Ambrilia Biopharma Inc, a biopharmaceutical company developing innovative therapeutics in the fields of cancer and infectious diseases, has received a milestone payment resulting from an agreement with its licensing partner in the US for its late-stage oncology specialty generic, Octreotide, for the treatment of acromegaly and certain rare digestive system cancers.
Ambrilia has a product development and license agreement for the US with an undisclosed major pharmaceutical company, which includes upfront payments, milestones and purchase of the final product, a sustained release formulation of Octreotide, via a product sale and marketing arrangement between the two companies, Ambrilia will manufacture the product at its cGMP (Good Manufacturing Practices) facility in Montreal, Canada, and supply the finished product to the partner for sale in the US.
The milestone payment from the partner became due, upon the manufacture of sterile batches of Octreotide meeting stability requirements and cGMP compliance. To date Ambrilia has received US $2.2 million in licensing fees and milestone payments from its partner. Further milestone payments are expected over the course of the next 20 to 24 months, as part of this multi-million dollar agreement between the two companies.
Ambrilia will sell the finished product to its partner at an agreed schedule and transfer price inclusive of royalties. Ambrilia is currently conducting pivotal pharmacokinetic studies to evaluate the pharmacokinetic properties (bodily absorption, distribution, metabolism and excretion) of Octreotide in comparison to Novartis's Sandostatin LAR (long-acting release) in human subjects. Sandostatin sales in 2005 reached approximately US $900 million.
"Octreotide's development programme is continuing to advance as planned, as signified by the milestone payment just received from our US licensing partner," stated Hans J. Mader, President and CEO of Ambrilia. "Octreotide represents an important marketing opportunity for us and our partners since the need for a sustained release formulation of the drug, for treatment of acromegaly and certain rare digestive tumours, keeps growing. Furthermore, we are delighted with the relationship with our partner and its sales and marketing capabilities in the US finally, we anticipate being in a position to announce updates on our other licensing agreements outside the US shortly," he added.
Acromegaly is a chronic disease resulting from the growth of an adenomatous tumour (epithelial tumour having a glandular origin and structure) on the pituitary gland, causing an excessive production of Insulin-like Growth Factor 1 (IGF-1). The latter is a hormone secreted from the liver and other tissues in response to Human Growth Hormone and accounts for the most part of the growth promoting effects of HGH. Excessive production of IGF-1 translates into uncontrolled growth of various appendages.