--制药巨头诺和诺德的新型糖尿病药物Tresiba去年被FDA否决给公司带来了巨大打击。不过诺和诺德公司CEO Lars Rebien S?rensen最近表示Tresiba的暂时失利并不代表公司在糖尿病领域的一败涂地。公司仍将致力于Tresiba的心血管疾病研究并努力说服FDA,打消其对Tresiba安全性的疑虑。
而另一方面,赛诺菲为了保护其畅销糖尿病药物Lantus而与礼来公司纠缠不清,也为诺和诺德的反攻争取到了宝贵时间。而当前公司短期内的首要目标还是说服FDA批准Tresiba在美国上市。另一方面诺和诺德公司仍在加紧研究其他糖尿病类药物。例如公司开发的每周一次的注射用GLP-1药物正处于临床三期研究阶段,其口服药物NN9924正在进行临床二期研究。
详细英文报道:
Last year's stinging FDA rejection for Novo Nordisk's ($NVO) Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
Speaking to Reuters at Novo's annual meeting, CEO Lars Rebien S?rensen said the company believes it can wrap up its FDA-mandated cardiovascular study and convince regulators of Tresiba's safety profile, launching the drug and salvaging some potential of treatment once expected to peak at $3.4 billion a year.
The company is now in a race with its competitors to market Tresiba before the crowded diabetes space gets further diluted by a new crop of hopefuls, and, thanks to rival Sanofi ($SNY), Novo may just succeed. In an effort to protect its top-selling Lantus, Sanofi filed suit to stall Eli Lilly's ($LLY) introduction of a biosimilar, extending the French outfit's market exclusivity but inadvertently stretching Novo's window of introducing its own long-acting insulin before generic competition enters the stage, Reuters notes.
First, of course, it has to finally win FDA approval for Tresiba, which Chairman G?ran Ando told the news service is one of Novo's biggest short-term goals. The drug is already on the market in Europe, but Novo needs to keep the pace in the U.S. if it wants to sustain 2013's sales growth, Ando said.
But the world's largest insulin outfit is hardly hitching its entire future to a me-too therapy. The company is staking about $3.7 billion on diabetes R&D to follow up on its blockbuster Victoza, working through Phase III for the weekly GLP-1 injection semaglutide and the daily liraglutide, Phase II development of the oral NN9924, and a host of early-stage therapies.