10/26/2010 7:20:08 AM
WOODCLIFF LAKE, N.J., Oct. 26 /PRNewswire/ -- Strativa Pharmaceuticals today announced that it has entered into an amended and restated license and supply agreement with Swedish Orphan Biovitrum (Sobi) covering the European development and commercialization rights of Strativa's Nascobal (cyanocobalamin) Vitamin B12 Nasal Spray. Strativa acquired the worldwide rights to Nascobal from QOL Medical, LLC in March 2009, which included a pre-existing agreement with Sobi.
Under the terms of the amended agreement, Sobi will conduct and pay for all development activities for European regulatory approval of Nascobal. Sobi is expected to begin clinical development in the first half of 2011. Strativa and Sobi will share in the expense of upgrading Strativa's manufacturing facility to comply with European regulations, and Strativa will supply European-ready product to Sobi. Sobi will be responsible for commercializing the product in Europe, including all sales and marketing activities. Strativa will receive double-digit royalty payments based on Sobi's net sales of Nascobal in Europe.
Nascobal Nasal Spray is a US FDA approved prescription vitamin B12 supplement indicated to treat vitamin B12 deficiency. It is the first and only once-weekly, self-administered alternative to B12 injections. The leading causes of vitamin B12 deficiency include pernicious anemia, a strict vegetarian diet, malabsorption of vitamin B12 resulting from conditions such as HIV infection, Crohn's disease, multiple sclerosis and partial or total gastrectomy, among others. In 2009, more than 48 million and 72 million vitamin B12 injections were prescribed to patients in the United States and Europe, respectively, according to IMS Health.
Nascobal Nasal Spray Safety Information
Nascobal® Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies including: dietary deficiency of vitamin B12 occurring in strict vegetarian diets; malabsorption of vitamin B12 resulting from conditions including HIV infection, AIDS, and Crohn's disease; inadequate secretion of intrinsic factor resulting from lesions that destroy the gastric mucosa, and other conditions associated with gastric atrophy, including multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy; total gastrectomy; competition for vitamin B12 by intestinal parasites or bacteria; and inadequate utilization of vitamin B12 that may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.
Nascobal Nasal Spray is contraindicated in patients with sensitivity to cobalt and/or vitamin B12 or any component of the medication. If a patient is not properly maintained with Nascobal Nasal Spray, intramuscular vitamin B12 is necessary. Vitamin B12 concentrations must be monitored.
Patients with pernicious anemia should be instructed that they will require weekly administration of Nascobal Nasal Spray for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Patients with early Leber's disease (hereditary optic nerve atrophy) who are treated with vitamin B12 suffered severe and swift optic atrophy. Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition. Hypokalemia and sudden death may occur in severe megaloblastic anemia, which is treated intensely with vitamin B12.
Side effects thought to be related to Nascobal are usually mild and include headache, nausea, and rhinitis.
About Strativa Pharmaceuticals
Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), excels at finding, enhancing, and bringing to market drugs that make a meaningful difference to patients. For more information about Strativa, visit www.strativapharma.com.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a U.S.-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press releases and other company information, visit www.parpharm.com.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty pharmaceutical company with an international market presence. The company is focused on providing and developing specialist pharmaceuticals for rare disease patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipe-line. The focus areas are: hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer supportive care and inherited metabolic disorders.
Swedish Orphan Biovitrum had pro-forma revenues 2009e of about 2 billion SEK and approximately 500 employees. The head office is located in Sweden and the share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information, please visit www.Sobi.com.
Safe Harbor Statement
Certain statements in this news release constitute "forward-looking statements" within the meaning of 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 essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Strativa Pharmaceuticals