Puma Biotech­nol­o­gy shares tank af­ter CHMP looks ready to hit a red light on ner­a­tinib

Six months af­ter Puma Biotech­nol­o­gy won an FDA OK for its can­cer ther­a­py ner­a­tinib, the EMA looks like its prepar­ing to throw up a big road­block in­to Eu­rope over con­cerns its reg­u­la­tors have about the drug. And the news im­me­di­ate­ly trig­gered an­oth­er sharp turn for the biotech’s stock $PBYI, which plunged 27% in af­ter-mar­ket trad­ing.

An­a­lysts have been fret­ting over the Eu­ro­pean de­ci­sion for months now, not­ing that a sci­en­tif­ic ad­vi­so­ry group meet­ing called by the EMA sug­gest­ed that Puma faced some broad chal­lenges that ex­tend­ed be­yond the ev­i­dence of se­vere di­ar­rhea linked to the drug.

Alan Auer­bach, Puma CEO

To­day Puma an­nounced that the CHMP no­ti­fied the com­pa­ny of a neg­a­tive trend vote, which loose­ly trans­lat­ed means that they are high­ly un­like­ly to get a green light in Eu­rope any­time soon to sell ner­a­tinib for the ex­tend­ed ad­ju­vant treat­ment of ear­ly stage HER2-pos­i­tive breast can­cer.

The com­pa­ny’s state­ment not­ed:

CHMP in­di­cat­ed that, in its opin­ion, the ben­e­fit risk as­sess­ment is neg­a­tive as the study re­sults are based on ev­i­dence from a sin­gle piv­otal tri­al and the 2- and 5-year in­va­sive dis­ease free sur­vival (iDFS) ben­e­fits ob­served to-date may lack suf­fi­cient clin­i­cal rel­e­vance.

That will like­ly make Puma’s jour­ney in search of an ap­proval in Eu­rope much, much longer, while it’s free to sell the drug in the US.

Leerink’s Michael Schmidt not­ed:

CHMP’s opin­ion was based on the re­sults from both the Phase III Ex­teNET tri­al in ex­tend­ed ad­ju­vant ear­ly stage HER2-pos­i­tive breast can­cer and the Phase II CON­TROL tri­al in ex­tend­ed ad­ju­vant ear­ly stage HER2-pos­i­tive breast can­cer ac­cord­ing to PBYI. In con­trast to that, the US FDA On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee (ODAC) vot­ed 12:4 in fa­vor of FDA ap­proval in­di­cat­ing that the risk-ben­e­fit pro­file of Ner­l­ynx was fa­vor­able. The FDA sub­se­quent­ly ap­proved Ner­l­ynx with a broad la­bel in the US which is not lim­it­ed to cer­tain pa­tient sub-pop­u­la­tions.

The de­bate over grade 3 di­ar­rhea seen in clin­i­cal tri­als ex­cit­ed con­sid­er­able short in­ter­est in the stock, but the FDA’s ad­vis­ers bare­ly hes­i­tat­ed in urg­ing an ap­proval, with a track record that has long fa­vored adding new op­tions for on­col­o­gists and patents when­ev­er pos­si­ble.

Puma’s shares — al­ways volatile in the back-and-forth de­bate over the drug’s side ef­fects and its ef­fi­ca­cy — dived 27% in­stant­ly.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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