Pipeline updates are eagerly awaited by investors in the
biotech/pharma space. An insight into late-stage candidates
(including regulatory approval) targeting lucrative markets often
influence their investment decisions on a particular stock.
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) announced that its Tafinlar-Mekinist combination has been
approved by the U.S. Food and Drug Administration (FDA). The FDA
approved Tafinlar plus Mekinist for BRAF V600 E or K
mutation-positive unresectable or metastatic melanoma.
FDA approval came on the basis of data from a phase I/II study
evaluating Tafinlar plus Mekinist versus Tafinlar alone in
patients suffering from BRAF V600E or K mutation positive
metastatic melanoma. The combination showed an impressive overall
response rate/ORR (76%) and a median duration of response (10.5
months) as compared to Tafinlar alone (ORR 54%, median duration
of response 5.6 months).
We remind investors that both drugs, Tafinlar and Mekinist, were
approved as monotherapy in the U.S. for melanoma, last year.
In the third quarter of 2013, Tafinlar ($4 million) and Mekinist
($3 million) generated combined sales of $7 million. Currently
approved melanoma drugs include
) Zelboraf and
Bristol-Myers Squibb Co.
Glaxo carries a Zacks Rank #3 (Hold). We are concerned about the
loss of revenues in the third quarter due to investigation in
China regarding fraudulent behavior and ethical misconduct. We
are also disappointed with pipeline setbacks for two late stage
candidates (drisapersen and darapladib). Moreover, Glaxo
continues to face challenges in the form of EU pricing pressure
and generic competition. We expect recent approvals,
restructuring and cost-cutting efforts to offset some of the
Some better-ranked stocks include
) carrying a Zacks Rank #2 (Buy).