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Biotech / Medical : Indevus Pharmaceuticals (NasdaqNM:IDEV)

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From: invbiotech12/12/2006 3:48:28 PM
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Indevus Pharmaceuticals to Acquire Valera Pharmaceuticals
Tuesday December 12, 7:00 am ET
Acquisition Establishes Indevus as a Leader in Urology and Men's Health
Companies to Host Joint Conference Call Today at 9:00 a.m. EST

LEXINGTON, Mass., and CRANBURY, N.J., Dec. 12 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) and Valera Pharmaceuticals, Inc. (Nasdaq: VLRX - News) today announced that they have entered into a definitive agreement under which Indevus will acquire Valera in a stock transaction for $7.75 per share, or an aggregate value of approximately $120 million, plus contingent payments of up to $3.50 per share based on the achievement of future product milestones.

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 and has multiple products in clinical development including SUPPRELIN®-LA for central precocious puberty. The Company has filed a New Drug Application (NDA) for SUPPRELIN-LA and under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to complete its review and act upon this NDA 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. Other products in development by Valera include a biodegradable ureteral stent for post-kidney stone lithotripsy and an octreotide implant for the treatment of acromegaly.

"The acquisition of Valera firmly establishes Indevus as an emerging leader in the specialty areas of urology and men's health 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(TM) for overactive bladder, NEBIDO® and DELATESTRYL® for male hypogonadism, PRO 2000 for the prevention of HIV and other STDs, as well as pagoclone for stuttering. 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.

Transaction Details

The merger will take the form of a tax-free stock-for-stock merger. Under the terms of the agreement, each share of Valera common stock will be exchanged for $7.75 in Indevus common stock, provided the volume weighted average closing price for Indevus common stock is between $6.59 and $8.05 during the 25 trading day period ending five trading days prior to the meeting of Valera stockholders to vote on the merger. Each Valera share exchanged would be converted into not more than 1.1766 shares of Indevus common stock and not less than 0.9626 shares of Indevus common stock.

In addition, each share of Valera common stock will also be converted into three contingent stock rights ("CSRs") relating to three Valera products in various stages of development. One CSR is convertible into $1.00 of Indevus common stock upon FDA approval of SUPPRELIN-LA and the availability of sufficient launch quantities, one CSR is convertible into $1.00 of Indevus common stock upon FDA approval of the biodegradable ureteral stent and one CSR is convertible into $1.50 of Indevus common stock upon FDA approval of the octreotide implant. The amount of Indevus common stock into which the CSRs convert will be determined by a formula based on the average stock price of Indevus prior to achievement of the applicable milestones and the CSRs convert into Indevus common stock only if the applicable milestones are achieved within three years of the closing of the merger in the case of SUPPRELIN-LA and within five years of the closing of the merger in the case of the biodegradable ureteral stent and the octreotide implant.

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, approval of Valera's stockholders, approval of Indevus' stockholders and other customary closing conditions. UBS Investment Bank is acting as the exclusive financial advisor to Indevus in this transaction. Banc of America Securities LLC is acting as the exclusive financial advisor to Valera.

Co-promotion Agreement

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.

Conference Call and Webcast

Indevus and Valera will host a joint conference call and webcast to discuss this announcement at 9:00 AM eastern time on December 12, 2006. The live call may be accessed by dialing 866-825-3209 from the U.S. and Canada, and 617-213-8061 from international locations. The participant passcode is 75311255. A replay of the call will be available beginning at approximately 11:00 AM on December 12, 2006 and lasting until 12:00 AM on January 11, 2007. To access the replay, please dial 888-286-8010 from the U.S. and Canada, and 617-801-6888 from international locations, using the passcode 67443390
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