Sci-B-Vac

StephenW

Frost Closes SciVac Deal, A Potential Blockbuster Lineup in Hepatitis

Published: Aug 5, 2015 12:12 p.m. ET      
        

Aug 05, 2015 (ACCESSWIRE via COMTEX) -- NEW YORK, NY / ACCESSWIRE / August 5, 2015 / Towards the end of last year, we got word that Dr Phillip Frost, chairman and CEO of Opko Health, Inc. (OPK), was looking to restructure then private company SciVac (now SciVac Therapeutics Inc. (SVACF)) into a public entity. Little more was heard of the matter until March 2015, when gold and precious metals exploration company Levon Resources Ltd announced that it had entered into an agreement pursuant to which Levon would acquire 100% of the issued and outstanding ordinary shares of SciVac. OPKO had a 45% stake in SciVac, and so the deal would see current SciVac owners take 68.4% of the outstanding shares of the new company after its close, and Opko take a little over 30%. At first glance the arrangement can seem a little bit convoluted, but a closer look reveals it is very similar in structure to a number of other public shell spins Frost has orchestrated in the past.

On July 10, SciVac announced the completion of the transaction, and its granting of approval by the Toronto Stock Exchange. Frost has a dedicated following of both individual and institutional investors that monitor his activity, so any stock in which he has a hand has the potential to revalue quickly on positive news. Further, he has an outstanding track record in the biotech space, and for both these reasons, his hands-on involvement with the SciVac deal warrants attention.

SciVac's flagship product is a Hepatitis B vaccine called Sci-B-Vac. Hepatitis B transfers from carrier to carrier through sexual contact, blood contamination and from mother to child. The virus gets into and replicates in hepatocytes, which are the primary functioning cell in the human liver. This invasion of hepatocyte cells leads to an immune response, during which the immune system attacks infected cells, causing damage not only to the infected cells, but also to wider liver function.

Currently, more than 170 countries have infant vaccination programs, and over 1 billion vaccines have been administered since 1982. The current standard of care necessitates three intravenous administrations over a period of six months. However, despite this vaccination effort, an astounding 2 billion people alive today have been infected with the virus at some point in their lives, an estimated 400 million people are currently carriers, 4 million individuals a year suffer from acute hepatitis B and 1.2 million people die every year from infection.

Infection rate is highest in central and southern Africa, Canada, the Middle East China and especially Southeast Asia where we see a higher than 8% prevalence. So if the current vaccination program is so widespread, why are there so many cases? First, there are a number of high-risk patients who don't respond to the current vaccines, including sufferers of diabetes, cancer, HIV and renal disease. 50% of chronic liver disease sufferers of which there are 300 million globally, do not respond to current available vaccines. In addition, the current vaccinations are ineffective in the more than 2 million children born to infected mothers each year. Finally, with the current standard of care taking six months, frequent travelers are unprovided for.

So what's different about Sci-B-Vac? It is a third-generation vaccine, and it differs from the second-generation vaccine currently used in the vast majority of cases in that it contains three hepatitis B surface antigens. Surface antigens are the viral antigen mimics, which display to the human immune system and initiate the immune response. In the second-generation, the vaccine only displays one antigen called the "S" antigen. Sci-B-Vac mimics two further antigens - "preS1" and "preS2". These extra displays improve vaccine response.

The third-generation vaccine has demonstrated efficacy in more than 20 company sponsored or investigator initiated trials across 5000+ individuals. The treatment is also already approved in 10 countries, and has been administered to more than 500,000 patients in these regions. Further, in two independent comparative studies, Sci-B-Vac demonstrated it produced seroprotection (i.e. protection from the virus the vaccination is designed to treat) more rapidly in both adults newborns than in healthy individuals treated with Engerix B - the current SOC vaccination.

This is all well and good, but why has Dr. Frost gotten involved? Perhaps because of the mitigated risks involved. The vaccine has already demonstrated safety and efficacy in 500,000 patients and is only approved in 10 countries. This gives us a clear path to phase 3 trials and US approval. As far as timeframes are concerned, SciVac expects to gain marketing approval for the vaccine in Latin America this year, while also meeting with the FDA and the BMA before the middle of 2016. The first quarter 2017, the company expects to have phase 3 enrolment complete in the US, and efficacy data for HIV and renal disease sufferers during first quarter 2018.

