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Pentech filed its ANDA for Luxiq foam containing a Paragraph IVCertification with the U.S. Food & Drug Administration and notified Connetics,the New Drug Application holder for the brand product. On November 6, 2007,Connetics filed suit alleging patent infringement in the United StatesDistrict Court for the Northern District of Illinois to prevent Pentech fromproceeding with the commercialization of its product. The lawsuit formallyinitiated the patent process under the Hatch-Waxman Act. Pentech believesthat it is the first to file an ANDA with a Paragraph IV certification againstLuxiq and Perrigo believes that it will be the first company to market thisproduct.
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Perrigo will also invest $12.5 million in cash in Cobrek in exchange for aminority ownership position. Pentech will contribute to Cobrek all of itsinterests in current and future ANDA filings including a potentialfirst-to-file on a generic version of Hectorol (Doxercalciferol).
Commenting on the announcement, Perrigo Chairman and Chief ExecutiveOfficer, Joe Papa, stated, "Cobrek will utilize its proven ability to developniche generic products while capitalizing on Perrigo's marketing anddistribution capabilities. This strategic collaborative agreement andinvestment enhances our existing U.S. product portfolio and future pipeline,demonstrating our on-going commitment to the generic prescriptiondermatological space. We believe that these new and future products willexpand Perrigo's leadership position in this category and provide anopportunity for us to improve returns on one of our core businesses. We lookto identify more such opportunities in the future."
Perrigo Company is a leading global healthcare supplier that develops,manufactures and distributes over-the-counter (OTC) and prescriptionpharmaceuticals, nutritional products, active pharmaceutical ingredients (API)and consumer products. The Company is the world's largest manufacturer of OTCpharmaceutical products for the store brand market. The Company's primarymarkets and locations of manufacturing facilities are the United States,Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet(http://www.perrigo.com).
Pentech Pharmaceuticals, formed in 1993, is a prescription pharmaceuticalsdevelopment company, whose strategy is to seek out special situations in thepharmaceutical industry, paying particular attention to the changinghealthcare requirements of an aging population. Special emphasis is placed onfinding products and market niches which offer strong revenue potential,limited competitive pressure, and extended product life cycles. As a rule,Pentech limits its activities to the validation of its products throughinternally conducted scientific, market and legal research, while seekingpartnerships with larger, more established companies such as Perrigo toexecute clinical, marketing and manufacturing functions. Prior to thetransaction described in this release, Pentech's past successes under itsstrategy included apomorphine HCL, a proprietary erectile dysfunction druglicensed to TAP, and generic Paxil, the subject of a joint manufacturing andmarketing arrangement with Par Pharmaceuticals. Visit Pentech on the Internet(http://www.pente
