VIENNA, Austria and CHAPEL HILL, N.C., May 26 /PRNewswire/ -- AOP Orphan Pharmaceuticals AG and Lantibio, Inc. announce today that the companies have entered into a licensing and commercialization agreement for the development of Moli1901 for the treatment of cystic fibrosis (CF) in European territories. AOP will assume full responsibility for the clinical and non-clinical development of a Lantibio proprietary technology for the treatment of cystic fibrosis in Europe. Lantibio will be responsible for technical development activities to support regulatory filings in the European Union and will have access to the data originated in the European Territory by AOP to support regulatory filings in the US.
AOP plans for the imminent initiation of Phase II clinical trials in Germany. Specific terms of the agreement include undisclosed upfront and milestone payments and a royalty stream linked to sales of Moli1901 in Europe.
"Moli1901 for treatment of cystic fibrosis does fit perfectly into our portfolio of products already marketed and under development," said Dr. Rudolf Widmann, CEO of AOP Orphan Pharmaceuticals AG. "We are pleased about the licensing and commercialization agreement and are very committed to complete the challenging preclinical/clinical development for Moli1901 marketing approval in Europe."
"We are certainly excited to have AOP as a licensee as they are qualified and eager to complete the development of Moli1901 in Europe," Dr. Luis Molina, President and CEO of Lantibio, Inc., said. "We will collaborate on the development, providing our accumulated experience with the compound, working with AOP in the spirit of partnership."
CF is a genetic disease characterized by the chronic formation of mucus plugs in a patient's airways, caused by abnormal salt and water transport. The compound Moli1901, commonly named duramycin, may normalize the mucus composition in the lung by activating an alternative salt channel present in the airway.
AOP Orphan Pharmaceuticals AG is a pharmaceutical company specializing in the development and marketing of medicines for rare diseases. The lead product of AOP Orphan Pharmaceuticals is Thromboreductin(R), which is indicated for the treatment of essential thrombocythemia. Thromboreductin(R) was given marketing authorizations in several countries in the EU and Asia based on an ambitious development program conducted in this rare disease. AOP Orphan Pharmaceuticals AG is well-prepared to accept the challenges inherent in bringing new products to the market for patients with rare and debilitating diseases.
Lantibio, Inc. is a development pharmaceutical company focused on the discovery, development, and marketing of products for the treatment of ocular disease and serious respiratory conditions. Lantibio's lead product, Moli1901, is currently in preclinical development in the United States for the treatment of dry eye syndrome. The same molecule formulated for inhalation has been studied in Phase clinical I trials for cystic fibrosis in the US under Orphan Drug status.
This press release might contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from AOP's and/or Lantibio's expectations and projections. Risks and uncertainties include success of clinical trials for AOP's Lantibio's products, intellectual property risks, need for additional financing or capital, ability to develop and successfully commercialize our products, ability to enter into licensing agreements, and the ability of the competition to render AOP's and Lantibio product candidates or technologies obsolete or noncompetitive. AOP and Lantibio assume no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.
For Further Information contact in the US:
Luis Molina, Ph.D. President/CEO (919) 960 0217
Rudolf S. Widmann, CEO 43-1-503 72 44
CONTACT: In the U.S., Luis Molina, Ph.D., President and CEO of Lantibio,Inc., +1-919-960-0217, or firstname.lastname@example.org; or in Europe, Rudolf S.Widmann, CEO of AOP Orphan Pharmaceuticals, 43-1-503 72 44, email@example.com