Can A European Approval of Pixantrone Save Cell Therapeutics? (CTIC)

Cell Therapeutics, Inc. (NASDAQ: CTIC) is about as controversial of a biotech stock as there can be.  It often traded huge volume around drug approval or study news, and shares rose after being halted earlier Thursday.

The company issued a press release noting that it has received conditional marketing authorization from the European Commission for Pixuvri®.  This pertains to the company’s controversial pixantrone as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. The company further noted that Pixuvri is the first approved treatment in the European Union in this patient setting.

Cell Therapeutics will get to market Pixuvri in the 27 Member States of the European Union but it will also get to market in Iceland, Liechtenstein and Norway.  The company also plans to make Pixuvri immediately available through a named patient program and the marketing and commercialization of Pixuvri will start with CTI’s own sales force in the EU starting in the second half of 2012.

Conditional approval is not an open-ended and endless approval.  On this front the company noted, “conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.”

Shares closed up almost 15% at $1.16 on more than 8 million shares today and the 52-week trading range of $0.95 to $2.40.  Even after the pop, this stock has a market value of $236 million.

JON C. OGG