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Arriva Pharmaceuticals Receives US Patent for AAT Production in Yeast

http://biz.yahoo.com/bw/081001/20081001005220.html

›Wednesday October 1, 11:30 am ET

ALAMEDA, Calif.--(BUSINESS WIRE)--Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced today that it had been granted a patent in the U.S. for methods to produce certain proteins in yeast. Among the proteins whose production is covered by the patent (United States Patent 7,419,801) is recombinant alpha 1-antitrypsin (rAAT), the protein used in Respriva™, the company’s lead product.

“This patent extends our patent portfolio and strengthens our intellectual property estate for Respriva™,” said Sue Preston, chief executive officer of Arriva. “As we move forward with the development of Respriva™, we have multiple competitive advantages that leave us well positioned in the global market.”

Respriva™ is an inhaled rAAT. Arriva is currently conducting clinical trials with Respriva™ as replacement therapy in hereditary emphysema (HE). Patients with HE have a congenital deficiency in naturally occurring alpha 1-antitrypsin (AAT). Respriva™ also has the potential to ameliorate lung disease in other indications, such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis.

“This patent provides us with a high-yield, low-cost production method for Respriva™,” said Dr. Philip Barr, chief scientific officer of Arriva. “It eliminates the issues of availability and expense for plasma-derived AAT, which is the current treatment for HE. Respriva™ also offers the additional benefit of being formulated for delivery by inhalation into the deep lung, using high-efficiency nebulizers, as opposed to plasma-derived AAT, which is delivered intravenously.”

AAT binds to and neutralizes excess proteolytic enzymes that are primarily responsible for the lung tissue degradation that results in emphysema. Arriva has successfully completed a Phase 1a safety study, and a Phase 1b/2a proof-of-concept study for Respriva™. In the phase 1b/2a study two serious adverse events were noted; one non-drug-related case of necrotizing pneumonia and one possibly drug-related exacerbation of underlying COPD. The Phase 1b/2a study showed that normal levels of AAT could be achieved in lung epithelial lining fluid even at the lowest dose tested.

Arriva’s manufacturing process for rAAT has been scaled up to commercial fermentation levels following transfer to contract manufacturers. Accordingly, Arriva is well placed to provide a lower cost-of-goods alternative therapeutic product upon approval of Respriva™.

A second biotherapeutic product in Arriva’s pipeline is Aeriva™, a fusion protein that combines Secretory Leukocyte Protease Inhibitor (SLPI) with AAT. The multifunctional protease inhibitor targets serine proteases that are involved in the airway hypperreactivity seen in asthmatic subjects. The fusion protein also inhibits neutrophil elastase, mast cell chymase and tryptase, and thrombin, all of which may be involved in airway remodeling in asthma.

Arriva is also developing inhaled ilomastat, a potent, broad-spectrum inhibitor of matrix metalloproteases that has shown to be active in an animal model for cigarette smoke-induced emphysema.

About Arriva

Arriva Pharmaceuticals is a privately held biopharmaceutical company focused on developing anti-inflammatory therapies for treating respiratory diseases. The company's areas of therapeutic focus are: hereditary emphysema, chronic obstructive pulmonary disease (COPD), including smoking-related emphysema, cystic fibrosis, asthma and other respiratory indications. Arriva Pharmaceuticals BV, is headquartered in Amsterdam, the Netherlands, and its majority-owned subsidiary, Arriva Pharmaceuticals, Inc., is located in Alameda, California. For additional information please visit: http://www.arrivapharm.com‹