March 19, 2001--Corixa Corporation (Nasdaq:CRXA - news), a developer of immunotherapeutics, today provided an update on a modified operating plan it has adopted after receiving a complete review letter from the U.S. Food and Drug Administration (FDA) following FDA's six-month review of the Bexxar Biologics License Application (BLA).
In a separate press release issued today (3-19-01, Corixa and GlaxoSmithKline Receive Complete Review Letter Following FDA Evaluation of Bexxar BLA), Corixa summarized additional clinical and manufacturing information that the company will submit as a result of the review.
Corixa has modified its operating plan as a result of Bexxar's delayed market introduction and the recognition of additional synergies that have been identified between Corixa and former Coulter workforces. Corixa will initiate immediate expense reductions, including a 10-15 percent reduction in total headcount that includes the elimination of unfilled open positions, as well as existing positions. The majority of these reductions will take place at Corixa's California operations.
These reductions in research and development and administrative support staff will result in the postponement of further internal development of certain programs. These programs will become the focus of potential territory-specific, out-licensing activities as they represent either clinical stage, or near-clinical stage partnership opportunities.
Additionally, in an effort to minimize expenses during the Bexxar delay, Corixa is currently pursuing several new opportunities in which Corixa would contract out the services of its sales personnel to promote and sell a potential partner's products. Under such an agreement, Corixa's sales and marketing personnel would be partnered until these resources were required to support Bexxar commercialization. If Corixa is unable to establish such an agreement, the company may be required to make additional headcount reductions within the direct sales and marketing groups.
The headcount reductions announced today will result in a first quarter restructuring charge of approximately $1.5 million, and could result in annual cost savings of approximately $6 million. Following today's reductions, the company will have approximately 512 employees employed at three different locations.
``The actions taken today will provide us with additional financial flexibility to help deliver on the promise of Bexxar and to continue the advancement of the high priority programs in our product pipeline,'' stated Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. ``We remain dedicated to the future success and commercialization of Bexxar and are committed to providing the FDA with answers to the questions raised in its complete review letter as completely and expeditiously as possible.''
The FDA requested updated and/or final safety and efficacy data from ongoing, recently completed and other additional trials to establish safety and effectiveness. Corixa and GlaxoSmithKline believe that safety and efficacy data from recently completed trials, beyond those contained in the Bexxar BLA, may fulfill FDA's requests. Recently completed trials, have:
* Examined comparative safety and efficacy in NHL patients treated either with Bexxar or the unlabeled antibody in Bexxar;
* Assessed clinical safety and efficacy of Bexxar treatment of relapsed, refractory NHL patients who did not respond to Rituxan® (rituximab)(a); and
* Assessed Bexxar safety and efficacy as front-line therapy in low-grade NHL patients.
The FDA also requested:
* Further documentation and analysis of patient diagnosis and confirmation of response from pivotal and non-pivotal trials that involved treatment of low-grade lymphoma patients, including those patients with transformed low-grade lymphoma;
* Additional information or source documentation regarding:
* Certain adverse events,
* Long-term follow-up on patient thyroid function and HAMA response,
* White blood cell counts following Bexxar administration, and
* Dosimetry calculations on certain patients whose response data was submitted in the BLA;
* Further documentation and analysis supporting comparability of tositumomab manufactured by different suppliers during the course of Bexxar clinical development; and
* Additional documentation and test results related to validation of various production processes and release tests as well as additional information concerning processes and procedures used in drug shipment.
Conference Call
Corixa will hold a conference call on March 19, 2001 at 8:30 a.m. EST to discuss today's announcement. Those who would like to participate in the conference call should dial 800/289-0529 (passcode 410501). A replay of the conference call will be available from Monday, March 19 through 12 a.m. EST, Wednesday, March 21. To access the replay, please dial 888/203-1112 (passcode 410501) or visit the ``events'' section of Corixa's website (http://www.shareholder.com/corixa/medialist.cfm). |
