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.