We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
United Therapeutics Tanks, Remodulin Pump Launch Delayed
Read MoreHide Full Article
United Therapeutics Corporation (UTHR - Free Report) shares plunged around 9% on Monday after the company announced that regulatory issues will delay the planned U.S. launch of RemoSynch - an implantable pump for delivering Remodulin. The company now expects to launch RemoSynch sometime in 2018 against the first half of this year, as expected previously.
A look at United Therapeutics’ share price movement shows that the stock has underperformed the Zacks classified Medical - Drugs industry this year so far. United Therapeutics declined 13.6% during this period, while the industry rose 2.5%.
United Therapeutics holds a strong position in the pulmonary arterial hypertension (PAH) market with four approved products targeting this indication. These include Remodulin, an injectable formulation of treprostinil; Orenitram, an oral version of treprostinil, and Tyvaso, an inhaled version of treprostinil. The company has another PAH treatment, Adcirca (tadalafil) tablets in its portfolio for which it has acquired exclusive commercialization rights in the U.S from Eli Lilly & Company (LLY - Free Report) .
However, as mentioned at the fourth-quarter conference call, the growth of Orenitram, Tyvaso and Remodulin was slower than expected due to rising competition from Actelion Ltd’s new drug Uptravi. The company said that patients were staying longer on oral PAH therapies like Adcirca, Letairis and Uptravi (selexipag). Competition in the PAH market is on the rise.
The company is therefore working on bringing multiple second generation Remodulin drug delivery systems to drive sales growth. United Therapeutics is working with medical device maker Medtronic, Inc. (MDT - Free Report) to get RemoSynch approved by the FDA. Medtronic’s catheter, which is necessary for the RemoSynch system to work, is also under FDA review with the agency expected to give its decision on Apr 10, 2017. An approval of Remodulin in the form of an implantable pump would expand its patient population and boost the commercial potential of the product.
However, United Therapeutics’ efforts to bring Remodulin in the form of an implantable pump system to market have been far from smooth. In Mar 2016, the FDA issued a complete response letter (CRL) to Medtronic for its premarket approval application (PMA) for the catheter for RemoSynch, saying that it was not approvable. The agency noted various measures that Medtronic needed to take for the approval of the PMA. United Therapeutics also received a CRL for its new drug application (NDA) requesting FDA approval for the use of Remodulin with RemoSynch. The CRL indicated that the FDA cannot approve United Therapeutics’ NDA before Medtronic’s PMA is approved. Both the NDA and PMA have to be approved in order to launch RemoSynch in the U.S. Medtronic resubmitted the PMA for the catheter in October.
The latest development on the regulatory front is another setback for United Therapeutics. The company refrained from providing any further details regarding the nature of the regulatory delay.
Meanwhile, United Therapeutics is also working with DEKA Research & Development Corp. for the development of a pre-filled, semi-disposable pump system for the subcutaneous delivery of Remodulin called RemUnity. An approval in the U.S. is anticipated by the end of 2018.
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
United Therapeutics Tanks, Remodulin Pump Launch Delayed
United Therapeutics Corporation (UTHR - Free Report) shares plunged around 9% on Monday after the company announced that regulatory issues will delay the planned U.S. launch of RemoSynch - an implantable pump for delivering Remodulin. The company now expects to launch RemoSynch sometime in 2018 against the first half of this year, as expected previously.
A look at United Therapeutics’ share price movement shows that the stock has underperformed the Zacks classified Medical - Drugs industry this year so far. United Therapeutics declined 13.6% during this period, while the industry rose 2.5%.
United Therapeutics holds a strong position in the pulmonary arterial hypertension (PAH) market with four approved products targeting this indication. These include Remodulin, an injectable formulation of treprostinil; Orenitram, an oral version of treprostinil, and Tyvaso, an inhaled version of treprostinil. The company has another PAH treatment, Adcirca (tadalafil) tablets in its portfolio for which it has acquired exclusive commercialization rights in the U.S from Eli Lilly & Company (LLY - Free Report) .
However, as mentioned at the fourth-quarter conference call, the growth of Orenitram, Tyvaso and Remodulin was slower than expected due to rising competition from Actelion Ltd’s new drug Uptravi. The company said that patients were staying longer on oral PAH therapies like Adcirca, Letairis and Uptravi (selexipag). Competition in the PAH market is on the rise.
The company is therefore working on bringing multiple second generation Remodulin drug delivery systems to drive sales growth. United Therapeutics is working with medical device maker Medtronic, Inc. (MDT - Free Report) to get RemoSynch approved by the FDA. Medtronic’s catheter, which is necessary for the RemoSynch system to work, is also under FDA review with the agency expected to give its decision on Apr 10, 2017. An approval of Remodulin in the form of an implantable pump would expand its patient population and boost the commercial potential of the product.
However, United Therapeutics’ efforts to bring Remodulin in the form of an implantable pump system to market have been far from smooth. In Mar 2016, the FDA issued a complete response letter (CRL) to Medtronic for its premarket approval application (PMA) for the catheter for RemoSynch, saying that it was not approvable. The agency noted various measures that Medtronic needed to take for the approval of the PMA. United Therapeutics also received a CRL for its new drug application (NDA) requesting FDA approval for the use of Remodulin with RemoSynch. The CRL indicated that the FDA cannot approve United Therapeutics’ NDA before Medtronic’s PMA is approved. Both the NDA and PMA have to be approved in order to launch RemoSynch in the U.S. Medtronic resubmitted the PMA for the catheter in October.
The latest development on the regulatory front is another setback for United Therapeutics. The company refrained from providing any further details regarding the nature of the regulatory delay.
Meanwhile, United Therapeutics is also working with DEKA Research & Development Corp. for the development of a pre-filled, semi-disposable pump system for the subcutaneous delivery of Remodulin called RemUnity. An approval in the U.S. is anticipated by the end of 2018.
United Therapeutics carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>