Still reeling from the FDA's second rejection of its inhaled insulin program, MannKind ($MNKD) executives are telling the Los Angeles Business Journal that they are redesigning two studies of Afrezza which are already underway in an effort to respond to the agency's CRL in the next 12 to 18 months.
"We already are recruiting patients for studies, so that may save some time," COO Hakan Edstrom tells the LABJ. In the meantime, the company will have to take a hard look at its financial position. Edstrom says the company has $98 million left in a $350 million credit line established by company founder Alfred Mann (photo). And there are other possibilities, such as the sale of its badly battered shares. Finally, the executives say they are wide open to a partnership deal with Big Pharma, which the story asserts has been "resisted" for some time.
Longtime observers of MannKind, though, will remember that rather than resisting a deal, MannKind has repeatedly gotten in trouble by promising deals that never materialized. Edstrom noted more than a year ago that the company's much-discussed partnership talks had lurched off a schedule it reviewed publicly with investors.
"Let me speak to our ongoing efforts which have been the subject of much commentary lately," he said in the fall of 2009. "As we reported last month we have updated our guidance regarding the timing of the partnership deal. Previously we had guided we were aiming for a deal by year-end with a Q3 stretch goal. However, as discussions progressed it became clear the uncertainty about the final label for AFRESA was creating a challenge to the deal structure and valuation, not just with the partner with whom we had made the most progress but for others as well."
Nothing happened, though, leaving MannKind relying on the Bank of Al.
"They have a lot of other options, but I'm sure the Bank of Al will be open," Rodman and Renshaw analyst Simos Simeonidis told the BJ. "How much I can't say. Al does have other obligations, of course."
- here's the report from the LABJ