After going on a hiring spree, Danbury innovator ships first treatment for lung conditions

Mike Castagna is no different than many CEOs, pulling the widget he sells out of a pocket to show anyone curious about it.

Where Castagna differs the most is that the widget in question helps him keep one of the deadliest diseases at bay – his company Danbury is now adding new manufacturing lines to produce many more for a unrelated disease.

For the first time this week, MannKind Corp. began shipping its “Dreamboat” inhalers to treat pulmonary arterial hypertension, as part of a 2018 partnership with Maryland-based United Therapeutics, known for its portfolio of drugs to treat the condition. The Food & Drug Administration approved the Tyvaso DPI product jointly developed by the companies the last week of May.

Tyvaso DPI – pronounced ty-VASE-o – is the first product launch for MannKind since the company relocated its headquarters to Danbury from Westlake Village, California. MannKind is currently expanding its factory on Taylor Street, just south of Danbury Hospital, to handle production of Tyvaso DPI. .

“Connecticut politicians want more biotech, they want innovation,” Castagna said of the decision to designate Danbury as the company’s headquarters. “We have doubled our size here and we will continue to grow here.”

MannKind has long made Afrezza in Danbury, a micro-powder diabetes treatment delivered by inhalers. The product was slow to develop at first, which Castagna says was partly due to difficulties determining the correct doses in clinical trials.

MannKind’s losses exceeded revenue both in 2021 and in the first quarter of this year, when it lost $26 million on net income of just $12 million, including amounts paid to distributors.

But with the United Therapeutics partnership now generating sales revenue, MannKind shares are now trading at around four times their price in March 2020 at the start of the COVID-19 pandemic. Castagna predicts MannKind will add more drugs that can treat lung conditions through its inhalers, even as it conducts clinical trials to make Afrezza available for pediatric prescriptions.

More than 102,000 Americans died from diabetes in 2020 according to the Centers for Disease Control & Prevention, making it the sixth deadliest disease after heart disease, cancer, COVID-19, stroke, respiratory and Alzheimer’s disease. Castagna lost his father to diabetes at an early age and is himself diagnosed with the disease, which he manages through diet and exercise as well as a prescribed regimen of Afrezza.

“It’s a disease that has plagued you for decades,” Castagna said. “I was pre-diabetic and I knew it wasn’t about diabetes, it was about when.”

Westlake Village remains MannKind’s diabetes treatment development center, with the company preparing a pediatric version of Afrezza for Food & Drug Administration review. MannKind recently expanded its diabetes drug portfolio with the $10 million acquisition of Zealand Pharma’s V-Go insulin patch.

Castagna said he wanted the development of new treatments for lung disorders to be centered in Danbury. In anticipation of Tyvaso DPI’s demand, Mannkind has built a cold store in Danbury with space for over 700 pallets, and is currently building a new production line.

After a wave of hiring prior to Tyvaso DPI production, MannKind now has some 200 employees in Danbury.

It is the second largest local pharmaceutical employer after Boehringer Ingelheim Pharmaceuticals, whose US headquarters are in Ridgefield just above the Danbury line. Boehringer Ingelheim sells Jardiance for type 2 diabetes and Spiriva for asthma and chronic obstructive pulmonary disease.

Pulmonary hypertension is caused by thickening of the small arteries in the lungs, restricting the flow of oxygen-rich blood and causing the heart to work harder to supply the body.

Existing treatments sold by United Therapeutics and other major pharmaceutical companies rely on nebulizers, tablets or syringes.

Like the nebulizer option, Mannkind’s inhalers deliver medication directly to the lungs for rapid treatment. But Mannkind’s inhalers and accompanying pods slip easily into pockets and purses and deliver a dose in a single breath rather than the nebulizing regimen that takes two minutes or more of continuous breathing several times a day.

As in the case of the late MannKind founder Alfred Mann, United Therapeutics founder Martine Rothblatt is a serial entrepreneur who co-founded SiriusXM Satellite Radio and played a key role in launching the formerly Connecticut-based PanAmSat. Rothblatt’s engineering genius extends to aviation, with a Guinness Book of World Records inclusion for the longest flight by an all-electric manned helicopter in 2018 at just under 45 minutes.

Rothblatt licensed one of Mann’s insulin pumps 25 years ago, while experimenting with ways to deliver a drug to treat the pulmonary hypertension that Rothblatt’s daughter had been diagnosed with. Costagna said Rothblatt approached him in 2018 about the possibilities of using MannKind inhalers as a treatment option for United Therapeutics.

“What can I do to help MannKind? Castagna recalls being asked by Rothblatt in 2018, after the topic of a collaboration came up. “(Rothblatt) is a visionary.”

[email protected]; 203-842-2545; @casoulman

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