LAVAL, QC, Nov. 8 /PRNewswire-FirstCall/ - Neurochem Inc. (NASDAQ: NRMX, TSX: NRM) announces today important initiatives including the expansion of its product candidate portfolio, the refocusing of its proprietary R&D assets and the expected reduction of its burn rate compared to fiscal 2007. As part of these initiatives, Neurochem is:
"Our goal is to provide innovative health solutions to patients suffering from serious diseases as soon as possible," said Dr. Francesco Bellini, Chairman, President and CEO of Neurochem. "With the strategy unveiled today, the Company plans to make tramiprosate available to consumers. As well, Neurochem is confirming its commitment to developing new drugs for AD by advancing into preclinical development a prodrug which improves tramiprosate concentration in the brain several fold, thus leveraging the wealth of knowledge the Company has gained from the work accomplished to date in this field. Neurochem will be dedicating its resources to building a strong and diversified pipeline of product candidates, which could potentially provide cash flow in the near term. As a result, our business model is expanding beyond the traditional biopharmaceutical strategy to one that embraces shorter term projects. These projects should fund research and development activities, while complementing our longer term prescription drug programs geared at sustaining the Company's future growth," he concluded.
As part of the initiatives announced today, Neurochem will leverage the numerous years of accumulated knowledge and the experience it has gained in developing tramiprosate (ALZHEMED(TM)) for AD, and will prioritize and accelerate the development of its next generation lead compound NRM-8499, a new chemical entity (NCE) and a prodrug(1) of tramiprosate for the treatment of AD. Pharmacokinetic studies performed in mice with NRM-8499 have already demonstrated greater than five-fold increases in brain concentration as compared to the original tramiprosate molecule.
As announced previously, descriptive data from the North American Phase III clinical trial shows numerical differences in favor of tramiprosate on the primary clinical endpoints. The descriptive data also shows by magnetic resonance imaging differences between groups on the primary disease modification endpoint of change in the volume of the hippocampus, a structure of the brain that is considered to be important in memory function.
Additional findings obtained from a preliminary post-hoc analysis performed by the Company's external team of statisticians that allowed adjustment for potential confounding factors showed a dose-dependent reduction in hippocampal atrophy in patients treated with tramiprosate. When compared to placebo, patients treated with 200 mg of tramiprosate per day experienced significantly less atrophy (relative difference of 65%; P = 0.036) and patients treated with tramiprosate with 300 mg of tramiprosate per day presented no atrophy (P = 0.003).
The Company is committed to analyzing and understanding the wealth of data generated by the Phase III clinical trials. It is pursuing several post-hoc analyses which are revealing promising preliminary results. Neurochem is currently working to submit results for publication in a peer-reviewed journal.
Nutraceutical Initiative
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In view of these results, coupled to the large number of physicians and families requesting access to the compound, and given that tramiprosate occurs naturally in certain foods, Neurochem is planning to provide commercial access to tramiprosate as a branded nutraceutical product, potentially as early as 2008, via the creation of a new self-sustaining company. This decision was taken in view of the fact that AD is a devastating disease and remains an unmet medical need.
Early discontinuation of Phase III Tramiprosate Clinical Trial in Europe
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In light of the information gathered to date, Neurochem was faced with the decision of completing the European Phase III clinical trial and/or initiating another Phase III study to support the approval of tramiprosate by regulatory agencies and/or investing in the development of a next generation compound related to the original product candidate. Considering the current scientific and medical knowledge about AD, and the changing environment with widespread use of currently available medications, Management strongly believes that the expected lengthy and costly clinical and regulatory paths for tramiprosate prohibit its further development as a pharmaceutical entity.
The Special Advisory Board highlighted the inherent challenges associated with advancing Phase III clinical trials for AD with large cohorts of patients over very long periods of time. The challenges include enrolling the patients that have the right disease profile while dealing with a high degree of patient heterogeneity.
In summary, Neurochem strongly believes that the best course of action is to terminate early the drug development activities surrounding the European Phase III clinical trial for the study of tramiprosate, but to complete the ongoing North American Phase III open-label extension study. The Company will redirect its in-house AD efforts to the development of NRM-8499 and plans to make tramiprosate available as a branded nutraceutical as soon as possible.
AA amyloidosis
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Following a second approvable letter received by the Company in July 2007, the United States Food and Drug Administration (FDA) is completing its review of Neurochem's New Drug Application for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis. Neurochem filed a response to the approvable letter in September 2007.
In September 2006, the European Medicines Agency (EMEA) confirmed that it had commenced a regulatory review of eprodisate (KIACTA(TM)). The Marketing Authorization Application is being reviewed under the Agency's centralized procedure. This means that an authorization from this Agency would apply to all 27 European Union member states, as well as Norway and Iceland. An oral hearing is scheduled with the EMEA later this month to discuss outstanding issues raised with respect to the eprodisate (KIACTA(TM)) application and a decision from the EMEA is expected by year-end, or shortly thereafter.
The Company also filed for marketing approval for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis in Switzerland. A decision is expected in 2008.
DiabetesType II/Features of Metabolic Syndrome
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As announced in May 2007, eprodisate has shown beneficial effects in preclinical in vivo models of Diabetes Type II/features of metabolic syndrome. Preliminary results have shown that eprodisate protects the kidney function in obese diabetic rats. As well, eprodisate has shown an impact on metabolic changes associated with Diabetes and obesity, including a significant decrease of triglyceride levels and cholesterol, a significant decrease of glycemia and an increase in insulin plasma levels.
The Company is on track to initiate a Phase II clinical trial in diabetic patients in Canada in early 2008.
Live Web Conference
Neurochem will host a teleconference and web cast at 8:30 A.M., E.T., today, November 8, 2007. The live web cast (audio and visual) will be available on the Company's web site at www.neurochem.com. The telephone numbers to access the audio portion of the presentation only are (514) 868-1042 or 1 (866) 862-3907.
Three hours following the teleconference and the web cast, a replay of the presentation will be available until November 15, 2007. The telephone numbers to access the audio replay are (514) 861-2272 or 1 (800) 408-3053, passcode 3241051#. The replay of the web cast (audio and visual) will be available on the Company's web site.
The dial-in number will allow participants to listen and ask questions, while the web cast will host a visual presentation. Please dial-in or access Neurochem's web site approximately 15 minutes before the teleconference is scheduled to begin.
About Neurochem
Neurochem Inc. is a global health company focused in research, development and commercialization of products to provide innovative health solutions to patients suffering from serious diseases.
To Contact Neurochem
For additional information on Neurochem and its drug development programs, please call the North American toll-free number 1 877 680-4500 or visit our Web Site at: www.neurochem.com.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond Neurochem's control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which Neurochem does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, as well as other risks disclosed in public filings of Neurochem. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on the forward-looking statements included in this news release. These statements speak only as of the date made and Neurochem is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise. Please see the Annual Information Form for further risk factors that might affect the Company and its business.
CONTACT: Lise Hebert, PhD, Vice President, Corporate Communications, (450) 680-4572, [email protected] SOURCE NEUROCHEM INC.
