The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season.
Lack of efficacy brought the development of two investigational agents for amyotrophic lateral sclerosis (ASL) to a halt over the past week. On May 23, Wave Life Sciences Inc. disclosed that its stereopure antisense oligonucleotide WVE-004 failed to demonstrate clinical benefit after 24 weeks of treatment on a phase Ib/IIa trial in familial ALS patients or frontotemporal dementia patients. And on May 25, Apellis Pharmaceuticals Inc. and its partner, Swedish Orphan Biovitrum International AB, said that pegcetacoplan failed to meet its primary endpoint of a one-year phase II trial in patients with sporadic disease.
Swedish Orphan Biovitrum (Sobi) AB is offering a hefty 95% premium to shareholders in CTI Biopharma Corp., as it tables a $9.10-per-share cash offer for the company, which implies a total equity valuation of $1.7 billion. Shares in Seattle-based CTI (NASDAQ:CTIC) had closed May 9 at $4.82 but surged 85% to close at $8.93 during trading May 10. The premium calculation is based on CTI’s 30-day volume-weighted average trading price of $4.67 prior to the deal announcement.
Selecta Biosciences Inc. and Swedish Orphan Biovitrum AB unveiled top-line phase III data from the Dissolve I and II trials testing SEL-212 in adults with chronic refractory gout (CRG) – results that position the companies for a regulatory filing in the U.S. during the first half of next year. SEL-212 could take on Horizon Therapeutics plc’s Krystexxa (pegloticase), a pegylated uric acid specific enzyme cleared by the U.S. FDA for CRG in September 2010.
In a new licensing deal cut with Swedish Orphan Biovitrum AB (Sobi), ADC Therapeutics SA is getting a $55 million up-front payment and could receive $50 million more upon regulatory approval of Zynlonta (loncastuximab tesirine) in third-line diffuse large B-cell lymphoma by the European Commission.
Partners Sanofi SA and Swedish Orphan Biovitrum AB (Sobi) said regulatory submissions are expected this year for once-weekly factor VIII therapy efanesoctocog alfa in hemophilia A following top-line success in a pivotal phase III study, which showed a clinically meaningful prevention of bleeds in people with severe disease receiving prophylaxis over 52 weeks. The drug, also known as BIVV-001, has fast track and orphan designations in the U.S., and the companies are banking on its extended half-life to go up against blockbuster bispecific antibody Hemlibra (emicizumab) from Roche Holding AG as well as a potential gene therapy from Biomarin Pharmaceutical Inc.
Swedish Orphan Biovitrum AB shares (STO:SOBI) fell 25% Dec. 3 as investors behind Agnafit Bidco AB, previously poised to pay about SEK72.17 billion (US$7.97 billion) for the company, withdrew their bid as shares tendered fell just short of the 90% needed to complete the deal. The bid was seen as likely to succeed after Investor AB, which owns 35% of the capital and votes in the company, commonly called Sobi, supported it. However, with only 87.3% of outstanding shares tendered as of Dec. 3, Agnafit decided to drop the offer, foregoing further extension of the acceptance period, which was earlier extended by ten days to Nov. 26 in hopes of collecting enough support.
Apellis Pharmaceuticals Inc. could receive up to $1.25 billion from Swedish Orphan Biovitrum (Sobi) AB in their collaboration to develop systemic pegcetacoplan, a C3 therapy for treating several rare diseases in hematology, nephrology and neurology.
A phase III failure of Swedish Orphan Biovitrum AB's oral thrombopoietin receptor agonist avatrombopag to effectively outperform a placebo in treating chemotherapy-induced thrombocytopenia, or low platelet counts, sent company shares down 17.9% on Oct. 9.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.