What's tak­ing the FTC so long? Roche won't say, but in­sists it will bag Spark on time — de­spite third de­lay

Roche is de­lay­ing its buy­out of Spark Ther­a­peu­tics for a third time, giv­ing it­self one last chance to com­plete the deal with­in the first half of 2019.

When the Swiss phar­ma gi­ant an­nounced in late April it was with­draw­ing a Pre­merg­er No­ti­fi­ca­tion and Re­port Form once again, it ex­pect­ed to re­file the doc­u­ments around May 9. But it now wants to push the re­fil­ing day back two weeks, set­ting May 23 as the new go time.

As was the case for the pre­vi­ous de­lays, Roche cit­ed an on­go­ing reg­u­la­to­ry re­view as the rea­son for re­fil­ing and ex­tend­ing its of­fer to ac­quire the gene ther­a­py biotech for $4.3 bil­lion.

Up­on my query, the spokesper­son re­spond­ed in 5 min­utes with what has be­come a fa­mil­iar an­swer:

Both Roche and Spark were aware that FTC re­view and clear­ance would be re­quired for the trans­ac­tion. This step in the process al­lows the FTC more time to com­plete its re­view and is not un­usu­al in a trans­ac­tion of this type.

There is no change in as­sump­tions. We ex­pect it will be com­plet­ed ac­cord­ing to our guid­ance in the first half of 2019.

Spark share­hold­ers now have un­til June 14 to ten­der their shares. The per­cent­age of shares al­ready sold has fur­ther de­clined to 21% at last count, com­pared to 26.1% and 29.4% reg­is­tered on pre­vi­ous dead­lines. Both were still a far cry from the 50% re­quired to com­plete the deal, though Roche main­tained that it’s not un­usu­al for “a sig­nif­i­cant por­tion of share­hold­ers” to wait un­til the last days of the of­fer pe­ri­od.

Philadel­phia-based Spark faces sev­er­al law­suits from in­vestors who feel cheat­ed by the lead­er­ship. A month ago, In­vestor rights law firm Halper Sadeh launched a class ac­tion suit al­leg­ing that when try­ing to win over share­hold­ers, the biotech $ONCE pro­vid­ed “ma­te­ri­al­ly in­com­plete and mis­lead­ing in­for­ma­tion con­cern­ing, among oth­er things, the val­u­a­tion analy­ses and method­olo­gies pre­pared by Sparks’ fi­nan­cial ad­vi­sor in con­nec­tion with the ren­der­ing of its fair­ness opin­ion.”

In a Feb­ru­ary Q&A doc­u­ment in­tend­ed to as­sure em­ploy­ees, Spark not­ed that Roche in­tends to keep it as a ded­i­cat­ed, au­tonomous gene ther­a­py spe­cial­ist, while pour­ing in the re­sources to build a whole unit around it.

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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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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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.

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).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

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.