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才高八斗

821
发表于 2015-3-6 16:48 |只看该作者
While the industry was largely focused on the jaw-dropping sum being paid for Pharmacyclics ($PCYC) today, Arrowhead Research has come in to buy up Novartis' ($NVS) cast-off RNAi business for the bargain rate of $10 million in cash and $25 million in stock.

As Arrowhead notes, the deal gives it all of the Big Pharma's work in the field, where it devoted close to a decade of work.

Arrowhead acquires patents as well as intellectual property rights to Alnylam's RNAi tech, 30 gene targets Novartis has picked from its partnership and a pipeline with three candidates that had generated preclinical data. And it follows their 2011 deal to buy out Roche's spurned RNAi work, providing some added boasting rights to being a leader in the field.

"This is an important deal for us. Novartis has been working in the RNAi field for over a decade and their developments in proprietary oligonucleotide formatting and modifications are some of the best we've seen. We anticipate this acquisition will provide us with substantially expanded freedom to operate, proprietary technology that appears to enhance the activity of RNAi triggers, access to non-delivery Alnylam RNAi IP for 30 targets, and three programs that went through the rigorous Novartis vetting process," said Chris Anzalone, president and chief executive officer of Arrowhead, in a statement.

John Maraganore, the CEO at Alnylam and a fierce defender of its RNAi work, scoffed at Arrowhead's boasts about the deal--"phantasmagorical," he called it--and said the acquisition only reflects the little that Novartis was able to accomplish after years of research.

"I think the deal reflects the value of those assets," Maraganore tells FierceBiotech this morning. "What Novartis did was frankly pretty disappointing in terms of any advance in the field. It's exactly what you'd expect from not much."

Chris Anzalone, though, says that once Maraganore gets a chance to study the assets, he'll eventually come around to at least privately acknowledge the value.

"I don't think John has looked at them like we did," says the Arrowhead CEO in response. "Because we entered early (into buyout discussions), no one had a chance to. We were thrilled by them."

Anzalone explains that Arrowhead quietly paid $7 million for an option to acquire the assets some months ago, part of the $10 million cash price it revealed today. Getting 30 targets from a Big Pharma company like Novartis, which had continued to be devoted to the RNAi field right up until it bowed out last spring, is a major deal. And the IP part of the acquisition gives Arrowhead "a very large right-of-way" in pursuing new programs, including a "right-of-way around Alnylam's position."

Shares of Arrowhead surged 11% after the news hit today, but later settled in up about 3% in mid-morning trading.  

Back in 2005, Novartis paid $56.8 million upfront to get started with Alnylam ($ALNY) on RNAi at a time when hopes for the field burned bright. Another $700 million was put on the table in partnership cash. Novartis devoted dozens of investigators to the field and took 31 targets from its pact with Alnylam. But by last spring, the Big Pharma declared that RNAi was still beset by difficulties, prompting their decision to wind down the work being done by a team of 26 staffers.

"This decision was driven by ongoing challenges with formulation and delivery and the reality that the current range of medically relevant targets where siRNA may be used is quite narrow," Novartis said in a statement to FierceBiotech at the time. "In the future we will have a small group working in this field and look for partnering opportunities."

News of the retreat, which also followed big exits by Roche ($RHHBY) and Merck ($MRK) earlier, raised fresh doubts about Alnylam, even as Sanofi ($SNY) was settling in to its own big partnership with the Boston-based RNAi specialists.


Did you mean: While the industry was largely focused on the jaw-dropping sum being paid for Pharmacyclics ($PCYC) today, Arrowhead Research has come in to buy up Novartis' ($NVS) cast-off RNAi business for the bargain rate of $10 million in cash and $25 million in stock. As Arrowhead notes, the deal gives it all of the Big Pharma's work in the field, where it devoted close to a decade of work. Arrowhead acquires patents as well as intellectual property rights to Alnylam RNAi tech, 30 gene targets Novartis has picked from its partnership and a pipeline with three candidates that had generated preclinical data. And it follows their 2011 deal to buy out Roche's spurned RNAi work, providing some added boasting rights to being a leader in the field. "This is an important deal for us. Novartis has been working in the RNAi field for over a decade and their developments in proprietary oligonucleotide formatting and modifications are some of the best we've seen. We anticipate this acquisition will provide us with substantially expanded freedom to operate, proprietary technology that appears to enhance the activity of RNAi triggers, access to non-delivery Alnylam RNAi IP for 30 targets, and three programs that went through the rigorous Novartis vetting process," said Chris Anzalone, president and chief executive officer of Arrowhead, in a statement. John Maraganore, the CEO at Alnylam and a fierce defender of its RNAi work, scoffed at Arrowhead's boasts about the deal--"phantasmagorical," he called it--and said the acquisition only reflects the little that Novartis was able to accomplish after years of research. "I think the deal reflects the value of those assets," Maraganore tells FierceBiotech this morning. "What Novartis did was frankly pretty disappointing in terms of any advance in the field. It's exactly what you'd expect from not much." Chris Anzalone, though, says that once Maraganore gets a chance to study the assets, he'll eventually come around to at least privately acknowledge the value. "I don't think John has looked at them like we did," says the Arrowhead CEO in response. "Because we entered early (into buyout discussions), no one had a chance to. We were thrilled by them." Anzalone explains that Arrowhead quietly paid $7 million for an option to acquire the assets some months ago, part of the $10 million cash price it revealed today. Getting 30 targets from a Big Pharma company like Novartis, which had continued to be devoted to the RNAi field right up until it bowed out last spring, is a major deal. And the IP part of the acquisition gives Arrowhead "a very large right-of-way" in pursuing new programs, including a "right-of-way around Alnylam's position." Shares of Arrowhead surged 11% after the news hit today, but later settled in up about 3% in mid-morning trading. Back in 2005, Novartis paid $56.8 million upfront to get started with Alnylam ($ALNY) on RNAi at a time when hopes for the field burned bright. Another $700 million was put on the table in partnership cash. Novartis devoted dozens of investigators to the field and took 31 targets from its pact with Alnylam. But by last spring, the Big Pharma declared that RNAi was still beset by difficulties, prompting their decision to wind down the work being done by a team of 26 staffers. "This decision was driven by ongoing challenges with formulation and delivery and the reality that the current range of medically relevant targets where siRNA may be used is quite narrow," Novartis said in a statement to FierceBiotech at the time. "In the future we will have a small group working in this field and look for partnering opportunities." News of the retreat, which also followed big exits by Roche ($RHHBY) and Merck ($MRK) earlier, raised fresh doubts about Alnylam, even as Sanofi ($SNY) was settling in to its own big partnership with the Boston-based RNAi specialists.

