BioTransplant Announces New Strategic Focus and Comprehensive Restructuring Plan
CHARLESTOWN, Mass., Jul 29, 2002 (BUSINESS WIRE) -- BioTransplant Incorporated (Nasdaq: BTRN) announced today a restructuring plan intended to streamline the Company's operations around a new strategic focus.
"We are implementing a multi-faceted restructuring initiative focused on BioTransplant's most promising proprietary products -- the AlloMune System and Eligix HDM Cell Separation technologies," commented Donald B. Hawthorne, President and Chief Executive Officer of BioTransplant. "We have set explicit, near-term operating goals that will help clarify the strategic rationale and clinical progress of BioTransplant's therapeutic products, and I look forward to providing updates on our progress and on our relationship with MedImmune as concerns MEDI 507."
The restructuring will integrate the following initiatives:
- Accelerate Eligix Sales: Employees of BioTransplant, including sales people, technical support and clinical support personnel, will spend a substantial amount of time working in Europe to support Gambro sales efforts. In addition, CD8-SC clinical data involving a 25 patient study by Dr. Robert Soiffer, Clinical Director of the Hematologic Oncology Center and the Co-Director of the Adult Hematopoietic Stem Cell Transplantation Program at the Dana-Farber Cancer Institute, will be submitted to the American Society of Hematology (ASH) for possible presentation at the ASH meeting in December. The ASH deadline for submissions is August 21, and applicants will be notified in the fourth quarter whether or not their abstracts have been accepted. This clinical data was used to support the European marketing approval announced last week for the CD8-SC Cell Separation System.
- Revamped AlloMune Development Strategy: BioTransplant is revising its clinical development strategy for the AlloMune System, employing kits consisting of siplizumab in combination with products that have already been approved in the United States. The Company is setting several near-term clinical goals for the AlloMune System:
- BioTransplant plans to file an Investigational New Drug (IND) application by the fourth quarter of 2002, with respect to a Phase I/II trial for the use of siplizumab as part of a kit with an already approved drug for use in non-myeloablative transplantation ("mini-transplant") patients. Pending FDA clearance, the Company anticipates beginning enrollment by the end of 2002. The trial will include matched-related and matched-unrelated patients to provide an indication of AlloMune's utility in these patient populations.
- Massachusetts General Hospital in collaboration with BioTransplant plans to begin enrollment in the fourth quarter 2002 for a mismatched Phase I trial using siplizumab in combination with an FDA approved ex-vivo purging device, for all hematological malignancies. Enrollment in the first cohort of patients is expected to be completed in early 2003. The trial will entail approximately 30 patients and will provide an indication of the utility of the AlloMune System in a mismatched patient population.
- Investigators will submit data to ASH from BTI-0301 for possible presentation at the ASH meeting in December 2002. This BTI-0301 trial was a Phase I/II study investigating the AlloMune System in non-myeloablative transplantation for the treatment of patients with refractory Non-Hodgkin's Lymphoma or Hodgkin's disease.
- Reduce Cash Burn Rate: BioTransplant today implemented a 23% reduction in headcount, which will lower the cash burn rate by 25%. The Company estimates that existing cash will now last until late in the third quarter of 2003, giving the Company greater operational and financial flexibility. The receipt of potential milestone payments could make existing cash last until the fourth quarter of 2003.
This restructuring arrangement will not impact the Company's agreement with MedImmune or MedImmune's development efforts for MEDI-507.
Management will host a conference call to discuss the new strategic focus and restructuring on Tuesday, July 30th at 8:30 am EDT. You may participate in the call by dialing 800-915-4836 in the United States and 973-317-5319 internationally. A digitized telephone replay of the call will be available until Friday, August 2nd by dialing 800-428-6051 or 973-709-2089. The access code is 254690. |
