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2014年7月9日国内国际新药信息大荟萃
一、国内
亚宝药业携手礼来开发糖尿病新药LY2608204 发布日期：2014-07-09 来源：大智慧阿思达克通讯社
亚宝药业7月7日宣布，正式和礼来达成战略伙伴关系，共同开发礼来糖尿病新药LY2608204。该药物在美国已经完成临床I期和大量临床前工作。
根据双方签订的协议，亚宝药业将拥有新药在中国的开发和使用权，负责项目的融资和开发，而礼来将负责其他市场，并拥有产品买回权。具体细节公司并未予以透露。
糖尿病新药LY2608204属于葡萄糖激酶激动剂，能促进胰岛素分泌以及降低葡萄糖生产。
二、国际
华急性淋巴细胞白血病（ALL）新药CTL019获FDA“突破性疗法”认证
瑞士诺华7月7日宣布，美国食品药品监督管理局（FDA）正式授予公司T细胞疗法CTL019“突破性疗法”认定。该疗法可用于治疗难治、复发性急性淋巴细胞白血病（r/r ALL）。
根据FDA的规定，突破性疗法认定主要是为了鼓励药企加速重大新药开发，并且在药物研发完毕后享受一切FDA审批的绿色通道。
该疗法由诺华和美国宾夕法尼亚大学共同开发，现在处于临床II期。CTL019使用嵌合抗原受体修饰（CAR）修改患者体内T细胞，并引导新T细胞攻击并杀死CD19+癌细胞。
急性淋巴细胞白血病多见于儿童，25%的患者都为15岁以下。
抗PD-1明星药物nivolumab获准在日本上市销售 发布日期：2014-07-09 来源：fiercebiotech
近日，抗PD-1明星药物nivolumab获准在日本上市销售，这是该药物首次赢得主要市场药监机构的批准，用于治疗不能手术切除黑色素瘤患者。小野制药早在2005年与Medarex公司合作获得了该药物在日本销售权利。
小野现在表示，它计划为该药物申请国民健康保险项目，以免费为患者提供这个广受瞩目的药物。该公司还打算继续研究该药物在其他癌症方面的用途，并计划对开展上市后研究。这款药物在日本以商品名Opdivo出售。不过，它并不是唯一一个在日本获得尖端疗法认证的药物。百时美施贵宝今天报道称，日本监管机构已批准了组合丙肝治疗药物——Daklinza和Sunvepra用于治疗基因型1型患者。这是第一个不含干扰素和利巴韦林的丙肝治疗复方制剂。Medarex公司已被百施美施贵宝收购，留下了这个尖端疗法，阻止癌细胞在免疫系统中保持隐藏的隐形机制。百施美拥有日本、韩国和台湾之外市场的销售权利。Nivolumab是领先的在研IO药物之一，和默克公司的pembrolizumab（MK-3475）一直在竞争，默克还在忙于提交美国和欧洲的审查。默克可能会这场竞赛中占得先机，但一些分析师认为百施美的药物更可能获得最大市场份额。这个领域很可能价值数十亿美元，组合药物和单一疗法有望改变癌症治疗的传统规则。同时罗氏也是该领域的领导者之一，而阿斯利康也在用自己雄心勃勃的发展计划紧跟他们的步伐。百施美为它的发展计划已经投入了数亿美元，但就在两个星期前公司宣布比原计划提前结束nivolumab的后期研究，因为监督委员会审查了中期数据后得出结论认为，作为一线治疗BRAF基因野生型晚期黑色素瘤的药物使用时，PD-1药物组的生存获益明显优于达卡巴嗪。“我们预计nivolumab将成为免疫疗法中的佼佼者，” 英国PMLive决策资源公司分析师Nawaz最近表示，“不过，这将面临其他抗 PD1/PDL1药物激烈的竞争，特别是在恶性黑色素瘤和非小细胞肺癌领域面临来自pembrolizumab的压力。”“我们很高兴获得针对PD-1药物的生产和销售许可，在肿瘤免疫方面它首次受到了世界上很多的关注，”小野总裁木桥相良表示，“小野公司希望继续发展该药物用于其他癌症适应症，并获得批准。”信源地址：http://www.fiercebiotech.com/sto ... approval/2014-07-07
Zogenix计划明年使止痛药Zohydro正式上市
Zogenix加速止痛药Zohydro研发审批进程
Zogenix公司最近宣布公司对于改进其强效止痛药Zohydro已经取得了重要进展。据了解，此次改进主要是为了满足FDA对其要求的防止Zohydro被滥用。公司表示计划在今年十月份向FDA提交胶囊型Zohydro，这种剂型的Zohydro将更难以被成瘾者滥用。公司计划于明年使Zohydro正式上市。然而，这对于Zogenix公司来说还不是高兴的时候。今年来世界各大制药巨头纷纷进军非成瘾类止痛药药物市场。如Purdue医药公司、梯瓦医药公司、辉瑞公司，他们都在这一领域投入了巨大人力物力。其中梯瓦公司的非成瘾止痛药产品已经取得了足够的数据。因此留给Zogenix公司的时间已经很少了。