By Mary Welch
ImmuLogic Pharmaceutical Corp. has retooled its Allervax allergy drugs, whose development was halted last year after late-stage clinical trial setbacks, and has entered an agreement with Sankyo Co. Ltd. for a treatment of allergies to Japanese cedar pollen.
The Waltham, Mass., company said the deal with Sankyo covers patents for recombinant proteins and peptides in exchange for a licensing fee, milestone payments and royalties to ImmuLogic.
"The drugs are similar [to the Allervax products] — the principles are the same, but in practice they are made differently," said J. Joseph Marr, president. "The Allervax program used several peptides to down-regulate the immune system and was specific to those allergies. This is a recombinant single protein but it captures all of the immunological features of the allergen. The recombinant treatment is less expensive, which is an added value. Frankly, we think it's a better product."
Marr said the company is in "early to mid-level" discussions with additional firms to develop other recombinant proteins to treat different allergies
He declined to disclose financial figures, citing an agreement with Sankyo. While the recombinant proteins must undergo clinical trials in Japan before reaching the market, Marr said much of the work already is done. "We can define the recombinant protein and we know the process and how to make and purify it. It will enter clinical trials soon."
Japanese cedar pollen is a "major health problem" in Japan, affecting about 35 percent of the population. "It's a seasonal issue but a number of Japanese companies are working on it. That is another reason why we're pleased with the agreement with Sankyo. They believe in our technology, and I think they have done a fair amount of work on their own with the technology. We're pleased they want to take it further to fight this major public health problem."
There are no plans to resurrect the company's work on Allervax Cat (for cat allergies) and Allervax Ragweed; instead, ImmuLogic is concentrating on its cocaine and nicotine vaccines.
Allervax products used allergy-causing peptides to teach the immune system not to respond to a specific invading allergen, such as ragweed pollen or cat dander. While clinical tests initially proved encouraging, Allervax eventually stalled.
Results from a Phase III trial reported in April 1996 showed Allervax Cat produced a statistically significant benefit in only one of four dosing regimens. (See BioWorld Today, April 29, 1996, p. 1.)
Results from a Phase III trial of Allervax Ragweed reported in January 1997 showed a significant benefit at one dose level but the benefit did not repeat that found in an earlier Phase II/III trial using another dosing regimen. The data were insufficient for a product license application. (See BioWorld Today, June 30, 1997, p. 1.)
Prior to the clinical trial setbacks, Hoechst AG, of Frankfurt, Germany, ended its collaboration with ImmuLogic and returned all rights to the Allervax products in March 1996. (See BioWorld Today, March 12, 1996, p. 1.)
Faced with conducting additional clinical studies, ImmuLogic in November 1997 decided the costs of commercializing the Allervax drugs would be too high.
ImmuLogic's stock (NASDAQ:IMUL) closed Wednesday at $1.906, up $0.156. *