Policy & Regulation
CTI BioPharma, Servier Expand Pixuvri License and Collaboration Agreement
25 April 2017 - - US-based biopharmaceutical company CTI BioPharma Corp. (NASDAQ: CTIC) and France-based Servier have agreed to expand their existing license and development collaboration agreement for Pixuvri (pixantrone), the companies said.

Under this expanded agreement, Servier will have rights to Pixuvri in all markets except the US, where CTI BioPharma will retain the commercialisation rights.

Servier will pay CTI BioPharma EUR 12m with the potential for CTI BioPharma to receive EUR 76m in additional sales and regulatory milestone payments as well as royalties on net product sales.

Pixuvri has been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.

As a specific post-authorization requirement, Pixuvri is currently being investigated in a Phase III clinical trial, PIX306.

If positive, the results from this trial will confirm the treatment's current indication and could support broader indications.

In 2014, CTI granted Servier rights to commercialize the drug globally except in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, UK and the US.

With this expanded agreement, which provides Servier's rights to all markets except the US, the companies will continue to work closely together to build the efficacy and safety evidence for Pixuvri and to ensure that as many eligible patients as possible are benefitting from it.

Pixuvri is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA.

This means that the cancer cells in B-cell NHL cannot divide and eventually die.

Pixuvri is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL.

The benefit has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.

Servier is an international pharmaceutical company governed by a foundation and headquartered in Suresnes (France).

With an international presence in 148 countries and a turnover of EUR 4bn in 2016, Servier employs 21,000 people worldwide.

CTI BioPharma is a biopharmaceutical company focused on the acquisition, development and commercialisation of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers.

The company has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.
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