where the key decision maker from the FDA — oncology czar Richard Pazdur — has clearly indicated he’s going to fight to nix their application for the PD-1 candidate sintilimab.
Despite earlier signals to the contrary, Pazdur and the FDA insiders who did the agency review on the drug want the agency to refuse to greenlight the drug based on data derived solely from China. In this situation, Pazdur holds all the cards, despite what the adcomm members may desire. And as Managing Editor Kyle Blankenship noted in an op-ed today, that would appear to be a sure-fire obstacle to the deep discounting Lilly has promised.
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Today was Pfizer CEO Albert Bourla’s chance to relish the market success of its Covid vaccine and drug and what a fresh flow of $54 billion-plus from the pandemic franchise this year can do for the company. First on the list? The BD team is buckling down to pick up the pace for more deals in the year ahead.
This is clearly Aamir Malik’s turn to shine, after taking the BD reins from John Young last summer as he completed a 34-year career run at Pfizer.
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Emma Walmsley has one central message for today’s Q4 update: Starting in 2022, GlaxoSmithKline will begin a new era of growth.
The long-anticipated spinoff of its consumer healthcare joint venture — with its numerous twists and turns, including a recent rejection of Unilever’s bid to buy it out instead — is expected to be completed some time this summer. That puts the emphasis entirely on innovation at the pharma giant.
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Eli Lilly has a big decision coming Thursday as an FDA advisory committee considers the merits of PD-1 blocker sintilimab, a drug developed in China with partner Innovent. That adcomm could swing either way — but if FDA oncology head Rick Pazdur’s word reigns supreme, sintilimab is already dead in the water.
Pazdur and FDA insiders think they have a compelling case against sintilimab for one reason: The drug’s pivotal trial was conducted in China alone with results that might not translate into a more heterogenous US patient pool.
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The year was 2018, and AskBio CEO Sheila Mikhail wanted 100% controlling interest in a joint venture with Touchlight. The company was in negotiation with an unnamed Big Pharma for a collaboration that would have provided it with enough cash to make that a reality. After 18 months of negotiations and agreements in place, the Big Pharma deal fell through, and so did Mikhail’s Touchlight ambitions.
As a startup, it can sometimes be tough to think too far ahead in the future. However, with a major manufacturing partnership announced Wednesday, CTO Carole Schwintner and her team at MaaT Pharma are taking the first steps toward establishing a long-term game plan for the seven-year-old company.
The French biotech and CDMO Skyepharma will partner to build the largest specialized manufacturing facility for microbiome-based therapeutics. The plant will help MaaT increase its output by ten-fold by 2030, with the aim to produce several thousand enemas of the lead candidate MaaT-013, to treat Graft-versus-Host disease (GvHD), which happens when donated bone marrow or stem cells view the recipient’s body as foreign, and donated cells and bone marrow attack the body. It will also produce “several hundreds of thousands capsules” of MaaT-033, for patients who receive an allogeneic stem cell transplantation.
Drug development can sometimes seem like a middle-aged game, but oftentimes the inspiration for the industry’s biggest innovations came when its creators were far younger.
Take CAR-T, the cell therapy researchers declared this month could conclusively cure some patients. Even though Carl June was pushing 60 when the therapy showed its first dramatic results a decade ago, he started working on the field as a young Navy doc in the 1980s.
In December 2019, a tiny decade-old California startup known as Cardero Therapeutics announced a new name — Epirium Bio — a new direction and $85 million in cash from blue-chip VCs such as ARCH and Vertex Ventures.
The company’s founders had a bold claim that a common type of anti-oxidant found in chocolate and grapes actually worked by influencing a previously undiscovered human hormone, the first of its kind discovered in decades. Activating that hormone, they claimed, could restore mitochondria, the powerhouse of the cell, and restore muscle tissue. It was effectively exercise-in-a-pill.
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Top Republicans are calling on HHS “to abandon and re-propose” a draft national coverage decision from CMS on anti-amyloid Alzheimer’s drugs, which seeks to restrict the use of such drugs to clinical trials until their benefits can be established.
Cathy McMorris Rodgers (WA), Kevin Brady (TX), Brett Guthrie (KY), and 75 others in the House sent a letter Wednesday to HHS Secretary Xavier Becerra, urging him to instead provide “reasonable access to FDA-approved [Alzheimer’s] treatments for a broader population of Medicare beneficiaries.”
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