For anyone expecting local biotech MannKind Corp.? new inhaled-insulin drug to hit the market soon: Don? hold your breath.
The Valencia drug developer hit a significant milestone last week by getting its new drug application for Afresa accepted by the U.S. Food and Drug Administration. But even if all goes smoothly with the regulatory review, it likely will be at least a year before the drug makes its way to pharmacy shelves.
Chief Financial Officer Matthew Pfeffer said the company internally is projecting to be able to launch Afresa in first quarter 2010. But it? difficult to predict with certainty when the FDA will make a decision on whether to approve the drug, so it? possible Afresa could hit the market sooner ?or later.
The FDA tends to give priority to drugs with critical, life-saving implications, and Afresa doesn? fall into that category. It? also likely that regulators will comb over MannKind? clinical trial results carefully, given what happened to the first inhaled-insulin product to hit the market.
Pfizer Inc., which once expected its Exubera to become a $2 billion blockbuster, abandoned the product in 2007 due to poor sales, and concerns it could damage lung tissue and cause lung cancer. Eli Lilly & Co. and Novo Nordisk A/S subsequently abandoned plans to release their own versions.
Working in MannKind? favor for a smooth regulatory review is that company founder Alfred Mann and his team stayed in close contact with regulators when concerns about Exubera came to light. MannKind was able to fine-tune its late-stage clinical trials to meet anticipated concerns about Afresa? safety.
Mann has long argued that his inhaler is safer than Pfizer?, and has therapeutic advantages over injected and oral insulin. Study data provided to the FDA aims to show the fast-acting insulin can quickly moderate the blood sugar spikes that diabetics experience at mealtime. The drug also clears the system quickly after its job is done, which reduces the chance of side effects.
If approved, MannKind would have the only inhaled-insulin product on the market. Afresa would be the company? first drug, and if successful will serve as a launching pad for the company? Technosphere inhaler technology to be used with other drugs.
Investors these days are far more optimistic about MannKind? prospects than when they sent its stock plummeting in April 2008. Shares closed at $6.27 on May 21, up 200 percent from that low point more than a year ago.
Mann, 82, who became a billionaire founding and selling medical device companies with unique products, controls 48 percent of shares and has poured more than $566 million into his namesake company.
