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Merck KGaA-Pfizer's Avelumab May Get Orphan Status in EU

Zacks Equity Research
Updated

Merck KGaA MKGAF and Pfizer PFE announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for immunotherapy candidate, avelumab.

Merck is seeking orphan drug designation for avelumab in Europe for the treatment of merkel cell carcinoma (MCC).

We remind investors that in Nov 2014, Merck KGaA had entered into a strategic collaboration with Pfizer to co-develop and co-commercialize avelumab. Avelumab is being developed for more than 15 types of tumor, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial cancer.

A decision from the EMA is expected by Dec 2015. We note that avelumab also enjoys orphan drug status for MCC in the U.S.

The FDA also granted fast track designation for avelumab for the treatment of metastatic MCC in Oct 2015 and breakthrough therapy designation in Nov 2015.

An orphan drug designation by the EMA will allow avelumab to enjoy a period of marketing exclusivity in the EU upon approval. The EMA generally grants orphan drug designation to drugs that are being developed for the treatment of life-threatening or chronically debilitating rare diseases/conditions that affect not more than 5 in 10,000 persons.

Currently, Merck and Pfizer are evaluating avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen in a phase II study, JAVELIN Merkel 200.

Meanwhile, immune-oncology is gathering a lot of attention in recent times. For example, Merck & Co. Inc. MRK’s Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer. Merck gained FDA approval for Keytruda for a non-small cell lung cancer indication in Oct 2015. It is also approved for metastatic melanoma.

Investors looking for top-ranked stocks in the health care sector may consider Corcept Therapeutics Incorporated CORT, sporting a Zacks Rank #1 (Strong Buy).

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