Alessan­dro Ri­va ex­its top No­var­tis on­col­o­gy post, heads to a trou­bled — but wealthy — Gilead

Alessan­dro Ri­va

With its pipeline mired in bad da­ta and se­r­i­al set­backs and an­a­lysts de­mand­ing some sort of co­her­ent strate­gic re­sponse to the omi­nous down­turn in its hep C fran­chise, Gilead $GILD has man­aged to re­cruit one of the top names in on­col­o­gy drug de­vel­op­ment to head up its can­cer R&D ef­forts.

Alessan­dro Ri­va is turn­ing in his Big Phar­ma cre­den­tials at No­var­tis $NVS to move in­to the big biotech, which has tak­en a drub­bing at the hands of dis­ap­point­ed an­a­lysts this year.

In the can­cer field, Gilead was forced to halt a slate of 6 stud­ies for Zy­delig in the spring of 2016 due to safe­ty is­sues. And that came af­ter the drug was clear­ly los­ing a race with Im­bru­vi­ca from J&J and Ab­b­Vie on leukemia and lym­phoma. Ab­b­Vie and Roche’s vene­to­clax, mean­while, is ex­pect­ed to gain mar­ket ground in CLL.

Then in No­vem­ber came sub­par da­ta for mo­melo­tinib, which has been strug­gling to dis­tin­guish it­self from Jakafi for myelofi­boris.

Clin­i­cal set­backs, though, are all the rage at Gilead, which has been rack­ing up fail­ures through­out 2016, in­clud­ing 4 straight flops late in the year.

What Gilead does have is cash, and plen­ty of it. Ri­vas may have less to do in the clin­ic right now than at the deal ta­ble, where Gilead may yet spend a sig­nif­i­cant amount of its cash re­serves on M&A and li­cens­ing. Gilead clear­ly needs to do more in on­col­o­gy/hema­tol­ogy.

Bri­an Abra­hams at Jef­feries thinks that could be the case. He not­ed:

We be­lieve the rel­a­tive­ly high-pro­file heme/onc chief hire sig­nals an in­creas­ing fo­cus in on­col­o­gy, a wel­come de­vel­op­ment, and ex­pect GILD to more ag­gres­sive­ly pur­sue BD to build out a broad­er can­cer pipeline– some­thing not sub­stan­tial­ly baked in­to most ex­pec­ta­tions but which we be­lieve could help im­prove sen­ti­ment around the name and LT rev­enue prospects. We ex­pect spec­u­lat­ed (s)mid-cap M&A can­di­dates like IN­CY could al­so trade up on this an­nounce­ment.

“I have al­ways ad­mired Gilead for its sci­en­tif­ic fo­cus and da­ta-dri­ven ap­proach to drug de­vel­op­ment,” Ri­va said in a state­ment. “I look for­ward to work­ing along­side Gilead’s ded­i­cat­ed and pas­sion­ate col­leagues through­out the R&D or­ga­ni­za­tion to tack­le the can­cer re­search and de­vel­op­ment chal­lenge with a goal of im­prov­ing the lives of pa­tients.”

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.

Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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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).