THYMOSIN MANUFACTURING PLANT IN ITALYAlpha 1 Biomedicals and Sclavo SpA of Siena, Italy, announcedthat Sclavo will build, at its own expense, a Thymosin alpha 1manufacturing facility in Italy.
The facility will produce annually sufficient quantities of thedrug to treat 100,000 patients with chronic hepatitis B. Alpha 1(NASDAQ:ALBM) of Bethesda, Md., and Sclavo will shareequally in the profits from product manufactured at the Italianfacility, which could be operational by 1994.
Sclavo-sponsored clinical trials in Italy are in progress on usingThymosin alpha 1 for treating chronic hepatitis B and C, cancer(melanoma, non-small cell lung carcinoma and hepatocellularcarcinoma) and AIDS.
CREATIVE BIO TO ACQUIRE VERAX FACILITY
Creative BioMolecules Inc. announced that it has entered intoan agreement to acquire a currently licensed GMP (goodmanufacturing practices) manufacturing facility from VeraxCorp. in Lebanon, N.H.
Creative Biomolecules (NASDAQ:CBMI) of Hopkinton, Mass., willuse the bioprocessing center to scale up the production of itsproprietary morphogenic proteins and growth factors. "Thenew facility will enable Creative to produce our leadtherapeutics, OP-1 (for regenerating bone in non-unionfractures) and PDGF, in quantities sufficient to support both anaggressive clinical development program and the subsequentcommercial sale of the product," said Charles Cohen, thecompany's chairman.
FDA APPROVES IMRE FACILITY
Imre Corp. (NASDAQ:IMRE) announced that the FDA hasgranted full approval for the company's new manufacturingfacility, which allows unrestricted commercial distribution ofthe Prosorba column.
The Seattle company had been restricted to shipping thecolumns only in emergency cases to treat patients withimmune thrombocytopenic purpura (ITP) until FDA hadapproved the new facility. Imre now has the capacity to meetits anticipated sales requirements for the Prosorba columnsthrough 1995.
MPS BEGINS FACILITY EXPANSION
Multiple Peptide Systems (MPS), a wholly owned subsidiary ofHoughton Pharmaceuticals Inc., announced that it has begunconstruction of an expansion of its FDA-certified GMP (goodmanufacturing practices) facility.
The $200,000 project will more than double the size andproduction capacity for the San Diego company's GMP peptidebusiness.
MPS produces peptides under contract; GMP production isrequired by FDA for any peptides used in human clinical trials.One of MPS's first clients was the Walter Reed Army Instituteof Research. MPS has provided five GMP peptides to theinstitute for a putative vaccine for malaria.
GENSET MANUFACTURING PLANT IN U.S.
Genset announced that it has established a manufacturing plantin La Jolla, Calif., the first U.S. facility for the French company.
Genset manufactures synthetic DNA for the molecular biologyresearch market, as well as for diagnostics and clinicalapplications. The company claims to have the largest DNAproduction facility in Europe, with a capacity of more than 300oligonucleotides per day. The U.S. manufacturing facility isintended to serve the market for DNA mass production,particularly human genome projects.
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