WARRINGTON, Pa., Feb. 6, 2006 (PRIMEZONE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced the appointment of Russell G. Clayton, D.O. as Vice President, Medical Affairs and Thomas Hofmann, MD, Ph.D. as Vice President, Worldwide Clinical Operations. Dr. Clayton will be responsible for the strategic and operational management of the Medical Affairs activities for the Company's pipeline of Surfactant Replacement Therapies (SRT). Dr. Hofmann will be responsible for the management of the Company's SRT clinical programs. Both executives have a broad background in pediatrics, pulmonology and respiratory care.
Dr. Clayton brings 17 years of extensive scientific and medical experiences in the field of pulmonary and pediatric medicine. Prior to joining Discovery, Dr. Clayton served as a Director of International Regulatory Affairs, and most recently as a Regional Medical Director, Medical and Scientific Affairs at Merck & Company. Previously, Dr. Clayton served as Attending Pulmonologist at both the Children's Hospital of Philadelphia (CHOP) and St. Christopher's Hospital for Children in Philadelphia. While at CHOP, Dr. Clayton was Director of the Asthma Program for the Division of Pulmonary Medicine and Associate Director for the Cystic Fibrosis Center. Dr. Clayton also served as Assistant Professor of Pediatrics at Temple University School of Medicine and the University of Pennsylvania School of Medicine. He has given over 100 invited presentations, both national and international, and has authored articles and chapters on a variety of topics in pediatric lung disease. Dr. Clayton received his B.A. degree in Biology from LaSalle College and his medical degree from the Philadelphia College of Osteopathic Medicine.
Dr. Hofmann brings 16 years of experience in pediatrics and pulmonary medicine, including managing clinical trials for European and U.S. biopharmaceutical companies. Most recently, Dr. Hofmann held the position of Senior Medical Director at Corus Pharma Inc. and was a co-founder. At Corus, he was responsible for several late stage clinical development programs in respiratory and critical care medicine with a strong focus on Cystic Fibrosis, Asthma and Sleep Apnea. Prior to that, Dr. Hofmann was the Medical Director of Pulmopharm GmbH (acquired by Chiron) where he provided a significant contribution in the development and German approval of inhaled Tobramycin for Cystic Fibrosis. Dr. Hofmann has an extensive academic background and is a recognized scientist in the field of pulmonology, specifically Cystic Fibrosis. Dr. Hofmann received his medical degree and Ph.D. in Electrophysiology from JLU Giessen in Germany and conducted postdoctoral research at the Cystic Fibrosis Center, University of North Carolina.
"We are extremely pleased to have Rusty and Thomas in these critical roles," commented Christopher J. Schaber, Ph.D., Executive Vice President and Chief Operating Officer of Discovery Labs. "Both gentlemen bring a wealth of medical experience in pediatrics, respiratory therapy, aerosolization and pulmonology which will be instrumental in providing long-term vision and growth strategies for Discovery's SRT pipeline."
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing its proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery Labs believes that through its technology, pulmonary surfactants have the potential, for the first time, to address respiratory diseases where there are few or no approved therapies available.
Discovery Labs' SRT pipeline is initially focused on the most significant respiratory conditions prevalent in the neonatal intensive care unit. The Company's lead product, Surfaxin(r), for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, has received an Approvable Letter from the FDA and is under review for approval in Europe by the EMEA. Surfaxin is also being developed for the prevention and treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants. Discovery Labs is preparing to conduct multiple Phase 2 pilot studies with Aerosurf(tm), aerosolized SRT administered through nasal continuous positive airway pressure (nCPAP), for the treatment of neonatal respiratory failure.
To address the various respiratory conditions affecting pediatric, young adult and adult patients in the critical care and other hospital settings, Discovery Labs is conducting a Phase 2 clinical trial to address Acute Respiratory Distress Syndrome (ARDS) in adults, and is also developing aerosol formulations of SRT to address Acute Lung Injury (ALI), asthma, COPD, and other respiratory conditions.
For more information, please visit our corporate website at www.Discoverylabs.com.
To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of Discovery's product development, events conditioned on stockholder or other approval, or otherwise as to future events, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect Discovery's actual results and could cause results to differ from those contained in these forward-looking statements are the risk that financial conditions may change, risks relating to the progress of Discovery's research and development, the risk that Discovery will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for aerosol and Surfactant Replacement Therapies), risk that Discovery will not be able to develop a successful sales and marketing organization in a timely manner, if at all, risk that Discovery's internal sales and marketing organization will not succeed in developing market awareness of Discovery's products, risk that Discovery's internal sales and marketing organization will not be able to attract or maintain qualified personnel, risk of delay in the FDA's or other health regulatory authorities' approval of any applications filed by Discovery, risks that any such regulatory authority will not approve the marketing and sale of a drug product even after acceptance of an application filed by Discovery for any such drug product, risks relating to the ability of Discovery's third party contract manufacturers and development partners to provide Discovery with adequate supplies of drug substance, drug products and expertise for completion of any of Discovery's clinical studies, other risks relating to the lack of adequate supplies of drug substance and drug product for completion of any of Discovery's clinical studies, risks relating to the ability of the Company and its collaborators to develop and successfully commercialize products that will combine our drug products with innovative aerosolization technologies, risks relating to the significant, time-consuming and costly research, development, pre-clinical studies, clinical testing and regulatory approval for any products that we may develop independently or in connection with our collaboration arrangements, and risks relating to the development of competing therapies and/or technologies by other companies. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Those associated risks and others are further described in Discovery's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.