NPS Pharmaceuticals, Inc. To Promote Allergan Inc.'s RESTASIS(R) To Rheumatologists In The United States
SALT LAKE CITY, Oct. 24 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. announced today that it has executed an agreement with Allergan, Inc. to promote RESTASIS(R) (cyclosporine ophthalmic emulsion 0.05%), the first and currently only prescription eye drop to increase tear production in patients with chronic dry eye disease (keratoconjunctivitis sicca), a common condition characterized by insufficient tear production to lubricate the eye. Chronic dry eye disease frequently affects patients with autoimmune disorders. Under the agreement Allergan will supply product, promotional materials, training and other support to NPS rheumatology sales professionals who will promote RESTASIS(R) Ophthalmic Emulsion exclusively to rheumatologists in the United States for a period of four years starting November 2005. The promotion of RESTASIS(R) Ophthalmic Emulsion expands the activities of the NPS sales force in preparation for the launch of PREOS(R), the company's proprietary drug candidate for the treatment of osteoporosis which is under review by the U.S. Food and Drug Administration (FDA).
Allergan will continue to promote RESTASIS(R) Ophthalmic Emulsion to ophthalmologists and optometrists through its sales force and its extensive direct to consumer (DTC) advertising, while NPS will support Allergan's promotional efforts through sales and marketing activities directed to rheumatologists. NPS also will continue to promote Kineret(R) (anakinra), a treatment for rheumatoid arthritis, to rheumatologists based on its agreement with Amgen Inc. The addition of RESTASIS(R) Ophthalmic Emulsion to its product mix expands the benefit to NPS from its current sales organization and strengthens the relationships that NPS is building within the rheumatology community. The agreement with Allergan is expected to generate additional revenue for RESTASIS(R) Ophthalmic Emulsion. NPS will share in that revenue by receiving a percentage of the incremental sales generated through its promotional activities.
Speaking for NPS, Dr. Hunter Jackson, Chairman, President and CEO said, "This agreement represents continuing implementation of our commercial development plan. It expands our product line in rheumatology and gives us an important new product to offer rheumatologists and their patients with chronic dry eye disease. We are excited about the opportunity to promote RESTASIS(R) Ophthalmic Emulsion and thereby increase our interactions with the rheumatology community and strengthen our franchise in this key therapeutic area as we pursue regulatory approval of PREOS(R) in the U.S. and Europe."
About Keratoconjunctivitis Sicca
Chronic dry eye disease currently affects more than 3.2 million women aged 50 years of age and older and is the most common ocular manifestation in rheumatoid arthritis. Chronic irritation to the surface of the eye can eventually cause a disruption in the normal tear producing system. This may result in declining quantity of tears. If left untreated, chronic dry eye can lead to impaired vision and an increased risk of ophthalmic infection (i)(ii)(iii). Risk factors for this condition include hormonal changes associated with aging and menopause, autoimmune diseases such as systemic lupus erythematosus (commonly called lupus or SLE), rheumatoid arthritis (RA) and Sjogren's syndrome, as well as medical conditions such as diabetes. Chronic dry eye can be a progressive, inflammatory disease, and is commonly observed in patients seen daily by rheumatologists. Artificial tears and steroid drops are frequently used to reduce the symptoms of chronic dry eye, but artificial tears will not increase tear production and potential toxicity limits the use of steroid drops.
About RESTASIS(R) Ophthalmic Emulsion
RESTASIS(R) (cyclosporine ophthalmic emulsion 0.05%) was approved by the U.S. Food and Drug Administration in December 2002 to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with chronic dry eye. This increased tear production was not seen in patients using topical steroid drops or tear duct plugs. RESTASIS(R) Ophthalmic Emulsion has been available in the U.S. since April 2003. RESTASIS(R) Ophthalmic Emulsion is the first and currently the only prescription eye drop that will increase the production of one's own tears.
RESTASIS(R) Ophthalmic Emulsion should not be used by patients with active eye infections and has not been studied in patients with a history of herpes viral infections of the eye. The most common side effect is a burning sensation. Other side effects include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision.
For full RESTASIS(R) prescribing information, visit www.Restasis.com.
About NPS Pharmaceuticals
NPS discovers, develops and intends to commercialize small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company's first FDA-approved product, Sensipar(R) (cinacalcet HCl), is licensed to Amgen Inc. for the treatment of hyperparathyroidism. PREOS(R) (parathyroid hormone [rDNA origin] for injection) is under review by the FDA for the treatment of osteoporosis. NPS also has investigational drugs in various stages of clinical development backed by a strong drug discovery effort.
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. Such statements include those regarding the likelihood that NPS will be successful in its efforts to promote RESTASIS(R) Ophthalmic Emulsion, that PREOS(R), which is pending FDA approval, will be approved by the FDA as an appropriate therapy for patients who have osteoporosis, and our intent to commercialize small molecules and recombinant proteins as drugs. 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: our product candidates may not prove to be safe or efficacious; the FDA may delay approval or may not approve any of our product candidates; current collaborators or partners may not devote adequate resources to the development and commercialization of our licensed drug candidates which would prevent or delay introduction of drug candidates to the market; 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 October 24, 2005, 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, as amended, for the year ended 2004, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2005. NPS, the NPS logo, and PREOS(R) are registered trademarks of NPS Pharmaceuticals, Inc. RESTASIS(R) Ophthalmic Emulsion is a registered trademark of Allergan, Inc. Kineret(R) and Sensipar(R) are registered trademarks of Amgen Inc.
(i) Kozma CM, Hirsch JD, Wojcik AR. Economic and quality of life impact of dry eye symptoms. Invest Ophthalmol Vis Sci. 2000;41:S928. (ii) Nelson JD, Helms H, Fischella R, et al. A new look at dry eye disease and its treatment. Adv Ther. 2000;17:84-93. (iii) Schaumberg DA, Sullivan DA, Buring JE, Dana, MR. Prevalence of Dry Eye Syndrome Among US Women. Amer J Ophth, 2003; 136:318-326.NPS Pharmaceuticals, Inc.
CONTACT: Gerard Michel, Chief Financial Officer of NPS Pharmaceuticals,Inc., +1-801-583-4939
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