Enzon Pharmaceuticals Inc. and Inex Pharmaceuticals Corporation have filed a New Drug Submission (NDS) with the Therapeutics Products Directorate (TPD) of Health Canada for Marqibo (formerly referred to as Onco TCS).
The NDS is seeking marketing approval in Canada for Marqibo as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL) previously treated with at least two combination chemotherapy regimens.
Inex and Enzon will hear from the TPD within 45 days of filing as to whether or not the submission has been accepted for review. Subject to acceptance of the NDS for review, a response is anticipated from Health Canada in 12 to 18 months, the release says.
The NDS follows a New Drug Application that was submitted to the US Food and Drug Administration (FDA) seeking marketing approval for the same indication. The NDA was completed in March of this year, and the FDA will include in its review an evaluation by the Oncologic Drugs Advisory Committee (ODAC) on December 1, 2004. INEX and Enzon expect the FDA's response on the NDA by January 15, 2005.
David Main, president and CEO of INEX said, "The New Drug Submission for Marqibo is a significant milestone as we work towards providing a promising treatment option for patients with relapsed non-Hodgkin's lymphoma in Canada."
Kenneth J. Zuerblis, executive VP and CFO of Enzon said, "The NDS reaffirms our commitment to bring this product to the North American market and builds on the potential near term approval in the US. Our commercial team eagerly awaits the opportunity to offer a new single-agent treatment option to patients with relapsed aggressive non-Hodgkin's lymphoma."
Marqibo is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in Inex's sphingosomal drug delivery technology.
In the completed multi center pivotal Phase 2/3 clinical trial, 119 patients with aggressive NHL who had not responded to their previous therapy or had responded and subsequently relapsed were treated with Marqibo.
The results of this pivotal trial were released in June 2003 and presented in December 2003 at the American Society of Haematology annual conference along with interim results from two ongoing Phase 2 trials in relapsed Hodgkin's disease and relapsed B-cell lymphoma.
In addition to the lead indication, Enzon and Inex are also exploring the development of Marqibo for use as a single-agent therapy or in combination therapy for several cancers in which vincristine is now used.
NHL is the fifth-leading cause of cancer deaths in the Canada (2,900 estimated in 2004) and the fifth-leading cause of cancer deaths in United States (19,400 estimated in 2004), according to estimates of the Canadian Cancer Society and the American Cancer Society.