Weekend News: Business, Finance and Innovations in Biotech and Pharma Industries (AstraZeneca, Sun Pharma, Gilead, Abbvie Multiple Sclerosis)
These are the top stories of the weekend;
Biogen and Abbvie’s Zinbryta got FDA approval for Multiple Sclerosis
Zinbryta’s approval is based on the results of two clinical trials, DECIDE which is the largest and longest head-to-head Phase III study and the other one is Phase 2b SELECT conducted on MS.
The study showed Zinbryta significantly reduced annualized relapse rate (ARR) by 45% compared to the Avonex (interferon beta-1a used to treat MS). It also showed superior efficacy for many measures of MS disease activity compared to Avonex. 67% patients taking Zinbryta were relapse free compared to 51% of those taking Avonex.
AstraZeneca’s ZS-9 FDA Rejection Became Relypsa’s Gain
AstraZeneca’s potassium-lowering drug, ZS-9 got rejected by the U.S. FDA which it acquired last year by the acquisition of ZS Pharma for $2.7 billion. FDA rejected ZS-9 after it found some manufacturing issues during the inspection. At this point, tackling the issue and getting a new date for approval may take a year or more.
This loss of AstraZeneca became a gain for Relypsa’s Veltassa, a potassium-lowering drug. Last year in October, it got FDA approval for the treatment of hyperkalemia. Relypsa has not gained much by Veltassa’s approval due to the FDA mandated black-box safety warning about the potential risk of interference of the Valtassa with the other hyperkalemia drugs that patients might be taking. Relypsa has submitted new clinical data to FDA for the loosening or removal of the safety warning.
Before the rejection of ZS-9, it was estimated by the sales analysts to outrun Veltassa with the sales forecast of about $100 million in 2020. Currently, the regulatory blow up of AstraZeneca’s ZS-9 provides a big opportunity to the Relypsa’s Veltassa to score big in the market before AstraZeneca finds its way back in the competition.
US Regulators Issued Summon to Sun Pharma Seeking Generic Drugs Pricing Info
Sun Pharmaceuticals Ltd received summon from the US Department of Justice (DoJ) to get all the information related to the pricing and marketing of its generic drug which it sells in US. The DoJ’s antitrust division also asked for the corporate records, employee related documents, communications with competitors.
A broad scrutiny is going on by the US regulators regarding the sharp increase in the price of generic medicines in few years and the issued summon is also a part of this probe.
Gilead’s Epclusa Got Positive Opinion of CHMP for HCV Treatment
Gilead’s Epclusa (sofosbuvir/velpatasvir) received positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) for Marketing Authorization Application (MAA) for the treatment of adults with all genotypes of chronic hepatitis C virus (HCV) infection.
This recommendation will be reviewed by European Commission (EC) which holds the authority for the approval of medicines for use in 28 countries of European Union (EU), Norway and Iceland.The results of four Phase III studies support the MAA for Epclusa.
Featured image credit: London, England, May 11th, 2015 © BCFC (Stock Photo ID: 90608006)