Ono Pharmaceutical is expanding its scope in oncology with a $2.4 billion deal to buy Deciphera Pharmaceutical, a company that has one commercialized cancer therapy and a drug pipeline that includes a late-stage candidate on track for an FDA submission.

小野制药（Ono Pharmaceutical）正在扩大其肿瘤学领域，斥资24亿美元收购了解密制药（Deciphera Pharmaceutical），该公司拥有一种商业化的癌症治疗方法和一条药物管道，其中包括一名有望提交FDA的晚期候选人。

According to deal terms announced Monday, Japan-based Ono has agreed to pay $25.60 in cash for each share of Deciphera. That price represents a 74.7% premium to Deciphera’s closing stock price on Friday and a 68.8% premium to the stock’s average price over the past month. Shares of Deciphera opened Monday at $25.18 each..

根据周一宣布的交易条款，总部位于日本的小野已同意以现金支付25.60美元，收购Deciphera的每股股份。该价格比Deciphera周五收盘价溢价74.7%，比该股过去一个月的平均价格溢价68.8%。Deciphera的股票周一开盘价为每股25.18美元。。

Deciphera’s cancer drugs are kinase inhibitors, small molecules that block enzymes key to driving cancer cell growth. The Waltham, Massachusetts-based company designs its drugs to target the region of the enzyme that activates it or inactivates it like an on-off switch. Deciphera contends its approach of directly targeting the switch pocket or other regions that control switch regulation and activation can lead to drugs that are broadly active against the target enzyme, covering the enzyme as it is found in nature as well as its mutant or amplified forms..

Deciphera的抗癌药物是激酶抑制剂，是一种小分子，可以阻断驱动癌细胞生长的关键酶。这家位于马萨诸塞州沃尔瑟姆的公司设计其药物的目标是激活或灭活酶的区域，就像开关一样。Deciphera认为，其直接针对开关口袋或控制开关调节和激活的其他区域的方法可以产生对靶酶具有广泛活性的药物，涵盖自然界中发现的酶及其突变或扩增形式。。

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With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

随着人工智能的兴起，医疗保健领域可能会出现哪些知识产权纠纷？

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.

Munck Wilson Mandala合伙人格雷格·豪森（GregHowison）在回答电子邮件中提出的问题时，分享了他对人工智能、IP、连接设备及其产生的数据产生的一些法律后果的看法。

Qinlock’s 2020 FDA approval made it the first Deciphera drug to enter the market. The regulatory decision covered use of the therapy as a fourth-line treatment of gastrointestinal stromal tumor (GIST). An effort to expand the drug’s use to include earlier lines of treatment resulted in a Phase 3 failure in 2021.

Qinlock于2020年获得FDA批准，成为首个进入市场的破译药物。监管决定涵盖了将该疗法用作胃肠道间质瘤（GIST）的四线治疗。为了扩大药物的使用范围以包括早期的治疗方案，2021年导致了第三阶段的失败。

An exploratory analysis of the Phase 3 data found “substantial clinical benefit” in the second-line setting for GIST patients whose cancer carried KIT exon 11 and 17/18 mutations. Those results were published in January in the journal Nature Medicine. A new Phase 3 study enrolling this patient population is underway.

对3期数据的探索性分析发现，癌症携带KIT外显子11和17/18突变的GIST患者在二线治疗中具有“实质性临床益处”。这些结果发表在1月份的《自然医学》杂志上。一项新的3期研究正在招募这一患者群体。

Qinlock generated $159 million in revenue in 2023, a 26.7% increase over sales in the prior year, according to Deciphera’s annual report. The vast majority of those sales came from the U.S..

根据Deciphera的年度报告，2023年，秦洛克的收入为1.59亿美元，比上一年的销售额增长了26.7%。这些销售额中的绝大多数来自美国。。

The most advanced drug candidate in Deciphera’s pipeline is vimseltinib, which is a potential treatment for tenosynovial giant cell tumor (TGCT), a group of rare, usually tumors benign tumors, that affect soft tissue around the joints. This drug is designed to selectively bind to the CSF1R switch pocket.

Deciphera研发中最先进的候选药物是vimseltinib，它是治疗腱鞘巨细胞瘤（TGCT）的潜在药物，TGCT是一组罕见的良性肿瘤，会影响关节周围的软组织。该药物旨在选择性结合CSF1R开关口袋。

Last October, Deciphera reported preliminary data showing this drug met the main goal of a pivotal study. In its annual report, the company said it expects to submit seeking FDA approval in the second quarter of this year, followed by regulatory submission to the Europeans Medicines Agency in the following quarter.

