VPRIV

Product

VPRIV

Approval Date

February 26, 2010

Release Date

First quarter 2010

Company

Shire

Class

Hydrolytic lysosomal glucocerebroside-specific enzyme

Indication

Type 1 Gaucher disease

Active Ingredient

Velaglucerase alfa

Agency Roster

Medicus Life Brands

Marketing Strategy/Execution

Before the FDA approved VPRIV (velaglucerase alfa) in February, Gaucher patients had access on a preapproval basis, and access figures as one plank in an aggressive launch strategy designed to exploit vulnerabilities in the market. VPRIV is priced at $1,350 per 400-unit vial, 15% less than the market leader, Genzyme’s Cerezyme, which has experienced supply issues. Experts on ultra-orphan genetic diseases view enzyme replacement therapies (ERTs)—including Cerezyme, VPRIV and Uplyso (under FDA review)—as very similar clinically. So ERT usage will “likely become more sensitive to pricing,” wrote Jefferies analyst Eun Yang in a research note. Shire’s injectable has reportedly captured about 13% of the US ERT Gaucher market and could supply several hundreds more patients by year’s end. Adds Yang, data from a European head-to-head study pitting VPRIV vs. Cerezyme, expected in coming weeks, could be a marketing tool for Shire to switch patients if results are positive.

Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: Genz-112638
Manufacturer: Genzyme
Indication: Gaucher’s disease type 1
Active ingredient: Eliglustat tartrate Phase: III

Drug: Uplyso
Manufacturer: Protalix
Indication: Gaucher’s disease
Active ingredient: Taliglucerase alfa
Phase: Prereg. (Fast Track)

Source: Wolters Kluwer Pharma Solutions

Pharmacology