下图为大智慧医药组根据国家食药监总局公开信息整理的10月8日重要新药受理信息,按注册类型排序,供参考。
会议指出,省委、省政府明确要求将新医药和大健康产业打造成为大数据产业“姊妹篇”,各地各部门要高度重视,围绕“做大规模、做强品种、做优结构”精准发力,针对新医药产业链的重点环节“建链”、优势环节“强链”、薄弱环节“补链”,带动上下游企业聚集和项目生成,促进产业实现集群化、差别化、特色化发展。
会议强调,当前要重点把项目建设作为主要抓手,依托“百千万”工程和“政企银”合作平台,强总体、抓关键、带龙头、保要素、攻难点,完善新医药产业联合推进机制;围绕药品批号资源和优势项目开展合作洽谈,加大招商引资力度;加快建立省级重大新药协同创新平台,强化人才引进和培养,提升自主创新能力;加强产业政策扶持和行业监督指导,提高行政服务效能。会议要求,各地各部门和有关企业要结合职责分工,抓紧制定贯彻落实《意见》和《规划》的实施意见;抽调骨干力量,全力以赴做好全省新医药产业项目集中开工仪式;超前谋划明年3月的新医药产业招商推介大会,确保高水平、高质量出色完成任务。
会上,省经济和信息化委与工行省分行签署了《新医药产业发展战略合作协议》,省科技厅等8家单位作了交流发言。
副省长王江平出席并讲话,副省长何力主持会议
Forward Pharma成立于2005年,其核心产品是一个富马酸二甲酯缓释制剂FP187。这个比firdapse还简单的化合物今年有望为百建艾迪(商品名tecfidera)带来25亿美元的销售。Forward Pharma准备用IPO募集的资金开始一个三期临床实验。由于富马酸二甲酯和有机化学的年龄差不多,百建艾迪和Forward Pharma都依靠剂型专利保护。两家现在正在打一场专利官司,Forward Pharma宣称他们的专利申请早于百建艾迪。如果胜诉将大大缩短tecfidera的专利保护期。
最近平民分子如pirfenidone和firdapse纷纷高调进军药典,但结构更简单的富马酸二甲酯却是价值最高的,今年上半年已经卖了12亿美元。现在的新药研发大概有两个阵营。以基因泰克为代表的长线研发体系以坚实的基础研究为基础,以独家领先研究为主要驱动力,整个研发过程纪律严明,该进则进,该退则退,打法严谨,如同足球界的德国队。这种策略依赖世界一流的科研人才和决策部门的高度纪律性。如果做得好可以长期稳定上市重要产品,基因泰克的Herceptin, Avastin, Perjeta, Rituxan个个重磅产品。和德国队连续16届世界杯打入四分之一决赛的成绩有一比。
另一个阵营就是这些小的生物制药公司,策略是一锤子买卖。不是为了长期稳定发现多个药物,就是赌手上的这个单个药物。各种怪异分子,千奇百怪的优化模型,和主流打法大相径庭。这样的公司孤注一掷,一路逆水行舟,如同过河卒子,不断寻找生存空间,经常即使失败还编出各种故事希望有投资者继续支持。由于我们对生物体系了解的非常有限,这种高风险但多元化的模式和基因泰克模式还有一拼,经常找到一些重要的药物。这些小公司也成了制药工业不可或缺的一个重要组成部分。当然随着我们对疾病了解的不断深入,这种模式会越来越被更职业的主流打法取代,但在目前这还是一个很有竞争力的模式。
当然也有很多企业即不敢象小公司那样冒险,也缺乏基因泰克的研究实力和纪律性,这在目前的环境下生存就比较艰难。这也是过去10年制药工业严重萎缩的重要原因。
试验的受试者为患有寻常天疱疮的患者,寻常天疱疮是一种严重疾病,该疾病患者的嘴及皮肤上发生疼痛的水泡,可引起感染。在严重病例中,这种感染可成为全身性感染,导致器官衰竭并死亡。
寻常天疱疮在全球大约感染着700万人,目前这种疾病的标准治疗药物是非常高剂量的全身糖皮质激素,而这些药物本身可引起严重并有时危及生命的副作用。
一年期的试验将测试奥法木单抗一种新型皮下注射剂型,在初始负荷剂量之后每月给药一次,这种剂型专门被开发用于自身免疫适应症。主要目标是控制疾病症状,同时让患者脱离类固醇类药物。
奥法木单抗是由Genmab最初开发的一种抗CD20抗体,这款药物的一种静脉注射剂型自2009年以来以Arzerra为商品名销售用于治疗慢性淋巴细胞白血病(CLL),根据葛兰素史克与诺华在今年初宣布的一项资产互换协议,这款药物被列入从葛兰素史克转移到诺华的癌症药物名单中。
奥法木单抗在罗氏利妥昔单抗的竞争下其销售业绩非常惨淡,利妥昔单抗的分子靶点与奥法木单抗相同。奥法木单抗作为一款一线治疗药物被批准用于CLL之后,可以说经历了一次新生,这款药物还可能作为一款维持治疗药物获得批准,但最近在一项用于B细胞淋巴瘤的试验中却遭到失败。
葛兰素史克保留了皮下注射剂剂型的权利,并打算与Genmab合作开发这款药物用于多种自身免疫疾病。在获得非常阳性的2期试验结果之后,该公司打算于2015年启动多项奥法木单抗用于复方缓解型多发性硬化症(MS)的3期研究,并表示该公司年底前还计划启动该药物用于另一种罕见疾病-视神经脊髓炎的试验。
信源地址:http://www.pmlive.com/pharma_news/gsk_unit_takes_new_ofatumumab_formulation_into_phase_iii_604548
目前吉利德正以一款新型复方治疗药物处于领先地位,在对竞争格局进行分析之后,百时美施贵宝选择放弃其NS3/4A蛋白酶抑制剂Asunaprevir在美国的上市申请,并不寻求批准Daclatasvir与Asunaprevir组成的复方药物用于基因型1b患者治疗。
