WARRINGTON, Pa., May 1, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its U.S. Patent Application Number 11/326,885 titled "Surfactant Treatment Regiment." The Notice of Allowance is the USPTO's official communication that the examination of the patent application has been successfully completed and that a patent will be issued. Once issued, the patent will provide broad coverage for methods of using pulmonary surfactant to treat infants at risk of developing bronchopulmonary dysplasia (BPD).
Robert Segal, M.D., F.A.C.P., Senior Vice President and Chief Medical Officer of Discovery Labs and one of the inventors, commented, "We are very pleased with the USPTO's decision to grant the patent for treatment of infants at risk of developing BPD. This patent provides additional intellectual property protection to our KL4 surfactant technology. We plan to continue strengthening our patent portfolio around KL4 surfactant to include treatment of a wide range of respiratory disorders."
Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations.
About BPD and Discovery Labs' Development Programs
BPD, also known as Chronic Lung Disease, affects premature infants and is associated with surfactant deficiency and the prolonged use of mechanical ventilation and oxygen supplementation. There are presently no approved drugs for the treatment of BPD. Infants diagnosed with BPD suffer from abnormal lung development and typically have a need for respiratory assistance, often for many months, as well as comprehensive continuing care potentially spanning years. It is estimated that the cost of treating an infant with BPD in the United States can approach $250,000 during the initial inpatient stay alone. Discovery Labs estimates that approximately 100,000 infants are at risk for BPD in the United States and Europe each year.
BPD is diagnosed when premature infants require mechanical ventilation or supplemental oxygen at 36 weeks post-menstrual age. Premature babies are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, resulting in Respiratory Distress Syndrome (RDS). These infants often require endotracheal intubation to administer surfactant (usually within the first hours of birth), and to provide respiratory support via mechanical ventilation. Unfortunately, many infants relapse following initial therapy and require reintubation and prolonged mechanical ventilation as well as supplemental oxygen, which increase their risk of developing BPD.
Discovery Labs believes that treatment with KL4 surfactant after the initial RDS treatment (on day one or two of life) may prevent BPD and improve the clinical outcome of these infants. Discovery Labs conducted a Phase 2 clinical trial for Surfaxin(r) (its lead product from its KL4 surfactant pipeline in liquid instillate formulation) for the prevention and treatment of BPD. The results from the trial suggest that Surfaxin may potentially represent a novel therapeutic option for infants at risk for BPD. These results were published in Pediatrics in January 2009. Discovery Labs plans further development of KL4 surfactant for the prevention of BPD with Surfaxin LS(tm) (lyophilized formulation of KL4 surfactant) or Aerosurf(r) (aerosolized formulation of KL4 surfactant).
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children. For more information, please visit our website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, 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. Examples of such risks and uncertainties are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (i) Discovery Labs and the U.S. Food and Drug Administration (FDA) will not be able to agree on the matters raised by the FDA in its Complete Response letter dated April 17, 2009, or the FDA may require Discovery Labs to conduct significant additional activities to potentially gain approval of Surfaxin, if ever (ii) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (iii) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; risks that (a) market conditions, the competitive landscape or otherwise, may make it difficult to launch and profitably sell products, (b) Discovery Labs may be unable to identify potential strategic partners or collaborators to market its products, if approved, in a timely manner, if at all, and (c) Discovery Labs' products will not gain market acceptance by physicians, patients, healthcare payers and others in the medical community; the risk that Discovery Labs or its strategic partners or collaborators will not be able to attract or maintain qualified personnel; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities, or that the share price at which Discovery Labs may access the facilities from time to time will not enable Discovery Labs to access the full dollar amount potentially available under the facilities; the risk that Discovery Labs will be unable to maintain The Nasdaq Global Market listing requirements, causing the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to reimbursement and health care reform; and other risks and uncertainties described in Discovery Labs' 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.