Jan. 5 Quick Takes: Myriad restructuring; plus ViGeneron-Biogen, Rhythm, Sosei and more
Myriad’s autoimmune unit on the block
Myriad Genetics Inc. (NASDAQ:MYGN) said it will focus on women’s health, cancer and mental health and pursue strategic alternatives for its autoimmune unit. In November on its earnings call, the company announced it is seeking alternatives for its contract research services and dermatology businesses.
ViGeneron, Biogen eye diseases gene therapy deal
ViGeneron Gmbh partnered with Biogen Inc. (NASDAQ:BIIB) to develop and commercialize adeno-associated viral (AAV) vector gene therapies against up to two undisclosed targets for inherited eye diseases using the German biotech’s engineered AAV capsids for retinal cell transduction. ViGeneron will receive an upfront payment and R&D funding, and is eligible for development, regulatory and commercial milestones plus tiered royalties. Financial details were not disclosed.
Rhythm sells voucher to Alexion for $100M
Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) said it sold for $100 million a rare pediatric disease priority review voucher it obtained upon the approval of Imcivree setmelanotide. Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) was the buyer, according to a regulatory filing. FDA approved Imcivree last year for chronic weight management in patients ages six and older with obesity due to POMC, PCSK1 or LEPR deficiency.
AbbVie returns rights to muscarinic agonists to Sosei
AbbVie Inc. (NYSE:ABBV) has returned rights to muscarinic agonist programs to Sosei Group Corp. (Tokyo:4565). Sosei said AbbVie returned the assets due to business decisions regarding pipeline strategy.
EUA for Nirmidas finger-prick COVID antibody test
FDA granted a second emergency use authorization to the MidaSpot COVID-19 Antibody Combo Detection Kit, from Nirmidas Biotech Inc., that permits use of the rapid finger-prick test in point-of-care settings; the earlier EAU applied to high and moderate complexity labs. In point-of-care settings, the test detects antigen-specific IgM after seven days of symptoms and IgG after 14 days with 100% sensitivity.
Academic investigators gain guidance on individualized therapy development
FDA released draft guidance on IND submissions for individualized antisense oligonucleotide drug products to support academic sponsors using FDA’s N-of-One pathway. The guidance, which is designed to help overcome the steep learning curve for academics who don’t typically run first-in-human studies, provides advice on interactions with FDA and application expectations. It also contains non-binding recommendations on ethical considerations to address complex issues that could arise from the non-traditional nature of drug development in an N-of-One study, where the patient functions more like a drug development collaborator than a traditional clinical trial participant.
FDA to review growth hormone agonist from Pfizer and Opko
Pfizer Inc. (NYSE:PFE) and Opko Health Inc. (NASDAQ:OPK) said FDA accepted a BLA for Somatrogon to treat pediatric patients with growth hormone deficiency. The PDUFA date is in October.
LEPR (CD295) – Leptin receptor
PCSK1 – Proprotein convertase subtilisin/kexin type 1
POMC – Proopiomelanocortin