Healthcare Industry News: osteoporosis
News Release - April 26, 2006
European Commission Issues Marketing Authorization for Preotact(R) (PREOS(R))Therapy Approved for the Treatment of Postmenopausal osteoporosis
SALT LAKE CITY and ROSKILDE, Denmark, April 26 (HSMN NewsFeed) -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP ; www.npsp.com) and its partner Nycomed (www.nycomed.com) announced today that the European Commission has granted marketing authorization for Preotact (parathyroid hormone [rDNA origin] for injection). Preotact is the European brand name for PREOS which NPS licensed to Nycomed in 2004 for development and marketing in Europe.
The EMEA approved Preotact for treatment of postmenopausal women with osteoporosis at high risk for fractures. More information will be available in the coming days on the EMEA website at www.emea.eu.int.
"We congratulate Nycomed on reaching this major milestone and look forward to the launch of Preotact in Europe later this year," said Hunter Jackson, Ph.D., NPS chairman and CEO. "This is a significant event for NPS and our partner Nycomed and for the women who will benefit from its efficacy advantages."
"Preotact is a valuable addition to our osteoporosis product portfolio. We are gratified by the European Commission's agreeing that Preotact provides a safe, effective, and user-friendly treatment option for patients suffering from post menopausal osteoporosis." said Hakan Bjorklund, Nycomed CEO.
Nycomed submitted the marketing authorization application for Preotact to the European Medicines Evaluation Agency (EMEA) in March, 2005. The marketing authorization for Preotact is valid in all 25 member states of the European Union. Nycomed is now preparing for the pan-European launch of Preotact, scheduled for second half of 2006. NPS Pharmaceuticals filed a new drug application for clearance to market PREOS in the U.S. with the U.S. Food and Drug Administration in May of 2005 and received an approvable letter in March of 2005.
About the Product
PREOS/Preotact is recombinant human parathyroid hormone. NPS has studied PREOS in a number of clinical settings to document its safety and effects on bone. The pivotal Phase 3 study, known as TOP (Treatment of osteoporosis with PTH), was a multi-center, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of PTH to reduce the risk of first and subsequent vertebral fractures in post-menopausal women.
In the TOP study PREOS demonstrated a statistically significant reduction in the risk of new vertebral fractures in women with and without pre-existing osteoporosis-related fractures. Results from the TOP study have been the foundation of both the E.U. and the U.S. marketing authorization applications.
About NPS Pharmaceuticals
NPS discovers, develops and commercializes small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has one FDA-approved product, one product candidate undergoing regulatory review for approval to market in the U.S. and Europe, as well as other drug candidates in various stages of clinical development backed by a strong discovery research effort. Additional information is available on the company's website, www.npsp.com.
Nycomed is a pharmaceutical company dedicated to meeting patient needs in Europe. The company provides hospital products throughout the region and general practitioner and pharmacy medicines in selected markets. New products are sourced through licensing agreements with research companies. Here Nycomed provides late-stage clinical development, registration and marketing.
Headquartered in Roskilde, Denmark, the company employs about 3,000 people throughout Europe and Russia-CIS. Nycomed is privately owned and had 2005 revenue of euro 747.5 million. For more information visit www.nycomed.com.
Safe Harbor Statement
Note: Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include: Nycomed's expectation that it will successfully launch Preotact; the FDA may delay approval or may not approve any of our product candidates, including PREOS; we do not have and may never develop any products that generate revenues; our product candidates may not prove to be safe or efficacious; failure to secure adequate manufacturing and storage sources for our products could result in disruption or cessation of our clinical trials and eventual commercialization of such products; and we may not have or be able to secure sufficient capital to fund development and commercialization of our product candidates. All information in this press release is as of April 26, 2006, and we undertake no duty to update this information. A more complete description of these risks can be found in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10 K for the year ended December 31, 2005.
Source: NPS Pharmaceuticals
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