Endpoints exclusive: Bob Nelsen’s Resilience snags Florida CDMO working with the Defense Department on Covid-19 antibody

Bob Nelsen (Michael Kovac/Getty Images)

April 12, 2021 04:33 PM EDTUpdated April 16, 12:44 PM

Endpoints exclusive: Bob Nelsen's Resilience snags Florida CDMO working with the Defense Department on Covid-19 antibody

Josh Sullivan

Resilience has only been in existence for less than six months, but Bob Nelsen’s next-gen manufacturing play has made plenty of moves shortly after debuting with an $800 million launch round. Now, the biotech looking to change drug manufacturing is picking up a Florida CDMO partnered with the Department of Defense on a Covid-19 antibody.

Resilience is acquiring CDMO Ology Bioservices in a deal that will add two manufacturing sites to the bicoastal biotech’s footprint as well as a government-backed monoclonal antibody, a source close to the matter said Monday. Financial terms of the deal were not available.

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June 27, 2022 07:00 AM EDT

R&D

Scoop: Boehringer quietly shutters a PhII for one of its top drugs — now under review

Kyle LaHucik

Associate Editor

John Carroll

Editor & Founder

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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June 27, 2022 01:29 PM EDT

Deals

A Merck partner is sucked into the financial quagmire as key lender calls in a note

John Carroll

Editor & Founder

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

David Loew (Ipsen)

June 27, 2022 03:19 AM EDTUpdated 07:29 AM

Deals

Ipsen snags an approved cancer drug in $247M M&A deal as another battered biotech sells cheap

John Carroll

Editor & Founder

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by Jan. 1, 2028.

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Director of Quality Assurance

ImmunityBio

Dunkirk, NY, USA

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June 27, 2022 02:30 PM EDTUpdated 05:31 PM

Financing

Pharma

Manufacturing

Alexion puts €65M forward to strengthen its position on the Emerald Isle

Tyler Patchen

News Reporter

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

June 27, 2022 02:03 PM EDT

FDA+

Law

State battles over mifepristone access could tie the FDA to any post-Roe crossroads

Zachary Brennan

Senior Editor

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

June 27, 2022 01:43 PM EDT

R&D

After a 5-year repeat PhIII sojourn, Lundbeck and Otsuka say they're finally ready to pursue OK to use Rexulti against Alzheimer's agitation

John Carroll

Editor & Founder

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

June 27, 2022 01:26 PM EDT

Financing

Manufacturing

Biden and G7 nations offer funds for vaccine and medical product manufacturing project in Senegal

Tyler Patchen

News Reporter

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

ENDPOINTS CAREERS

Product Sales Manager

ImmunityBio

Remote

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June 27, 2022 01:19 PM EDT

Pharma

Law

Federal judge denies Bristol Myers' attempt to avoid Celgene shareholder lawsuit

Nicole DeFeudis

Editor

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

June 27, 2022 11:12 AM EDT

R&D

Takeda, Arrowhead spotlight data from small trial showing RNAi works in a rare liver condition

Amber Tong

Senior Editor

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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