Af­ter paint­ing a poor safe­ty pro­file, Pfiz­er and Eli Lil­ly are shoot­ing for a new pain drug OK any­way

Months af­ter an­a­lysts wrote off the NGF pain drug tanezum­ab as a per­pet­u­al los­er, Pfiz­er and Eli Lil­ly have de­cid­ed to push ahead and see if they can’t squeeze past the FDA with the low-dose ver­sion of this ther­a­py.

Pfiz­er post­ed the news with their Q2 up­date on Mon­day, not­ing that they de­cid­ed to go for it on the 2.5 mg dose af­ter a sit-down with reg­u­la­tors and a care­ful re­view of the “to­tal­i­ty” of the da­ta. The 5 mg dose is be­ing shelved.

But it’s go­ing to be an up­hill slog on this one.

In their piv­otal tri­al, in­ves­ti­ga­tors re­port­ed a dose-de­pen­dent in­crease for the pri­ma­ry com­pos­ite joint safe­ty end­point: 7.1% in the 5 mg arm, 3.8% in the 2.5 mg group and 1.8% for NSAIDs. Rapid­ly pro­gres­sive os­teoarthri­tis was the main con­cern, while “to­tal joint re­place­ment was 8% per­cent in the tanezum­ab 5 mg arm, 5.3% in the tanezum­ab 2.5 mg arm and 2.6% in the NSAIDs arm.” 

With a dou­bling of the joint blowout rate in that 2.5 mg group, the drug mak­ers may find a skep­ti­cal group of re­view­ers at the FDA. But reg­u­la­tors have steered away from opi­oids, now drop­ping any re­views of new meds in the same cat­e­go­ry — as Nek­tar re­cent­ly found out. So maybe they’ll be more open to a new mech­a­nism of ac­tion.

Eli Lil­ly at least has a track record of suc­cess­ful­ly nab­bing ap­provals based on bet­ter safe­ty pro­files for their low-dose drugs. The FDA first re­ject­ed Olu­mi­ant, than OK’d it on the low dose. And the phar­ma gi­ant is clear­ly hop­ing for the same here. But an ap­proval is cer­tain­ly no guar­an­tee of the big sales once en­vi­sioned for this drug. Wolfe’s Tim An­der­son shook his head over the last da­ta set, con­clud­ing that even if it got by reg­u­la­tors, pay­ers would like­ly throt­tle any com­mer­cial up­side.

Six years ago Eli Lil­ly paid Pfiz­er $200 mil­lion up­front and promis­ing $1.6 bil­lion in mile­stones for a shared rights pact on tanezum­ab. And that was af­ter the FDA forced a pause for the class as they as­sessed just what kind of threat they were deal­ing with.

The news on tanezum­ab ar­rived with an up­beat as­sess­ment of Pfiz­er’s Q2 num­bers. Prof­its rose 30% with Ibrance, Eliquis and Xel­janz all per­form­ing well. Shares are down 1% in ear­ly trad­ing Mon­day.

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.

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.

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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.

#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.

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.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

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.

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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