Lupus Drug Wins Approval and M/A Trends – News of the Week
First Treatment for Lupus in 50 Years Approved by FDA
For the first time in half a century, there is a new treatment for lupus – a chronic, incurable immune system disease in which the body attacks its own healthy cells and tissues. The FDA approved the injectable drug Benlysta (belimumab) for the treatment of patients with the most common form of lupus who are already on standard therapies like steroids, antimalarial drugs, and immunosuppressive drugs.
With lupus, a patient’s joints, skin, kidneys, heart, lung, blood vessels and brain can be affected. The drug is the first product developed by Human Genome Sciences and will be marketed by GlaxoSmithKline. It works by blocking a protein that fuels lupus. The drug however doesn’t work in African Americans who are three times more likely to get the disease but there were too few African Americans in the trial to draw a definitive conclusion. The FDA has asked the manufacturer to conduct a trial in only African Americans to assess the safety and effectiveness of this drug in this patient population. FDA approval is huge news for the more than 1.5 million Americans suffering from the disease as at least seven drugs in the last several years have suffered setbacks in clinical trials.
This news is significant on multiple levels. While it’s a step forward for the lupus community, it also underscores big pharma continuing to work with outside technologies – something we have talked about on this blog in the past. Importantly, this news also demonstrates how betting on the human genome is paying off in the discovery of new drugs. While it may have taken 18 years since the two companies partnered, it shows that patience has it rewards – in this case identifying functions of genes and their proteins and developing new drugs.
Large Medical Device Companies Look to M&A to Supplement Growth
Under increasing pressure to supplement product lines in markets that are flattening, large med-tech companies will continue to look to acquire smaller companies, according to a report published by the Walden Group. Examples include Novartis acquiring Nestle’s large stake in Alcon for $51.6 billion – one of the largest deals of 2010 – and one this blogger saw firsthand with our then client Invatec being acquired by Medtronic for $350 million. In addition, just this week Schwartz client Accuray announced it will buy TomoTherapy Inc. for $277 million. According to Medical Device Daily, the Walden Group expects the trend of big deals to continue with large companies looking to complement their offerings in their best growth markets.
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