美国食品和药物监管局(FDA)1月1日晚宣布，2014年核准的新药数量为41种，创18年来新高，为历史第二高纪录，仅次于1996年的53种。
与此同时，欧洲药监局去年核准的新药(含新仿制药)数量为82种，超过2013年的79种和2012年的57种。
作为FDA批准药物丰硕的一年，其中抗肿瘤领域有9只药物获批，成为获得批准药物最多的领域。其次，4只糖尿病药物，4只新型抗菌药物，其中新型抗菌药物获得批准对该领域目前疲软的新药研发，无疑起着积极的推动作用。 1月 ★ 达格列净
适应症：2型糖尿病
看点：钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂达格列净是FDA批准的第二种SGLT2抑制剂，通过抑制表达于肾脏的SGLT2，减少肾脏的葡萄糖重吸收，从而降低血浆葡萄糖水平。
★ 他司美琼
适应症：失明患者非24小时睡醒障碍(Non-24)
看点：这是该适应症获得批准的首只药物。Non-24是一种严重、罕见、慢性昼夜节律紊乱的疾病。
2月 ★ elosulfase alfa
适应症：粘多糖沉积症 IVA型
看点：首个被FDA批准的粘多糖沉积症 IVA型治疗药物，比预期提前两周获得批准。粘多糖病Ⅳ型(Morquio综合症)，有两个亚型:ⅣA为半乳糖-6-硫酸酯酶(GALNS)缺乏，ⅣB为β-D半乳糖酶缺乏。该病为常染色体隐性遗传，其临床特点为明显的生长迟缓、步态异常和骨骼畸形且逐渐显著，病人寿命多为20～30岁。
★ 屈昔多巴
适应症：原发性自主神经衰弱(帕金森病，多系统萎缩症和纯自主神经衰弱)、多巴胺β羟化酶缺乏症、非糖尿病性自主神经病变等患者的症状神经源性体位性低血压(NOH)
看点：屈昔多巴是首个也是唯一一个获FDA批准用于NOH治疗的药物，也是近20年NOH对症治疗的首个新治疗选择，被FDA授予加速审批。
★ 美曲普汀
适应症：因全身性脂肪营养不良，无法分泌足够的瘦素而引起的代谢异常，包括胰岛素抵抗
看点：美曲普汀作为替代疗法治疗该症，这也是治疗该症的首个药物。
3月 ★ Florbetaben F18
适应症：阿尔兹海默病
看点：Florbetaben F18是FDA批准的第3只阿尔茨海默病诊断试剂，用于PET扫描检测β-淀粉样蛋白斑，之前还批准了Vizamyl (flutemetamol F18)、Amyvid (florbetapir F18)，florbetaben F18与flutemetamol F18属于同类化合物。
★ 米替福新
适应症：利什曼原虫病
看点：米替福新是FDA批准第一个治疗皮肤或粘膜利什曼原虫病药物。利什曼原虫病是由利什曼原虫引起的一种疾病，通过沙蝇叮咬传播给人类，该疾病主要发生热带和亚热带地区。
★ 阿普斯特
适应症：活动性银屑病关节炎
看点：阿普斯特的临床应用还在继续开发，日后可能应用于类风湿性关节炎、Crohn病、溃疡性结肠炎等多个适应症的治疗。据 FDA声明，作为上市后要求，生产商将通过一项妊娠注册研究评估该药物对妊娠女性的暴露效应。
4月 ★ 阿必鲁泰
适应症：2型糖尿病
看点：阿必鲁泰属于胰高血糖素样肽-1(GLP-1)受体激动剂。每周1次皮下注射剂阿必鲁泰，结合饮食和锻炼，可改善2型糖尿病患者的血糖控制情况。
★ ramucirumab
适应症：晚期胃癌或胃食管结合部腺癌
看点：ramucirumab是特异性阻断血管内皮生长因子受体2(VEGFR2)及下游血管生成相关通路的人源化单克隆抗体。ramucirumab被批准用于治疗化疗失败的胃癌或胃食管连接处腺癌。
★ siltuximab
适应症：罕见病多中心型巨大淋巴结增生症(MCD)
看点：该病亦称Castleman病(Castleman’s disease，CD)，属原因未明的反应性淋巴结病之一，临床较为少见。该病症主要发生在成年人身上，由于某种类型的白细胞过度生产导致淋巴结肿大，该病可能削弱免疫系统，使之难以对抗感染。患者通常出现夜间盗汗，发烧，体重下降以及虚弱等症状。
★ 色瑞替尼
适应症：晚期(转移)非小细胞肺癌(NSCLC)
看点：色瑞替尼是一种间变性淋巴瘤激酶(ALK)酪氨酸激酶抑制剂，阻断促进癌细胞发生蛋白，适用于接受克唑替尼治疗后发生转移的ALK-阳性NSCLC患者的治疗。克唑替尼是先前唯一被批准的ALK酪氨酸激酶抑制剂。
5月 ★ 沃拉帕沙
适应症：心脏病、中风等心血管疾病
看点：沃拉帕沙是一种首创的蛋白酶激活受体1(PAR-1)拮抗剂，可以抑制血凝凝块的形成。PAR-1是一种可被凝血酶激活的受体，而凝血酶是一种有效的血小板激活剂。沃拉帕沙能够抑制血小板上PAR-1受体，从而抑制凝血酶诱导的血小板聚集。
★ vedolizumab
适应症：中重度克罗恩病和溃疡性结肠炎(UC)
看点：该药物是一种可注射的单克隆抗体，适用于那些对一种或者多种常规治疗(例如糖皮质激素，免疫调节剂，肿瘤坏死因子抑制剂)不应答的患者。
