Cadence Pharmaceuticals entrust Grifols the manufacturing of OFIRMEV® (paracetamol) injection in flexible IV bags


08.03.2013

 

  • This agreement allows Cadence to expand the range of available formats for Ofirmev® (paracetamol, or acetaminophen) injection, while promoting Grifols' third-party drug manufacturing activities in line with the ongoing internationalization strategy of the Hospital division

BARCELONA, Spain – March [8], 2013 – Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced a new supply agreement with Grifols (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS), a global healthcare company focused on producing life-saving plasma medicines, hospital pharmacy products and diagnostic technology for clinical use, for the development, manufacture and supply of commercial quantities of OFIRMEV® (paracetamol) injection in flexible IV bags for the U.S. market.

"As a result of our new collaboration with Grifols, we anticipate that by the second half of 2014, we will be able to offer our customers in the U.S. the option of purchasing OFIRMEV® in flexible IV bags," said Ted Schroeder, President and CEO of Cadence.

According to José Antonio García, President of Laboratorios Grifols, "this agreement will further enhance Grifols third-party drug manufacturing activities, contributing to the geographical diversification of the division, and helping to maximize the use of the manufacturing facilities at Parets del Vallès (Barcelona, Spain)"

Cadence plans to submit a supplemental authorizations (NDA or sNDA), to the FDA in the second half of 2013, seeking approval of the product to be manufactured by Grifols.

The agreement will be in place for six years from the date of the approval by the FDA of the product manufactured by Grifols.

About Cadence Pharmaceuticals, Inc.

Cadence Pharmaceuticals is a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting. The current version of Cadence Pharmaceuticals' corporate overview may be viewed on the Investors page of www.cadencepharm.comunder "Events & Presentations" by selecting "Corporate Overview."

About Grifols

Grifols is a global healthcare company with a 70-year legacy of improving people's health and well being through the development of life-saving plasma medicines, hospital pharmacy products and diagnostic technology for clinical use.

As the third largest global producer of plasma medicines, Grifols has a presence in more than 100 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S. Grifols is committed to increasing patient access to its life-saving plasma medicines through significant manufacturing expansions and the development of new therapeutic applications of plasma proteins. The company is headquartered in Barcelona, Spain and employs more than 11,000 people worldwide.

In 2011, Grifols' sales exceeded 2,300 million euros. The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit www.grifols.com

About OFIRMEV® (Acetaminophen) Injection

OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age. For more information, please see the complete OFIRMEV Prescribing Information, available at www.OFIRMEV.com or www.cadencepharm.com

Important Safety Information
Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. OFIRMEV should be administered only as a 15-minute intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated for post-surgical pain.

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