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news.The FDA has approved a recently submitted Investigational New Drug Application by AEterna Zentaris' North American partner, Spectrum Pharmaceuticals, for D 63153, a fourth generation luteinizing hormone releasing hormone antagonist, for use as a potential treatment for prostate cancer.
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Spectrum is now in a position to conduct a phase I/II trial with D 63153 in hormone-dependent prostate cancer and, thereby, expand the clinical development of D 63153 to the US.
“We are very encouraged by the continued progress of D-63153, including this near-term expansion of clinical development to the US, as well as the recently initiated European phase II trials with this product in hormone- dependent prostate cancer and benign prostate hyperplasia,” said Gilles Gagnon, president and CEO of AEterna Zentaris.
“D-63153 is an important element of our strategic development and we are pleased with the strong commitment by our new North American partner, Spectrum, to work towards the full development of this innovative Luteinizing Hormone Releasing Hormone antagonist compound.”
In August 2004, AEterna Zentaris granted to Spectrum Pharmaceuticals an exclusive license to develop and market D-63153 for all potential indications in North America (including Canada and Mexico) and India. AEterna Zentaris received an upfront payment which included cash and equity of Spectrum, at signature, and is eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to royalties on potential net sales.
AEterna Zentaris retains exclusive rights to the rest of the world and will share with Spectrum upfront and milestone payments, royalties or profits from potential sales in Japan.