百时美施贵宝早先已落后于吉利德的Sovaldi,该公司曾寻求Asunaprevir的国际开发项目,密切关注像西班牙这样拥有大量基因型1b患者人群的市场。该公司于7月份在日本赢得了一款复方药物的批准,开创了一种新型无干扰素治疗方案,并正在帮助改写这一领域的治疗标准。
但这不是在美国,百时美施贵宝在美国正继续致力于为Daclatasvir扩张市场,Daclatasvir是一种NS5A抑制剂,商品名为Daklinza。几年前,当百时美施贵宝的核苷酸聚合酶抑制剂在诊所发生爆炸时,该公司受到了沉重打击。一些分析师认为,在默沙东及其它公司进行一系列交易之后,百时美施贵宝急需收购一款在市场上具有竞争力的核苷酸聚合酶抑制剂。
与此同时,吉利德正接近于为其NS5B抑制剂Sovaldi与NS5A抑制剂Ledipasvir组成的复方药物赢得批准。同时,艾伯维与默沙东一直在致力于缩小他们自己复方药物后期试验的差距,这有望进一步破坏这一市场,该市场自打Sovaldi上市以来其8.4万平均的价格使支付者感到震惊。
这场竞赛正在将百时美施贵宝排齐出美国这一世界最大药物市场。在10月7日的一份投资者报告中,科学信息研究所的分析师Schoenebaum写道,百时美施贵宝的复方药物与吉利德与艾伯维的复方药物相比竞争力看起来比较弱。
“我们认为,这款两药复方药物在美国的营收预期相当低,因这其与吉利德及艾伯维的方案相比疗效较差,并且该两家公司的产品正等待今年获得批准,”Schoenebaum指出称。现在对百时美施贵宝来说,关键的是一款由Daclatasvir、Asunaprevir和BMS-791325组成的三药复方药物,这款复方药物可能于2015年在美国获得批准。
“我们计划向美国提交我们正在进行的专门针对难治性患者临床试验项目的数据,包括用于丙型肝炎基因型3患者、肝移植前或肝移植后的患者及合并HIV感染的患者,”该公司在一分声明中表示称。“在下个月的美国肝病研究协会年会上,我们将发布几项以Daclatasvir为基础治疗方案的新数据。”
FDA根据III期PREVAIL研究的总生存期(OS)利益批准了Xtandi。数据显示,与安慰剂相比,Xtandi使放射学恶化或死亡风险降低83%,使死亡风险降低29%,同时也显著延迟了首次化疗时间及首次骨骼相关事件的发生。
Xtandi有其独特优势,即可单独用药,而强生Zytiga须联合强的松(prednisone)用药。因此,Xtandi自上市之初,便已经有能力挑战Zytiga。
Zytiga已收获的化疗前用药适应症,已助推该药在2014年上半年销售额达到10.7亿美元,而Xtandi今年第二季度在美国的销售额已达到1.44亿美元。业界认为,从强劲的市场接纳来看,早在化疗后用药适应症中,Xtandi就已经表现出抗衡Zytiga的能力。
在前列腺癌临床治疗中,Xtandi已被临床医生快速采纳,作为前列腺癌化疗后治疗的首选药物。因此,与Zytiga相比,鉴于Xtandi的单独用药优势及近期获批的化疗前适应症,该药有望颠覆Zytiga的霸主地位。
U.S. FDA Approves New Indication for the Use of XTANDI® (enzalutamide) Capsules for Patients with metastatic Castration-Resistant Prostate Cancer
HEADLINE2Approval based on improved overall survival, delayed time to radiographic progression and an overall positive benefit-risk profile
TOKYO and SAN FRANCISCO, Sept. 10, 2014 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo: 4503) and Medivation, Inc. MDVN, +2.50% announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase 3 PREVAIL trial.
To view the multimedia assets associated with this release, please clickhttp://www.multivu.com/players/English/7261951-u-s-fda-approves-new-indication-xtandi-capsules-astellas-pharma-medivation
The FDA initially approved XTANDI, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves XTANDI for use in men with metastatic CRPC who have not received chemotherapy. metastatic CRPC is defined as a cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone (i.e., with a gonadotropin-releasing hormone (GnRH) therapy or with removal of the testes).
