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Last Post: 10/24/2016 4:21:49 PM - Followers: 2 - Board type: Free - Posts Today: 0

United Therapeutics gets FDA nod for oral PAH drug

* Expects to launch oral PAH drug in U.S. in August

* Shares up 10 pct before the bell

(Adds details, share movement, analyst comments)

May 26 (Reuters) - United Therapeutics Corp (UTHR.O) said the U.S. Food and Drug Administration approved its orally administered drug tadalafil for the treatment of pulmonary arterial hypertension (PAH).

Tadalafil will be sold under the brand name Adcirca as a once-daily treatment for PAH with a 40 mg dose. The company expects to launch the drug commercially in the U.S. at the beginning of August.

"Based on the results of our survey as well as conversations with our consultants, we expect Adcirca to capture share from (Pfizer Inc's) Revatio," Lazard Capital Markets analyst Terence Flynn said in a note to clients.

The analyst cited Adcirca's more convenient dosing, a lower price point, and easier reimbursement when the dosage has to be adjusted, as reasons why the drug could grab market from the Pfizer (PFE.N) drug.

United Therapeutics acquired the U.S marketing rights for this indication of tadalafil from Eli Lilly & Co (LLY.N) in November 2008. Tadalafil is already approved for the treatment of erectile dysfunction under the brand name Cialis.

Flynn projects U.S. Adcirca sales of $8 million, $57 million and $87 million for the three years beginning 2009. The brokerage projects peak U.S. Adcirca sales of more than $150 million.

In the late-stage trial, the most common side-effects to the drug include headache, muscle pain, flushing, nasopharyngitis and respiratory tract infection.

United Therapeutics shares were trading at $72.50 before the bell Tuesday. They had closed at $66.54 Friday on Nasdaq. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Anthony Kurian)

http://www.reuters.com/article/marketsNews/idINBNG5998420090526?rpc=44
 

 

Company website

 

Shares Outstanding: 26.45M
Float: 25.56M

 

 

 

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UTHR News: Statement of Changes in Beneficial Ownership (4) 12/09/2016 04:07:01 PM
UTHR News: Statement of Changes in Beneficial Ownership (4) 12/07/2016 04:22:20 PM
UTHR News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 04:21:46 PM
UTHR News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 04:21:19 PM
UTHR News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 04:17:26 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 12/09/2016 04:07:01 PM
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#14   Multiple valuation analyses show United Therapeutics is highly ValueInvestor15 10/24/16 04:21:49 PM
#13   $UTHR Daily and Weekly Charts http://www.stock $Pistol Pete$ 02/18/16 09:31:28 PM
#12   $UTHR Daily Chart http://www.stockcharts.com/c $Pistol Pete$ 02/14/16 05:24:23 PM
#11   $UTHR recent news/filings stocktrademan 12/15/15 03:26:13 PM
#10   $UTHR H.C. Wainwright Reiterates Buy On United Therapeutics maytepper 09/15/14 04:13:54 PM
#9   * * $ECYT Video Chart 8-29-14 * * ClayTrader 08/29/14 05:02:47 PM
#8   * * $UTHR Video Chart 8-26-14 * * ClayTrader 08/29/14 04:59:29 PM
#7   New drug application for high blood pressure rejected mlkrborn 10/24/12 06:33:45 PM
#6   ~ Monday! $UTHR ~ Earnings posted, pending or Penny Roger$ 02/11/12 04:05:30 PM
#5   UTHR hit almost 52 weeks low level-$40 mlkrborn 08/24/11 02:16:18 PM
#4   5:31AM United Therapeutics: FREEDOM-C trial of oral treprostinil surf1944 08/24/11 08:51:48 AM
#3   United Therapeutics Reports First Quarter 2009 Financial Results Kristallweizen 05/27/09 04:33:45 AM
#2   Shorts covering today? Kristallweizen 05/26/09 03:35:21 PM
#1   Check out pre market action after the approval Kristallweizen 05/26/09 09:29:25 AM
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