Bris­tol-My­ers dodges a bul­let as PT­AB turns down in­ter partes re­view pitch for Cel­gene's cash cow

Cel­gene just won an­oth­er cru­cial patent skir­mish in its on­go­ing fight to keep its block­buster rev­enue pump­ing in from Revlim­id — a key fea­ture in the shaky $74 bil­lion buy­out deal that Bris­tol-My­ers Squibb has been de­fend­ing in a se­ries of ap­pear­ances over the last few days.

The Patent Tri­al and Ap­peal Board has de­nied a pe­ti­tion from Alvo­gen for an in­ter partes re­view of the Revlim­id patents. That move comes a month af­ter Dr. Red­dy’s was al­so stiff armed.

Charles Ban­croft

Alvo­gen has be­gun rolling out a gener­ic ver­sion of Revlim­id in cer­tain small Eu­ro­pean mar­kets in re­cent weeks, rais­ing fresh ques­tions about the dura­bil­i­ty of the fran­chise, which pro­duced $9.7 bil­lion of Cel­gene’s $15.2 bil­lion in sales rev­enue last year — a whop­ping 64% of its to­tal rev­enue.

Crit­ics have not­ed that Bris­tol-My­ers is buy­ing in­to one of the great patent cliffs in all of bio­phar­ma and an IPR process right now would have raised se­ri­ous con­cerns about ac­cel­er­at­ing the loss of patent pro­tec­tion. As it stands, an­a­lysts ex­pect to see Revlim­id to start fac­ing off against cheap­er gener­ics in 2022, when Nat­co has a deal to be­gin lim­it­ed mar­ket­ing that steadi­ly ramps up to a full scale cam­paign.

In the mean­time, Bris­tol-My­ers is bet­ting that it can gain ap­provals on 6 late-stage drugs in Cel­gene’s pipeline — in­clud­ing ozan­i­mod, JCAR017 and bb2121. But the tightrope walk is rais­ing qualms that one mis­step could cost the com­pa­ny dear­ly, with sev­er­al ob­servers won­der­ing if an ac­ci­dent-prone Cel­gene team is set­ting up Bris­tol-My­ers for a set­back.

“When we got in­to more broad­er dili­gence, the first thing we looked at again was Revlim­id IP, be­cause a cer­tain­ty of those cash flows were fun­da­men­tal to our cal­cu­lus in all of this,” said Bris­tol-My­ers CFO Charles Ban­croft in a Q&A with Bar­clays’ Ge­off Meacham yes­ter­day. Through it all, he main­tained, Bris­tol-My­ers took a more con­ser­v­a­tive ap­proach than any­one to what Revlim­id will be­ing in.

Bris­tol-My­ers ex­ec­u­tive team, led by CEO Gio­van­ni Caforio, have been rat­tled by some out­spo­ken op­po­si­tion to the deal. Af­ter its largest in­vestor turned against the buy­out, they’ve been mak­ing their case for the M&A deal. But new ques­tions have arisen re­lat­ed to the ozan­i­mod patent that Cel­gene holds.

To­day, the cards fells in Bris­tol-My­ers’ fa­vor. Its shares are down 2.2% in mid-morn­ing trad­ing.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.