It was business as usual for the biotech sector last week with highlights including a deal for the acquisition of product rights, encouraging study results and the granting of breakthrough therapy status for an experimental cancer treatment. Here we take a look at all these news in detail.
Regado Biosciences saw its shares plunging 58% on news that a data safety monitoring board (DSMB) is conducting an unplanned review of data from the phase III REGULATE-PCI study on Revolixys Kit. While the safety and treatment/benefit risk ratio for all patients will be analyzed, focus will be on serious adverse events related to allergic reactions. Until the analysis is completed and the DSMB’s recommendation is available, new patients will not be enrolled.
The news is disappointing considering Revolixys Kit is the lead candidate in the company’s pipeline. The cropping up of safety issues would be a major setback for the company and would limit the potential of the candidate even if development continues.
Jazz Pharmaceuticals & Agenus Inc
Jazz Pharmaceuticals entered into an agreement worth up to $250 million last week to boost its product portfolio. The company will acquire rights to defibrotide in the U.S. and all other countries in the Americas from Sigma-Tau. This means that Jazz will own full rights to defibrotide – the company is already marketing the candidate in the EU under the trade name Defitelio. Jazz’s shares were up almost 7% on the agreement.
Agenus Inc. saw its shares gaining on final results from a phase II study on its Prophage autologous cancer vaccine. The study was conducted in patients with newly diagnosed glioblastoma multiforme (GBM). Results were encouraging – median overall survival, the primary endpoint of the study, was 23.8 months for Prophage compared to 14.6 months for the standard of care alone. 50% of the patients on Prophage lived for two years.
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While nothing specific is lined up, stay tuned for the usual pipeline and regulatory updates. Moreover, with AbbVie upping its offer for Shire, these two companies will remain in the news as investors mull the renewed offer.
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