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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Ed Kaye, Stoke Therapeutics CEO

Stoke touts ear­ly signs of ef­fi­ca­cy for Dravet syn­drome drug

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.