Server: Microsoft-IIS/3.0 Date: Thu, 18 Dec 1997 17:57:46 GMT Content-Type: text/html Accept-Ranges: bytes Last-Modified: Wed, 12 Nov 1997 19:04:38 GMT Content-Length: 12800 NTI Corporate Profile

Corporate Profile


Neurobiological Technologies, Inc. (NASDAQ: NTII), an emerging drug development company, is identifying and developing potential therapeutic products based on advancing neuroscience research. NTII's strategy is to in-license early stage products that have the potential to preserve neurologic function by protecting nerve cells from injury. These compounds target major medical needs and appear to have a clear path through clinical testing and regulatory approval. NTII has assembled a talented and experienced management team to move therapeutics through the final stages of drug development. The company intends to establish alliances with larger pharmaceutical companies to bring its approved products to the marketplace.

NTI® is currently evaluating two drug candidates in human clinical trials: Memantine, an orally available NMDA receptor antagonist, for treatment of neuropathic pain and AIDS-related dementia; and XereceptTM, the company's synthetic preparation of the natural human peptide Corticotropin-Releasing Factor (CRF), for reduction of cerebral edema associated with brain cancer (peritumoral brain edema). The company is also planning a Phase II human clinical trial of Xerecept for traumatic brain injury.

The company's scientific focus is neuroprotection, or the prevention of neuronal injury and death associated with a variety of acute, chronic and degenerative neurological conditions. Neuronal injury contributes significantly to functional impairment in many peripheral and central nervous system disorders, including stroke and traumatic brain injury; and chronic diseases such as diabetes, AIDS, and Alzheimer's Disease. NTI® develops potential neuroprotective drugs to block important pathways of nerve cell damage, including calcium influx caused by glutamate leak (excitotoxicity) and ischemia resulting from cerebral edema (swelling of the brain).

NTI® is seeking partnerships with pharmaceutical and biotechnology companies which, if successful, may allow NTI® to secure increased financial resources and additional product development expertise and enable the company to draw upon the sales and marketing capabilities of its partners. NTI® will also continue to evaluate new technology and other business opportunities that could serve to build the long-term value of the company.

The company was founded in 1987 and went public in February 1994. It is located in Richmond, California and employs 19 persons. As of September 30, 1997, NTI® had $2.3 million in cash and cash investments, which it believes are adequate to fund its operations through the quarter ending December 31, 1997. The company will need to raise substantial capital to fund subsequent operations. As of September 30, 1997, NTI® had 6.5 million shares of common stock outstanding.

PRODUCTS IN DEVELOPMENT

Memantine is being evaluated as a potential neuroprotectant drug for the treatment of injured and dying neurons. Memantine is an orally available compound which acts to modulate the N-methyl-D-aspartate ("NMDA") receptor in the central nervous system. Modulating the NMDA receptor may protect against the neuronal injury and death associated with a number of disorders, including chronic conditions of neuropathic pain, dementia, and Alzheimer's disease, as well as acute conditions of traumatic brain injury and stroke. In October 1997, patient enrollment was completed in NTI®'s Phase II human clinical trial to evaluate the analgesic efficacy and safety of Memantine for neuropathic pain (persistent pain in the absence of any obvious stimulus). This indication is the company's initial priority. Patients with peripheral neuropathy due to diabetes mellitus and patients with post-herpetic neuralgia, a chronic pain condition due to shingles (infection with the herpes Zoster virus) are being enrolled in the trial. The company is also supplying the drug for a Phase II NIH-sponsored study of Memantine for the treatment of AIDS-dementia complex and neuropathic pain.

Xerecept is the company's synthetic preparation of the natural human peptide CRF. In preclinical studies, Xerecept has been found to be a potent inhibitor of swelling, or edema. The compound is being developed for its ability to reduce cerebral edema (swelling in the brain), a dangerous condition associated with brain tumors, traumatic brain injury, and stroke.

Evaluating the efficacy of Xerecept to control neurological symptoms caused by brain tumor edema (peritumoral brain edema) is the company's initial priority. The company recently submitted an application for orphan drug status of Xerecept for peritumoral brain edema and initiated a Phase II clinical trial. This randomized, double-blind placebo-controlled trial is expected to enroll 90 patients with malignant brain tumors and active neurological symptoms. NTI®'s objective is to confirm the results of two previously completed pilot Phase I/II trials of Xerecept for this condition in which the compound was well-tolerated and appeared to improve neurological function by an average of 42% when administered to seven patients for seven days.

