US biotech bluebird bio saw its shares closed down more than 5% at $117.66 on Friday, after the company announced pricing plans for its gene therapy Zynteglo in Europe, but that also came with suggestions that the beta-thalassemia treatment’s launch will likely be delayed.
Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene), which is still under review by the US Food and Drug Administration, was granted conditional marketing authorization by the European Commission last week.
bluebird has priced Zynteglo, offered as a one-time infusion, at nearly $1.8 million, with the cost spread over five years.
Healthcare systems will pay an initial instalment of 315,000 euros ($353,745) but will only pay more instalments if the treatment helps the patient avoid blood transfusions.
So for each transfusion-free year, bluebird bio will receive another 315,000 euros for four years.
The price news comes soon after Swiss pharma giant Novartis revealed announced a $2.1 million price per patient for its gene therapy Zolgensma (onasemnogene abeparvovec-xioi), a spinal muscular atrophy treatment, that was approved by the FDA last month.
Meanwhile Yaron Werber, an analyst at Cowen wrote in a client note quoted by Baron’s, that the European Medicines agency has, unexpectedly, requested amendments to the final drug product specifications and to the manufacturing parameters, “hence this delays the launch and would remove any sales in FY19 to early ’20.”
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