★ 达巴万星
适应症：急性细菌性皮肤和皮肤结构感染(ABSSSI)
看点：达巴万星是首个也是唯一一个获批用于ABSSSI治疗的双剂量方案的静脉注射(IV)抗生素。它属于第二代、半合成脂糖肽，可将一个亲脂性侧链加入到一种增强的糖肽主链。该药在体外对多种革兰氏阳性菌(包括MRSA和化脓性链球菌)及其他链球菌种细菌均表现出杀菌活性，将用于治疗革兰氏阳性菌(包括耐甲氧西林金黄色葡萄球菌，MRSA)导致的急性细菌性皮肤和皮肤结构感染。
6月 ★ 磷酸泰地唑胺
适应症：急性细菌性皮肤和皮肤组织感染(ABSSSIs)
看点：磷酸泰地唑胺获批具体的目标是由革兰氏阳性细菌引起的感染，包括：金黄色葡萄球菌(包括耐甲氧西林[MRSA]和甲氧西林敏感[MSSA]菌株)、酿脓链球菌、无乳链球菌、咽峡炎链球菌群(包括咽峡炎链球菌，中间型链球菌和星群链球菌)以及粪肠球菌。
★ efinaconazole
适应症：灰指甲
看点：该药是首个外用三唑类抗真菌药物。灰指甲是一种发生在人指(趾)甲上的传染性疾病的俗称，是由一大类称做病原真菌的微生物感染引起，该病目前治疗不足，很大程度上是由于现有治疗药物的局限性。
★ Belinostat
适应症：侵袭性非霍奇金淋巴瘤(NHL)
看点：这是自2009年以来第三种获准用于这一罕见的NHL治疗型的药物。另外两种药物分别是2009年批准的叶酸类似物代谢抑制剂普拉曲沙注射剂(Folotyn)，以及2011年批准的组蛋白去乙酰化酶(HDAC)抑制剂罗米地辛(Istodax)。该药适用于至少接受过一种治疗的PTCL患者。
★ Tavaborole
适应症：趾甲真菌感染
看点：Tavaborole是首个用于治疗趾甲感染的氧硼戊环(oxaborole)类抗真菌药物。Tavaborole未来还有望用于手指甲感染。
★ idelalisib
适应症：复发性慢性淋巴细胞白血病(CLL)、滤泡性淋巴瘤(FL)和小淋巴细胞性淋巴瘤(SLL)
看点：idelalisib为口服激酶抑制剂，和利妥昔单抗(Rituxan)联合治疗复发性CLL，作为单药治疗复发性滤泡B细胞FL和复发性SLL。FDA对后两个适应症授予加速审批，要求患者之前至少接受过两次全身治疗。
★ olodaterol
适应症：慢性阻塞性肺病(COPD)
看点：该药是一种吸入性长效β-肾上腺素受体激动剂(LABA)，有助于肺气道周围肌肉保持松弛而预防疾病症状。
8月 ★ empagliflozin
适应症：2型糖尿病
看点：empagliflozin是一种钠糖共转运蛋白2(SGLT2)抑制剂，可阻断肾脏对葡萄糖的重吸收，增加葡萄糖排泄，降低血糖水平。该药每日一次口服。
★ oritavancin
适应症：急性细菌性皮肤和皮肤结构感染(ABSSSIs)
看点：该药是FDA批准用于ABSSSIs治疗的首个和唯一一种单剂量治疗方案的抗生素。
★ suvorexant
适应症：睡眠障碍
看点：新型催眠药物suvorexant是首个获批的食欲素受体拮抗剂，它通过阻断神经肽食欲素A和B与食欲素受体的结合，从而抑制神经元对唤醒系统的激活作用。
★ 聚乙二醇干扰素β-1a
适应症：复发性多发性硬化症(MS)
看点：聚乙二醇干扰素β-1a在干扰素β基础上经过了结构改良，延长药物半衰期，从而在不影响疗效的情况下，减少给药频率。具体给药方案为皮下注射聚乙二醇干扰素β-1a，两周一次。
★ eliglustat
适应症：1型戈谢病
看点：该药用于长期治疗1型戈谢病成年患者。
9月 ★ pembrolizumab
适应症：晚期或不可切除黑色素瘤
看点：pembrolizumab是FDA批准的首只人程序性死亡受体-1(PD-1)类药物。
★ naloxegol
适应症：阿片诱发性便秘
看点：naloxegol属于作用于外周的阿片受体拮抗剂，用来减轻成年慢性非癌性疼痛患者的阿片类药物便秘影响。
★ dulaglutide
适应症：2型糖尿病
看点：该药物为一周一次皮下注射剂，是一种胰高血糖素样肽-1(GLP-1)受体激动剂。
10月 ★ sofosbuvir/ledipasvir
适应症：基因1型的丙型肝炎(HCV)感染
看点：该复方制剂取名为Harvoni。它是第一个批准用于治疗基因I型HCV感染，且不需要联合注射药物干扰素或利巴韦林的全口服抗丙肝方案。
★ netupitant/palonosetron hydrochloride
适应症：癌症化疗患者的恶心及呕吐
看点：其复方制剂名为Akynzeo。palonosetron hydrochloride于2008年获得批准，用于预防癌症化疗开始之后急性期(24小时内)产生的恶心和呕吐。netupitant是一种新药，用于预防癌症化疗开始后急性期与延迟期(从化疗后25～120小时)恶心和呕吐。
