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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

UP­DAT­ED: Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Ear­ly-stage can­cer biotech nails $85M C round; Flem­ming Orn­skov's Gal­der­ma scores 'break­through' sta­tus

→ Zentalis Pharmaceuticals just nabbed an $85 million round from a syndicate that includes Matrix Capital, Viking Global Investors, Redmile Group, Farallon Capital, Perceptive Advisors, Surveyor Capital and Eventide Asset Management. Their lead drug is ZN-c5, which is currently in Phase I/II trials. The biotech describes that drug as a “potential best-in-class oral Selective Estrogen Receptor Degrader for estrogen receptor-positive, HER2-negative (ER+/ HER2-) breast cancer.”