Ambrilia and Mallinckrodt Announce IND Filing for Phase III Clinical Study of Improved Octreotide Formulation

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

MONTREAL, Canada | Mar 13, 2007 |
Ambrilia Biopharma Inc. (TSX:AMB) and Mallinckrodt Pharmaceuticals' Brands business today announced the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal Phase 3 clinical trial in the United States for Ambrilia's proprietary, improved formulation of Octreotide.

Ambrilia and Mallinckrodt, a division of Tyco Healthcare, have a U.S. 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 United States along with a track record of successful pharmaceutical product commercialization," said Hans J. Mader, president and chief executive officer of Ambrilia. "Our Octreotide development program 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 United States," 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 (Good Manufacturing Practices) 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 U.S. during the first half of 2008.


Ambrilia will be hosting a conference call on Tuesday, March 13 at 9:00 AM ET, to discuss its agreement with Mallinckrodt and upcoming milestones for Octreotide.

Interested parties may access the conference call by way of telephone or webcast. The numbers to access the conference call are 1(800) 595-8550 (toll free) or (416) 644-3421 (local). The webcast will be available at, Investors section, Conference calls and webcasts.

A replay of the call will be available at, Investors section, Conference calls and webcasts, and the numbers to access the replay are (416) 640-1917 (local) and 1(877) 289-8525 (toll free) with access code 21223002.


Ambrilia's lead oncology product is a prolonged release formulation of Octreotide, a synthetic analogue of the natural hormone somatostatin. The original Octreotide product is commercialized as Sandostatin®LAR (octreotide acetate for injectable suspension, a registered trademark and product of Novartis Pharmaceuticals Corporation). Octreotide is used for the treatment of a rare disease called acromegaly, and for certain rare digestive tumors. Acromegaly is a serious chronic condition related to a permanent hypersecretion of growth hormone (GH) by the pituitary gland, generally of tumoral origin. This in turn translates into uncontrolled growth of various organs, and debilitating symptoms. Control of the GH levels by somatostatin analogues 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 a few, mild side effects.


Tyco Healthcare's Mallinckrodt division offers a diverse line of imaging and pharmaceutical products that diagnose disease and relieve pain. As a major business segment of Tyco International Ltd., Tyco Healthcare manufactures, distributes and services an extensive product line including disposable medical supplies, monitoring equipment, innovative wound closure products, advanced surgical devices, medical instruments and bulk analgesic pharmaceuticals. With industry-leading brand names such as AutoSuture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, Syneture and Valleylab, Tyco Healthcare products are found in virtually every healthcare setting.


Ambrilia Biopharma Inc. (TSX:AMB) is a biopharmaceutical company developing novel small molecules and peptides to treat infectious disease and cancer. Ambrilia's product portfolio includes an anti-cancer therapeutic peptide (PCK3145), a Tumor Vasculature Targeting (TVT) technology platform, an improved, prolonged release formulation of Octreotide, a new formulation of Goserelin, promising anti-HIV treatments (PPL-100 and a HIV Integrase Inhibitor Program), other anti-virals and immunomodulators. Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for a $US 17 million upfront payment, potential milestones that could reach $US 212 million, and royalties. Ambrilia's head office, research and development and manufacturing facilities are located in Montreal with a regional office in France. For more information, please visit the Company's web site:

Ambrilia's forward-looking statements

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the Company's filings. Such statements are also based on various assumptions, including the successful and timely completion of clinical studies on Ambrilia's products demonstrating efficacy and safety for human use, their successful commercialization within the forecasted timelines and the attainment of the forecasted milestone payments and other revenues. While Ambrilia anticipates that subsequent events and developments may cause Ambrilia's views to change, Ambrilia specifically disclaims any obligation to update these forward looking statements.

SOURCE: Ambrilia Biopharma Inc

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