"Wait 'til next year!" was the rallying cry of the old Brooklyn "Dem Bums" Dodgers faithful, perennial runners-up to the mighty Yankees in the golden-age 1950s; Zogenix investors could be saying the same thing. The firm hopes to file for marketing approval of its second product, a single-dose, controlled release oral formulation of hydrocodone, in early 2012, so buying low (again) could make for some well-earned last-laughing.
FOTF might have its deep-seated prejudices and sympathies on the diamond side, but unless a company is throwing spitballs at the financial rules or patient safety, we have no particular dog in anyone's hunt for financial return or regulatory approval. Though we admit, there's nothing like a good comeback story. One we're working on, which you'll see in the pages of START-UP soon, is the re-emergence of the quest for a cure for HIV/AIDS. Written off as a pipe dream most of the past decade, serious work is underway again. One big question, however, is who'll pay for it. If Big Pharma resources are shrinking and VCs are skittish, can public dollars be deployed in creative new ways?
As the king of all baseball wise men once said, the game isn't over until it's over. Unless, of course, you make too many wrong mistakes. One last piece of Yogic advice: If you come to a fork in the road, take...
Mannkind: Despite the setbacks for its inhaled insulin Afrezza, MannKind is far from drawing its last breath. The firm said Sept. 23 it hopes to sell $370 million in debt, partly to help pay for a pair of pricey Phase III studies needed to get the drug approved by FDA. In addition to the Phase III trials, the proceeds will be used to commercialize the product and build out a manufacturing facility in Connecticut. Afrezza’s development program has been long and tortuous. After two "complete response" letters from FDA, the company said in August that the agency had confirmed designs of two Phase III trials -- one in type 1 diabetes and one in type 2 disease -- using a new next-generation inhaler developed for the product. With the complete response letters, the agency had questioned, among other things, the use of an older inhaler in clinical trials, but the company had hoped new trials would not be necessary. During a Sept. 12 investor meeting, CEO Alfred Mann said the two new trials would include about 1,000 patients and wrap up in the second half of 2012. “We have a clear path to approval now,” he said. But investors know to be wary. Company executives have been prone to overly optimistic pronouncements, such as the near-promise of a big partnership for Afrezza by the end of 2009 that never materialized.-- Emily Hayes
Photo courtesy of flickr user Blyzz via a Creative Commons license.