Af­ter an R&D odyssey filled with set­backs, Clo­vis wins an FDA OK for ru­ca­parib

Richard Padzur, On­col­o­gy Cen­ter of Ex­cel­lence, FDA

Clo­vis On­col­o­gy $CLVS won some re­demp­tion to­day, gain­ing an ac­cel­er­at­ed ap­proval for its first drug and set­ting it on a short path to com­mer­cial­iza­tion.

The FDA has ap­proved its PARP in­hibitor ru­ca­parib, to be sold as Rubra­ca, to treat ovar­i­an can­cer cas­es with BR­CA mu­ta­tions. The drug is en­ter­ing a mar­ket that will be sliced and diced by a va­ri­ety of com­peti­tors. The Foun­da­tion­Fo­cus CDxBR­CA com­pan­ion di­ag­nos­tic was al­so OK’d for use with Rubra­ca.

Just last Oc­to­ber the Boul­der, CO-based biotech’s stock tanked af­ter an­a­lysts were unim­pressed by the lat­est da­ta cut, with me­di­an pro­gres­sion-free sur­vival time in a sin­gle-arm study at ten months. That’s fine for an FDA ap­proval in can­cer, though, and Rubra­ca will now weigh in against As­traZeneca’s pi­o­neer­ing Lyn­parza, which may prove the fa­vorite of the two.  There’s al­so an up­com­ing de­ci­sion on Tesaro’s ri­val ni­ra­parib, though that is for a dif­fer­ent ini­tial pa­tient pop­u­la­tion. Pfiz­er is com­ing up from be­hind with a PARP, ta­la­zoparib, that it ac­quired in the $14 bil­lion Medi­va­tion buy­out.

Leerink’s Sea­mus Fer­nan­dez not­ed:

While this cur­rent ap­proval is un­like­ly to im­pact the ini­tial com­pet­i­tive dy­nam­ics for TSRO’s (OP) ni­ra­parib or AZN’s (OP) Lyn­parza (ola­parib) in 2L main­te­nance, da­ta from Rubra­ca’s Phase 3 ARIEL3 tri­al in this set­ting are now ex­pect­ed in mid-2017 (vs. 2H:17 pre­vi­ous­ly). De­spite this ear­li­er read­out, we con­tin­ue to see ni­ra­parib as the ul­ti­mate win­ner in 2L main­te­nance (ap­proval like­ly in 1H:17), with its Phase 3 NO­VA tri­al hav­ing al­ready es­tab­lished a strong pro­gres­sion-free sur­vival (PFS) ben­e­fit in a broad pop­u­la­tion.

Tesaro re­port­ed ear­li­er that the ni­ra­parib arm hit the pri­ma­ry end­point of their study with a me­di­an PFS of 12.9 months com­pared to 3.8 months for the con­trol arm. Among germline BR­CA mu­ta­tion pa­tients, the me­di­an PFS for pa­tients treat­ed with ni­ra­parib was 21.0 months, com­pared to 5.5 months for con­trol.

It’s all good for Clo­vis to­day, though, which saw its shares surge an ini­tial 15% af­ter gain­ing an ap­proval that fol­lowed mul­ti­ple set­backs along the way. The biotech was forced to re­state its da­ta sub­mit­ted for an ap­proval of rocile­tinib, prompt­ing an em­bar­rass­ing and dev­as­tat­ing drop in the num­ber of re­spons­es that the biotech had claimed for their drug. An FDA pan­el sub­se­quent­ly re­ject­ed the drug, prompt­ing Clo­vis to re­struc­ture and lay off staffers, while bury­ing ro­ci as a los­er.

Clo­vis did not cut its com­mer­cial group, though, con­fi­dent that it could fi­nal­ly score a win here.

“To­day’s ap­proval is an­oth­er ex­am­ple of the trend we are see­ing in de­vel­op­ing tar­get­ed agents to treat can­cers caused by spe­cif­ic mu­ta­tions in a pa­tient’s genes,” said Richard Paz­dur, MD, di­rec­tor of the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search and act­ing di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence. “Women with these gene ab­nor­mal­i­ties who have tried at least two chemother­a­py treat­ments for their ovar­i­an can­cer now have an ad­di­tion­al treat­ment op­tion.”

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.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.