To put the market potential for these two indications into perspective, anywhere between 34 and 81% of 10 million chronic renal failure sufferers do not respond to Engerix B, and approximately 30% of 3 million HIV sufferers globally also do not respond. SciVac expects to gain approval for both of these indications in the US and Europe before the middle of 2018.

Hepatitis B is not the only liver disease Frost is involved in either. He is also involved in a hepatitis C vaccine company called Cocrystal Pharma, Inc. (COCP). Cocrystal is up 256% since August last year, down from gains of around 300% logged in April. Frost currently owns about 20% of Cocrystal individually through his investment trust, and his healthcare company Opko also has an 8% position - structuring its ownership in a very similar way to how Frost has set up in SciVac. Cocrystal itself went public through an acquisition structured in an almost identical fashion to SciVac, through an acquisition by BioZone Pharmaceuticals, Inc, then trading under the ticker "BZNE" and since renamed Cocrystal.

What's even more interesting, is that there is speculation that we could see a further deal between Cocrystal and SciVac somewhere down the line. From a pipeline perspective, it seems to make sense, with both companies being involved in the hepatitis vaccination space. Additionally, from an ownership perspective, it looks to make even more sense - with Frost holding a high percentage stake in both.

Conclusion

Over the last couple of years Dr. Phillip Frost has racked up his holdings in the hepatitis vaccine space through two reverse merger public offerings, and one of them is up in the triple digit percentage range since his involvement. He has now cemented his involvement in the second, and with a risk-mitigated path to what looks like a high percentage chance of regulatory approval, we could see similar growth in SciVac. Of course, in development stage biotech, nothing is certain. However, if there is a man to keep an eye on in the space, it's Frost.

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The post Frost Closes SciVac Deal, A Potential Blockbuster Lineup in Hepatitis appeared first on Market Exclusive.

StephenW

Frost闭SciVac新政，准一鸣惊人阵容肝炎

发布时间：2015年8月5日下午12时12分ET
        

2015年8月5日（通过COMTEX ACCESSWIRE） - 纽约，NY / ACCESSWIRE / 2015年8月5日/迈向去年年底，我们得到消息说菲利普博士弗罗斯特，OPKO Health公司的董事长兼首席执行官（OPK） ，正寻求重组，然后私营公司SciVac（现SciVac Therapeutics公司（SVACF））到公共实体。多一点听到的问题，直到2015年3月，当黄金和贵金属勘探公司捷尔资源有限公司宣布，它已签订了一项协议，据此，列翁将收购SciVac的已发行及发行在外普通股的100％。 OPKO曾在SciVac 45％的股权，因此，该交易将看到当前SciVac业主后其接近采取新公司的流通股的68.4％，并OPKO取少许超过30％。乍一看安排似乎有点令人费解，但仔细观察，可以发现它在结构上非常相似，许多其他上市壳旋转弗罗斯特在过去的精心策划。

7月10日，SciVac宣布完成交易，以及由多伦多证券交易所的批准授予的。霜冻监视他的活动包括个人和机构投资者的专用以下，所以他在其中有一只手任何股票都有快速升值对利好消息的可能性。此外，他还拥有在生物技术空间骄人的业绩，并为这两个原因，他亲自参与的SciVac交易权证的关注。

SciVac的主打产品是一个乙肝疫苗被称为科技-B-VAC。从载体乙肝转移到运营商通过性接触，血液污染和母婴。该病毒进入和复制在肝细胞中，这是在人类肝脏主要的功能单元。这个侵入肝细胞导致的免疫应答，在此期间，免疫系统攻击感染的细胞，造成损害不仅对被感染的细胞，但也更广泛的肝功能。

目前，170多个国家有婴幼儿疫苗接种计划，和超过十亿疫苗已经给予自1982年以来的护理现行标准历时六个月就必须三次静脉给药。然而，尽管这种疫苗接种工作，惊人的2十亿人今天还活着已经感染了该病毒在他们的生活中，估计有4亿人，目前运营商，每年400万人患急性乙肝和1.2亿人患有每年从感染死亡。

