Entry into a Material Definitive Agreement

On July 25, 2019, Verastem, Inc. (the "Company") reported that it has entered into a license and collaboration agreement (the "Agreement") with Sanofi, under which the Company granted exclusive rights to Sanofi to develop and commercialize products containing duvelisib in Russia, the Commonwealth of Independent States, Turkey, the Middle East and Africa (collectively the "Territory") for the treatment, prevention, palliation or diagnosis of any oncology indication in humans or animals (Filing, 8-K, Verastem, JUL 29, 2019, View Source [SID1234537875]).

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Under the terms of the Agreement, Sanofi receives an exclusive right to develop and commercialize products containing duvelisib in the Territory under mutually agreed development and commercialization plans at its own cost and expense. Sanofi also receives certain limited manufacturing rights, in the event that the Company is unable to manufacture or supply sufficient quantities of products containing duvelisib to Sanofi during the term of the Agreement. The Company retains all rights to duvelisib outside of the Territory, except for those territories previously and exclusively licensed to other partners.

Sanofi is required to pay the Company an upfront, non-refundable payment of $5 million by August 8, 2019. The Company is also entitled to receive aggregate payments of up to $42 million if certain regulatory and commercial milestones are successfully achieved. Sanofi is obligated to pay the Company double-digit royalties on net sales of products containing duvelisib in the Territory, subject to reduction in certain circumstances. The Company and Sanofi have made customary representations and warranties and have agreed to certain customary covenants, including confidentiality and indemnification.

Unless earlier terminated by either party, the Agreement will expire upon the fulfillment of Sanofi’s royalty obligations to the Company for the sale of any products containing duvelisib in the Territory, which royalty obligations expire, on a product-by-product and country-by-country basis, upon the last to occur, in each specific country, of (a) expiration of valid patent claims covering such product, (b) expiration of regulatory exclusivity for such product, or (c) 10 years from the first commercial sale of such product in such country. Sanofi may terminate the Agreement on a product-by-product or on a country-by-country basis at any time with 180 days’ written notice. Either party may terminate the Agreement in its entirety with 60 days’ written notice for the other party’s material breach if such party fails to cure the breach. Subject to certain limitations, the Company may terminate the Agreement immediately if Sanofi challenges any patent covering a product or compound licensed by the Company to Sanofi under the Agreement. The Company also has the right to terminate Sanofi’s rights to products containing duvelisib in any specific country if Sanofi fails to use certain efforts to develop and commercialize products containing duvelisib in such country. Either party may terminate the Agreement in its entirety upon certain insolvency events involving the other party.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the text of the Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2019.

Bristol-Myers Squibb Announces European Commission Approval of Pending Acquisition of Celgene

On July 29, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Commission (EC) has granted unconditional approval of Bristol-Myers Squibb’s pending acquisition of Celgene Corporation (NASDAQ:CELG) (Press release, Bristol-Myers Squibb, JUL 29, 2019, View Source [SID1234537840]).

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"Clearance from the European Commission is an important milestone toward completing our combination with Celgene and moves us one step closer to creating a leading biopharma company that is well positioned to develop and deliver innovative, meaningful medicines to patients," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb.

The transaction remains subject to additional customary closing conditions and other regulatory approvals. Bristol-Myers Squibb intends to close the Celgene transaction at the earliest possible date, which it currently expects to be by the end of 2019 or the beginning of 2020.

Rainier Therapeutics Announces Vofatamab FIERCE-22 Data Accepted for Presentation at ESMO 2019 Annual Congress

On July 29, 2019 Rainier Therapeutics, Inc., a privately held clinical stage drug development company, reported that updated interim results from the FIERCE-22 trial evaluating vofatamab in combination with pembrolizumab in metastatic bladder cancer will be presented at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, which will take place September 27 to October 1, 2019 in Barcelona, Spain (Press release, Rainier Therapeutics, JUL 29, 2019, View Source [SID1234537856]).

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"We look forward to presenting updated interim results on clinical activity from our FIERCE-22 trial at ESMO (Free ESMO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes longer term follow-up of vofatamab in combination with pembrolizumab in patients with metastatic urothelial carcinoma (bladder cancer), providing a preliminary look at overall survival."

