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.

Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.