There are three PDUFA dates next week that should cause investors and traders to put four stocks onto their radar. Fibrocell Science (FCSC.OB) has a PDUFA date on 6/22 for laViv (azfibrocel-T) for wrinkle reduction. The next day there are two PDUFA dates that will make for a busy day for the FDA. Lannett (LCI) has a PDUFA for Morphine Sulfate Oral Solution. Partners Durect (DRRX) and Pain Therapeutics (PTIE) have a PDUFA date for Remoxy for moderate-to-severe chronic pain.
For some background, PDUFA dates are dates set by the FDA by which it expects to respond to a New Drug Application. The two most common replies are either an approval or a Complete Response Letter (CRL). There are also sometimes delays if the FDA is backed up. An approval is straight forward. A CRL is the FDA’s way of saying that there will be no approval, at least for now. The FDA might require additional trials, ask its Committee to look at it, change the labeling, or another request.
Fibrocell Science is first up. The company is expecting a response from the FDA for its laViv for wrinkle reduction NDA. Back in October of 2009, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T. The committee voted 11 yes to 3 no that the data presented on azfibrocel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication. Two months later, the FDA followed the Committee’s advice and issued a CRL to Fibrocell. The letter requested that the firm provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling.
In 2010, the company did the requested trial and submitted a response to the CRL at the end of last year. On 1/12, the company received the 6/22 PDUFA from the FDA. On 3/10, the company announced that it submitted a final study report to the FDA for a completed, six-month histological study examining skin after injections of azficel-T.
The market for this product candidate is large. According to the company, the total expenditures for aesthetic procedures in the U.S. were almost $10.5 billion in 2009. Rodman and Renshaw has big expectations for the drug, coming up with a price target of $3/share for the stock just based on laViv for wrinkle reduction. If approved, this would be the company’s first drug to market.
Lannett has a PDUFA next Thursday for Morphine Sulfate Oral Solution. Analysts broadly expect approval so any kind of non-approval might cause a drop in the stock. This product is not new. It was already on the market before issues with the company’s manufacturing facilities forced the company to halt product. Lannett provided an update on 2/1 and said that it met with the FDA to discuss the status of the company’s NDA. The FDA informed the company that it intends to conduct a Pre-approval Inspection of Lannett’s manufacturing facility as part of its review of the Morphine Sulfate NDA.
The company stated that its manufacturing facilities were previously inspected by the FDA in January and February 2010, and it responded to the observations within seven days. The FDA conducted a follow-up inspection in September, resulting in zero observations at Lannett’s plants in Philadelphia and a total of two minor 483 observations at its pain management products facility in Wyoming. On 6/6, the company announced revised PDUFA date on 6/23.
Last but not least, Durect and Pain Therapeutics have a PDUFA date next Thursday for Remoxy for moderate-to-severe chronic pain. The company originally had a PDUFA date for Remoxy in December of 2008. However, the FDA disappointed the company and issued a CRL in response to the NDA. The agency said that it believed additional non-clinical data will be required to support the approval of Remoxy. The FDA did not request or recommend additional clinical efficacy studies prior to approval. In July of 2009, the companies announced that King Pharma (now Pfizer (PFE) and the 3rd partner) met the FDA to discuss the CRL. The outcome of the meeting provided King with a clear path forward to resubmit the Remoxy NDA and to address all FDA comments in the CRL. In December of last year, the companies announced that they resubmitted the Remoxy NDA in response to the CRL. Earlier this year in January, the FDA announced a PDUFA date of 6/23.
All though investors are excited that the PDUFA date is nearby, there were some cautious comments by Pfizer on the Remoxy PDUFA date in May that has dampened expectations. In response to the commentary, on 5/3 PTIE fell 8% and DRRX fell 12%.
The companies believe there will be a large market for Remoxy. Approximately 50 million Americans suffer from persistent pain each year, according to the American Pain Foundation.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.