★ sulfur hexafluoride lipid-type a microspheres
适应症：超声波心动图左心室浑浊
看点：该药用于超声心动图图像难以辨认，改善左心室心内膜边界划界。
★ nintedanib和pirfenidone
适应症：特发性肺纤维化
看点：这两款新药均获得FDA快速审批、优先审批、突破性药物和孤儿药四种地位。
12月 ★ blinatumomab
适应症：染色体阴性前B细胞急性淋巴细胞白血病(B-细胞ALL)
看点：免疫疗法具有独特的作用机制，特别是blinatumomab，对于白血病患者疗效较好。FDA曾主动与赞助商协商对药物进行突破性疗法指定，以促进这一新型药物的批准。
★ finafloxacin
适应症：急性外耳道炎
看点：finafloxacin属于FDA批准的最新氟喹诺酮类抗菌类药物，用于治疗由绿脓杆菌和金黄色葡萄球菌引起的急性外耳道炎。
★ ceftolozane/他唑巴坦
适应症：复杂腹内感染(cIAI)和复杂性尿路感染(cUTI)
看点：ceftolozane含有头孢菌素抗菌药物ceftolozane和β-内酰胺酶抑制剂他唑巴坦的组合产品。
★ olaparib
适应症：有缺陷的BRCA基因晚期卵巢癌治疗
看点：olaparib是聚ADP-核糖聚合酶(PARP)抑制剂，参与修复受损的DNA。批准olaparib的同时，FDA还批准了同伴诊断测试产品BRACAnalysis CDx。
★ ombitasvir/paritaprevir/dasabuvir
适应症：基因1型慢性丙型肝炎病毒(HCV)感染，包括晚期肝硬化
看点：这款组合产品名为Viekira Pak，它包含的三种新药ombitasvir，paritaprevir和dasabuvir协同抑制HCV的增长。还包含以前批准的药物利托那韦，用于增加paritaprevir的血液水平。
★ 帕拉米韦
适应症：流感感染
看点：帕拉米韦是流感病毒神经氨酸苷酶抑制剂，神经氨酸苷酶是从感染细胞的病毒颗粒释放的酶。神经氨酸酶抑制剂是常用于治疗流感感染的药物。帕拉米韦是第一只批准用于静脉内(IV)给药的神经氨酸酶抑制剂。
★ nivolumab
适应症：晚期黑色素瘤
看点：nivolumab是pembrolizumab以外，今年FDA加速审批的另一只PD-1药物，用于用于其它药物无效而不可切除或转移性(晚期)黑素瘤治疗。
Specialty drug approvals: Review
of 2014 and a forecast for 2015
Specialty Pharmacy Section
The impact of specialty drugs continues to increase in both drug utilization and spend. In 2012, specialty drug spend accounted for approximately $87 billion, or about 3.1% of national health spend in the United States. In 2020, the forecasted specialty drug spend is expected to be $400 billion, or about 9.1% of national health spend. In addition, within 4 years, analysts predict that 7 of the top 10 drugs in terms of sales will be specialty products.1 Given this expected growth, the specialty drug pipeline will be of particular interest to patients, prescribers, payers, and pharmacies.
New specialty drug approvals
As of December 3, 2014, FDA had approved 39 new molecular entities and new therapeutic biologics this year. While there is no universal definition of a specialty drug, approximately 19 of this year’s approvals fit commonly used definitions of specialty products (Table 1).6,7 Of these 19, oncology and rare diseases represented the majority of approvals, a trend that is expected to continue through 2015.2
