Univax Biologics Inc. and ImmuCell Corp. said Wednesday thatthey have entered into a license and supply agreement forImmuCell's antibody-based therapeutic to treatcryptosporidiosis in AIDS patients.
Under the agreement, Rockville, Md.-based Univax(NASDAQ:UNVX) will fund and manage the clinical trialprogram. ImmuCell will receive about $2 million in researchsupport and milestone payments over the next two to threeyears. ImmuCell has exclusive manufacturing rights.
ImmuCell has begun Phase I trials of the drug, which hasorphan designation. But the Portland, Maine, company, withless than $500,000 in cash, was not in a position to support afull clinical trial. Michael Brigham, ImmuCell's chief financialofficer, said the deal will enable ImmuCell (NASDAQ:ICCC) torun at break-even for the rest of the year. The company lost$119,000, or 6 cents a share, on revenues of $823,000, in thefirst quarter.
The compound is a polyclonal antibody derived from the firstmilking of cows. Univax will develop it as an oral hyperimmunegamma globulin therapy to treat Cryptosporidium parvum,which causes severe, chronic diarrhea in immunocompromisedpatients. Cryptosporidium infections occur in 5 percent to 10percent of AIDS patients in the U.S., causing about 60 percentmortality. There are no effective treatments.
The drug is designed to eliminate infectious organisms from thegastrointestinal tract by binding to the invasive stages of theorganism as they're budding out from the host epithelial cells,said Joseph Crabb, director of research at ImmuCell.
Univax closed unchanged at $6.75 and ImmuCell rose 25 centsto $1.31.
In a separate announcement, Univax and a unit of Buena, N.J.-based IGI Inc. (AMEX:IG) agreed to establish a jointly ownedcorporation to develop human vaccines using IGI's Novasometechnology as a protective antigen carrier and adjuvant.
Novasomes are microvesicles with surfactant properties. Theyhave been approved since 1987 for use in a poultry vaccine forNewcastle disease. In 1991, they were approved as an adjuvantin Reovirus vaccine, also for poultry.
Univax said it plans to incorporate Novasomes in the design ofseveral bacterial and viral vaccines, including Pseudomonas, E.coli, HIV and Varicella-zoster.
The companies haven't decided how much money they willinvest in the 50-50 venture. -- Karen Bernstein
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