Inex targets spin-off
The Board of Directors at Inex Pharmaceuticals, a Canadian biopharmaceutical company, has approved a reorganisation scheme that would include the spin-off of its targeted immunotherapy technology and product candidates into a new company.
The Board of Directors at Inex Pharmaceuticals, a Canadian biopharmaceutical company, has approved a reorganisation scheme that would include the spin-off of its targeted immunotherapy technology and product candidates into a new company.
The major objectives for the new company would be to complete an equity financing in 2006 and complete preclinical development in order to file an Inves-tigational New Drug application for INX-0167, its lead product candidate in this area, enabling it to commence clinical development.
The company claims that: 'The reorganisation would enable the new company to focus on Inex's targeted immunotherapy programme and raise the additional capital necessary to advance this technology. It would also allow Inex to continue its focus on extracting value from its late stage targeted chemotherapy platform, including Marqibo (dphingosomal vincristine), INX-0125 (sphingosomal vinorelbine) and INX-0076 (sphingosomal topotecan).'
If the proposal is approved by shareholders and the Supreme Court of British Columbia, the majority of shares in the new public company would be distributed to INEX shareholders. The shareholder meeting on is expected to take place on 26 January 2006.
In a related development Inex has received a Notice of Non-Compliance from the Therapeutics Products Directorate of Health Canada for Marqibo, a proprietary drug comprised of the off-patent anticancer drug vincristine. The decision means that Inex will be required, as is already the case following denial of US FDA (Food and Drug Administration) approval in January 2005, to provide data from randomised phase III clinical trials before consideration for marketing approval.
Inex states that is has reached 'agreement in principle' with the FDA on a path to commercial approval for Marqibo 'based on phase III clinical trial designs using complete response rate as the primary end-point', that will evaluate it as a treatment for both first-line non-Hodgkin's lymphoma (NHL) and first-line acute lymphoblastic leukemia (ALL). The company is now in partnering discussions for the drug with phar-maceutical companies.