Verastem Oncology Announces Executive Leadership Appointments and Changes

On October 18, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the appointment of Ironwood Pharmaceuticals, Inc.’s Chief Financial Officer Gina Consylman to its Board of Directors (Press release, Verastem, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372372 [SID1234530233]). Ms. Consylman, who will also serve as the Chair of the Board’s Audit Committee, replaces Louise Phanstiel who is leaving the Board to pursue other professional opportunities.

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In addition, Hagop Youssoufian, MSc, MD is transitioning to serve as Verastem Oncology’s Head of Medical Strategy from his prior role as Head of Hematology and Oncology Development. Dr. Youssoufian will be taking over responsibilities from Diep Le, MD, PhD who is stepping down as Chief Medical Officer. Kirk Taylor, MD has also joined the Company as Senior Vice President, Medical Affairs Strategy and Operations.

"We are delighted to have Gina and Kirk join the Verastem Oncology team as we enter this new period of growth with our first commercial product launch," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "Gina brings a unique financial acumen to the Board of Directors with more than 25 years of experience in the fields of corporate finance, accounting and tax management for commercial-stage pharmaceutical companies, including organizations navigating through first commercial product launches. Kirk is an accomplished medical affairs executive and prior practicing clinician with vast experience leading global cross-functional teams and successfully bringing drug candidates and products to market. On behalf of the entire Board and management team, we sincerely welcome Gina and Kirk and look forward to their insights and contributions."

Mr. Forrester added, "Over the past several years, Hagop has played a pivotal role in the growth and success of Verastem Oncology and I have no doubt he will continue delivering successful results with distinction. The Board and I wish to express our gratitude to Louise and Diep for their outstanding contributions and service. They have each played important roles in building the Company into what we believe will be a successful commercial organization. We wish both Louise and Diep all the very best in their future endeavors."

"Verastem Oncology is entering an exciting new chapter and I am honored to join the Board of Directors to help the Company execute on its strategic and commercial corporate goals," said Ms. Consylman. "I believe the Company is well-positioned for the next stage of evolution with a robust commercialization plan to help address the significant unmet need for the patients and families suffering from hematological malignancies."

Ms. Consylman currently serves as Senior Vice President and Chief Financial Officer of Ironwood Pharmaceuticals, Inc., a commercial biotech company, where she oversees the finance, planning, accounting, tax, treasury and insurance functions. Prior to joining Ironwood, Gina was Vice President, Corporate Controller and Principal Accounting Officer of Analogic Corporation, a healthcare and security technology solutions company, where she led the company’s global accounting and treasury teams. Prior to Analogic, Gina held senior level accounting and corporate controller positions at Biogen Inc. and Varian Semiconductor Equipment Associates, Inc. (acquired by Applied Materials, Inc.). She began her career in public accounting at Ernst & Young LLP. Ms. Consylman holds a Bachelor of Science degree in accounting from Johnson & Wales University, a Master of Science degree in taxation from Bentley University, and is a Certified Public Accountant.

Dr. Taylor brings more than 21 years of pharmaceutical industry experience and 12 years in clinical practice to Verastem Oncology. He has led cross-functional teams as Chief Medical Officer and Senior Vice President, covering many parts of the world including the United States, Europe, Latin America, North America and Asia. Dr. Taylor has held executive leadership positions at Pfizer, Actelion, Biogen, Alzheon, Sanofi Genzyme, Prescient Medicine and Finch Therapeutics. Dr. Taylor specializes in late phase development and medical affairs. Dr. Taylor received his B.A. from Harvard University and his M.D. from SUNY Downstate. He completed his internship at Roosevelt Hospital Columbia University, his residency at the Albert Einstein College of Medicine, and a Post Doctorate at The University of California San Francisco, where he also served as a faculty member.

Covance and Definiens Collaborate to Integrate Digital Pathology into Precision Medicine Design and Development

On October 18, 2018 LabCorp (NYSE: LH), a leading global life sciences company, and Definiens, a pioneer in artificial intelligence (AI) based image analysis reported a strategic collaboration to improve global development of precision medicine (Press release, LabCorp, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372210 [SID1234530176]). The collaboration, between Definiens and LabCorp’s Covance drug development business, will enable seamless integration of digital pathology with clinical-trial design and tissue-based testing solutions, resulting in a faster and more rigorous approach to biomarker validation and companion diagnostic co-development.

