Cell Therapeutics (CTIC) has recently been in the spotlight, as the company recently said that it was ready to launch its lead therapeutic candidate Pixuvri, a novel treatment for B-cell non-Hodgkin's Lymphoma, in Europe where it received regulatory clearance earlier in the year. The company, which has been developing the treatment for years, finally has the opportunity to recoup some of its investment. The lure of revenue from Europe may be what makes this the time to look closely at Cell Therapeutics.
In May of this year, CTI announced that it had received conditional marketing authorization from the European Commission for Pixuvri® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL"). Pixuvri is the first approved treatment in the European Union in this patient setting. The decision cleared the way for CTI to market Pixuvri in the 27 Member States of the EU as well as in Iceland, Liechtenstein and Norway. After months of preparation, CTI plans to market Pixuvri with its own sales force beginning next week in the EU.
So what is the revenue opportunity and how does that impact investors? There are 37,000 new cases of B-cell non-Hodgkin's Lymphoma reported in Europe annually, and if first and second line treatments fail, Pixuvri is currently the only treatment available. The World Health Organization's International Agency for Research on Cancer's 2008 GLOBOCAN database most recent estimates state that in the EU, approximately 74,162 people will be diagnosed with NHL and 31,371 are estimated to die from NHL every year.
There are many subtypes of NHL, but aggressive B cell NHL is the most common and accounts for about 60% of cases. Initial therapy for aggressive NHL with anthracycline-based combination therapy cures up to 60% of patients. Of the remaining patients, approximately half will respond to intensive second-line treatment and some are cured by stem cell transplantation. Of those not eligible for intensive second line therapy and those patients who fail to respond or relapse, until the approval of Pixuvri, no therapeutic has received regulatory approval for this patient group. Rolling out the drug throughout Europe could mark a turning point for the company, which has had to rely upon the capital markets to fund its operations to date. The European market could generate up to $240 million in annual revenue, once the company is able to penetrate the market, and successful use overseas could also bolster the company's prospects for US approval. The company has a dedicated sales force to sell the drug, which has been outsourced, providing it with the flexibility to increase or decrease its size as circumstances warrant, without being locked into costly severance or other expenses.
There are few companies trading at valuations approaching CTI's that have approved products on the market with substantial revenue opportunities. While the company may still be in the "penalty box" with investors due to the FDA's reluctance to approve the drug in the U.S., the market opportunity in Europe alone could provide investors with significant upside from current levels.