After hiring spree, Danbury innovator ships 1st treatment for lung ailments

Mike Castagna is no different from many CEOs, in pulling from a pocket on cue the widget he is selling to show anyone curious to learn more.

Where Castagna differs from most is the fact that the widget in question is helping him hold at bay one of the more deadly diseases — with his Danbury company now adding new manufacturing lines to produce many more of them for an unrelated ailment.

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

Tyvaso DPI — pronounced ty-VASE-o — is the first product release for MannKind since the company switched its headquarters address to Danbury from Westlake Village, Calif. MannKind is now expanding its Taylor Street plant just south of Danbury Hospital to handle Tyvaso DPI production.

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“Connecticut politicians do want more biotech, they do want innovation,” Castagna said of the decision to designate Danbury the company’s headquarters. “We’ve doubled our size here and we are going to keep growing here.”

MannKind has long made Afrezza in Danbury, a diabetes treatment in micro-powder form that is delivered via inhalers. The product was slow to catch on in the early going, which Castagna said was partly due to struggles in pinpointing correct doses during clinical trials.

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

But with the United Therapeutics partnership now generating sales revenue, MannKind shares are trading today at roughly four times their price in March 2020 at the beginning of the COVID-19 pandemic. Castagna anticipates MannKind adding more drugs that can treat lung ailments through its inhalers, even as it proceeds with clinical trials to make Afrezza available for pediatric prescriptions.

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

“It’s a disease that creeps up on you over decades,” Castagna said. “I was pre-diabetic, and I knew it wasn’t a matter of if I would get diabetes — it was a matter of 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 added recently to its diabetes drug portfolio with the $10 million acquisition of Zealand Pharma’s V-Go insulin patch product.

Castagna said he wants development of new treatments for lung disorders to be centered in Danbury. In anticipation of demand for Tyvaso DPI, Mannkind has built a refrigerated warehouse in Danbury with space for more than 700 pallets, and is now building out a new production line.

After a hiring spree ahead of Tyvaso DPI production, MannKind now has some 200 employees in Danbury.

It is the second largest pharmaceutical employer locally after Boehringer Ingelheim Pharmaceuticals, which has its U.S. headquarters in Ridgefield just over the Danbury line. Boehringer Ingelheim sells Jardiance to fight type 2 diabetes and Spiriva for asthma and chronic obstructive pulmonary disorder.

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

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

Like the nebulizer option, Mannkind’s inhalers allow for the delivery of a drug directly to the lungs for rapid treatment. But Mannkind’s inhalers and accompanying pods fit easily in pockets and purses, and deliver a dose in a single breath rather than the nebulizer regime that takes two minutes or more of continuous respiration multiple times a day.

As the case with the late MannKind founder Alfred Mann, United Therapeutics’ founder Martine Rothblatt is a serial entrepreneur whose co-founded SiriusXM Satellite Radio and played a key role in the launch of PanAmSat once based in Connecticut. Rothblatt’s technical genius extends to aviation, with an inclusion in the Guinness Book of World Records for the longest flight by an all-electric piloted 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 pulmonary hypertension which Rothblatt’s daughter had been diagnosed with. Costagna said Rothblatt approached him in 2018 about the possibilities to use MannKind inhalers as a treatment delivery option for United Therapeutics.

“What can I do to help MannKind?” Castagna recalls Rothblatt asking him in 2018, after the topic of a collaboration was broached. “(Rothblatt) is a visionary.”

Alex.Soule@scni.com; 203-842-2545; @casoulman