"The FDA's priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease," said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc. "We are pleased that these patients now have XTANDI available as a treatment option."
"All of us at Medivation extend our thanks to the clinicians and patients who participated in the PREVAIL clinical trial culminating in today's approval," said David Hung, M.D., founder, president and chief executive officer, Medivation, Inc. "As a company dedicated to the rapid development of novel therapies to treat serious diseases, we are pleased to see XTANDI approved in this important patient population."
In the Phase 3 PREVAIL trial, men receiving XTANDI and GnRH therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy.
When compared to placebo, treatment with XTANDI also delayed time to initiation of chemotherapy and time to a skeletal related event.
The safety profile for XTANDI was updated to reflect data from both the AFFIRM and PREVAIL Phase 3 trials.
"Enzalutamide has been studied and is approved for patients with metastatic prostate cancer that is resistant to primary hormonal therapy, a disease state we call castration-resistant prostate cancer. In this setting, enzalutamide has been shown to extend overall survival and significantly delay the progression of prostate cancer," said Tomasz M. Beer, M.D., F.A.C.P., co-principal investigator of the PREVAIL study, deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University. "Furthermore, in the PREVAIL trial, the median time to initiating chemotherapy was delayed by 17 months with enzalutamide treatment as compared to placebo, so the result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy."
A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24, 2014.
The approval of this new indication for XTANDI triggers $90 million in milestone payments to Medivation under its collaboration agreement with Astellas.
Enzalutamide Mechanism of Action
Enzalutamide is an androgen receptor inhibitor that acts on three different steps in the androgen receptor signaling pathway.
about XTANDI ® (enzalutamide) capsules XTANDI (enzalutamide) was approved by the FDA today, September 10, 2014, for the treatment of patients with metastatic CRPC.
important Safety Information
Contraindications: XTANDI (enzalutamide) capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.
