百济神州收回PD-1抗体全球授权；辉瑞114亿美元收购ARRAY BIOPHARMA
百济神州收回在研抗PD-1抗体替雷利珠单抗全球授权，新基将支付1.5亿美元
2019年1月3日，美国制药巨头百时美施贵宝（Bristol-Myers Squibb）宣布，将以740亿美元的价格收购新基公司（Celgene）。
这项交易为BMS带来了一条新的多元化的大型管线，其中包括几个潜在的重磅炸弹。合并后的公司将拥有9款上市产品以及在肿瘤学、免疫学、炎症和心血管疾病等核心疾病领域的巨大的增长潜力。BMS希望不远的将来每年从新基的后期管线中获得约150亿美元的收入。这些产品包括：两个免疫学、炎症（TYK2和ozanimod）和四个血液学（luspatercept、liso-cel（JCAR017）、bb2121和fedratinib）。
2017年，百济神州与新基公司达成全球战略合作关系，授权新基公司在亚洲（除日本）以外开发替雷利珠单抗治疗实体瘤。因为BMS有自己的拳头PD-1产品Opdivo（欧狄沃），所以新基与百济神州两家公司就替雷利珠单抗的合作备受业界关注。这个合作的命运如何呢？
今天，百济神州发布新闻稿，宣布收回在研抗PD-1抗体替雷利珠单抗全球授权。
“北京时间2019年6月17日，百济神州（纳斯达克代码：BGNE; 香港联交所代码：06160）公司今日宣布与新基公司达成共识，在百时美施贵宝完成对新基公司的收购前，终止双方关于百济神州在研抗PD-1抗体替雷利珠单抗的全球合作。新基公司同意就合作终止向百济神州支付1.5亿美元。”
这个结果应该是预料之中。
目前，中国国家药品监督管理局（NMPA，前身为CFDA）药品审评中心（CDE）正在对替雷利珠单抗用于治疗R/R cHL患者（被纳入优先审评）和治疗先前接受过治疗的局部晚期或转移性尿路上皮癌患者的新药上市申请（NDA）进行审评。
业内预计该产品应该很快获得批准。
收回全球授权，替雷利珠单抗将完全属于百济神州！
参考资料：
百济神州收回在研抗PD-1抗体替雷利珠单抗全球授权
官宣！辉瑞114亿美元收购ARRAY BIOPHARMA
2019年6月17日，全球制药巨擘辉瑞宣布，公司将以114亿美元的价格收购ARRAY BIOPHARMA，以加强辉瑞的创新性生物制药业务，有助于公司的长期发展。
了解详情，请阅读官方新闻稿。
—Proposed acquisition strengthens Pfizer’s innovative biopharmaceutical business and is expected to accelerate its growth trajectory particularly in the long term
—Opportunity to strengthen category leadership in Oncology with the addition of a breakthrough combination of BRAF/MEK inhibitors under investigation for a potential first-in-class therapy for patients with BRAF-mutant metastatic colorectal cancer
—Expands Pfizer’s pipeline with multiple high-potential targeted investigational cancer therapies and adds a large portfolio of royalty-generating out-licensed medicines
—Plans to maintain highly productive research unit in Boulder to complement Pfizer’s research hubs
—Transaction valued at $48 per Array share in cash, for a total enterprise value of approximately $11.4 billion
Monday, June 17, 2019 - 6:45am EDT
NEW YORK & BOULDER, Colo.--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Array BioPharma Inc. (NASDAQ: ARRY) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. The Boards of Directors of both companies have approved the merger.
Array’s portfolio includes the approved combined use of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in over 30 clinical trials across several solid tumor indications, including the Phase 3 BEACON trial in BRAF-mutant metastatic colorectal cancer (mCRC).
In the U.S., colorectal cancer is the third most common type of cancer in men and women. An estimated 140,250 patients were diagnosed with cancer of the colon or rectum in 2018, and approximately 50,000 are estimated to die of their disease each year.1BRAFmutations are estimated to occur in up to 15% of colorectal cancer cases and represent a poor prognosis for these patients.
“Today’s announcement reinforces our commitment to deploy our capital to bring breakthroughs that change patients’ lives while creating shareholder value,” said Albert Bourla, chief executive officer of Pfizer. “The proposed acquisition of Array strengthens our innovative biopharmaceutical business, is expected to enhance its long-term growth trajectory, and sets the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer’s existing expertise in breast and prostate cancers.”
In addition to the combination therapy for BRAF-mutant metastatic melanoma, Array brings a broad pipeline of targeted cancer medicines in development, as well as a portfolio of out-licensed potentially best-in-class and/or first-in-class medicines, which are expected to generate significant royalties over time.
