Jim M. emails, "I was wondering what you thought about Depomed (DEPO)? They have a PDUFA date next month but it seems to have been left off of all the FDA calendars."
Guilty as charged. I inadvertently omitted Depomed and its shingles pain drug DM-1796 from my 2011 FDA Approval Decision Calendar. The FDA is expected to issue a decision on DM-1796 on or before Jan. 30, 2011.
I apologize, but I don't know enough about DM-1796 to help handicap the FDA's approval decision. DM-1796 is an extended-release, once-daily formulation of the pain drug gabapentin, which Pfizer (PFE) sold as Neurontin and which is now available as a generic.
The FDA approval being sought for DM-1796 is for the treatment of post-herpetic neuralgia (PNH), or pain caused after an attack of shingles, also known as herpes zoster. Approximately 70,000 to 100,000 Americans are affected by PHN each year, according to Depomed.Depomed has already licensed North American commercial rights for DM-1796 to Abbott Labs (ABT). If you're interested in learning more about DM-1796, you should check out the data from the phase III study conducted in PHN patients which demonstrated a statistically significant reduction in pain scores compared to placebo. On a related note, it might be interesting to see how the DM-1796 data compares to the herpes and PHN pain data recently announced by Inhibitex (INHX) from a phase II study of its drug FV-100.
Again via Twitter, @granbebe1 asks, "Mannkind (MNKD), any news?" Not a lot of news on Mannkind but tons of speculation and stock volatility as we get closer to the Dec. 29 FDA approval decision date for the company's inhaled insulin delivery device Afrezza. Mannkind was trading for $6-plus around Thanksgiving but was up to $8.50 intraday Thursday. Wednesday was a particularly volatile day, with the stock trading as high as $9.23 and as low as $7.31. On Wednesday, Mannkind founder Al Mann disclosed via an SEC filing that he purchased another 700,000 shares of the company, which a lot of investors interpreted as a sign of confidence so close to the FDA approval decision for Afrezza. That's not entirely true, however. Mann's 700,000-share purchase was required under an equity financing agreement signed in August with an outfit known as Seaside 88. Mannkind has been selling discounted stock to Seaside 88 as a way to raise cash. Under the agreement, whenever Seaside buys and resells Mannkind shares, Mann has to buy an equal amount of Mannkind stock.
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