In the pipeline
OncologyLooking ahead to the remainder of 2014 and 2015, the pipeline is again forecasted to have the highest number of approvals in oncology, with approximately one dozen expected approvals for a variety of cancers (Table 2).3 Programmed cell death–1 (PD-1) drugs stand out as an especially promising class of therapy. Pembrolizumab (Keytruda—Merck) was the first of this class to earn FDA approval for the treatment of unresectable or metastatic melanoma. Pembrolizumab, along with fellow experimental PD-1 drug nivolumab (Opdivo—Bristol-Myers Squibb), have earned breakthrough designations from FDA and are likely to see success expanding into other indications.
Trials are currently under way with PD-1 agents for a number of cancers, including lung, liver, brain, and solid tumors. Other pipeline drugs are in late stages of development for the treatment of breast, melanoma, non–small cell lung, ovarian, and pancreatic cancers, as well as hematologic malignancies such as leukemia and multiple myeloma.3
Hepatitis CHepatitis C (HCV) continues to have one of the most intriguing pipelines of any disease state. Within the last year, the approvals of sofosbuvir (Sovaldi—Gilead) and simeprevir (Olysio—Janssen) as individual agents have led to major changes in the treatment of HCV. Gilead’s Harvoni, the combination of sofosbuvir and ledipasvir, was approved in October 2014. In addition, sofosbuvir and simeprevir used together was approved in November 2014. Both of these combination therapies show high sustained viral response rates and are interferon-free, oral regimens.
Competition should come from the AbbVie “3D” HCV combination therapy compose of ombitasvir, paritaprevir, and ritonavir (Viekirax) used in combination with dasabuvir (Exviera). An FDA decision for this combination is expected by December 22, 2014. In addition, Merck’s HCV combination of MK-5172 and MK-8742 is also showing good effectiveness in clinical trials.
