On January 29, 2015 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) reported that it has entered into a "stalking horse" asset purchase agreement to acquire certain assets of Dendreon Corporation ("Dendreon") for $296 million in cash (Press release Valeant, JAN 29, 2015, http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Valeant-Selected-As-Lead-Bidder-To-Acquire-Dendreon-And-Its-Leading-Immunotherapy-Treatment-PROVENGE-sipuleucel-T/default.aspx [SID:1234501430]).

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Pursuant to the terms of the agreement, Valeant will acquire the world-wide rights to Dendreon’s PROVENGE (sipuleucel-T) product and certain other Dendreon assets. PROVENGE (sipuleucel-T) is an immunotherapy treatment designed to treat men with advanced prostate cancer by taking the body’s own immune cells and reprograming them to attack advanced prostate cancer. The product was approved by the U.S. Food and Drug Administration (FDA) in April 2010 and realized revenues of approximately $300 million in 2014. PROVENGE was approved by the European Medicines Agency in 2013.

Dendreon has been a debtor pursuant to chapter 11 of the U.S. Bankruptcy Code since November of 2014. The asset purchase agreement constitutes a "stalking horse bid" in a sale process being conducted under Section 363 of the U.S. Bankruptcy Code. As the "stalking horse bidder," Valeant will be entitled to a break-up fee and expense reimbursement if it ultimately does not prevail as the successful bidder at a subsequent auction for Dendreon’s assets. Valeant’s role as a stalking horse bidder, and the sale itself, are subject to approval by the Bankruptcy Court. In addition, completion of the transaction remains subject to higher or better offers at such auction and customary closing conditions.

"We believe that oncology has similar characteristics to our current therapeutic portfolios, such as strong growth, high durability, strong patient and physician loyalty, and a terrific reimbursement regime," stated J. Michael Pearson, chairman and chief executive officer. "We have not previously found an economic way to enter this market, but with the unique dynamics of this situation, we believe that this transaction will create significant shareholder value."

Court documents and additional information are available through Dendreon’s claims agent, Prime Clerk, at View Source or 844-794-3479.

Weil, Gotshal & Manges LLP is serving as Valeant’s legal advisor. Skadden, Arps, Slate, Meagher & Flom LLP is serving as Dendreon’s legal advisor, AlixPartners is serving as its financial advisor and Lazard is serving as its investment bank.

On January 29, 2015 Dendreon reported that it has reached an agreement with Valeant Pharmaceuticals International pursuant to which, subject to bankruptcy court approval, Valeant will serve as the "stalking horse" bidder in conjunction with a court-supervised sales process (Press release Dendreon, JAN 29, 2015, View Source [SID:1234501440]).

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Under the terms of the agreement, Valeant would acquire the world-wide rights of PROVENGE (sipuleucel-T) and certain other Dendreon assets for $296 million, subject to higher and better bids.

Valeant is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics.

"We are pleased to reach this agreement with Valeant and to move forward with the court-supervised sales process," said W. Thomas Amick, president and chief executive officer of Dendreon. "We are confident that this process will result in a strong new owner for PROVENGE, and that patients will continue to receive treatments with no disruption moving forward. We thank our employees for their continued hard work, dedication and commitment to serving our physicians and their patients."

The Company also announced that it would be extending the bid deadline for interested parties to submit qualified bids to participate in an auction for the Company’s assets from January 29, 2015 at 5:00 p.m. Eastern Time to February 10, 2015 at 5:00 p.m. Eastern Time. Assuming additional qualified bids are submitted, an auction would be held on February 12, 2015.

The full terms of the agreement will be filed with the Securities and Exchange Commission. Court documents and additional information are available through Dendreon’s claims agent, Prime Clerk, at View Source or 844-794-3479.

Skadden, Arps, Slate, Meagher & Flom LLP is serving as the Company’s legal advisor, AlixPartners is serving as its financial advisor and Lazard is serving as its investment bank.

Weil, Gotshal & Manges LLP acted as legal advisor to Valeant.

On January 28, 2015 Sorrento Therapeutics reported that the last patient in (total n = 111 patients) has been randomized in the ongoing TRIBECA (TRIal establishing bioequivalence [BE] between Cynviloq and Albumin-bound paclitaxel) registrational trial (Filing 8-K , Sorrento Therapeutics, JAN 28, 2015, View Source [SID:1234501408]). Patients were enrolled globally from sites in USA, Eastern Europe, and Asia. The ongoing safety assessment from treated patients continues to reveal no unexpected adverse events and the data is consistent with the toxicity profile reported in the literature with albumin-bound paclitaxel. Previously, Sorrento announced positive pharmacokinetic (PK) data from the first eight (8) patients enrolled in the TRIBECA study.

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On January 26, 2015 Provectus Biopharmaceuticals reported that it has received notification of allowance from the Chinese Patent Office for its patent application protecting the synthetic process used to produce the small molecule Rose Bengal, the active pharmaceutical ingredient (API) in PV-10, the Company’s lead oncology drug candidate (Press release Provectus Pharmaceuticals, JAN 26, 2015, http://www.pvct.com/pressrelease.html?article=20150126.1 [SID:1234501388]).

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The pending Chinese patent covers the same process as the one granted by the US Patent Office in September 2013, as U.S. Patent 8,530,675, "Process for the Synthesis of 4,5,6,7-tetrachloro-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenzofuran-1,9-xanthen]-3-one (Rose Bengal) and Related Xanthenes." The application details a new process for the manufacture of Rose Bengal and related iodinated xanthenes in high purity. The allowed claims cover the process under which pharmaceutical grade Rose Bengal and related xanthenes are produced, reducing the formation of certain previously unknown transhalogenated impurities that currently exist in commercial grade Rose Bengal in uncontrolled amounts. The requirement to identify and control related substances is in accordance with International Conference on Harmonisation (ICH) guidelines for manufacture of API suitable for phase 3 clinical trial material and commercial pharmaceutical use. Once issued later this year, the patent is expected to provide protection for Rose Bengal API to 2031 and covers any hypothetical process that controls the amount of transhalogenated impurities in Rose Bengal through the awarded Jepson style claims.

Eric Wachter, CTO of Provectus, stated, "The issuance of this patent will enhance the protection of our novel synthesis process for the manufacture of Rose Bengal covering the entire Chinese market. As we prepare to begin our phase 3 clinical trial for intralesional PV-10 as a treatment for melanoma and as we discuss with Chinese interests licensing PV-10 for other indications, it is important that we defend our intellectual property in this way. We are pleased that the Chinese authorities have been so helpful in this, and we will continue to protect our stockholders’ interests in this way as we seek out partners globally to further develop our product line."

On January 26, 2015 AMATSIGROUP, the leading French supplier of services devoted to the development of both human and veterinary pharmaceutical products, reported the acquisition of Belgian company SEPS Pharma, which provides drug product development services, encompassing preformulation and formulation development, analytical drug product development, process development and clinical trial manufacturing (Press release, Amatsigroup, JAN 26, 2015, View Source [SID1234520755]). Founded in 2007 and located in Ghent, Belgium, SEPS Pharma counts a team of 30 highly-qualified people specialized in the development of innovative oral (liquid and solid dosage forms), inhalable and injectable formulations with acknowledged expertise in enhancing the bioavailability and controlling the drug release. With over 25 clients in Europe, US and Japan, the Belgian company recorded a 2014 revenue of €5 million.

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