Alembic Pharmaceuticals announced that its associate company, Rhizen Pharmaceuticals S.A (Rhizen) has been granted by the USFDA the orphan-drug designation for the active moiety of Tenalisib (RP6530), the company's highly selective and orally active dual PI3K delta/ gamma inhibitor, for the treatment of peripheral T-cell lymphoma (PTCL).
"We are pleased to receive US FDA orphan-drug designation for the active moiety of Tenalisib (RP6530), our company's highly selective and orally active dual PI3K delta/gamma inhibitor and we look forward to advancing the drug into further development for treatment of peripheral T-cell lymphoma (PTCL)," said Swaroop Vakkalanka, Ph.D., Founder & President of Rhizen Pharmaceuticals S.A.
The orphan-drug designation is granted to a drug or biological product intended to treat a rare disease in the United States. A number of incentives are provided for an orphan-drug such as a 7-year marketing exclusivity, tax credit for clinical development costs, exemption/ waiver of application (filing) fees and assistance from the USFDA office of Orphan Products Development during the development process.
Shares of the company gained Rs 4.5, or 0.85%, to trade at Rs 533.85. The total volume of shares traded was 996 at the BSE (10.18 a.m., Tuesday).