Tough competition from fast-paced innovation in the HCV market has taken a toll on other pipeline agents. Faldaprevir, a late-stage drug from Boehringer Ingelheim, was abandoned. Bristol-Myers Squibb’s daclatasvir and asunaprevir, taken together as a two-drug combination therapy, was discontinued. However, studies continue with daclatasvir as a component of other drug combinations, including a three-drug combination of daclatasvir with asunaprevir and BMS-791325. A two-drug combination of daclatasvir paired with sofosbuvir is also being evaluated in clinical trials.3
ImmunologyIn the immunology pipeline, top agents of interest include the IL-17 class of drugs: secukinumab (Novartis), brodalumab (AstraZeneca, Amgen), and ixekizumab (Eli Lilly). These agents are showing promise particularly for the treatment of psoriasis. In clinical trials, some IL-17 inhibitors have demonstrated efficacy that is superior to etanercept (Enbrel—Amgen), a commonly used drug in the treatment of psoriasis. These drugs are also being investigated for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. Sarilumab (Sanofi—Regeneron) is an additional late-stage pipeline agent being evaluated for the treatment of rheumatoid arthritis.3
Rare diseasesOpportunities in an area with limited competition have made rare disease treatments an attractive category for many manufacturers. Examples of these types of products include the recently approved drugs for idiopathic pulmonary fibrosis, pirfenidone (Esbriet—InterMune) and nintedanib (Ofev—Boehringer Ingelheim), as well as the experimental drugs eteplirsen (Sarepta) and drisapersen (Prosensa), which are currently being studied for the treatment of Duchenne muscular dystrophy. These drugs treat diseases wher currently available therapies are limited.
Growing trend
This trend toward the development of rare disease treatments is expected to continue growing. As of 2013, more than 450 drugs were in various stages of development for rare diseases.4 Further evidence of the growth in rare disease drug development is shown by the fact that in 2010, of the top 100 drugs in the United States, 23 were for the treatment of diseases with 100,000 or fewer patients. In 2014, that number of rare disease drugs had increased to 41. Meanwhile, drugs targeting diseases with higher patient populations became less popular. In 2010, of the top 100 drugs, 55 treated diseases with 500,000 or more patients. By 2014, that total was reduced to 35 drugs.5
The pipeline is stocked with exciting treatments for many disease states. While we can’t be certain how many of these agents will earn FDA approval, the possibility of bringing patients better treatments makes the drug pipeline worth watching.
http://www.pharmacist.com/specia ... 4-and-forecast-2015
A blueprint for health?A surge in approvals and a record year for M&A led many investors to believe the pharmaceuticals industry is poised for strong growth
©Marco Betti
Three days before Christmas, as most of the US government slowed down for the holidays, regulators at the Food and Drug Administration were still going strong.
Bristol-Myers Squibb, the US pharmaceutical company, received FDA approval for a much-hyped medicine called Opdivo — one of the first in a new category of cancer drugs that harness the immune system to fight tumours.
It was the 41st time in the year that the FDA had given the green light to a new therapy — the highest tally since 1996 and well above the annual average of 26 over the past decade.
Not all the medicines generated as much excitement as Opdivo. Treatments for ear infections, insomnia and fungal infections of the toe were among other, less heralded advances for medical science in 2014.
But the surge of approvals has increased the confidence of those who believe the pharmaceuticals industry is entering a new era of growth. Scientific advances unleashed by the decoding of the human genome a decade ago are finally reaching commercial fruition, these optimists say, promising a resurgence in drug research and development after the innovation drought of recent years. “The science has never been better,” says Bahija Jallal, head of AstraZeneca’s Medimmune research and development unit. “The next five or 10 years are looking very exciting.”
While few would dispute that the pace of innovation has picked up, the outlook varies from one company to another — and many appear to be relying more on mergers and acquisitions than homegrown R&D to deliver new products. A record $250bn worth of deals was struck in 2014, and bankers and executives predict more this year as companies tap plentiful cash and cheap credit.
To bullish investors in pharma, the dealmaking is a sign of confidence from an industry rearming for new growth. But there are still plenty of sceptics who instead see desperate companies resorting to financial engineering to cover up a broken business model.
Which of these is closer to the truth? The answer matters not only to investors but also to societies around the world relying on pharmaceuticals to help meet the growing healthcare needs of an ageing population.
