By Randall Osborne

West Coast Editor

SAN FRANCISCO - With good news exploding like corn kernels in a pan of hot oil, Alkermes Inc. - which last month won FDA approval of pediatric growth hormone delivered by the company's ProLease delivery system - sealed a deal worth up to $30 million with Ares-Serono to use the same technology.

Richard Pops, CEO of Alkermes, was gearing up for an afternoon presentation at the 18th annual Chase H&Q Healthcare Conference here, and James Frates, vice president and chief financial officer of the company, said Alkermes would not disclose much more about the multi-year collaboration.

"The way we work with partners, there's not a whole lot we can say," Frates told BioWorld Today.

But the partner itself was ready to talk. Jim Breitmeyer, chief medical director of Geneva, Switzerland-based Ares-Serono's operations in the U.S., said the company will provide development funding and milestones in exchange for exclusive worldwide rights, with Alkermes, of Cambridge, Mass., in charge of manufacturing and Ares-Serono conducting clinical trials, securing regulatory approvals and handling marketing.

"We're keeping mum about the specific therapeutic [that ProLease will be tested to deliver]," Breitmeyer said. "We've talked to them about more than one."

He said Ares-Serono had been "looking hard at alternate ways of developing protein therapeutics, and now we've gotten to a point where we're ready to go forward."

ProLease encapsulates the compound in biodegradable microspheres, which are injected for sustained-release. The method ideally fits Ares-Serono's protein therapeutics, Breitmeyer said, because they must be administered under the skin and must enter the body gradually to avoid "spiking" effects.

"The hardest part is getting your drug into the microspheres," Breitmeyer said. "It's the yield question. Protein pharmaceuticals are extremely expensive to produce for us, and if we give them 10 grams and we get one gram back in microspheres, that's a problem."

Alkermes, he said, has found a way to efficiently package the drug into the microspheres.

Late last month, the FDA approved Nutropin Depot, a long-acting injectable form of human growth hormone for pediatric deficiencies, which Alkermes developed with Genentech Inc. (See BioWorld Today, Dec. 27, 1999, p. 1.)

"The approval was no surprise," Breitmeyer said. "Alkermes has done a first-rate job from the beginning with Nutropin, and we've been following that closely because we're in the growth-hormone business ourselves."

In April, the Janssen Research Foundation said it will start Phase III trials of an intramuscular injectable formulation of the antipsychotic drug Risperdal (risperidone), using another Alkermes sustained-release technology, Medisorb, which employs biodegradable microspheres in a polymer matrix. (See BioWorld Today, April 16, 1999, p. 1.)

Alkermes' stock (NASDAQ:ALKS) closed Tuesday at $62, down $2.25.

In other news at H&Q:

Affymetrix Inc., of Santa Clara, Calif., entered into an EasyAccess Silver agreement with Novartis Pharmaceuticals Corp., of East Andover, N.J. Novartis will gain broad access to Affymetrix's standard and custom GeneChip arrays, instrumentation and software to monitor gene expression for use in their drug development and research activities.

Alexion Pharmaceuticals Inc., of New Haven, Conn., filed an investigational new drug application with the FDA to begin a Phase Ib pilot clinical trial with its anti-inflammatory complement inhibitor drug candidate, 5G1.1, in patients with severe psoriasis. The single-center, double-blinded, placebo-controlled study is expected to enroll about 12 patients and is designed to gather data regarding the safety, biological and clinical effects of the drug.

Boston Life Sciences Inc., of Boston, said its anticancer fusion toxin licensed from Hebrew University in Jerusalem significantly inhibited experimental colon cancer growth in a well-recognized animal model. The fusion toxin is comprised of an antigen-specific targeting molecule coupled to a bacterial-derived cell-killing toxin.

Corixa Corp., of Seattle, said it received clearance from the FDA to initiate Phase II, randomized, placebo-controlled trials to further study PVAC treatment in patients with moderate to severe psoriasis. Three of these studies will be conducted in the U.S., Brazil and the Philippines.

Emisphere Technologies Inc., of Tarrytown, N.Y., and Novartis Pharma AG, of Basel, Switzerland, said results of a Phase I study of the protein calcitonin using Emisphere's drug delivery technology indicated that therapeutic blood levels of salmon calcitonin were achieved using the solid dosage formulation. Salmon calcitonin is a synthetic version of a natural hormone that inhibits bone resorption. Calcitonin is used to treat osteoporosis.

Genzyme General, of Cambridge, Mass., reported revenues of $635 million for 1999, up from revenues of $569 million for the previous year. The company also said revenues grew to $173 million for the fourth quarter, compared with $155 million for the previous year's fourth quarter.

Maxim Pharmaceuticals Inc., of San Diego, said two randomized preclinical studies of the company's topical gel to treat oral mucositis demonstrated significant reductions in the duration and extent of ulcerative lesions when treated with the gel, compared to a placebo control.

Ribozyme Pharmaceuticals Inc., of Boulder, Colo., and Eli Lilly & Co., of Indianapolis, submitted an investigational new drug application to the FDA to begin clinical testing of RPI's anti-hepatitis C ribozyme, LY466700, previously called Heptazyme. If approved, the initial safety and pharmacokinetic study in healthy volunteers will be followed by a second study in hepatitis C-infected, treatment-naove patients.

Targeted Genetics Corp., of Seattle, and the University of Pittsburgh entered into a sublicensing agreement with Genetic Therapy Inc. (GTI), of Gaithersburg, Md., and SyStemix Inc., of Palo Alto, Calif. The agreement grants GTI and SyStemix a limited, non-exclusive, worldwide sublicense to a patent covering the T7 autogene technology. Financial terms were not disclosed.

Transkaryotic Therapies Inc., of Cambridge, Mass., said its partner, Aventis Pharma, of Collegeville, Pa., completed dosing for its pivotal Phase III trials of gene-activated erythropoietin (GA-EPO) in the U.S. and the UK. The studies were designed to assess the safety and efficacy of GA-EPO as a treatment for anemia of renal failure in dialysis and pre-dialysis patients. They are intended to support regulatory filings in both countries.