United Therapeutics Corp. is taking a new product to market after pandemic-related delays.
The Silver Spring drugmaker said Wednesday it has officially kicked off commercial sales of Remunity, its subcutaneous pump with disposable cartridges that administers Remodulin, the company’s flagship drug for patients with pulmonary arterial hypertension.
It’s the first pump of its kind for PAH patients. United Therapeutics (NASDAQ: UTHR) developed Remunity with New Hampshire-based DEKA Research and Development Corp.
The partners received clearance from the Food and Drug Administration to launch the Remunity pump in May 2019, ahead of a second clearance in February 2020 that allowed contracted specialty pharmacies to pre-fill the cassettes with Remodulin to make administration easier for patients.
But its commercialization comes several months after an initial target of July 2020, a delay related to the pandemic, UT President Michael Benkowitz said in October. The company’s stock was trading up 1.5% to $168.72 per share just before 2 p.m. Wednesday.
UT opens sales for Remunity after closing in late January on a $105 million acquisition of a Priority Review Voucher from New York biopharma Y-mAbs Therapeutics Inc. (NASDAQ: YMAB) to speed up the regulatory review of Tyvaso DPI, an inhaler that dispenses a dry powder form of PAH drug treprostinil. The following week, the company announced positive data from its clinical trial of Tyvaso DPI showing strong safety and tolerability.
The company told the FDA it plans to redeem its voucher when it submits its new drug application for that product, it said in filings with the Securities and Exchange Commission. It also said it intends to submit its application to the agency in April.
“If approved, we expect Tyvaso DPI will provide a major advancement in the delivery of inhaled treprostinil therapy, offering convenience benefits compared to our existing Tyvaso nebulizer,” Dr. Leigh Peterson, UT’s vice president of product development, said in a Jan. 28 statement.
The Maryland drugmaker is also studying treprostinil, the active ingredient in Tyvaso and multiple other products, as an inhaled form for other uses. In December the FDA granted orphan drug status to treprostinil as a treatment for patients with idiopathic pulmonary fibrosis, a type of interstitial lung disease that hinders breathing and scars the lungs. UT is preparing to start a late-stage clinical trial of Tyvaso for patients with IPF. That win from regulators followed a clinical trial in February that showed Tyvaso was effective in increasing the distance patients with interstitial lung disease could walk.
Both developments clear a path for UT to expand further beyond its core PAH business, into the pulmonary fibrosis space — important as generic competition grows. The company is also studying Tyvaso in patients with pulmonary hypertension resulting from chronic obstructive pulmonary disease, or COPD, which blocks airflow and makes breathing difficult.