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Companion diagnostics are used in conjunction with targeted drugs and therapies to identify patients who are likely to benefit from a specific treatment regimen or who may have increased risk for certain side effects. The companies expect the first application of these processes will be in oncology, particularly immuno-oncology.

LabCorp and Covance have been involved in the development of drugs and their associated companion diagnostics for more than 20 years and have supported approximately two-thirds of all FDA-approved companion diagnostics. Definiens leverages machine learning and deep-learning to comprehensively profile the tumor microenvironment and create unique patient phenotypic profiles. Its digital pathology applications enable biopharma companies to make more informed decisions regarding their oncology and immuno-oncology pipelines.

The collaboration will initially focus on multiplex immunohistochemistry (IHC) and in situ hybridization (ISH) applications in early-stage clinical programs, which allow researchers to obtain significantly more information from a single sample than with other standard methods. This approach is designed to enable the therapy to advance more quickly to pivotal clinical trial scale studies. Terms of the agreement have not been disclosed.

"This collaboration unites Definiens’ ground-breaking technology and innovation with Covance’s extensive experience in biomarker identification and companion diagnostics development," said John Ratliff, CEO, Covance. "Together, we can accelerate the pace of drug development, delivering the transformative potential of oncology therapies – and immuno-oncology in particular – to patients around the globe faster and more efficiently than ever before."

"Based on years of AI development, Definiens Tissue Phenomics is recognized as the premier technology for characterizing the tumor microenvironment for immuno-oncology applications," said Thomas Heydler, CEO, Definiens. "We are very excited to partner with Covance, the world leader in companion diagnostics, to demonstrate the power of Tissue Phenomics as an integral part of CDx development for clinical trials worldwide."

IntelGenx Announces Pricing of $12 Million Equity Offering

On October 18, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported the pricing of an agency offering (the "Offering") of 17,144,314 units (the "Units") for gross proceeds of approximately US$12,000,000 million at a price of US$0.70 per Unit (the "Offering Price") (Press release, IntelGenx, OCT 18, 2018, View Source [SID1234530113]). Each Unit will consist of one share of common stock of the Company (an "Offered Share") and one half of one warrant (a "Warrant") each whole Warrant to purchase one share of common stock of the Company at an exercise price of US$1.00 per share (a "Warrant Share"). The Warrants will be exercisable immediately and will expire on the third anniversary of the date of their issuance.

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The Offering is made on a best efforts basis in the United States and the Canadian provinces of British Columbia, Alberta, Manitoba, Ontario and Québec. H.C. Wainwright & Co. ("Wainwright") is acting as the exclusive agent for the Units offered in the United States. Echelon Wealth Partners Inc. ("Echelon") is acting as the exclusive placement agent for the Units offered in Canada.

The closing of the Offering is expected to occur on or about October 22, 2018.

The Company has granted Echelon an over-allotment option exercisable, in whole or in part, at the sole discretion of Echelon, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the closing of the Offering, to purchase shares of common stock of the Company and/or Warrants in an amount representing up to an additional 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The Company intends to use the net proceeds of the Offering for its 2a Montelukast study, Tadalafil 505(b)(2) submission to U.S. Food and Drug Administration, and working capital.

The Company has applied to the TSX Venture Exchange ("TSXV") for approval of the listing of the Offered Shares and the Warrant Shares. The approval is subject to fulfillment by the Company of customary conditions of TSXV. There is no established trading market for the Warrants and IntelGenx does not expect a market to develop. IntelGenx does not intend to list the Warrants on any national securities exchange or any other nationally recognized trading system

The Company intends to file a final prospectus supplement (the "U.S. Supplement") to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement (the "Canadian Supplement") to the Canadian MJDS short-form base shelf prospectus dated October 15, 2018 (the "MJDS Prospectus") with respect to the Offering today.

Before investing, you should read the Canadian Supplement, the U.S. Supplement, the MJDS Prospectus and the Registration Statement as well as other documents the Company has filed or will file later today with the United States Securities and Exchange Commission (the "SEC") and the Canadian securities regulators for more complete information about the Company and this offering. Copies of the Canadian Supplement and the MJDS Prospectus are available under the Corporation’s profile at www.sedar.com and copies of the U.S. Supplement and the Registration Statement can be obtained from the SEC’s website at www.sec.gov.

