Ambrilia Biopharma Inc., a biopharmaceutical company developing innovative therapeutics in the fields of oncology and infectious diseases, has entered into a Licensing/Distribution agreement with Teva Europe for the marketing of its improved sustained-release formulation of Octreotide for the treatment of acromegaly. No financial terms are released.
Teva Europe, a subsidiary of the global generic pharmaceutical leader Teva Pharmaceutical Industries Ltd., is Octreotide's licensee for France, Germany, Benelux, Spain and Scandinavia. The agreement comprises of development, regulatory and sales milestones payments, product supply at fixed price as well as royalties on sales and agreed upon minimal annual sales. Ambrilia will manufacture the product at its cGMP (Good Manufacturing Practices) facility in Montreal, Canada, and supply the finished product to its partner for sale in Europe.
"We are very pleased to have Teva as our partner for the marketing of our improved formulation of Octreotide in those important jurisdictions in Europe. We believe this partnership with the world's largest generic pharmaceutical company bodes well for the future commercial success of Octreotide in Europe," said Hans J. Mader, President and chief executive officer of Ambrilia.
As previously announced, Ambrilia is currently setting up limited clinical studies of its formulation in acromegalics, as scheduled in the development plan of the product. Completion of these studies is expected in the second half of 2007. Ambrilia expects to file for European approval shortly thereafter.
Ambrilia's lead oncology product is a prolonged release formulation of Octreotide. The original product is commercialized as Sandostatin LAR (octreotide acetate for injectable suspension, a registered trademark of Novartis Pharmaceuticals Corporation) and is owned by Novartis. Octreotide is used for the treatment of a rare disease called acromegaly caused by a tumour of the pituitary gland, and for certain rare digestive tumours.
Acromegaly is a rare and serious chronic condition related to a permanent hypersecretion of growth hormone (GH) by the pituitary gland, generally of tumoural origin. This causes an excessive production of Insulin-like Growth Factor 1 (IGF-1), a hormone secreted from the liver and other tissues. Excessive production of IGF-1 and GH translates into uncontrolled growth of various organs, and debilitating symptoms. Control of the GH and IGF-1 levels by Sandostatin LAR results in normalizing such excessive growth and symptoms. Medical treatment has an important role to play in the management of patients with acromegaly. It is a life long treatment, with few, mild side effects.