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UTHR to Move PAH Drug into Phase I

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United Therapeutics Corporation (UTHR - Free Report) recently gained approval for the commencement of a phase I study in Australia using Pluristem Therapeutics Inc.’s (PSTI - Free Report) PLacental eXpanded (PLX-PAD) cells. The study will be conducted in patients suffering from pulmonary arterial hypertension (PAH).

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 intravenously (IV).

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 UCB (UCBJF - Free Report) and QLT Inc. .

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