Poster Presentation Details:

Clinical Activity of Vofatamab (V), an FGFR3 Selective Antibody in Combination with Pembrolizumab (P) in Metastatic Urothelial Carcinoma (mUC), Updated Interim Analysis of FIERCE-22

Abstract: 2673

Poster Display Session 3
Presentation Number: 917P
Date: Monday, September 30, 2019
Presentation Time: 12:00 p.m. to 1 p.m.
Location: Poster Area Hall 4

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

About FIERCE-22

FIERCE-22 is a Phase 1b/2 trial evaluating vofatamab, a FGFR3-targeted antibody, in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and preliminary efficacy in the treatment of patients with locally advanced or metastatic bladder cancer who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

Athenex, Inc. to Report Second Quarter 2019 Earnings Results on August 7, 2019

On July 29, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that it will release second quarter and six-months ended June 30, 2019 financial results on Wednesday, August 7, 2019, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update (Press release, Athenex, JUL 29, 2019, View Source [SID1234573889]).

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13691069. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

Exact Sciences and Genomic Health to Combine, Creating Leading Global Cancer Diagnostics Company

On July 29, 2019 Exact Sciences Corp. (NASDAQ: EXAS) and Genomic Health, Inc. (NASDAQ: GHDX) reported that the companies have entered into a definitive agreement under which Exact Sciences will combine with Genomic Health for $72.00 per share in a cash and stock transaction valued at $2.8 billion (Press release, Exact Sciences, JUL 29, 2019, View Source [SID1234537841]). The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to be completed by the end of 2019.

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Together, Exact Sciences and Genomic Health will create a leading global cancer diagnostics company. The combined company will offer two of the strongest and fastest growing brands in cancer diagnostics, Cologuard and Oncotype DX, providing a robust platform for continued growth. With this enhanced platform, including a commercial presence in more than 90 countries, the combined company expects to continue to increase adoption of current tests, and to bring new innovative cancer diagnostics to patients throughout the world.

On a pro forma basis, the combined company expects to generate revenue of approximately $1.6 billion and gross profit of approximately $1.2 billion in 2020. Additionally, the combination is expected to generate annualized cost synergies of approximately $25 million within the third full year following close, primarily through reducing public company costs and purchasing optimization.

"Uniting the best minds and molecular diagnostics capabilities will advance the fight against cancer. Combining industry pioneers Exact Sciences and Genomic Health is a pivotal step toward building the leading cancer diagnostics company in the world," said Kevin Conroy, chairman and CEO of Exact Sciences. "Exact Sciences is continuing to grow sales and expand adoption of Cologuard at a rapid pace, and Genomic Health’s Oncotype DX is the global standard of care to inform treatment decisions for women with breast cancer. Together, with our collective resources and broader platform, we will be able to provide our existing tests to more people, while also accelerating the development and launch of future cancer diagnostic tests. We are excited to join together two teams who are united in their dedication to making a positive impact on patients’ lives."

"We are very pleased to join forces with Exact Sciences, a company and team with which we have a shared vision to revolutionize the way cancer is diagnosed and treated," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Genomic Health has achieved incredible success over nearly two decades in pioneering cancer diagnostics, and the recent landmark TAILORx trial results set a new standard of care for the use of the Oncotype DX test for women with early-stage invasive breast cancer. This transaction provides immediate value to Genomic Health stockholders through an upfront cash payment, as well as ownership in a combined company with enhanced financial strength and the commercial and R&D capabilities to continue to drive significant growth into the future."

Combining Talented Teams with Proven Capabilities to Create a Leading Cancer Diagnostics Company

Joins two of the strongest brands in cancer diagnostics into one entity and provides platform for continued growth: Cologuard and Oncotype DX, the companies’ leading brands, will respectively continue to help detect colorectal cancer and inform treatment decisions in colorectal, breast and prostate cancer, which collectively represent approximately 40% of all solid tumor incidence.

