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Apr 30, 2012

MannKind Out-Licenses BTK Program to Tolero

  • Tolero Pharmaceuticals and MannKind have decided to work together on MannKind’s BTK (bruton’s tyrosine kinase) program, which is currently being tested in hematological malignancies and inflammatory diseases. In return for exclusive, worldwide rights to develop and commercialize these compounds, Tolero will pay $130 million to MannKind in up-front and milestone fees linked to development, approval, and commercialization.

    MannKind will also receive tiered royalties on sales of products and a percentage of sublicensing revenue. In addition, MannKind has an option to re-acquire the rights to the program at pre-specified terms until 60 days after the conclusion of the first Phase I study.

    “BTK has already been demonstrated to be a validated clinical target in multiple disease settings,” David Bearss, Ph.D., founder of Tolero, points out. “We believe that MannKind has developed a series of novel compounds with unique mechanisms of action that may lead to important treatments for cancer and autoimmune diseases such as rheumatoid arthritis.”

    The deal adds to Tolero’s pipeline, which has been focused on anticancer agents. It has four preclinical-stage candidates targeting cancer anemia, pancreatic cancer, endometrial cancer, and multiple myeloma.

    For MannKind, the money obtained through this deal will help move Afrezza beyond Phase III. MannKind’s IPO took place in July 2004, and it has been investing in development of Afrezza, an ultrarapid-acting inhaled insulin product. Since submitting its NDA in March 2009, the company has received two complete response letters, most recently in January 2011. The company now says that it will resubmit its Afrezza NDA in 2013.

    At the end of 2011, MannKind reported that it had $3.2 million in cash, cash equivalents, and marketable securities. The company recently completed a secondary offering that raised $86 million.


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