LAVAL, Quebec, May 9 /PRNewswire-FirstCall/ - At its annual general meeting of shareholders, Neurochem Inc. highlighted important developments for its advanced investigational product candidates, eprodisate (Fibrillex(TM)) for the treatment of Amyloid A (AA) amyloidosis and tramiprosate (Alzhemed(TM)) for the treatment of Alzheimer’s disease (AD). Neurochem emphasizes its commitment to remain focused on the development and commercialization of new therapies for patients facing serious, life threatening diseases.
“We have achieved major milestones for Fibrillex(TM) and Alzhemed(TM) in the past year and fiscal 2006 promises to be as exciting,” said Dr. Francesco Bellini, Neurochem’s Chairman, President and CEO. “We continue to strengthen our Company by reaching important stages in the development of our key product candidates. The filing by the FDA of the NDA for Fibrillex(TM), along with the priority review designation that we have recently announced is a major accomplishment for our Company. With the completion of the North American Phase III clinical trials for Alzhemed(TM) scheduled for January 2007, we are taking important strides towards the possibility of introducing our innovative product candidates to patients around the world, pending approval by the regulatory agencies.”
Eprodisate (Fibrillex(TM))
NDA Filed by the FDA and Granted Priority Review
The new drug application (NDA) for eprodisate (Fibrillex(TM)) for the treatment of AA amyloidosis has been filed and granted priority review by the US Food and Drug Administration (FDA). Priority review status of the application normally reduces the standard review time for an application to six months and the FDA’s target for a response will be around August 13, 2006, on eprodisate’s (Fibrillex(TM)) NDA.
“There is currently no approved therapy for AA amyloidosis, and we look forward to continuing to work closely with the FDA in the coming months as we seek regulatory approval for this potential new treatment for this serious disease,” stated Denis Garceau, Ph.D., Neurochem’s Senior Vice President, Drug Development. “Fast track and priority review designations are used to expedite the drug development and review process of products addressing diseases with significant unmet medical needs. The priority review designation is an acknowledgement that the FDA intends to direct attention and resources to review the eprosidate (Fibrillex(TM)) application.”
While eprosidate (Fibrillex(TM)) did not achieve the study’s pre- specified p-value of 0.01 on the composite primary endpoint, the 12-month analysis of the open-label extension combined with the randomized Phase II/III clinical trial showed that, in patients continuously treated with eprodisate (Fibrillex(TM)) for three years, there was a reduction in the risk of renal decline or all-cause mortality to 41% (p(equal sign)0.011) relative to patients who received placebo for two years and then switched to eprodisate (Fibrillex(TM)) for one year. The data also show that by impacting on the kidney function, as measured by the rate of creatine clearance, continuous treatment with eprodisate (Fibrillex(TM)) could delay dialysis by many years. Furthermore, eprodisate (Fibrillex(TM)) has a safety profile that is comparable to placebo.
In December 2004, Neurochem signed a definitive collaboration and distribution agreement, granting Centocor, Inc. exclusive distribution rights for eprodisate (Fibrillex(TM)) worldwide, with the exception of Canada, Switzerland, Japan, China, South Korea and Taiwan.
Tramiprosate (Alzhemed(TM))
Two Phase III Clinical Trials on Track
In April 2006, data from the open-label extension study of the Phase II clinical trial for tramiprosate (Alzhemed(TM)), involving mild-to-moderate AD patients, continued to show clinically important benefits on cognitive and global performance measures, consistent with the stabilization of the disease in a proportion of mild patients (four out of nine) after three years on study medication. The data were presented by Paul S. Aisen, M.D., Professor of Neurology and Medicine at Georgetown University Medical Center, and principal investigator in the United States of the ongoing Phase III clinical trial for tramiprosate (Alzhemed(TM)). The presentation was given at the 9th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy (Geneva, Switzerland).
Additional efficacy results on tramiprosate (Alzhemed(TM)) were also presented. Further to the capability of tramiprosate (Alzhemed(TM)) to bind to soluble amyloid (beta) (A(beta)) peptide and interfere with the amyloid cascade, data from in vitro studies have shown that tramiprosate (Alzhemed(TM)) has an effect on neuronal cells, protecting against A(beta) peptide-induced toxicity and cell death. Tramiprosate (Alzhemed(TM)) decreases A(beta)42-induced cell death in primary rat neuronal cell cultures by 38% (p- value(less than)0.01).
Tramiprosate (Alzhemed(TM)) is currently in a multicenter, randomized, double-blind, placebo-controlled, three-armed, parallel-designed Phase III clinical trial in North America. A total of 1,052 patients in close to 70 clinical sites across the United States and Canada have been randomized to receive study medication over a period of 18 months. The clinical trial is scheduled to be completed in January 2007. To date, 108 patients completed the trial and 573 patients have already completed 12 months. All patients who complete the North American Phase III clinical trial will be offered the opportunity to receive tramiprosate (Alzhemed(TM)) in an open-label extension study.