The bullish view rests on a belief that big pharma is beginning to generate more value from the tens of billions of dollars poured into research and development each year. According to a report by Deloitte last month, return on investment from R&D rose in 2014 for the first time since 2010, to 5.5 per cent, up from 5.1 per cent the previous year.
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Improving productivity should help the industry to meet — and profit from — the rising demand for its products that is flowing from two big trends. The first is demographic: the number of over-65s on the planet is forecast to triple between 2010 and 2050 to 1.5bn, bringing with it a commensurate increase in age-related diseases such as cancer, heart disease and diabetes.
The second is economic: growing wealth in the developing world is increasing the ability of countries such as China and Brazil to provide high-quality healthcare — and increasing the demand from their burgeoning middle classes for access to modern medicines. Chinese per capita spending on pharmaceuticals is forecast to grow by more than 75 per cent in the next five years, according to the IMS Institute for Health Informatics. This will contribute to a 30 per cent increase in global spending on medicines to $1.3tn over the same period, IMS predicts.
“From a commercial business point of view you couldn’t be in a better industry,” says Severin Schwan, chief executive of Roche. Most investors appear to share his optimism: the S&P pharmaceuticals index is up 29 per cent in the past year. So why are some people unconvinced?
Producing new medicines remains among the most costly, protracted and risky ventures in global business. only about 7 per cent of experimental drugs in early-stage trials reach the market. The average development cost of those that make it is $2.6bn, according to the Tufts Center for the Study of Drug Development in Boston. This is three times the previous Tufts estimate in 2003, reflecting the greater cost of developing the new generation of biological medicines that are supplanting less complex chemical-based pills.
Sceptics of the pharma renaissance story question whether drug companies will be able to sustain the high prices needed to keep profits up. Instead of seeing an ageing population as a growth opportunity, they fear it will squeeze the industry as overburdened health systems battle to contain costs.
Disputes with publicly-funded European providers, such as the UK’s National Health Service, over access and pricing for new medicines are already commonplace. Last year’s high-profile backlash by US insurers and politicians against the price of new breakthrough treatments for hepatitis C — particularly Gilead Sciences’ $1,000-a-day Sovaldi — suggests that America’s bloated health system is also becoming more cost-sensitive.
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China, too, is trying to keep a tight lid on prices in a bid to make its expanding health budget stretch further. India, meanwhile, has taken an aggressive approach to challenging drug patents in hopes of widening access to cheap generic medicines for the country’s poor. If such a stance were replicated by other big developing countries it could weaken the foundations of the intellectual property framework on which the industry’s economic model is based.
“This industry is financially falling apart because we do not know how to discover drugs in an affordable way,” says Chas Bountra, professor of translational medicine at the Nuffield Department of Medicine at Oxford university.
This gloomy view seems at odds with the average 67 per cent profit margin reported by the 10 biggest pharma companies in 2013. However, this was down from 74 per cent a decade earlier because of patent expiries and pricing pressure, according to Lloyds Banking Group. Companies have shielded shareholders from this squeeze by cutting operating costs and increasing dividends and share buybacks. “Shareholders are expecting growth and a return of cash, which is like having your cake and eating it,” says Philipp Gutzwiller, head of healthcare at Lloyds. “My question is how long will this be sustainable.”
A closer inspection of the 41 new medicines approved by the FDA this year provides further cause for caution. Fewer than half came from traditional pharma groups. The rest were developed by the smaller biotech companies that increasingly provide the strongest engine of industry innovation.
Even those drugs brought to market by big pharma often originate from smaller companies. According to Deloitte, almost 60 per cent of forecast revenues from the late-stage R&D pipelines of the 12 biggest drugmakers involve assets brought in through acquisitions or partnerships. “There is an inverse correlation between scale and innovation,” says Julian Remnant, head of Deloitte’s European R&D advisory practice. “If 60 per cent of your innovation is coming from outside the company do you really need so much fixed infrastructure?”
These pressures explain the sense of upheaval in pharmaceuticals as drugmakers scramble to restructure. Companies have been making choices about which diseases and product areas to focus on — and how much R&D to keep in-house and how much to outsource. This has spurred the rush of dealmaking as non-core assets are offloaded and others acquired to bolster innovation. These decisions will help determine pharma’s winners and losers in the decades ahead. As for the industry as a whole, Mr Remnant says: “We see some signs that a new era of growth could be on the horizon but it would be premature to declare victory.”
