Novacea Inc. registered for an estimated $75 million initial public offering.
The South San Francisco company, which applied for a Nasdaq listing under the symbol "NOVC," has yet to specify the number of shares or their price. But in a prospectus, the oncology-focused biopharmaceutical firm said it would use any proceeds largely for continued product development.
Its lead candidate, DN-101, is in a Phase III study called ASCENT-2 for androgen-independent prostate cancer. The 900-patient trial is testing its use with Taxotere (docetaxel, from Sanofi-Aventis Group), a combination that demonstrated a clinically meaningful improvement of 49 percent in overall survival, compared to Taxotere alone in a Phase II/III trial. DN-101 is a high-dose, oral formulation of the hormone calcitriol, an active form of vitamin D. Taxotere is the current standard of care in that indication.
A second product in the pipeline, vinorelbine oral, is ready to begin Phase III pending FDA clearance and is expected to enter a registration trial by the end of the year. A more convenient form of a long-approved intravenous chemotherapy, it is being developed for lung and breast cancers. Novacea in-licensed vinorelbine oral’s U.S. and Canadian rights from Pierre Fabre Medicament SA, a division of Paris-based bioMerieux Pierre Fabre. (See BioWorld Today, July 26, 2005.)
A third clinical product is AQ4N, a tissue-targeted cytotoxic prodrug for solid tumors that is scheduled to enter Phase I/II development in the second half of this year. Its active form, AQ4, is a topoisomerase II inhibitor. Novacea has North American rights to AQ4N per terms of a deal with KuDOS Pharmaceuticals Ltd., of Cambridge, UK.
Additional IPO proceeds are tabbed for pre-launch marketing preparations for those products, to identify new candidates for in-licensing and for general corporate purposes and working capital. (See BioWorld Today, Dec. 12, 2003.)
The company was founded in February 2001 by Eckard Weber, its chairman, and since has posted cumulative losses totaling $54.8 million. Since its inception, Novacea primarily has funded operations through private sales of $107.2 million worth of preferred stock. Most recently, the company raised $25.1 million last month through an extension of its Series C round. (See BioWorld Today, Jan. 5, 2005.)
Its largest shareholder is Domain Associates LLC, a Princeton, N.J.-based venture capital firm that controls 24.1 percent (or 13.6 million) of Novacea’s shares. New Enterprise Associates LP in Menlo Park, Calif., has a 23.3 percent stake, worth 13.1 million shares. Versant Ventures, also of Menlo Park, has 11.3 percent, or 6.4 million; Sofinnova Ventures in San Francisco has 11.5 percent, or 6.5 million; ProQuest Investments, also of Princeton, has 9.2 percent, or 5.1 million; and Apax Excelsior VI LP in New York has 8.9 percent, or 5 million.
Novacea had $31.7 million in cash, cash equivalents and marketable securities as of Sept. 30.