For immediate release: June 21, 2005
Vancouver, BC - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) today announced extensive management changes and a restructuring to conserve cash and to facilitate a new strategic path to advance its lead anticancer drug Marqibo™, its other Targeted Chemotherapy cancer products and its promising early-stage Targeted Immunotherapy pipeline. Timothy M. Ruane has been appointed President and Chief Operating Officer (COO), effective immediately.
The Company said it will reduce its workforce from 57 to 22 employees and cut its expenditures to less than $1 million per month. After severance costs of approximately $4.4 million, INEX will begin its Fiscal Third Quarter July 1, 2005 with working capital of approximately $16 million, which it believes is sufficient to fund the Company into the second half of 2006.
David J. Main, who joined INEX in September 1996 as Vice-President, Corporate Development and was appointed President and CEO in July 1999, will leave the company. Also leaving INEX are Tom MacRury, Senior Vice-President of Technical Operations, who joined INEX in April 1993, and Alexandra Mancini, Senior Vice-President of Clinical and Regulatory Affairs, who joined INEX in January 2001.
Darrell J. Elliott, Chairman of the Board, expressed the gratitude of the Board for the considerable contributions made by these executives. “David’s outstanding leadership was critical in the company’s transformation from a research-driven to a product-focused biopharmaceutical company and Tom and Alex both made important contributions to the company over many years. We are also grateful for the dedication of our other departing employees,” Elliott said. “The board strongly believes that Tim’s extensive experience in the business of cancer drug development and marketing makes him the ideal President to lead a leaner and more focused INEX to achieve its corporate objectives.”
Ruane joined INEX as Senior Vice-President, Corporate Development, on December 22, 2004 after his previous employer, ILEX Oncology, was acquired by Genzyme Corporate. He joined ILEX as Senior Vice-President, Business Management in February 2002 and served as a member of the senior management team that led the conversion of ILEX from a services-based oncology contract research organization (CRO) into an oncology product-focused pharmaceutical company. While at ILEX, he was responsible for all commercial operations of the company including marketing, sales and business development. He successfully partnered ILEX’s core asset, Campath (alemtuzumab), for clinical development with diagnostic companies and for commercialization in the Japan and Asia Pacific markets. He successfully out-licensed non-core lipid-focused cardiovascular assets and was also responsible for the development of commercial launch plans for Clofarabine.
Previous to ILEX, Ruane was Senior Director, Global Oncology Commercial Development, at Pharmacia Oncology and was responsible for all oncology franchise in-licensing and pipeline development. He has a BS from Wake Forest University and an MBA from the University of Washington.
Marqibo™
INEX has reached agreement in principle with the US Food and Drug Administration (FDA) on a path to commercial approval based on phase 3 clinical trial designs using complete response rate as the primary endpoint. The phase 3 trials would evaluate Marqibo as a treatment for both first-line non-Hodgkin’s lymphoma (NHL) and first-line acute lymphoblastic leukemia (ALL). Marqibo has shown promising anti-tumor activity in clinical trials in both of these cancers. Large cooperative medical groups have expressed an interest in participating in these phase 3 trials.
INEX is now in a position to finalize protocols for the phase 3 trials. INEX will not file Special Protocol Assessments with the FDA until after a partner is secured for Marqibo. A Special Protocol Assessment (SPA) is an FDA process that allows for formal FDA agreement on trial design and endpoints. INEX is continuing discussions with pharmaceutical companies with the intention of securing a commercial partnership, out-licensing agreement or other arrangement that would maximize the value of Marqibo for INEX.
Targeted chemotherapy pipeline
INEX has received approval from the FDA to begin clinical trials to evaluate INX-0125 (sphingosomal vinorelbine). In order to conserve cash, INEX will not initiate the phase I clinical trial for INX-0125 and will undertake discussions with pharmaceutical companies with the intention of securing a commercial partnership or out-licensing agreement that would maximize the value of this drug. INEX’s third targeted chemotherapy product, INX-0076 (sphingosomal topotecan), is ready for advancement towards clinical trials and the company is also looking for partnering arrangements to advance INX-0076 into clinical development.
Targeted immunotherapy pipeline
INEX’s second technology platform, Targeted Immunotherapy, induces the body's immune system to fight cancer and infectious diseases by delivering drugs that stimulate an immune response directly to the appropriate cells. The Company’s primary focus for this pipeline is on INX-0167.
INX-0167 is a therapeutic drug candidate in early research development. The Company has published preclinical data indicating INX-0167 has demonstrated the capacity to stimulate the immune system and significantly enhance the anti-tumor activity of monoclonal antibodies. This product candidate presents a significant opportunity for INEX given the increased use of monoclonal antibodies to treat cancer. INEX is looking to accelerate the development of this product candidate and the entire early stage promising Targeted Immunotherapy platform.
Convertible debt
INEX is continuing to pursue its options with regard to restructuring the Company’s convertible debt that, on March 31, 2005, totaled $41.2 million (US$34.1 million), including accrued interest. INEX has had several discussions with the majority debt holder regarding the potential restructuring of the debt and expects to continue to advance these discussions with all note holders.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. Further information about INEX and Marqibo can be found at www.inexpharm.com.
Forward Looking Statements
There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words “believes,” “may,” “plans,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, INEX’s stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market INEX’s products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
Contact Information
Investors
Ian Mortimer
Vice President, Finance and Chief Financial Officer
Phone: 604-419-3200
Email: info@inexpharm.com
Website: www.inexpharm.com
Media
Karen Cook Boas
James Hoggan & Associates Inc.
Phone: 604-739-7500
Email: kcook@hoggan.com
