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.