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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.