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.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scangos went back to Wall Street, and came back 700 million pennies short.

Scangos’ vaunted startup Vir Biotechnology raised $143 million in an IPO they hoped would earn $150 million. Shares were priced at $20, the low-end of the $20-$22 target.

Launched with backing from ARCH Venture’s Robert Nelsen, Masayoshi Son’s SoftBank Vision Fund, and the Bill & Melinda Gates Foundation, the infectious disease startup was one of a new wave of well-resourced biotechs that emerged with deep enough coffers to pursue a full R&D line rather than slowly build their case by picking off a single lead program.

Ex-Ab­b­Vie part­ner Prin­cip­ia posts en­cour­ag­ing PhII re­sults for its BTK-in­hibitor

Months after their breakup with high-profile partner AbbVie, Principia announced positive preliminary results from the second half of a Phase II trial on their lead drug.

The San Francisco biotech announced data from part B of its Phase II open-label trial testing the BTK inhibitor PRN1008 on patients with pemphigus vulgaris, a rare autoimmune disease affecting the skin and mucous membranes. Of 15 enrolled patients, 6 achieved complete responses and 4 remain on the therapy.

Roche vice-chair: Let's re­pair the dam­age that short-term prof­it dri­ve has done to the plan­et

In his latest push for environmental advocacy, the vice chairman of Roche’s board of directors has told a group of business executives that “short-term profit maximization has destroyed the planet, environmentally and socially.”

Andre Hoffman
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In re­ver­sal, NICE backs Rubra­ca af­ter Clo­vis agrees to a price cut

NICE has changed its mind, agreeing to cautiously endorse Clovis Oncology’s Rubraca after the drugmaker agreed to cut its price — about two months after the UK cost-effectiveness agency’s initial rejection.

Rubraca, known chemically as rucaparib, is approved for use in the EU as monotherapy for the maintenance treatment of adult patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after platinum-based chemotherapy.

Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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