Univax Biologics Inc. and Genzyme Corp. announced today thatthey have signed a collaborative agreement worth up to $22million to develop and commercialize products for treating thebacterial infections associated with cystic fibrosis (CF).
Under the terms of the agreement, Genzyme of Cambridge,Mass., will make a $5 million equity investment in Univax ofRockville, Md., as well as provide Univax with up to $6 millionin license fees and milestone payments.
Both parties will share in the development funding, which theyestimate at $11 million. Univax (NASDAQ:UNVX) will retain themanufacturing rights, while Genzyme (NASDAQ:GENZ) willreceive worldwide marketing rights.
In a separate agreement, Genzyme said it will assign its licenseand development rights to Neozyme II Corp. in return for thefunding of Genzyme's expenses associated with the program.Genzyme spun off Neozyme II in April 1992 specifically tocontract with Genzyme to develop CF therapies. The publicoffering raised $73.5 million.
The products under development will target the commonlyoccurring lung infections associated with CF, which are causedby Pseudomonas bacteria. Up to 90 percent of CF patientseventually experience obstructive bronchitis associated withthese bacteria, and in many cases the immediate cause of deathis pulmonary failure associated with the bacterial infection.
Univax scientists have been developing a polyclonal antibodypreparation, HyperGam+CF, which is designed to providepassive immunity against the Pseudomonas bacteria. CFpatients, who cannot themselves mount an immune response tothe bacteria, are immunized with antibodies produced fromhealthy donors.
In fact, Univax has already inoculated more than 200 plasmadonors with its vaccine, which consists of polysaccharidespurified from mucoid strains of Pseudomonas aeruginosa.
In preliminary clinical trials, this vaccine was well-toleratedand has been able to elicit the production by the donors ofpolyclonal antibodies against Pseudomonas.
Univax is currently producing clinical trial quantities of HyperGam+CF and is planning a Phase I/II trial of the vaccine in CFpatients for early 1994.
While Univax has been concentrating on a means to immunizeCF patients against the devastating bacterial infections,Genzyme researchers have been working to correct the geneticdefect responsible for the disease per se.
In fact, the Recombinant DNA Advisory Committee (RAC) of theNational Institutes of Health approved in December 1992Genzyme's gene therapy protocol for treating CF by which itwould insert a good copy of the defective gene (the cysticfibrosis transmembrane regulator, or CFTR, gene) into patients'nasal epithelium via an adenovirus vector.
The FDA granted Genzyme orphan drug designation for thisgene therapy in July 1992; during the previous January thecompany also received orphan drug designation on itsrecombinant CFTR replacement protein, also a possible therapyfor the disease.
-- Jennifer Van Brunt Senior Editor
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