VC/PE/M&A. Healthcare Weekly(海外版)(2017.10.24)

 2017-10-24 A- A+

作者:克莱尔

导语:

— A轮继续备受肯定,4250 万美元助力 Gemini Therapeutics 干性黄斑部退化治疗方案研发。

— ShifaMed 孵化出又一明星公司,Apama Medical 被波士顿科学收购。

— 号外号外!Impax Labs 和Amneal 完成合并,美国第五大仿制药公司新鲜出炉!

— 诺华快跑!Kite 和吉利德手握 axi-cel 准入许可,强势逐鹿 CAR-T 市场。

私募融资 & IPO

1. A轮继续备受肯定,4250万美元助力 Gemini Therapeutics 干性黄斑退化治疗方案研发

位于美国麻省剑桥的 Gemini Therapeutics 公司最近宣布 A 轮筹资 4250 万美元,主要用于进一步研发干性黄斑部退化的治疗方案。与年龄相关的黄斑退化是不可逆转性失明的通常来源之一,分为干性和湿性。Atlas Venture,Lightstone Ventures 和 OrbiMed 在此轮共同领投,它们在去年的种子轮也参与了投资。公司的联合创始人和 CEO James McLaughlin 表示,公司的关注重点在于具有较高遗传风险的人群:“我们首先对于这一人群的潜在变化及其功能上的症状进行观察,接着将这些人各自的斑点的异常情况对应到合适的治疗候选药物上。”

相关报道:

Gemini Therapeutics closes $42.5M Series A for dry age-related macular degeneration therapy

Oct 18, 2017

Gemini Therapeutics has closed a Series A round to advance its precision medicine therapy for dryage-related macular degeneration. The Cambridge, Massachusetts company zeroesin on genetic causes of the condition. Atlas Venture, Lightstone Ventures and OrbiMed co-led the Series A, according to a news release. They also took part in the seed round last year.

James McLaughlin, Gemini Therapeutics cofounder and CEO, said that the company focuses on patients with a high genetic risk profile, according to the release. “We assessed the functional implications of their underlying mutations. We then matched each molecular abnormality with an appropriate therapeutic candidate: a recombinant protein, a monoclonal antibody or a gene therapy.”

Source: MedCity News

https://medcitynews.com/2017/10/dry-age-related-macular-degeneration-therapy/?rf=1

并购

1. ShifaMed孵化出又一明星公司,Apama Medical被波士顿科学收购

位于美国麻省的医疗科技公司波士顿科学(Boston Scientific)近日收购了治疗心房颤动的射频球囊导管研发商 ApamaMedical,后者将获得高达1.25亿美元的里程碑付款及后续付款,用于2018-2020年间到达临床和监管等方面的里程碑。去年11月,Apama Medical筹得了1300万美元的C轮投资。这家创业公司位于美国加州,其宗旨是结合单点射频消融方案和射频球囊导管方案,研发出治疗心房颤动的导管消融术。Apama Medical是硅谷知名医疗器材孵化器ShifaMed孵化的第三家被收购的公司,前两个公司是Kalila Medical(去年被雅培收购)和Maya Medical(2012年被柯惠医疗收购)。

Apama Medical 是第三个由医疗科技孵化器 ShifaMed 孵化后被收购的公司。

相关报道:

Boston Scientific picks up a fib player Apamain deal worth up to $300M

Oct 16, 2017

Boston Scientific closedits acquisition of Apama Medical, a developer of a radio frequency balloon catheter for the treatment of a trial fibrillation. While the device maker forked over $175 million in cash up front, Apama stands to earn up to $125million in milestone payments. Apama will collect follow-on payments for achieving clinical and regulatory milestones from 2018 to 2020, according to a statement. Boston Sci announced the deal earlier thismonth. Last November, Apama raised $13 million in series C financing. The Campbell, California-based startup is developing a catheter ablation system for a fib that combines the best of two major approaches used to treat the condition—single-pointradio frequency ablation and balloon catheter ablation. Apama is the third company out of medtech incubator Shifamed to be acquired. The other two were Kalila Medical, snatched up by Abbott last year and Maya Medical, sold off to Covidien in 2012.

"Shifamed was formedout of my passion for engineering in the medical field and the ability to work along side and enable others to develop innovative solutions that make apositive impact on patient lives," said Amr Salahieh, who founded Shifamed in 2009. "We are thrilled to collaborate with companies like Boston Scientific that excel at bringing advanced solutions to the patients and care providers we serve."

Source: FierceBiotech

http://www.fiercebiotech.com/medtech/boston-scientific-picks-up-a-fib-player-apama-deal-worth-up-to-300m

2. 号外号外!Impax Labs和Amneal完成合并,美国第五大仿制药公司新鲜出炉

Impax Labs在仿制药定价压力下,近日和Amneal完成合并,将形成价值64亿美元的美国第五大仿制药公司。新公司将以Amneal命名,并将使得Impax的股东获得其 25% 的股权,原有Amneal的股东获得剩下的部分。交易背后是并购专家保罗·比萨罗(Paul Bisaro)的努力斡旋。比萨罗原为瑞士制药公司阿特维斯(Actavis)的CEO,自今年3月起担任Impax的CEO。

Paul Bisaro

相关报道:

Bisaro steers Impax to $6.4B Amneal merger, creating fifth-largest U.S. generics company

Oct 17, 2017

Surprise, surprise: Impax Labs, looking to bulk up amid generics pricing pressure and newly helmed by M&A specialist Paul Bisaro, has struck a deal. On Tuesday, the company said it had inked an all-stock pact to merge with Amneal in a transaction that would make it the fifth-largest U.S. generics player. The move will hand Impax shareholders 25% of the new company—which will take Amneal’s name and have an expected value of $6.4 billion, The Wall Street Journal says—while Amneal’s ownerswill control the rest. Those Impax shareholders weren’t too thrilled with the news, though: By late morning, they had sent shares down by more than 12%. And there’s reason to bewary, especially considering how awry the generics’ industry’s last bigdeal—Teva’s $40.5 billion buyout of Allergan’s generics unit—has gone. With consolidated buyers putting on the pricing squeeze, Teva has had to walk back guidance by $1 billion-plus twice already, and it’s announced 7,000 layoffs andother cost-cutting measures, too.

