Strativa Pharmaceuticals has entered into an amended and restated license and supply agreement with Swedish Orphan Biovitrum (Sobi) for the European development and commercialisation rights of Strativa's Nascobal (cyanocobalamin) Vitamin B12 nasal spray.
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 have no nervous system involvement.
As per the terms of the amended agreement, Sobi is expected to 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.
However, Sobi will be responsible for commercialising 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.
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.