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Biotech / Medical : Sonus Pharma (SNUS) ? Opinions -- Ignore unavailable to you. Want to Upgrade?

To: nanoh who wrote (281)	4/28/1998 11:34:00 AM
From: Milk	Read Replies (2) \| Respond to of 384

Tuesday April 28, 10:40 am Eastern Time Company Press Release SOURCE: SONUS Pharmaceuticals, Inc. SONUS Reports Status of EchoGen(R) New Drug Application After FDA Meeting Company Continues to Move Toward Amended Filing After Receiving Clarification And Direction From FDA at April 27, 1998, Meeting BOTHELL, Wash., April 28 /PRNewswire/ -- SONUS Pharmaceuticals, Inc. (Nasdaq-NNM: SNUS - news) today announced that the Company has met with the U.S. Food and Drug Administration (FDA) regarding the EchoGen(R) (perflenapent emulsion) New Drug Application (NDA). SONUS requested the meeting, seeking to work closely with the FDA to clarify certain issues set forth in an FDA action letter received by SONUS in late February and to review the Company's proposed plan to address these issues. ''This meeting reflects our commitment to working collaboratively with the FDA as we continue to prepare our amendment to our EchoGen(R) NDA,'' said Steven C. Quay, M.D., Ph.D., president and CEO of SONUS. ''Now that we have received further clarification from the FDA on certain issues contained in the action letter, we are moving forward with our amendment, and plan to submit it within the next 60 to 120 days.'' Once SONUS has filed the amendment with the FDA, the agency has up to 180 days to review the amendment. The Company believes the amendment will be responsive to the issues raised in the FDA action letter. Accordingly, once the FDA review is completed, the Company expects that the agency will be in a position to issue another action letter. SONUS received an action letter from the FDA on February 25, 1998. The letter indicated that the EchoGen(R) NDA was inadequate for approval, citing issues with manufacturing processes, including chemistry and analytical methods validation, and analysis of some of the animal and clinical data. Also related to regulatory status, SONUS announced on March 31, 1998, that EchoGen(R) had received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP) for use in patients with suspected or established cardiovascular disease. The CPMP is the scientific review committee of the European Medicines Evaluation Agency (EMEA) and makes its recommendations to the EMEA. The next step following the positive opinion is expected to be the issuance of a marketing authorization by the European Commission, which covers the 15 member states of the European Union. SONUS Pharmaceuticals, Inc., based in Bothell, Wash., is engaged in the research and development of ultrasound contrast agents and drug delivery systems based on its proprietary PhaseShift(TM) and fluorocarbon technology. The Company's products are being investigated to improve the diagnosis and treatment of heart disease, cancer and other debilitating conditions. Certain of the statements made in this news release are forward looking such as those relating to the regulatory approval of EchoGen(R). As discussed in SONUS' annual report on Form 10-K filed March 31, 1998, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: EchoGen(R) will require regulatory approval, which approval is subject to certain regulatory requirements and can be lengthy and may include additional requests by the FDA and EMEA; and market acceptance of EchoGen(R) will depend on a number of factors, including safety, efficacy, ease of administration and the presence of competitive imaging products or technologies. There can be no assurance that the FDA or EMEA will grant final approval of EchoGen(R). NOTE: SONUS Pharmaceuticals' press releases are available via PR Newswire's Company News on Call service. To receive previous SONUS press releases via fax, dial 1-800-758-5804, ext. 108377. SONUS releases also can be accessed on the Internet at prnewswire.com. Additional information about SONUS can be accessed at the SONUS Homepage, sonuspharma.com. SOURCE: SONUS Pharmaceuticals, Inc. --------------------------------------------------------------------------------