January 18, 2012
Ceptaris Therapeutics Receives EMA Orphan Drug Designation
for Proprietary Mechlorethamine Gel
MALVERN, PA (January 18, 2012) – Ceptaris
Therapeutics, Inc., a privately held specialty pharmaceutical
company, announced today that the European Medicines Agency (EMA)
has granted Orphan Drug Designation to Ceptaris’ investigational
drug, chlormethine gel (also known as mechlorethamine gel in the
US), for the treatment of Cutaneous T-Cell Lymphoma (CTCL).
Orphan Drug Designation is granted by the
European Medicines Agency (EMA) to promote the development of
products that offer potential therapeutic benefits for diseases
affecting less than five in 10,000 people in the EU. Products
with Orphan Drug Designation are eligible for ten years of
market exclusivity in the EU upon approval.
“The EMA’s decision to grant Orphan Drug
Designation to our proprietary mechlorethamine gel underscores
the need for additional therapeutic alternatives for patients
with Cutaneous T-Cell Lymphoma,” said Ceptaris Chairman of the
Board and CEO Steve Tullman. “We look forward to the continued
execution of our European regulatory strategy.”
Ceptaris’ mechlorethamine gel is currently
undergoing review by the U.S. Food and Drug Administration (FDA)
for the treatment of early stage (stages I-IIA) mycosis
fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL). The FDA
previously granted Orphan Drug Status to this investigational
drug. The New Drug Application (NDA) for Ceptaris'
mechlorethamine gel was filed in the U.S. in July 2011.
About Ceptaris Therapeutics
Ceptaris Therapeutics, Inc. is a privately
held, specialty pharmaceutical company that is developing a
proprietary gel formulation of mechlorethamine hydrochloride for
the treatment of early stage (stages I-IIA) mycosis fungoides, a
type of Cutaneous T-Cell Lymphoma (CTCL). If approved, Ceptaris'
investigational drug would be the first topical mechlorethamine
gel widely available to relieve the signs and symptoms of this
rare cancer. Please visit www.ceptaris.com for more information.
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