With the SPDR S&P Biotech Index up 41% over the trailing 12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
As we head into the New Year, I'm a firm believer in starting us off on a positive note, so this week we'll be looking at only positive developments in the biotech sector last week.
One drug ruling that I noted investors should keep their eye on last month was the multidrug-resistant tuberculosis treatment Sirturo (previously known as Bedaquiline), developed by Johnson & Johnson's (NYSE:JNJ) subsidiary Janssen Pharmaceuticals. On Monday, the Food and Drug Administration approved Sirturo under the accelerated approval program, making it the first new TB medication approved in 40 years, and giving patients who had exhausted their previous treatment options new hope. In midstage clinical trials, Sirturo removed the TB virus from patients' sputum in a median time of 83 and 57 days in two concurrent trials, versus the 125 days needed for the placebo to perform to the same standard.
The other big news for the week came from Bristol-Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE), whose blood-thinning drug, Eliquis, which had recently received approval in Japan, Canada, and in the European Union, was finally approved in the United States. As I opined previously, Eliquis has game-changing, life-saving, and blockbuster potential, given the scope of heart attack and stroke victims worldwide and its sheer dominance of Warfarin in clinical trials. With its potential for $3 billion to $5 billion in peak sales, shareholders of Bristol-Myers and Pfizer finally have something to cheer about.
Because of the shortened week, two otherwise noteworthy stories slipped under my radar from the previous Friday: clinical data from Amicus Therapeutics (NASDAQ:FOLD) and a clinical update from Aeterna Zentaris (NASDAQ:AEZS).
Amicus Therapeutics, which you may recall was slaughtered two weeks ago after its Fabry disease trial failed to meet its end point, made up some ground this week after announcing positive midstage results for AT2220, which is co-administered with enzyme replacement therapy, or ERT, for Pompe disease. For those affected by Pompe disease, a deficient GAA enzyme leads to glycogen buildup in tissue affected by the disease. In Amicus' trial, human proof-of-concept exists that AT2220 co-administered with ERT increased GAA enzyme activity, and the company has planned additional studies of the drug.
For Aeterna Zentaris, a holding in my own portfolio, it received an agreement from the FDA on a special protocol assessment for its endometrial cancer drug, AEZS-108. In short, this means the FDA has accepted the company's testing protocols, clinical endpoints, and planned analyses as sufficient to file a new drug application, assuming a positive phase 3 trial. Despite being a microcap, Aeterna Zentaris has a huge pipeline, and it's one reason I'm giving the small biotech a shot with my real money.