Business Wire

Celgene Corporation Enters Into Global Strategic Immuno-Oncology Collaboration with BeiGene to Advance PD-1 Inhibitor Program for Solid Tumor Cancers

Del

Celgene Corporation (NASDAQ:CELG) and BeiGene, Ltd. (NASDAQ:BGNE) entered into a strategic collaboration to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia. BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally and for solid tumors in Asia (with the exception of Japan). BeiGene will acquire Celgene’s commercial operations in China and gain an exclusive license to commercialize Celgene’s approved therapies in China – ABRAXANE®, REVLIMID® and VIDAZA®.

BGB-A317 is an advanced clinical-stage investigational PD-1 inhibitor, which has been dosed in over 500 patients. Initial clinical data suggest that BGB-A317 is well tolerated and exhibits anti-tumor activity across a range of solid tumor types. BGB-A317 has high affinity and specificity for PD-1 and may be differentiated from the currently approved PD-1 antibodies through an engineered Fc region, potentially minimizing interactions with other immune cells that may exert a negative impact on effector T-cell function. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of solid tumor cancers. It is currently in two pivotal trials in China, and global pivotal studies of BGB-A317 are planned for initiation in 2018. Celgene and BeiGene will collaborate in the global development of BGB-A317. In addition, BeiGene retains the right to develop BGB-A317 in hematology and in combination with its other portfolio compounds.

“The acquisition of BGB-A317 significantly accelerates and expands our opportunity to develop and deliver novel T-cell checkpoint inhibitor-based therapies in solid tumor cancers to patients worldwide and adds to our ongoing PD-L1 FUSION™ program in hematological malignancies,” said Mark J. Alles, Chief Executive Officer of Celgene. “China is an important market for Celgene, and our collaboration with BeiGene positions us exceptionally well to optimize research, manufacturing, and the long-term commercial potential of our portfolio in China.”

“This strategic partnership with Celgene is a transformational event for BeiGene, transitioning us into a commercial-stage company and preparing us well for the future potential launch of our internally developed compounds, some of which are already in pivotal trials in China,” said John V. Oyler, Co-founder, CEO, and Chairman of BeiGene. “Aligned in our mission and therapeutic focus, we believe that we have forged a promising alliance with Celgene that will help both companies fulfill their ultimate commitments of bringing new, life-altering treatments to patients in China and worldwide.”

BeiGene will acquire Celgene’s operations in China. BeiGene will also license and assume commercial responsibility for Celgene’s approved therapies in China, consisting of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), REVLIMID® (lenalidomide) and VIDAZA® (azacitidine). In addition, BeiGene is granted licensing rights in China to CC-122, under the same terms and conditions as the approved commercial products. CC-122 is a next generation CelMOD currently in development by Celgene for lymphoma and hepatocellular carcinoma. BeiGene plans to expand manufacturing and commercial operations in China in preparation for the potential approvals of BGB-A317 and future innovative therapies developed by BeiGene in greater China.

Celgene will maintain a strategic and R&D presence in China dedicated to long-term commercial activities, regulatory affairs and clinical development of new therapies in the country. Celgene will also continue supporting BeiGene with management of the REVLIMID® Risk Minimization Program.

Upon closing, BeiGene will receive upfront licensing fees totaling $263 million, and in addition Celgene will acquire an equity stake in BeiGene by purchasing 32.7 million, or 5.9 percent, of BeiGene’s ordinary shares at $4.58 per share, or $59.55 per BeiGene’s American Depositary Shares (ADS), representing a 35% premium to an 11-day volume-weighted average price of BeiGene’s ADS. BeiGene is eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties on future sales of BGB-A317.

The transactions have been approved by the boards of directors of Celgene and BeiGene. Both companies expect to complete the transaction during the third quarter of 2017, subject to the expiration or termination of applicable waiting periods under all applicable antitrust laws and satisfaction of other usual and customary closing conditions.

BGB-A317 is not approved in any country for any indication.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1. It is believed to be differentiated from the currently approved PD-1 antibodies, as the engineering of its Fc region is believed to minimize potentially negative interactions with other immune cells. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on social media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

About BeiGene

BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 400 employees in China, the United States, and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene and BeiGene undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene's Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission, with respect to Celgene’s forward-looking statements, and BeiGene’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission, with respect to BeiGene’s forward-looking statements.

