On December 23, 2014 Teva Pharmaceutical Industries reported that the U.S. Food and Drug Administration (FDA) has approved GRANIX (tbo-filgrastim) Injection for self-administration by patients and caregivers (Press release Teva, DEC 23, 2014, View Source [SID:1234501241]). With the approval of this additional administration option, physicians will soon have the flexibility to prescribe GRANIX for either in-office or at home use.

GRANIX, a leukocyte growth factor, is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX has been commercially available in the U.S. since November 2013. The currently marketed GRANIX syringe is indicated only for administration by a healthcare professional. Teva plans to launch a new GRANIX syringe, for self-administration by patients and caregivers, in early 2015.

“In partnership with their physician, patients will be able to decide whether administering GRANIX via self-injection at home or by a healthcare professional is the right course for them,” said Lee S. Schwartzberg, MD, FACP, Division Chief of Hematology Oncology at the University of Tennessee Health Science Center. “Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers.”

“This new administration option demonstrates Teva’s continued commitment to enhancing the patient experience by providing patients, in partnership with their physician, with flexibility in their treatment regimen,” said Paul Rittman, Vice President and General Manager, Teva Oncology. “We are proud to be adding to the value of this important product.”

On December 23, 2014 ARIAD Pharmaceuticals and Otsuka Pharmaceutical reported that they have entered into an agreement for Otsuka to commercialize ARIAD’s Iclusig (ponatinib) in Japan and nine other Asian countries and to fund future clinical trials in those countries (Press release Ariad, DEC 23, 2014, View Source [SID:1234501239]). ARIAD will lead the completion of the Japanese New Drug Application (NDA) for Iclusig, and Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL) in 2015. Iclusig is an approved BCR-ABL inhibitor in the United States, Europe and Australia.

The agreement provides for Otsuka to receive exclusive rights to market Iclusig in Japan and nine other Asian countries (the “Territory”) in return for an upfront payment of $77.5 million to ARIAD, a milestone payment upon regulatory approval in Japan for patients with resistant and intolerant Philadelphia-positive leukemias, and additional milestone payments for approval in other indications.

Following approvals in the Territory, Otsuka will conduct sales activities and record sales. ARIAD will also receive a substantial share of net product sales.

ARIAD will continue to fund the completion of its ongoing pivotal trial of Iclusig that will form the basis of the filing for regulatory approval in Japan, while Otsuka will fund additional agreed-upon clinical studies in the Territory. For ARIAD-sponsored global studies that include sites in Japan, Otsuka has the option to contribute to the funding and gain access to the data for use in the Territory.

“This agreement meets one of our key strategic objectives – establishing a strong partnership with an experienced and committed Japanese pharmaceutical company to commercialize and co-develop Iclusig in Japan and Asia,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Otsuka is building a leading hematology and oncology business in Japan and Asia and is an outstanding partner to successfully commercializing Iclusig in these markets.”

“Over the past several years, we have worked with the leading hematology experts in Japan and have run the Phase 1/2 clinical trial that will form the basis for our marketing authorization application,” he added. “Together with Otsuka, we will be able to make this cancer medicine available to refractory Philadelphia-positive leukemia patients in need of new treatment options.”

Otsuka Pharmaceutical President and Representative Director Taro Iwamoto noted, “The future arrival of ARIAD’s ponatanib in Japan and elsewhere in Asia will be an important evolution for patients with CML and Philadelphia-positive ALL with BCR-ABL gene expression, said to be particularly difficult to treat. Treatments have been inadequate for patients with these life-threatening conditions and we aim to contribute to improve the treatment available to them. ARIAD’s high-level drug discovery technology powered its discovery of ponatanib and Otsuka aims to maintain this momentum by making it part of our expanded portfolio in blood cancers from pre-treatment conditioning to treatments.”

A joint development and commercialization committee will oversee clinical development and commercialization of Iclusig in the Territory, including approval of any development or commercialization plans. Otsuka will have exclusive commercial rights to Iclusig and will promote it as its sole tyrosine kinase inhibitor in the Territory. In addition to Japan, the other Asian countries that are included in this agreement are China, South Korea, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam.