40-40 Drugs and Targets

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EU Approves Imbruvica In MCL, CLL Patients

The European Commission granted marketing approval for Imbruvica (ibrutinib)
throughout the European Union, for relapsed or refractory mantle cell lymphoma, or chronic lymphocytic leukemia patients who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.

Imbruvica, a first-in-class, oral, once-daily, non-chemotherapy treatment, is being jointly developed and commercialized in the U.S. by Pharmacyclics Inc. and Janssen Biotech Inc., which will market Imbruvica in Europe.

The approval was based on data from a phase II study in MCL, the phase III RESONATE study in CLL and small lymphocytic lymphoma and the phase Ib/II study in CLL/SLL. A worldwide regulatory filing program for ibrutinib currently is underway, according to the drug’s sponsor.

Imbruvica is approved in the U.S. for three indications: for the treatment of patients with MCL and CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment-naive and previously treated del 17p CLL patients.

Pharmacyclics also entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and preliminary efficacy of Imbruvica in combination with Gazyva (obinutuzumab), a CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system, in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma.

Initially, a phase III study will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development. Gazyva is a registered trademark of Genentech Inc.

The study of the investigational combination of Imbruvica and Gazyva through several investigator-sponsored trials also is being considered. Additional details of the agreement were not disclosed.

Janssen Research & Development also submitted a supplemental New Drug Application for Imbruvica to FDA for the treatment of patients with Waldenstrom’s macroglobulinemia. If approved, this will become the fourth indication for Imbruvica, which received an FDA Breakthrough Therapy Designation for WM in February 2013.

The Centers for Medicare and Medicaid Services published two draft local coverage determinations
for prostate cancer tests. The drafts were issued through Medicare contractor Palmetto GBA’s MolDx Program.

One a draft LCD, for use of the Decipher Prostate Cancer Classifier test in men who have undergone radical prostatectomy, is the only genomic test for prostate cancer to receive a draft LCD for use in the post-surgery setting. The Decipher test is developed by GenomeDx Biosciences.

Under Medicare policies, a 45-day comment period will commence on Nov. 10. After comments are received and revisions, if any, are made to the draft LCD, the final LCD will be posted within the following 45 calendar days.

MolDX, developed in 2011, facilitates the clinical review, coverage and payment policies for molecular diagnostic tests. The MolDX Program is a contractor to Noridian, a national contractor that administers Medicare benefits for Jurisdiction E, where GenomeDx is located.

According to GenomeDx, Decipher predicts the aggressiveness of a patient’s disease based on genomic information that is distinct from that provided by PSA and other clinical risk factors. Clinical studies have demonstrated that Decipher can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer. Decipher was developed in partnership with the Mayo Clinic.

Palmetto also issued a draft local coverage determination for Prolaris, a prostate cancer test developed by Myriad Genetics Inc.

The determination is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services website, and establishes the coverage policy for Medicare beneficiaries. The current language in the Prolaris draft LCD provides reimbursement coverage for the approximately 50 percent of prostate cancer patients defined as low and very low risk.

Priority Health announced it plans to cover the FoundationOne and FoundationOne Heme
genomic profiles for patients with cancer developed by Foundation Medicine Inc.

FoundationOne interrogates the entire coding region in 315 genes and select introns in 28 genes commonly altered in solid tumors, according to Foundation Medicine. FoundationOne Heme analyzes DNA in 405 genes and RNA in 265 genes that are most commonly altered in hematologic malignancies, sarcomas and select pediatric cancers.

Celgene Corporation and Sutro Biopharma will collaborate
on developing multispecific antibodies and antibody drug conjugates.

This agreement follows a previous December 2012 collaboration, and focuses on the immuno-oncology space, including established targets such as PD-1 and PD-L1, and novel targets using Sutro’s cell-free biologics development platforms, Xpress CF and Xpress CF+.

Celgene will have the exclusive option to acquire Sutro, including rights to all Sutro-owned programs at that time, on pre-specified terms: Sutro will receive upfront payments totaling $95 million, which includes an equity investment. Sutro may also receive up to an additional $90 million during the initial research term, including payments for manufacturing-related and productivity milestones.

Sutro will be responsible for discovery and early pre-clinical development of all collaboration multispecific antibodies and ADCs, as well as the manufacturing of pre-clinical product candidates. Celgene may assume responsibility for global development and commercialization and will have worldwide rights to all collaboration products, with the exception of certain collaboration products for which Sutro retains U.S. development and commercialization rights, in the event Celgene does not exercise its option to acquire Sutro.