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Market Access Granted In France For Aggressive Non-Hodgkin Lymphoma Treatment, PIXUVRI® (pixantrone)

Stocks in this article: CTIC

SEATTLE, Aug. 19, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported that the Transparency Commission (Commission de la Transparence  or CT) of the French National Health Authority (Haute Autorite de Sante or HAS) has granted market access for the medicinal product PIXUVRI ® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy).  The next and final step in France's pharmaceutical reimbursement process is inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France, which CTI now intends to pursue.

"The availability of PIXUVRI in France means physicians will be able to extend an approved salvage regimen to those patients that fail second line therapy," said Gilles Salles, M.D., PhD., Professor of Medicine at the University Claude Bernard Lyon-1 and President of LYSA, the Lymphoma Study Association.

"The data from the pivotal EXTEND study of PIXUVRI clearly indicate that this drug is effective in heavily pretreated patients with relapsed or refractory aggressive NHL," commented Bertrand Coiffier, M.D., Professor of Haematology at the Department of Haematology, Hospices Civils de Lyon and the University Claude Bernard, Lyon, France.

The CT noted that aggressive NHL is a serious disease and that there are no standard treatments for patients with this stage of disease.  All registered pharmaceuticals in France are subjected to an evaluation process known as Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by the CT, with the resulting evaluation expressed as a classification between 1 and 6.  The CT rated PIXUVRI at level 5, which allows PIXUVRI to be included in the reimbursed drugs list for hospital use.  The CT will reassess the ASMR rating for PIXUVRI within two years.

"We are pleased to receive the CT's favorable opinion for reimbursement of PIXUVRI and look forward to bringing this new approved therapy to patients in France with aggressive NHL," said James A. Bianco, M.D., President and CEO of CTI.

In May 2012, the European Commission (EC) granted conditional marketing authorization in the European Union (E.U.) for PIXUVRI as a monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial.  PIXUVRI was made available to patients in eight countries in the European Union in the fourth quarter of 2012, and some patients in other countries have already started to receive the treatment.  Prior to the approval of PIXUVRI in the E.U., there were no approved agents or standard of care in this disease.  The PIX301 trial was designed utilizing agents in the comparator arm that have anti-tumor activity in relapsed disease and are typically employed as palliative therapy for these patients.

About PIXUVRI (pixantrone)PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties.  Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds.  PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity.  These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.  The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication.  The SmPC is available at  www.pixuvri.eu

CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL.  PIXUVRI does not have marketing approval in the United States.

About Non-Hodgkin LymphomaNHL is caused by the abnormal proliferation of lymphocytes, cells that are key to the functioning of the immune system.  It usually originates in lymph nodes and spreads through the lymphatic system.  NHL can be broadly classified into two main forms—aggressive and indolent NHL.  Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.

According to France's Institut de Veille Sanitaire, in 2010 there were 10,800 newly diagnosed patients with NHL in 2010. 1  There are many subtypes of NHL, but aggressive B-cell NHL is the most common and accounts for about 50 percent of NHL cases. 2  After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease. 3  Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50 percent are expected not to respond. 3  For those patients who fail to respond or relapse following second-line treatment, treatment options are limited, and usually palliative only. 3

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the E.U. 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.

The European Medicines Agency's (the EMA) Committee for Medicinal Products for Human Use has accepted PIX306, CTI's ongoing randomized controlled Phase 3 clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant.  As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

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