TORONTO, Oct. 1, 2007 (PRIME NEWSWIRE) -- Polydex Pharmaceuticals Limited (Nasdaq:POLXF) today issued the following report on Company operations and objectives for the future.
Cash and cash equivalents totaled $794,745 at the end of the Company's second quarter, ending July 31, 2007. Total assets in the Company at that time were reported to be $10,092,061. Total liabilities were reported at $2,368,016 and there are a total of 3,072,846 common shares issued and outstanding, making the current book value per share of approximately $2.51. Company management, directors and insiders hold approximately 22% of the outstanding shares.
The Company is near completion of a $3.5 million refurbishment of its production facility. Management expects to see an increase in sales in the fourth quarter of this year as the new equipment is brought online and the increased demand for the Company's core products begins to be met.
Ushercell, the company's lead candidate compound in development, is a cellulose sulphate gel that has shown promise as a highly effective contraceptive and in a number of other potential uses. Nearly $75 million has been expended on the research and development of this compound, a vast majority of which has been borne by the Company's research partners. The Company is under no obligation to repay the research investments made by outside sources.
During the course of the development of Ushercell, a series of safety and acceptability studies established that Ushercell is safe for use by women and men, even numerous times per day. Further studies found that Ushercell is 96.1% effective as a contraceptive when used as directed. For the purpose of comparison, the U.S. Food and Drug Administration says that the male condom offers 86% to 97% effectiveness in prevention of pregnancy and the female condom effectiveness ranges from 79% to 95%.
Ushercell is a clear, odorless gel packaged in individual dose applicators, which is inserted into the vagina anytime during a period of several hours before sexual intercourse, and acts as a barrier by immobilizing sperm. The compound is not absorbed into the body and therefore offers none of the health disincentives of the Pill or the Patch, and as a pharmacologically inert substance, would also make an excellent lubricant or excipient (carrier) for other drugs. According to available market research, the U.S. contraceptive market was estimated at $2.2 billion at the end of 2003, and was noted to be a stable market that grows at a steady pace each year.
The Company is currently looking into further development of the compound and is looking to partner with a leading company with a history in household, consumer and specialty-products markets.
Phase III trials to determine Ushercell's effectiveness at the prevention of HIV were halted earlier this year, when interim perusal of the data being gathered in the trials revealed a higher number of HIV seroconversions than were expected. (See company news release January 31, 2007). In follow-up to the halted Phase III trials earlier this year, CONRAD, the program at Eastern Virginia Medical School that was the lead investigator of these trials, is preparing to further assess the safety of Ushercell in an upcoming clinical trial to be conducted in the United States. Trial sites have been identified, funds are in place to conduct the trials, and patient screening is expected to begin in mid-October.
Dr. Lut Van Damme, a principal investigator of the Ushercell trials, presented final data analysis from the halted trials at the recent International AIDS Society conference in Sydney, Australia, explaining that there was no statistical difference in HIV seroconversions between the users of Ushercell and those using the placebo (inactive gel). It is also important to note that these trials offered extensive behavioral counseling and provided unlimited condoms to trial participants, ultimately averting hundreds of new infections among typical participants during the course of the trial.
Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry.
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Note: This press release contains forward-looking statements, within the meaning of the United States Securities Act of 1933, as amended, and the United States Securities Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals Limited, including, without limitation, statements regarding expectations about future revenues or business opportunities and developments relating to Ushercell, partner relationships or other potential research projects. These statements are typically identified by use of words like "may", "could", "might", "expect", "anticipate" or similar words. Actual events or results may differ materially from the Company's expectations, which are subject to a number of known and unknown risks and uncertainties including but not limited to changing market conditions, future actions by the United States Food and Drug Administration or equivalent foreign regulatory authorities as well as results of pending or future clinical trials. Other risk factors discussed in the Company's filings with the United States Securities and Exchange Commission may also affect the actual results achieved by the Company.
News Releases and other information available at company website: www.Polydex.com