SCICLONE PHARMACEUTICALS PLANS B2D CANCER DRUG IND FILING
SCICLONE PHARMACEUTICALS PLANS B2D CANCER DRUG IND FILING this year, the startup says in a preliminary prospectus for an initial public offering filed with the Securities and Exchange Commission on Jan. 31. Patents on B2D are held by SRI (formerly Stanford Research Institute), which has licensed exclusive worldwide marketing rights for the drug to SciClone. The company describes B2D as a chemotherapeutic compound belonging to the anthracyline class, chemically similar to the approved cancer agent doxorubicin. "On the basis of animal studies conducted to date, the company believes that B2D could be used for many of the current indications of doxorubicin and that the market for B2D could be larger due to B2D's significantly lower toxicity and its potential for oral administration," the prospectus states. While doxorubicin is widely prescribed, its use "is currently restricted because of significant cardiac toxicity," SciClone says. B2D, on the other hand, "has significantly lower cardiac toxicity and showed 35 times less toxicity than doxorubicin based on rat [electrocardiogram] activity." Also, doxorubicin must be administered intravenously, while B2D "has shown the potential for oral administration," the firm claims. Likely indications for clinicals include breast and colon tumors. The prospectus registers the proposed sale of 2.6 mil. units, each consisting of one share of common and one redeemable warrant, at an expected price of $6 to $8 per unit. Josephthal Lyon & Ross is underwriting. In the three years since its inception, SciClone has incurred a net loss of $2.6 mil. The firm has not yet generated any product sales. Proceeds from the offering will go to support clinical trials and testing of proprietary drugs ($1.25 mil.), product rights acquisitions ($900,000), repayment of promissory notes issued during an earlier round of private financing ($1.1 mil.) and working capital. Principals include President and Chief Operating Officer Philip Vander Werf, most recently senior director of pharmaceutical operations at Schering Plough-Italy. Former FDA Commissioner Jere Goyan, PhD, is a member of SciClone's board. The firm has 10 employees and is located in San Mateo, California. If approved, B2D would be SciClone's first product in the U.S. market. The firm's marketing strategy turns largely on non-U.S. business, focusing on Asia and the Far East. SciClone's lead project is thymosin alpha 1, licensed from Alpha 1 Biomedicals for world-wide sale in markets excluding the U.S., Canada, Europe, Israel and Korea. Thymosin alpha 1 is in Phase III trials in the U.S. for the treatment of hepatitis B, and SciClone will have certain rights to that data for use in seeking regulatory approvals overseas. "A Phase II trial [of thymosin alpha 1] funded by the FDA resulted in a favorable response in 75% of patients with chronic active hepatitis B with no reported side effects or relapses," the prospectus notes. "The company is not aware of any FDA-approved drug that has produced comparable results." Alpha 1 Biomedicals is studying thymosin alpha 1 for both chronic active and chronic persistent hepatitis B at three sites: Wayne State University, the University of California at Los Angeles and the University of Miami. According to the prospectus, Alpha 1 plans to file an NDA in 1993. Currently the only approved drug for hepatitis B is alpha interferon. SciClone plans to begin hepatitis B clinicals in Singapore this year through a newly- formed joint venture with the government of Singapore and a Singapore venture capital firm and may also conduct independent trials elsewhere. Future applications of thymosin alpha 1 may include hepatitis C, the prospectus suggests -- Alpha 1 Biomedicals is planning additional trials at its hepatitis B study sites, and a Phase II/III trial for that indication is about seven months along at the Department of Veterans Affairs Hospital in Denver. In other projects, SciClone has licensed marketing rights to a group of five Ben Venue cancer drugs in 11 Asian nations. That agreement is expected to provide an initial base of marketable drugs for the Singapore joint venture.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth