The phrase "PDUFA date" is thrown around frequently when discussing biotech and pharma companies. PDUFA
stands for the Prescription Drug User Fee Act, which is a law allowing the Food and Drug Administration to charge companies that file new drug applications. The money goes toward expediting the review process that takes six months for drugs with an accelerated approval and 10 months for a standard filing. Adding the appropriate number of months to the date of filing equals the PDUFA date -- or date by which the FDA is expected to make an approval decision.
Take the PDUFA dates as a suggestion rather than an appointment. The FDA is prone to making decisions earlier -- or later. But the date provides investors a general hint as to when a catalyst could impact share prices.
Here's a look at three PDUFA dates that will kick off 2014.
Forxiga tries again
The diabetes partnership of AstraZeneca plc (ADR) (NYSE:AZN)
and Bristol-Myers Squibb Co (NYSE:BMY)
have a Jan. 11 PDUFA date for SGLT-2 inhibitor
Forxiga. It's another try for Forxiga after the companies received a complete response letter requesting more safety data. The delay allowed Johnson and Johnson's Invokana to become the first-in-class drug in the U.S. market. But Forxiga did become the first SGLT-2 approved in Europe.
Decision Resources predicts that the type 2 diabetes market will double to about $50 billion by 2021. Older drug classes such as DPP-4
will hold on to a large percentage of the market. But SGLT-2s were so highly anticipated because they're insulin-independent and can appear in combo therapies with insulin without the risk of counteraction, which could prove a major selling point for patients.
How much are AstraZeneca plc (ADR) (NYSE:AZN) and Bristol-Myers Squibb Co (NYSE:BMY) depending on Forxiga's U.S. launch?
AstraZeneca plc (ADR) (NYSE:AZN) is limping following the patent expiration of antipsychotic Seroquel IR last year. The drug's sales fell 77% in the first half of this year, compared to last year's numbers. It was a drop that took Seroquel from blockbuster territory to $226 million for the period. And the loss fueled the company's 10% drop in overall revenues for the half.
Bristol-Myers Squibb Co (NYSE:BMY)' U.S. net sales dropped 22% in the second quarter thanks to the 2012 expirations of high blood pressure drug Avapro and blood thinner Plavix. The company lowered its 2013 forecast due to unexpectedly sluggish sales for blood thinner Eliquis -- and for diabetes drug Bydureon.