METHYLGENE REACQUIRES RIGHTS TO MGCD0103 FROM CELGENE AND IMPLEMENTS STRATEGIC PLAN TO FOCUS ON DEVELOPMENT OF PROPRIETARY CLINICAL PIPELINE
- MethylGene to Host Conference Call Today at 10:00 a.m. Eastern Time -
Montreal, Quebec. October 27, 2008 - MethylGene Inc. (TSX:MYG) today announced that Celgene has terminated their licensing agreement for oncology histone deacetylase (HDAC) inhibitors, including MGCD0103. As a result, MethylGene will reacquire the rights to these programs. Furthermore, the Company announced that it will implement a strategic initiative to focus its resources on the clinical development of its proprietary pipeline.
MethylGene will reacquire all rights to MGCD0103 and other HDAC and sirtuin inhibitors in territories licensed to Celgene including North America and the European Union. As part of the termination provisions, Celgene will continue to support MGCD0103 for a period of 90-days to ensure a smooth transition. This termination does not affect MethylGene's relationship with Taiho for Japan and certain other Asian countries. Celgene acquired the rights to MGCD0103 through its March 2008 acquisition of Pharmion Corporation. MethylGene now owns the worldwide rights to three compounds, MGCD0103 (with the exception of certain Asian territories), MGCD265 and MGCD290, all of which are at various stages of clinical development.
"We believe regaining exclusive rights to MGCD0103 will allow MethylGene to accelerate submissions to the FDA aimed at lifting the partial clinical hold for MGCD0103," said Donald F. Corcoran, President and Chief Executive Officer of MethylGene. "We believe that MGCD0103 represents a promising opportunity for the treatment of cancer and has demonstrated clinical activity in a number of tumor types evaluated to date. Its single-agent and combination activity in advanced refractory and relapsed cancers is encouraging for a cancer compound at this stage of clinical development. With MGCD0103 back in MethylGene's hands, upon successful lifting of the partial clinical hold, we will evaluate the funding requirements, development pathway, partnerships and alternative arrangements needed to potentially move the program forward."
MethylGene also announced that after a review of the Company's current research, development and business activities, the Company will focus on advancing its clinical pipeline, which represents the most attractive, near term value-generating opportunities. Accordingly, the Company will begin a process to discontinue its discovery research activities, including a phased workforce reduction. The first phase of the reduction will occur over the next two months with additional reductions planned during 2009 as funded discovery research with Celgene for sirtuin inhibitors for cancer and with Otsuka Pharmaceutical for kinase inhibitors for ocular diseases are concluded. It is expected that approximately half of the Company's current staff of 109 full-time employees will be affected by the transition when completed as planned.
"We are aligning the organization toward our development opportunities in order to better realize the value of our proprietary clinical pipeline. By streamlining the organization to focus on development, we expect to extend our current cash resources and progress our clinical pipeline toward nearer term value enhancing milestones," said Mr. Corcoran. "Decisions such as this are difficult. We are a company that has grown due to the talent, hard work and expertise of our employees and we greatly appreciate their contributions. We owe it to our colleagues and to our shareholders to seek success in the clinical development and ultimate commercialization of our lead compounds."
With the implementation of this initiative, it is estimated that the Company will have sufficient resources to carry out currently planned development and operational activities into approximately the third quarter of 2010. This estimate does not include any additional significant financings, partnerships or licenses. These plans include the continuing development of MGCD265 into Phase II trials, MGCD290 through Phase I studies and pursuing the removal of the partial clinical hold on MGCD0103. MethylGene will evaluate progressing MGCD290 into Phase II trials after reviewing Phase I data and evaluating potential partnerships and/or additional funding requirements. The Company will also evaluate the status of MGCD0103 once the compound is released from partial clinical hold.
MethylGene's current goals expected during the next 12 months:
MGCD0103, a histone deacetylase inhibitor for cancer
MGCD265, a multi-targeted kinase (c-Met) inhibitor for cancer
MGCD265, a multi-targeted kinase (c-Met) inhibitor for cancer
MGCD290, a fungal Hos2 (HDAC) inhibitor
Conference Call Information
MethylGene will host a conference call to discuss events mentioned in this release. The call is scheduled for today, October 27 at 10:00 a.m. ET. MethylGene would like to invite all interested parties to participate by dialing 416-644-3418 or 1-866-249-1964 shortly before 10:00 a.m. ET. Participants may also listen via a live audio webcast, accessible through the Company's website at www.methylgene.com. On the call from MethylGene will be:
Mr. Donald F. Corcoran, President and Chief Executive Officer
Dr. Jeffrey M. Besterman, Executive Vice President R&D and Chief Scientific Officer
Dr. Robert E. Martell, Vice President and Chief Medical Officer
Mr. Klaus B. Kepper, Vice President Finance and Chief Financial Officer
A question and answer session will follow at which time the operator will direct participants as to the correct procedure for submitting questions.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's product candidates include: MGCD265, an oral, multi-targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases which is in Phase I clinical trials for solid tumor cancers; MGCD290, a fungal Hos2 (HDAC) inhibitor used in combination with azoles for fungal infections which is also in a Phase I clinical trial; and MGCD0103, an oral, isoform-selective HDAC inhibitor which has been in multiple clinical trials for solid tumors and hematological malignancies and is licensed to Taiho Pharmaceutical. MethylGene's development and commercialization partners include Taiho Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd. and EnVivo Pharmaceuticals. Please visit our website at www.methylgene.com.