The transfer establishes Eisai as the marketing authorization holder responsible for regulatory activities in the United States related to the commercialization of BELVIQ, including pharmacovigilance requirements.
Regarding transfer of applications, the Federal Regulations (21 CFR 314.72) say (in part):
§314.72 Change in ownership of an application.
(A) An applicant may transfer ownership of its application. At the time of transfer the new and former owners are required to submit information to the Food and Drug Administration as follows:
(1) The former owner shall submit a letter or other document that states that all rights to the application have been transferred to the new owner.
(2) The new owner shall submit an application form signed by the new owner and a letter or other document containing the following:
(i) The new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application;
(ii) The date that the change in ownership is effective; and
(iii)Either a statement that the new owner has a complete copy of the approved application, including supplements and records that are required to be kept under §314.81, or a request for a copy of the application from FDA's files. ...
The most interesting part of the regulation is that the new owner has to agree to take over "agreements, promises, and conditions made by the former owner". This includes all post marketing studies and all pharmacovigilance (reporting of adverse events to FDA) requirements.
What is not explicitly stated in today's announcement is that Eisai, not Arena, will be running all of the pediatric and cardiovascular outcomes trials that are required according to BELVIQ's FDA approval letter (pdf).
This Clinical Lead position is being created for a dynamic individual with an MD and at least five years of experience or a PhD and at least ten years of experience in clinical development within the pharmaceutical industry.
The position is intended to provide the organization with an individual who has sufficient knowledge, skills and experience to fulfill the roles of a Clinical Lead and Study Director for lorcaserin.
This will involve design and oversight of post-marketing and late phase safety and efficacy clinical studies for lorcaserin in the following indications: obesity, metabolic syndrome and/or diabetes.
Direct experience of conducting cardiovascular outcomes studies is highly desirable. Direct experience of conducting clinical pharmacology studies and pediatric studies is also desirable.
Two things strike me about this job posting in light of today's announcement. First, it is clear that Eisai has been preparing for this transfer of the BELVIQ NDA for at least a few weeks now including addressing staffing needs. Second, the job description above specifically mentions Diabetes. In an earlier article I mentioned that the astounding Hba1c results seen in the BLOOM-DM trials meant that Arena and Eisai would eventually pursue a diabetes indication for BELVIQ. This job description confirms my speculation that exploring a diabetes indication for BELVIQ is probably part of the development plan.
The key takeaway from today's announcement is that Arena and Eisai are further cementing their working relationship through this transfer. The dedicated research team at Arena is being relived of administrative burdens related to marketing BELVIQ so that they can focus on developing the rest of Arena's pipeline. ARNA longs would do well to tamper their speculation that another large pharmaceutical company will swoop in and buyout Arena. It could happen since both Arena and Eisai have the right to terminate their partnership under certain circumstances and since Arena has not given Eisai the rights to BELVIQ in Europe or the rest of the world, but it is highly unlikely. A much more likely scenario is the Eisai will eventually acquire Arena once initial sales numbers come in and EU approval is obtained.