Roche CEO Sev­erin Schwan may have pre­pared the staff at Spark for the fifth de­lay of its $4.3 bil­lion ac­qui­si­tion — adding a few months of cush­ion and push­ing the dead­line as far as April 30, 2020 — but that’s not stop­ping an­a­lysts from be­com­ing se­ri­ous­ly con­cerned.

Sev­erin Schwan Roche

The FTC’s dragged on in­ves­ti­ga­tion, which is hold­ing up the deal, points to some­thing big­ger than Spark or Roche, Mani Foroohar of SVB Leerink told Bloomberg. It sends a wor­ry­ing sig­nal to any buy­ers look­ing to make a move in gene ther­a­py M&A.

“For any­one try­ing to make that deal there’s a par­a­lyz­ing ef­fect,” Foroohar said in an in­ter­view with the news out­let. “What would’ve been seen as a low ex­e­cu­tion risk, low reg­u­la­to­ry risk, straight­for­ward deal is sud­den­ly some­thing caught up for a year and a half, and you have to look at di­vest­ing,” he said.

The group of po­ten­tial takeover tar­gets in­cludes uniQure and Bio­Marin, both of which have late-stage gene ther­a­py pro­grams lined up.

Gene ther­a­pies for he­mo­phil­ia, too. While ex­ecs and reg­u­la­tors have re­peat­ed­ly de­clined to shed light on the road­block, a com­mon as­sump­tion is that the FTC is prob­ing for po­ten­tial over­laps be­tween Spark’s ex­per­i­men­tal he­mo­phil­ia treat­ments and Roche’s new­ly launched Hem­li­bra. More re­cent­ly, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty has al­so launched its own in­ves­ti­ga­tion.

Jef­feries an­a­lysts con­tend­ed that “there is un­like­ly any ma­jor is­sue” as the he­mo­phil­ia mar­ket is crowd­ed and gene ther­a­pies work quite dif­fer­ent­ly than Hem­li­bra, an an­ti­body that bridges two oth­er blood clot­ting fac­tors.

Hav­ing con­fi­dent­ly pre­dict­ed that the deal would close in the first half of this year, Roche is now look­ing to wrap it by year-end. Spark stock­hold­ers — which have col­lec­tive­ly ten­dered 25.2% of their shares — now have un­til Sep­tem­ber 3 to pon­der if there will be yet an­oth­er ex­ten­sion.

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.

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.

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.

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.

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).

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.