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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

A Canadian CDMO with roots in Seattle is coming to the east coast.

Altasciences announced the acquisition of Calvert Laboratories Wednesday, a preclinical CRO in Pennsylvania. The move will complement Altasciences’ Seattle-area operations.

Headquartered in Laval, Canada, Altasciences operates six facilities that run the gamut on early drug development: preclinical safety testing, clinical pharmacology, bioanalytical, CRO services, and even CDMO capacity. Novo Holdings scooped them up in February with the goal of courting small and medium-sized biopharma clients. CEO Chris Perkin said back in February that the move would help the company foster its ambitious growth plan, and this acquisition and the presence it brings to the east coast is evidence.

Johnson Lau (front), Athenex CEO (Derek Gee/Buffalo News via AP Images, Pool)

Bounc­ing back from a shock­ing CRL, Athenex shares soar with buy­out of nat­ur­al killer T cell play­er

Several weeks after Athenex was hit with a surprise CRL for its oral chemotherapy candidate — and a class-action lawsuit to boot — the company’s stock is getting a much-needed boost as it snatches up a natural killer T cell player.

Athenex is shelling out $70 million upfront (primarily in equity) to buy out Kuur Therapeutics, the companies announced on Tuesday. In response, the company’s stock $ATNX soared more than 49% on Wednesday morning, pricing in around $5 apiece. In addition to the upfront payment, Kuur stands to pocket another $115 million in milestones, either in cash or common stock, at Athenex’s discretion.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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