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Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
Date:5/17/2012

SAN DIEGO and JERUSALEM, May 17, 2012 /PRNewswire/ -- Ambit Biosciences and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") today announced the clearance of an Investigational New Drug application (IND)  with the U.S. Food and Drug Administration (FDA) for CEP-32496, a novel BRAF (V600E) kinase inhibitor. 

The IND filing was based upon promising therapeutic potential for this agent, as evidenced by data revealed in recent publications in the Journal of Medicinal Chemistry and Molecular Cancer Therapeutics characterizing the preclinical properties of CEP-32496. The two publications feature results that demonstrate CEP-32496 is a selective and potent inhibitor of BRAF (V600E) in cells.  The published preclinical findings also demonstrate that CEP-32496 possesses potent and sustained anti-tumor activity in xenograft models of melanoma and colon carcinoma.  CEP-32496 possesses attractive pharmacokinetic properties upon oral administration and benchmarks favorably with respect to other kinase inhibitors that have activity at the BRAF (V600E) mutated kinase. 

"The data that we have generated to date in these preclinical studies lead us to believe that we have a promising drug candidate with CEP-32496 and is further validation of our successful drug discovery collaboration with Ambit," said Bruce Ruggeri, Ph.D., Senior Director, Oncology and Inflammation Discovery Research of Teva. "We look forward to exploring the full potential of this drug candidate to improve outcomes in patients with tumors possessing the BRAF(V600E) mutation."

Added Michael A. Martino, Ambit's President and Chief Executive Officer, "The filing of this IND represents a significant milestone for the Teva-Ambit collaboration and for the CEP-32496 program, and we look forward to advancement of the molecule into the clinic. The demonstrated selectivity and anti-tumor activity of this kinase inhibitor give it real promise in tumors that express the mutated BRAF gene and is further validation of Ambit's distinct competencies in kinase inhibitor drug discovery and optimization.

The manuscript published in Journal of Medical Chemistry describes the process that was employed to identify CEP-32496 as a clinical candidate. The publication includes data from preclinical models that highlight the selectivity and pharmacokinetic profile of the drug candidate.

The manuscript published in Molecular Cancer Therapeutics describes the pharmacokinetic profile and anti-tumor activity of CEP-32496 in preclinical models. In these studies, CEP-32496 demonstrated tumor stasis and regressions with favorable activity compared to other kinase inhibitors, including sorafenib and RAF-265, at doses that were well tolerated.

About CEP-32496

CEP-32496 is a small molecule kinase inhibitor of V600E mutated BRAF that is being developed as part of a collaborative agreement with Teva, initiated in 2006. This mutation in the BRAF gene has been identified in forms of melanoma, thyroid, colon, ovarian, and lung cancers. In addition to targeting mutations in BRAF, CEP-32496 targets other select kinases of interest in oncology with potentially desirable clinical application. Animal models in multiple cancer types suggest CEP-32496 may possess best-in-class potential. The CEP-32496 program is testament to the successes that can be achieved when two companies leverage their respective strengths in collaboration.

About BRAF Kinase in Cancer

Mutations in the BRAF gene have been identified in approximately seven percent of all cancers, including 60 percent to 70 percent of melanoma cases, four to 16 percent of colorectal cancer cases, 29 to 83 percent of papillary thyroid carcinomas and to a lesser extent in serous ovarian cancer and non-small lung cancer.  The BRAF gene is a key component of a pathway involved in normal cell growth and survival.  Mutations such as BRAF (V600E) are believed to be drivers of disease and can lead to uncontrolled cell growth and disease progression, and therefore represent a promising target for pharmacological intervention.

Melanoma is the most serious type of skin cancer and is growing at a rate of approximately five to six percent annually. More than 75,000 people in the U.S. plus an additional 85,000 people worldwide are diagnosed with melanoma each year. Patients with melanoma have limited treatment alternatives and experience some of the poorest outcomes, with 5-year survival rates of less than 20 percent for people with advanced (Stage IV) melanoma, according to the American Cancer Society.

About the Ambit-Teva Collaboration

In November 2006, Ambit and Cephalon Inc (acquired by Teva) entered into an exclusive collaboration agreement with multiple parts: (i) a drug discovery and development collaboration aimed at identifying and developing a clinical candidate for the BRAF(V600E) mutated kinase, and a separate effort for identifying and developing a clinical candidate for a second undisclosed kinase, and (ii) kinase screening services for Cephalon's small molecule library of kinase inhibitors.  Cephalon paid Ambit an upfront fee of $15.5 million as partial consideration for access to Ambit's kinase profiling technology and licenses contributed by Ambit to the drug discovery part of the collaboration. Ambit may be entitled to receive greater than $45 million in development and commercial milestone payments if CEP-32496 is successful, and may receive further milestones if a compound is successfully developed and commercialized against the second target in the collaboration.  In addition, Ambit may receive tiered royalty payments on net sales of the collaboration compounds.

About Ambit Biosciences

Ambit Biosciences is a privately held biopharmaceutical company engaged in the development of a robust pipeline of small molecule kinase inhibitors for the treatment of cancer, inflammatory disease and other indications. Ambit's lead compound, quizartinib (AC220), is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor, and is currently under clinical investigation in patients with relapsed or refractory AML and treatment-naive AML. Ambit is developing quizartinib in collaboration with Astellas Pharma Inc. as part of a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications. In addition to quizartinib, Ambit's clinical pipeline includes AC430, an oral JAK2 inhibitor, and CEP-32496, a BRAF inhibitor licensed to Teva.  Ambit's preclinical portfolio includes a proprietary CSF1R inhibitor program. For more information, visit www.ambitbio.com.

About Teva

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.

Contacts:

Ambit Biosciences:
Alan Fuhrman
Chief Financial Officer
(858) 334-2133

Ian Stone or David Schull (Media)
Russo Partners
(619) 308-6541
(212) 845-4271
ian.stone@russopartnersllc.com
david.schull@russopartnersllc.com

Cindy McGee (Investors)
Russo Partners
(619) 308-6538
cindy.mcgee@russopartnersllc.com


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