The Food and Drug Administration will make a number of decisions in the first quarter regarding market clearance for experimental medicines. Here are five potential drug approvals scheduled for that period and the reason they’re key to strategies for the companies who developed the therapies. The descriptions are listed in chronological order. The date represents the deadline for the FDA to make a ruling on each drug. Some of these dates can be delayed.
Rytary for Parkinson’s disease is the lead drug candidate for the branded pharmaceutical division of Impax Laboratories (IPXL). Impax is a generic drug maker that’s looking to boost revenue with branded products. In October, the company said it expected fourth-quarter revenue to decline by as much as 20% from third-quarter sales as Impax’s generic business faces more competition. The company also is hoping to resolve manufacturing issues at a California plant after an FDA warning. Rytary looks approvable but may face some insurance coverage challenges early in its launch, according to an analysis by Leerink Swann. GlaxoSmithKline (GSK) has rights to sell the drug in most countries outside the US.
Celgene’s (CELG) multiple myeloma drug pomalidomide slowed the progression of cancer and improved length of survival in patients, according to study results released in early December. The data seems to support approval by the FDA. Celgene seeks approval for pomalidomide as a treatment for patients who were previously treated with other drugs. William Blair analyst John Sonnier estimates there are about 100,000 relapsed multiple myeloma patients in the US and Europe who have failed at least one prior therapy. Celgene CEO Robert Hugin previously called the drug a potential blockbuster, a drug that exceeds $1 billion in annual sales.
ImmunoGen (IMGN) and Roche (RHHBY) are expected to win approval for the breast cancer treatment trastuzumab emtansine, or T-DM1. The drug combines ImmunoGen’s chemotherapy with Roche’s Herceptin to better target cancer. The companies are bullish on the potential success for T-DM1, and it looks like Roche negotiated a good deal for itself. In October, shares of ImmunoGen fell after the company disclosed royalty payments that Wall Street analysts and investors viewed as skimpy for the biotech company. ImmunoGen would get only 3% royalties on sales of the drug in the US and abroad. The payments would only reach 5% if sales jump to more than $700 million in a single year. (See also: ImmunoGen Shares Drop on Roche Drug Royalty Payments.)
Big drug makers Bristol-Myers Squibb (BMY) and Pfizer (PFE) know they have a potentially big-selling drug in the blood thinner Eliquis. The companies seek approval of the product for the prevention of stroke and a clotting blockage known as systemic embolism. The drug is considered more effective and much safer than the longtime standard of care, warfarin. Even though other new anti-clotting treatments made by Johnson & Johnson (JNJ), Bayer, and Boehringer Ingelheim are already approved, Eliquis is seen as a potential leader among the recent wave of improved therapies. In June, the FDA rejected the drug, saying that it wanted more proof of the medicine’s effectiveness and safety. Both Pfizer and Bristol-Myers need new drugs as their former top-selling products lose sales to generic rivals. Eliquis is approved in Europe and Canada and it just won market clearance in Japan this week.
Biotech giant Biogen Idec (BIIB) was supposed to hear from the FDA about its experimental multiple sclerosis pill by late December. But the agency said it needed additional time to review the drug, known as BG-12. There are huge expectations on Wall Street and in the medical community for this drug, which would go head to head with Novartis’ (NVS) Gilenya. The Novartis pill, approved in late 2010, was the first oral treatment approved for MS, a disabling disease that attacks the central nervous system. The disease, an important therapeutic area for Biogen, historically was treated with injected or infused drugs. BG-12 is considered a sure blockbuster for Biogen, which has seen its shares rise by more than a third in 2012.
More from Minyanville
- 6 Brands That Reinvented Themselves Overseas
- 5 Up-and-Coming Fast Food Restaurants for 2013
- The Five Biggest Fast-Food Controversies of 2012
- The 18 Best Financial Tumblrs
DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer