LONDON (Alliance News) - Tiziana Life Sciences PLC on Tuesday said it has signed a deal to gain exclusive licensing for cancer treatment milciclib from Italian drug discovery company Nerviano Medical Sciences Group.
Milciclib has demonstrated positive results in phase 1 and 2 clinical trials and has been granted orphan designation by the European Commission and by the US Food and Drug Administration for the treatment of malignant thymoma or thymic epithelial tumours.
An orphan drug qualification means that the product has been designed specifically to tackle a rare disease that affects a small percentage of the population. The designation means that developers are entitled to a longer exclusive marketing period for the product.
Subject to a successful completion of the ongoing phase 2 trials, Tiziana has committed to initiating a phase 3 study for the drug in 2016.
Under the terms of the licensing deal, Tiziana will make an upfront payment of USD3.5 million to Nerviano for the licence and will make milestone payments to the company of up to USD35 million, along with a royalty on net sales of any products that contain milciclib.
"Nerviano is a high-value partner for Tiziana with immense scientific heritage in oncology that started with the success of the anthracyclines and is now continuing with innovative targeted therapies," said Tiziana Chairman Gabriele Cerrone.
"The addition of milciclib, with its robust safety profile, significantly strengthens Tiziana's pipeline and offers us the potential to provide a new treatment for liver cancer, an additional approach for treating breast cancer and continuing phase II trials in thymic carcinoma," Cerrone added.
Shares in Tiziana were untraded on Tuesday, having last traded at 47.92 pence.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance
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