Bay­er steps up with $1.55B deal to take a lead role in com­mer­cial­iz­ing Loxo’s can­cer drugs

Bay­er is buy­ing in­to the close­ly-watched piv­otal can­cer pro­gram un­der­way at Loxo On­col­o­gy $LOXO. And they are pay­ing big to part­ner on Loxo’s pipeline of ge­net­i­cal­ly de­fined can­cer ther­a­pies.

Bag­ging com­mer­cial­iza­tion rights on larotrec­tinib, its fol­low-up drug LOXO-195 and the whole pipeline at Loxo, Bay­er is hand­ing over a $400 mil­lion up­front, $450 mil­lion in mile­stones for the de­vel­op­ment and first sale of larotrec­tinib, with an­oth­er $200 mil­lion on the ta­ble for LOXO-195. There’s al­so $500 mil­lion on the books for com­mer­cial goals.

Both of the lead drugs tar­get rare cas­es of TRK fu­sion, but LOXO-195 — which has be­gun to pro­duce the first set of pos­i­tive da­ta — is for pa­tients who de­vel­op re­sis­tance to a TRK in­hibitor. Rather than de­vel­op a drug for a spe­cif­ic or­gan type, Loxo’s drugs are de­signed to be used wher­ev­er ge­net­i­cal­ly de­fined cas­es de­vel­op.

Loxo and Bay­er will split the costs and the prof­its in the US in the deal, with Bay­er tak­ing the lead role on the reg­u­la­to­ry side out­side of the US.

Loxo’s shares, though, have been swelling as a large group of in­vestors be­gan bet­ting on a buy­out, with a big up­side for share­hold­ers. Now that Loxo is sig­nal­ing that it’s go­ing com­mer­cial with a part­ner, though, its shares re­act­ed by drop­ping 8%.

Robert La­Caze

For a small com­pa­ny with just a few dozen staffers, Loxo has enor­mous am­bi­tions that in­clude shoot­ing at some ground­break­ing ad­vances in drug de­vel­op­ment. At AS­CO last sum­mer, the biotech boast­ed a 76% tu­mor re­sponse rate for larotrec­tinib among pa­tients with mul­ti­tude of dif­fer­ent tu­mor types. Un­like a typ­i­cal can­cer drug fo­cused on the anato­my, Loxo is go­ing af­ter a bio­mark­er — tropomyosin re­cep­tor ki­nase (TRK) fu­sions — and at AS­CO it cob­bled to­geth­er re­sponse da­ta from three ear­ly-stage tri­als.

Like oth­ers in the field, Loxo — helmed by CEO Josh Bilenker — has been able to vault from ear­ly to late-stage de­vel­op­ment in a blur of re­cent ac­tiv­i­ty.

Loxo has been say­ing for months now that it’s plan­ning to file for an ap­proval on larotrec­tinib ei­ther late this year or ear­ly next. In a re­cent call with an­a­lysts, Chief Busi­ness Of­fi­cer Ja­cob van Naar­den said:

In­ter­nal­ly, we’re prepar­ing for a mid-2018 ap­proval and launch. But again, that’s more from a pre­pared­ness per­spec­tive not a sort of guid­ance of when we think the drug will ac­tu­al­ly get ap­proved.

Bay­er, mean­while, has had mixed re­sults this year. Look­ing to as­sure the mar­kets that its phar­ma busi­ness wouldn’t lan­guish as it pur­sued Mon­san­to, Bay­er had pre­dict­ed that its pipeline in­clud­ed 6 drugs — veri­ciguat, finerenone, vi­laprisan, BAY-1841788, the can­cer drug ane­tum­ab rav­tan­sine and co­pan­lis­ib — with 6 bil­lion eu­ros in peak sales.

Ane­tum­ab was Ex­hib­it A in that case, but it re­cent­ly failed a Phase II study. Co­pan­lis­ib, though, was ap­proved.

Bay­er’s will­ing­ness to pay big to jump in­to a lead role here un­der­scores just how high val­u­a­tions are run­ning and al­so how hot the whole on­col­o­gy field is right now.

“We see great po­ten­tial in larotrec­tinib and more­over the fol­low-on com­pound LOXO-195 which may pro­vide ad­di­tion­al ben­e­fit for pa­tients who might progress on an ini­tial TRK in­hi­bi­tion ther­a­py. These agents have the po­ten­tial to ful­fill the promise of pre­ci­sion med­i­cine, where tu­mor ge­net­ics rather than tu­mor site of ori­gin de­fine the treat­ment ap­proach for pa­tients”, said Robert La­Caze, ex­ec­u­tive vice pres­i­dent and head of the On­col­o­gy Strate­gic Busi­ness Unit at Bay­er.

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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'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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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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