Endo's (ENDP) BLA For Cellulite Treatment Accepted By FDA
Zacks Investment Research | Nov 21, 2019 03:20AM ET
Endo International plc (NASDAQ:ENDP) announced that the FDA has accepted for review the original Biologics License Application (BLA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
The BLA is supported by the results of the phase III studies — RELEASE-1 and RELEASE-2.
RELEASE-1 and RELEASE-2 were two identical, multicenter, randomized, double-blind, placebo-controlled studies that enrolled 845 women (423 and 422 in each separate trial) aged 18 years or above in the United States with moderate-to-severe cellulite. Each subject received up to three treatments of CCH (0.84 mg/treatment area) or placebo with an interval of around 21 days between each session.
The results of the studies showed that CCH delivered a clinically meaningful and statistically significant improvement as compared to placebo for all primary and secondary endpoints.
The agency set a Prescription Drug User Fee Act (PDUFA) or target action date of Jul 6, 2020.
A potential approval of CCH should boost Endo’s top line, given the wide market potential.
Earlier this month, Endo reported better-than-expected results for the third quarter, wherein it beat on both earnings and sales on the back of Xiaflex. Xiaflex’s performance has been solid in the year so far on higher demand in both Peyronie's disease and Dupuytren's contracture. The Sterile Injectables segment has also boosted the top line, owing to continued strong growth in Vasostrict, Adrenalin and Aplisol.
Shares of Endo have lost 39.1% in the year so far against the industry ’s 7.8% growth. It has been embroiled in various opioid litigations lately, which affected the share price.
Apart from Endo, many pharma companies like Mallinckrodt (NYSE:MNK) and Teva Pharma (NYSE:TEVA) are embroiled in multiple opioid litigations filed by several states, counties and political subdivisions in the United States regarding the abuse of opioid-based drugs. The industry players are accused of faulty marketing practices, which downplayed addiction risks from these drugs and spurred their consumption instead.
Zacks Rank & A Stock to Consider
Endo currently carries a Zacks Rank #3 (Hold). A better-ranked stock in this space is Jazz Pharmaceuticals (NASDAQ:JAZZ) , which sports a Zacks Rank #1 (Strong Buy). You can see Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.