May 4, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Carlsbad, Calif.-based Isis Pharmaceuticals, Inc. inked a $155 million deal with Bayer HealthCare to develop and market ISIS-FXIRx, a treatment and preventative for thrombosis.
The deal is structured so that Isis will receive an upfront payment of $100 million, with another $55 million when the program moves out of a Phase II study. Additional milestone payments are included, as well as tiered royalties. Bayer will take on global clinical development, as well as global regulatory and commercialization responsibilities.
ISIS-FXIRx targets Factor XI, a chemical produced by the liver that is a major component in blood clotting. Individuals with high levels of Factor XI are at increased risk of heart attacks and strokes. In a Phase II trial, patients treated with ISIS-FSIRx had a seven-fold lower rate of venous thromboembolic events (VTEs) than patients treated with enoxaparin.
“This first-in-class FXI inhibitor perfectly complements our in-house thrombosis pipeline and is an innovative development candidate for a variety of anti-coagulation needs,” said Joerg Moeller, member of the Bayer HealthCare Executive Committee and Head of Global Development in a statement. “We believe the novel mechanism of Factor XI inhibition may offer an additional pathway for treating patients for whom there are currently no suitable therapeutic options available.”
Isis is on a roll, having announced on April 30 that it had earned a $10 million milestone payment from Biogen related to the validation of an unidentified target used to treat a neurological disorder. The two companies signed a broad strategic alliance in 2012, which has successfully advanced nine programs, including four drugs that are in development.
“Together with Biogen, Inc., we have made significant progress advancing multiple programs,” said B. Lynne Parshall, chief operating officer of Isis in a statement. “In our pipeline, we have four drugs in development with Biogen, including ISIS-SMNRx, ISIS-DMPK-2.5Rx and two drugs to undisclosed targets. In addition, we have a number of earlier stage programs, like this one, that we will be advancing this year. To date, we have generated $329 million in payments from our broad collaboration with Biogen.”
Which including the $155 million from Bayer, makes a whopping $484 million. ISIS will release its first quarter earnings tomorrow, May 5. Analyst are projecting earnings per share of ($0.21) and revenue of $52.74 million for the quarter.
Zacks analysts have downgraded ISIS shares from “buy” to “hold.” Based on a research note from March 17, analysts at Janney Montgomery Scott set a “neutral” rating. Analysts at TheStreet upgraded their rating from “sell” to “hold” on March 5.
The company’s stock has been on an overall increase since May 20, 2014, when it sold for $23.58. It peaked on April 19, 2015 with a price of $77.08. ISIS stock is currently selling for $61.00.
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