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XenoPort (Nasdaq: XNPT) $8.08. Today announced that it had reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of arbaclofen placarbil (AP), previously known as XP19986, as a potential treatment of spasticity in multiple sclerosis (MS) patients. An SPA is a written agreement with the FDA on the design, including the scope and size of the patient population, the efficacy endpoints and safety assessments, the duration of treatment and the statistical analysis plan, of a pivotal Phase 3 trial to support an efficacy claim in a New Drug Application (NDA).
In addition, XenoPort reported that it has completed an End of Phase 2 meeting with the FDA regarding the additional studies required to enable submission of an NDA for AP as a treatment for spasticity. The FDA indicated that the Phase 3 pivotal trial that is the subject of the SPA and these additional studies could form the basis of an NDA to be filed under Section 505(b)(2), which allows reference to published literature and the FDA’s previous finding of safety and effectiveness for baclofen, a drug that has been approved by the FDA for the alleviation of signs and symptoms of spasticity in individuals with MS or spinal cord injury.
What They Do: XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.
POZEN Inc. (Nasdaq: POZN) $5.78. Today announced that it and AstraZeneca filed a lawsuit against Dr. Reddy’s Laboratories (Dr. Reddy’s) in the United States District Court for the District of New Jersey, for infringement of U.S. Patent No. 6,926,907 relating to VIMOVO (naproxen / esomeprazole magnesium) delayed-release tablets. In a Notice Letter sent to AstraZeneca and POZEN in March 2011 (Notice Letter), Dr. Reddy’s informed AstraZeneca and POZEN that it submitted an Abbreviated New Drug Application (ANDA) seeking U.S. Food and Drug Administration (FDA) approval to market a generic version of VIMOVO prior to expiration of U.S. Patent No. 6,926,907, which is one of seven patents listed in the FDA’s Orange Book for VIMOVO. The patent expires in 2023. Under the terms of its agreement with POZEN, AstraZeneca has exercised its first right to defend the patent at issue and will take the leading role in prosecuting the infringement suit against Dr. Reddy’s.
The filing of this patent infringement lawsuit by AstraZeneca and POZEN within forty-five days of receipt of Dr. Reddy’s Notice Letter will result in the FDA automatically instituting a stay, or bar, of final approval of Dr. Reddy’s ANDA for up to 30 months or until a final court decision is entered in the infringement suit in favor of Dr. Reddy’s, whichever occurs first. VIMOVO currently has regulatory exclusivity through April 30, 2013.
What They Do: POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs.
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