Endo Targets Opana ER Abuse-Deterrent Filing In 2016
This article was originally published in The Pink Sheet Daily
Executive Summary
Endo continues to believe it can rebuild Opana ER, despite generic competition, by adding abuse-deterrent labeling and securing critical intellectual property protection.
Endo International PLC plans to file supplemental data supporting abuse-deterrent labeling for the opioid Opana ER (oxymorphone HCI extended release) in early 2016 following a meeting with FDA, CEO Rajiv De Silva said during the company’s second quarter sales and earnings call Aug. 10.
“We continue our comprehensive efforts to protect the Opana ER franchise including the promotion and development of the product, as well as the vigorous assertion of its intellectual property,” he said.
The filing and ongoing patent infringement litigation are part of an effort by Endo to rebuild the pain franchise, following the introduction of generic competition in January 2013. Endo launched an improved crush-resistant version of Opana ER in June 2012, ahead of generics, but FDA did not allow abuse-deterrent claims in labeling for the drug (Also see "No Abuse-Resistance Claim For Endo’s Opana ER Reformulation" - Pink Sheet, 12 Dec, 2011.).
Further, in May of 2013, the agency said generic versions of Opana ER could remain on the market, despite the availability of a reformulated crush-resistant version (Also see "Opioid Market Snapshot: No Pain, No Gain For Abuse-Deterrence Claims" - Pink Sheet, 24 Mar, 2014.).
The result has been disappointing for Endo, which saw sales of the drug plummet. The decline continued in the second quarter, with sales of Opana down 20% versus a year ago to $43.1m. Opana generated $299.3m in sales in 2012, the last full year before generics launched.
The company is also defending the intellectual property supporting Opana. It is awaiting a decision in a case held earlier this year in a New York federal court, and has also initiated another patent infringement suit in Delaware. If the patents are upheld they will provide IP protection on Opana until 2023 or perhaps longer.
“We’re cautiously optimistic on this but it will be 2016 before we have any clear view on if there’s true upside or not,” De Silva said of Opana.
Endo has been struggling to regain its footing ever since generics entered the market, not only because of Opana but because generic versions of its top-seller Lidoderm (lidocaine) patch also entered the market in 2013.
De Silva has been working to rebuild the company through acquisitions, including the $2.6bn acquisition of Auxilium Pharmaceuticals Inc., announced in October 2014 and the $8bn buyout of Par Pharmaceutical Inc., announced earlier this year, while also divesting non-core businesses .
On Aug. 4, the company closed on the sale of its American Medical Systems’ (AMS) men’s health and prostate health business to Boston Scientific Corp. for $1.65bn.
Acquisitions Boost Second Quarter Sales
The Par acquisition is still yet to close, but the addition of Auxilium’s revenues, mainly from Xiaflex (collagenase clostridium histolyticum), helped Endo’s second quarter results. Branded pharmaceutical sales of $316m increased 27% in the second quarter. Total Revenues increased 24% to $735m, which the company attributed to new product revenues from strategic M&A transactions.
Xiaflex is approved to treat Dupuytren’s contracture, a clawing of the hand, and Peyronie’s disease, curvature of the penis. The drug was originally approved for Dupuytren’s contracture in 2010 and gained the additional indication in 2013, which is helping to drive sales growth.
On a pro forma basis, US sales of the product grew 52% in the second quarter compared to the second quarter of 2014, De Silva said. Sales slowed in April and May as Endo made commercial changes and integrated Auxilium, but rebounded in June following the implementation, he added.
“Overall, we are pleased with Xiaflex’s performance today and after gaining experience with the product, we are focused on optimizing the reimbursement processes and sales force execution as key levers to maintaining and expanding its growth profile,” he said.
Endo is also investing behind Stendra (avanafil), a drug for erectile dysfunction, which it gained with Auxilium; Auxilium licensed rights to the drug from Vivus Inc.[See Deal]. It competes in a challenging market filled with generic competitors, but recently added a 15-minute onset of action claim, which Auxilium believed would give it an edge over competitors.
“Our efforts are focused on building brand awareness and driving trial use as we believe those are key to growth in this category,” De Silva said. Endo launched a targeted direct-to-consumer advertising campaign in the second quarter, including digital and print ads. The company also deployed a new contract sales force. “In order to be successful, however, we need to increase surveillance and access in a highly competitive market,” he added.
Endo also has a substantial generic drug business, which grew 24% in the second quarter over the year ago period to $338m in sales. The growth came from organic sales growth, the addition of revenues from the August 2014 acquisition of Dava Pharmaceuticals Inc. and increased sales of the authorized generic version of Lidoderm, launched in May 2014.
The acquisition of Par will substantially expand the business, adding nearly 100 products and a pipeline of 115 filed ANDAs; the generic business generated $1.3bn in revenues in 2014.