Leonard Schleifer (AP Images)

Re­gen­eron adds more pos­i­tive PhI­II da­ta for its NGF pro­gram — but safe­ty is still a big con­cern

Two years af­ter fas­inum­ab hit its first late-stage bar, Re­gen­eron is stand­ing by its “high-risk, high re­ward” bet on the NGF an­ti­body. But while new Phase III da­ta so­lid­i­fied the po­ten­tial re­ward, the risk is still threat­en­ing to blow it all up.

Re­gen­eron ex­ecs and an­a­lysts alike now have their eyes set on a ri­val drug from Pfiz­er and Eli Lil­ly, whose fate at the FDA will like­ly set the scene for the class.

The news comes from FACT OA1 and FACT OA2, which com­pared fas­inum­ab to place­bo over 16 weeks and 24 weeks, re­spec­tive­ly, for co-pri­ma­ry end­points mea­sur­ing pain and phys­i­cal func­tion among os­teoarthri­tis pa­tients. Across the tri­als, the 1 mg month­ly dose in­duced sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in both.

In­ves­ti­ga­tors al­so re­port­ed that fas­inum­ab seemed to of­fer more ben­e­fits than non-steroidal an­ti-in­flam­ma­to­ry drugs, al­though the dif­fer­ences were mere­ly “nom­i­nal.”

All of it shows that fas­inum­ab can have a place in the pain field, where NSAIDs aren’t help­ing all of the mil­lions of peo­ple liv­ing with os­teoarthri­tis pain and opi­oids come with their own prob­lems and con­cerns.

George Yan­copou­los

But even George Yan­copou­los, Re­gen­eron’s typ­i­cal­ly out­spo­ken pres­i­dent and CSO, ad­mit­ted that the safe­ty pro­file re­mains the biggest con­cern, as ini­tial safe­ty analy­ses sug­gest an in­crease in arthropathies (joint is­sues) among those who took the drug.

SVB Leerink an­a­lyst Ge­of­frey Porges heard it as a “fair­ly tepid de­fense of the drug’s pro­file,” but isn’t mak­ing any calls un­til da­ta from a long-term safe­ty study are out ear­ly next year.

At Te­va — the de­vel­op­ment and com­mer­cial­iza­tion part­ner — CEO Kåre Schultz is no­tably more up­beat.

Kåre Schultz

“If you look at it holis­ti­cal­ly and look at the prod­uct it­self, the strong im­prove­ment it has on pain and phys­i­cal func­tion, which has proven be­yond doubt in the clin­i­cal tri­al, and then the as­so­ci­at­ed im­prove­ment, which is that you will be avoid­ing al­ter­na­tive ther­a­pies that have a risk of abuse,” he said on an an­a­lyst call. “And in that sense, from a com­mer­cial point of view, if it does end up get­ting ap­proved by FDA, then I think it has a strong com­mer­cial op­por­tu­ni­ty here to the ben­e­fit of many pa­tients suf­fer­ing from se­vere pain.”

Will the FDA ap­prove it? With what con­straints? As the two com­pa­nies pre­pare their fil­ing, Re­gen­eron chief Len Schleifer said they will be pay­ing at­ten­tion in De­cem­ber, when reg­u­la­tors are ex­pect­ed to hand down a de­ci­sion on tanezum­ab.

Pfiz­er and Eli Lil­ly have tak­en the 2.5 mg dose to reg­u­la­tors, hav­ing shelved the 5 mg dose. Scrap­ping high­er dos­es ap­pear to be a com­mon theme in the class; in the first Phase III (which has since been con­vert­ed in­to the long-term safe­ty study), Re­gen­eron was al­so forced to aban­don the two high-dose arms due to side ef­fects.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

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UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

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R&D ex­ec faces up to 10 years in prison on charges he stole “thou­sands” of top se­cret re­search doc­u­ments from Mer­ck

Back in the fall of 2019, Merck’s security team was scrambling to review the work records of one of their recently departed research execs.

According to a lightly redacted review of the FBI investigation displayed by the Justice department, Shafat Quadri, an immuno-oncology specialist, had transferred thousands of internal research documents by way of email and thumb drives just before leaving his job to take a job with a rival pharma company.

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