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Threshold Pharmaceuticals, Inc. (THLD) and Merck KGaA (MKGAF) recently announced the commencement of a global phase III study (MAESTRO) on their hypoxia-targeted candidate, TH-302. The study will evaluate the efficacy and safety of TH-302 plus Eli Lilly and Company’s (LLY - Analyst Report) Gemzar (gemcitabine) in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma.

We note that the study is being conducted under the US Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) program. The randomized, double-blind, placebo controlled, international and multi-center study will enroll roughly 660 patients and will compare TH-302 plus Gemzar with placebo plus Gemzar. The study’s primary endpoint is overall survival and the secondary endpoints include efficacy measured by progression-free survival (PFS), overall response rate and disease control rate.

On Feb 21, 2012, Merck KGaA had presented encouraging phase IIb data on the TH-302 – Gemzar combination for the first-line treatment of patients suffering from advanced pancreatic cancer. The study met its primary endpoint by achieving a 63% improvement in PFS in patients treated with TH-302 and Gemzar in comparison to Gemzar alone.

Another phase III trial is being conducted with Merck’s TH-302 under the FDA’s SPA program. The study will compare TH-302 in combination with doxorubicin to doxorubicin alone for treating patients with soft tissue sarcoma (STS). Merck KGaA has orphan drug status in the US as well as the EU for TH-302 for the STS indication.

According to information provided by Merck KGaA, pancreatic cancer accounts for 2.2% of all cancers reflecting roughly 277,000 cases every year. It is the eighth most common type of cancer in Europe and the eleventh most prevalent in the US.  

We believe the approval of TH-302 will boost Merck KGaA’s oncology sales significantly. Erbitux is one of the marketed cancer treatments in Merck KGaA’s product portfolio. Erbitux is indicated for metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN). Erbitux’ revenues for the nine months ending Sep 30, 2012 were $664 million. Other cancer candidates in Merck KGaA’s pipeline include cilengitide and Sym004.

Meanwhile, the successful development of TH-302 will be a major milestone for Threshold Pharma, which currently does not have any marketed products in its portfolio. Threshold Pharma carries a Zacks Rank #3 (Hold). Right now, Agenus Inc. (AGEN - Snapshot Report) looks more attractive with a Zacks Rank #1 (Strong Buy).

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