First and Only Once-weekly, Self-administered Alternative to Injections for Treatment of Vitamin B12 Deficiency
WOODCLIFF LAKE, N.J., April 1 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced it has acquired the worldwide rights to Nascobal(R) (Cyanocobalamin, USP) Nasal Spray from QOL Medical LLC. Nascobal Nasal Spray is an 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.
Under the terms of the all cash transaction, Strativa Pharmaceuticals will pay QOL Medical $54.5 million for the worldwide rights to Nascobal Nasal Spray. Revenues of Nascobal exceeded $8.0 million in 2008. Nascobal Nasal Spray will be manufactured by Par, which also acquired the MDRNA (formerly Nastech) facility where the product is manufactured.
"The acquisition of Nascobal Nasal Spray represents an important milestone in the execution of our corporate strategy to accelerate the growth of Strativa," said Patrick G. LePore, Chairman, Chief Executive Officer and President of Par. "The addition of Nascobal to our current portfolio, coupled with our promising product pipeline, well positions Strativa within the U.S. specialty pharmaceutical industry."
Millions of Americans are treated for vitamin B12 deficiency. 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, AIDS, Crohn's disease, multiple sclerosis and partial or total gastrectomy, among others. In 2008, more than 45 million vitamin B12 injections were prescribed to patients in the United States.
John A. MacPhee, President of Strativa Pharmaceuticals, said, "We believe that Nascobal Nasal Spray offers important benefits to people with a vitamin B12 deficiency. Given the large size of the prescription vitamin B12 market and Strativa's sales and marketing expertise, we believe that Nascobal is poised for significant growth."
Nascobal Nasal Spray, approved by the U.S. Food and Drug Administration in 2005, contains a synthetic form of vitamin B12 that is readily absorbed into the bloodstream through the nose and provides steady serum levels without the need for monthly injections received at the physician's office. Nascobal Nasal Spray's once-weekly dosing is convenient for patients and can minimize peaks and troughs in B12 serum levels that may be associated with monthly injections.
Nascobal Nasal Spray Safety Information
Nascobal(R) 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. 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 use are usually mild and include headache, nausea and rhinitis.
Please see full prescribing information.
About Strativa Pharmaceuticals
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.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 Annual Report on Form 10-K for the year ended December 31, 2008, in other of the Company's filings with the SEC from time to time, including 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 Par Pharmaceutical, Inc.|
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