而行业主要是集中在令人瞠目结舌的款项被支付Pharmacyclics的($ PCYC)今天,箭头研究已经在买涨诺华($ NVS)投过的RNAi业务1000万美元的现金讨价还价率和2500万美元的股票。

作为箭头的笔记,这笔交易给了它所有的大型制药公司的工作领域,它致力于近十年的工作。

箭头获得专利以及知识产权Alnylam公司的RNA干扰技术,30靶基因诺华已经从伙伴关系,并与已经产生的临床前数据三名候选人管道回升。它遵循其2011价格收购了罗氏公司的唾弃RNAi技术工作,提供一些额外的拥有权,成为该领域的领导者。

“这对我们来说是一个重要的交易。诺华一直在RNA干扰领域超过十年及其专有的寡核苷酸格式和修改进展是一些我们所见过的最好的。我们预计此次收购将为我们提供大幅扩大出现提升的RNAi触发器的活动自由运作,专有技术,获得未送达Alnylam公司的RNAi IP为30个目标,并通过严格的诺华审批过程去三个节目,“克里斯Anzalone,总裁兼首席执行官说:箭头的,在一份声明中。

约翰Maraganore,在Alnylam公司的CEO和RNAi技术工作的坚决捍卫者,嘲笑箭头的吹嘘这笔交易 - “幻影似”,他把它叫做 - 和表示,此次收购只是反映了这一点诺华能够完成经过多年研究。

“我认为这笔交易反映了这些资产的价值,”Maraganore告诉媒体FierceBiotech今天上午。 “什么诺华所做的是坦言在该领域的任何进步方面相当令人失望。这正是你所期待的并不多东西。”

克里斯Anzalone,虽然说,一旦Maraganore得到研究资产的机会,他最终会围过来,至少私下承认的价值。

“我不认为约翰看着他们像我们一样,”响应箭头CEO说。 “因为我们进入早期(到收购讨论),任何人都没有。我们通过他们被兴奋的机会。”

Anzalone解释说,慈姑默默付出了700万美元的期权收购资产几个月前,1000万美元现金的价格今天透露的一部分。获得30个目标从大型制药公司诺华一样,它继续进行直到致力于RNA干扰场,直到它退出了去年春天,是一个重大的交易。而收购的IP部分给出箭头“一个非常大的铁路地役权”,在寻求新的方案,其中包括“围绕Alnylam公司的地位右的路。”

箭头的股价飙升11%,此前该消息,今天打了,但后来落户上涨约3%,中期早盘交易。

早在2005年,诺华公司支付56800000美元前期开始使用Alnylam公司($ ALNY)的RNA干扰的时候希望的田野焚烧明亮。另外$ 7亿放在桌子上的合作伙伴的现金。诺华致力于几十调查人员到现场,把31目标从契约与Alnylam公司。但到去年春天,在大型制药公司宣布,RNAi技术仍然被困难所困扰,促使他们决定放松下来的工作由一个团队的26名员工完成。

“这个决定是通过制定,执行和现实的电流范围的医学相关指标,其中的siRNA可以用来比较窄持续的挑战带动下,”诺华公司在一份声明中向媒体FierceBiotech当时说。 “在未来,我们将有一个小团体在这一领域的工作,寻找合作机会。”

新闻撤退,这也跟着大出口由罗氏公司($ RHHBY)和默克(MRK $)的早期,人们对Alnylam公司新鲜的疑虑,甚至赛诺菲(SNY $)的定居在其与波士顿的自己的大伙伴关系RNAi技术专家。

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822
发表于 2015-3-6 17:21 |只看该作者
arc520不是最好的,也不是最快的,birinapant不知能不能赶上

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风雨同舟

823
发表于 2015-3-6 17:22 |只看该作者
静观其变
日行一善(百善孝为先)

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824
发表于 2015-3-6 18:19 |只看该作者
回复 战天斗hbv 的帖子

应该不是啥新技术,是原先诺华放弃的这块的资产。。完善一下自己,资本市场就是这样,你得让人有想像的空间。就像TEK 跟ONcore的合并一样。但最终达到巅峰就得看出来的产品。

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825
发表于 2015-3-11 18:58 |只看该作者
祈祷所有新药早日成功!