去年10月，Deciphera报告了初步数据，显示这种药物达到了一项关键研究的主要目标。该公司在其年度报告中表示，预计将在今年第二季度提交寻求FDA批准的申请，然后在下一季度向欧洲药品管理局提交监管报告。

Four other Deciphera programs are in early clinical or preclinical development..

其他四个Deciphera程序正在早期临床或临床前开发中。。

Ono’s main presence in cancer is Opdivo, the blockbuster immunotherapy it developed in partnership with Bristol Myers Squibb. The Japanese company’s oncology pipeline currently spans 17 internal and partnered programs, some of which are being evaluated in combination with Opdivo. The only kinase inhibitor listed in the pipeline is the internally developed ONO-4059, a Bruton’s tyrosine kinase inhibitor in mid-stage clinical development.

小野在癌症中的主要存在是Opdivo，它是与百时美施贵宝合作开发的一种重磅炸弹免疫疗法。这家日本公司的肿瘤学管道目前跨越17个内部和合作项目，其中一些项目正在与Opdivo联合评估。管道中列出的唯一激酶抑制剂是内部开发的ONO-4059，它是临床开发中期的布鲁顿酪氨酸激酶抑制剂。

Ono’s growth strategy includes a fiscal 2031 goal of becoming a global specialty pharma company that invests 200 billion yen (about $1.28 billion) annually in R&D..

小野的增长战略包括2031财年的目标，即成为一家每年在研发方面投资2000亿日元（约12.8亿美元）的全球专业制药公司。。

“We expect that this acquisition of Deciphera will not only expand ONO’s target oncology portfolio, but also accelerate ONO’s business development in the United States and Europe, and strengthen kinase drug discovery research,” Gyo Sagara, representative director, chairman of the board and CEO of ONO, said in a prepared statement..

“我们预计，此次收购Deciphera不仅将扩大小野的target肿瘤学投资组合，还将加速小野在美国和欧洲的业务发展，并加强激酶药物发现研究，”小野的代表董事、董事会主席兼首席执行官Gyo Sagara在一份准备好的声明中表示。。

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A Personalized Approach to Medication Nonadherence

个性化的药物不依从性方法

At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.

在今年早些时候的Abarca Forward会议上，德勤董事总经理乔治·范安特卫普（GeorgevanAntwerp）讨论了健康的社会决定因素和个性化的会员体验如何改善药物依从性和健康结果。

Oncology is one of four priority areas for Ono, along with immunology, neurology, and specialty drugs addressing high unmet patient need regardless of therapeutic indication. The company has been an active dealmaker as it picks up pieces to execute on its growth strategy. In February, it began a collaboration with Austin, Texas-based Shattuck Labs focused on developing bifunctional proteins for autoimmune and inflammatory diseases.

肿瘤学是Ono的四个优先领域之一，以及免疫学，神经学和特种药物，无论治疗适应症如何，都可以满足高度未满足的患者需求。该公司一直是一个积极的交易撮合者，因为它正在收拾残局，执行其增长战略。2月，它开始与德克萨斯州奥斯汀的Shattuck实验室合作，专注于开发用于自身免疫和炎症性疾病的双功能蛋白。

Soon after, Ono announced a collaboration with InveniAI, an artificial intelligence drug discovery company based in Guilford, Connecticut..

不久之后，小野宣布与位于康涅狄格州吉尔福德的人工智能药物发现公司InveniAI合作。。

The boards of directors of both Ono and Deciphera have unanimously approved the acquisition. It still needs clearance from antitrust regulators and for the majority of Deciphera shareholders to tender their shares. Deciphera said certain shareholders owning about 28% of outstanding shares have already agreed to tender their shares.

Ono和Deciphera的董事会一致批准了此次收购。它仍需要获得反托拉斯监管机构的批准，并且需要大多数解密股东来投标其股份。Deciphera表示，持有约28%已发行股份的某些股东已经同意投标其股份。

The deal is expected to close in the third quarter of this year. After it does, Deciphera will remain in Waltham, operating as a standalone business of Ono Group..

该交易预计将于今年第三季度完成。之后，Deciphera将留在沃尔瑟姆，作为小野集团的独立业务运营。。

Image: istocksdaily, via Getty Images

图片：istocksdaily，通过Getty Images

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