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US
Companies: Johnson & Johnson, Pfizer, Merck & Co, Gilead, Abbott, Eli Lilly, Amgen, AbbVie, Bristol-Myers Squibb
Outlook: The fortunes of US big pharma are as diverse as the companies themselves — from old guard Pfizer, Merck and Eli Lilly battling to refresh their product pipelines to fast-growing young biotech companies. Standard-bearer for this latter group is Gilead Sciences, whose hepatitis C medicine, Sovaldi, broke industry records in 2014 by generating about $10bn of sales in its first year.
2014 deals: Merck bought biotech companies cubist and Idenix for a combined $13.4bn; Botox-maker Allergan was bought by Dublin-based Actavis for $66bn in the biggest pharma deal of the year.
Pipeline: Merck and Bristol-Myers Squibb are racing for leadership of a new category of cancer drugs, called PD-1 checkpoint inhibitors, which boost the immune system’s ability to attack tumours.
UK
Companies: GlaxoSmithKline, AstraZeneca
Outlook: AstraZeneca has long been junior partner to GSK in Britain’s pharma industry. But, in a reversal of recent fortunes, it is AstraZeneca whose R&D pipeline is showing greatest promise. GSK is battling to stem decline in its core respiratory drugs business as prices come under pressure in the US, while facing fallout in China from a damaging corruption scandal.
2014 deals: AstraZeneca repelled a hostile $117bn takeover from Pfizer; GSK agreed a $20bn asset swap with Novartis to boost its vaccines and consumer healthcare businesses.
Pipeline: Much of the optimism around AstraZeneca stems from an experimental cancer medicine, called Medi4736, which is in late-stage trials with the company targeting peak annual sales of up to $6.5bn.
Switzerland
Companies: Novartis, Roche
Outlook: Situated on opposite sides of the river Rhine in basel, Switzerland’s rival pharma superpowers are among the industry’s best-performers. Roche has focused on two markets — oncology and diagnostics — and dominates both. Novartis is also strong in cancer as well as cardiovascular medicines, eyecare and generic drugs.
2014 deals: Roche agreed to pay $8.3bn for InterMune, a US biotech company whose main drug treats a previously incurable lung disease. Novartis sold its sub-scale animal health unit to Eli Lilly while trading its vaccines business for GSK’s cancer business.
Pipeline: A new Novartis heart drug, called LCZ696, looks set to be one of the biggest launches of 2015, with analysts forecasting peak annual sales of up to $10bn.
France
Company: Sanofi
Outlook: France’s sole representative at the top table of global pharma is facing turbulent times. Christopher Viehbacher was fired as chief executive in October after a downturn in its core diabetes business and a falling out with chairman Serge Weinberg, who has taken temporary charge.
2014 deals: Sanofi has steered clear of the M&A frenzy but a dispute with the board over an abortive plan to sell some of the company’s older drugs helped seal Mr Viehbacher’s fate.
Pipeline: New products are finally arriving to replac those such as its Plavix blood thinner and Ambien sleeping pill which have lost patent protection. Sanofi predicts an “unprecedented” period of product launches with up to 18 new drugs by 2020, including the first vaccine for dengue fever and a new treatment for high cholesterol.
Germany
Companies: Bayer, Merck KGaA
Outlook: Germany’s pharma groups are sometimes overlooked because they form parts of broader industrial groups. Yet, they are two of the world’s oldest drugmakers and remain important players. Bayer, the larger of the pair, has invested heavily in emerging markets, building a top four position in China. Its sprawling healthcare division ranges from glucose monitoring meters to animal medicines.
2014 deals: Bayer is planning to spin off its plastics business to focus on healthcare and crop science. It paid $14.2bn for the consumer business of US-based Merck & Co, which shares a name with its German counterpart but is a separate company. Merck of Germany paid $17bn for US speciality chemicals company Sigma-Aldrich.
Pipeline: Bayer has 18 medicines in late-stage trials but Merck, without a major drug launch since 2003, is still struggling to revive its pipeline.
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