Boston Life Sciences Announces Successful GMP Scale-up of Altropane; Initial Commercial Capacity of 20,000 Doses Per Year Established by MDS Nordion.

Business/Technology Editors & Medical/Science Writers

BOSTON--(BUSINESS WIRE)--Sept. 4, 2001

Boston Life Sciences, Inc. (NASDAQ: BLSI) announced the completion of the GMP commercial manufacturing process that constitutes a major component of the Company's NDA for the use of Altropane(TM) to diagnose early stage Parkinson's Disease.

The commercial scale-up process was developed and completed by MDS Nordion, the Company's contract manufacturer for the commercial supply of Altropane. According to the terms of the Development and Supply Contract, Nordion will supply the necessary data for the Chemistry, Manufacturing and Controls ("CMC") section of the NDA. Nordon will also supply GMP Altropane for the Company's Attention Deficit Hyperactivity Disorder (ADHD) and other clinical trials, as well as manufacture and distribute Altropane following commercial launch, when and if the NDA filing is approved by the FDA.

"The successful completion of the commercial scale-up production of Altropane will enable us to finish the compilation of the NDA. Development of a successful methodology for economic GMP production has been the major goal in our PD diagnostic program for this year. We can now incorporate the CMC section into our NDA application for filing," stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. "Not only is this successful completion significant from the regulatory point of view, but it also assures us the means by which we can meet early foreseeable market demand for Altropane for the diagnosis of Parkinson's Disease," added Dr. Lanser.

There are presently no objective tests for either Parkinson's Disease or ADHD, and Altropane is the only such test for both disorders in commercial development in the U.S. The Company previously announced that a Phase III study demonstrated with statistical significance that Altropane could reliably differentiate Parkinson's Disease from non-Parkinsonian movement disorders. In a separate Phase II ADHD study, Altropane demonstrated that there was a highly statistically-significant elevation in the number of Dopamine Transporters in adult subjects with ADHD compared to age-matched normal individuals. The results of both studies have been separately submitted to peer review journals for consideration.

There are approximately 250,000 new cases of movement disorders per year in the U.S., with 20% of those eventually being diagnosed with PD. The trend in the U.S. continues to be one of earlier diagnosis and treatment, with the hope of arresting or slowing the progression of the disease prior to severe functional deterioration. Since clinical diagnosis is less reliable at the earliest stages of the disease, the Company believes that there is a significant unmet need for a rapid, objective, diagnostic agent such as Altropane.

The diagnosis and treatment of ADHD has become extremely controversial in the U.S. with studies indicating that up to 20% of boys in some school districts have been diagnosed as having ADHD and are being prescribed some form of stimulant medication for the disorder. In other school districts, the prevalence rate is closer to 2%. This extreme variability strongly suggests the lack of a consistently applied standard and/or a lack of understanding of the basic biology of the disorder. BLSI and its collaborating scientists were the first to detect an easily measurable, consistent, and reproducible abnormality in the midbrains of individuals with expertly-diagnosed ADHD. Altropane, due to its high selectivity and potency, is the only radio-imaging agent being commercially developed that is able to detect this abnormality. There are approximately 1 million new cases of ADHD diagnosed yearly in children, and 600,000 new cases per year diagnosed in adults. The Company believes that these numbers represent an enormous potential market for Altropane.

BLSI is developing novel diagnostics and therapeutics for Parkinson's Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD) as well as treatments for cancer, autoimmune disease, and central nervous system disorders. BLSI's products in development include: Altropane and Fluoratec, radioimaging agents for the diagnosis of PD and ADHD; Troponin, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve growth factors for the treatment of acute and chronic CNS disorders; novel therapies for the treatment of PD and ADHD; and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies.

Statements made in this press release other than statements of historical fact may represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as the expected timing and results of clinical trials, discussions with regulatory agencies, schedules of IND, NDA and all other regulatory submissions, the timing of product introductions, the possible approval of products, and the market size and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties, and actual results may vary materially from these statements. Factors that may affect future results include: the availability and adequacy of financial resources, the ability to obtain intellectual property protection, delays in the regulatory or development processes, results of scientific data from clinical trials, the outcome of discussions with potential partners, regulatory decisions, market acceptance of the Company's products, and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.