In an unprecedented move, the U.S. Food and Drug administration (FDA) requested that Endo International PLC (NASDAQ: ENDP) remove its Opana ER from the market. Ultimately, the agency held concerns about abuse surrounding the drug.
As a result, this has helped competitors to swoop in and gain a foot-hold in the market. Impax Laboratories Inc. (NASDAQ: IPXL) is seeing some benefit from this debacle as 479,877 prescriptions filled for Opana in the trailing 12-months (TTM) will switch to other products like generic extended-release oxymoprhone ER sold by Impax and Xtampza from Collegium Pharmaceutical Inc. (NASDAQ: COLL).
This provides meaningful potential upside to Collegium and it should also help the company’s messaging about Xtampza’s superior abuse deterrent features because it highlights the unique nature of each product in the market. Collegium already has shown through comparative studies that Xtampza has superior abuse-deterrent features relative to branded-market leader Oxycontin, which generated 3.2 million prescriptions TTM, and Collegium has only just begun to deliver this message to physicians.
The FDA’s decision to remove Opana ER is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of the serious blood disorder thrombotic microangiopathy.
Shares of Impax were up 1% at $16.85 early Friday, with a consensus analyst price target of $15.45 and a 52-week trading range of $7.75 to $33.50.
Collegium shares were trading up 12% at $11.22, with a consensus price target of $22.20 and a 52-week range of $7.37 to $20.55.
Endo traded down 12% at $12.11, with a consensus price target of $15.88 and a 52-week range of $9.70 to $24.93.