FDA ex­e­cutes a 180 on Ther­a­peu­tic­sMD ther­a­py, hand­ing it an OK — and stok­ing con­cerns about po­lit­i­cal in­flu­ence

A year af­ter the FDA hand­ed Ther­a­peu­tic­sMD $TXMD a re­jec­tion let­ter for its ther­a­py pre­vent­ing vagi­nal pain dur­ing sex, the agency has done a com­plete 180 — ap­prov­ing the treat­ment af­ter wav­ing off the safe­ty con­cerns that had once war­rant­ed a CRL.

The de­ci­sion to drop the CRL and al­low the ap­pli­ca­tion to pro­ceed with­out meet­ing spec­i­fied hur­dles is one of three the FDA ex­e­cut­ed in the weeks af­ter Scott Got­tlieb jumped in­to the top job at the FDA, rais­ing con­cerns that po­lit­i­cal in­flu­ence was chang­ing the for­tunes of some of the com­pa­nies with busi­ness be­fore the agency. In this case, Got­tlieb — hand­ed a man­date to speed ap­provals — won the nom­i­na­tion the day af­ter the re­jec­tion was an­nounced by Ther­a­peu­tic­sMD.

Scott Got­tlieb

Two oth­er com­pa­nies al­so earned a re­prieve un­der Got­tlieb: Am­i­cus, where CEO John Crow­ley had lob­bied of­fi­cials claim­ing that their re­jec­tion of its ex­per­i­men­tal Fab­ry drug mi­gala­s­tat would de­lay it by 5 to 7 years, far more than the 2 years he told share­hold­ers; and Eli Lil­ly, which re­cent­ly won over an ex­pert pan­el on a ques­tion­able low dose of baric­i­tinib. 

In Am­i­cus’ case, the FDA put the drug on the agency’s in­side track, of­fer­ing a fast pri­or­i­ty re­view ahead of an ex­pect­ed ap­proval.

In this case, Ther­a­peu­tic­sMD — which is chaired by ex-HHS sec­re­tary Tom­my Thomp­son, who ran a group of promi­nent Bush ad­min­is­tra­tion Re­pub­li­cans back­ing Don­ald Trump for pres­i­dent — told in­vestors last year that the agency had flagged con­cerns about the ab­sence of safe­ty da­ta be­yond the 12-week stretch test­ed in the clin­ic. It al­so didn’t help ini­tial­ly that there are oth­er prod­ucts for the con­di­tion, less­en­ing the ur­gency of an ap­proval.

The agency doesn’t pub­lish CRLs and nev­er of­fered an ex­pla­na­tion for its re­ver­sal, an agency stan­dard on in­di­vid­ual com­pa­nies. 

Their estra­di­ol vagi­nal in­serts will be sold as Imvexxy.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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