Exact Sciences’ Cologuard has a total available U.S. screening market of $15 billion, with an additional potential $3 billion opportunity among people ages 45-491. To date, Cologuard has captured less than 6% of the large addressable market of people over 50 years old, and is rapidly building on its 174,000 health care provider customer base, with a goal of reaching 40% share of the market over the long-term. In the second quarter of 2019, Cologuard revenue grew 94% year-over-year.

Genomic Health’s Oncotype IQ portfolio has guided personalized treatment decisions for more than one million cancer patients worldwide, and delivered more than 19% year-over-year overall revenue growth in the second quarter of 2019. Genomic Health estimates that its Oncotype DX suite of products in oncology and urology have a total available market of $2 billion.

Forms best-in-class commercial, R&D and clinical organization, with enhanced scale and scope in cancer diagnostics: The transaction will create a combined R&D team with extensive clinical capabilities and a robust evidence generation engine, complemented by proven regulatory expertise, and key relationships with oncologists. The combined commercial organization will have more than 1,000 team members inclusive of sales, marketing and reimbursement teams. The combined company will have the financial strength to support a high level of investment in R&D. This will support the development of innovative products across the diagnostic paradigm, including the ongoing work to identify proprietary biomarkers across the world’s 15 deadliest cancers, while continuing to advance the adoption of current products.

Provides global infrastructure to accelerate the ability to provide new innovative cancer diagnostics to patients: The combined company will have a commercial presence in more than 90 countries and expanded reach across primary care, oncology, OB/GYN, gastroenterology, and urology to support growth of existing and future cancer tests. The combined company will build upon Genomic Health’s presence in the San Francisco Bay Area, providing lab infrastructure in a state where the Medicare Administrative Contractor participates in the MolDx program, which may facilitate reimbursement of future liquid biopsy products.
Transaction Terms

Under the terms of the agreement, for each share of Genomic Health common stock they own, Genomic Health stockholders will receive $27.50 in cash and $44.50 in shares of Exact Sciences stock, subject to a 10% collar centered on Exact Sciences’ volume-weighted average price for the 45 trading days ended July 26, 2019.

Based on the parties’ closing stock prices as of July 26, 2019, the last trading day prior to today’s announcement, the total per-share consideration represents a premium of approximately 19% to Genomic Health’s volume-weighted average price ("VWAP") for the last 30 trading days. Upon closing, Exact Sciences shareholders are expected to own approximately 91% of the combined company, and Genomic Health stockholders are expected to own approximately 9%.

Transaction Approvals

The transaction is subject to customary closing conditions and regulatory approvals, including the approval of stockholders of Genomic Health. Felix and Julian Baker and certain funds advised by entities with whom they are affiliated, which collectively own approximately 25.3% of the outstanding shares of Genomic Health common stock, have entered into agreements to vote in favor of the transaction.

Advisors

Centerview Partners and XMS Capital Partners are serving as financial advisors to Exact Sciences and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor. Goldman Sachs & Co. LLC is serving as financial advisor to Genomic Health and Sullivan & Cromwell LLP and Pillsbury Winthrop Shaw Pittman LLP are serving as legal advisors.

Conference Call Information and Transaction Website

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

The two companies will host a joint conference call today at 8:00 a.m. ET to discuss this transaction. The call will include a slide presentation and participants are encouraged to view the presentation via webcast at View Source

Date:

Monday, July 29, 2019

Time:

8 a.m. ET, 7 a.m. CT, 5 a.m. PT

Webcast:

The live webcast can be accessed at www.exactsciences.com and
www.genomichealth.com

Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 8288326

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay is 8288326. The webcast, conference call and replay are open to all interested parties.

Exact Sciences and Genomic Health Second Quarter 2019 Earnings Results

In separate news releases, Exact Sciences and Genomic Health today both announced their financial results for the second quarter of 2019, ended June 30, 2019. Exact Sciences and Genomic Health will address any questions regarding their earnings on the joint transaction call at 8 a.m. ET. Exact Sciences and Genomic Health have cancelled their previously scheduled earnings calls on July 30, 2019, and August 1, 2019, respectively.