By Jim Shrine

Special To BioWorld Today

Glyko Biomedical Ltd.'s spin-off company, BioMarin Pharmaceutical Inc., purchased Glyko Biomedical's wholly owned subsidiary in a deal valued at $14.5 million.

Privately held BioMarin purchased sister company Glyko Inc. for stock considerations. The companies already share facilities in Novato, Calif. The deal leaves Glyko Biomedical, of Toronto, as a holding company, with a 41.7 percent stake in BioMarin, up from 36 percent.

BioMarin has raised about $30 million in private financing since it was spun off in March 1997 to develop carbohydrate enzyme therapies for genetic diseases. Glyko Inc. provides analytic services primarily to research, biopharmaceutical and industrial laboratories, and diagnostic services using carbohydrates as markers.

The merging of the companies provides benefit in three areas, Bill Anderson, BioMarin's chief financial officer, told BioWorld Today.

"First, the diagnostics will help optimize the treatment of some of these genetic disorders," he said. "Second, even though it's a relatively small company, we believe the carbohydrate and carbohydrate enzyme technology help us create critical mass in that field. A third point is it gives us a lot of connections and relationships with people who are working in our field."

BioMarin's lead product is alpha-L-iduronidase, a recombinant enzyme to treat the rare genetic disorder mucopolysaccharidosis (MPS) I, a lysosomal storage disease. It is being developed in a joint venture with Genzyme Corp., of Cambridge, Mass.

The product is in a "pivotal Phase I" study designed to support a biologics license application (BLA) submission. It has been granted orphan drug status by the FDA and will get fast-track review.

"We are nearing the completion of the patient phase of the trial," Anderson said. "It required 10 patients to be enrolled for six months." Once that phase is completed, the company will get to work on a BLA, even though patients will be followed for 18 months.

When it entered the joint venture in September, Genzyme made an $8 million equity investment in BioMarin, agreed to pay $12.1 million upon approval of the enzyme therapy, and will invest another $10 million when BioMarin goes public. The companies are sharing development costs and will share profits. (See BioWorld Today, Sept. 16, 1998, p. 1.)

Genzyme already is marketing enzyme treatments for Gaucher's disease. The company earns more than $300 million per year from sales of Cerezyme (recombinant glucocerebrosidase) and Ceredase, the natural version of the enzyme.

Development of a treatment for MPS I follows BioMarin's strategy of using recombinant chemistry to target genetic diseases affecting small populations of patients. The addition of Glyko complements that effort, the company said, by enabling BioMarin to offer both diagnosis and treatment of genetic diseases.

Glyko 'Modestly Profitable'

Glyko's Flourophore Assisted Carbohydrate Electrophoresis technology gives BioMarin access to products and services that help separate, analyze, sequence and produce carbohydrate enzymes. Glyko has an approved diagnostic kit used to screen for lysosomal storage diseases, including MPS I.

Anderson said Glyko, in business since 1991, had revenues of $750,000 in the first half of this year and is "modestly profitable."

The addition of Glyko's 12 employees brings BioMarin to a staff of about 42.

MPS I afflicts 2,000 to 3,000 people, mostly children. The disease, characterized by a halt in development, causes carbohydrate buildup in the body, leading to enlargement of the liver and spleen, skeletal deformity, stunted growth and other conditions. *