详细英文报道：Zogenix knows it needs to step on the gas. If the company doesn't develop an abuse-resistant version of its controversial-and-powerful painkiller Zohydro--and quickly--another drugmaker will speed past. And that could put Zohydro out of the race completely.Zogenix recently met with FDA officials to hash out a timeline for new versions of Zohydro, the first all-hydrocodone painkiller. It's now planning to submit a version of the extended-release drug in capsule form in October, aiming to launch early next year. That formulation would be more difficult to abuse by injection or snorting, the company said in a statement. And it's aiming for the first half of 2016 for a filing on a hard-to-abuse tablet.It's none too soon. Purdue Pharmaceuticals, inventor of the notorious painkiller blockbuster OxyContin, is already hard at work on a hydrocodone-only, abuse-resistant pill. Given that it has already introduced an abuse-deterrent version of OxyContin, Purdue obviously has the technology to pull off a similarly formulated hydrocodone pill.Meanwhile, Teva has racked up enough Phase III data on an abuse-resistant version of extended-release hydrocodone for an FDA filing later this year. AndPfizer has its own high-powered painkiller on the way, with tamper-resistant features already built in. The drug giant recently touted results of three key studies on that drug, ALO-02.Aside from the competitive considerations, there's the public relations factor to consider. Since Zohydro won FDA approval last year, Zogenix has been under fire for marketing such a powerful painkiller without tamper-resistant features. After all, the U.S. has experienced an epidemic-level addiction problem, and law enforcement officials across the country have been scrambling to fight back. Massachusetts Gov. Deval Patrick even tried to ban the drug from his state, citing its potential for abuse. And the FDA hasn't gone unscathed, either; lawmakers and activists panned the agency's approval and lobbied for FDA to revoke it.The FDA has staunchly defended its decision, saying there are plenty of legitimate patients who need a drug like Zohydro to deal with excruciating pain. Zogenix set up an oversight board to help track sale stats to identify any misuse early on.But the FDA has also said that it's eager to approve abuse-deterrent alternatives to Zohydro if they became available. In fact, the agency's pain drug chief Bob Rappaport has said that FDA would consider pulling Zohydro from the market if those alternatives win approval.
