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ARIAD and Medison Pharma Announce Approval of Iclusig (Ponatinib) in Israel

On March 24, 2015 ARIAD Pharmaceuticals and Medison Pharma reported that the Israeli Ministry of Health has granted regulatory approval for Iclusig (ponatinib) in Israel for adult patients with (Press release, Ariad, MAR 24, 2015, View Source [SID:1234502503]):

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Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib, who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation
Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib, who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.

ARIAD submitted its application for Iclusig to the Israeli Ministry of Health in June 2014. Commercial launch of Iclusig is expected to occur in the second quarter of 2015.

"Iclusig is an important addition to the treatment armamentarium," said Professor Arnon Nagler, head of hematology and the Bone Marrow Transplant Division at the Chaim Sheba Medical Center in Israel, and chairman of the Israeli Bone Marrow Transplant Association. Dr. Nagler added, "Patients in Israel have an excellent health care system, and having this potent and promising drug is an important addition to the national health basket."

"The swift approval by the Ministry of Health in Israel speaks to the importance of this new therapy to appropriate patients in Israel. We look forward to continued success working with ARIAD and fulfilling Medison’s vision to provide innovative and unique treatments to patients in Israel," said Meir Jakobsohn, chief executive officer and founder of Medison Pharma.

"We are very pleased with the rapid approval of Iclusig in Israel and the strength of our ongoing collaboration with Medison. This milestone further recognizes the major importance of Iclusig for the treatment of patients with refractory Philadelphia-positive leukemias," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "Approval in Israel is an important step in our effort to make Iclusig available to CML patients in need in key regions throughout the world."

The Ministry of Health decision was based on results from the pivotal Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial in patients with CML or Ph+ ALL who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, or who had the T315I mutation of BCR-ABL. Iclusig demonstrated anti-leukemic activity achieving a major cytogenetic response (MCyR) in 54 percent of chronic-phase CML patients and in 70 percent of patients with the T315I mutation.1, 2 MCyR within the first 12 months was the primary endpoint of the PACE trial for chronic-phase patients.1, 2

In patients with advanced disease, 57 percent of accelerated-phase CML patients and 34 percent of blast-phase CML patients achieved a major hematologic response (MaHR) with Iclusig. MaHR within the first 6 months was the primary endpoint in the trial for patients with advanced disease. 1, 2

The most common serious adverse reactions >1% were pancreatitis, pyrexia, abdominal pain, myocardial infarction, atrial fibrillation, anaemia, platelet count decreased, febrile neutropenia, cardiac failure, lipase increased, dyspnea, diarrhoea, neutrophil count decreased, pancytopenia, and pericardial effusion.

Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively. Serious venous occlusive reactions occurred in 4.5% of patients. The most common (≥20%) adverse reactions of any severity were decrease in platelet count, rash, dry skin, and abdominal pain.2

Based on the European Medicines Agency’s orphan drug designation and the HAEMACARE project, it is estimated that there are approximately 700 patients with CML in Israel.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

GenSpera has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, GenSpera, MAR 23, 2015, View Source [SID1234502489]).

20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

BioLineRx has filed a 20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, BioLineRx, MAR 23, 2015, View Source [SID1234502488]).

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

BioLineRx has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, BioLineRx, MAR 23, 2015, View Source [SID1234502466]).

Bristol-Myers Squibb and ZAI Lab Enter Licensing Agreement to Develop,Manufacture and Commercialize Brivanib in China

On March 23, 2015 Bristol-Myers Squibb Company (NYSE: BMY) and ZAI Lab Limited (ZAI Lab), a leading innovative biotech company based in China, reported that the companies have signed a definitive agreement under which ZAI Lab will acquire exclusive rights in China (including Hong Kong and Macau) to develop, manufacture and commercialize brivanib, an orally available kinase inhibitor in Phase 3 development for oncology indications including hepatocellular carcinoma (HCC).

ZAI Lab will be responsible for developing, manufacturing and commercializing brivanib in China. Bristol-Myers Squibb will be eligible to receive developmentbased milestone payments and tiered royalties from the commercial sales of brivanib in China, if brivanib is approved for marketing by Chinese authorities. Bristol-Myers Squibb also will have the option to co-promote brivanib in China with ZAI Lab and share commercial profits. Bristol-Myers Squibb retains all development and commercialization rights to brivanib outside of China, Macau and Hong Kong. Additional terms were not disclosed.

"HCC is the most common form of primary liver cancer and patients with intermediate-stage HCC typically live only 20 months after diagnosis on average," said Karl Lintel, president, Bristol-Myers Squibb China. "We are pleased to partner with ZAI Lab to further investigate brivanib as a potential treatment for patients living with HCC in China. Earlier studies of brivanib in this patient population suggest brivanib may be an effective therapy, prolonging time to progression to advanced disease for patients who have no other effective treatment options."

Samantha Du, Ph.D., founder and CEO of ZAI Lab said: "We are very excited about this agreement. Brivanib has already been tested in multiple global Phase 3 studies with a large number of Chinese HCC patients participating in the trials. Encouraging
efficacy data have been observed among the Chinese HCC patients with an acceptable safety profile. China accounts for more than 50% of global annual incidence of liver cancer, with more than 400,000 new cases and 371,000 deaths in 2012. Based on the
preliminary analysis of the extensive Phase 3 data, brivanib may offer a new treatment option for Chinese HCC patients."