News
Banner Announces Submission of Its First-to-File ANDA for Targretin®
October 11, 2011
Expects to qualify for 180 days of generic marketing exclusivity
High Point, NC. October 11, 2011 — Banner Pharmacaps Inc. (“Banner”) has confirmed that its Abbreviated New Drug Application (“ANDA”) for Bexarotene 75 mg soft gelatin capsules, a generic version of Targretin, has been accepted for review by the US Food and Drug Administration (FDA). Based upon available information, Banner believes that it is the first applicant to file an ANDA for Targretin containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act, and expects to qualify for 180 days of generic marketing exclusivity upon FDA approval.
“Banner’s ANDA filing of Bexarotene marks an important milestone in the steady growth of our Rx portfolio”, said Dr. Roger Gordon, President and CEO. “Knowing that our company is able to have a positive impact on the healthcare costs and treatment for cancer patients in the United States is inspiring and immensely rewarding.”
Bexarotene capsules are used in the treatment of cutaneous T-cell lymphoma (CTCL skin cancer) and sold by Eisai Inc. under the brand name Targretin. Targretin is a registered trademark of Eisai Inc.
About Banner Pharmacaps Inc.
Banner Pharmacaps Inc. is an emerging specialty pharmaceutical company dedicated to the research, development, and manufacturing of unique gelatin-based dosage forms. Banner has developed patent-pending drug delivery platforms which enhance and control the absorption of poorly soluble active pharmaceutical ingredients. The Company focuses on improving the formulation of existing molecules to provide increased efficacy and improved patient compliance and safety through innovative gelatin and polymer-based technologies. Banner is headquartered in High Point, North Carolina, with additional research labs and manufacturing facilities in The Netherlands, Canada, and Mexico. For more information, please visit the Company’s website at: www.banpharm.com
The parent company of Banner is VION, N.V., an international food group. VION’s annual sales in 2010 were €8.9 billion with 27,000 employees worldwide. The VION head office is in Eindhoven, the Netherlands.
