MorphoSys’ chief scientist hits the exit, triggering R&D reorganization as they shift focus to US in anticipation of looming FDA approval

Malte Peters, Endpoints UK Bio

November 21, 2019 06:51 AM ESTUpdated 10:44 AM

John Carroll

MorphoSys’ chief scientist hits the exit, triggering R&D reorganization as they shift focus to US in anticipation of looming FDA approval

Just a few days after opening up its new US headquarters on Boston harbor in prep for what they believe is the imminent approval of a new CAR-T rival, MorphoSys says that its top scientist is stepping down and they’re reorganizing R&D under development chief Malte Peters.

Markus Enzelberger MorphoSys

We don’t know the details about what’s up, aside from the fact that they said in an announcement that 17-year company veteran Markus Enzelberger is leaving his job as chief scientific officer to explore new opportunities. And with his departure, they will be “integrating” research into the development operation.

This is the latest in a pair of high-profile changeups in the executive crew at MorphoSys this year. CEO Simon Moroney announced he would step aside near the beginning of the year. He was replaced by Jean-Paul Kress, the former CEO at Boston-based Syntimmune, which was bought out by Alexion.

The German biotech has been beefing up its US commercial team in preparation for the likely approval of their CD19-targeting antibody tafasitamab — or MOR208. Combined with lenalidomide they believe they can offer a more appealing alternative to Kymriah and Yescarta — the first 2 CAR-Ts, after a trial showed that patients suffering from treatment-resistant DLBCL, a common form of non-Hodgkin’s lymphoma, produced a median on progression-free survival rate 12.1 months with a median duration of response at 21.7 months. The overall response rate among 80 patients was 60% with a 43% complete response rate.

They’ve been discussing a mid-2020 market launch in the US.

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

December 13, 2019 04:35 PM ESTUpdated 04:55 PM

John Carroll

Pharma

Regulatory

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.”

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Paul Hudson, Getty Images

December 9, 2019 05:27 PM ESTUpdated December 10, 08:48 AM

John Carroll

R&D

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.”

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December 12, 2019 06:40 PM ESTUpdated December 13, 04:42 AM

Amber Tong

R&D

Regulatory

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.

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Paul Biondi (File photo)

December 13, 2019 08:26 AM ESTUpdated 03:15 PM

John Carroll

R&D

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.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

December 13, 2019 05:52 PM EST

Jason Mast

Cell/Gene Tx

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.

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December 13, 2019 04:23 PM EST

Jason Mast

Regulatory

FDA expert panel unanimously recommends approval for Horizon Therapeutics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

December 13, 2019 10:43 AM EST

Endpoints Contributor

Biotech Voices

Biopharma has abandoned antibiotic development. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

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December 13, 2019 10:21 AM ESTUpdated 11:48 AM

Kathy Wong

Peer Review

Shehnaaz Suliman dives back into Alzheimer's at Alector; Pyxis recruits SpringWorks founder Lara Sullivan as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

December 13, 2019 10:04 AM EST

Natalie Grover

R&D

PhII failure in rare neurodegenerative disease? No matter, Biogen will motor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.