William Blair Raises Red Flags on Endo International plc – Ordinary Shares (ENDP) Ahead of FDA AdCom for Opana ER Drug

William Blair analyst Tim Lugo is quite apprehensive on Endo International plc – Ordinary Shares (NASDAQ:ENDP) on the heels of yesterday morning’s review materials from the FDA regarding post-marketing safety concerns circling the biotech firm’s Opana ER – an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate.

The FDA materials are related to the forthcoming Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) joint meeting from March 13th to 14th, where from Lugo’s stance it is a “definite possibility” the committee will decide to remove Opana ER from the market. Believing the AdCom documents underscore safety concerns and a rising IV abuse potential for the pipeline drug, the analyst reiterates a Market Perform rating on shares of ENDP without listing a price target.

Lugo opines, “We note that AdCom documents usually read negatively, and while a likely outcome could include a more restrictive label listing the risks of TMA and IV abuse potential, we would not be surprised if the product was voted on to be pulled from the market. Unlike when the product was originally approved there now are several formulations of abusedeterrent opioids with better benefit/risk profiles (i.e., those approved post-abuse deterrent formulation guideline publication) on the market, such as Collegium’s […] Xtampza ER. Lastly, we recall how negative the sentiment was surrounding the approval of Zohydro (which was not an abuse deterrent product) and do not discount the potential for any opioid panel to turn negative given the strong public sentiment surrounding the opioid abuse crisis.”

In the bigger picture, “While we see 2017 guidance as part of a larger financial reset, we are still wary of continued base-business erosion, consortium pressure, and competition,” Lugo concludes.

According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, four-star analyst Tim Lugo is ranked #536 out of 4,515 analysts. Lugo has a 38% success rate and gains 15.8% in his yearly returns. When recommending ENDP, Lugo earns 0.0% in average profits on the stock.

TipRanks analytics indicate ENDP as a Hold. Based on 8 analysts polled by TipRanks in the last 3 months, 1 rates a Buy on Endo stock while 7 maintain a Hold. The 12-month average price target stands at $16.14, marking a 53% upside from where the stock is currently trading.

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