Here is an update on developments at IMUL as discussed at their annual meeting held today (May 23).
Timeline-if IMUL is not asked by the FDA to re-do the Phase III trial for Allervax Cat, co. expects PLA filing in late 1996. If they are required to re-run the trial, they expect a PLA filing no later than mid-1997, so the loss in time will be 3 to 6 months. Assuming that the FDA takes 18 months to review IMULÆs application-average time is 12 months-Cat could be approved as early as mid-1998. Interestingly, IMUL CEO Garrity says that odds that FDA will require re-run of Phase III for Cat are 50/50. I thought they were much higher-80/20 or so. (I still think so.) Could be potential for upside (for a change!) surprise.
Ragweed trial-Phase III trial for Allervax Ragweed will begin in late summer. Co. is designing a new trial that will allow them to measure the drugÆs effect not only vis-a-vis the placebo, but also from a baseline class of patients who receive no treatment. This design is now before the FDA. IMUL assumes PLA submission in Q1 1997, 12-18 months for FDA to make decision, and approval by mid-1998. IMUL says that FDA knows that itÆs important for IMUL to have approval for Allervax Ragweed before 1998 allergy season begins. Also, if Cat has approval by this time, FDA would probably take less time to approve Ragweed. Other allergy products-house dust mites, spring grasses, Japanese cedar-will start trials in about one year.
Partner-IMUL expects to secure a new worldwide marketing partner within 6 to 12 months. IMUL is looking for partner with experience selling drugs to allergists. MMD did not have this experience; their product, Seldane, is sold primarily to generalists, not specialists. Why did HMR drop Allervax program? Garrity said that HMR reduced its drug program from 80 to 30 drugs. TheyÆre not too keen on allergy drugs these days because Seldane is taking a beating in the marketplace (see todayÆs Wall Street Journal). And they would have had to build a new sales force and yet would have only received 50% of profits. So deal didnÆt look that good to HMR management. IMUL is now negotiating with HMR over HMRÆs final payment to company. Garrity hinted it might be $5M or so.
Schering/MS program-MS clinical trials will start this fall. Everything with Schering is fine. So why did Schering sell their stock in IMUL?, I asked. Stock was held by an investment group owned by Schering and they only purchased the stock at IMULÆs insistence in early 1994. Schering agreed only to hold stock for one year. By poor coincidence, that one year came up right after HMR bombshell. Schering wanted to sell because investment company needed funds for other investments and IMUL stock was up 50%. So Schering asked IMUL if it was okay to sell now. IMUL management figured that with more trials coming during the year, no time was good for sale, so why not do it now and get it over with? IMUL brokered the stock to Amerindo Partners. PG note: Schering would be a perfect partner for IMUL in allergy programs since they own Claritan, #1 antihistamine on market, and already have sales force selling to allergists.
Remember the proposal to have staggered board of director terms? (ItÆs in proxy statement.) Proposal was defeated by shareholders-a sign that we shareholders are somewhat restless, I would say!
I felt management was pretty candid and I came away with a renewed appreciation for their depth of expertise (after talking to IMUL scientists) and for the broadness of their program.
Paul |
