Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ Af­ter Te­va spin­out 89bio re­cent­ly an­nounced that its IPO was be­ing held up, the com­pa­ny is back in the game of­fer­ing 5,304,687 shares at a price of $16 per share. The com­pa­ny has raised $84.9 mil­lion IPO in gross pro­ceeds and will be list­ed un­der the tick­er sym­bol $ETNB. Bo­fA Se­cu­ri­ties, SVB Leerink and RBC Cap­i­tal Mar­kets are the joint book-run­ning man­agers for the of­fer­ing. Op­pen­heimer & Co is the co-man­ag­er for the of­fer­ing.

→ Look­ing to amp up its pres­ence in Japan’s hos­pi­tals, No­var­tis has struck a deal to buy out As­pen’s port­fo­lio of gener­ics in the world’s third largest health­care mar­ket. The phar­ma gi­ant is pay­ing $440 mil­lion for As­pen’s Japan­ese sub­sidiary.

No­var­tis said tropifex­or, a non-bile acid FXR ag­o­nist, has scored on sev­er­al key bio­mark­ers of NASH in a Phase IIb tri­al, in­clud­ing re­duc­tions in he­pat­ic fat, ala­nine amino­trans­ferase and body weight com­pared to a place­bo at 12 weeks.

Daré Bio­science has ac­quired Gates-Foun­da­tion-backed Mi­crochips Biotech, which is de­vel­op­ing an im­plant en­gi­neered to de­liv­er hun­dreds of ther­a­peu­tic dos­es over months or years. The tech­nol­o­gy, first cre­at­ed in the lab of pro­lif­ic MIT sci­en­tist Bob Langer, has been val­i­dat­ed in os­teo­poro­sis pa­tients and is be­ing eval­u­at­ed for use as a re­versible con­tra­cep­tive. “The ad­di­tion of this user-con­trolled, long-act­ing re­versible con­tra­cep­tive op­por­tu­ni­ty to Daré’s pipeline, which al­ready in­cludes the nov­el month­ly, hor­mone-free con­tra­cep­tive Ovaprene, will unique­ly po­si­tion Daré with two of the po­ten­tial­ly most dis­rup­tive in­no­va­tions in the con­tra­cep­tive cat­e­go­ry, said Daré chief Sab­ri­na Mar­tuc­ci John­son. Daré is prep­ping to re­port the da­ta from the ovaprene post­coital test clin­i­cal tri­al and a pre-piv­otal study to sup­port prod­uct reg­is­tra­tion.

→ The tide of an­tibi­ot­ic re­sis­tance shows no signs of stop­ping, and the FDA is re­ward­ing the com­pa­nies that are still in the field. A Phase III in­tra­venous com­bi­na­tion an­tibi­ot­ic, ATM-AVIfrom Al­ler­gan and Pfiz­er has scored the FDA’s QIDP des­ig­na­tion and fast track sta­tus. The drug, de­signed to tar­get Gram-neg­a­tive pathogens, is in de­vel­op­ment com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions (cIAI), com­pli­cat­ed uri­nary tract in­fec­tions, and hos­pi­tal-ac­quired bac­te­r­i­al pneu­mo­nia,  and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

→ On the heels of pos­i­tive da­ta un­veiled at ES­MO, Chi-Med has se­cured a place in line at Chi­na’s drug reg­u­la­to­ry agency for su­r­u­fa­tinib. The Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion is re­view­ing an NDA for the ki­nase in­hibitor in ad­vanced non-pan­cre­at­ic neu­roen­docrine tu­mors, which would be Chi-Med’s sec­ond prod­uct on the mar­ket. The Lon­don-list­ed biotech re­port­ed last month in the SANET-ep tri­al, su­r­u­fa­tinib ex­tend­ed me­di­an pro­gres­sion-free sur­vival to 9.2 months com­pared to 3.8 months on place­bo.

No­vo Nordisk is tak­ing an­oth­er care­ful step in­to the NASH space by li­cens­ing a pre­clin­i­cal com­pound from Japan’s UBE. UD-014 is a semi­car­bazide-sen­si­tive amine ox­i­dase/vas­cu­lar ad­he­sion pro­tein-1 in­hibitor that is be­lieved to have both an­ti-in­flam­ma­to­ry and an­tiox­ida­tive ef­fects. The Dan­ish drug­mak­er, known for its di­a­betes fran­chise, has col­lab­o­rat­ed with Gilead to test its GLP-1 drug semaglu­tide as part of a triple NASH com­bo.

Ab­cam signed off a cash pay­ment of €120 mil­lion to pur­chase Ex­pe­deon AG‘s pro­teomics and im­munol­o­gy busi­ness ac­tiv­i­ties. The agree­ment is still sub­ject to a share­hold­er ap­proval at a meet­ing held next month by Ex­pe­deon.

Paul Hudson, Getty Images

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 67,600+ biopharma pros reading Endpoints daily — and it's free.

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.