瑞士模式的启发 抗癌药研发需要统一战线 发布日期：2014-07-09 来源：中国新药杂志
当1971年美国总统尼克松呼吁发起“抗癌战争”的时候，人们相信，医学上的科研一定能在10年内战胜这一病症，但是实际情况却复杂得多。
瑞士40%的医药研究用于癌症科研。科研重点在心血管、免疫系统和大脑疾病的研究上。癌症依然是一个难以破解的病症，目前发现了250种癌症的类型，而引发癌症的机制至今依然是个迷。而且每一种癌症类型，都需要不一样的观察角度。Frings说，因为癌细胞可以渗透到人的身体中，因此它们也带有超强的适应能力，它们可以逃跑；可以变异；可以分散；可以生长及产生抗体。所以癌症科研的进展非常缓慢，几年之内可能也就迈出一小步。
2015年抗癌药销售额将增长到710亿瑞郎，与2009年相比增长40%。然而科研的最终目的是，找到治疗癌症的有效药，根据瑞士抗癌协会(Krebsliga)的数字，每三个人中就会有一个受到癌症的威胁。“瑞士抗癌协会是一个非营利单位，他们的目的也与制药中心一致，该组织的最大问题是，缺乏资金，”瑞士抗癌研究联盟(SAKK)的Beat Thürlimann这样说：“工业范畴对于研发抗癌药物的投资比学术机构多30倍。”肿瘤是重点制药大王罗氏，50年前研究出了第一个癌症分子，现在它是世界范围内第三大抗癌药物生产商，10种最畅销的抗癌药物中的5种，来自罗氏。罗氏控制着药物市场的三分之一。肿瘤药物占其中的50%以上，2012年罗氏投资85亿瑞郎用于科研和发展。相当于其销售额的19%。罗氏肿瘤部负责人Stefan Frings表示：“每年的科研投资必须能研发出最新的畅销药物，这样才能有收益进行更多的科研。”传统的癌症治疗，如放疗和化疗，占市场份额的四分之一。患者、政府、医生和制药业的梦想是：增加更有效、副作用少、因人而异的治疗方法。这就需要对肿瘤学更深度的了解。大范围的拓展比较困难这样的药物虽然需要很多资金，但是疗效显着。诺华2011年得到了生产格列卫(Glivec)的许可，该药物当时被予以众望，而今天它失去了部分光芒。对于抗癌药物的科研来说，专利的丧失、严格化的制度和政府拒绝承担费用，都是严峻的挑战，这也是为什么大范围内推广的困难所在。艾美仕市场研究公司的Frings认为，制药业应该尝试研发或者购买专利，并在这方面开展革新，开发畅销新药。个性化治疗个性化治疗是指根据个人具体情况采取不同的治疗。重要的分子研究得出这样的重要认知：没有同样形式的癌症。癌症并不是一种独一无二、能够清晰描述的疾病，而是一种拥有250种类型的疾病，人身体的所有器官都有可能受到癌症的侵袭，癌症的症状各式各样。无论是乳腺癌、肺癌、肝癌、肠癌还是皮肤癌，所有癌症都由基因病变引发。基因科研的进步，令人能够更好地了解基因对于癌症的影响。引发癌症的基因名单尚不完善，因此世界各地的科学工作者们都在致力于从事“癌症基因组”项目的研究。以找出癌症的引发原因。这一国际科研项目的目标是，找出引发50种最常见癌症的原因。噩梦：费用无人支付倘若没有专利保护制度，那么药物开发商们则会失去兴趣，Thürlimann对瑞士资讯这样表示，研发药物有时候得不偿失，这是因为专利马上到期了或者市场不够大。对于瑞士抗癌研究联盟来说，目标不在于发明什么灵丹妙药，而是找出对患者最有利的治疗方案。该联盟每年1200万瑞郎资金中用于临床调查的40%，来自官方机构，30%来自补贴，另外30%来自工业范畴。但是Thürlimann认为：“癌症患者的噩梦是，那些有疗效的药物，非常昂贵，没有人愿意报销这笔费用，”他说：“药物的价格不应该只与疗效挂钩。我们可以尝试一下，短疗程内小剂量用药的效果如何。”2014年财富500强制药公司排名 发布日期：2014-07-09 来源：《财富》杂志 《财富》杂志7月7日全球同步发布了最新的《财富》世界500强排行榜，零售业巨头沃尔玛重回榜首，中国上榜公司数量创纪录地达到100家，中石化取代埃克森美孚，排名第三，打破了该公司与沃尔玛和壳牌三足鼎立的历史。2014年《财富》世界500强排行榜上中国上榜公司的数量继续保持增长态势，总数已经达到100家。
在制药板块，除了强生、中国医药和罗氏排名上升外，其他制药公司2014年排名均比2013年排名略有下降，下滑最快的两家公司为辉瑞和阿斯利康，分别下跌了43位和55位。雅培直接从去年261名跌出500强之外，很可能与艾伯维的剥离有关。强生稳居第一宝座，第二名的位置则被诺华占据，尽管排名比去年下降了一些，辉瑞则从去年的第二职位退到第3位。详细榜单见下图。2014年财富500强制药公司排名2009年财富500强制药公司排名本排行榜按照截止日不晚于2013年3月31日的财务年度的营业收入对公司进行排名。所有上榜公司必须公布其财务数据并将部分或全部数字提交政府机构。数字以各公司报告为准，比较对象为最初报告的上一年数字。《财富》杂志不因会计规则变化而重新确定上一年的数字。如欲了解雇员人数、首席执行官、公司总部、官方网站、收入年增减情况等更详细内容，请点击相应公司名称。(生物谷Bioon.com)
勃林格殷格翰白血病新药VolasertibII期临床效果显著 发布日期：2014-07-09 来源：boehringer-ingelheim
德国勃林格殷格翰7月8日在其官网上公布了Volasertib II期临床的最新进展。该药物可用于65岁及以上、不适合诱导化疗方案的急性髓细胞性白血病(AML)患者。 Volasertib是一种Polo样激酶(Plk)抑制剂，用于抑制Plk1的活性，进而抑制细胞分裂，延长细胞周期停滞时间以及最终导致细胞死亡。 临床II期数据显示，Volasertib联合低剂量阿糖胞苷(LDAC)能延缓AML患者平均寿命，从原先单单使用LDAC的5.2个月上升至8个月。联合用药的应答率也从原先的13.3%上升至31%。 美国食品药品监督管理局于2013年给予Volasertib突破性疗法认定，并在2014年和欧盟药监局共同授予volasertib孤儿药地位。现在Volasertib联合低剂量阿糖胞苷正在临床III阶段。 AML是一种罕见的、极具侵略性的骨髓、血液系统肿瘤，约占成人白血病的30%，AML在所有白血病类型中成活率最低，确诊后的平均生存期仅为1年或更低。
Boehringer Ingelheim’s volasertib showed in a Phase II study an improvement in overall survival in older AML patients• In older, untreated AML patients not suitable for intensive chemotherapy, volasertib* combined with chemotherapy led to prolonged survival times compared to chemotherapy alone
• Volasertib* also more than doubled remission rates
• AML is a rare type of aggressive cancer of the bone marrow and blood predominantly affecting adults over 60For media outside of the US/UK only
