Shire's New Formulation Of Oncaspar Gets Approval In Europe
Zacks Investment Research | Dec 13, 2017 10:09PM ET
Shire plc (NASDAQ:SHPG) announced that the European Commission (“EC”) has granted marketing authorization to its new freeze-dried formulation of Oncaspar for treating acute lymphoblastic leukemia ("ALL") in Europe. The new lyophilized formulation is approved as a component of a multi-agent chemotherapeutic regimen in pediatric patients (from birth to 18 years) as well as adult patients.
The approval in EU was expected as the drug was recommended by the Committee for Medicinal Products for Human Use (“CHMP”) in October. Presently, the drug is approved in liquid form for treating the same indication. The approval of the new formulation will increase the shelf life of Oncaspar up to three times to 24 months.
Shire’s shares have underperformed the industry so far this year. The company’s shares have lost 13.8% against the industry’s gain of 6.2%.
The CHMP had recommended the approval of the new formulation based on analytical and nonclinical studies, which showed that lyophilized Oncaspar has comparable efficacy to the liquid formulation.
The formulation is now approved in all 28 European Union ("EU") member countries plus Iceland, Norway and Liechtenstein.
Lyophilized Oncaspar works in a similar way as liquid Oncaspar and has the same dosing regimen as well.
Shire’s oncology segment witnessed growth of 24% in the third quarter of 2017 driven by strong sales of Oncaspar and pancreatic cancer drug, Onivyde. The increase in shelf life with this new formulation is expected to help the company improve the supply of this critical drug. Moreover, the new formulation will improve the accessibility of the drug to ALL patients in countries where the liquid form is not allowed.
The company expects the new formulation of Oncaspar to be available in Europe in the first half of 2018.
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