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Nevakar and Endo Enter into Exclusive Licensing Agreement for Multiple 505(b)(2) Injectable Products
BRIDGEWATER, N.J., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Nevakar Inc., a specialty pharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today that it recently entered into an exclusive licensing agreement with Endo International plc’s (NASDAQ: ENDP) subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the U.S. and Canada. Pursuant to the agreement, Nevakar will develop and seek U.S. Food and Drug Administration (FDA) approval for these products and Endo’s Par Pharmaceutical Sterile Products division will launch and distribute the products upon approval.
“We are pleased to establish this partnership with Endo, a respected pharmaceutical company with a significant and growing presence in sterile and critical care products. This agreement validates Nevakar’s strong pipeline and business model and furthers our mission to develop innovative pharmaceutical products that improve patient care and quality of life,” stated Navneet Puri, Ph.D., Founder, President and Chief Executive Officer of Nevakar.
“This important strategic initiative provides us with products that align well with our goal of expanding our sterile injectables’ business and adding more complex 505(b)(2) products into our pipeline. If approved, these drugs will benefit patients by providing new treatment options in the hospital and critical care environment,” said Paul Campanelli, President and CEO of Endo. “We look forward to once again working with Dr. Navneet Puri and the Nevakar team to bring these products to market.”
Par Pharmaceutical currently markets several products that were developed by InnoPharma, a company which was also founded by Dr. Navneet Puri and subsequently sold to Pfizer in 2014.
About Nevakar Inc.
Nevakar Inc. is growing as a fully integrated specialty pharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patient care and quality of life. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
About Par Pharmaceutical
Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses a portfolio that includes sterile injectables, alternative dosage forms and many other differentiated products. Par is advancing a research and development (R&D) pipeline of approximately 200 potential new products. Par is an operating company of Endo International plc. Learn more at www.parpharm.com.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements by Dr. Puri and Mr. Campanelli and statements relating to the development of sterile injectable products in the U.S. and Canada. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties, including, but not limited to, the possibility that the FDA or other regulatory authorities do not approve any product(s) on a timely basis, or at all; the failure to achieve the expected financial and commercial results from the transaction; other business effects, including effects of industry, market, economic or political conditions; transaction costs; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; the timing or outcome of any pending or future litigation, investigations, claims or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings; and governmental laws and regulations affecting domestic and foreign operations. Given these uncertainties and risks, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and are qualified by these risk factors. There is no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.
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