Savient Pharmaceuticals Inc. filed for regulatory clearance of Soltamox, an oral liquid solution of tamoxifen for the treatment of hormonally sensitive breast cancer.
The specialty pharmaceutical company submitted its new drug application at the end of last month. The product, which already is marketed in the UK, was developed by Rosemont Pharmaceuticals Ltd., a wholly owned subsidiary of East Brunswick, N.J.-based Savient.
Company officials did not return calls seeking comment.
Tamoxifen is a non-steroidal anti-estrogen product that inhibits the effects of endogenous estrogen, and oral administration of the compound produces maximum serum concentrations within four to seven hours. The dosage range is 20 mg to 40 mg daily, given either in divided doses twice daily or as a single dose once daily.
Rosemont, which is located in Leeds, UK, recently completed a series of modifications to its Britain-based liquids manufacturing facility to meet the FDA's Current Good Manufacturing Practices standard.
Following an agency review of the production site, Savient plans to move forward with additional oral liquid filings this year and beyond, and expects to seek U.S. marketing and distribution alliances for those other products.
But on the partnering front, Savient said Soltamox's German rights were out-licensed to O.R.C.A.Pharm GmbH, which will market and distribute the product there. Rosemont will produce Soltamox and earn manufacturing profits on each unit produced, and also will receive profit-share payments based on sales to German wholesalers. O.R.C.A.Pharm is based in Penzberg, Germany.
Tamoxifen has not been shown to be mutagenic in a range of in vitro and in vivo mutagenicity tests. Investigations in different in vivo and in vitro systems have shown that tamoxifen has a genotoxic potential following hepatic activation. Gonadal tumors in mice and liver tumors in rats receiving tamoxifen have been reported in long-term studies.
Savient already markets a pair of products in the U.S., Oxandrin (oxandrolone), an oral anabolic agent used as adjunctive therapy to promote weight gain following weight loss due to extensive surgery, chronic infection, or severe trauma; and Delatestryl (testosterone enanthate), an injectable testosterone-replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone.
Separate from its drug development activities, the company expects to amend and restate previously reported unaudited interim results for the third quarter after correcting the method by which it recognizes revenue for certain of its product sales. The restatement involves a transfer of revenue to last quarter, revenue which previously was recognized in the third quarter. There is not expected to be any transfer of revenue from last quarter into this one, as the company said there were few shipments made in the final week of last year.
On Thursday, Savient's shares (NASDAQ:SVNT) fell 6 cents to close at $2.42.