WARRINGTON, Pa., May 13, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), a biotechnology company developing its proprietary Surfactant Replacement Therapies (SRT) to address respiratory conditions, announced today that, on April 29, 2008, the U.S. Court of Appeals for the Third Circuit affirmed the dismissal of the Second Consolidated Amended Complaint that was filed against the Company and two of its executive officers in November 2006. The Court's order is now final and this matter is now concluded.
The Second Consolidated Amended Complaint, like the First Consolidated Amended Complaint that was dismissed without prejudice in November 2006, alleged violations of Section 10(b) of the Securities Exchange Act of 1934 (Exchange Act), Rule 10b-5 and Section 20(a) of the Exchange Act in connection with various public statements made by the Company. The United States District Court for the Eastern District of Pennsylvania dismissed the complaint on March 15, 2007. The District Court, in May 2007, also dismissed a related shareholder derivative action brought against the Company and several of its officers and directors. Plaintiffs in that proceeding did not file an appeal and that matter is also finally concluded.
Mary B. Templeton, Esq., Deputy General Counsel of Discovery Labs commented, "Discovery Labs is committed to full and prompt disclosure of all material information about our Company and our efforts to develop our SRT portfolio. Our counsel in this matter, Pepper Hamilton, LP has represented us effectively and both the Third Circuit Court of Appeals and the District Court have recognized the quality of our disclosures and finally dismissed with prejudice this class action."
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' technology produces a peptide-containing synthetic surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to advance respiratory medicine and address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs' lead product candidate, SURFAXIN (r), is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. SURFAXIN(r) is also being developed for other neonatal and pediatric indications. AEROSURF(tm), Discovery Labs' aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at www.Discoverylabs.com.
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, including, without limitation, the risks that: Discovery Labs may be unable to timely respond, if at all, to the recent approvable letter; Discovery Labs may not succeed in the FDA or other regulatory agency review process, including that such regulatory authority may not approve the marketing and sale of a drug product or may withhold, delay and/or limit marketing of a drug product by indication or impose other label limitations; Discovery Labs may not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for development or commercialization of SRT); changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval of drug products; Discovery Labs may be unable to profitably develop and market its products; Discovery Labs' significant, time-consuming and costly research and development activities, including pre-clinical studies, clinical trials and other efforts to gain regulatory approval for any products may not progress or may be subject to potentially significant delays or regulatory holds, or fail; Discovery Labs may be unable to successfully manufacture or provide adequate supplies of drug substances on a timely basis; Discovery Labs may be unable to transfer its manufacturing technology to third-party contract manufacturers or its contract manufacturers or any of its materials suppliers may encounter problems manufacturing drug products or drug substances on a timely basis or manufacture in amounts sufficient to meet demand; Discovery Labs and its collaborators may be unable to develop, manufacture and successfully commercialize products that combine Discovery Labs' drug products with innovative aerosolization technologies; Discovery Labs may be unable to maintain and protect the patents and licenses related to its SRT; other companies may develop competing therapies and/or technologies or health care reform may adversely affect Discovery Labs; and Discovery Labs may become involved in securities, product liability and other litigation. The foregoing risks and others are further 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.