Summary:
Acute Myeloid Leukaemia (AML) is an aggressive and devastating blood cancer. 1,2 It predominantly affects people over 60 and is one of the most common adult leukaemias in the Western World.1 The current standard of care is intensive chemotherapy, but many older patients cannot tolerate this therapeutic approach; their options are limited and their prognosis is poor. For older AML patients not suitable for intensive chemotherapy, low dose cytarabine (LDAC) is a well-established form of chemotherapy. Volasertib*, currently being developed by Boehringer Ingelheim, showed in recent studies to be a potentially promising alternative treatment for these patients. In this Phase II clinical trial volasertib*, combined with LDAC, led to prolonged survival times and more than doubled the percentage of patients achieving remission compared to LDAC alone. Volasertib* is currently being investigated in combination with LDAC in a Phase III clinical trial.Ingelheim, Germany, 08 July 2014 – Results from a Phase II study, published (today) in the American Society of Hematology journal Blood,3 showed patients with previously untreated acute myeloid leukemia (AML) aged 65 or older and ineligible for intensive remission induction therapy, lived longer when treated with volasertib* combined with low dose cytarabine (LDAC), a form of chemotherapy, compared to LDAC alone. The overall survival data showed that volasertib*, when used in combination with LDAC, increased the percentage of older AML patients who achieved remission.“Despite being a rare disease, AML is one of the most common leukaemias in adults and predominantly affects older people. The established approach to treat younger AML patients is an intensive chemotherapy regimen, called intensive induction therapy. However, older patients often cannot tolerate these chemotherapy doses, and have very limited treatment options,” commented Prof. Döhner from the Department of Internal Medicine III of the University Hospital Ulm and principal investigator of the Phase II trial. “These clinical trial results that evaluated volasertib in combination with a lower intensity chemotherapy are important and have informed future research for this rare disease, wher new treatment options are greatly needed.”The Phase II clinical trial showed patients treated with volasertib* combined with LDAC had a median overall survival of 8 months versus 5.2 months in patients treated with LDAC alone. The response rate (complete remission or complete remission with incomplete blood count recovery) was more than doubled for patients receiving volasertib* and LDAC versus LDAC alone (31% versus 13.3%).Volasertib* is an investigational compound that inhibits enzymes called Polo-like kinases (Plks). Plk1 is the best characterized kinase of the Plk family. Inhibition of Plk1 by volasertib* ultimately results in cell death (apoptosis).4 By inhibiting Plk1 activity, the extremely high cell division that is characteristic of AML should be blocked, which may result in cancer regression.
