To: Dave K who wrote (4894 ) 11/5/1997 9:48:00 PM From: scaram(o)uche Read Replies (4) | Respond to of 9262
[ GLIA ] First, one more plea that people not ask me about specific biotechs in this thread. Dave, you've helped me out in the past with research, and I very much appreciate it. Rebecca also asked here. So, I'll answer here. Yup, I did some research. NOT ENOUGH YET. First..... several individuals at SI commented on the lack of response from IR at GLIA. I won't comment on specifics, but there's a very good reason. Once burned, twice shy........ GLIA seems to have had a good working relationship with FDA, and I got the impression that their every breath is devoted to a professional presentation at the Advisory Committee. I. The H3 receptor antagonist (attention deficicit disorder) Development is not on target. They will not be taking either 2227 or 2208 into the clinic. They have found a new oral-active candidate which is of "tremendous potency". Clinicals are expected to begin mid-'98. They have had a formal proposal by a potential partner. It was for all indications, world-wide, royalty and milestones only. They rejected it, correctly in my opinion. They would love to have the endorsement for a second research program, but the offer was just too much of a cheapie. They want to take it further into development and thus potentially increase its value. Usual noises, but, heck, we all know that they're the correct ones. Benefit of doubt to what I read as sincerity. II. Janssen (Alzheimer's) Renewal funded same number of GLIA scientists. 6-7 lead candidates identified. Chemists hired in Belgium to assess them. If all goes well, a milestone payment approx. end of Q3 '98 for the selection of a clinical candidate. III. Adcon Talked only about -L. Probably should have asked for more, but didn't think of it. FDA was reviewing data from Europe, and working with GLIA on U.S. trial. FDA asked if they had considered submission based only on the data from Europe. This is what I suspected had happened, as their was pressure from congress, mid- to late-'96, for FDA to accept data from Europe. Europe trial was 260 patients. U.S. is 370 (now fully enrolled). GLIA will present Europe and interim data from 166 of the U.S. The U.S. trial could have been halted at the interim peak, as results were significant for both scarring and patient outcome. The 166 have been submitted as an addendum. FDA sent investigators to three of the sites in Europe where the trials were conducted. To me, this indicates that FDA is taking the submission seriously. GLIA only had six month data. FDA wanted twelve months and additional endpoints (some sort of leg lift, etc.). GLIA says that the data looked better at one year that six months. Tom (DEPO thread) is correct. There *is* controversy. Some docs do not believe that scar is associated with pain. At a recent spine docs meeting, the data met some skeptical questions from the floor. There were "heads nodding" in agreement when GLIA's answers were given. Advisory committe will invite about five surgeons to join as ad hoc members for the meeting. There is no way of knowing if any of these members will have a strong negative reaction to the scar -----> pain proposal. Jeff Ross will present the scar data from a blinded trial. GLIA will get the editorial pages that follow the Einhaus manuscript and FAX them to me. IV. Slow penetration in Europe Same story...... reimbursement and economic issues more than "Adcon" issues. Physician satisfaction is high in Spain and Scandinavia. England is picking up. They are in final stages of registration in France. The German FDA wanted a trial (MRI only perhaps, I wasn't clear.... but the endpoints are not as demanding as other trials) that was run in Germany. It won't be completed until the end of the year. I buy this explanation. Period. However, it is also obvious that, given the fragmented market and the new nature of the treatment, penetration will continue at a slow pace. Approval in France and Germany for reimbursement would make those Europe sales perky. As we know, they just hired a Director, Marketing, to handle the U.S. launch. The company now has 64 employees. Morale is good. V. Conclusions I think that Tom D. in the DEPO thread has a point, that the *perception* will be that penetration in the U.S. will also be slow if Adcon is approved. Sales in Europe this year will be double those of last year, however small. They *are* growing. I feel that penetration in the U.S., if Adcon-L is approved, will be less of a hurdle. I, for one and given the data I've seen, would choose a physician that was using Adcon. IMO, a small differential between market cap and cash buys you a company with increasing product sales, the near-term potential for blessing in the U.S., France and Germany, and two interesting research programs that address huge markets and where lead molecules are in-hand. Hope this helps. I want to disclaim everything relating to investment advice, and note that I own shares in the company. Do your own homework.