Emergent BioSolutions to Release First Quarter 2018 Financial Results and Conduct a Conference Call on May 3, 2018

On April 19, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported that it will host a conference call on Thursday, May 3, 2018 at 5:00 pm (Eastern Time) to discuss the financial results for the first quarter of 2018, recent business developments, revenue guidance for the second quarter of 2018, and revenue and net income guidance for full year 2018 (Press release, Emergent BioSolutions, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343377 [SID1234525532]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93329114

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

Atreca Announces John A. Orwin Appointed President and CEO Atreca Co-Founder Dr. Tito A. Serafini Will Serve as Chief Strategy Officer Lead Anti-Cancer Candidate Slated to Enter Clinical Testing in 2019

On April 19, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that John A. Orwin, formerly CEO of Relypsa, has been appointed President and Chief Executive Officer of Atreca (Press release, Atreca, APR 19, 2018, View Source [SID1234525531]). He will also serve on the Company’s Board of Directors. Mr. Orwin replaces Atreca co-founder Dr. Tito A. Serafini in this role. Dr. Serafini will assume the newly created position of Chief Strategy Officer, responsible directly for research, preclinical development, technology, and intellectual property. Dr. Serafini also will remain on Atreca’s Board of Directors.

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"John Orwin is a seasoned leader with a very strong track record in scaling up clinical-stage companies. He brings core capabilities that will complement Tito’s vision and his ability to drive Atreca’s innovative science and the development and application of its broadly enabling technology platform," stated Brian Atwood, Atreca’s Chairman, and Founder and former President and CEO of Cell Design Labs. "We believe their combined talents and expertise will be highly synergistic, further differentiating the Company from others in the space and accelerating Atreca’s progress."

Mr. Atwood continued, "During Tito’s tenure leading Atreca, the Company went from early concept through the buildout of its Immune Repertoire Capture (IRC) technology, the creation of a discovery engine generating multiple scientific discoveries and a large collection of preclinical assets, and the rapid advancement of a lead candidate, with an anticipated IND filing in mid-2019. We are proud of the corporate culture of excellence Tito established, attracting a fantastic team and leading life sciences institutional investors, and for the considerable accomplishments achieved under his leadership."

"I am enthusiastically committed to Atreca, a company that I believe can both continue to transform the way new therapies are discovered and ultimately deliver life-changing treatment options to patients in need," said Dr. Serafini. "John’s joining the Company as CEO will have a profoundly positive impact on Atreca, given his successful track record scaling R&D companies, building out their clinical development organizations, manufacturing capabilities, and commercial and G&A functions. This is a very exciting time for Atreca, and I am thrilled with the Company’s prospects for continued and accelerated growth."

Mr. Orwin brings over 25 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhône-Poulenc Rorer, Genentech, and most recently Relypsa. During Mr. Orwin’s tenure at Relypsa, the company launched and commercialized its lead candidate, Patiromer (US brand name Veltassa), and was acquired by Galenica (Vifor Pharma) in a transaction worth over $1.5 billion. Prior to Relypsa, he served as Chief Executive Officer and a member of the Board of Directors of Affymax. Previously, Mr. Orwin was Senior Vice President of the BioOncology Business Unit at Genentech (now a member of the Roche Group), where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech’s oncology portfolio in the United States. He has also held senior marketing and sales positions at Johnson & Johnson, Alza Pharmaceuticals, Sangstat Medical Corporation, Rhône-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin received an M.B.A. from New York University and a B.A. from Rutgers University.

"Under the collective vision of Tito and his team, Atreca has become the first mover in discovering and advancing candidates based on its unique approach of understanding the active adaptive immune response at the single cell level in patients," commented Mr. Orwin. "The Company has differentiated itself through its foundational technology, its discovery engine, its strategy for advancing candidates, and in terms of productivity, having generated a library of nearly 1,000 antibodies targeting public tumor antigens. I look forward to contributing to the next chapters of the Company’s evolution, including preparations to bring the first candidates into clinical development in 2019 and 2020."

Athenex, Inc. Receives U.S. FDA Orphan Drug Designation for Oraxol for the Treatment of Angiosarcoma

On April 19, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Drug Designation from the U.S. FDA for Oraxol for the treatment of angiosarcoma (Press release, Athenex, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343439 [SID1234525530]). Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor).

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Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are pleased to receive Orphan Drug Designation for Oraxol for the treatment of angiosarcoma, a form of malignant blood vessel cancer. This designation represents our commitment to expand the use of Oraxol, in which the active pharmaceutical ingredient is paclitaxel, to additional clinical indications based on the known efficacy of paclitaxel and the observed improved pharmacokinetic profile of Oraxol. This is a parallel development with our clinical studies in metastatic breast cancer and gastric cancer, in which Oraxol has already shown promising efficacy and safety profile. We will be initiating the angiosarcoma clinical study soon."

