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.

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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