Senior Staff Writer
BioMarin Pharmaceutical Inc. is planning a 6-million-share public offering, pulling the stock down from a $150 million shelf registration filed in December that became effective last month.
Based on Wednesday's closing price of $10.55, the offering would raise $63.3 million. Underwriters would have an option to purchase 900,000 additional shares to cover overallotments. UBS Warburg LLC, of New York, is acting as lead underwriter in the offering, with CIBC World Markets Corp. and SG Cowen Securities Corp., both of New York, acting as co-managers.
BioMarin's stock (NASDAQ:BMRN) fell 56 cents Thursday to close at $9.99.
The Novato, Calif.-based company said in its prospectus it would use the funds for development and commercialization of Aldurazyme, an enzyme replacement therapy for the treatment of mucopolysacchariodosis-1 (MPS-I). It also said it would fund additional clinical trials and the manufacturing of its product, Neutralase; preclinical studies and clinical trials for other product candidates; potential licenses and acquisitions of complementary technologies, products and companies; general corporate purposes; and working capital.
The rolling biologics license application for Aldurazyme was completed July 29 and the companies submitted a marketing authorization application to the European Medicines Evaluation Agency March 1. Aldurazyme in January received a positive FDA advisory panel recommendation, and BioMarin got a complete response letter two weeks later from the FDA that did not ask for additional trials. The product also is being evaluated for approval in Canada and Australia. Aldurazyme has received fast-track designation and orphan drug designation for the treatment of MPS-1 in the U.S., the European Union and Australia. The product is being developed through a joint venture with Genzyme Corp., of Cambridge, Mass. BioMarin said it expects a response on the MAA this quarter. (See BioWorld Today, Jan. 16, 2003, and Jan. 30, 2003.)
Neutralase is a carbohydrate-modifying enzyme that cleaves heparin, allowing coagulation of blood and potentially aiding patient recovery following surgery. The first indication for the product is the reversal of anticoagulation by heparin in coronary arterial bypass grafting surgery. BioMarin, which has worldwide rights to the drug, said it expects to begin enrolling patients in a Phase III trial this month and anticipates the trial would be completed in the fourth quarter or the first quarter of 2004.
BioMarin also is developing other enzyme-based therapeutics. In March, it began a Phase II trial of Aryplase in mucopolysaccharidosis-VI (MPS-VI). The six-month treatment phase of the Phase II trial ended in January but patients continue to receive Aryplase as part of an extension phase. Aryplase has orphan drug status in the U.S. and the European Union.
Vibrilase, a topical enzyme product for removing burned skin tissue in preparation for skin grafting or other therapy, is in a Phase I trial in the UK, and the company expects to start a Phase II trial in either the U.S. or UK following the completion of Phase I work. Also, the company has other enzyme products in preclinical work.
Upon completion of the offering, BioMarin would have about 59.8 million shares outstanding. As of Sept. 30, the company had $86.5 million in cash, cash equivalents and short-term investments. Its net loss from continuing operations was $16.9 million for the third quarter of 2002.