The FDA grants Orphan Drug status to support development of medicines for the treatment of diseases that that affect fewer than 200,000 people in the United States. Orphan Drug Designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Athenex previously announced that it had met its enrollment target for the second interim analysis for the Oraxol Phase III clinical trial for metastatic breast cancer and is scheduled to conduct this interim analysis in the third quarter of 2018. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018. Athenex also announced initial results of a clinical study in Taiwan in patients with metastatic breast cancer, as well as results of the first cohort of patients in a study in Taiwan on the combination with ramucirumab (Cyramza, Eli Lilly’s monoclonal antibody against VEGFR2) in patients with gastric cancer.

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex, in territories including North and Latin Americas, Europe, Japan, greater China and Southeast Asia, Australia and New Zealand. Athenex is leading the registration effort from IND and clinical studies.

The Medicines Company to Announce First-Quarter 2018 Financial Results on April 25

On April 19,2018 The Medicines Company (NASDAQ:MDCO) reported that it will host a conference call and audio webcast on Wednesday, April 25, 2018, at 8:30 a.m., Eastern Time, to discuss first-quarter 2018 financial results and operational developments (Press release, Medicines Company, APR 19, 2018, View Source [SID1234525526]).

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The conference call may be accessed by telephone as follows:

U.S./Canada: (877) 359-9508
International: (224) 357-2393
Conference ID: 5683598

A taped replay of the conference call will be available after the call concludes, and may be accessed by telephone as follows:

U.S./Canada: (855) 859-2056
International: (404) 537-3406
Conference ID: 5683598

A live audio webcast of the conference call may be accessed in the Investors section of The Medicines Company website. An archived webcast will be available after the call concludes.

Novartis appoints John Tsai Head of Global Drug Development and Chief Medical Officer

On April 19,2018 Novartis reported the appointment of John Tsai, M.D. as Head of Global Drug Development (GDD) and Chief Medical Officer (Press release, Novartis, APR 19, 2018, View Source [SID1234525524]). Dr. Tsai will join Novartis on May 1, 2018, and will be based in Basel, Switzerland. He will report to Vas Narasimhan, M.D., CEO of Novartis and will become a member of the Executive Committee of Novartis (ECN). He succeeds Dr. Narasimhan who became CEO of Novartis on February 1, 2018. Dr. Rob Kowalski, who led GDD ad interim since February 1, 2018, will resume his responsibilities as Head of Global Regulatory Affairs for GDD.

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Dr. Tsai has been Chief Medical Officer and Senior Vice President of Global Medical at Amgen Inc., since May 2017 and oversees all clinical and medical functions across multiple sites worldwide. At Novartis, he will be responsible for advancing the company’s industry-leading pipeline of innovative medicines and biosimilars. Dr. Tsai will also lead the GDD organization’s ongoing transformation embracing the power of advanced data sciences and digital technologies to create a more agile model for drug development.

"I am delighted to welcome John to Novartis," said Dr. Narasimhan. "As we continue to reimagine drug development, his expertise across multiple therapeutic areas, including cardiovascular, oncology and neuroscience combined with his background in electrical engineering will be a source of great strength for Novartis. John has a great track record in nurturing talent across clinical development, medical affairs and development operations and shares our commitment to build an empowered and inspired organization. I also want to express my sincere gratitude to Rob Kowalski for his excellent ad interim leadership of the GDD organization."

Dr. Tsai said: "I feel honored to have the opportunity to lead the Novartis Global Drug Development organization and do my part in bringing forward the company’s strong pipeline of medicines that address some of humanity’s biggest health challenges. I am also excited to work with my colleagues at Novartis to pioneer novel paradigms for drug development with data and digital technologies at the core."

Prior to joining Amgen, Dr. Tsai spent eleven years with Bristol-Myers Squibb (BMS), where he served as Global Head of Clinical Development for marketed products and global clinical operations. He also played a leadership role in advancing the company’s late-stage pipeline across multiple therapeutic areas including cardiovascular, oncology and neuroscience. As the company’s Chief Medical Officer, Europe and prior to that, as Head of U.S. Medical and Vice President of Cardiovascular Medical, Dr.Tsai played a critical role in driving multiple transformation initiatives within the development and medical organizations. Before joining BMS, he was a cardiovascular group leader at Pfizer where he led the strategy development and execution of over 26 pivotal trials for a major cardiovascular medicine. He started his career at GE as an electrical engineer before returning to school to study medicine.

Dr. Tsai holds a medical degree from the University of Louisville School of Medicine and a Bachelor of Science in Electrical Engineering from Washington University in St. Louis. He completed his residency at Kaiser Permanente in San Francisco, California, where he then served as a physician in internal medicine, Chief Resident and as a member of the hospital’s faculty.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "will," "pipeline," "ongoing," "to create," "continue," "commitment," "opportunity," "excited," "to pioneer," or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products express or regarding potential future sales or earnings of the Novartis Group. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee Novartis will be commercially successful in the future, or achieve any particular financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant reorganizations of recent years may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products; our ability to obtain or maintain proprietary intellectual property protection on key products; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; uncertainties regarding actual or potential legal proceedings; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.