FDA Ad Com thumbs up on CV benefit of Amarin’s Vascepa
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 backing the cardiovascular (CV) benefit of Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl).
The key remaining question is the specific breadth of the label (the approved population).
Acasti, Matinas rise on Amarin heart drug news
Acasti Pharma (NASDAQ:ACST) and Matinas BioPharma Holdings (NYSEMKT:MTNB) are jumping after hours following Amarin’s FDA panel win to expand the label for its heart drug Vascepa.
ACST is up 12.3% and and MTNB is up 12.2% in postmarket trading.
The two are similar-sized peers to Amarin in the space.
FDA OKs BeiGene’s zanubrutinib for mantle cell lymphoma
The FDA grants accelerated approval to BeiGene’s (BGNE -0.6%) BTK inhibitor zanubrutinib, branded as Brukinsa, for the treatment of mantle cell lymphoma, an aggressive type of non-Hodgkin lymphoma, its first approved drug in the U.S. The approved use is for patients who have received at least one prior line of therapy.
Zanubrutinib had Breakthrough Thera
Biogen off 3% as MS Society takes issue with Vumerity cost
In a statement released yesterday, the National MS Society expressed disappointment with the wholesale acquisition cost (WAC) of Vumerity (diroximel fumarate), approved by FDA on October 30 for relapsing forms of multiple sclerosis (MS).
The Society considers the $88K WAC excessive, citing that the price is only $500 lower than the least expensive oral disease-modifying treatment and “does not show the commitment to affordable access that we had hoped.”
The compound was initially developed by Alkermes (ALKS +1.3%) and exclusively licensed to Biogen (BIIB -2.7%) in November 2017.
Biogen, like almost all other biotechs, has a track record of consistent price hikes for its medicines. For example, Tecfidera (dimethyl fumarate), was approved in the U.S. for relapsing forms of MS in March 2013 at a WAC of $54,750 which has increased over $40K to today’s WAC of $94,991, a compounded increase of almost 10% annually.
Bayer teams up with Dewpoint Therapeutics in CV and gynecological disorders
Bayer (OTCPK:BAYRY -0.3%) will collaborate with privately held Cambridge, MA-based Dewpoint Therapeutics to develop small molecule drugs to treat cardiovascular (CV) and gynecological diseases.
The partnership will leverage Bayer’s small molecule compound library and R&D capabilities with Dewpoint’s biomolecular condensate technology and know-how.
Under the terms of the agreement, Bayer will have the option to exclusively in-license a certain number of programs. Specific financial terms are not disclosed.
Bayer participated in Dewpoint’s Series A financing round in January via the purchase of LEAPs.