公司之前于8月7日宣布暂停类风湿性关节炎新药白细胞介素-20抗体研发。公司称，研发受挫将会拖延公司进入炎症性疾病领域时间至2020年，并基于此决定专注于研发核心糖尿病药物，但未透露具体金额。
此次研发暂停会影响到公司400名员工，并为公司在2014年带去7亿丹麦克朗（合7.58亿元）的非再现成本。
Insulin jabs are pictured on a production line in Novo Nordisk's plant in Kalundborg November 4, 2013.
CREDIT: REUTERS/FABIAN BIMMER
(Reuters) - Danish pharmaceutical company Novo Nordisk has stopped research and development activities in inflammatory disorders to concentrate on the prevention and treatment of diabetes, its biggest business.
This follows a decision to halt development of the company's most advanced drug candidate used to treat rheumatoid arthritis and known as anti-IL-20, announced on Aug. 7.
Chief Science Officer Mads Krogsgaard Thomsen said with the setback for anti-IL-20, the earliest possible entrance into the market for anti-inflammatory therapeutics would have been in the late 2020s. Instead, the company aimed to increase its research and development within its core diabetes business.
"Significant un-met opportunities remain within diabetes, including prevention, obesity and diabetes complications," Thomsen said in a statement.
Novo Nordisk, the world's top insulin maker, said it would increase its research and development in these areas but did not disclose any numbers.
The company, whose main rivals include Sanofi and Eli Lilly & Co, aims to increase the number of people using its drugs to 40 million in 2020 from 23 million in 2012, as the world faces a big jump in type 2 diabetes linked to over-eating and lack of exercise.
Last month, the group said it could launch a new long-lasting insulin Tresiba, a future growth driver for the company, at the start of 2016 in the United States. This is the company's largest market, wher it has been facing competition from generic drugs and broader pricing pressures.
NEW PILL
Another new area within diabetes treatment, wher investment is needed to stay ahead of the pack, is in the development of insulin doses in pill form instead of via injection.
"They can see a growth adventure with oral diabetes drugs, so I think that's wher they are going to move the R'n'D money," said Alm. Brand Markets' analyst Michael Friis, who has a 'Buy' recommendation on the stock.
An insulin pill would mark a step change in therapy by making treatment more convenient, opening a major new market.
Sydbank analyst Soren Lontoft saw the enforced focus on diabetes as positive. "In the short run this is negative because of the 700 million crowns of non-recurring costs, but in the long run this can give a more focused Novo, which is positive," he said.
Novo Nordisk, the Nordic region's most valuable company by market capitalization, said it would look into selling or licensing out some of the drugs from the inflammatory business pipeline but it could not yet put a valuation on them.
It expects to incur a non-recurring cost of around 700 million Danish crowns ($124 million) this year from the decision to dro the business.
It said 400 employees would be affected by the decision but that it hoped to offer other positions within the company to more than half of those.
Novo Nordisk has not received any revenues from the business with no drugs on the market so this will not affect analysts' estimates.
"The decision was made because they no longer have anything of significance in their pipeline and if they were to advance with a new product, investments would need to be huge, so it would not be worth the risk," said Alm. Brand Markets analyst Frills.
The company said it would updat its full-year financial guidance on Oct. 30 following this announcement.
Novo Nordisk shares were 0.69 percent lower by 1210 GMT (8.10 a.m. EDT) against a broadly flat Copenhagen benchmark index. The company's shares are up nearly 30 percent year-to-date, outperforming a 13.3 percent rise in the Thomson Reuters Global Pharmaceuticals Index
(1 US dollar = 5.6742 Danish crown)
美国FDA批准UCB(优时比)拉科酰胺新适应症意味着美国的部分发作性癫痫成人患者可接受拉科酰胺单独用药作为初始治疗，已在使用其它癫痫治疗药物的患者可切换到拉科酰胺单药治疗。
这款药物是优时比正在向前发展的主要产品之一，该公司正寻求克服因仿制药竞争而导致的其老款癫痫治疗药物左乙拉西坦的销售损失。2014年前6个月，拉科酰胺获得了2.17亿欧元的收入，如果优时比能有效地同目前的治疗药物相竞争，如Lamotragine和托吡酯，拉科酰胺单药治疗的获批应该会使公司销售额大大增加。
癫痫患者额外的治疗选择是非常重要的，因为这种疾病的复杂度要求一种非常个体化的方式去护理。“尽可能多地给患者提供不同的治疗选择以减少他们的发作是优时比的目标，”优时比首席医疗官Friedrich博士称。“现在，美国的医师和癫痫患者有更多的拉科酰胺选择来治疗部分发作性癫痫。”
除了单药治疗的批准，FDA还对所有剂型的拉科酰胺推荐了一种新的单一载荷剂量给药方式。优时比还计划向欧盟提交这款药物单药治疗的上市申请，以扩大其现有的辅助治疗适应症。
为了支持这次的申请，优时比正在实施一项中期研究，以在确诊或最近新确诊的部分发作性癫痫患者身上对比拉科酰胺与卡马西平一款缓控释制单药治疗的有效性及安全性。
The FDA has approved a monotherapy indication for UCB's Vimpat in the treatment of epilepsy.
The approval means the drug can now be used by itself to treat partial-onset seizures in adult patients with epilepsy. This expands the use of Vimpat(lacosamide) beyond its 2008 approval as an adjunctive treatment in this group of patients.
The terms of the US regulator's new recommendation mean that adults in the country with partial-onset seizures can receive can receive Vimpat monotherapy as an initial treatment and patients already on an epilepsy treatment can switch to monotherapy with Vimpat.
The drug is one of UCB's main products going forward as it looks to overcome the loss of sales for older epilepsy treatment Keppra(levetiracetam) due to generic competition.
Vimpat achieved revenues of
作者: 伴云 时间: 2014-9-3 10:28 PM
能真的治愈么，生活中确实很多人困扰于癫痫中。
作者: xiaoxiao 时间: 2014-9-4 08:42 AM
呵呵，一上论坛都不停的看帖，信息量真强大
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