De­spite block­buster boasts for R&D work, pres­sure in­creas­es on Pfiz­er to do a megadeal

Some new prod­ucts like Ibrance are gain­ing ground in the mar­ket­place, help­ing Pfiz­er weath­er the storm of gener­ic com­pe­ti­tion. But sales de­clined in Q2 as Pre­vnar rev­enue weak­ened and com­pe­ti­tion loomed for Vi­a­gra and Lyri­ca. And that will have an­a­lysts look­ing to see what CEO Ian Read will do next to right the course at the phar­ma gi­ant; whether that’s big deals, new cost-cut­ting ef­forts, a com­pa­ny breakup, or a mix of all of the above.

Pfiz­er is al­ready one of the top R&D spenders in the busi­ness, and this year ex­pects to spend up­wards of $8 bil­lion on new drug de­vel­op­ment. In its Q2 re­lease out Tues­day morn­ing, the com­pa­ny boast­ed of 25 to 30 po­ten­tial ap­provals over the next 5 years, in­clud­ing 15 “pos­si­ble block­busters” — with half of those up for an ap­proval by 2020.

“Our strat­e­gy re­mains fo­cused on max­i­miz­ing in-mar­ket op­por­tu­ni­ties while con­tin­u­ing to ad­vance the pipeline and man­ag­ing our cost struc­ture to de­liv­er at­trac­tive fi­nan­cial per­for­mance over time,” said Read in a state­ment.

Ian Read, Pfiz­er CEO

Ex­hib­it A in Read’s case to­day is the can­cer pipeline, topped by ta­la­zoparib, a PARP in­hibitor it ac­quired in the big $14 bil­lion Medi­va­tion buy­out. It’s mov­ing for­ward on dou­bles and triple com­bos with Baven­cio (avelum­ab), in­clud­ing a tie-up with chemother­a­py, as it looks to ex­pand its check­point pres­ence. Like Pfiz­er’s PD-L1 drug, though, Pfiz­er will be steer­ing in­to a mar­ket that is al­ready well pop­u­lat­ed with ri­val drugs. And an­a­lysts see lit­tle chance that at a time pay­ers are get­ting in­creas­ing­ly tough on high prices for brand­ed drugs Pfiz­er will be able to re­ly on its pipeline to get the top line grow­ing again any­time soon, even as it comes on strong in biosim­i­lars — with 8 in mid- to late-de­vel­op­ment.

That leaves deal­mak­ing as the short­est path to growth, and af­ter be­ing frus­trat­ed in its at­tempts to buy As­traZeneca as well as Al­ler­gan, any­thing could hap­pen on this front. Read has put the BD team on hold for now, in part be­cause he wants to see how tax re­form could al­low for the repa­tri­a­tion of over­seas cash, in­flu­enc­ing the val­u­a­tions on new prod­ucts. And that didn’t change to­day.

“We look at BD as a way of im­prov­ing re­turns for share­hold­ers,” Read told an­a­lysts. “There are short term events in the mar­ket­place such as tax re­form that may change as­set val­ues. Any fo­cus on BD is some­what de­layed by res­o­lu­tion of that.”

De­layed but by no means fin­ished, as Read made clear as sev­er­al an­a­lysts like Ja­mi Ru­bin pressed him for some clar­i­ty on what the com­pa­ny plans next.

Pfiz­er’s pause, in turn, could hold back play­ers like No­var­tis from mak­ing a bid to buy As­traZeneca, notes a re­port from Reuters.

As­traZeneca was weak­ened bad­ly last week with the ini­tial set­back in MYS­TIC last week.

“Pfiz­er has tak­en a break on M&A for now and no-one ex­pects them to make an­oth­er move for As­traZeneca. But M&A is like a game of chess and no­body will go af­ter As­traZeneca un­til Pfiz­er picks its next tar­get,” one banker told Reuters.

That next tar­get is fore­most on an­a­lysts’ minds.

Astel­las con­ced­ed last week that it is stop­ping a Phase III pro­gram for Xtan­di – part­nered with Pfiz­er – as a treat­ment for breast can­cer. That was the biggest move in terms of clean­ing up the pipeline this past quar­ter at Pfiz­er. The phar­ma gi­ant al­so dropped a slate of 4 Phase I stud­ies, in­clud­ing a stem cell ther­a­py for age-re­lat­ed mac­u­lar de­gen­er­a­tion. You can see them all at the end of its pipeline re­view slide show.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.