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Biotech / Medical : Neurobiological Tech (NTII) -- Ignore unavailable to you. Want to Upgrade?


To: BRAVEHEART who wrote (465)3/24/1999 6:24:00 PM
From: Dr. John M. de Castro  Read Replies (1) | Respond to of 1494
 
I had a conversation with Paul Freiman, CEO of NTII, this afternoon. We discussed a broad range of issues surrounding the company. These are the high points of what I learned.

FINANCES: A private placement of NTII stock is nearly complete. At this time commitments are in place for over $1 million and there are a couple more investors who might add to this total. The investors include a major financier and further investment by NY Life.

STRATEGIC PARTNERSHIPS: Active negotiations are ongoing with four different companies to partner with NTII/Merz for the development of Memantine. One of the companies has already placed a contract on the table. But, the deal is not complete. It was estimated that a deal would be signed, sealed, and delivered by Summer. The proposed deal involves significant up- front payments, milestone payments, and royalties.

CLINICAL TRIALS: Memantine for Diabetic Neuropathy - The trial is going great. Quintiles is doing a first rate job and 230 of the required 375 patients have been recruited. It was estimated that the trial should be completed in the Fall (ahead of schedule). The trial is double blinded. So, there cannot and will not be any data on the nature of the results until after the blind is broken.

CLINICAL TRIALS: Memantine for Aids Dementia - Patient accrual for the trial is nearly complete. It is estimated that the last of the 120 required patients will be recruited during the Spring. The trial is four 16 weeks with a four week follow-up. So, it should be complete in the Fall.

CLINICAL TRIALS: Merz Memantine for Dementia trials - Merz has completed recruitment for two 900 patient Phase III trials in England and France for studying Memantine in a range of dementia cases from mild to severe. Enrollment is nearly complete in the pivotal Phase III trial in the U.S. for Alzheimer's Dementia. NDA's are expected to be filed first in Europe and then in the U.S. in early 2000.

CLINICAL TRIALS: Xerecept - This trial is creeping along. Only 30 of the needed 90 patients have been recruited. NTII is working with the FDA to extend the trial duration to 4 weeks. This could help because the current two week duration is not long enough to attract patient interest in participating. Treatment is simply required for a longer period of time than the two weeks of the trial. Patients are reticent to enroll knowing that they would not be able to complete treatment in the trial. The FDA has suggested that NTII perform a trial with pediatric populations. The current treatment of peritumoral edema with steroids is appropriate in adults but not children. So, this would appear to be a more appropriate target population. NTII will only undertake such a trial as resources are available.

In general, things are going well at NTII and the mood is very upbeat. Paul indicated that by the end of this year they would know the worth of Memantine for all indications. This is an exciting time for the company. If all goes well, NTII could be seeing a significant royalty revenue stream in 2001 to 2002.

There aren't many biotech companies that are this close to success, especially one with a market cap of less that $5 million. Just think of what the stock value would be if NTII received a market cap in the range, even on the low end of the range, of a typical profit making biotech. It brings a smile to my lips.

Best regards
John de C