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June 16, 2021

Drug company adding CT jobs in anticipation of FDA OK

IMAGE | Pixabay.com
By Natalie Missakian

A California biopharma company said it will add 100 jobs at its Danbury R&D and manufacturing facility as it scales up production of a new drug that is nearing FDA approval.

The Connecticut site will “practically double in size” ahead of the drug’s anticipated commercial launch, a company official said. 

The Food and Drug Administration has agreed to a speedy review of Tyvaso DPI, a drug MannKind Corp. is developing with Maryland biotech United Therapeutics, the two companies announced Wednesday.

The companies said the FDA’s acceptance of the new drug application (NDA) for a priority review puts Tyvaso DPI on track for FDA approval in October.

The drug, which uses MannKind’s Technosphere technology, is a dry powder inhaled version of the drug treprostinil. 

MannKind and United Therapeutics inked a licensing and collaboration agreement in 2018 to develop and commercialize the drug.

The companies are seeking approval to market it to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The FDA did not signal any “potential review issues,” according to MannKind.

MannKind said in a statement Wednesday that its Danbury facility is hiring more than 100 people and is preparing essential equipment and production lines ahead of the expected commercial launch.

The new hires will include jobs in commercial manufacturing, engineering, quality control, warehouse operations, and maintenance, the company said.  

The expansion comes as MannKind transitions from producing clinical supply to building its pre-launch inventory of the drug, according to the company.

“It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere technology,” said Chief Technology Officer Joe Kocinsky. “Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”

MannKind said it develops and commercializes inhaled therapeutics for patients with endocrine and rare lung diseases. It also makes Afrezza, an inhalable insulin product.

Contact Natalie Missakian at news@newhavenbiz.com

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