Healthcare Industry News: Sutent
News Release - September 13, 2007
Cadence Pharmaceuticals Names Malvina Laudicina Vice President of Regulatory Affairs and Quality AssuranceSAN DIEGO, Sept. 13 (HSMN NewsFeed) -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX ), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that Malvina Laudicina has joined Cadence's management team as Vice President, Regulatory Affairs and Quality Assurance. She will lead the regulatory and quality assurance activities for the Company's two ongoing Phase III clinical development programs.
"Malvina's extensive experience in the area of regulatory filings and clinical development requirements is a great asset to Cadence and will play a vital role in helping us achieve our clinical development and regulatory objectives for our two Phase III product candidates, intravenous acetaminophen for the treatment of acute pain and fever and Omigard(TM) for the prevention of catheter related infections," stated Jim Breitmeyer, M.D., Executive Vice President, Development and Chief Medical Officer of Cadence.
Ms. Laudicina joins Cadence from Pfizer where she was most recently involved in safety and risk management activities at the company's La Jolla site. Also at Pfizer, as Executive Director and Regulatory Site Head, she had responsibility for four therapeutic areas and led the regulatory team responsible for the registration of Sutent® (sunitinib malate), a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer and gastrointestinal stromal tumors. Prior to Pfizer, Ms. Laudicina held senior regulatory and clinical research positions at Prometheus Laboratories, Dura Pharmaceuticals and Schering-Plough Corporation. She received her B.S. in Chemistry from Pedro Henriquez Urena University, Santo Domingo, and her M.S. in Chemistry from West Virginia University.
About Cadence Pharmaceuticals
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. The company currently has two Phase III product candidates in development, including intravenous acetaminophen for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% aqueous gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit http://www.cadencepharm.com.
Cadence cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding Cadence's expectations for achieving its clinical and regulatory objectives for its two product candidates, intravenous acetaminophen and Omigard. The inclusion of forward-looking statements should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those included in this presentation due to the risks and uncertainties inherent in the company's business, including, without limitation: delays in the initiation or completion of enrollment in the company's ongoing or planned clinical trials; the adequacy of the clinical trial designs to support regulatory approvals in the stated indications or at all, and the possibility that additional clinical trials or preclinical studies may be required to support regulatory approvals; unexpected adverse side effects or inadequate therapeutic efficacy of Cadence's product candidates that could delay or prevent their regulatory approval or commercialization, result in recalls or product liability claims, or diminish market acceptance; other difficulties or delays in developing, testing, manufacturing and marketing the company's product candidates; the scope and validity of patent protection; the company's ability to maintain patent protection for and to commercialize its product candidates without infringing the patent rights of others; the market potential for its product candidates; the company's ability to compete with new or existing products; the company's ability to raise sufficient capital to complete its clinical development programs and to successfully launch its product candidates; and other risks detailed in Cadence's press releases and public filings with the U.S. Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Cadence undertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Cadence(TM) and Omigard(TM) are registered trademarks of Cadence Pharmaceuticals, Inc.
Source: Cadence Pharmaceuticals
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