Healthcare Industry News: DITROPAN XL
News Release - August 2, 2007
Neuromed Appoints Mario Orlando as Vice President of MarketingCONSHOHOCKEN, PA and VANCOUVER, Aug. 2 (HSMN NewsFeed) - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today that Mario Orlando has joined the company as Vice President of Marketing, a newly created position.
Mr. Orlando brings to Neuromed more than 25 years of marketing and sales experience of major medicines. Mr. Orlando was most recently at Wyeth as the Executive Director of Rapamune® Global Strategy, in charge of global marketing and commercial strategy of Rapamune®, an immunosuppressant drug for the prevention of transplant rejection. Prior to Wyeth, Mr. Orlando held senior marketing roles with Genentech, Glaxo and Eli Lilly and has been responsible for the sales and marketing of such brands as Activase®, Pulmozyme® Ventolin®, Flonase®, Fortaz®, and Humulin®. At Neuromed, Mr. Orlando will be responsible for precommercial and commercialization activities in preparation for the U.S. launch of NMED-1077 (OROS® Hydromorphone) and other Neuromed products, upon Food & Drug Administration (FDA) approval.
"Mario's significant commercial experience with Eli Lilly, Glaxo, Genentech and Wyeth will be a tremendous asset to Neuromed as we prepare NMED-1077 for commercialization in the U.S.," said Dr. Christopher Gallen, President & CEO of Neuromed. "With NMED-1077 in Phase 3 clinical trials, we are in a position to start building our commercialization capabilities to bring much needed alternative chronic pain treatments to the market. Mario is the ideal person to lead this charge."
OROS® Hydromorphone was developed by ALZA and has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name Jurnista(TM). The product received an Approvable Letter from the U.S. Food and Drug Administration (FDA) in October 2000. Neuromed anticipates that one successful adequate and well-controlled clinical trial will be needed to support approval of NMED-1077 in the U.S.
Hydromorphone is a Schedule II opioid that has been widely used for many years under the brand name Dilaudid® and is also available from various generic manufacturers. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times per day.
NMED-1077 uses the OROS® PUSH-PULL(TM) delivery system to release the opioid at a controlled rate. The OROS® osmotic drug delivery technology has been employed as a sustained release formulation for many successful products, including Concerta®, DITROPAN XL®, Covera-HS®, and Procardia XL®.
NMED-1077 is an investigational product and is not approved by the FDA for use in the U.S. NMED-1077 has been studied in more than 1,000 pain patients in the U.S. The most common adverse events seen in clinical trials to date were opioid-related events of constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including NMED-1077.
Neuromed is a privately held biopharmaceutical company in business to develop new and improved pain medicines. We have three programs aimed at addressing this important unmet medical need. Neuromed acquired the U.S. marketing rights to NMED-1077 (OROS® Hydromorphone), a Phase 3 once-daily form of hydromorphone. Hydromorphone is a potent and widely-used pain reliever which is short-acting and therefore currently requires several doses a day. Neuromed is also developing oral drug candidates to block N-type calcium channels, a new and important target directly involved in pain signaling. Our third program of T-type calcium channel blockers is producing promising compounds aimed at treating pain, epilepsy and hypertension. For more information visit www.neuromed.com.
CONCERTA®, DITROPAN XL®, OROS® and PUSH-PULL(TM) are trademarks of ALZA Corporation; RAPAMUNE® is a trademark of Wyeth-Ayerst Laboratories; ACTIVASE® and PULMOZYME® are trademarks of Genentech; VENTOLIN®, FLONASE®, and FORTAZ® are trademarks of GlaxoSmithKline; HUMULIN® is a trademark if Eli Lilly; Jurnista(TM) is a trademark of Janssen-Cilag; Procardia XL® is a trademark of Pfizer Inc.; COVERA-HS® is a trademark of G.D. Searle & Co.; DILAUDID® is a trademark of Abbott Laboratories.
Neuromed cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Neuromed's forward-looking statements due to the risks and uncertainties inherent in Neuromed's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Neuromed does not assume any obligation to update any forward-looking statements.
Source: Neuromed Pharmaceuticals
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