Sanofi Invests EUR 80m (approx. USD 91.5m) in BioNTech as Partners Extend Collaboration and Advance mRNA-based Cancer Immunotherapy into Clinical Testing against Multiple Solid Tumors

On January 4, 2019 BioNTech AG, a rapidly growing biotechnology company developing precise and individualized immunotherapies for the treatment of cancer and the prevention of infectious diseases, reported that it has extended its research collaboration with Sanofi initiated in late 2015 and Sanofi is investing* EUR 80 million (approximately USD 91.5 million) in equity in BioNTech (Press release, BioNTech, JAN 4, 2019, View Source [SID1234532446]).

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Simultaneously BioNTech has entered into an agreement with Sanofi to co-develop the first cancer immunotherapy candidate from the collaboration that is entering clinical testing in multiple solid tumors. This follows BioNTech’s decision from early 2018 to exercise one of its option rights under the 2015 research collaboration to co-develop and co-commercialize this product candidate with Sanofi.

The investigational therapy consists of an mRNA mixture encoding immunomodulatory cytokines that are injected directly into the tumor. Local administration of immunotherapies to the tumor microenvironment provides the opportunity to stimulate innate and adaptive immune responses against tumors, while potentially avoiding toxicities related to systemic administration of immuno-modulatory therapeutics.

"The extension of the research collaboration and equity investment demonstrates a deepening of our partnership with Sanofi as we seek to rapidly drive novel, disruptive programs through clinical testing to commercialization together," said Prof. Dr. Ugur Sahin, Co-Founder and CEO of BioNTech. "We are pleased that with this program we have moved from concept to clinical stage in well under three years."

"We are pleased to be initiating clinical testing of our first mRNA-based cancer immunotherapy in collaboration with our partners at BioNTech," commented Yong-Jun Liu, Global Head of Research, Senior Vice President R&D, Sanofi. "Our joint team, consisting of scientists and clinicians from both Sanofi and BioNTech, has worked tirelessly to expedite development of this new and innovative clinical candidate because targeted mRNA therapies may have the potential to be effective for cancer patients. We look forward to continuing a productive partnership with BioNTech in the years to come."

C4 Therapeutics Announces Transformation of Strategic Collaboration to Discover and Develop Degrader-Based Medicines with Roche

On January 4, 2019 C4 Therapeutics (C4T) reported the transformation of its ongoing research and development partnership with Roche focusing on new cancer treatments based on C4T’s targeted protein degradation technology (Press release, C4 Therapeutics, JAN 4, 2019, View Source [SID1234532465]).

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"We are excited to see our partnership with Roche evolve and further accelerate our efforts to bring degrader-based medicines into the clinic," said Andrew Phillips, PhD, President and CEO of C4 Therapeutics. "Roche has been a valued and excellent partner since we started our collaboration in 2016. This transformed partnership reflects how much both parties believe in the potential of degraders as a new treatment modality for patients."

Under the terms of the expansion, C4T will lead efforts from discovery through defined preclinical or early clinical milestones, depending on the program. Upon C4T reaching these milestone events, Roche will have exclusive options for worldwide rights to continue development and commercialize drugs from these programs. In addition, C4T will have the option to co-develop and co-promote in the U.S. on selected programs. C4T will receive a significant upfront payment and near-term preclinical milestones. Upon success C4T may also receive royalties and potential clinical, regulatory, and commercial milestone payments totaling over $900 million.

Diffusion Pharmaceuticals Chief Executive Officer David Kalergis to Present at 37th Annual J.P. Morgan Healthcare Conference

On January 4, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, reported that Chief Executive Officer David Kalergis will join investors, executives, civic leaders, and scientists to present at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 7:00pm EST/4:00pm PST (Press release, Diffusion Pharmaceuticals, JAN 4, 2019, View Source [SID1234532482]). The Conference will be held on January 7-10, 2019 at the Westin St. Francis Hotel in San Francisco, California.

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"Advancements in the biotechnology, pharmaceutical, and medical industries don’t happen in a vacuum; they require collaboration between investors, scientists, and business leaders," said David Kalergis, Chairman and CEO of Diffusion. "Diffusion was founded in that same spirit of collaboration, and at the 37th Annual J.P. Morgan Healthcare Conference, we’ll have the opportunity to share our progress with an even larger audience of leaders who can potentially work with us to fuel life and fight deadly conditions such as cancer and stroke."