Copies of the U.S. Supplement, when filed, and the Registration Statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected], and copies of the Canadian Supplement and the MJDS Prospectus may also be obtained from Echelon Wealth Partners Inc., 1 Adelaide Street East, Suite 2100, Toronto, ON M5C 2V9, by calling (416) 479-7370 or emailing [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, Units, Warrants or shares of common stock of the Company in any state or province in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state, province, or other jurisdiction.

Spectrum Pharmaceuticals Announces Dr. Francois Lebel as Chief Medical Officer

On October 18, 2018 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 the appointment of Francois Lebel, M.D., F.R.C.P.C. as Chief Medical Officer, effective November 5, 2018 (Press release, Spectrum Pharmaceuticals, OCT 18, 2018, View Source [SID1234530082]).

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"Dr. Lebel is an accomplished leader and has deep expertise in biopharmaceuticals with an emphasis in oncology drug development," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Given his qualifications, we believe Dr. Lebel will add significant value to Spectrum and our clinical programs. We have several near-term milestones and priorities including expanding the development of poziotinib in broader patient populations, gaining regulatory clarity for breakthrough designation on poziotinib, and filing the ROLONTIS BLA in the fourth quarter."

Dr. Lebel will be responsible for leading the Spectrum clinical program which includes directing the clinical research staff, overseeing the company’s ongoing clinical trials, and regulatory submissions. He will also direct clinical development strategies, life-cycle management, relationships with regulatory bodies and provide strategic counsel on all business development activities.

"It is a great time to have the opportunity to lead the medical and scientific organization at Spectrum ahead of multiple FDA submissions," said Francois Lebel, M.D., F.R.C.P.C, Chief Medical Officer of Spectrum Pharmaceuticals. "In evaluating Spectrum’s pipeline drugs, I have been very impressed with the robust clinical data, especially the recently released poziotinib data in heavily pretreated lung cancer patients who have very few options. I plan to aggressively expand the utility of this targeted therapy in areas of high unmet medical need. I look forward to leading Spectrum into a new era in medical and clinical development with the goal of significantly advancing patient care in oncology."

Dr. Lebel brings nearly 30 years of clinical leadership experience within the biopharmaceutical industry. He has designed and managed global medical organizations to deliver results, enhance productivity and practice sound risk management. Most recently, he served as the Executive Vice President of Research & Development, Chief Medical Officer at ZIOPHARM Oncology. He also held various leadership roles including Vice President of Research & Development at Baxter International and Global Head of Medical and Scientific Affairs at MedImmune. In the last 25 years, he provided strategic leadership on eight NDA/BLAs in various therapeutic areas and on a number of mergers and acquisitions. Dr. Lebel has broad and deep experience in oncology drug development, medical affairs, regulatory and pharmacovigilance acquired through various roles of increasing responsibilities at Chiron (Novartis), Warner-Lambert (Pfizer) and Burroughs Wellcome (GSK). He received his medical degree from the University of Ottawa, Canada, and he completed his post graduate training at McGill University and Harvard Medical School. He is Board Certified in Internal Medicine and a fellow of the Royal College of Physicians of Canada.

Shire to announce third quarter 2018 results

On October 18, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), reported that it will announce third quarter 2018 earnings on Thursday November 1, 2018 (Press release, Shire, OCT 18, 2018, View Source [SID1234530027]).

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Results press release will be issued at:

12:00 GMT / 08:00 EDT

Investor conference call time:

14:00 GMT / 10:00 EDT

Live conference call for investors:
Flemming Ornskov, MD, M.P.H., Chief Executive Officer and Thomas Dittrich, Chief Financial Officer will host the investor and analyst conference call at 10:00 am EDT / 14:00 GMT.

The details of the conference call are as follows:

UK dial in:

0800 358 9473 or +44 333 300 0804

US dial in:

1 855 857 0686 or 1 631 913 1422

International Access Numbers:

Click here

Password/Conf ID:

28705371 #

Live Webcast:

Click here

Replay:
A replay of the presentation will be made available, subject to approval by the UK Takeover Panel, for two weeks by phone and for three months by webcast. Replay information made available will be contained on the Investor Relations section of Shire’s website at View Source

For further information please contact:
Investor Relations

Christoph Brackmann [email protected] +41 41 288 4129
Sun Kim [email protected] +1 617 588 8175
Scott Burrows [email protected] +41 41 288 4195
Media
Katie Joyce [email protected] +1 781 482 2779