Merck joins Threshold to co-develop TH-302 drug

5th February 2012 (Last Updated February 5th, 2012 18:30)

Merck and Threshold Pharmaceuticals have entered into a global agreement to jointly develop and commercialise Threshold Pharmaceuticals' hypoxia-targeted drug, TH-302, which is thought to be activated under tumour hypoxic conditions.

Merck and Threshold Pharmaceuticals have entered into a global agreement to jointly develop and commercialise Threshold Pharmaceuticals' hypoxia-targeted drug, TH-302, which is thought to be activated under tumour hypoxic conditions.

Under the global agreement, Merck will receive co-development rights and exclusive global commercialisation rights, and will provide Threshold with an option to co-commercialise the therapeutic in the US.

In addition, Threshold will receive an upfront payment of €19m and up to €26.5m in additional development milestones during 2012.

It is also eligible to receive a €15m milestone payment based on positive results from its randomised Phase II trial in pancreatic cancer.

According to the royalty-bearing portion of the deal, Threshold retains the option to co-promote TH-302 in the US, and Merck will be responsible for the commercialisation of TH-302 outside the US.

TH-302 is now being investigated in a global Phase III clinical trial in patients with soft tissue sarcoma and in a randomised Phase II trial in patients with advanced pancreatic cancer, as well as additional clinical studies in other solid tumours and hematological malignancies.

To date, TH-302 has been investigated in over 550 patients in Phase I/II clinical trials in a variety of tumour types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs.

The Phase III study is a randomised multi-centre trial that is intended to investigate the use of TH-302 plus doxorubicin compared with doxorubicin alone in patients with first-line advanced soft tissue sarcoma (STS).

The randomised controlled multi-centre Phase II trial of TH-302 enrolled 214 previously untreated patients with locally advanced unrespectable or metastatic pancreatic adenocarcinoma, to investigate two different doses of TH-302 in combination with the chemotherapeutic gemcitabine when compared to gemcitabine alone.

Susan Jane Herbert, head of global business development and strategy at Merck Serono, said: "The addition of TH-302 to our pipeline provides an important opportunity in several different tumor types to expand our oncology development program."