Notes from IMUL conference call 1/28/97. I am paraphrasing the call unless I put a statement in quotation marks. Brackets are my comments.
Presented by Joe Marr, acting CEO. Let's summarize the trial. Purpose was to demonstrate the safety and efficacy of Ragweed. Trial had 500 patients divided into 5 arms of 100 each. Double blinded with placebo control. It's important to understand how this trial's design was changed from last year's trial. Here are the five arms of the trial:
1. An observational group (n=100) that received no injections at all (this is new).
2. 750 mg injection 2 doses 2 times week
3. 750 mg placebo group
4. 250 mg injection 8 doses 2.5 times week
5. 250 mg placebo group
Endpoints of trial were to reduce rhinoconjunctival and nasal and ocular symptoms (symptom scoring).
Safety profile: in the observational group there were quite a few number of adverse effects (69% of group) even though these people received no injections. This goes to show you how high the placebo rate can be. In the placebo group, 84% of patients had adverse effects, 15 points higher than in the observational group. But in the 250 mg treated group, only 74% of patients had adverse effects, less than the placebo group. All events were mild.
Efficacy: the 250 mg group showed a 17% improvement in symptom scoring versus the placebo and a 31% improvement over the observational group. Both improvements are statistically significant [i.e., extremely unlikely they occurred by chance]. [This is significant because it means that the placebo effect is now dead for Ragweed.]
In last year's Ragweed trial, the 750 mg group showed the most statistical significance, yet in this year's trial the 250 mg group was significant and the 750 mg was not. Why did the result change? This trial had fewer people in each arm than last year's group. FDA insisted on this because they wanted IMUL to show efficacy with smaller population. So IMUL thinks the 750 mg didn't come in significant because too small group was used.
Here are the most important concepts to take home from the trial. The trial validates the science and says that our technology works. We now have a potential series of products. What we must do now is to demonstrate that they work.
Q&A
Q: How does this effect chances of partnership in 1997?
A: This enhances our opportunities for partnership. Validates our technology and makes us more attractive for companies looking further downstream for products 2 to 5 years out. We are in midst of talking to couple of companies and we are flying to meet some additional companies next month.
Q: Isn't it more inconvenient to take 8 shots over 2 weeks at 250 mg rather than 4 shots over 2 weeks? [This guy obviously never had allergy shots as a kid. I went every week for 2 years.]
A: Not if you contrast this to standard immunotherapy, which can last for months to up to 5 years.
Q: Why can't you file with the FDA as is now that you've demonstrated that the drug works? [Finally, someone asks good question.]
A: We have not yet talked with the FDA about these results. This trial showed the best activity at a different dosage than our last trial, so the FDA may want another trial. [They are being conservative here by letting us know this in advance; I'm sure the FDA will require another trial to make sure that the best dosage doesn't flip again.]
Q: Aren't you really searching for the best dose?
A: The 250 mg is the dose IMUL intends to go forward with as a product. Lower doses given over longer time work best ragweed. For cat, higher dose given at a shorter time seems to work best. Actual dosing may be dependent upon the disease.
Q: How often will the dosing regimen have to be repeated?
A: For Ragweed, once per year. For Cat, we're uncertain. Probably multiple times per year.
Q: When will you meet with the FDA?
A: No meeting is set, we need to put our tables together. We have the constraint that we want to run the next trial in July, so before then for sure.
Q: Who are your ideal partners? [Note how questions have shifted away from results and towards marketing. This is good sign.]
A: We have the choice of a larger company that would give us lots of cash but demand a high royalty rate or a midsized company with a marketing and distribution arm in place and one with allergy expertise but one that doesn't need our research capabilities. We prefer midsized company. We can do a global agreement, but we'll adjust it geographically for some products like Japanese Cedar.
Q: What's your current cash level and burn rate?
A: $70 million at year end 1996. We'll burn $20 million this year; that includes expenditures for trials for Cat, Ragweed, MS, and clinical research in cocaine.
Q: Don't you really need a partner in place before you design the next Ragweed trial?
A. No! We'll run it regardless of whether we have a partner in place or not.
IMUL is apparently doing a road show in the third week of February.
Overall, my impressions were very favorable. They got the results they needed. Now, they need to find a partner. That will demonstrate once and for all that they have a viable product line.
Paul |
