Eagle wins lawsuit
Eagle Pharmaceuticals (EGRX), a US-based drug maker and a partner of Teva Pharmaceutical that specializes in the development of critical care drugs, won a lawsuit against the US FDA. The FDA had refused to grant orphan drug status to Teva Pharmaceutical and Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride) for the treatment of individuals with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. The orphan drug status will grant Teva Pharmaceutical an extra seven years of patent protection and market exclusivity. Now that Eagle Pharmaceuticals has won the lawsuit, Teva will continue to have US market exclusivity rights and protection from generic drug makers.
On May 23, the FDA extended the PDUFA (Prescription Drug Fee User Act) action date of Teva Pharmaceutical’s (TEVA) biologics license application for fremanezumab for the treatment of migraines to September 16. The FDA didn’t request additional data. The news about the lawsuit also improves the probability of winning FDA clearance of fremanezumab. Patent protection for Bendaka and the approval of fremanezumab could boost Teva’s revenue growth.
Celltrion refiled the regulatory application
Celltrion, a partner of Teva Pharmaceutical for commercialization of biosimilars in the US and Canada, announced that it refiled the US FDA application for the approval of its biosimilar version of Roche’s (RHHBY) Rituxan for commercialization in the United States.
Celltrion also announced its plans for re-submitting the regulatory application for the Herceptin biosimilar to the FDA. Celltrion anticipates FDA approval by the end of 2018. Teva Pharmaceuticals and Celltrion will share the profit generated from the sales of the biosimilars.
Of the 29 analysts tracking Teva Pharmaceutical in June 2018, one of them recommended a “strong buy,” while five analysts recommended a “buy” rating. 15 analysts recommended a “hold,” while six of them recommended a “sell,” and two analysts recommended a “strong sell.”
On June 10, Teva Pharmaceutical had a consensus 12-month target price of $19.13, which represents a ~17.2% decline over the next 12 months.
Of the four analysts tracking Eagle Pharmaceuticals in June 2018, ~75% of the analysts recommended some form of a “buy.” Among the 21 analysts tracking Mylan (MYL) in June 2018, ~67% of the analysts recommended a “buy.” Of the 22 analysts tracking Pfizer (PFE) in June 2018, ~55% of the analysts recommended some form of a “buy.”
On June 10, Eagle Pharmaceuticals, Mylan, and Pfizer had consensus 12-month target prices of $68.67, $49.6, and $39.86, which represents a ~4.7% decline, a ~19.9% increase, and an 8.7% increase over the next 12 months, respectively.