BEDMINSTER, N.J., Oct. 31 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. announced today that Nycomed, after an in-depth review of the results from the recently completed Phase 3 study in Short Bowel Syndrome, has confirmed its intention to proceed with the development and commercialization of GATTEX(TM) (teduglutide) outside North America. Under the terms of the partnership agreement signed in September, Nycomed will pay NPS the $25 million up-front payment balance due and receive licensing rights to develop and commercialize GATTEX outside the United States, Canada and Mexico for the treatment of gastrointestinal disorders. NPS will retain the right to develop and commercialize GATTEX in North America.
In addition to the $35 million total up-front payment, NPS has the potential to earn up to $150 million in payments related to the attainment of certain regulatory milestones for the SBS indication, the successful development of new indications and the achievement of sales-based milestones. Additionally, the agreement provides for double-digit royalties on GATTEX sales in the Nycomed territories. The agreement also provides for development cost-sharing on a 50:50 basis for indications which are pursued jointly.
Nycomed CEO Hakan Bjorklund stated: “We look forward to working with NPS to develop and commercialize GATTEX as a new therapy for SBS and potentially for other serious gastrointestinal conditions. We believe GATTEX will be an important addition to our product pipeline and expect it to complement our development and marketing capabilities in the gastroenterology field.”
NPS president and CEO Dr. Tony Coles stated: “We are pleased that our partner, Nycomed, has confirmed its commitment to the development of GATTEX outside North America based upon the results of the recently completed Phase 3 SBS study. We greatly appreciate their vote of confidence in GATTEX and look forward to discussing the study results with the FDA so we can proceed as rapidly as possible with the next steps required to obtain regulatory approval of the drug in the United States. With our recent successful financing and asset monetization activities and Nycomed’s commitment to GATTEX, NPS is now in an excellent position to complete the registration of GATTEX in SBS and pursue its development in multiple indications.”
A potential first-in-class drug, GATTEX is a proprietary analog of naturally occurring human glucagon-like peptide 2 (GLP-2), a peptide secreted primarily in the distal intestine and involved in the regeneration and repair of the intestinal epithelium. In addition to its potential use in short bowel syndrome, NPS is also pursuing development of GATTEX as a possible treatment for chemotherapy-induced gastrointestinal mucositis in cancer patients and necrotizing enterocolitis in preterm infants.
About NPS
NPS Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has drug candidates in various stages of clinical development. Additional information is available on the company’s website, http://www.npsp.com.
About Nycomed
Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets. The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region, Nycomed has a presence in about 50 markets worldwide. Privately owned, the combined group had annual sales of approximately euro 3.4 billion and an EBITDA of euro 933.4 million (2006 results). For more information visit http://www.nycomed.com
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. All information in this press release is as of October 31, 2007 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, 2006 and our Quarterly Report on Form 10-Q for the quarter-ended June 30, 2007.
CONTACT: Brandi Simpson of NPS Pharmaceuticals, Inc., +1-908-450-5616
Web site: http://www.npsp.com/
