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 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.

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.