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Glaxo Seeks Tafinlar-Mekinist Approval

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GlaxoSmithKline (GSK) recently announced that it has submitted supplemental New Drug Applications (sNDA) to the US Food and Drug Administration (:FDA) for the Tafinlar (dabrafenib)-Mekinist (trametinib) combination. The company is looking to get Tafinlar in combination with Mekinist approved for the BRAF V600 E or K mutation-positive unresectable or metastatic melanoma indication.

The regulatory applications contain data from a phase I/II study evaluating Tafinlar in combination with Mekinist versus Tafinlar alone in patients suffering from BRAF V600E or K mutation positive metastatic melanoma. The company is also looking to get the combination therapy approved in Europe for use in adults with BRAF V600 mutation-positive metastatic melanoma and submitted a marketing application for the same in Feb 2013. Glaxo has also submitted marketing application for Mekinist as a monotherapy in Europe.

We remind investors that both the melanoma drugs, Tafinlar and Mekinist, received approval as monotherapy in the US in May 2013. The FDA approved Tafinlar for BRAF V600E mutation-positive unresectable or metastatic melanoma patients. However, Tafinlar is not recommended for patients suffering from wild-type BRAF melanoma. The FDA also cited several warnings and precautions related to the use of Tafinlar, which can lead to fatal side effects including increasing the risk of developing new primary cutaneous malignancies.

Mekinist was approved for the treatment of patients suffering from unresectable or metastatic melanoma with BRAF V600E or V600K mutations. Mekinist has not been approved for treating patients who have received a prior BRAF inhibitor treatment.

Glaxo intends to launch the drugs in the US by early third quarter 2013. Currently approved melanoma drugs include Roche’s (RHHBY) Zelboraf and Bristol-Myers Squibb Co.’s (BMY) Yervoy.

Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo’s label expansion efforts. Moreover, Glaxo boasts of a robust pipeline. A number of pipeline-related news is expected in the coming quarters. Given the declining sales from generic competition, we believe Glaxo’s pipeline must deliver. Companies that currently look attractive include Valeant Pharmaceuticals International, Inc. (VRX) carrying a Zacks Rank #1 (Strong Buy).

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