Hollister-Stier Laboratories LLC, the Spokane-based allergy-products maker, has signed two agreements that result from the companys ongoing efforts to diversify its activities, says Bill Bauernschmidt, Hollister-Stiers vice president of business development.


As part of its growing contract-manufacturing business, Hollister-Stier has agreed to filter and package an enzyme-replacement product for BioMarin Pharmaceutical Inc., of Novato, Calif., Bauernschmidt says. Separately, Hollister-Stier has agreed to market a newly approved type of eye drop for Santen Inc., a Napa, Calif.-based subsidiary of Santen Pharmaceutical Co., an Osaka, Japan, company that is one of the worlds largest eye-care medication businesses, he says. Santen selected Hollister-Stier to market its product, in part, because of the Spokane companys expertise in the allergy-treatment marketplace, he says.


Hollister-Stier previously has announced plans to boost revenues and to broaden its scope by marketing its capabilities to other pharmaceutical companies as a contractor. This is a good start, Bauernschmidt says.


Under its contract with BioMarin, Hollister-Stier filters and packages in sterile vials an enzyme called rhASB, which can be injected intravenously to treat a type of rare, genetic disease caused by the deficiency of an enzyme needed to metabolize carbohydrates, says Charlie Moore, Hollister-Stiers director of contract manufacturing. The disorder is one of a group of inherited metabolic diseases, called mucopolysaccharidoses, that are caused by enzyme deficiencies.


Hollister-Stier processed its first batch of the BioMarin product about a month ago and is scheduled to filter and package another batch this month, he says. The Spokane company also tests the enzyme product for sterility and stability.


We hope to continue to do this well enough that they can keep producing the enzyme, and we can keep processing it for them, Moore says. Hollister-Stier cant project the revenue that it expects to receive under the contract, which is open ended, he says.


BioMarin is just beginning clinical testing of rhASB to determine the enzymes effectiveness in treating patients, Moore says. Because the disease that rhASB will be used to treat is rare, the U.S. Food and Drug Administration has granted the enzyme product orphan status, a designation given to drugs that would be used to treat fewer than 200,000 patients in the U.S. Pharmaceutical companies can have a difficult time recouping development costs from such a small potential market, and because of that, makers of orphan-status drugs qualify for federal grants, tax credits, help applying for FDA approval, and market exclusivity for seven years, Moore says.


Separately, Hollister-Stier has signed a three-year agreement with Santen to market the Japanese companys eye drops, which the FDA approved about a year ago for use in the U.S. in the treatment of allergic conjunctivitis, an itchy swelling of the eyes surface, Bauern-schmidt says. The value of Hollister-Stiers marketing agreement with Santen will be determined by the sales generated through the Spokane companys marketing efforts, he says.


The allergy eye drops, marketed under the product name Alamast, are Santens first product to be marketed in the U.S., Santens Web site says.