感染率最高的是非洲中部和南部，加拿大，中东和中国特别是东南亚地区，我们看到一个高于8％的患病率。因此，如果目前的疫苗接种计划是如此普遍，为什么有这么多的情况下？首先，有一些高风险的病人谁不应对当前的疫苗，包括糖尿病，癌症，艾滋病和肾脏疾病的患者中。其中慢性肝病患者50％有3亿全局，不为当前的疫苗反应。此外，目前接种疫苗是无效的超过200万儿童每年出生到受感染母亲。最后，小心的现行标准服用6个月内，经常出差的未拨备的。

那么，什么是关于科技-B-VAC有什么不同？它是一个第三代疫苗，它不同于目前的情况下，绝大多数使用的第二代疫苗，它包含三个乙型肝炎表面抗原。表面抗原是病毒抗原模拟物，它们显示到人的免疫系统，并启动免疫应答。在第二代中，疫苗只显示一种抗原被称为“S”的抗原。 SCI-B-VAC模仿另外两个抗原 - “前S1”和“前S2”。这些额外的显示器提高疫苗反应。

第三代疫苗已经证明疗效超过20家公司赞助或研究者发起的试验横跨5000+个人。治疗也已经批准在10个国家，并已给予超过500,000名患者在这些地区。另外，在两个独立的比较研究，科学-B-吸尘器证明它产生血清保护在成人新生儿（即保护从病毒的疫苗接种的目的是治疗）的速度比在与的Engerix乙治疗健康个体 - 当前的SOC接种。

这是一切都很好，但为什么弗罗斯特博士囊括在内？也许是因为所涉及的风险，减轻的。该疫苗已经证明安全性和有效性的500,000名患者，并且只在批准的10个国家。这给了我们3期临床试验，并批准美国一个清晰的路径。至于时间表方面，SciVac希望获得上市批准，今年拉美地​​区的疫苗，与FDA和BMA的2016年中期第一季度2017年，该公司预计将有3阶段入学前，同时也满足在今年第一季度完成2018年在美国和有效性艾滋病和肾脏疾病患者的数据。

把市场潜力这两个适应症的角度看，任何地方之间的34和1000万慢性肾功能衰竭患者81％的人不来的Engerix乙回应，300万艾滋病患者约30％，在全球也没反应。 SciVac预计2018年中期前获得批准这两个适应症在美国和欧洲。

乙型肝炎是不是唯一的肝病弗罗斯特涉及任一。他还参与了C型肝炎疫苗的公司叫共晶体制药公司（COCP）。共结晶是高达256％，去年8月以来，从上下左右300％记录在四月的收益。冰霜目前拥有约20％的共结晶单独通过他的投资信托基金，他的医疗保健公司OPKO也有8％的位置 - 构建其所有权在一个非常相似的方式如何冰霜先后成立了SciVac。共晶体本身的结构，通过以几乎相同的方式来SciVac收购上市，通过收购BIOZONE制药公司，然后上市，股票“BZNE”，并更名以来共晶体交易。

什么是更有趣的是，有传言称，我们可以看到共晶体和SciVac之间的进一步交易的地方的路线。从管道的角度来看，这似乎是有道理的，与所涉及的肝炎疫苗接种空间两家公司。此外，从所有权的角度来看，它看起来做得更感 - 冰霜持有高比例的股权，两者。

结论

在过去的几年菲利普博士弗罗斯特已经折磨了他的藏品在肝炎疫苗的空间通过两个反向并购公开募股，其中之一是在，因为他参与了三位数百分比范围。现在他已经巩固了他在第二个参与，并与风险缓解的路径是什么样子监管机构批准的高百分比的机会，我们可以看到在SciVac类似的增长。当然，在开发阶段的生物技术，没有什么是一定的。但是，如果有一个人留意的空间，它的冰霜。

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后冰霜关闭SciVac新政，准一鸣惊人阵容肝炎首次出现在市场独占。

咬牙硬挺

这是新药吗？

StephenW

回复 咬牙硬挺 的帖子

不，是一种预防性疫苗, 更有效.