Healthcare Industry News: Novasome
News Release - May 19, 2006
Novavax and Esprit Pharma to Co-develop Novel Medicine for Female Sexual Desire DisorderEsprit Receives North American Marketing Rights
MALVERN, Pa., May 19 (HSMN NewsFeed) -- Novavax, Inc. (Nasdaq: NVAX ), today announced that it has entered into a definitive agreement with Esprit Pharma to co-develop, supply and commercialize Novavax's(TM) micellar nanoparticle testosterone medicine currently in development to treat female hypoactive sexual desire disorder (HSDD).
Women who suffer from HSDD have low sexual desire. Approximately 25% of women in the United States are estimated to be affected by this condition. Novavax's testosterone medicine, which applied as a lotion, is currently in Phase II clinical development.
Under terms of the License Agreement, Esprit will receive exclusive rights to market the product in North America. Esprit will make certain minimum payments to Novavax upon the achievement of pre-determined clinical and regulatory milestones, and royalties on all net sales of the product. The anticipated milestone and royalty payments from this new agreement will be similar in scope to our prior license agreement with Esprit executed last year. Esprit will be responsible for all development costs and will lead clinical programs. Novavax will be responsible for manufacturing the product in its existing state-of-the-art facility located in Philadelphia.
"We are delighted with our second new partnership with Esprit and believe that we have the opportunity to develop and commercialize a best-in-class product for women with HSDD," said Ray Hage, Senior Vice President and Chief Operating Officer of Novavax. "John Spitznagel and his team at Esprit have a remarkable track record of launching successful new products and this product will be a strong addition to their portfolio."
Novavax first collaborated in a business relationship with Esprit late last year when Esprit licensed Novavax's estrogen therapy lotion, ESTRASORBŪ, in North America.
"We are very excited about adding this key development program to our product pipeline," said John T. Spitznagel, Esprit's Chairman and Chief Executive Officer. "Novavax's unique technology delivers testosterone through the skin in a therapeutically effective and easy-to-use lotion. This product will be very appealing to women who suffer from this condition."
Novavax President and Chief Executive Dr. Rahul Singhvi, President said the agreement "further substantiates Novavax's capabilities in product development and validates the company's novel delivery system as an important technology." The U.S. Food and Drug Administration approved ESTRASORBŪ, Novavax's first lotion therapy, in 2003.
"We are confident that our novel technology will continue to enable us to develop products that have the potential to improve patient health and quality of life as well as provide unique opportunities for companies like Esprit," Dr. Singhvi said.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on NovasomesŪ, non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against H5N1, H9N2 and other avian influenza viruses and a seasonal flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORBŪ. In addition to MNP, Novavax drug delivery technologies include NovasomesŪ and SterisomesŪ, solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2005 and quarterly report on Form 10Q for the quarter ended March 31, 2006 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at http://www.sec.gov.
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