Flexion secures China deal for osteoarthritis drug; Struggling to find a buyer, Akorn throws in the towel

April 1, 2020 10:53 AM EDTUpdated 01:01 PM

Flexion secures China deal for osteoarthritis drug; Struggling to find a buyer, Akorn throws in the towel

Amber Tong

Editor

→ Flexion may be hitting the brakes on clinical trials, including one for its osteoarthritis drug Zilretta, but that’s not stopping the biotech from plotting regulatory action in China. Hong Kong Tainuo has committed $10 million upfront to seize the development and commercialization rights to Zilretta, with plans to apply for a clinical trial in China by the end of the year. Flexion, which said it has 10 months of finished goods in the US and 12 months of active pharmaceutical ingredient available, will supply all products to the Chinese partner.

→ Struggling specialty generic maker Akorn has given up on finding a buyer, ending a sale process that it said was negatively impacted by the broader market uncertainties under the Covid-19 crisis. There are no bids on the table that would sufficiently pay off all its loans, the company said.

AUTHOR

Amber Tong

Editor

amber@endpointsnews.com @AmberTongPW

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Jude Samulski, Marianne De Backer

October 26, 2020 03:30 AM EDTUpdated 06:26 AM

Deals

Cell/Gene Tx

Bayer buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at going big into gene therapy

John Carroll

Editor & Founder

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

October 27, 2020 09:44 AM EDT

People

Coronavirus

In Focus

After falling behind the leaders, dissed by some experts, biotech showman Patrick Soon-Shiong finally gets his Covid-19 vaccine ready for a trial. But can it live up to the hype?

Jason Mast

Associate Editor

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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October 27, 2020 11:10 AM EDT

News Briefing

News briefing: Novartis' Zolgensma hits blockbuster status, triggering $80M milestone; Caris raises $310M for genomic profiling expansion

John Carroll

Editor & Founder

Novartis reported that Zolgensma earned $291 million in Q3, which puts the SMA gene therapy squarely in the blockbuster category. That, in turn, is paying benefits to Regenxbio, which provided the NAV AAV9 vector used by Zolgensma.

The biotech $RGNX reported Tuesday morning that it is getting an $80 million milestone payment from Novartis, which now has earned more than $1 billion cumulatively from the new gene therapy franchise. And with large percentages of newborns now being screened for the rare, lethal ailment, the franchise can continue to grow.

ENDPOINTS CAREERS

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Vigeo Therapeutics

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Cedric Francois, Apellis CEO (Optum via YouTube)

October 27, 2020 11:06 AM EDTUpdated 12:02 PM

Deals

UPDATED: Sobi bets $250M cash, about $1B in milestones for rights to a C3 therapy being pushed through 5 pivotal trials

Nicole DeFeudis

Associate Editor

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

October 27, 2020 10:46 AM EDT

People

R&D

Bayer follows R&D deal spree by raiding Roche's cancer group for its new research chief

John Carroll

Editor & Founder

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

October 27, 2020 08:01 AM EDTUpdated 10:42 AM

R&D

Coronavirus

UPDATED: Where's the Pfizer efficacy readout? CEO Bourla says 'soon,' but you're going to have to wait for it

John Carroll

Editor & Founder

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

October 25, 2020 10:45 AM EDTUpdated October 26, 06:33 AM

R&D

UPDATED: Mirati plots a march to the FDA for its KRAS G12C drug, breathing down Amgen’s neck with better data

John Carroll

Editor & Founder

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Yung Chyung, Scholar Rock CMO (Business Wire)

October 27, 2020 04:53 PM EDTUpdated 05:39 PM

R&D

A dark horse entrant into the spinal muscular atrophy field doubles its value on some PhII data

Jason Mast

Associate Editor

The last four years have seen a sudden explosion in treatments for spinal muscular atrophy, a neurodegenerative condition that once led patients — often young ones — with a grim prognosis and no options. The prognosis still isn’t rosy, but now there are three FDA-approved options, enough to make the choice of one difficult.

Now a fourth potential option has entered the mix. Today, Scholar Rock announced the results from a proof-of-concept testing their SMA drug by itself and in combination with Ionis’ Spinraza, showing that all patient cohorts improved on standard scales used for measuring motor function in people with SMA.

October 26, 2020 07:44 PM EDTUpdated 14 hours ago

Coronavirus

UPDATED: Researchers shutter 2 Covid-19 studies as monitors flag Eli Lilly antibodies as a flop for pneumonia, hospitalized patients — but EUA hunt continues

John Carroll

Editor & Founder

Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.

The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.