The "largest and most informative healthcare investment symposium in the industry," the J.P. Morgan Healthcare Conference brings together "industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community." Over 9,000 attendees and representatives from over 450 public and private companies have had the chance at past conferences to hear from speakers including Bill Gates, Vice President Joe Biden, and CEO of 23andMe Anne Wojcicki. To listen to Mr. Kalergis’s presentation live, you can go to the Investor Relations section of the Diffusion Pharmaceuticals website at www.diffusionpharma.com. An archived webcast of the presentation will also be available on the Company’s website for a period of time.

US Patent Office Grants the 100th Patent to Immatics Underpinning the Company’s Leading Role in the Field of Innovative Immunotherapies

On January 3, 2019 Immatics, a leading company in the field of cancer immunotherapy, reported that the United States Patent and Trademark Office has issued the 100th patent to Immatics (Press release, Immatics Biotechnologies, JAN 3, 2019, View Source [SID1234569547]).

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This is a significant achievement for the Company and demonstrates the breadth of Immatics’ innovation power and the quality of its science. Immatics’ strong patent portfolio enables the Company to develop its pipeline of cancer immunotherapies, to protect Immatics’ innovations and to safeguard the Company’s technology investments.

Immatics’ 100th patent (US Patent No 10,143,731) is directed against a peptide target discovered using the Company’s XPRESIDENT technology. The peptides identified by XPRESIDENT are presented by human leucocyte antigen (HLA) receptors on the surface of cells and are central to developing a range of novel powerful immunotherapies.

"Since its inception, Immatics has put a key focus on the development of its Intellectual Property estate, in order to protect our technology innovations in this highly competitive field", said Dr. Rainer Kramer, CBO of Immatics. "Being awarded the 100th issued US patent in the Life Science industry is fantastic, proving that our inventions move Immatics further to the forefront of the highly competitive field of Immunotherapy development."

Immatics’ patenting strategy ensures broad protection of the Company’s products, technologies and methods while still meeting the patentability requirements in the USA in a fast-paced environment.

Bristol-Myers Squibb to Acquire Celgene to Create a Premier Innovative Biopharma Company

On January 3, 2018 Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) reported that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion (Press release, Bristol-Myers Squibb, JAN 3, 2019, View Source [SID1234532379]). Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination.

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The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach.

Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR (as described below). When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent.

"Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. "As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms."

Dr. Caforio continued, "We are impressed by what Celgene has accomplished for patients, and we look forward to welcoming Celgene employees to Bristol-Myers Squibb. Our new company will continue the strong patient focus that is core to both companies’ missions, creating a shared organization with a goal of discovering, developing and delivering innovative medicines for patients with serious diseases. We are confident we will drive value for shareholders and create opportunities for employees."

"For more than 30 years, Celgene’s commitment to leading innovation has allowed us to deliver life-changing treatments to patients in areas of high unmet need. Combining with Bristol-Myers Squibb, we are delivering immediate and substantial value to Celgene shareholders and providing them meaningful participation in the long-term growth opportunities created by the combined company," said Mark Alles, Chairman and Chief Executive Officer of Celgene. "Our employees should be incredibly proud of what we have accomplished together and excited for the opportunities ahead of us as we join with Bristol-Myers Squibb, where we can further advance our mission for patients. We look forward to working with the Bristol-Myers Squibb team as we bring our two companies together."

Compelling Strategic Benefits

Leading franchises with complementary product portfolios provide enhanced scale and balance. The combination creates:
Leading oncology franchises in both solid tumors and hematologic malignancies led by Opdivo and Yervoy as well as Revlimid and Pomalyst;
A top five immunology and inflammation franchise led by Orencia and Otezla; and
The #1 cardiovascular franchise led by Eliquis.

The combined company will have nine products with more than $1 billion in annual sales and significant potential for growth in the core disease areas of oncology, immunology and inflammation and cardiovascular disease.

Near-term launch opportunities representing greater than $15 billion in revenue potential. The combined company will have six expected near-term product launches:
Two in immunology and inflammation, TYK2 and ozanimod; and
Four in hematology, luspatercept, liso-cel (JCAR017), bb2121 and fedratinib.

These launches leverage the combined commercial capabilities of the two companies and will broaden and enhance Bristol-Myers Squibb’s market position with innovative and differentiated products. This is in addition to a significant number of lifecycle management registrational readouts expected in Immuno-Oncology (IO).

Early-stage pipeline builds sustainable platform for growth. The combined company will have a deep and diverse early-stage pipeline across solid tumors and hematologic malignancies, immunology and inflammation, cardiovascular disease and fibrotic disease leveraging combined strengths in innovation. The early-stage pipeline includes 50 high potential assets, many with important data readouts in the near-term. With a significantly enhanced early-stage pipeline, Bristol-Myers Squibb will be well positioned for long-term growth and significant value creation.