Prof. Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim
The most common non-haematological adverse events for patients receiving the combination treatment were decreased white blood cells with fever and infections and gastrointestinal side effects. These side effects were clinically manageable and were expected given the mechanism of action of volasertib*.3,5
“As with other rare and life threatening diseases, the need for new treatment options in AML is very high. Boehringer Ingelheim is committed to research in areas of unmet medical need, including those in rare diseases.” commented Prof. Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “We are pleased to see that volasertib* has shown promising overall survival results in this clinical trial and we are optimistic that the drug will further demonstrate its potential benefit in this rare disease in the ongoing Phase III study.”Volasertib* was awarded Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in 2013 and Orphan Drug Designation by the FDA and the European Commission in 2014. It is currently being investigated in combination with LDAC in a randomised, double-blind, multi-centre, controlled Phase III clinical trial for AML called POLO-AML-2.Indication
Acute Myeloid Leukaemia (AML)Product
Volasertib*Notes to editors:about the volasertib* Phase II resultsThe results of the Phase II clinical trial published in Blood3 included the following endpoints:- Response rate (complete remission or complete remission with incomplete blood count recovery) was more than doubled for patients receiving volasertib* and LDAC vs LDAC alone (31% vs 13.3%, 13 of 42 patients vs 6 of 45 patients; odds ratio, 2.91; P=0.052).
- Median event-free survival was prolonged in patients receiving volasertib* and LDAC vs LDAC alone (5.6 months vs. 2.3 months; hazard ratio [HR] 0.57, 95% confidence interval [CI], 0.35–0.92; P=0.021)
- Remissions achieved by the combination appeared to be more durable (the relapse free survival for volasertib* and LDAC vs LDAC alone was 18.5 vs. 10.0 months, 13 vs 6 patients)
- Median overall survival was 8.0 months vs 5.2 months, respectively (HR 0.63, 95% CI, 0.40-1.00; P=0.047).
- Responses in patients receiving volasertib* and LDAC were observed across all genetic groups, including 5 of 14 AML patients with adverse genetics.
- Patients receiving volasertib* and LDAC showed a higher rate of adverse effects (AE), in particular febrile neutropenia grade 3 (38% vs. 7%), infections grade 3 (38% vs. 7%) and gastrointestinal AEs grade 3 (21% vs. 7%).
about volasertib*
Volasertib* is an investigational, selective and potent inhibitor of enzymes called Polo-like kinases (Plks). Plk1, the best understood of the five known Plks, has an important role in cell division.6 Inhibition of Plk1 by volasertib* results in cell cycle arrest with subsequent induction of apoptosis (programmed cell death).4 Volasertib is currently being evaluated in clinical trials for acute myeloid leukaemia and is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for the treatment of cancer.about the POLO-AML-2 Study
POLO-AML-2 (NCT01721876) is a randomised, double-blind, multi-centre, controlled Phase III clinical trial of volasertib* in combination with LDAC in patients aged 65 years and older with newly diagnosed AML, not suitable for intensive induction therapy.
