Shares of drug maker Kamada rose 21% last week after the company said the U.S. Food and Drug Administration is expected to wind up its examination of a key lung drug by the end of June with formal approval coming in July.
In August 2009, Kamada filed a request with the FDA to market the drug, Glassia, in intravenous form following the success of Phase III testing on humans in the United States. The good news for the Israeli company comes amid problems encountered by a U.S. competitor, Talecris.
Glassia would treat a genetic lung disease, Alpha-1 Antitrypsin deficiency (AATD ), which causes emphysema and other ailments.
Kamada is developing its drug by using human plasma. While the FDA considers Kamada's request for approval for the intravenous version, the company is developing an inhaler version.
That version has received orphan drug status in the United States and Europe to treat AATD and cystic fibrosis.
This status gives companies an incentive to develop drugs that would only treat a small number of patients. The first producer on the market gets seven-year exclusivity in the United States and 10 years in Europe.
Kamada says it should finish recruiting patients for the final Phase III human trials on the inhaler this year; it says the market potential for the intravenous and inhaler versions combined could reach $400 million in the United States and 500 million euros in Europe.
The inhaler version is considered more attractive; it's simply easier to take a drug that way than to receive it intravenously.
Recently American drug producer Talecris, which was developing a drug administered by inhaler against AATD, announced that it was abandoning its efforts. Talecris was seen as a competitor to Kamada's Glassia, but it is reportedly still pursuing an intravenous version.
Talecris says it is in the final stage of trials on a plasma-based intravenous drug to treat AATD and is investing in genetic-engineering technology for producing the Alpha-1 protein.
Kamada, meanwhile, inked a five-year distribution agreement with the U.S. company AmerisourceBergen.
Kamada is trading at a market cap of $9 billion and is considered a leader in plasma-based products. It had first-quarter profits of $181 million on $19.3 billion in revenues.