Mannkind (MKND) stock rose more than 20%, showing increased investor confidence after the fledgling pharmaceutical company confirmed that it has received approval from the FDA for clinical trials on its key product. Mannkind received FDA clearance to conduct efficacy trials on a new inhaled insulin product dubbed Afrezza, designed to treat patients with both Type 1 and Type 2 diabetes.
Mannkind has navigated rough financial waters, seeing its stock fall upon news of delays in developing the drug but the company has seen its fortunes reversed in light of the new agreement regarding the design of the clinical trials. One trial will compare Mannkind’s new inhaler design with the MedTone inhaler, subject of previous trials. The FDA has requested data on the impact of various inhalers on the cardiovascular systems of users.
Mannkind’s fortunes have hinged on Afrezza and the market for inhaled insulin. The company has suffered numerous setbacks to the development and approval of Afrezza amidst a general reduction in interest of inhaled insulin. Eli Lilly and Pfizer backed out of the inhaled insulin race; chairman and CEO of Mannkind, Alfred Mann, believes that there is a market for inhaled insulin. Mannkind currently has no products on the market.
“We are very encouraged and pleased with this outcome,” said Mann of the FDA approval. “Our attention now turns to the execution of these trials. The protocol for Study 171 has already been sent to Institutional Review Boards and the protocol for Study 174 is being finalized and will be distributed to our sites shortly,” Mann said, referring to the two recently approved trials.
Mannkind focuses primarily on treating patients with cancer and diabetes. While it has no products on the market, it is hopeful that Afrezza will give it a heady boost. The medication is an meal-time inhaled insulin.
Inhaled insulin was on the market in the United States from September 2006 through October 2007. The first FDA-approved inhaled insulin product, called Exubera, was approved in January 2006 and marketed by Pfizer. Studies determined that inhaled insulin was no more effective than subcutaneously injected insulin. Both Type 1 and Type 2 diabetics would still require injections of long-lasting insulin in addition to inhaled insulin. The possibly of dosing errors with inhaled insulin, along with its prohibitive cost, caused major players Pfizer and Eli Lilly to discontinue their programs and market interest in the product dwindled. Mannkind is the only company still pursuing production of inhaled insulin with its Afrezza product.
Mannkind received notification from the FDA in January that additional clinical trials would need to be performed before Mannkind received the green light for marketing Afrezza. The product was first submitted for approval in March of 2009, when the FDA notified Mannkind that it would need to provide additional data before trial approval was granted.
The approval of the trials is a boon for Mannkind, which saw losses of $44.5 million in the second quarter of 2011 and $42.3 million in the same quarter last year. Per-share losses saw no change at 37 cents. Mannkind did not see any revenue in the second quarter of 2011 compared with revenue of $93,000 in the same quarter of 2010.
In the wake of the news, company shares rose 47 cents to $2.84.
Mannkind has its corporate headquarters located in Valencia, California, with the manufacturing facility for Afrezza located in Danbury, Connecticut. Though technically founded in 1991, the current form of Mannkind was founded in 2003 with a merger between three of Alfred Mann’s companies. Mann has invested over $900 million in the company.