Warnings and Precautions: In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of patients who were treated with XTANDI and 0% treated with placebo. In Study 2, conducted in patients with chemotherapy-naïve metastatic CRPC, seizure occurred in 0.1% of patients who were treated with XTANDI and 0.1% treated with placebo. Patients experiencing a seizure were permanently discontinued from therapy and all seizure events resolved. There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited clinical trial experience in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold, wheras Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Adverse Reactions: The most common adverse reactions (≥ 10%) reported from the two combined clinical trials that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.
Other Adverse Reactions include:
Drug Interactions:
在新的指南中,两款药物被认为纳入英国NHS用于治疗多发性硬化症(MS)过于昂贵。国家卫生保健优化研究所(NICE)在新指南中未推荐GWPharma的Sativex(nabiximols)和百健艾迪的Fampyra (fampridine),Sativex是从植物大麻中提取的一种成分。
NICE表示,这两药物“以显著的成本纳入NHS仅提供适度的收益”, Sativex每质量调整生命年(QALY)的花费为5万欧元,Fampyra每QALY的药费为16万欧元,均远远超出NICE每质量调整生命年3万欧元的准入门槛。
这项决定受到包括MS协会在内的英国MS患者组织的批评,它们表示称,NICE对这款药物拒绝“基于有缺陷的评估及不适当的程序。”
MS协会行政长官Mitchell表示称:“NICE拒绝Sativex和Fampyra作为治疗选择的决定真的令人失望。NHS应该追求最创新的治疗药物及可供MS患者使用的护理,而不是进一步限制治疗选择。”
因此,MS协会发布一项号召,呼吁NICE对Sativex进行一个全面的技术评估,意味着对该药物进行一个更“彻底及稳健”的评估。
患者组织对于其它内容表示非常乐观,其旨在基于英国NHS改善MS的诊断及治疗。具体建议包括疑似MS患者应该拜访专科医生,MS不应只基于核磁共振结果而被确诊。
据NICE的信息,每位MS患者每年至少进行一次全面治疗综合检查,治疗应该受一个包含不同卫生保健专业人员团队的监督。MS协会将这些举措描述为“重要进步”。
信源地址:http://www.pmlive.com/pharma_news/nice_denies_two_drugs_in_new_ms_guidance_604553
美国百特宣布,公司将斥资购买Merrimack Pharmaceutical旗下胰腺癌新药MM-398,代价总计最高或为10亿美元。但是业界均认为这是一桩划算的买卖,因为MM-398瞄准的是“癌王”——胰腺癌市场,这是一种纳米脂质体密封的伊立替康,而且FDA和欧洲药监局授予孤儿药的权益。Merrimack公司是一家新兴的美国生物技术企业,目前在研产品为6个抗肿瘤药物。
根据双方签署的协定,美国百特将预付Merrimack公司1亿美元,后者将会在新药第一个和第二个适应症研究和批准达到预期目标之后额外获得总计4亿美元。
此外,Merrimack公司在额外拓展MM-398两个适应症之后获得2.2亿美元,并在产品上市之后获得2.5亿美元销售分成。
收购完成后,美国百特将拥有MM-398在除美国和台湾之外所有地区的使用权。Merrimack Pharmaceutical负责美国市场,而台湾地区的销售权则被智擎生技股份有限公司(Pharma Engine)在2011年以2.2亿美金的价格获得。
据悉,Merrimack公司计划在2014年向FDA提交MM-398的新药申请。百特将会在2015年启动其他地区新药申请。
作为一家以医疗产品为主的公司,百特大手笔收购药品并不常见。结合公司3月27日宣布拆分生物制药业务单独上市的消息,尽管公司宣称相信制药业务能够自立门户,祭出此举或仍可视做为分拆做最后的铺垫。
资料显示,2013年,百特制药业务单元年销售收入为60亿美元,大约是艾伯维的三分之一。其主要产品以血友病药物、免疫肿瘤产品为主,其中血友病产品Advate、Rixubis及Feiba实现销售收入34亿美元,衍生出来的血浆生物治疗药物如Gammagard,实现销售收入21亿美元。值得一提的是,在2014年7月30日以前,疫苗业务也是百特制药的组成部分之一,如今该业务单元被辉瑞以6.35以美元的价格打包收购。
Merrimack Licenses MM-398 - Value Potential Dramatically ImprovesIn early July, I wrote a bear article on Merrimack (NASDAQ:MACK), with a thesis stating that the company's prospects could be limited. In highlighting the implications of Sanofi's (NYSE:SNY) recent action to sever ties to MM-121, I argued that MM-121's poor clinical success rate could have prompted Sanofi to conclude the license agreement because it anticipates further clinical failure. Deeper under the hood, Merrimack's remaining assets are still in early stage trials, which, in fact, have an inherently low success rate. However, the company announced today a license agreement with Baxter (NYSE:BAX) for MM-398, sending shares as much as 27% higher in pre-market trading. As a result, I amen my bear thesis to "hold" since Merrimack is on course to continue developing and eventually commercialize MM-398 under a lucrative partnership arrangement.