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826
发表于 2015-3-15 21:57 |只看该作者

南非替诺、印度替诺,维力青、雷易得、贝双定,甘倍轻、恩甘定、和恩,阿甘定,贺甘定等。,正规渠道,货真价实!国家乙肝防治指南批准为一线抗病毒药物。是我国批准的唯一的一线高档药。初始要用恩替或替诺,不能拉米、阿德或替比。每盒都有电子监管码,
详情QQ:3052797110
共同学习乙肝知识,本人诚信代购乙肝抗病毒药:南非替诺 印度替诺 恩替卡韦 维力青 雷易得 甘倍轻 贝双定等,经济困难没有医保的战友可以加我详情QQ:3052797110 微信号:wenwendaigou520  QQ群号:327101739

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才高八斗

827
发表于 2015-3-27 19:17 |只看该作者
ARC520二期临床试验在香港招募

多中心,随机,双盲,安慰剂对照,剂量递增研究,以确定联合恩替卡韦的深度和乙肝表面抗原(HBsAg)减少持续时间后ARC-520的单次静脉剂量的慢性肝炎患者B病毒(HBV)感染。
乙肝表面抗原滴度>1000 IU/ mL的筛选确定
HBeAg阴性的筛查
HBV DNA<200 IU/ mL的筛选

患者>6个月的连续,0.5毫克/天口服恩替卡韦,并愿意继续服用恩替卡韦在整个研究

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风雨同舟

828
发表于 2015-3-29 10:19 |只看该作者
顶楼上好消息
日行一善(百善孝为先)

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829
发表于 2015-4-13 15:35 |只看该作者
还有什么新药进展,请多多说一下!

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才高八斗

830
发表于 2015-4-13 19:52 |只看该作者
Arrowhead Cleared to Proceed with Multiple Dose Phase 2b Study of ARC-520


PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that the United States Food and Drug Administration (FDA) informed the Company that it can proceed with a multiple-dose Phase 2b clinical study of ARC-520, its clinical candidate for the treatment of chronic hepatitis B infection, under an investigational new drug (IND) application previously filed with the FDA.

"This notification from the FDA allows us to begin a multiple-dose Phase 2b study of ARC-520, and we are working diligently to get treatment sites up and running. Our goal is to gain site IRB approvals and perform site initiation visits to begin recruiting and enrolling patients for this study in about a month, " said Bruce Given, M.D., chief operating officer and head of R&D for Arrowhead. "We are also working with various regulatory agencies outside of the United States to initiate additional Phase 2b studies."

The clinical study, titled Heparc-2004, is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520 administered intravenously to patients with chronic immune active HBV infection maintained on entecavir or tenofovir therapy. The study is planned to enroll up to 12 patients who will be randomized at a ratio of 2:1 with 8 patients receiving 1 mg/kg of ARC-520 and 4 patients receiving placebo. Each patient will receive 3 total doses, once every 4 weeks. Patients will be followed through Day 147.

The primary objective of Heparc-2004 is to evaluate the depth of hepatitis B surface antigen (HBsAg) decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic, immune active HBV infection as a measure of drug activity. Secondary objectives are to measure safety and tolerability and pharmacokinetics of ARC-520, and to evaluate the effect of ARC-520 on entecavir or tenofovir pharmacokinetics, in addition to other exploratory safety and pharmacodynamic objectives.

In connection with an IND filed in December 2014, Arrowhead proposed a parallel design multiple-dose Phase 2b study testing doses of 2 mg/kg and 4 mg/kg simultaneously. In January 2015, the FDA notified the Company that a partial clinical hold had been placed on the program. In order to proceed with the proposed parallel design study, the FDA requested that the Company provide additional information including data from the single-dose Phase 2a study in patients who receive 1-4 mg/kg ARC-520, data from an ongoing multiple-dose non-clinical study, and data from Heparc-2004 which is now cleared to begin.

About ARC-520

Arrowhead's RNAi-based candidate ARC-520 is being investigated in the treatment of chronic HBV infection. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically, to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. Arrowhead has completed a Phase 1 single ascending dose study in normal volunteers and the company is conducting single dose Phase 2a studies and multiple dose Phase 2b studies in chronic HBV patients. Approximately 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

About Arrowhead Research Corporation

Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate™ delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead's pipeline includes ARC-520 for chronic hepatitis B virus, ARC-AAT for liver disease associated with Alpha-1 antitrypsin deficiency, and partner-based programs in obesity and oncology.

For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadresearch.com/alerts.cfm.
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