The safety profile of tramiprosate’s (Alzhemed(TM)) is well characterized. During 2005 and subsequent to year end, Neurochem received four consecutive recommendations from its Independent Safety Review Board for tramiprosate (Alzhemed(TM)) to continue the Company’s North American Phase III clinical trial for the treatment of AD. The Company also launched its Phase III clinical trial in Europe in September 2005. This international, multicenter, randomized, double-blind, placebo-controlled, three-armed, parallel-designed Phase III clinical trial is progressing on schedule. Just as for the North American trial, the European study will investigate the safety, efficacy and the potential to arrest or slow the progression of AD with tramiprosate (Alzhemed(TM)) in some 930 mild-to-moderate AD patients. Enrolment is on schedule with more than 290 patients randomized in the clinical trial; enrolment is expected to be completed in the fall of 2006.
Appointments
The Company announced the appointment of Mr. Barry D. Greenberg, Ph.D. as Senior Director, Pharmacology, and the promotion of Mr. David Skinner to the position of Vice President, General Counsel and Corporate Secretary.
Dr. Greenberg’s responsibilities will include strategic planning for biological and pharmacological development including in vitro and in vivo pharmacology and toxicology studies. With almost 25 years experience in pharmaceutical and biotech R&D, Dr. Greenberg comes to Neurochem from AstraZeneca Pharmaceuticals where, over the past eight years, he held a series of discovery and strategic positions in the United States and in Sweden. He also served as Director, Alzheimer amyloid research program at Cephalon, Inc. from 1993-1997. Dr. Greenberg has a Ph.D degree from the University of North Carolina and postdoctoral training at Stanford University. He also holds Masters and Bachelor degrees from Northwestern University in Evanston (Illinois).
Mr. Skinner, a lawyer, joined Neurochem as General Counsel and Corporate Secretary in April 2003. He has more than thirteen years experience, mostly international, including complex cross-border mergers and acquisitions and private equity transactions. Among his previous positions, Mr. Skinner served in the corporate commercial departments of two leading international law firms. He holds a Bachelors degree in Geology from Williams College in Massachusetts, as well as a Bachelor of Common Law and a Bachelor of Civil Law from McGill University. He is a member of the Quebec, the New York and the Massachusetts bars.
Financial Position
Neurochem strengthened its financial position early in 2005, by raising additional capital through a public offering of 4 million common shares, resulting in total gross proceeds of approximately US$61.2 million. In July 2005, and in February 2006, Picchio Pharma exercised warrants previously issued generating proceeds of approximately C$18.1 million to Neurochem. In November 2005, Neurochem concluded a sale and leaseback of its campus located in Laval, Quebec, generating gross proceeds of C$32 million for the Company. As of December 31, 2005, pro-forma the warrant exercised by Picchio Pharma in February 2006, Neurochem reported cash, cash equivalents and marketable securities of approximately $US69 million.
Future Outlook
Fiscal 2006 and 2007 will feature major milestones for Neurochem’s development into an international biopharmaceutical company. In August 2006, the Company expects a decision from the FDA on eprodisate (Fibrillex(TM)). This will be followed in the fall of 2006 by the expected completion of patient recruitment for the European Phase III clinical trial for tramiprosate (Alzhemed(TM)) and by a planned submission of a Marketing Authorization Application for eprodisate (Fibrillex(TM)) to European regulatory authorities. In January 2007, Neurochem expects to complete the North American Phase III clinical trial for tramisprosate (Alzhemed(TM)) for an expected release of the results from this trial in the spring of 2007.
About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics to address critical unmet medical needs. Eprodisate (Fibrillex(TM)) is designated as an orphan drug, is a Fast Track product candidate and is also part of the US Food and Drug Administration’s (FDA) Continuous Marketing Application Pilot 1 and Pilot 2 programs. In April 2006, the FDA filed and granted the eprodisate (Fibrillex(TM)) new drug application for priority review. Tramiprosate (Alzhemed(TM)), for the treatment of Alzheimer’s disease, is currently in Phase III clinical trials in both North America and Europe and tramiprosate (Cerebril(TM)), for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial.
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 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, 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.
For further information, please contact: Lise Hebert, PhD Vice President, Corporate Communications Tel: (450) 680-4570 lhebert@neurochem.com
NEUROCHEM INC.
CONTACT: Lise Hebert, PhD, Vice President, Corporate Communications, (450)680-4570, lhebert@neurochem.com
