Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone for the treatment of schizophrenia.
In India, the Pharmaceutical business of Intra-Cellular Therapies, Inc. is focused on inhibitors of phosphodiesterase, substituted heterocycle fused gamma-carbolines, treatment of dementia.
Intra-Cellular Therapies Inc. filed patent application numbered 9921/DELNP/2012 that is titled as ORGANIC COMPOUNDS. This patent application has been granted as Patent Number 317695.
The invention covers chemical compound. The invention relates to particular substituted heterocycle fused gamma-carbolines, their prodrugs, in free, solid, pharmaceutically acceptable salt and/or substantially pure form as described herein, pharmaceutical compositions thereof, and methods of use in the treatment of diseases involving 5-HT2A receptor, serotonin transporter (SERT) and/or pathways involving dopamine D2 receptor signaling systems.
During patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act that claims recited derivatives of known compound and new use of known compound which do not differ significantly in properties with regard to efficacy over the above cited prior art.
As a response to the said objection, the applicant pointed out that there are unexpected therapeutic benefits due to higher plasma concentration and AUC. Resulting in reduced toxicity and adverse effects.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
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