Novo Nordisk复方胰岛素产品Ryzodeg在墨西哥上市 - 药群论坛

根据Novo Nordisk首席科学官Mads Krogsgaard Thomsen的报告，该产品相比基础胰岛素和餐时胰岛素单独使用时，所需的注射天数明显减少，并且该产品对2型糖尿病患者的强化胰岛素治疗至关重要。

Tresiba和Ryzodeg去年在欧洲、日本以及一些其他国家被批准，但是这两种产品在美国都遭遇红灯，而美国是基础胰岛素市场最大的国家。

FDA拒绝了Novo Nordisk的上市申请，因为Tresiba的心血管风险较Lantus大。Lantus是赛诺菲公司的一种长效基础胰岛素产品，是Tresiba的竞争品种。但是Novo Nordisk声称该观点没有足够的证据。

更令人失望的是Novo Nordisk上个月收到了丹麦金融监管局500,000挪威币（相当于90,000美元）的罚款，因为其没有及时告知投资者来自美国监管机构的拒绝。

该公司已经开始了一项心血管安全性试验，称为DEVOTE，该试验将回复FDA对Tresiba的怀疑，并声称将会在下个月内完成注册。如果试验结果理想，Novo Nordisk将在明年上半年再次向FDA提交Tresiba和Ryzodeg的上市申请。

美国监管机构的拒绝虽然阻碍了Tresiba的发展，Tresiba本有希望成为本年度销售领军品种，但是这次拒绝也提醒了Novo Nordisk开始大力推进老的长效胰岛素类似物Levemir（地特胰岛素）来控制市场的短缺。

根据Novo Nordisk董事长LarsRebien Sorensen的说法，已上市的Tresiba进展良好。在日本，尽管有来自Lantus和Levemir的竞争压力，但是Tresiba在上市18个月以后就占据了20%的市场。

最近，该公司声称，DEVOTE试验的病人招募工作比预期的快，Tresiba和Ryzodeg有希望在2016年初在美国上市，届时，现有的24%的市场占有率将更上一层楼。

同时，由于Tresiba和Ryzodeg的发展道路受阻，NovoNordisk把希望放在准备上市的Xultophy/IDegLira(insulin degludec/liraglutide)上，该药已经在欧盟获得了肯定，将成为市场上第一种结合胰岛素和GLP-1受体激动剂的药物。

updat 1-Novo Nordisk launches Ryzodeg in Mexico after pricing in Denmark

(Reuters) - Novo Nordisk has launched its type 2 diabetes treatment Ryzodeg in Mexico, a combination drug that could reap the company billions in revenue in years to come.

The company said Mexico was its first commercial launch and that its previously-announced introduction of the drug in Denmark was just a "technical" move and not a fully-blown campaign as in the central American country.

Ryzodeg combines Tresiba, its great hope for future growth, with insulin aspart, which is a man-made form of insulin.

In Denmark, neither Tresiba nor Ryzodeg received the status that allows its costs to be covered by the state health service as similar but cheaper versions already existed on the market, meaning virtually no-one would buy the drugs.

But a launch still made sense because prices set at home are often used for reference elsewher, a fact which encourages Novo Nordisk to set high prices that would not attract state reimbursement, said Sydbank analyst Soren Lontoft Hansen.

"Novo sacrifices sales in Europe, which is a difficult market at the moment, to take the price they want into countries which in the future will be more important to them such as China, Latin America etc," he said.

The analyst saw Ryzodeg as having "double blockbuster" potential, which means sales of $2 billion a year within 8-10 years of launch around the world.

A spokeswoman from Novo Nordisk confirmed sales of Ryzodeg and Tresiba in Denmark were "limited" and that there had been no marketing campaign for the drugs.

By contrast, "Mexico is a typical mixed market and in addition, as opposed to Denmark, they have a private market too wher Tresiba has been received very well", Katrine Rud von Sperling said in response to questions from Reuters on Tuesday.

The International Diabetes Federation says 8.7 million people live with diabetes in Mexico, with 70,281 diabetes-related deaths in 2013.

Last month, the group said it could launch Tresiba at the start of 2016 in the United States, after the Food and Drug Administration unexpectedly refused to approve the drug last year and requested for more tests. (Reporting by Shida Chayesteh; writing by Sabina Zawadzki; Editing by Mark Potter and David Evans)