Bisaro, though, knows a thing or two about that deal. As CEO of generics heavy weight Actavis, he builtup that unit, and after Allergan bought the company, he helped orchestrate theTeva deal from the chairman’s seat. And he and Amneal are rosyabout the new company’s prospects. The way they see it, the combination will pad Impax’s EPS in the first year and generate double-digit revenue growth and adjusted EPS growth over the three years postclose. There’s ample cost-cutting opportunity, too, with the companies expecting to wring out $200 million over that time frame. Plus, the deal will create a more diversified company with “one of the industry's leading high-value generic product pipelines and a growing specialty business,” Bisaro said in a statement; the new company will boast more than 300 candidates in development or already filed with the FDA.

Source: FiercePharma

http://www.fiercepharma.com/pharma/bisaro-steers-impax-to-6-4b-amneal-merger-creating-u-s-s-fifth-largest-generics-co

行业盘点

1. 诺华快跑!Kite和吉利德手握axi-cel准入许可,强势逐鹿CAR-T市场

近日,FDA批准了Kite的CAR-T药物axi-cel(“Yescarta”),这比预计时间提前了6个礼拜。这一药物目前已确定为针对复发或患有严重的弥漫性大B淋巴瘤的成年患者,包括在传统疗法中失败了两次或以上的严重的非霍奇金淋巴瘤患者。这一疗法售价 37.3万美元,过程复杂,包括将患者体内的免疫细胞移除身体,并再次植入体内、对抗癌症。早在今年8月,诺华就获得了FDA首肯,批准其价值47.5万美元的CAR-T疗法 Kymriah,用于急性淋巴性白血病的治疗。而FDA的最新许可使得Kite及其母公司吉利德(Gilead)逐鹿CAR-T市场。尽管两种疗法针对的患者群体有所区别,但是它们都经过了复杂的制作过程,且以高昂的价格出售。而且,由于两种疗法都在试图拓展适用人群,所以可能会在最终形成直接竞争。Kite的首席医学官David Chang博士表示,Yescarta的意义在于给那些经历了多次化疗和造血干细胞移植而未见成效的患者以选择和希望。

相关报道:

Move over, Novartis: Kite and Gilead breakinto CAR-T market with early axi-cel nod

Oct 18, 2017

When non-Hodgkin lymphoma patient Becky Revoir learned last year that her cancer was pushed into remission by Kite Pharma’s experimental CAR-T treatment, she had one big wish.“ My hope is that no patient ever has to hear that their chemo didn’t work and they have no other treatment options,” said Revoir, 51, in an interview with FiercePharma. Revoir is getting herwish. The FDA has approved Kite’s CAR-T, axicabta gene ciloleucel (axi-cel), about six weeks earlier than expected. Now dubbed Yescarta, the drug is cleared to treat adults with relapsed or refractory large B-cell lymphoma, including aggressive non-Hodgkin lymphoma, who have failed two or more traditional treatments. The complicated treatment, which involves removing immune cells from individual patients and engineering them to recognize and destroy their cancers, will sell for $373,000. The FDA nod vaults Kiteand its new parent Gilead into a market first launched by Novartis, which won approval in August for its $475,000 CAR-T treatment, Kymriah, to treat pediatric patients with acute lymphoblastic leukemia. Although the audiences for the two CAR-T treatments differ, the products share many similarities,including a complex manufacturing process and a hefty price tag that will no doubt pull their manufacturers into the ongoing debate over high drug prices. And the two leading CAR-T players could eventually become direct rivals, asboth are working to expand the labels for their products. Kite’s chief medical officer, David Chang, M.D., Ph.D., told FiercePharma that Yescarta’s value liesin its potential to offer hope to patients who have run out of options.Patients who relapse after multiple rounds of chemo or a stem-cell transplant“rarely achieve complete remission,” he said. “Their chance of complete remission from salvage therapy is only 7%.” In Kite’s pivotal study, 72% of patients responded and 51% achieved complete remission during the median follow-up period of about 8 months.

Source: FiercePharma

http://www.fiercepharma.com/regulatory/kite-and-gilead-join-novartis-red-hot-car-t-market-early-axi-cel-approval

以上,难免有疏漏或不正确之处,请多多指出。

*声明:本文由入驻新浪医药新闻作者撰写,观点仅代表作者本人,不代表新浪医药新闻立场。
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肖恩大侠 华盖医疗基金董事总经理,北京。 毕业于北京大学工学院医学院(医学硕士)、北京大学法学院(法学硕士)。资浅PE从业人士。躬耕于太湖,游学至未名,当过医生,学过法律,改行至风险投资,喜好读书写作,经史文集,现代科技都甚喜欢,总是怀着理想,万一,实现了呢?欢迎交流医疗、文化、消费,欢迎交流一级市场、二级市场,欢迎交流国内及海外并购。 邮箱:shawn.shiqq.com
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