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

To: Apache Indian who wrote (362)	11/6/1998 2:28:00 PM
From: BRAVEHEART	Read Replies (1) \| Respond to of 1494

Hi Apache Indian, Here is a brief synopsis of the Annual report as I see it and how things appear to be unfolding. biz.yahoo.com The Good news is the trial is initiated. "Neurobiological Technologies, Inc. (OTC Bulletin Board: NTII - news) today announced the initiation of a Phase IIB human clinical trial to evaluate Memantine as a treatment for painful peripheral diabetic neuropathy. The trial will evaluate the ability of Memantine to relieve chronic pain due to peripheral neuropathy or nerve damage, particularly nocturnal pain that frequently interferes with sleep. Quintiles CNS Therapeutics, a leading contract research organization with experience in neurology, will jointly manage the trial with NTI." Quintiles is no slouch in conducting human trials. "Quintiles CNS Therapeutics is a business unit of Quintiles Transnational Corp. [Nasdaq:QTRN - news], the market leader in providing a full range of integrated product development and marketing services to the pharmaceutical, biotechnology and medical device industries. Quintiles is headquartered near Research Triangle Park, North Carolina." Stuff from the recent Annual Report: (Fiscal year 98 ended June 30th). Key objectives for fiscal year 1999 (ends June 30th 1999): 1. "The initiation and ongoing mgmt of the diabetic nuropathy trial". ( Today's press release has announced the initiation of said trials ). a. "Approx. 800,000 patients in the U.S. were treated for the symptoms for diabetic Neuropathy. As well as 1,240,000 in Western Europe and 193,000 in Japan." {( Currently existing treatments are essentially ineffective thus a considerably large market exists for rapid penitration ) Also consider that Memantine has a seven year treatment history in Europe for other indications so the risk of Clinical failure because of side-effects is reduced considerably } i. I have yet to discuss the issue of the foreign markets with the company. The collaboration with MERZ ( A German based operation ) could go a long way to gaining entry into these markets. In the annual Report NTII stated it recieved $5 million savings in development costs {( MERZ is conducting large clinicals both here and in Europe ( two trials in Europe ) for other indications for Memantine ) due to the exchange of scientific information. This included clinical trial data which NTII may use in submitting it's findings with the FDA and possibly in Europe. " We are sharing our results, building a safty data-base, and along with MERZ, seeking a large global marketing partner." 2. Complete Phase 2 clinical trial of Memantine for AIDS dementia. 3. Complete Phase 2 trial of Xiracept for peritumoral brain edema. ( Another condition with only corticosteriods { not desirable in tumorous conditions } as a form of treatment ) 4. Obtain relisting of the company's common stock on NASDAQ. 5. "Signing a corporate marketing partner for Memantine". a. "MERZ and NTII will jointly seek a worldwide Marketing partner for the many indications. MERZ has P-3 trials progressing in Europe and recently began a large P-3 trial in the US for treating moderate to severe senile dementia, including Alzheimer's disease." b. QUINTILES is the same organization which is conducting MERZ's Memantine Clinicals. I personally believe the trial will take into consideration P-2A data and be designed to prove successful. One would normally be hard pressed in the anticipation of a collaborative agreement. This one reeks of sooner rather than later. MERZ is already in P-3 testing hence this could accelerate one's expectations of some sort of collaboration for NTII. It will be a very interesting 8 months for NTII shareholders if the company manages to accomplish all of it's stated goals. I believe a joint corporate collaboration for the development and marketing of Memantine will be the most interesting of all stated goals. MERZ the company NTII will jointly collaborate with in seeking a marketing and distribution partner has a targeted market size of 4 million patients here in the US alone. There are two P-3 trials ongoing in Europe and one large P-3 trial here in the US, where the market size is of similar size. Conducted by non-other than Quintiles. Note how NTII will be piggybacking along given Paul Freiman's unique gift at negotiating. ntii.com Paul Freiman is a former Chairman for the Pharmaceutical Manufacturers Association of America. Former Chairman & CEO of Syntex corp where he was instrumental in selling that organization to Roche Holdings for 5.3 billion Dollars. He joined NTII in April of 1997 and has cut costs ever sense. He was instrumental in the MERZ deal recently and will be in any future joint marketing and distribution agreements. He serves as chairman on the boards of Digital Gene Technologies and Otsuka American pharma. He also serves on the boards of Penford Corp, Calypte Biomedical and Lifescience Economics. He also is an advisor to Burrill & Co., a merchant bank. In my opinion he is extremely well connected to negotiate this little biotech along. Especially if one considers there is only 7 million shares outstanding with later stage clinicals with large markets with unmet needs. The company still needs cash. A collaboration with big-pharma could go a long way in satisfying this need. Given enough cash and who knows the company may have all the elements to apply for relisting as it stated as one of it's goals over the next fiscal year. The stock traded down because of cash needs & the final delisting early this year and popped a bit in April with the MERZ announcment and traded back under a buck in Aug on extremely low volume. My point is once the company establishes a Big Pharma partner for "sig cash" ( see the annual report ). It will then satisfy the reason NASDAQ delisted it in the first place. The company will be a year further along in negotiations and clinicals for nothing intrinsically with the company has changed outside of it having better leadership and operating much more efficiently. Here is their web site: ntii.com Quiet frankly I believe NTII is considerably undervalued. Jeffrey