ContraVir Pharmaceuticals' HBV Compound CMX157 Receives Extended Patent Life

战天斗hbv

EDISON, N.J., Feb. 4, 2015 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that its licensing partner, Chimerix Inc., has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent titled, "Nucleoside Phosphonate Salts."  The patent covers composition of matter for CMX157, ContraVir's Phase 2-ready, highly potent analog of the successful antiviral drug tenofovir DF (Viread®), which ContraVir is developing to treat hepatitis B virus (HBV).  The new patent extends ContraVir's intellectual property protection for CMX157 to at least 2031.

"This Notice of Allowance is a significant development for ContraVir, as it inherently increases the value of CMX157, allowing us the added time to expand the potential for this asset," said James Sapirstein, Chief Executive Officer of ContraVir. "The extended patent life also provides additional flexibility for the Company to pursue different combination therapies, as well as new development pathways for CMX157.  We are looking to position ContraVir as a leader in the HBV space, an area that is poised for substantial further growth."

CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate.  Its novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. A completed Phase 1 clinical trial in healthy volunteers, demonstrated a favorable safety, tolerability and drug distribution profile.  In vitro, CMX157 is highly active against HBV and was more than 200-fold more potent as compared to tenofovir against all major HIV subtypes resistant to current therapies.  ContraVir licensed CMX157 through a strategic collaboration with Chimerix, Inc. (CMRX) in December 2014.

About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the discovery and development of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir's lead candidate, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is an infection caused by the reactivation of varicella zoster virus (VZV).  In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study.  ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir DF (Viread®).  CMX157 is active against HBV and more than 200-fold more potent in vitro versus tenofovir against all major HIV subtypes resistant to current therapies.  CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects.  ContraVir intends to develop CMX157 for HBV and HIV in Phase 2 clinical studies.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on ContraVir's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in ContraVir's Form 10-K for the year ended June 30, 2014, and other periodic reports filed with the Securities and Exchange Commission.

战天斗hbv

EDISON，新泽西州，2015年2月4日/新华美通/ - ContraVir制药公司（CTRV），一家生物制药公司，专注于开发和有针对性的抗病毒治疗的商业化，今天宣布，其授权合作伙伴，Chimerix公司，已收到津贴从美国专利商标局（USPTO）用于其专利题为通知书“核苷膦酸盐。”该专利涉及此事的CMX157组成，ContraVir的第2阶段就绪，高度有效的，成功的抗病毒的药物替诺福韦DF（Viread®），其中ContraVir正在开发用于治疗乙型肝炎病毒（HBV）的模拟。新专利扩展ContraVir的对CMX157知识产权保护到至少2031。

“津贴本通知是ContraVir一个显著的发展，因为它本质上增加了CMX157的价值，使我们的补时扩大了该资产的潜力，”詹姆斯Sapirstein，ContraVir首席执行官说。 “在延长专利期限还提供了额外的灵活性，为公司寻求不同的组合疗法，以及为CMX1​​57新的发展途径。我们正在寻找定位ContraVir作为HBV领域的领导者，这有望大幅增长进一步面积“。

CMX157是一种新型的脂质无环核苷膦酸盐，可提供高浓度的细胞活性的抗病毒药物替诺福韦二磷酸。其新颖的结构的结果中的替诺福韦的下降循环水平，降低全身暴露，从而减少了对肾脏的副作用的潜力。已完成的一期临床试验在健康志愿者中，表现出了良好的安全性，耐受性和药物分布曲线。在体外，CMX157是抗HBV活性高并且是较泰诺福韦针对所有主要HIV亚型耐当前疗法超过200倍更有效的。 ContraVir在2014年12月授权CMX157通过与Chimerix公司（CMRX）的战略合作。

关于ContraVir制药
ContraVir是一家生物制药公司，专注于发现和有针对性的抗病毒治疗的发展，两位候选人在中期到后期临床开发。 ContraVir的铅候选，FV-100，是被用于治疗带状疱疹，或带状疱疹，这是由水痘带状疱疹病毒的再活化（VZV）感染开发了一种可口服的核苷类似物的前药。除了直接的抗病毒活性，FV-100已经证明，减少在2期临床研究衰弱带状疱疹相关疼痛称为带状疱疹后神经痛（PHN）的发生率的潜力。 ContraVir也在开发CMX157，成功的抗病毒药物替诺福韦DF（Viread®）的高度有效的模拟。 CMX157是积极的抗HBV和超过200倍更有效的在体外对替诺福韦兑各主要HIV亚型耐电流疗法。 CMX157的新颖的结构的结果在替诺福韦降低循环水平，降低全身暴露，从而减少了对肾脏的副作用的潜力。 ContraVir打算在二期临床研究制定CMX157的HBV和HIV。

前瞻性声明
本新闻稿中的某些陈述是1995年美国私人证券诉讼改革法案的这些陈述可通过使用前瞻性的话，如被认定所指的前瞻性“预期”，“相信”，“预期” “估计”和“打算”，等等。这些前瞻性声明是基于ContraVir当前的预期和实际结果可能大不相同。有许多因素可能导致实际事件与此类前瞻性陈述中表明的差异。这些因素包括，但不限于，大量竞争;我们能否继续作为一个持续的关注;我们需要更多的资金;专利保护和诉讼的不确定性;相对于冗长和昂贵的临床试验中的不确定性，即早期的研究和试验的结果可能不是预测的未来试验结果，政府或第三方付款人报销的不确定性;有限的销售和营销工作的，对第三方的依赖;以及与未能获得FDA许可或批准和不遵守FDA法规风险。与正在开发的任何候选药物，也有在发展显著的风险，监管部门的批准，及新产品的商品化。有没有保证，在本新闻稿中讨论今后的临床试验将完成或成功，或任何产品将获得监管部门批准的任何说明或证明是商业上的成功。 ContraVir不承担更新或修改任何前瞻性陈述的义务。投资者应阅读载于ContraVir的Form 10-K中截止2014年6月30日这一年的风险因素，并提交给美国证券交易委员会的其他定期报告

战天斗hbv

这家公司的股价，6个月来，从0.65涨到了4.94，二百倍有效的替诺，核苷类真的越来越强了，可惜还缺个伴来组成鸡尾

newchinabok

替诺加了个化学基团，还早

hao2014

真的200倍
但也是抑制
比较好奇，是否会无限接近0?

战天斗hbv

回复 hao2014 的帖子

这个药物应该很靠谱，有确切的传闻会有吉利德来收购，看股价就知道了。现有核苷类是有表抗转阴的，只是概率小，所以，我认为，治疗HBV，加大药效是可行的

高高山顶立

替诺加强减毒版本，期待

yelanglms

期待！