Contact information

FOR CELGENE
Investors:
+1-908-673-9628
ir@celgene.com
or
Media:
+1-908-673-2275
media@celgene.com
or
FOR BEIGENE
Lucy Li, Ph.D., +1 781-801-1800
ir@beigene.com
media@beigene.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

ResMed-sponsored Studies Show Combining Home Oxygen and Home Non-invasive Ventilation is a Cost Effective Treatment for COPD20.5.2018 21:15Pressemelding

ResMed (NYSE: RMD, ASX: RMD) announced today the results of two clinical analyses conducted for the U.K. and U.S., demonstrating the cost effectiveness of combining home oxygen therapy and home non-invasive ventilation (NIV) therapy for patients with persistent hypercapnia following a life-threatening exacerbation of chronic obstructive pulmonary disease (COPD). The ResMed-backed Home Oxygen Therapy – Home Mechanical Ventilation (HOT-HMV) health economic studies, presented today at the ATS 2018 International Conference, build on earlier data demonstrating the clinical and cost effectiveness of HOT-HMV therapy (i.e. combining home oxygen therapy with home NIV), compared to treating with oxygen alone. The U.K. study found that HOT-HMV treatment reduced exacerbation frequency and 28-day hospital readmission. The U.S. analysis found a 58.3 percent reduction in 30-day readmissions for HOT-HMV patients compared to those on home oxygen alone – and that HOT-HMV can actually save patients money

WELL Building Standard Gaining Momentum in Europe18.5.2018 14:47Pressemelding

As Greenbuild Europe came to a close in Berlin, the International WELL Building Institute™ (IWBI™) used the occasion to highlight how the WELL Building Standard™ (WELL™) has elevated health and well-being to the forefront of sustainability conversations across Europe. WELL continues to advance the healthy building movement as the premier standard for buildings, interior spaces and communities seeking to implement, validate and measure features that promote human health and wellness. The resonance of the program has spurred innovations across the building, design and construction industries, providing projects with customizable approaches to address geographical and cultural health concerns. To date, WELL has enrolled more than 830 projects encompassing over 155 million square feet of real estate in 32 countries worldwide. In Europe nearly 190 projects across 13 countries are engaged with WELL, representing 25% of global WELL project square footage. The strong growth of WELL over the pa

Utimaco Announces Intent to Acquire Atalla from Micro Focus18.5.2018 09:03Pressemelding

Utimaco, the global #2 in Hardware Security Modules (HSMs), today announced the intent to acquire the Atalla HSM and ESKM business lines from Micro Focus, which were previously owned by Hewlett Packard Enterprise (HPE) prior to the September 2017 merger of its Software business with Micro Focus. Germany-based Utimaco, active in the HSM market for over 35 years, is a global manufacturer of general purpose HSMs. Utimaco has built its market leading position focusing on indirect sales through OEM or channel business partners and selling its SecurityServer product line into industries as diverse as automotive, government, media & entertainment, smart metering, semiconductors, telecommunications and the banking and financial services sectors. Utimaco is traditionally strong in its German home market based on its longstanding German banking association certification (DK) and has recently achieved PCI accreditation for the SecurityServer product line. With the acquisition of Atalla, one of th

Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections18.5.2018 07:00Pressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson, today announced 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1-5. New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica® (ibrutinib), Darzalex® (daratumumab), and Zytiga® (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers. Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Wald

Karisma Hotels & Resorts to Open Allure Palazzi Kotor Bay Hotel by Karisma in June 201818.5.2018 06:00Pressemelding

Karisma Hotels & Resorts, an award-winning luxury hotel collection which owns and manages properties in Latin America, the Caribbean and Europe, is pleased to announce the opening of Allure Palazzi Kotor Bay Hotel by Karisma in June 2018. Built from the ground up in Montenegro’s idyllic Dobrota, the exclusive five-star beachfront property seamlessly blends stunning architecture and design with its mountainous landscape, offering spellbinding views of Kotor Bay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180517006456/en/ Rendering of Allure Palazzi Kotor Bay (Photo: Business Wire) Sitting on Kotor Bay’s only private beach, the resort features 89 premium guestrooms, 10 villas with private beachfront access, and three breathtaking penthouse suites, each with a balcony or terrace. Allure Palazzi Kotor Bay’s accommodations encompass sumptuous bedding, divine amenities, and carefully selected color palettes bringing the sunny

Siemens Financial Services Selects GTC’s @GlobalTrade Platform for Management of Export Documentary Credits18.5.2018 04:00Pressemelding

GlobalTrade Corporation (GTC) has announced today that Siemens Financial Services (SFS) has selected its @GlobalTrade Multi-bank Trade Finance Platform for management of its export documentary credits. The platform will be initially rolled out in Germany and thereafter expanded to Siemens entities globally. The system will electronically aggregate all incoming documentary credits in a global database, facilitate review and approval, assist in preparation of compliant documents and enable faster presentation of documents electronically to advising and issuing banks. Gerhard Heubeck, Head of Trade Finance Advisory at Siemens Financial Services, reasons the need for the new system implementation as follows: "After many years of using one of the first standard IT systems available for export documentary credits, the time has come to find a successor tool capable to meet the new requirements such as multi-client capability, processing of new SWIFT message formats, global accessibility, and