Opaxio awaits EMEA approval by the end of 2009
There is some good news for Cell Therapeutics (CTIC) as the European Medicines Agency (EMEA) today agreed to an oral explanation in support of the Opaxio Marketing Authorization Application (MAA) in September, 2009. The agency has extended the timeframe for review by the Committee for Medicinal Products for Human Use (CHMP) regarding the approval until the fourth quarter of 2009.
Earlier, in April, 2008 the EMEA accepted for review the MAA of Opaxio for the treatment of patients with advanced non-small cell lung cancer (NSCLC). The meeting with the EMEA was scheduled to take place on June 2009, but did not occur as the company was busy submitting the pixantrone (for the treatment of NHL) New Drug Application (NDA).
Although Opaxio was undergoing clinical trials since 2005, all of them failed to meet the primary end-point of extended survival; some benefits of tolerability, convenience, and safety were met. Later on, CTIC presented another important characteristic of Opaxio; it was more effective in women than men in terms of survival.
As a result, in 2006, FDA agreed to review the NDA submission of Opaxio for the treatment of women with lung cancer based on interim results of the PGT307 trial (trial for women with advanced lung cancer). The company started PGT307 trial in September 2007 and originally planned an interim analysis in the first half of 2008.
However, in order to save cash and re-allocate its limited resources, in early 2008, the company announced that the PGT307 will be limited to US sites only. Due to this limitation, the NDA filing will be delayed till the end of the current year.
The fourth quarter of 2009 will be important for CTIC as we expect decisions regarding its drug candidates, Pixantrone and Opaxio. The company has already submitted NDA for Pixantrone and awaits FDA decision. We think that EMEA will wait for the results of PGT307 trial for making the final decision on Opaxio.
The company is under great pressure to raise additional cash to fund its operations. But under the current financial and economic conditions, it will be extremely difficult for the company to raise any additional resources. With the current low share price, any equity issuance does not look possible.
Although the company says it is on target to accomplish cash flow break-even in the fourth quarter of 2009, we will keep a close eye on the company’s cash position. We maintain our Hold rating on CTIC.
Read the full analyst report on “CTIC”
Zacks Investment Research
