26 de mayo de 2009 / 15:43 / hace 9 años

UPDATE 4-United Therapeutics gets FDA nod for oral PAH drug

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

* Says Adcirca pricing comparable to Cialis on mg-to-mg basis

* Says distribution will be through retail pharmacies

* Sees launch of tyvaso first week of Sept, if approved

* Shares up as much as 12 pct (Updates share movement, adds analyst’s comment)

By Jennifer Robin Raj

BANGALORE, May 26 (Reuters) - United Therapeutics Corp (UTHR.O) said the U.S. Food and Drug Administration approved its orally administered drug to treat high pulmonary blood pressure, sending its shares up as much as 12 percent.

The drug tadalafil -- already approved for the treatment of erectile dysfunction under the brand name Cialis -- will be sold under the brand name Adcirca as a once-daily treatment for pulmonary arterial hypertension (PAH), high blood pressure in vessels connecting the lungs to the heart, with a 40 mg dose.

The company expects to launch the drug commercially in the United States at the beginning of August.

“We expect on an mg-to-mg basis the pricing of Adcirca will be comparable to the pricing of Cialis,” Chief Executive Martine Rothblatt said on a conference call with analysts.

The distribution of Adcirca will be through the normal retail pharmacies, Rothblatt said, adding that the company had hired sales representatives in anticipation of the launch and does not require any new hiring.

The drug will compete with Pfizer Inc’s (PFE.N) Revatio, a 20 mg pill taken thrice a day.

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

The analyst cited Adcirca’s more convenient dosing and lower pricing among the reasons as to why the drug could grab market from the Pfizer drug.

Collins Stewart analyst Salveen Kochnover agreed.

Physicians expect Adcirca to cannibilize Revatio, Kochnover said and raised the price target on the shares of United Therapeutics to $100 from $97. The analyst rates the stock “buy”.

United Therapeutics acquired the U.S marketing rights for this indication of tadalafil from Eli Lilly & Co (LLY.N) in November 2008.

Lazard’s Flynn sees peak U.S. Adcirca sales of more than $150 million. Deutsche Bank’s Mark Schoenebaum said in a best case scenario, Adcirca U.S. sales could reach $200 million before the 2017 patent expiration.

J.P. Morgan analyst Geoffrey Meacham sees 2009-2012 sales of $34 million, $90 million, $153 million and $212 million, respectively.

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

The company also has an inhaled drug for PAH -- tyvaso, on which the FDA had raised certain questions regarding human factors testing and the instructions for use of the portable nebulizer that delivers the drug. [ID:nBNG228579]

The FDA action date on the drug had been pushed back to July 30 from April 30. The company sees a launch of tyvaso in the first week of September, if approved.

United Therapeutics shares were up more than 11 percent at $74.29 Tuesday afternoon on Nasdaq. They had touched a high of $74.65 earlier in the session. (Editing by Anthony Kurian, Himani Sarkar)

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