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Liquidia Completes RareGen Acquisition, Strengthening Commitment to PAH

Joana Carvalho, PhD avatar

by Joana Carvalho, PhD |

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Liquidia, RareGen

Liquidia Technologies, the developer of an inhaled formulation of treprostinil (LIQ861) for the treatment of pulmonary arterial hypertension (PAH), has completed its acquisition of RareGen, the marketer of generic treprostinil injections.

The acquisition — part of a definitive merger agreement both companies agreed to enter earlier this year — reinforces Liquidia’s commitment to the PAH community and strengthens its efforts in the PAH field.

Under the terms of the original agreement, with the closing of the merger transaction, both companies have become wholly owned subsidiaries of Liquidia Corporation, which will serve as the successor to Liquidia Technologies.

“We are very pleased to have achieved this important milestone, one that we believe significantly strengthens our position through an enriched understanding of and presence in the PAH market to better serve patients with PAH throughout their continuum of care,” Neal Fowler, CEO of Liquidia, said in a press release.

As part of the merger transaction, Paul B. Manning and Roger A. Jeffs, PhD, former board members of RareGen, will become part of the new board of directors of Liquidia Corporation.

“We welcome the RareGen team to the Liquidia family and firmly believe that, together, we will achieve our goal of improving patients’ lives by advancing much needed treatment options, including LIQ861, if approved, to the PAH community. Through this merger, we believe we are well poised to deliver long-term benefits to patients and value for our stockholders,” Fowler said.

Treprostinil is a vasodilator that is able to relax and widen blood vessels in the lungs, lowering blood pressure. This compound is the active ingredient of three approved PAH therapies in the U.S., all marketed by United Therapeutics: an injectable formulation called Remodulin, an inhaled formulation called Tyvaso, and an oral extended-release formulation called Orenitram.

Last year, Sandoz and RareGen entered into a collaboration to commercialize a generic version of Remodulin in the U.S. With the new merger agreement with Liquidia now completed, the holder company will now assume RareGen’s role in its previous collaboration with Sandoz and continue commercializing this generic version of treprostinil.

Liquidia Corporation also will take control over the development of LIQ861, an investigational dry powder inhaled formulation of treprostinil, that is currently under review in the U.S. for the treatment of PAH. The experimental therapy is based on Liquidia’s proprietary PRINT technology, which enables the production of highly uniform drug particles with controlled size, shape, and chemical properties.

The therapy’s approval request to U.S. Food and Drug Administration (FDA) was supported by data from the Phase 3 INSPIRE trial (NCT03399604), which evaluated the safety, tolerability, and pharmacological properties of multiple doses of LIQ861 in 121 adults with PAH.

Data from INSPIRE showed LIQ861 was safe and well-tolerated when given over the course of two months. It also was found to improve both patients’ exercise capacity and quality of life, as well as ease the severity of symptoms associated with heart failure.

A final decision from the FDA regarding LIQ861’s approval for PAH is expected soon.

“As we emerge from this transaction as a fully integrated business with a commercially available product for PAH and LIQ861 on the horizon, pending FDA approval, I and the board believe that the breadth of investment and therapeutic area expertise that Paul and Roger bring further complement the Liquidia Board of Directors and positions the company well for future growth,” Fowler concluded.

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