On December 26, 2017 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, DEC 26, 2017, View Source [SID1234522769]).

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The Alkeran brand and generic had U.S. sales of approximately $107 million MAT for the most recent twelve months ending in October 2017 according to IMS Health*.

Dr. Reddy’s Melphalan Hydrochloride for Injection is available in a carton containing one singledose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.

On December 26, 2017 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CG’806, a highly potent pan-FLT3/pan-BTK inhibitor, for the treatment of patients with acute myeloid leukemia (AML) (Press release, Aptose Biosciences, DEC 26, 2017, View Source;p=RssLanding&cat=news&id=2324031 [SID1234522772]). AML is a particularly devastating cancer of the blood and bone marrow and is the most common type of acute leukemia among adults, with an annual incidence of approximately 21,000 patients and causing more than 10,000 deaths each year in the U.S.

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"We are pleased that the FDA has recognized the unique potential of CG’806 to address AML and has assigned CG’806 the status of orphan drug designation," said William G. Rice, Ph.D., Chairman, President and CEO. "Results from non-clinical studies that we and our research collaborators have generated are promising and give reason for our eagerness to begin clinical trials in both AML and B-Cell malignancies in 2018."

AML cells utilize multiple forms of the FLT3 receptor tyrosine kinase and other pathways to promote rapid proliferation and to escape the inhibitory activities of many therapeutics. CG’806 is a highly potent inhibitor that simultaneously targets all known forms of FLT3 and other key oncogenic pathways that drive the proliferation of AML cancer cells, thereby providing CG’806 with a broad range of activity against AML and a strategy to delay mutational escape.

The FDA’s Office of Orphan Drug Products assigns orphan drug designation to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan drug designation provides Aptose certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

About CG’806

CG‘806 is an oral, first-in-class pan-FLT3/pan-BTK inhibitor. This small molecule demonstrates potent inhibition of all wild type and mutant forms of FLT3 tested (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), suppresses multiple oncogenic pathways operative in AML, eliminates AML tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with FLT3-driven AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinases operative in B cell malignancies, suggesting CG’806 may also be developed for CLL and MCL patients that are resistant/refractory/intolerant to covalent BTK inhibitors.

On December 26, 2017 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. The presentation will begin at 3:00 p.m. Pacific Time (6:00 p.m. Eastern Time) on Monday, January 8, 2018 at the Westin St. Francis (Press release, Allergan, DEC 26, 2017, View Source [SID1234523070]).

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at www.allergan.com/investors. The webcast can also be accessed through the following URL: View Source;.

An archived version will be available within 24 hours of the live presentation, and can be accessed at the same location for 90 days.

On December 26, 2017 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a company committed to improving patient lives by manufacturing and delivering high quality biologics, reported the appointment of Roger J. Lias, Ph.D., as the company’s new president and chief executive officer (Press release, Peregrine Pharmaceuticals, DEC 26, 2017, View Source [SID1234522773]). Dr. Lias, who has more than 20 years of contract development and manufacturing organization (CDMO) management experience, currently sits on the Peregrine board of directors and serves as president of Avid Bioservices, Peregrine’s wholly-owned CDMO subsidiary. Dr. Lias succeeds Steven W. King, who resigned as president and chief executive officer of Peregrine to pursue other professional interests.

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Dr. Lias’ appointment is an important step in Peregrine’s ongoing transition to a dedicated CDMO and builds upon the company’s recent appointment of several proven CDMO industry veterans to the company’s board and management team. As part of this transformation, Peregrine is actively implementing a multi-pronged strategic plan designed to diversify and broaden its customer base and project mix, expand and strengthen its CDMO service offerings, and drive increased growth and profitability. Additionally, Peregrine is in the process of officially changing the company’s name to Avid Bioservices and adopting a new NASDAQ ticker symbol. The company expects this process to be completed in early 2018.

"We believe that Roger is best equipped to lead Peregrine, including the completion of the company’s transition to a pure play CDMO operating under the Avid Bioservices name. With the demand for biologics manufacturing exceeding the industry’s current capacity and expected to continue to grow in coming years, Roger and his team have worked aggressively to establish a strategic plan that we anticipate will allow the company to take advantage of this significant market opportunity. The team has already made important progress implementing this plan and we look forward to their continued execution of the strategy to best position our CDMO business for success," said Joseph Carleone, Ph.D., chairman of Peregrine. "We would like to thank Steve King for the important contributions that he has made to both the Peregrine and Avid businesses and wish him luck with his future endeavors."

Dr. Lias has previously held senior management positions at several leading CDMOs including Cytovance Biologics, KBI BioPharma, Diosynth RTP (formerly Covance Biotechnology Services) and Lonza Biologics. At each of these companies, he was primarily charged with overseeing commercial operations, including growing and diversifying their respective client bases. During this time, Dr. Lias’ achievements ranged from building start-up Cytovance’s contract process development and biopharmaceutical cGMP production business, to increasing revenues at Diosynth from $16 million to $120 million over a four-year period.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a company transitioning from an R&D focused business to a pure play contract development and manufacturing organization (CDMO). Peregrine’s in-house CDMO services, including cGMP manufacturing and development capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com).

Peregrine is pursuing the licensing or sale of its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab, which is currently being evaluated in clinical trials in combination with immune stimulating therapies for the treatment of various cancers. For more information, please visit www.peregrineinc.com

On December 26, 2017 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that Ron Cohen, M.D., Acorda’s President and CEO, reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 10, 2018 at 9:30am PST / 12:30pm EST (Press release, Acorda Therapeutics, DEC 26, 2017, View Source [SID1234522771]).

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A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

View Source