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Last $1.79 USD
Change Today +0.08 / 4.68%
Volume 440.5K
As of 8:10 PM 08/28/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

100 Princeton South

Suite 300

Ewing, NJ 08628

United States

Phone: 609-359-3020

Fax:

n gel product, Gelnique 3%, for the treatment of overactive bladder. The company has a licensing agreement with Actavis plc (Actavis) under which Actavis is marketing Gelnique 3% in the U.S. Elestrin (estradiol gel) is marketed by Meda Pharmaceuticals, Inc. in the U.S. for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. The company has a development agreement with the Population Council, an international, nonprofit research organization, to develop a novel hormonal contraceptive comprising a combination of the progestin Nestorone and a form of estrogen, called 17b-estradiol, which is chemically identical to the naturally occurring estrogen. The company has a joint development agreement with the Population Council to develop a contraceptive formulation product containing Nestorone using the Population Council’s patented compound and other proprietary information covering the compound, and its transdermal delivery gel. The company is responsible for research and development activities as they relate to the gel and the Population Council would be responsible for clinical trial design development and management. Together, the company is looking for a commercial development partner to complete the development of this product. The company has a joint development agreement with the Population Council to develop a contraceptive formulation product containing Nestorone using the Population Council’s patented compound and other proprietary information covering the compound, and its transdermal delivery gel. The company is responsible for research and development activities as they relate to the gel and the Population Council would be responsible for clinical trial design development and management. Sales and Marketing OTREXUP In 2013, the company announced the approval of OTREXUP (methotrexate) injection by the FDA, and in 2014, the company announced the launch of OTREXUP. It has worldwide marketing rights for OTREXUP and commercializes OTREXUP on its own in the U.S. for the treatment of RA. Partnered Products Revenue from Teva also included development and product revenue related to license agreements with Teva for the company’s Vibex system and for its pen injector device. Distribution In connection with the launch of OTREXUP the company has contracted with a third-party logistics provider, Cardinal Health 105, Inc., also known as Specialty Pharmaceutical Services (Cardinal), for key services related to logistics, warehousing and inventory management, distribution, contract administration and chargeback processing, accounts receivable management and call center management. Agreements In 2011, the company entered into a licensing agreement with Pfizer Consumer Healthcare (Pfizer) for one of its drug delivery technologies to develop an undisclosed product on an exclusive basis for North America. Seasonality of Business The company is subject to and affected by the business practices of its pharmaceutical/device partners. Additionally, development revenue the company derives from its partners is subject to fluctuation based on various programs being conducted by its partners, as well as delays or lack of funding for those programs. Proprietary Rights The company holds various patents and numerous additional patent applications pending in the U.S. and other countries. Its patents have expiration dates ranging from 2015 to 2031. In addition to issued patents and patent applications, the company is also protected by trade secrets in all of its technologies. Government Regulation Drug-device combination products developed by the company, such as OTREXUP, Vibex QS T, and Vibex QS M, and those being developed by its partner, Teva, are subject to the New Drug Application, ANDA, sNDA, sANDA and 505(b)(2) regulations, as well as the device approval process. In addition to regulations enforced by the FDA, the company must comply with regulations under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other federal, state, and local regulations. Hist

 

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