Indevus to acquire Valera.Indevus Pharmaceuticals, Inc. (Lexington, MA) and Valera Pharmaceuticals, Inc. (Cranbury, NJ) have entered into a definitive agreement under which Indevus will acquire Valera in a stock transaction. Valera is a specialty pharmaceutical company focused on the development and commercialization of urology and endocrinology products. The company markets VANTAS for advanced 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. and has multiple products in clinical development including SUPPRELIN-LA for central precocious puberty Precocious Puberty Definition Sexual development before the age of eight in girls, and age 10 in boys. Description Not every child reaches puberty at the same time, but in most cases it's safe to predict that sexual development will . The company has filed a New Drug Application for SUPPRELIN-LA and under the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. , the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. is expected to complete its review and act upon this NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any submission by May 3, 2007. The company also expects to submit a supplemental NDA in the first half of 2007 for VALSTAR, which is indicated for the treatment of BCG-refractory bladder cancer bladder cancer Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor. . Other products in development by Valera include a biodegradable ureteral stent Ureteral stent A surgical device implanted in patients with damaged ureters that holds the ureter open so that urine can flow freely from the kidneys to the bladder. Mentioned in: Kidney, Ureter, and Bladder X-Ray Study for post-kidney stone lithotripsy Lithotripsy Definition Lithotripsy is the use of high-energy shock waves to fragment and disintegrate kidney stones. The shock wave, created by using a high-voltage spark or an electromagnetic impulse, is focused on the stone. and an octreotide implant for the treatment of acromegaly acromegaly (ăk'rōmĕg`əlē), adult endocrine disorder resulting from hypersecretion of growth hormone produced by the pituitary gland. . "The acquisition of Valera firmly establishes Indevus as an emerging leader in the specialty areas of urology and men's health Men's Health Definition Men's health is concerned with identifying, preventing, and treating conditions that are most common or specific to men. and fully leverages our national sales force," said Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "Upon closing, Indevus' robust product portfolio will include three marketed products and the combined company anticipates five new product launches within two years, including three products from Valera." "The Indevus and Valera strategies and objectives are very consistent and this combination is a perfect match. Importantly, we expect that this transaction will be accretive within 2 years and will significantly increase earnings per share upon the achievement of profitability," continued Dr. Cooper. "We see tremendous value in Valera. Our product portfolios are complementary and target the urology and endocrinology specialty physician bases of both companies. In addition to VANTAS, SUPPRELIN-LA and VALSTAR, there is a significant value opportunity in Valera's Hydron implant technology platform, their biodegradable ureteral stent program, and their octreotide implant. Valera's products fit extremely well with our current focused portfolio of marketed and late stage products, including SANCTURA and SANCTURA XR for overactive bladder, NEBIDO and DELATESTRYL for male hypogonadism, PRO 2000 for the prevention of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. and other STDs, as well as pagoclone for stuttering stuttering or stammering, speech disorder marked by hesitation and inability to enunciate consonants without spasmodic repetition. Known technically as dysphemia, it has sometimes been attributed to an underlying personality disorder. . We are very excited to announce this transaction." "We have greatly admired Indevus as a company and we believe this partnership is a smart fit for Valera. As we entered into discussion for a co-promotional arrangement with Indevus, it became apparent that our product offerings, the patient and physician benefits, and the potential for shareholder returns would be enhanced by leveraging the strengths of the combined companies," stated David S. Tierney, M.D., president and chief executive officer of Valera. "After surveying a range of strategic alternatives, we concluded that this transaction was in the best interests of Valera's shareholders. We are excited to bring Valera's growing portfolio of approved and development stage products into Indevus' organization given Indevus' proven commercialization reach and ability to bring pipeline products to market." Upon completion of the transaction and subject to the approval of the Indevus board of directors, James C. Gale, chairman of the board of directors of Valera and chief investment officer of the Corporate Opportunities Funds and Life Sciences Opportunities Fund, affiliates of Sanders Morris Harris, will join the Indevus board of directors. Sanders Morris Harris is currently the largest shareholder of Valera Pharmaceuticals. Additionally, Dr. Tierney will provide consulting services during a transition period after the completion of the transaction. Valera's facility in Cranbury, New Jersey, which contains significant manufacturing operations and research and development capabilities, will be maintained and become an integral part of Indevus' operations. In connection with the transaction, certain affiliated funds of Sanders Morris Harris, Valera's largest shareholder, and one other large shareholder of Valera, have entered into voting agreements in which they have agreed to vote shares representing approximately 41% of Valera's outstanding shares in favor of the merger. The merger has been approved by the boards of directors of Indevus and Valera and is expected to be completed on or around April 30, 2007. Closing of the merger is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R. , approval of Valera's stockholders, approval of Indevus' stockholders and other customary closing conditions. UBS UBS Union Bank of Switzerland UBS United Bible Societies UBS United Blood Services UBS United Buying Service UBS Used Bookstore UBS University Business Services UBS Universal Building Society (UK) UBS Ulaanbaatar Broadcasting System Investment Bank is acting as the exclusive financial advisor to Indevus in this transaction. Banc of America Securities LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control is acting as the exclusive financial advisor to Valera. Separately, Indevus and Valera have entered into a co-promotion agreement under which Indevus' sales force will co-promote VANTAS in the United States. Terms of the agreement provide Indevus with royalties of 13.5% on sales of VANTAS up to a specified unit level and increases to 30% above the specified level. For sales of VANTAS to specified specialty pharmacy accounts, Indevus will receive royalties of 35%. Indevus anticipates beginning to co-promote VANTAS in January 2007. Indevus is a biopharmaceutical company engaged in the acquisition, development and commercialization of products to treat urological, gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. and men's health conditions. The company's marketed products include SANCTURA for overactive bladder and DELATESTRYL to treat male hypogonadism. The compounds in development include SANCTURA XR, the once- daily formulation of SANCTURA, NEBIDO for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, IP 751 is for interstitial cystitis, pagoclone for stuttering, and aminocandin, which the company recently out-licensed to Novexel. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to SANCTURA should not use SANCTURA. DELATESTRYL is contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. Valera is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products to treat urology and endocrinology diseases and disorders. Utilizing its innovative Hydron technology, Valera is developing soft, compact and flexible hydrogel-based implants which can be designed to release therapeutic agents at a controlled rate for up to twelve months. VANTAS, a patent protected once-per-year implant currently marketed by Valera for the palliative treatment of advanced prostate cancer, employs this drug delivery technology. Valera Pharmaceuticals, Inc. +1-609-235-3202 www.valerapharma.com Indevus Pharmaceuticals, Inc. +1-781-402-3405 www.indevus.com |
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