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BioSpecifics Technologies Corp. Names J. Kevin Buchi as Chief Executive Officer

On October 10, 2019 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company reported that originated and continues to develop collagenase-based therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, named life sciences industry veteran Kevin Buchi chief executive officer of BioSpecifics. He will also serve on the company’s board of directors (Press release, BioSpecifics Technologies, OCT 10, 2019, https://www.prnewswire.com/news-releases/biospecifics-technologies-corp-names-j-kevin-buchi-as-chief-executive-officer-300936191.html [SID1234540925]).

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"We are extremely pleased to have Kevin join BioSpecifics as chief executive officer. The board of directors believes that Kevin’s diversified life sciences leadership experience and business acumen will drive transformative vision and strategy for generating both near- and long-term shareholder value," said Jenn Chao, Chair of the Executive Search Committee.

"I am thrilled to be joining BioSpecifics. This is a unique company with very significant opportunities to further advance its collagenase-based therapies both commercially and clinically," said Mr. Buchi. "There are several key milestones on the near-term horizon including a potential third marketed indication for XIAFLEX, with the BLA filing submitted in early September for the treatment of cellulite, and the continued growth of the XIAFLEX commercial franchise and development portfolio."

Mr. Buchi is currently the chairman of the board of directors at Dicerna Pharmaceuticals and a director of Amneal Pharmaceuticals and Benitec Biopharma Ltd. Mr. Buchi was most recently president and chief executive officer at TetraLogic Pharmaceuticals from 2012 to 2016. Previously, he served as Impax Laboratories’ interim President and chief executive officer from December 2016 to March 2017. Earlier, he served as corporate vice president of Global Branded Products at Teva Pharmaceutical from 2011 to May 2012. Mr. Buchi also served as chief executive officer of Cephalon, which was acquired by Teva in October 2011. He had been at the company since 1991. Mr. Buchi holds a Masters of Management degree from the J.L. Kellogg Graduate School of Management from Northwestern University and a B.A. in Chemistry from Cornell University.

Seattle Genetics Announces Initiation of Phase 3 Clinical Trial of Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®) for Patients with Advanced or Metastatic HER2-Positive Breast Cancer

On October 10, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported dosing of the first patient in HER2CLIMB-02, a randomized phase 3 clinical trial evaluating investigational agent tucatinib versus placebo, in combination with standard-of-care ado-trastuzumab emtansine (T-DM1, Kadcyla), for patients with locally advanced or metastatic HER2-positive (HER2+) breast cancer (Press release, Seattle Genetics, OCT 10, 2019, View Source [SID1234540924]). This trial is intended to support registration in the U.S. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.

"We are building a comprehensive strategy for tucatinib in combination with other medicines across a range of HER2-positive cancers," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1. This trial has the potential to support tucatinib use in earlier lines of therapy."

HER2CLIMB-02 is a multi-center, randomized, double-blind, placebo-controlled phase 3 trial designed to evaluate tucatinib versus placebo, in combination with T-DM1, in patients with unresectable locally-advanced or metastatic HER2+ breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab in any setting. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints include overall survival, objective response rate and duration of response. The trial is expected to enroll approximately 460 patients. More information about this phase 3 trial, including enrolling centers, is available at www.clinicaltrials.gov.

HER2CLIMB-02 is based on the results from a completed phase 1b study. The manuscript entitled "Tucatinib combined with ado-trastuzumab emtansine in advanced ERBB2/HER2-positive metastatic breast cancer: The results of a phase 1b trial" evaluating tucatinib with the current standard of care HER2-targeted antibody-drug conjugate, T-DM1, in previously treated metastatic HER2-positive breast cancer was published in the July 2018 print edition of JAMA Oncology.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 directed agents such as trastuzumab.1,2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, ovarian and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tumors that overexpress HER2 are more aggressive and historically have been associated with poor overall survival compared with HER2-negative cancers. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

Tucatinib is being evaluated in an ongoing randomized, double-blind, placebo-controlled pivotal trial called HER2CLIMB comparing tucatinib vs. placebo, in combination with capecitabine and trastuzumab in patients with pretreated, unresectable, locally advanced or metastatic HER2-positive breast cancer, including patients with or without brain metastases. In addition, tucatinib is being evaluated in other solid tumor clinical trials, including colorectal cancer.

About HER2-Positive Metastatic Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. BreastCancer.org estimates 271,270 new cases of invasive breast cancer will be diagnosed in the U.S. in 2019.3 Approximately 25 percent of breast cancers are HER2-positive.4 Historically, HER2 disease has been associated with shorter survival times as well as a higher risk of recurrence and CNS disease (brain metastases). Approximately 30 to 50 percent of HER2-positive breast cancer patients develop brain metastases over time.5,6 Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib and T-DM1) have led to improved progression-free survival and survival rates of patients with metastatic HER2-positive breast cancer. Despite these advances, there is still a significant need for new therapies that can impact metastatic disease, including brain metastases, and be tolerated for longer periods of time.

Altimmune to Participate in Upcoming Investor Conferences

On October 10, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that management will participate in the following investor conferences during the months of October and November (Press release, Altimmune, OCT 10, 2019, View Source [SID1234540923]):

H.C. Wainwright 3rd Annual NASH Investor Conference
Date: Monday, October 21
Time: 11:20am ET
Speaker: M. Scott Harris M.D., Chief Medical Officer
Location: St. Regis Hotel, New York City
Webcast: View Source

BIO Investor Forum
Date: Wednesday, October 23
Time: 12:45pm ET/9:45am PT
Speaker: Vipin K. Garg Ph. D., President and Chief Executive Officer
Location: Westin St. Francis Hotel, San Francisco, CA
Webcast: View Source

Jefferies 2019 London Healthcare Conference
Date: November 20 and November 21 (one-on-one meetings only)
Attendees: Vipin K. Garg Ph.D., President and Chief Executive Officer
Will Brown, Chief Financial Officer
Location: Waldorf Hilton, London, UK

West to Host Third-Quarter 2019 Conference Call

On October 10, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release third-quarter 2019 financial results before the market opens on Thursday, October 24, 2019, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, OCT 10, 2019, View Source [SID1234540922]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 9278868.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the West website three hours after the live call and will be available through Thursday, October 31, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 9278868.

4SC AG: Conference call to be hosted on 17 October 2019 to present the Q3 Announcement 2019

On October 10, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its Q3 Announcement 2019 on 17 October 2019 (Press release, 4SC, OCT 10, 2019, View Source [SID1234540921]). On this day, the Management of 4SC AG will host a conference call at 2:30 pm CEDT (8:30 am EDT) to inform about important developments in the reporting period and beyond.

Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

Date: 17 October 2019
Time: 2:30 pm CEDT (8:30 am EDT)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 646 664 1960 (United States)
Confirmation Code: 304466

A presentation document supporting the conference call will be available on 17 October 2019, at 4SC’s website. After the event, a replay can be accessed from there as well.