For additional information on the trial, please visithttp://clinicaltrials.gov./ct2/show/NCT01721876?term=Volasertib&rank=4about Acute Myeloid Leukaemia (AML)
Acute myeloid leukaemia is an aggressive and devastating blood cancer mainly affecting people over age 60.2 It is one of the most common types of acute leukaemia in adults, accounting for approximately one third of all adult leukaemias in the Western world1 and with one of the lowest survival rates of all leukaemias.2In AML patients the prognosis worsens with increasing age, with a median survival of less than a year7 following diagnosis. The current standard of care for younger AML patients is intensive chemotherapy. However, 40% of AML patients cannot tolerate this treatment due to their age and comorbidities and the debilitating side effects.8 Especially for those older patients there is an unmet medical need for new and effective treatment options.about Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Volasertib* is the most advanced pipeline compound for haematological cancers. The pipeline for haematological cancers also includes two new biological entities (NBEs) using an immunotherapeutic approach: BI 836858 is an anti-CD33 antibody targeting AML and BI 836826 is an anti-CD37 antibody targeting chronic lymphocytic leukaemia (CLL) and B-cell non-Hodgkin's lymphoma (B-NHL).Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to advance the disease area.Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.*Volasertib is an investigational compound and is not yet approved. Its safety and efficacy have not yet been fully established.Endo新型止痛药BEMA 叔丁啡三期临床研究达到预期目标
Endo、BDSI止痛药物三期临床研究获得良好结果即将申报FDA
著名止痛药生产者Endo生物医药公司最近宣布公司开发的新型止痛药BEMA 叔丁啡临床三期研究达到了预期目标，这也为Endo公司向FDA提交上市申请扫清了障碍。BEMA（BioErodable MucoAdhesive）是一种基于BioDelivery Sciences International公司的载药系统开发而成的新型止痛药。临床研究显示，患者使用这种药物15分钟内即可明显抑制病痛。BEMA三期临床的成功不仅让Endo公司股价上扬15％，还为其赢得了BDSI公司1000万美元的里程碑经费。分析人士认为BEMA的年销售峰值约为3亿美元。但是考虑到近期辉瑞、剃瓦等制药巨头纷纷推出自己的止痛药产品，BEMA前景如何应该尚属未知之数。详细英文报道：More than two years ago the pain specialist Endo Pharmaceuticals ($ENDP) stepped up with a $180 million deal to license rights to BEMA Buprenorphine, a pain therapy that had been repackaged using delivery tech from BioDelivery Sciences International ($BDSI), even though it had just failed the primary endpoint in a critical Phase III study. Today, Endo put out the word that its gamble had paid off, saying that a new Phase III trial hit the goal line on reduction in pain compared to a placebo, putting the treatment on a path to the FDA for a marketing decision.BEMA--or BioErodable MucoAdhesive--technology relies on a dissolvable polymer from BDSI that is put on the inside of the cheek, delivering its dose through the mucous membranes in less than 30 minutes so patients can get a quick hit of pain relief from the buprenorphine in the package.The successful Phase III triggers a $10 million milestone for Raleigh, NC-based BDSI. The company's shares surged 15% on the news this morning."We are highly encouraged by today's announced study results, which we believe are meaningful for appropriate patients requiring an opioid," said Dr. Susan Hall, Endo's Dublin-based executive vice president, chief scientific officer and global head of research and development and quality. "And we look forward to now focusing on our upcoming pre-NDA meeting this month with FDA followed by the preparation and submission of our NDA for BEMA buprenorphine as soon as possible."Endo needs all the help it can get. The recent loss of patent protection on the pain patch Lidoderm triggered a tidal wave of red ink at the company as low-priced generics scooped up the market. Endo chief Rajiv De Silva responded by going on an M&A spree. A few weeks ago the company bought out the generics company DAVA Pharmaceuticals in a deal worth up to $600 million. And earlier it bought out Paladin Labs for $1.6 billion. The buyouts followed a restructuring a year ago that led to the loss of 700 jobs--a move that came soon after De Silva took the reins as one of its biggest investors scouted for someone to make a bid for the company.Some analysts have estimated peak sales for this product at about $300 million. But there are a number of new products nearing the opioid market as a variety of developers from Teva ($TEVA) to Pfizer ($PFE) and Zogenix race ahead with new and improved treatments.
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