HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patents listed in connection with JALYN® (dutasteride and tamsulosin hydrochloride 0.5 mg/0.4 mg) capsules.
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of JALYN® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification. Impax and its partner Banner Pharmacaps jointly developed the product.
On September 8, 2011, GlaxoSmithKline LLC filed suit for patent infringement against Impax in the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, intends to commercialize the product.
JALYN® is indicated for the treatment of benign prostatic hyperplasia in men with an enlarged prostate. According to Wolters Kluwer Health, U.S. sales of JALYN® were approximately $41 million for the twelve-month period ending July 2011.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (“Impax”) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
About Banner Pharmacaps Inc.
Banner Pharmacaps Inc. is a specialty pharmaceutical company dedicated to the research, development, and manufacturing of unique gelatin-based dosage forms. Banner has created proprietary drug delivery platforms that enhance and control the absorption of poorly soluble active pharmaceutical ingredients. Banner is building a portfolio of Rx, OTC and nutritional products that utilize these innovative gelatin- and polymer-based technologies; and also actively seeks to develop and market products through strategic alliances and partnerships. Banner’s headquarters is located in High Point, North Carolina, with additional research labs and manufacturing facilities in the Netherlands, Canada, and Mexico. Additional information is available on the website www.banpharm.com.
The parent company of Banner Pharmacaps Inc. is VION N.V., an international food group. VION’s annual sales in 2010 were €8.9 billion with 27,000 employees worldwide. The VION head office is in Eindhoven, the Netherlands.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer or a reduction in sales of any significant product, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the pharmaceutical and healthcare industries, the regulatory environment, the ability to protect the Company’s intellectual property, exposure to product liability claims and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Impax Laboratories, Inc.
Mark Donohue, Sr. Director
Investor Relations and Corporate Communications
KEYWORDS: United States North America California Delaware
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical FDA