Blame the ozan­i­mod fi­as­co on the Re­cep­tos team? Just wait a sec, says ex-CEO, who sold the com­pa­ny to Cel­gene for $7.2B

Ear­li­er to­day we picked up some crit­i­cal re­marks that a se­nior Cel­gene ex­ec had to say about the team at Re­cep­tos, the sub­sidiary or­ga­ni­za­tion which hand­ed in an ap­pli­ca­tion for the would-be block­buster ozan­i­mod on­ly to have FDA reg­u­la­tors kick it right back with an em­bar­rass­ing refuse-to-file no­tice. And it didn’t play well with the CEO who sold the com­pa­ny to Cel­gene for $7.2 bil­lion.

Fa­heem Has­nain

“I think that 99% of folk at Cel­gene wouldn’t have sub­mit­ted, but we had Re­cep­tos out on the West Coast and, for what­ev­er rea­son, the de­ci­sion was made to sub­mit,” Cel­gene’s head of hema­tol­ogy and on­col­o­gy Nadim Ahmed told David Crow at the Fi­nan­cial Times. “We learned a les­son of hu­mil­i­ty and that when you do an ac­qui­si­tion it’s bet­ter to be more in­te­grat­ed rather than be com­plete­ly away from the moth­er ship.”

Now, wait a sec, says ex-Re­cep­tos CEO Fa­heem Has­nain. There’s more to the sto­ry than that. And the moth­er ship was in di­rect com­mand of the sit­u­a­tion in San Diego, in­clud­ing the crit­i­cal con­tacts with the FDA reg­u­la­tors who wound up rolling their eyes at the ap­pli­ca­tion.

“It’s im­por­tant to know that Cel­gene had on-site con­trol and over­sight for two-and-a-half years be­fore this fil­ing took place,” Has­nain tells me in a fol­low-up. And just maybe it was the Cel­gene crew that left out a few crit­i­cal de­tails in the run-up to the fil­ing.

“Reg­u­lar en­gage­ment and com­mu­ni­ca­tions with the FDA is crit­i­cal to fil­ing,” Has­nain adds. “A refuse-to-file is a dif­fi­cult thing to achieve, and it ap­pears there was some en­gage­ment (with the FDA) that ap­pears to be miss­ing.”

At the time of the buy-out, he adds, the biotech had mapped out the rest of the de­vel­op­ment and reg­u­la­to­ry plans, with the rest of the phar­ma­col­o­gy stud­ies that need­ed to be done in a time­ly fash­ion. 

“We’re kind of dis­ap­point­ed with some of the com­ments that have been made,” says Has­nain. “It’s un­for­tu­nate that this kind of fin­ger point­ing is go­ing on.”

Cel­gene’s top ex­ecs have every rea­son to be red-faced over the in­ci­dent. The refuse-to-file came on top of a ma­jor late-stage im­plo­sion at the big biotech, and the fi­as­co over the ap­pli­ca­tion made the top ex­ecs look vir­tu­al­ly dys­func­tion­al. That hap­less rep lies in stark con­trast to the can-do ef­fi­cien­cy and clean ex­e­cu­tion that marked the Bob Hug­in era.

I asked Cel­gene if they want­ed to re­spond to Has­nain’s re­marks, but no one re­spond­ed.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

That puts J&J in charge of a drug on the threshold of pivotal — though pricey — R&D work for a broad patient group with other related fields to explore. And it’s a very busy development arena.

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Sangamo CEO Sandy Macrae

Pa­tient #9 has been a con­cern, but Sang­amo and Pfiz­er are bull­ish about win­ning the marathon he­mo­phil­ia A gene ther­a­py race

Patient number 9 has given Sangamo and its partners at Pfizer some heart palpitations in their high profile hemophilia A gene therapy program.

After watching his Factor VIII level rise following treatment like the rest, the crucial efficacy gauge they track saw a sudden and significant plunge. At week 13, the FVIII level had dropped below normal. Then it began to rise again.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.