Powerful combined discovery capabilities with world-class expertise in a broad range of modalities. Together, the Company will have expanded innovation capabilities in small molecule design, biologics/synthetic biologics, protein homeostasis, antibody engineering and cell therapy. Furthermore, strong external partnerships provide access to additional modalities.

Compelling Financial Benefits

Strong returns and significant immediate EPS accretion. The transaction’s internal rate of return is expected to be well in excess of Celgene’s and Bristol-Myers Squibb’s cost of capital. The combination is expected to be more than 40 percent accretive to Bristol-Myers Squibb’s EPS on a standalone basis in the first full year following close of the transaction.
Strong balance sheet and cash flow generation to enable significant investment in innovation. With more than $45 billion of expected free cash flow generation over the first three full years post-closing, the Company is committed to maintaining strong investment grade credit ratings while continuing its dividend policy for the benefit of Bristol-Myers Squibb and Celgene shareholders. Bristol-Myers Squibb will also have significant financial flexibility to realize the full potential of the enhanced late- and early-stage pipeline.
Meaningful cost synergies. Bristol-Myers Squibb expects to realize run-rate cost synergies of approximately $2.5 billion by 2022. Bristol-Myers Squibb is confident it will achieve efficiencies across the organization while maintaining a strong, core commitment to innovation and delivering the value of the portfolio.

Terms and Financing

Based on the closing price of Bristol-Myers Squibb stock on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders is valued at $102.43 per share. The cash and stock consideration represents an approximately 51 percent premium to Celgene shareholders based on the 30-day volume weighted average closing stock price of Celgene prior to signing and an approximately 54 percent premium to Celgene shareholders based on the closing stock price of Celgene on January 2, 2019. Each share also will receive one tradeable CVR, which will entitle its holder to receive a one-time potential payment of $9.00 in cash upon FDA approval of all three of ozanimod (by December 31, 2020), liso-cel (JCAR017) (by December 31, 2020) and bb2121 (by March 31, 2021), in each case for a specified indication.

The transaction is not subject to a financing condition. The cash portion will be funded through a combination of cash on hand and debt financing. Bristol-Myers Squibb has obtained fully committed debt financing from Morgan Stanley Senior Funding, Inc. and MUFG Bank, Ltd. Following the close of the transaction, Bristol-Myers Squibb expects that substantially all of the debt of the combined company will be pari passu.

Accelerated Share Repurchase Program

Bristol-Myers Squibb expects to execute an accelerated share repurchase program of up to approximately $5 billion, subject to the closing of the transaction, market conditions and Board approval.

Corporate Governance

Following the close of the transaction, Dr. Caforio will continue to serve as Chairman of the Board and Chief Executive Officer of the company. Two members from Celgene’s Board will be added to the Board of Directors of Bristol-Myers Squibb. The combined company will continue to have a strong presence throughout New Jersey.

Approvals and Timing to Close

The transaction is subject to approval by Bristol-Myers Squibb and Celgene shareholders and the satisfaction of customary closing conditions and regulatory approvals. Bristol-Myers Squibb and Celgene expect to complete the transaction in the third quarter of 2019.

Advisors

Morgan Stanley & Co. LLC is serving as lead financial advisor to Bristol-Myers Squibb, and Evercore and Dyal Co. LLC are serving as financial advisors to Bristol-Myers Squibb. Kirkland & Ellis LLP is serving as Bristol-Myers Squibb’s legal counsel. J.P. Morgan Securities LLC is serving as lead financial advisor and Citi is acting as financial advisor to Celgene. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to Celgene.

Bristol-Myers Squibb 2019 EPS Guidance

In a separate press release issued today, Bristol-Myers Squibb announced its 2019 EPS guidance for full-year 2019, which is available on the "Investor Relations" section of the Bristol-Myers Squibb website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call

Bristol-Myers Squibb and Celgene will host a conference call today, at 8:00 a.m. ET to discuss the transaction. The conference call can be accessed by dialing (800) 347-6311 (U.S. / Canada) or (786) 460-7199 (International) and giving the passcode 4935567. A replay of the call will be available from January 3, 2019 until January 17, 2019 by dialing (888) 203-1112 (U.S. / Canada) or (719) 457-0820 (International) and giving the passcode 4935567.

A live webcast of the conference call will be available on the investor relations section of each company’s website at Bristol-Myers Squibb View Source and Celgene View Source." target="_blank" title="View Source." rel="nofollow">View Source

Presentation and Infographic

Associated presentation materials and an infographic regarding the transaction will be available on the investor relations section of each company’s website at Bristol-Myers Squibb View Source and Celgene View Source as well as a joint transaction website at www.bestofbiopharma.com.