November 30, 2004
Inyx’s Lipid-Binding Technology Proves Development Success in Non-Ozone-Depleting ‘Salbutamol’ Inhaler for Asthma
NEW YORK, Nov. 30 /PRNewswire-FirstCall/ -- Inyx, Inc. (BULLETIN BOARD: IYXI) , a specialty pharmaceutical company focused on aerosol drug delivery technologies and products, reported today positive results from a two-year stability study for a non-ozone-depleting hydrofluoroalkane (HFA) propelled "salbutamol" metered dose inhaler (MDI) for treating asthma and other respiratory conditions utilizing Inyx's patented lipid-binding technology for enhancing the delivery of inhalation-therapy drugs.
Jack Kachkar, M.D., Chairman and CEO of Inyx, said, "As a result of this successful study, we have added to Inyx's own development portfolio of proprietary products an all-important HFA-MDI delivery of salbutamol, which is the most widely prescribed short-term bronchodilator medication to treat asthma, chronic bronchitis and other breathing disorders." Salbutamol relieves asthma attacks by opening the airways in a fast-acting manner and quickly making breathing easier. (Salbutamol is the generic name preferred by the World Health Organization and used internationally; "albuterol" is the generic name used in the United States.)HFA is the prime substitute for the ozone-depleting chlorofluorocarbon (CFC) gas propellant used in MDI sprays, by which approximately 95% of all asthma medication is administered to the approximate 100 million people worldwide who suffer from asthma. CFC use in pharmaceutical products is already banned in Europe, Canada, Japan and many other countries. The United States is expected to start implementing the ban by 2006. In 2003, 90% of the asthma inhalers sold in the U.S. contained CFC. The conversion from CFC to CFC-free pharmaceuticals is estimated to be up to a $5 billion-plus niche market.
"The U.S. is the largest asthma market in the world, and Inyx has the proven HFA and MDI development technology and production expertise to be a significant and proprietary player now," stated Dr. Kachkar. "Inyx plans to commence scale-up studies on the salbutamol HFA formulation in early 2005, with a view to commencing clinical efficacy equivalence studies as soon as possible. It is anticipated that these studies should be concluded in time to allow submissions to the U.S. and European regulatory authorities in 2006," he reported.
The results of the successful two-year study on the salbutamol HFA-MDI are part of the intellectual property related to the patented lipid technology that Inyx acquired this September from Phares Technology BV, the parent company of Phares Drug Delivery AG of Muttenz, Switzerland, the developer.
Commenced Feasibility Studies on Combination Drugs
Inyx also reported that it has already commenced conducting feasibility studies on HFA-MDI formulations of various lipid-enhanced combinations of respiratory drugs, including: short- and long-acting bronchodilators, inhaled corticosteroids, and non-steroidal anti-inflammatory medications.
"This novel lipid-binding technology," Dr. Kachkar explained, "has the capability of enhancing aerosol delivery of not only single molecule but also combination drugs. Moreover, this technology provides Inyx with a platform to develop inhalation-therapy products that overcome present drug stability or compatibility delivery problems across a broad spectrum, not only for respiratory treatments but also for other pharmaceutical sectors such as acute and systemic pain management."
The use of combination drug therapy is an increasing trend today in medicine. However, while many drugs work well in tandem biologically in the body, often there are molecular structural incompatibility problems to prevent the use of a single, combined delivery. Inhalation-therapy combination drugs are estimated to be in excess of a $10 billion annual global market today.
Inyx, Inc. is a specialty pharmaceutical company with aerosol drug delivery technologies and products for the treatment of respiratory, allergy, dermatological, topical and cardiovascular consulting services to the international healthcare market. In addition, Inyx is developing its own proprietary products to be marketed by selected clients and strategic partners, which include some of the largest pharmaceutical companies. The company's operations are conducted through its wholly owned subsidiary, INyX Pharma Limited, with R&D and production facilities located near Manchester, England, which serves global markets including: North America, Europe, Latin & South America and the Middle East. Another wholly owned subsidiary, Inyx Canada, Inc. based in Toronto, provides business development and support services. Inyx, Inc.'s corporate offices are in New York City. For more information, please visit: http://www.inyxinc.com/.
Statements about Inyx's future expectations, including future revenues and earnings, and all other statements in this press release other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
For more information, please contact:
Jay M. Green, Executive VP
CONTACT: Jay M. Green, Executive VP of Inyx, Inc., +1-416-250-1999,[email protected]
Web site: http://www.inyxinc.com/