Spectrum Pharmaceuticals Announces Leadership Changes

On December 17, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that its Board of Directors has terminated Rajesh C. Shrotriya, MD without cause from his position as Chief Executive Officer, and announced leadership changes under which Joseph W. Turgeon, the current President and Chief Operating Officer, has been named President and Chief Executive Officer and elected to the Board of Directors, and current Director Stuart M. Krassner, ScD, PsyD, has been named Chairman of the Board (Press release, Spectrum Pharmaceuticals, DEC 17, 2017, View Source [SID1234522672]). In addition, Thomas J. Riga, who currently serves as Executive Vice President, Chief Commercial Officer and Head of Business Development, has been named Chief Operating Officer. These changes are effective immediately.

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"The Board of Directors thanks Dr. Shrotriya for his contributions to Spectrum over the past fifteen years," said Dr. Krassner, Chairman. "The Board believes that now is the right time to effect these leadership changes. Mr. Turgeon and Mr. Riga have nearly 50 years of combined industry experience and the Board believes that they are the right leaders for Spectrum as the Company enters its next chapter."

"I am honored to serve as Spectrum’s next CEO and appreciate the confidence the Board has placed in me to guide the Company forward," said Mr. Turgeon, President and CEO. "We are at an exciting point in Spectrum’s history, and I look forward to driving the operation forward as we maintain our focus on our product pipeline."

Mr. Turgeon brings more than 30 years of experience in the pharmaceutical industry, including various executive leadership roles at Amgen Inc. He had served as Spectrum’s President and Chief Operating Officer since April 2014, and had previously served as the Company’s Senior Vice President and Chief Commercial Officer from October 2012 to April 2014. Prior to joining Spectrum, Mr. Turgeon spent 22 years at Amgen Inc. as Vice President of Sales.

Mr. Riga brings over 15 years of pharmaceutical sales and management experience in various positions at Amgen, Eli Lilly and Dendreon, including as Vice President of Sales at Dendreon. He had served as Spectrum’s Executive Vice President, Chief Commercial Officer and Head of Business Development since June 2017, and previously served as Spectrum’s Senior Vice President and Chief Commercial Officer from August 2014 to June 2017, and Vice President, Corporate Accounts from July 2013 to August 2014.

Dr. Krassner has served as a director of Spectrum since December 2004, and was previously a member of Spectrum’s Scientific Advisory Board from 1996 to 2001. Dr. Krassner’s career spans nearly four decades of experience in positions of increasing responsibility at the University of California at Irvine, most recently as Professor of Developmental and Cell Biology at the School of Biological Sciences. Dr. Krassner is Professor Emeritus, University of California, Irvine and has also been retained by pharmaceutical, medical device and other companies, including Allergan Pharmaceuticals, Lasermed Corporation, Automated Microbiology Systems, and In Vitro International, among others, to provide scientific and regulatory advisory services, including FDA compliance. He is a past member of the American Academy for the Advancement of Sciences, and the American Society of Tropical Medicine and Hygiene, among others.

Celltrion’s Herzuma® (trastuzumab biosimilar) receives positive opinion from EMA’s CHMP for early breast cancer, metastatic breast cancer, and metastatic gastric cancer

On December 16, 2017 Celltrion, Inc. (KOSDAQ: 068270) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification (Press release, Celltrion, DEC 16, 2017, View Source [SID1234522673]). The CHMP’s opinion will now be sent to the European Commission (EC) for final review.

Herzuma is a biosimilar to Herceptin​[i], a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin is a blockbuster drug which had worldwide sales of CHF 6.8 billion[ii] (US$6.8 billion) in 2016, of which CHF 2.1 billion[iii] (US$2.1 billion) was in European sales.

"We welcome the CHMP’s recommendation. By providing more treatment options, biosimilars open more opportunities for greater affordability and improve access to wider use of biotherapeutics. Herzuma could become a cost-effective alternative to biologics for treatment of breast cancer and gastric cancer, since biologics, which cost much more than conventional anticancer drugs, place undue financial burden on patients and the general healthcare system." said Woo Sung Kee, Chief Executive Officer of Celltrion.

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About Herzuma
Herzuma is an anticancer monoclonal antibody (mAb) biosimilar used to treat breast cancer and gastric cancer. Similarity of Herzuma to the reference product, Herceptin, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials covering various indications such as HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer. Celltrion also submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA). In 2017, Celltrion launched Herzuma in Korea.

10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Genoptix to Acquire Rosetta Genomics for $10 Million in Cash

On December 15, 2017 Genoptix, Inc., a leading oncology diagnostic laboratory, and Rosetta Genomics Ltd. (NASDAQ: ROSG), a genomic diagnostics company that improves treatment decisions by providing timely and accurate diagnostic information to physicians, reported that they have entered into a definitive merger agreement under which Genoptix will acquire all of the outstanding shares of Rosetta Genomics for a total gross purchase price of $10 million (Press release, Rosetta Genomics, DEC 21, 2017, View Source [SID1234522760]). After deducting expected payments for outstanding debt, convertible debentures, warrant termination payments, professional fees, expenses and other items, this purchase price equates to an amount that is preliminarily estimated to be $0.60, in cash, for each ordinary share of Rosetta Genomics outstanding at closing. Genoptix is a portfolio company of Ampersand Capital Partners and 1315 Capital.

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Genoptix is also providing a secured bridge loan facility of up to $1.8 million to fund the operations of Rosetta Genomics through the closing of this transaction.

This merger has been unanimously approved by the Board of Directors of both companies, and the closing is expected to occur during the first quarter of 2018, subject to approval by Rosetta Genomics’ shareholders and customary closing conditions. In connection with the proposed transaction, Rosetta Genomics intends to file a proxy statement with the Securities and Exchange Commission ("SEC"). Shareholders of Rosetta Genomics are urged to carefully review the proxy statement, when available, because it will contain important information about the proposed transaction and the estimated closing purchase price for each ordinary share.

Upon closing, trading in shares of Rosetta Genomics on the Nasdaq Capital Market will cease, and Rosetta Genomics will become a wholly owned subsidiary of Genoptix.

"After a comprehensive review of strategic alternatives that included financings, acquisitions, mergers, asset monetization and corporate partnerships, we determined that this proposed transaction with Genoptix is in the best interest of all Rosetta Genomics stakeholders, including our equity holders. Our current cash position is sufficient to fund operations only until the end of 2017, and given our current market capitalization, potential for pending delisting from the Nasdaq Capital Market and the difficult financing environment for microcap molecular diagnostics companies, we do not believe we could raise sufficient capital to continue as a going concern for an extended period of time," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

"As a leader in cancer diagnostics with a more significant infrastructure, Genoptix is in a position to deploy the resources necessary to accelerate the growth of RosettaGX Revealä ("Reveal"), as well as add our solid tumor testing services to their existing product portfolio," added Mr. Berlin.

Joseph M. Limber, President and Chief Executive Officer of Genoptix, said, "The acquisition of Rosetta Genomics will broaden our product offering in oncology diagnostics, particularly in the solid tumor area. We believe that there is a significant opportunity in the diagnosis of thyroid cancer utilizing Reveal and we intend to leverage our world-class commercial capabilities to become a leader in this space. Furthermore, Rosetta’s cutting edge microRNA-based technology will be the foundation of many more diagnostic tests to be incorporated into Genoptix’ oncology portfolio."

Cantor Fitzgerald is serving as financial adviser to Rosetta Genomics on this transaction.

10-Q – Quarterly report [Sections 13 or 15(d)]

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Champions Oncology, 2017, DEC 15, 2017, View Source [SID1234522666]).

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