Ambrilia Biopharma Inc. Reports Positive Final Phase III Results for its Octreotide Formulation C2L
MONTREAL, QUEBEC--(MARKET WIRE)--May 14, 2008 -- Ambrilia Biopharma Inc. (Toronto:AMB.TO - News) today reported positive 24-week Phase III ("Study 301") top-line results for its proprietary prolonged-release formulation of Octreotide ("C2L"). The preliminary statistical analysis confirms its safety and efficacy in acromegaly patients, and its ability to replace Sandostatin LAR® with less frequent injections and non-inferior efficacy on Growth Hormone ("GH") and Insulin-like Growth Factor 1 ("IGF-1"). Concurrently, the Company announced the termination of the U.S. licensing agreement with Covidien Ltd. As a result, Ambrilia regains all license and marketing rights for its C2L formulation in the U.S.A. Termination agreement also provides for a one time payment of US$1.2M to Ambrilia.
"We are very pleased with the positive outcome of C2L's Phase III safety and efficacy study as this represents a major achievement and turning point for the Company. With its ease of reconstitution and superior dosing regimen leading to patient convenience and to pharmacoeconomic benefits, Ambrilia's Octreotide formulation C2L offers significant advantages over the original product. Moreover, the results indicate that patients may switch safely and effectively from Sandostatin LAR® to C2L," said Dr. Philippe Calais, President and Chief Executive Officer of Ambrilia. "After several years of excellent relationship with Covidien, both companies mutually agreed to part on good terms as the initial strategic fit no longer exists. Ambrilia is now in an ideal position to extract maximum value from a safe and effective Phase III product."
"We are terminating our development agreement with Ambrilia as a result of a change in strategic direction in our Pharmaceutical Products segment," said Vince Kaiman, Vice President and General Manager Covidien Pharmaceutical Products. "We are focusing our pharmaceutical business on therapeutic pain management. Acromegaly falls outside of that focus."
Improved formulation of Octreotide C2L: Phase III 24-week results (Study 301)
Trial Design and Results
This open label, multicenter, randomized study compared the safety and efficacy of C2L to Sandostatin LAR® ("SLAR") in acromegalic patients. Acromegaly is a serious chronic condition related to a permanent hypersecretion of GH by the pituitary gland, generally of tumoral origin. The primary objectives of the study were the reduction in IGF-1 and GH. Secondary objectives were safety and clinical efficacy of both products as measured by changes in signs and symptoms of acromegaly and patient health status.
In the first phase of Study 301, patients with acromegaly were randomly allocated to either SLAR 30 mg every 4 weeks or C2L 30 mg every 6 weeks, for a period of 12 weeks (84 days). Both C2L and SLAR induced a highly statistically significant decrease of IGF-1 and GH plasma levels. The results of this first phase of the study were reported by the Company on January 22, 2008.
In the second phase of the study, all 65 patients received C2L every 6 weeks for another 12 weeks.
In the group of 34 patients who received C2L throughout the study, significant efficacy was maintained on day 168 ("D168"), on GH, IGF-1, and clinical symptoms of acromegaly. In the group of 31 patients who switched treatment after the first phase, analysis comparing IGF-1 and GH plasma levels show that C2L administered every 6 weeks is able to maintain an efficacy comparable to that of SLAR on both parameters. In this group, the total number of patients reaching normal values of GH and IGF-1 was maintained after C2L given every six weeks. For GH, 42% were normalized at D168 with C2L versus 33% with SLAR at D84. For IGF-1, 42% were normalized with C2L at D168 versus 45% at D84 with SLAR. Preliminary non-inferiority statistical analysis on both GH and IGF-1 supports the equivalent efficacy of C2L at D168 compared to SLAR's efficacy on D84. The results also show the absence of a "carry-over" effect, by which the initial treatment with SLAR would have benefitted the patients even after 12 weeks of C2L treatment. In addition, the improvement of clinical symptoms of acromegaly is highly significant in both groups, and equivalent with C2L to that observed during the SLAR treatment period.
