Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. These updates
provide information on experimental drugs and at times give an
insight into the commercial potential of the candidate once it is
successfully developed and commercialized.
) holds a strong position in the attention deficit and
hyperactivity disorder (ADHD) market driven by key drugs like
Vyvanse, Intuniv and Adderall XR. The growth engine of Shire is
Vyvanse which is being developed for additional indications as
However, Shire recently suffered a setback when Vyvanse failed
to meet the primary efficacy endpoint in two pivotal phase III
studies (SPD489-322 and SPD489-323) even though the safety
profile of Vyvanse was consistent with other studies in adults
Shire was evaluating the efficacy and safety of Vyvanse in the
two phase III studies as compared to placebo as an adjunctive
treatment for major depressive disorder (MDD) in adults who did
not adequately respond to antidepressants.
As Vyvanse did not meet the primary efficacy endpoint versus
placebo for either study, the disappointing results of the trials
have forced Shire to discontinue the clinical development
Nevertheless, Shire is evaluating Vyvanse for the indication
of binge eating disorder (BED) and expects to submit a filing to
the U.S. Food and Drug Administration (FDA) later in the
We were disappointed with the top-line results from the two
studies. The successful development and commercialization of
Vyvanse for additional indications would have boosted sales in
the coming quarters.
Shire currently carries a Zacks Rank #2 (Buy). Other pharma
stocks that look attractive at current levels include
Salix Pharmaceuticals Ltd.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
ENDOCYTE INC (ECYT): Free Stock Analysis
FOREST LABS A (FRX): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
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