EU Nod for UTHR's Remodulin IV - Analyst Blog
December 28 2011 - 11:37AM
Zacks
United Therapeutics Corporation (UTHR) recently
received approval in the EU for the intravenous (IV) use of its
pulmonary arterial hypertension (PAH) treatment, Remodulin
(treprostinil). Approval was granted by the French regulatory
agency Agence Francaise de Securite Sanitaire des Produits de
Sante (AFSSAPS).
Remodulin is already approved in several European countries, as
a subcutaneous (SC) infusion treatment, for idiopathic or heritable
PAH in patients classified as New York Heart Association (NYHA)
functional class III.
Remodulin sales totaled $403.6 million in 2010, up 21.7%. EU
approval for the intravenous formulation should drive sales
further. The company is looking to launch Remodulin in new
territories including Japan and China. The Japanese market, where
approval is expected by late 2013, could bring in incremental sales
of about $100 million.
Oral Treprostinil Filed in the US
Meanwhile, United Therapeutics applied for US approval of oral
treprostinil for the treatment of PAH. Remodulin, United
Therapeutics’ lead product, is currently approved for both
subcutaneous (SC) and intravenous (IV) use in the US. Assuming the
US Food and Drug Administration (FDA) accepts the filing for the
oral formulation, a final response should be out in the second half
of 2012.
Data on oral treprostinil has been mixed. In August 2011, United
Therapeutics had reported that oral treprostinil failed to meet its
primary endpoint in a late stage study (FREEDOM-C2). FREEDOM-C2 was
a combination therapy study, which was examining oral treprostinil
in combination with PDE-5 inhibitors or endothelin receptor
agonists.
However, earlier in June 2011, United Therapeutics had presented
positive data from another late stage study (FREEDOM-M) which
evaluated oral treprostinil as a monotherapy for PAH. Management
hopes to get oral treprostinil approved on the basis of data from
the FREEDOM-M trial. Other players in the PAH market include
Pfizer's (PFE) Revatio and
Gilead's (GILD) Letairis.
Outperform on United Therapeutics
We currently have an Outperform recommendation on United
Therapeutics, which carries a Zacks #1 Rank (short-term Strong Buy
rating). We believe the company is well-positioned to gain share in
the PAH market. Lead product, Remodulin, continues to look very
strong in both the IV and SC form. With the approval of Adcirca and
Tyvaso, the company now has a varied range of therapies available
for the treatment of PAH. We believe the company’s PAH product
portfolio will drive strong top-and bottom-line growth.
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