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| CADX > SEC Filings for CADX > Form 8-K on 7-Jan-2013 | All Recent SEC Filings |
7-Jan-2013
Termination of a Material Definitive Agreement, Other Events
On January 4, 2013, Cadence Pharmaceuticals, Inc. (the "Company" or "Cadence") was notified that Incline Therapeutics, Inc. ("Incline") closed its previously announced merger with The Medicines Company. In connection with the closing, the Company received a payment of approximately $13.1 million as consideration for entering into a Waiver, Consent and Option Termination Agreement pursuant to which the Company agreed to the buy-out and termination of its option to purchase Incline. Additionally, the Company will receive approximately $1.5 million and, potentially, a pro rata share of future milestone payments, if any, related to the purchase by The Medicines Company of the shares of Incline stock held by the Company.
Compensation Committee Chairman
Effective January 1, 2013, Samuel L. Barker was appointed Chairman of the Board's Compensation Committee.
Litigation Update
On December 19, 2012, the United States District Court for the Eastern District of Virginia dismissed with prejudice the lawsuit brought by Exela Pharma Sciences, LLC, et al. ("Exela"), against David J. Kappos and the United States Patent and Trademark Office ("USPTO"). Exela brought this lawsuit to obtain a declaratory judgment seeking a reversal of the decision by the USPTO refusing to act on a petition by Exela to vacate the USPTO's April 2003 order reviving the international application for U.S. Patent No. 6,992,218 (the "'218 patent"). The lawsuit followed the USPTO's rejection of Exela's petition to the USPTO filed in November 2011, which sought to vacate the April 23, 2003 order granting SCR Pharmatop S.A.'s petition to revive the application that eventually became the '218 patent.
On December 24, 2012, Cadence received a notice from Sandoz, Inc. ("Sandoz"), a New Jersey-based company, stating that Sandoz filed an Abbreviated New Drug Application ("ANDA") containing a "Paragraph IV" patent certification with the U.S. Food and Drug Administration (the "FDA") for a generic version of Cadence's drug, OFIRMEV® (acetaminophen) injection (1000 mg/100 mL, 10 mg/mL). This notice states that the "Paragraph IV" patent certification was made with respect to both patents for OFIRMEV listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. A Paragraph IV patent certification is a certification by a generic applicant that, in the opinion of that applicant, the patent listed in the Orange Book for a branded product is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of the generic product. Cadence is currently reviewing the details of the notice. Under the Federal Food, Drug, and Cosmetic Act and the FDA's implementing regulations, the filing of a patent infringement lawsuit within 45 days of the receipt of notice of a Paragraph IV patent certification automatically prevents the FDA from approving the ANDA until the earlier of the expiration of a 30-month period, the expiration of the patents, the entry of a settlement order stating that the patents are invalid or not infringed, a decision in the infringement case that is favorable to the ANDA applicant, or such shorter or longer period as the court may order. Cadence intends to vigorously enforce its intellectual property rights relating to OFIRMEV, but cannot predict the outcome of this matter or guarantee the outcome of any litigation. OFIRMEV is protected by two patents, both of which are listed in the Orange Book.
For a discussion of risks related to the ANDA filing by Sandoz, see the discussion of "Intellectual Property" under the "Business" section of Cadence's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission (the "SEC") on March 13, 2012 and the "Risk Factors" section of Cadence's Quarterly Report on Form 10-Q for the period ended September 30, 2012 filed with the SEC on November 6, 2012, including the risks described under the headings "If the government or third-party payors fail to provide coverage and adequate coverage and payment rates for OFIRMEV or any future products we may license or acquire, if any, or if hospitals choose to use therapies that are less expensive, our revenue and prospects for profitability will be limited" and "The patent rights that we have in-licensed covering OFIRMEV are limited to a specific intravenous formulation of acetaminophen, and our market opportunity for this product candidate may be limited by the lack of patent protection for the active ingredient itself and other formulations that may be developed by competitors," as well as any updates to such sections contained in Cadence's subsequent reports filed with the SEC.
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