Some key highlights of the license agreement with Baxter are as follows:
I have amended my bear thesis on Merrimack to "hold" for reasons two-fold. First, I expect that Merrimack will benefit from enhanced earnings growth going forward into next year. For in addition to the $120 million in milestone payments for the initial indication of MM-398, the company established a lucrative $280 million auxiliary agreement if the compound shows promise in a second pancreatic cancer indication. Merrimack will also receive tiered royalties and $100 million upfront from Baxter, which should benefit earnings for Q3 2014. Second, I maintain that MM-398 could become the standard of care for pancreatic cancer, which resembles a $1.2 billion market opportunity going into 2015. I believe Merrimack's ability to license the drug to a proven winner in Baxter demonstrates the drug's viability. However, I continue to be skeptical about the viability of Merrimack's other cancer treatment in MM-121. As a reminder, Sanofi spent in upwards of $400 million developing MM-121 before walking away from it. Thus, until we learn more about the conditions of the termination, as well as Merrimack's plans to acquire another partner, I will maintain coverage at "hold."
9月17日,位于旧金山的生物技术公司Sutro公司透露公司已经与德国默克公司(Merck KGaA)达成协议,共同开发用于治疗癌症的抗体-药物偶联疗法(ADC)。
根据协议,默克公司将投入总计3亿美元的投资和一些未特殊说明的技术支持。抗体-药物偶联疗法旨在将一些具有明显细胞毒性的药物成分与特异性抗体偶联在一起使其对癌症细胞具有良好的靶向性。
默克与Sutro共同合作开发新型抗体药物偶联疗法
目前这一技术领域的先驱当属Seattle Genetics公司。Sutro公司希望能够进入这一领域开辟新一代的ADC疗法。
而默克公司绝不是最先发现Sutro公司这个”千里马”的伯乐,此前Sutro公司就先后和Celgene、礼来等医药巨头签订合作协议并已经顺利进行了总额为2600万的融资。通过此次与默克公司的合作,Sutro公司将把公司现有员工人数扩展至65人。
此外Sutro公司CEO Bill Newell还表示,公司现在正在考虑进行IPO的可行性。
如此多的制药巨头都争先恐后的与Sutro公司建立合作关系也从一个侧面反映出目前癌症治疗领域中一个热点:癌症的免疫治疗。Sutro公司表示将把ADC与检验点疗法如PD-1、PD-L1等通路相结合,从而达到更有效治疗多种癌症的目的。
而默克公司也希望借助这样的协议重振自己的雄风。近年来,默克公司一直在寻找类似的合作伙伴来促进自己的研究机构重组。几年前公司开发的治疗多发性硬化症药物失败直接促成了公司高层对本公司研究机构的改革措施,而就在不久之前,默克公司开发的癌症疫苗tecemotide正式宣告失败也暗示着默克公司距离涅盘尚有一段距离。
附:Sutro公司的在研产品线(pipeline)
这种抗癌药物的研究主要是以一种名为端锚聚合酶为基础。端锚聚合酶是一种多聚腺苷二磷酸核糖聚合酶,前期研究发现这种酶直接作用于Wnt信号通路,而后者与多种癌症的发生有着密切关系。研究人员希望寻找到一种能够阻断端锚聚合酶的药物分子,并检测其是否具有抗癌作用。
据了解,默克雪兰诺公司和Wellcome Trust将负责提供资金支持,而大部分研究将在癌症研究中心完成,负责此项研究的是ICR的Dr. Chris Lord和Professor Alan Ashworth。而此次研究将以此前由Wellcome Trust投资的课题为基础。Dr. Chris Lord等人表示,对于端锚聚合酶的研究使科学家将治疗癌症的靶点锁定在WNT通路这一具有重要意义的通路上,能够帮助科学家寻找治疗多种癌症的新疗法。而目前ICR的工作人员已经在这一相关领域取得了重要成绩。
根据三方达成的协议,一旦这一药物开发的进程取得预期进展,默克雪兰诺公司将会支付可观的里程碑奖金。而公司除了负责提供相关资金支持外,还将承担药物进入临床研究阶段后的研究工作。
默克雪兰诺公司是德国默克公司旗下的生物医药部门,具有重要地位。近年来默克公司正在对公司的研发系统进行整合重组,然而一直未能见到较好的成效。此次合作也可以看做是公司进一步加强与科研单位合作以深化自身研发单位重组,提高研发效率的措施之一。
详细英文报道:
Darmstadt, Germany, October 07, 2014 - Merck Serono, the biopharmaceutical division of Merck, The Institute of Cancer Research (ICR), and the Wellcome Trust, London, today announced a co-development and license agreement building on two independent research programs at both the ICR and Merck Serono to identify inhibitors of tankyrase, an enzyme of the poly (ADP-ribose) polymerase family.
The collaboration will be jointly funded by Merck Serono and the Wellcome Trust. The existing drug discovery program at the ICR is supported by a Wellcome Trust Seeding Drug Discovery Award.
