UPDATED: Biogen pulls PRIME designation for aducanumab in Europe; Merck closes merger with Acceleron
Following news last week that Biogen received “a negative trend vote” in Europe for its controversial Alzheimer’s drug aducanumab, the EMA updated a list of PRIME designations indicating that some, including Biogen, pulled out of the EU’s priority medicines scheme, known as PRIME.
But Biogen said in a statement to Endpoints News that it actually pulled the PRIME designation for aducanumab in 2019, noting that it occurred “following the discontinuation of the EMERGE and ENGAGE studies,” and that it “was a procedural requirement at the time.”
Aducanumab was first granted entry into the PRIME program back in May 2016, EMA said in its running list of PRIME designations.
The negative news for Biogen in Europe follows an extremely slow start in selling the infused drug in the US. But the Cambridge, MA-based biotech is still awaiting a major decision from the Centers for Medicare and Medicaid Services on whether the US federal government will pay for use of the drug. A draft of that decision is expected on Jan. 12. — Zachary Brennan
Merck completes acquisition of Acceleron
Merck’s highly publicized acquisition of Acceleron Pharma is now complete, Merck announced this morning — making it the biggest biotech merger of the year.
The $11.5 billion deal to acquire the biotech and its lead pulmonary arterial hypertension drug sotatercept had been highly publicized — and confirmed days of rumors and insider leaks when it was officially announced at the end of September.
“This is an important and strategic opportunity for our company to continue growing our cardiovascular portfolio and pipeline,” Merck president and CEO Rob Davis said in a statement.
Sotatercept, which had been in testing to improve outcomes in patients with PAH, is currently in Phase III trials as an add-on to current standard of care treatments. — Paul Schloesser
Decibel’s R&D deal with Regeneron is getting an extension
Decibel Therapeutics’ research collaboration with Regeneron is getting extended.
The collaboration, which started in 2017 to discover and develop gene therapies for hearing loss, will be extended to Nov. 15, 2023, and Regeneron will pay $10 million as an extension fee in Q4 2022.
Under the collaboration, Decibel is developing three gene therapy programs with Regeneron — targeting congenital, monogenic hearing loss. Decibel plans to initiate a Phase I/II clinical trial of DB-OTO, its lead gene therapy product candidate, next year. Decibel is also advancing two other gene therapy programs targeting other monogenic forms of hearing loss as part of the collab — AAV.103 and AAV.104.
“We are pleased that Regeneron has elected to extend the research term, which extends our access to Regeneron’s world-leading genomic and genetic technologies, and therapeutic discovery and development expertise,” said Decibel’s CEO Laurence Reid. — Paul Schloesser
Kamada buys portfolio from Saol Therapeutics in deal with $95M upfront
Israeli biotech Kamada acquired a portfolio of four FDA-approved products from Saol Therapeutics for $95 million upfront.
The products, which are “plasma-derived hyperimmune commercial products” according to a company statement, have an expected combined annual global revenue of between $40 and $45 million, with approximately 95% of sales between the US and Canada.
The four acquired products include:
- Cytogam (Cytomegalovirus Immune Globulin Intravenous [Human]) for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas, and heart.
- Winrho SDF, which is indicated to increase platelet counts to prevent excessive hemorrhage in the treatment of non-splenectomies, for Rho(D)-positive children with chronic or acute immune thrombocytopenia (ITP), adults with chronic ITP, and children and adults with ITP secondary to HIV infection.
- Hepagam B, a hepatitis B immune globulin product indicated to both prevent hepatitis B virus recurrence following liver transplantation in hepatitis B surface antigen positive (HBsAg- positive) patients and provide post-exposure prophylaxis.
- Varizig, which contains antibodies specific to the varicella zoster virus, and is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns, and pregnant women.
According to Kamada CEO Amir London, the company hopes to expand further into the US next year. Alongside the $95 million upfront to Saol, Kamada will pay up to an additional $50 million in sales milestones until 2034. — Paul Schloesser
Editor’s note: Article corrected to note that Biogen actually pulled its PRIME designation from the EMA in 2019 when it discontinued the two studies of its Alzheimer’s drug. Reanalyses of those halted studies helped aducanumab win its approval in the US.