The US Food and Drug Administration (FDA) recently issued a
second complete response letter (CRL) for
United Therapeutics Corporation's
) new drug application for oral Remodulin (treprostinil).
The company is looking to get oral Remodulin approved for the
treatment of pulmonary arterial hypertension (PAH).
At the time of issuing the first CRL, the FDA had raised
questions about the clinical importance of the 6 Minute Walk
Distance (6MWD) effect size shown in the FREEDOM-M study, the
lack of improvement in time to clinical worsening in all three
phase III studies conducted with oral Remodulin, and the failure
to show a statistically significant effect on 6MWD in the two
United Therapeutics said that it will seek an "end of review"
meeting with the FDA to discuss the latest CRL.
The second CRL does not really come as a surprise - with no
new data being provided in the re-submitted NDA, chances of
gaining approval were low, in our opinion. We believe the company
will need to conduct an additional trial with oral Remodulin. We
expect more clarity on the situation once the company conducts a
meeting with the FDA.
We note that United Therapeutics is facing a patent challenge
for Remodulin injection. Sandoz is seeking approval for its
generic version of Remodulin (10 mg/mL). United Therapeutics has
filed a patent infringement lawsuit against Sandoz. Remodulin,
the key revenue generator at United Therapeutics, accounts for
almost 50% of sales.
United Therapeutics currently carries a Zacks Rank #3 (Hold).
Even without oral Remodulin, the company is well-positioned in
the pulmonary arterial hypertension market. Remodulin continues
to look very strong in both the intravenous (IV) and subcutaneous
With the approval of Adcirca and Tyvaso, United Therapeutics
has a varied range of therapies available for the treatment of
pulmonary arterial hypertension. We believe the company's
pulmonary arterial hypertension product portfolio will drive
strong top-and bottom-line growth. However, with several
companies working on bringing additional therapies to the market,
competition is increasing. Moreover, generic competition in the
market has increased with the entry of generic versions of
Companies that currently look better-positioned include
Lannett Company, Inc.
). All three are Zacks Rank #1 (Strong Buy) stocks.
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