Recently Shire plc (SHPGY) announced that its Gaucher disease product VPRIV (velaglucerase alfa) has received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The committee recommended the approval of the enzyme replacement therapy for treating type I Gaucher disease.
Furthermore, the drug has been granted accelerated assessment by the EMA in the European Union (EU) and enjoys orphan drug status from the Committee for Orphan Medical Products.
Shire should be in a position to launch Vpriv in the EU by year end. Meanwhile, product launch in other countries should commence in 2011. Vpriv is already available in the U.S. where it received approval from the U.S. Food and Drug Administration (FDA) in late February 2010.
Vpriv Could Eat into Cerezyme’s Market Share
Vpriv is seen as an alternative to Genzyme’s (GENZ) Cerezyme (imiglucerase), which is in short supply due to manufacturing problems faced by the company in 2009. Although Genzyme holds a leading position in the treatment of Gaucher disease, the company is still struggling to normalize its supply schedule for Cerezyme.
We believe that a delay in resuming full supply of Cerezyme will lead to increased market share for to Shire’s Vpriv. We expect competition in the Gaucher disease market, where the patient population is not very large, to intensify further later this year with the potential approval of Protalix’ BioTherapeutics’ (PLX) Uplyso. Protalix has a marketing agreement with Pfizer Inc. (PFE) for Uplyso. We note that both Vpriv and Uplyso were made available to patients under the FDA’s expanded access program due to the shortage in supply of Cerezyme.
Our Recommendation
Shire is a Zacks #3 Rank ('hold') company, which indicates that the stock is expected to perform in line with the overall U.S. equity market for the next 1 to 3 months. Our long-term Neutral stance on the company indicates that the stock is expected to replicate its short-term performance, but over 6 to 12 months. Consequently, we advise investors to retain the stock over the time-period.
Read the full analyst report on "SHPGY"
Read the full analyst report on "GENZ"
Read the full analyst report on "PLX"
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