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Friday, May 20, 2022

MannKind Joins Hunt for EpiPen Replacement

With limited cash and a large debt load, MannKind Corp. is looking to tip the financial scale back in its favor with its newest endeavor — an inhalable dose of epinephrine to calm severe allergic reactions. Last month Mylan Inc.’s EpiPen, an injectable epinephrine, ignited a controversy with media coverage pointing out the price for an EpiPen two-pack has increased more than 400 percent to approximately $600 over the past several years. The Canonsburg, Penn. pharmaceutical company has come under fire for the drastic price hike, with Democratic presidential nominee Hillary Clinton publicly criticizing the company. In the midst of the controversy, as consumers and commentators looked for alternatives, a news story about MannKind highlighted its project to develop an inhalable epinephrine, which utilizes its current inhaler technology used to administer its sole commercial product Afrezza Inhalation Powder, an inhalable insulin. The Valencia biotech began working on the project last year. But the announcement of its progress on the project sparked a nearly 15 percent rise in its share price, although the spike deflated the following day. Keith Markey, an analyst for New York-based Griffin Securities Inc. and current MannKind shareholder, said the small jump doesn’t indicate an increase in company value. “I didn’t see any real movement in the stock price,” he said. “You have to take everything within the context of the overall market.” The hype may have been short-lived due to other difficulties the company has experienced over the years. Sales of Afrezza have been disappointing, which led French pharma giant Sanofi to terminate its licensing agreement with MannKind earlier this year. After the manufacturing and marketing rights to Afrezza reverted back to MannKind, the drug has registered a small uptick in sales. “We have successfully reversed many months’ period of sales decline,” said MannKind Chief Executive Matthew Pfeffer. “Sales trends are hitting back upwards. We have all the tools in place, and now we just need to execute our plans.” Cash has historically been a challenge for the company, but luckily, its epinephrine alternative is in early-stage development, which is less costly and allows MannKind to utilize its existing resources and technology. However, once the biotech and the U.S. Food and Drug Administration agree on a clinical approach, costs for the project will rise rather quickly, and its current $63 million in cash just won’t suffice. MannKind hopes that Afrezza sales will pick up enough to offset the costs of clinical trials, but if not, the pharma company will have to explore other opportunities, he said. One potential option is partnering with a well-capitalized drug developer that is able to support the pricey process, which Pfeffer said the company is open to. But for now, MannKind is banking on Afrezza sales, which Pfeffer and Griffin’s Markey believe has a positive outlook. “I think for the near term, we are going to see some success with their own (Afrezza) marketing efforts,” said Markey. “They are making some progress by reaching out to doctors in a more effective manner and procuring relatively consistent copay levels for patients.”

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