FDA decision on Dacogen expected March 8 (NYSE: ESALY.PK)

Eisai Co., Ltd. is a corporation that is operating in several countries across the world. It has a number of companies in the United States of America, too, such as Morphotek, Inc. (which sells specialized antibodies for the treatment of monoclonal diseases), Eisai Research Institute of Boston, Inc. (that discovers novel organic chemicals) and Eisai Inc. (which is responsible for commercializing Eisai’s pharmaceutical products in the US). The operations of all these companies are coordinated by Eisai Corporation of North America (NYSE: ESALY.PK). Over the past few years, the corporation has developed a drug called Dacogen® for treating patients who are suffering from myelodysplastic syndromes (MDS). The company had already submitted a new drug application (NDA) to the US Food and Drug Administration for getting the regulator’s approval to commercialize the drug. And the NDA was accepted by the FDA. However, the NDA proposed to use Dacogen® as a three-day dosing regimen. However, now, Eisai wants to use the drug as a five-day dosing regimen. For this purpose, the company had to submit a supplemental new drug application (sNDA) to the FDA. On July 8, 2009, Eisai disclosed to its stockholders that the FDA found that the sNDA contained all the necessary information that would allow it to make a thorough investigation, i.e. the sNDA was accepted for further review. The regulator is expected to announce its decision on March 8, 2010.

The MDS is a group of several diseases that affect the bone marrow and prevent it from producing blood cells. If treatment is not taken, the diseases can be fatal. There are several drugs for MDA in the market. However, most of them have inappropriate dosing regimens. The five-day dosing regimen of Dacogen® needs to be taken just once every day. In addition, it can be administered in a relatively short duration. All these make it easier for patients to take the drug.

After the news of the FDA acceptance came out, Eisai Inc.’s President, Cynthia Schwalm, said,

“We’re pleased that the FDA has agreed to review our application for the alternative dosing regimen, and we look forward to working with the agency throughout the review process. This application is one part of a full complement of clinical development programs we have omitted for Dacogen and is a vital part of our human health care mission of increasing patient benefits and fulfilling unmet medical needs.”