U.S. Markets open in 4 hrs 35 mins

Update on Glaxo's Mekinist-Tafinlar

Zacks Equity Research

Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned.

Earlier this week, GlaxoSmithKline (GSK) came out with disappointing news regarding its Tafinlar-Mekinist combination for BRAF V600 E or K mutation-positive unresectable or metastatic melanoma. The company has withdrawn its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA.TO) for the combination.

Glaxo took this decision after the Committee for Medicinal Products for Human Use (CHMP) indicated that the currently available data of Tafinlar-Mekinist combination are insufficient to form an opinion on its benefit-risk profile. The company plans to resubmit the MAA once additional data from an ongoing phase III program matures.

We remind investors that the Tafinlar-Mekinist combination was approved by the U.S. Food and Drug Administration (:FDA) for the melanoma indication earlier this year. In the U.S., both Tafinlar and Mekinist are available as monotherapy. In EU, Mekinist is currently under regulatory review.

In the fourth quarter of 2013, Tafinlar (£11 million) and Mekinist (£7 million) generated combined sales of £18 million. Currently approved melanoma drugs include Roche’s (RHHBY) Zelboraf and Bristol-Myers Squibb Company’s (BMY) Yervoy.

Glaxo carries a Zacks Rank #4 (Sell). Gilead Sciences Inc. (GILD) is an example of a better ranked stock in the medical sector. The stock carries a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on GSK
Read the Full Research Report on RHHBY
Read the Full Research Report on BMY
Read the Full Research Report on GILD

Zacks Investment Research