Am I the only person who thinks this is a great development.
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Genzyme Transgenics Announces Expression of 'Second Generation' Recombinant Human Growth Hormone and Beta-Interferon in Transgenic Mice
FRAMINGHAM, Mass., Aug. 14 /PRNewswire/ -- Genzyme Transgenics Corporation (Nasdaq:GZTC) today announced that it has successfully expressed high levels of recombinant human growth hormone (hGH) and recombinant human beta- interferon in the milk of transgenic mice, a major milestone that suggests that the proteins can be produced successfully in the milk of transgenic dairy animals.
Genzyme Transgenics intends to develop these products as second-generation generics in the milk of dairy animals both through internal funding and in collaboration with corporate partners. The company believes that transgenic production will lower the cost and increase the availability of these biopharmaceuticals. It also expects that the transgenic versions of these molecules may qualify for patent protection, and that their market introduction will not be blocked by any patent or orphan drug restrictions at the time of product launch.
Recombinant hGH, a treatment for growth failure in children, Turner's Syndrome, and cachexia, a wasting condition associated with AIDS, is currently produced in bacteria. Annual worldwide consumption of hGH amounts to 20 kg, or $1.1 billion dollars. Genzyme Transgenics has achieved expression of this hormone at 3 to 5 mg/ml in the milk of transgenic mice, levels that have the potential to substantially lower hGH production costs and increase its availability for new applications.
Recombinant human beta-interferon, produced in either bacteria or in mammalian cells, is used to treat multiple sclerosis (MS), a progressive disease that interferes with movement, speech, vision and short-term memory. One hundred grams of beta-interferon are required annually to treat MS, generating revenues of approximately $500 million. Expression of this protein in mouse milk has produced levels as high as 400 mg/ml.
Mice are used to determine the feasibility of introducing a desired human gene into a dairy animal for therapeutic protein production. Genzyme Transgenics expects to use either goats or cows to produce these proteins.
``High level expression of these scarce recombinant proteins reaffirms the potential of transgenic technology to enable production of important therapeutic products in quantities sufficient for use in new and expanded indications,'' said James A. Geraghty, Genzyme Transgenics' president and chief executive officer. ``Their successful expression is another milestone in our program to produce high-value biotherapeutics transgenically.''
Genzyme Transgenics is a biotechnology company focused on biopharmaceutical development through transgenic production of genetically engineered therapeutic products; specialized contract research services for pharmaceutical, biotechnology, medical device and other companies; and the production of cancer vaccines. Genzyme Corp. owns approximately 43 percent of the outstanding stock of Genzyme Transgenics and has allocated these shares to Genzyme General (Nasdaq:GENZ).
This news release contains forward-looking statements about extending the clinical applications and the commercialization of transgenic recombinant hGH and beta-interferon, the patent protection that will be provided to these products, and scale-up of production in large animals.
Actual results may differ materially from these projections depending on Genzyme Transgenics' ability to obtain patents for transgenic hGH and transgenic beta-interferon, the company's ability to transfer the production of the proteins from mice to dairy animals, the outcome of clinical trials, and the timing and content of decisions made by the U.S. Food and Drug Administration. Genzyme Transgenics' ability to commercialize the proteins is also dependent on the accuracy of the company's information about its competition and the price-sensitivity of customers.
Genzyme's releases are on the World Wide Web at genzyme.com. They are also available from Genzyme's fax-on-demand service at 1-800-436-1443 within the United States or 201-521-1080 outside the United States.
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