Nice call, Ben -
QLT expands pipeline with acquisition of late-stage compound for multidrug resistance in cancer
VANCOUVER, Aug. 13 /PRNewswire/ - QLT Inc. (NASDAQ:QLTI - news; TSE:QLT - news) today announced that it has entered into an exclusive development and license agreement for XR9576, a Phase II P-gp inhibitor for multi-drug resistance (MDR) in oncology with Xenova Group plc (NASDAQ:XNVA; London Stock Exchange:XEN), a publicly traded biotechnology company based in the UK. Under the agreement QLT will assume responsibility for the continued development of XR9576 and marketing rights for North America. Xenova will retain marketing rights in Europe and the rest of world.
One of the major barriers to successful cancer treatment is the development of resistance by cancer cells to several drugs used in chemotherapy, known as multi-drug resistance (MDR). XR9576 targets the most common form of this drug resistance through the inhibition of P-glycoprotein, a membrane based ``pump'' that acts to expel the chemotherapy drug from the tumor cell, thereby reducing its efficacy. XR9576 has completed a series of three separate Phase IIa trials, in which the product was administered together with three of the world's most commonly used chemotherapy agents (paclitaxel, doxorubicin, vinorelbine), each of which is known to be affected by this resistance mechanism.
``We have proven our drug development capabilities with the commercialization of Visudyne(TM) and Photofrin® and look forward to applying our expertise to the development of XR9576 in an area with such a high unmet medical need,'' said Dr. Julia Levy, President and Chief Executive Officer of QLT. ``This collaboration underlines QLT's commitment to expand beyond photodynamic therapy and supports our longer term plan to become a fully integrated biopharmaceutical company with a North American sales force.''
Dr. Levy added, ``Our internal evaluation of this product confirms that XR9576 is the leading MDR inhibitor in development based on its potency, selectivity and stage of development.''
``The studies done to date suggest that XR9576 could offer significant advantages over previous generations of MDR inhibitors,'' said David Oxlade, Chief Executive Officer of Xenova Group plc. ``We are very pleased to be pursuing the development of this compound with QLT given their proven track record in drug development and expertise in oncology.''
Financial Terms
Under the terms of the agreement, QLT will pay Xenova an initial licensing fee of US$10 million and milestone payments up to a maximum of US$50 million, in addition to paying future development costs for the product. Upon commercialization, QLT will pay a royalty to Xenova in the range of 15 to 22 per cent depending on the level of North American sales.
Clinical Development Plan
Xenova has received clearance from the U.S. Food and Drug Administration (FDA) to proceed to Phase III development. QLT expects to initiate the Phase III program in the first half of 2002 once the clinical study protocol is finalized. An interim analysis is planned for mid-2003 in order to mitigate the financial risk of the program. Upon successful completion of the Phase III program, it is anticipated that QLT will initially file for approval of XR9576 in the U.S. for use in combination with first line chemotherapy in advanced non-small cell lung cancer (NSCLC) in 2005. NSCLC is the first of several indications for which XR9576 will be investigated.
XR9576 and Multi-drug Resistance
Multi-drug resistance (MDR) is a problem for many of the most common cancers and involves some of the most widely administered chemotherapeutic agents. In 1999, these drugs accounted for over 1.45 million office-based administrations by medical oncologists in the U.S.
The successful outcome of the XR9576 trials was announced in late 2000/early 2001. The trials demonstrated that the combination of XR9576 with a chemotherapy agent was safe and well tolerated. Further, no clinically significant pharmacokinetic interaction was found between XR9576 and the chemotherapy drug, a problem encountered by previous generation MDR inhibitors. This benefit allows the chemotherapy agent to be administered at its full normal clinical dose for optimal efficacy.... |