“We are incredibly proud that Pfizer has recognized the value Array has brought to patients and our remarkable legacy discovering and advancing molecules with great potential to impact and extend the lives of patients in critical need,” said Ron Squarer, Array chief executive officer. “Pfizer shares our commitment to patients and a passion for advancing science to develop even more options for individuals with unmet needs. We’re excited our team will have access to world-class resources and a broader research platform to continue this critical work.”
In May 2019, Array announced results from the interim analysis of the Phase 3 BEACON mCRC trial: The second-or-third-line treatment with the BRAFTOVI triplet combination (BRAFTOVI + MEKTOVI + cetuximab) showed statistically significant improvement in overall response rate and overall survival compared to the control group, reducing the risk of death by 48%. The triplet combination could be the first chemotherapy-free, targeted regimen for patients with BRAF-mutant mCRC. Array intends to submit these data for regulatory review in the United States in the second half of 2019.
“We are very excited by Array’s impressive track record of successfully discovering and developing innovative small-molecules and targeted cancer therapies,” said Mikael Dolsten, Pfizer chief scientific officer and president, Worldwide Research, Development and Medical. “With Array’s exceptional scientific talent and innovative pipeline, combined with Pfizer’s leading research and development capabilities, we reinforce our commitment to advancing the most promising science, regardless of whether it is found inside or outside of our labs.”
Upon the close of the transaction, Array’s employees will join Pfizer and continue to be located in Cambridge, Massachusetts and Morrisville, North Carolina, as well as Boulder, Colorado, which becomes part of Pfizer’s Oncology Research & Development network in addition to La Jolla, California and Pearl River, New York.
Pfizer expects to finance the majority of the transaction with debt and the balance with existing cash. The transaction is expected to be dilutive to Pfizer’s Adjusted Diluted EPS by $0.04 -$0.05 in 2019, $0.04 -$0.05 in 2020, neutral in 2021, and accretive beginning in 2022, with additional accretion and growth anticipated thereafter. Pfizer will provide any appropriate updates to its current 2019 guidance in conjunction with its third quarter 2019 earnings release.
Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all outstanding shares of Array common stock for $48 per share in cash for a total enterprise value of approximately $11.4 billion. The closing of the tender offer is subject to customary closing conditions, including regulatory approvals and the tender of a majority of the outstanding shares of Array common stock (on a fully-diluted basis). The merger agreement contemplates that Pfizer will acquire any shares of Array that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the second half of 2019.
Pfizer’s financial advisors for the transaction were Guggenheim Securities, LLC, and Morgan Stanley & Co. LLC, with Wachtell, Lipton, Rosen & Katz acting as its legal advisor. Centerview Partners served as Array’s exclusive financial advisor, while Skadden, Arps, Slate, Meagher & Flom LLP served as its legal advisor.
Conference Call
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 9:00 a.m. EDT on Monday, June 17, 2019.
To view and listen to the webcast visit Pfizer’s web site at www.pfizer.com/investors or directly at https://www.webcaster4.com/Webcast/Page/748/30866. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.
You can listen to the conference call by dialing either (855) 895-8759 in the United States or Canada or (503) 343-6044 outside of the United States and Canada. The password is “Analyst Call.” Please join the call five minutes prior to the start time to avoid operator hold times.
Pfizer Inc.: Breakthroughs that change patients’ lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About Array BioPharma
Array BioPharma Inc. is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of transformative and well-tolerated targeted small molecule drugs to treat patients afflicted with cancer and other high-burden diseases. Array markets BRAFTOVI® (encorafenib) capsules in combination with MEKTOVI® (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600Kmutation in the United States and with partners in other major worldwide markets. Array's lead clinical programs, encorafenib and binimetinib, are being investigated in over 30 clinical trials across a number of solid tumor indications, including a Phase 3 trial in BRAF-mutant metastatic colorectal cancer. Array's pipeline includes several additional programs being advanced by Array or current license-holders, including the following programs currently in registration trials: selumetinib (partnered with AstraZeneca), LOXO-292 (partnered with Eli Lilly), ipatasertib (partnered with Genentech), tucatinib (partnered with Seattle Genetics) and ARRY-797. Vitrakvi® (larotrectinib, partnered with Bayer AG) is approved in the United States and Ganovo® (danoprevir, partnered with Roche) is approved in China. For more information on Array, please visit http://www.ArrayBioPharma.com or follow @ArrayBioPharma on Twitter and LinkedIn.
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