Celgene Corporation (NASDAQ:CELG) announced that it got a Paragraph IV Notice Letter regarding an ANDA (Abbreviated New Drug Application), submitted by Actavis LLC to the Food and Drug Administration. The prime objective of this ANDA is to seek FDA’s authorization to manufacture ABRAXANE 100 mg/vial and market it within the boundaries of United States of America.
Insights of Matter
The Notice Letter comes along with Paragraph IV certifications against a few patients with regard to ABRAXANE. At present, Celgene is trying to assess this notice and take a note of the arguments mentioned in it. The company looks forward to taking appropriate actions for defending its intellectual property rights on ABRAXANE.
Before receiving this letter, Celgene had made some changes in its Board of Directors. As per the reports, two significant changes came in the form of a selection of Jacqualyn Fouse Ph.D. and Mark Alles to BOD. When it comes to candidature, Alles has been working with Celgene for over 12 years now. Previously, he worked as company’s President and Chief Operating Officer. He’s the new Chief Executive Officer of Celgene.
Earlier he took care of Oncology and Hematology departments of Celgene, but now he will look after all the departments and try to maximize the value of all the shareholders.
The another change came in the form of Jacqualyn Fouse, who has been promoted to company’s President and COO position. Fouse joined Celgene in the year 2010 and touched all new heights in a very short period of time. Previously, he worked as company’s Chief Financial Officer and took many critical decisions on a regular basis.
Both have been working in each other’s company for a long time and know their priorities very well. Going forward, they will look forward to touching newer heights in terms of corporate performance, sales, revenues, and market image. Initiatives taken to achieve these milestones will be shared from time to time with all the shareholders.