I attended a presentation and break-out session given in early September by IMUL at a biotech conference in New York City. There was no "new" news, but there were several indications by IMUL that some good news will come out over the next six months.
Recall from previous postings that the Allervax Cat Phase III trial results ended with some ambiguity since only one dosing regimen proved statistically significant vis-a-vis placebos. IMUL said in May that they would meet with the FDA in June to determine whether or not they had to re-run the trial. In fact, they have yet to meet. IMUL decided to press the FDA to help it design the Phase III trial for Allervax Ragweed. Since the FDA cannot devote resources to IMUL for both Cat and Ragweed simultaneously, the company decided to press for help with Ragweed since the ragweed season was about to begin. Now that the Ragweed trial has begun, the company expects to meet with the FDA in September or October about the Cat results. They would not say anything outright, but I got the distinct impression that they're not going to fight very much with the FDA over the results, and if the FDA suggests they do it over, they'll do so. The Cat trials will cost $2 million to re-run; IMUL has $76 million in cash.
IMUL feels that the Cat drug was perhaps "oversold" to prospective patients, and this is why the placebo effect was so high. The intensive nature of the therapy tends to lead to high placebo effects; the fact that patients are dosed often makes some of them feel as if the drug has to work, yet they may be getting dosed with the placebo. (As discussed in a previous posting, the design of the current Ragweed trial now includes two separate placebo groups to better isolate the placebo effect. This design was done in conjunction with the FDA.)
There have been no adverse side effects recorded to date with any Allervax products.
The current ragweed season is robust, which is good for IMUL, bad for us allergy sufferers.
IMUL has come to the conclusion that the number of doses, and the frequency with which they are given, are more important than the dose size in achieving trial endpoints. So once again, size is not important. (PG note: too bad they didn't figure this out before they started the Phase III Cat trial.)
Ragweed is now IMUL's lead product. The Cat allergy endpoint may be changed, depending on what the FDA recommends. IMUL now feels that cat allergies are more a disease of the lung than the throat or the eyes, so the primary endpoint may be changed to lung scores.
According to the CFO, IMUL insiders have been buying stock recently. (I have not seen any indication of this in Barron's yet.)
One of the participants asked Michael Slater, IMUL's EVP for Development, whether the trial design for Cat would await the signing of a new corporate partnership. The thinking here is that the partner may want a say in the trial design. Slater replied that the partnership was secondary in their thinking to the research program and that they would seek assistance in trial design only from the FDA. This response got the Wall Street types howling (mildly, at least). They told IMUL that, in Wall Street's eyes, the company HAS TO HAVE a partner AS SOON AS POSSIBLE and getting a new partner has to be a PRIORITY. I think the IMULers got the message. (I have sympathy for IMUL in this regard, but sometimes you just have to give the Street what it wants.)
IMUL is sticking to its prediction that it will have a global partner by March 1997. Some analysts feel that IMUL will announce a partnership before year end. IMUL feels no need to wait until the Phase III Allervax trials are over to announce a partnership. Slater said that the multinationals are familiar enough with the Allervax program to buy in before the Phase III results are known. Besides, potential partners are interested in the whole pipeline of drug research at IMUL (grass, cedar, etc), not just one or two indications.
This new partnership will be different in important aspects from the HMR deal. First, IMUL insists that it cover the entire allergy program; HMR covered only Ragweed and Cat. Second, IMUL insists that the program cover all variations of Allervax (for example, oral dosing). HMR balked at this. Third, IMUL may choose to have more than one partner. (Gerrity hinted at this in the annual meeting.) Also, I don't know what to make of this, but several times during the break-out session, Slater said that IMUL might do something "creative" in its new partnership. PG advice: Don't get too creative, guys, just get yourselves a partner(s).
After much pressing from the Wall Street types, IMUL said flatly that they could sign a deal today if they wanted to: one major company "is keen to sell their wares" to IMUL. The potential partners IMUL is talking to believe the Allervax products are approvable.
Finally, the discussions with HMR are still on-going as to HMR's final $$$ payment to IMUL and other issues such as their manufacturing agreement.
One of the analysts told me that IMUL was selling at a ridiculously low price given its pipeline and cash position, and I have to second that opinion.
Paul |
