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October 01, 2012 at 15:58 PM EDT
Pamlab, LLC and Breckenridge Pharmaceutical, Inc. Announce Joint Venture to Provide Authorized Generics on Pamlab Branded Medical Food Products

COVINGTON, La. and BOCA RATON, Fla., Oct. 1, 2012 (GLOBE NEWSWIRE) -- Pamlab and Breckenridge have entered into a joint venture for the marketing and distribution of authorized generic versions of Pamlab's medical food products containing Metafolin®. Breckenridge expects to launch the first of these products on October 1, 2012. The joint venture includes a sub-license from Pamlab to Breckenridge for exclusive patents applicable to Pamlab's popular medical foods such as Metanx®, Deplin® and CerefolinNAC®.

"This partnership will finally ensure that patients who want generics of Pamlab's medical foods will be able to obtain products that are exactly the same as the brand. Breckenridge's authorized generics will be manufactured in the same facility and with the same ingredients and quantities as Pamlab's brand products. Other safeguards for product quality and therapeutic verification of generics for medical foods have recently proven to be inadequate," explained Eric Wingerter, CEO at Pamlab. "We believe that Breckenridge's stability and credibility in the generic market will help to ensure that only authorized generic products are substituted for Pamlab products in patient's prescriptions."

"The medical food category is exciting to us as a rapidly expanding area of patient and physician demand. We are pleased to serve as a guiding influence in this category and to protect the integrity of the supply chain through authorized generics. We believe this partnership is a win-win-win- that will include retailers and wholesalers in a better supply process that benefits the patient as well as the manufacturer," added Larry Lapila, Executive Vice President at Breckenridge.

The following Patents are included in the sub-license to Breckenridge:

  • "Merck Patents" – licensed to Pamlab in 2002 by Merck & Cie, a Swiss company and South Alabama Medical Science Foundation, covering Metafolin®, the active ingredient used in most of Pamlab's medical food products. 
  • "Cobalz Patent" – licensed to Pamlab in 2003 covering a method of treating and/or preventing vitamin B12 deficiencies.
  • "Isis Patents" – licensed to Pamlab in 2004 covering a method of treating Alzheimer's Disease. 
  • "Metabolite Patents" – licensed to Pamlab in 2000 by two hematology professors at the University of Colorado School of Medicine, Dr. Robert H. Allen and Dr. Sally P Stabler, covering combinations of folic acid and Vitamins B6 & B12.

Pamlab markets the following branded medical food products to health care providers and physicians throughout the United States. Breckenridge will now distribute authorized generics of each product through wholesalers, chains and retail pharmacies in the same locations.

  • Metanx® is a medical food for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. The Breckenridge generic product will be marketed under the name Foltanx™.
  • Deplin® is a medical food for the dietary management of the metabolic imbalances associated with depression. The Breckenridge generic products will be marketed under the names L-methylfolate 7.5mg (30 count and 90 count options) and L-methylfolate 15mg.
  • CerefolinNAC® is a medical food for the dietary management of certain metabolic processes identified with early memory loss. The Breckenridge generic products will be marketed under the name Metafolbic™ and Metafolbic™ Plus.

The term "medical food," as defined by law, means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

In 2007, Breckenridge entered into a patent sublicense with Pamlab under several Metabolite patents, to begin exclusive marketing of Folbic®, a licensed generic version of Pamlab's Foltx®.  Since that time, Folbic® has been distributed and dispensed at retail pharmacies nationwide.

About Pamlab, LLC

Founded in 1957, Pamlab is a fully integrated pharmaceutical company, with approximately 300 employees, specializing in medical foods. Pamlab's products are marketed and sold nationally, helping hundreds of thousands of patients with depression, diabetic peripheral neuropathy, dementia, high-risk pregnancy and other diseases and conditions. For more information, please visit www.pamlab.com.

About Breckenridge Pharmaceutical, Inc.

Breckenridge is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products and Medical Foods in many therapeutic categories. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets over 60 products in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, and Liquids, and Powders.

CONTACT: Breckenridge Pharmaceutical, Inc. (FL)
         Legal Counsel - Gene Kim
         (561) 443-3314/ekim@bpirx.com
         
         Pamlab, LLC (LA)
         Legal Counsel - Keith Daigle
         985-893-4097 / kdaigle@pamlab.com
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