Ambrilia Biopharma Inc. and Mallinckrodt Pharmaceuticals' Brands business has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to conduct a pivotal phase 3 clinical trial in the US for Ambrilia's proprietary, improved formulation of Octreotide.

Ambrilia and Mallinckrodt, a division of Tyco Healthcare, have a US licensing and product development agreement for Ambrilia's proprietary improved formulation of Octreotide. Ambrilia is a biopharmaceutical company developing innovative therapeutics in the fields of cancer and infectious diseases. Mallinckrodt Pharmaceuticals' Brands business is dedicated to providing a broad range of medications focused on sleep, depression, palliative care, pain management and other areas of the Central Nervous System.
"Mallinckrodt has the sales and marketing expertise to reach specialists who will prescribe Octreotide throughout the US along with a track record of successful pharmaceutical product commercialisation," said Hans J Mader, president and chief executive officer of Ambrilia. "Our Octreotide development programme is moving ahead as planned. A pivotal clinical trial in acromegaly patients already has started in Europe, and we look forward to extending it to Canada and the US," he concluded.

The agreement between Ambrilia and Mallinckrodt covers development, regulatory and sales milestone payments, product supply at a fixed price and agreed upon minimum annual sales. Ambrilia will manufacture the final product at its cGMP facility in Montreal, Canada.

This collaboration with Ambrilia is part of Mallinckrodt's efforts to expand its pipeline of products for the palliative care market.

"Octreotide will complement other products in our portfolio that will serve patients' palliative care needs," said Vince Kaiman, vice president and general manager of Mallinckrodt Pharmaceuticals. "This relationship with Ambrilia enables us to leverage patented delivery technology in innovative sustained release peptide formulations."

As previously announced, Ambrilia is currently setting up phase 3 clinical studies of its Octreotide PR formulation in acromegaly patients. A pivotal clinical trial already has started in Europe, where Ambrilia plans to file an application for marketing approval at the beginning of 2008. Ambrilia expects to file for marketing approval in the US during the first half of 2008.