Two firms cast their lines in the financial waters by filing for initial public offerings - Sucampo Pharmaceuticals Inc., which seeks up to $86.25 million, and BioVex Inc., which hopes to raise as much as $45 million.
Sucampo, of Bethesda, Md., did not specify the number of shares or the price per share.
In late January, the FDA approved the firm's selective chloride channel activator Amitiza (lubiprostone) capsules for chronic idiopathic constipation in adults. In pivotal trials, about 60 percent of patients who used the drug experienced a spontaneous bowel movement within the first 24 hours.
Partnered in the U.S. and Canada with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, Amitiza is undergoing two pivotal Phase III trials for irritable bowel syndrome with constipation, and results are expected in the first quarter of next year. In the works are Phase II/III trials with the compound for opioid-induced bowel dysfunction, slated to begin by early 2007.
Also in the pipeline is SPI-8811 for ulcers induced by non-steroidal anti-inflammatory drugs, portal hypertension, non-alcoholic fatty liver disease, cystic fibrosis and chronic obstructive pulmonary disease. Sucampo has finished Phase I trials of SPI-8811 for NSAID-induced ulcers, as well as a Phase IIa trial for non-alcoholic fatty liver disease and a Phase IIa trial for cystic fibrosis. For other indications, the drug still is preclinical.
Behind SPI-8811 is SPI-017 for peripheral arterial and vascular disease and central nervous system disorders. Sucampo is developing first an intravenous formulation for peripheral arterial disease, with an oral form for Alzheimer's disease following closely. Phase I trials with both are expected to begin next year.
Banc of America Securities LLC and Deutsche Bank Securities Inc., both of New York, will serve as joint book-runners and lead managers for the IPO, and Leerink Swann & Co., of Boston, will be the co-manager for the offering. Sucampo hopes to trade on Nasdaq under the symbol "SCMP."
Cambridge, Mass.-based BioVex Inc., which is focused on cancer and infectious disease, did not give a proposed number of shares or price per share in its SEC paperwork, either, but said it would use about 75 percent of the potential $45 million in proceeds for development of its product OncoVEX.
The compound is an oncolytic virus designed to selectively kill tumor cells while also inducing tumor cells to secrete GM-CSF, an immune stimulator that enhances the destruction of metastatic tumor deposits. In February, BioVex said the first patients in its Phase II trials in malignant melanoma and in head and neck cancer had received their initial doses. The melanoma trial is a 50-patient multicenter study, and the head and neck cancer trial is a 16-patient open-label study in combination with chemoradiotherapy.
About 5 percent of the IPO proceeds would go for funding of preclinical and research programs with other OncoVEX products, and another 10 percent will pay for development of ImmunoVEX HSV2, a vaccine for genital herpes, through Phase I trials.
The rest of the IPO money will go for general corporate purposes, including the build-out of BioVex's manufacturing facility in Woburn, Mass. Underwriters of the offering are Janney Montgomery Scott LLC, of Philadelphia, and Stifel, Nicolaus & Co., of New York. BioVex intends to trade on Nasdaq under the symbol "BVEX."