United Therapeutics Corporation
) recently gained approval for the commencement of a phase I
study in Australia using
Pluristem Therapeutics Inc.
) PLacental eXpanded (PLX-PAD) cells. The study will be conducted
in patients suffering from pulmonary arterial hypertension
The company gained permission to go ahead with the phase I
study on the basis of preclinical studies. The single center,
open-label, dose-escalation phase I study will evaluate three
levels of dosing with PLX-PAD cells being administered
While the primary endpoint is the safety of PLX-PAD cells in a
follow-up period of one year, secondary efficacy endpoints at six
weeks post-treatment include six-minute walk distance, cardiac
hemodynamic parameters via a right heart catheterization and
echocardiogram and pulmonary metabolism via a positron emission
tomography (PET) scan.
United Therapeutics and Pluristem's licensing agreement for
the development, marketing and sale of the latter's PLX-PAD cells
for PAH was signed in Jun 2011. Pluristem has already received a
$7 million upfront payment from United Therapeutics and could
receive up to an additional $48 million in the form of regulatory
milestone and other payments. Moreover, all clinical trial costs
will be borne by United Therapeutics. United Therapeutics will
also make royalty payments once a PLX-PAD cell based product is
commercialized under this agreement.
United Therapeutics currently carries a Zacks Rank #3 (Hold).
The company is well-positioned in the PAH market. Lead product,
Remodulin, continues to look strong in both the intravenous (IV)
and subcutaneous (SC) forms. With the approval of Adcirca and
Tyvaso, United Therapeutics 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.
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 Revatio.
Companies that currently look more attractive include
PLURISTEM THERA (PSTI): Free Stock Analysis
QLT INC (QLTI): Free Stock Analysis Report
UCB SA (UCBJF): Get Free Report
UTD THERAPEUTIC (UTHR): Free Stock Analysis
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