NTI® has also submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to begin testing Xerecept in traumatic brain injury patients. The company expects to initiate Phase II testing of Xerecept in the fourth quarter of fiscal 1998. Based on preclinical studies demonstrating Xerecept's ability to reduce cerebral edema following traumatic brain injury, the American Brain Injury Consortium ("ABIC") has agreed to collaborate with NTI® to plan such a Phase II human clinical trial. The consortium includes 160 centers which benefit from standardized study procedures. This collaboration is expected to facilitate trial initiation, enrollment of patients and trial completion.

CORPORATE OFFICERS

Paul E. Freiman, joined the company as a director in April 1997, and was elected President and Chief Executive Officer in May 1997. He is the former chairman and chief executive officer of Syntex Corporation, where he was instrumental in the sale of Syntex to Roche holdings for $5.3 billion. He is credited with much of the marketing success of Syntex's lead product Naprosyn® and was responsible for moving the product to over-the-counter status, marketed by Procter & Gamble as Aleve® . Mr. Freiman is currently serving on the board of Digital Gene Technologies, Inc., a private genomics company, and serves on the boards of Penwest Corp., LifeScience Economics, Inc., and several other biotechnology companies. He has been chairman of the Pharmaceutical Manufacturers Association of America (PhARMA) and has also chaired a number of key PhARMA committees. He is also an advisor to Burrill & Co., a San Francisco merchant bank. Mr. Freiman holds a B.S. degree from Fordham University and an honorary Doctorate from the Arnold & Marie Schwartz College of Pharmacy.

Ronald Goldblum, M.D., has been Vice President of Medical Affairs since he joined the company in January 1995. Before joining, Dr. Goldblum was Director of Clinical Investigations at Syntex Laboratories where he supervised all Phase IIIB and Phase IV studies. Dr. Goldblum has worked extensively with clinical investigators to screen and enroll patients and collect the necessary data; and interacted with marketing groups regarding project results and future development plans. He held various managerial positions as department head and department director at Syntex Research. Prior to joining Syntex, Dr. Goldblum practiced for twelve years as a rheumatologist in both hospital and private settings. Dr. Goldblum holds A.B. and M.D. degrees from Case Western University.

Jian Johnson joined the company in October 1992 as Director of Clinical and Regulatory Affairs. In August 1995, Ms. Johnson was promoted to Vice President, Regulatory Affairs. Prior to joining NTI®, she spent twenty years with the Upjohn Company. Three of those years were spent in the area of drug discovery followed by positions of increasing responsibility in clinical research and drug registration. Ms. Johnson has extensive experience in drug development strategy, design of clinical protocols, management of clinical trials, and preparation of regulatory submissions, including INDs and NDAs. Ms. Johnson holds a B.S. degree from National Taiwan University and an M.S. degree from the University of Minnesota.

Behzad Khosrovi, Ph.D., has been Vice President of Pharmaceuticals Development since he joined the company in January 1992. From July 1990 to December 1991, Dr. Khosrovi was a consultant to the pharmaceutical industry. Prior to July 1990, Dr. Khosrovi was employed 14 years with Cetus Corporation, where he held various senior management positions, including Vice President, Development. At Cetus, he was responsible for manufacturing sciences, including process development, formulation design, product characterization and the manufacture of products for clinical trials. Dr. Khosrovi holds a M.A. degree from the University of Cambridge in England and M.Sc. and Ph.D. degrees from the University of Manchester's Institute of Science and Technology.

Calvert Yee has been Vice President, Operations and Administration of the company since February 1991. Prior to joining NTI®, Mr. Yee was employed for 15 years with Cetus, where he held both research and management positions, serving as Senior Director, Research and Development Administration and Operations from 1987 until September 1990. Mr. Yee holds A.B. and M.B.A. degrees from the University of California at Berkeley.

 

Except for the historical information contained herein, the matters discussed in this company profile are forward-looking statements that involve risks and uncertainties, including the company's ability to raise capital to fund operations, properly design, implement, and complete planned trials, meet regulatory requirements, demonstrate safety and efficacy for its products, manage third-party contractors, and avoid infringement of third-party proprietary rights, as well as other risks detailed from time to time in the company's Securities and Exchange Commission filings. Actual results may differ materially from those projected. These forward-looking statements represent the company's judgment as of the date of this company profile. The company disclaims, however, any intent or obligation to update these forward-looking statements.

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