Side effects were mild and transient, becoming very rare during the second phase of treatment (only four patients out of 65 had mild adverse events during the last treatment period). No patient withdrew from the trial due to the occurrence of adverse events, or for any other reason, despite the expected higher plateau observed in the pharmacokinetic profile of C2L.
Overall, the top-line analysis of the results supports the ability of C2L 30 mg given every 6 weeks to replace Sandostatin LAR® given every 4 weeks at the same dose
"These are extremely encouraging results which strongly support the ability of C2L 30 mg given every six weeks to replace the identical dose of Sandostatin LAR® given every four weeks. This has the dual advantage of improved acceptability for the patient and decreased cost for the health authorities," said Professor Stafford Lightman, Professor of Medicine, University of Bristol and Henry-Wellcome Center for Integrative Neuroscience & Endocrinology (LINE), U.K., and principal investigator of the study.
Clinical Development Plan
In light of these results, and as previously reported, the Company is moving forward with its planned clinical development of C2L. The ongoing long term safety study (Study 302), a continuation of Study 301, and the open-label multicenter study evaluating the safety and efficacy of the 10 and 20 mg doses in the same indication (Study 303) are both progressing as scheduled.
The Company still expects the regulatory filings to be initiated during the second half of 2008 (H2/08).
Pursuant to Ambrilia regaining all license and marketing rights for its C2L formulation in the U.S., the Company is exploring different options with third parties, aiming to extract the maximum value from this mature asset by year end.
Ambrilia's strategy is to capitalize on its broad product portfolio and original expertise in virology. During the course of 2008, execution of the strategy aims to monetize the non-virology assets through third parties agreements, in turn strengthening the Company's financial position to continue building its novel pipeline of antivirals.
CONFERENCE CALL AND WEBCAST DETAILS
Ambrilia will be hosting a conference call and webcast today at 9:00 am ET to discuss the 24-week Phase III results for its C2L. The call will be moderated by Dr. Philippe Calais, President and Chief Executive Officer, who will be joined by Dr. Bonabes de Rouge, Senior Executive Vice-President and Chief Scientific Officer.
During the same call, Ms. Monique Letourneau, Executive Vice-President, Finance and Chief Financial Officer, will also review the Company's financial results for the first quarter ended March 31, 2008.
Interested parties may access the conference call by way of telephone or webcast. The numbers to access the conference call are 416 644 3426 (international) and 1 800 590 1508 (toll free). The webcast will be available on the Company's website at www.ambrilia.com, Investors' section, Conference calls and webcasts, and will be archived for 365 days.
A replay of the call will be available on the Company's website at www.ambrilia.com, Investors' section, Conference calls and webcasts, from Wednesday, May 14, 2008, 11:00 am ET to Wednesday, May 21, 2008, 11:59 pm ET, and the numbers to access the replay are 416 640 1917 (international) and 1 877 289 8525 (toll free) with access code 21271117.
AMBRILIA'S FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. There is a risk that expectations and forward looking statements will not prove to be accurate. Readers are cautioned not to place undue reliance on these forward-looking statements as they involve risks and uncertainties, which could make actual results 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. We refer you to the Risk Factors section of the Company's annual information form which contains a more exhaustive analysis of the risks and uncertainties that are generally connected to the business of the Company. 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, unless obligated to do so by applicable securities laws.
ABOUT AMBRILIA BIOPHARMA
Ambrilia Biopharma Inc. (Toronto:AMB.TO - News) is a biotechnology company focused on the discovery and development of novel treatments for viral diseases and cancer. In the latter part of 2007, Ambrilia adopted a new strategic plan, the primary objective of which is to progressively refocus R&D activities solely on antivirals. The strategy aims to capitalize on the Company's broad portfolio and original expertise in virology. Today, Ambrilia's product portfolio is comprised of oncology and antiviral assets, including two new formulations of existing peptides for cancer treatment, a therapeutic peptide for prostate cancer, a targeted delivery platform for cancer, a HIV protease inhibitor program (exclusive worldwide rights granted to Merck & Co., Inc.), HIV integrase inhibitor and entry inhibitor programs, and a HCV polymerase inhibitor program. 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: www.ambrilia.co