Hospira plans big study for new Epogen biosimilar

In what's described as an early-stage clinical trial, Hospira (NYSE: HSP) has unveiled plans to take its biosimilar of Amgen's anemia drug Epogen directly into a head-to-head study designed to swiftly pivot into a large, late-stage study. The Chicago-based company plans to recruit hemodialysis patients at 20 different centers across the U.S. But unlike a typical Phase I study, researchers will immediately study both safety and efficacy of the therapy, Retacrit, in comparison with the...

Durect’s pain drug fails to clear key hurdle in PhIIb

Just days after signing a $212.5 million U.S. licensing deal with Hospira, Durect (DRRX) reports that its pain drug Posidur--a long-acting version of the anesthetic bupivacaine--equaled an injectable therapy in a Phase IIb trial but failed to demonstrate an ability to reduce patients' use of rescue opioids. Durect signed up 115 women to test Posidur's ability to manage pain following hysterectomies. The mixed results on its two primary endpoints include the observation that all the treatment...

Hospira gains EMA OK for Neupogen biosimilar

Hospira says that it won European approval for its follow-on therapy to Amgen's blockbuster Neupogen. In winning the OK, Hospira provided late-stage data demonstrating that its therapy, Nivestim (filgrastim), had a comparable efficacy and safety profile to Neupogen. Europe has sprinted ahead of the U.S. in its approval of biosimilars, follow-on therapies to the biologics like Neupogen that have dominated the market for years. This is the fifth European approval for a biosimilar to...

Javelin and Myriad terminate merger pact

Javelin Pharmaceuticals and Myriad Pharmaceuticals have officially terminated their merger pact, clearing the way for Javelin to accept Hospira's $141 million buyout offer. Hospira's offer was considerably higher than Myriad's $90 million purchase price, and it included $4.4 million to cover the termination fee. Javelin submitted an NDA for its postoperative pain therapy Dyloject last December....

Javelin jilts Myriad in favor of Hospira’s $141M takeover offer

Javelin Pharmaceuticals is dumping Myriad Pharmaceuticals and its $81 million takeover deal in exchange for a much, much better deal from Hospira. Javelin shares skyrocketed 63 percent this morning after it announced that Hospira will pay $141 million for the company. Hospira not only offered $2.20 a share for Javelin--which is awaiting final word from the FDA on its application for the pain therapy Dyloject--but sweetened the deal with financing and an offer to cover a $4.4 million...