Once again, Alfred Mann's quest to bring his Valencia company's inhaled insulin to market could be in jeopardy.
It turns out MannKind Corp. was in serious negotiations with an international pharmaceutical firm to market the potential blockbuster treatment when talks fell apart over the value of the drug, sending the biotech's stock into a tailspin last week.
Now, MannKind plans to wait to secure a marketing partner for its Afresa medication until after it receives Food and Drug Administration approval. But the turn of events, disclosed in a regulatory filing, has raised fresh questions on Wall Street as to whether the medication will actually reach pharmacy shelves.
"It was a significant disappointment," said Jon Ogg, the Houston-based editor of Biohealth Investor, an Internet publication that follows the pharmaceutical industry. "The fact that they disclosed that they don't expect to get a marketing partner for Afresa until after FDA approval of the drug means the whole pharmaceutical industry has told them, 'We're rooting for you, but call us when the FDA is on your side.'"
Investors didn't take kindly to the news. Shares, which had closed at $9.21 on Oct. 5, closed at $6.28 on Oct. 8.
Hakan Edstrom, MannKind's president, disputed Ogg's interpretation. He said the fact that the company could not secure a marketing partner had no bearing on the likelihood of Afresa gaining the FDA's OK.
"I have to say I feel very comfortable in regards to approval of product," he said.
Afresa could be worth billions of dollars if it makes it to market, but even if it gets FDA approval, it could be a bust. Pfizer Inc. pulled inhaled insulin product Exubera from store shelves in 2007 amid concerns it could cause lung cancer, and after receiving a weak reception from patients and doctors.
Mann has always maintained that his company's version of the drug is far superior to Exubera or other versions in development. MannKind has released clinical data supporting its position, but so far potential industry partners appear not entirely convinced.
In fact, the billionaire has been forced to pour more than $1 billion of his own money into company loans and stock purchases to keep clinical trials of Afresa float.
The company did not provide Mann for comment.
However, this summer investors were optimistic. In May, the company announced that the FDA had accepted Afresa for review, and in June it said talks had started with a potential marketing partner. MannKind shares hit an 18-month high of $12.30 in July, not long after trading as low as $1.83 in April.
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