By Randall Osborne

To develop and market a vaccine against rotavirus, a severe illness that strikes infants, Virus Research Institute Inc. (VRI) has signed its second agreement with SmithKline Beecham plc.

Under terms of the deal, Cambridge, Mass.-based VRI will get license fees and milestone payments in undisclosed amounts, along with royalties if the product wins approval. SmithKline, of London, gets exclusive worldwide marketing rights.

"We're running the Phase II efficacy study [of the rotavirus vaccine] now, and it will report in the middle of next year," said Barrie Ward, chairman and CEO of VRI. "In parallel, SmithKline is putting in place a manufacturing process," using its biologicals division in Rixensart, Belgium, which produces more than 750 million doses of vaccines annually.

When the Phase II study is completed, SmithKline will pick up all further costs of moving the vaccine toward the market, Ward said. The vaccine deal was SmithKline's second of the week. Earlier, it made public a collaboration in which the company agreed to pay $85 million plus royalties to MedImmune Inc., of Gaithersburg, Md., for worldwide marketing rights to a papillomavirus vaccine. (See BioWorld Today, Dec. 12, 1997, p. 1.)

Rotavirus is a group of viruses from the family Reoviridae. The disease, which is responsible for gastroenteritis in infants, causes potentially fatal acute diarrhea and dehydration. About 500,000 infants per year require medical treatment for it, and about 15 percent of those are hospitalized.

VRI's vaccine uses a live oral human rotavirus. In Phase I/II trials, its side effects were "very, very minor — occasional fever," Ward said. The Phase II trial is under way with 215 infants in Cincinnati, Baltimore, Pittsburgh and Philadelphia.

"We've just completed enrollment and the babies have gotten the first dose of vaccine," Ward said. "The immune response was good, and showed development of mucosal antibodies in the gut." The start date of Phase III trials "will be dependent on SmithKline, but certainly not before 1999," he added.

VRI went public in 1996, raising $28 million in gross proceeds from an initial public offering of 2.3 million shares. (See BioWorld Today, June 11, 1996, p. 1.)

SmithKline first partnered with VRI in 1995 in a deal to identify bacterial genes expressed during infection and determine potential targets for new drugs. SmithKline agreed to fund research and make milestone payments. Terms were not disclosed. (See BioWorld Today, June 23, 1995, p. 1.)

Other Vaccines Under Developement

VRI's main collaborator, Pasteur Merieux Connaught France (formerly known as Pasteur Merieux Serums & Vaccins SA), of Lyon, France, is partnering the development of an influenza vaccine that uses as its delivery system a product called Adjumer, which is a synthetic derivative of the polymer polyphospazene, designed to boost a vaccine's ability to trigger immune response.

Pasteur Merieux, the French vaccine maker, is a subsidiary of Rhone-Poulenc SA, of Paris. It entered a collaboration with VRI in 1994, making an equity purchase of $3 million.

Based on results of a Phase I trial for the flu vaccine, which showed it was well tolerated, Pasteur Merieux started a Phase II trial, the results of which are not consistent with Phase I results, VRI said. The degree of improvement in immune response elicited by the vaccine was less in comparison to the control group than was shown in the Phase I study. However, certain other results in the control group appear to be higher in Phase II than in Phase I.

In the Phase I study, 48 young adults and 41 older adults participated. In the Phase II study in Peru, 430 adults participated. Patients were given a single injection of the vaccine formulated with Adjumer or the same vaccine without it. VRI and Pasteur Merieux are analyzing the data to determine the next step with the product.

"We're talking to all the major vaccine companies about our technology," Ward said.

Other vaccine delivery systems under development include VibrioVec, which uses a recombinant bacterial vector for oral transport of vaccines to the gastrointestinal tract. VibrioVec is being developed through collaborations with CSL Ltd., of Victoria, Australia, and with a joint venture partnership set up by Pasteur Merieux and OraVax Inc., of Cambridge, Mass.

VRI also is developing with its collaborators vaccines for preventing Lyme disease and Helicobacter pylori infections, and the company is working on its own vaccine for genital herpes.

As of Sept. 30, VRI had $20.3 million cash, with a net loss of $5.3 million for the first nine months of 1997. The company's stock (NASDAQ:VRII) closed Friday at $4.50, unchanged. *

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