In a joint effort, a team led by Dr. Chris Lord and Professor Alan Ashworth at the ICR and a research group at Merck Serono will aim to progress chemical compounds that have emerged from both organizations' tankyrase inhibitor programs towards clinical development. At the end of the collaboration period, Merck Serono will take over full responsibility for the selected clinical development candidate, with the goal of bringing a new cancer therapeutic drug to patients.
Dr. Chris Lord, Team Leader in the Division of Breast Cancer Research at The Institute of Cancer Research, London, said: "Tankyrase inhibitors provide a uniqueopportunity to target one of the most common characteristics of cancer cells - their dependency on the so-called 'Wnt signaling' pathway. Both Merck Serono and the group at the ICR have already made notable progress in developing tankyrase inhibitors. Working with Merck Serono will allow us to jointly accelerate our program with the aim to ultimately make tankyrase inhibitors available to cancer patients."
"We are delighted to work together with Dr. Chris Lord and Professor Alan Ashworth. With this partnership, we aim to harness the already well advanced tankyrase programs at both ICR and Merck Serono and hope to ultimately translate these in to novel treatment options for cancer patients. We will build on a joint compound base of potent tankyrase inhibitors and will leverage both sites' scientific knowledge about the 'Wnt pathway' that plays a major role in signal transduction for tumor growth", saidDr. Andree Blaukat, Head of the Translational Innovation Platform oncology at Merck Serono. "The interest of the Wellcome Trust shows its belief in our researchers' scientific data. It also shows the importance of academia-industry collaboration models in pharmaceutical development to progress the most promising investigational compounds into clinics with the aim of bringing them to patients."
"This agreement highlights the importance of translational funding, such as the awards provided under the Seeding Drug Discovery scheme, to reduce the risk of drug discovery programs so that they become attractive to partners who have the ability to bring a product to market", said Dr. Ted Bianco, Director of Innovations at the Wellcome Trust. "We welcome the strategic collaboration with Merck Serono, which brings together a world-leading academic drug discovery group, and an industry partner with such a strong commitment to oncology, to give the program the best possible chances of success."
Some of the most promising advances in cancer research have been small-molecule inhibitors which block the activity of members of the poly (ADP-ribose) polymerase (PARP) enzyme family, which includes the enzyme tankyrase.1
Under the terms of the agreement, Merck Serono will make milestone payments based on achieving regulatory and sales goals plus royalty payments on net sales of future products discovered or developed under the agreement.
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