Global Pharma Briefs: News from Biogen, Biocon, and bluebird bio
A roundup of news from India (Biocon) and the US (Biogen and bluebird bio).
Biocon Biologics OKs $150-M Capital Injection from Goldman Sachs
The board of Biocon Biologics, a biosimilars company and a subsidiary of Biocon, a Bangalore, India-based pharmaceutical company, has approved an approximate $150-million capital injection from Goldman Sachs. Goldman Sachs has valued Biocon Biologics at $3.94 billion. The transaction is subject to customary approvals and conditions.
Biocon Biologics is developing biosimilars and is also partnered with Mylan on a broad portfolio of biosimilars and insulin analogs. In late August (August 2020), Biocon Biologics and Mylan announced the US launch of of Semglee (insulin glargine injection), a diabetes drug that has an identical amino acid sequence to Sanofi’s Lantus. The companies have also launched in the US biosimilars of Roche’s Herceptin (trastuzumab) and Amgen’s Neulasta (pegfilgrastim).
FDA Advisory Committee Offers Opinion on Biogen’s Alzheimer’s Drug
An advisory committee of the US Food and Drug Administration (FDA) provided an evaluation of Biogen’s aducanumab, an investigational drug for treating Alzheimer’s disease. FDA advisory committees provide non-binding recommendations for consideration for approval by the FDA.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 8-1 that data from a Phase III Biogen’s study evaluating aducanumab in patients with mild Alzheimer’s disease was not enough to show efficacy. The committee voted 7-0 (and four uncertain) that Biogen’s Phase Ib study failed to show supporting evidence of efficacy. The committee voted 5-0 (and six uncertain) that Biogen presented strong evidence of aducanumab’s pharmacodynamic effect on Alzheimer’s disease.
With the opinions expressed at the advisory committee and the data presented, the FDA will continue the review process with a decision on whether to approve aducanumab by March 7, 2021.
bluebird bio’s BLA for Gene Therapy Delayed Due to Mfg Issues
bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, is adjusting the timing of its biologics license application (BLA) submission to the US Food and Drug Administration (FDA) for LentiGlobin (betibeglogene darolentivec), a gene-therapy for treating sickle-cell disease (SCD), to late 2022 due to manufacturing issues.
The company had reached a general agreement with the FDA on its path to transition to commercial manufacturing using an analytical comparability strategy, including a suspension-based lentiviral vector. However, the FDA requested the use of drug product manufactured from SCD patient cells in addition to healthy donors as well as a commercial lentiviral vector to demonstrate drug-product comparability. Given this feedback, alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts, bluebird is adjusting its submission timing to late 2022.
Source: bluebird bio