Bentley Announces Approval of Its First Generic Oncology Product in Spain.EXETER, N.H. -- Bentley Pharmaceuticals, Inc. (NYSE NYSE See: New York Stock Exchange : BNT BNT Bentley Pharmaceuticals, Inc. (stock symbol) BNT Boston Naming Test (psychology) BNT Bermuda National Trust BNT Bulgarian National TV BNT Broadband Network Termination BNT Binary File Transfer ), a specialty pharmaceutical company, today announced that its subsidiaries, Laboratorios Belmac and Laboratorios Davur, have received product approvals of bicalutamide from the Spanish Ministry of Health. Bicalutamide is the generic equivalent to AstraZeneca Pharmaceuticals' Casodex[R]. Bicalutamide is prescribed as a treatment to prevent the growth of prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. by blocking the effects of androgens Androgens Male sex hormones produced by the adrenal glands and testes, the male sex glands. Mentioned in: Acne, Congenital Adrenal Hyperplasia, Finasteride, Homocysteine, Polycystic Ovary Syndrome, Salpingo-Oophorectomy on the cancer cells. The treatment is a non-steroidal, anti-androgenic product orally administered as a 50 mg. tablet. "This is our first generic product in the oncology area," said John Sedor, president Bentley Pharmaceuticals, Inc. "We are pleased to continue to leverage our generic expertise, including proven formulation capabilities in solid oral dosage, to serve this important, growing market." The next steps towards market launch of bicalutamide for Bentley are to apply for product pricing and building inventory. According to IMS Health Inc., the annual market size for bicalutamide in Spain is approximately $65 million (USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ) and has grown 12% over the trailing twelve months In commerce, the trailing twelve months (TTM) is a moving measurement (for example, an average or a sum) over the 12 previous months, using the most recent data available. Also sometimes known as last twelve months (LTM). . To date, this branded product has been very expensive for the healthcare system. Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and central nervous system diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API. Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley's web site at www.bentleypharm.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This press release contains forward looking statements, including without limitation, statements regarding Bentley's new bicalutamide product approval in Spain and its market prospects. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, risks associated with the timing and nature of regulatory approvals, changes in third party reimbursement and government mandates which impact pharmaceutical pricing, competition from other manufacturers of generic and proprietary pharmaceuticals, and other uncertainties detailed in Bentley's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and its other subsequent periodic reports filed with the Securities and Exchange Commission. Bentley cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Bentley undertakes no obligation to update or revise the statements, except as may be required by law. |
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