MannKind Has New Partner but Faces Class Action Suit

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Matthew Pfeffer, the chief executive officer of MannKind, speaks during last year’s annual meeting. Pfeffer announced Thursday that the company has a new licensing agreement for its Technosphere particle.
Matthew Pfeffer, the chief executive officer of MannKind, speaks during last year’s annual meeting. Pfeffer announced Thursday that the company has a new licensing agreement for its Technosphere particle.

DANBURY — Local drug manufacturer MannKind said it found a licensing partner for its metered dose inhaler on Thursday, a day after a New York City law firm disclosed a class action lawsuit against the company.

Matt Pfeffer, the company’s CEO, said in a statement it reached an the agreement with Seattle-based Receptor Life Sciences – a newly formed firm – for the development, manufacture and commercialization of “multiple inhaled therapeutic products.”

The agreement, which includes up to $102 million in milestone payments but no up-front cash, comes after Sanofi pulled out of its marketing contract for Afrezza, the inhalable form of insulin that is MannKind’s only FDA-approved drug.

“We are pleased that Receptor Life Sciences has selected our formulation and delivery technology to advance its portfolio of innovative inhaled products,” Pfeffer said. “This collaboration demonstrates the fundamental value of our platform technology while the risk-sharing structure of the transaction allows us to diversify our product opportunities without losing focus on our lead program.”

Despite high hopes for Afrezza, sales have been lackluster since the product’s launch in February and are not expected to surpass $10 million for 2015. While some of the blame for the slow sales has fallen on Sanofi and what some analysts said were weak efforts to seek insurance reimbursements for the drug, a group of lawyers are questioning whether the company’s board was up front with investors about Afrezza’s problems.

Levi & Korsinsky, a Manhattan-based law firm that specializes in securities litigation, announced late Wednesday a class action lawsuit against MannKind alleging that board members made misleading statement or failed to disclose that “mandated pulmonary testing or spirometry was still a significant issue impeding sales of Afrezza,” according to a statement from the firm. The attorneys did not immediately respond to a request to elaborate on the claims.

Concerns were raised last year by some investors that the FDA’s mandate lung-function testing prior to taking Afrezza would hamper the drug’s acceptance by the medical community, arguing that many diabetes doctors don’t have access to the spirometry equipment needed to perform the tests. However, company officials downplayed the issue in calls with investors stating that it wasn’t a serious problem.

Harwood Feffer, another Manhattan law firm, also disclosed Wednesday that it had initiated its own investigation into claims that the board may have breached its fiduciary duties to shareholders and grossly mismanaged the company. Benjamin I. Sachs-Michaels, an attorney with the firm, declined to provide additional specifics on the claims when reached by The News-Times Thursday.

Besides Afrezza, MannKind executives also have high hopes for its Technosphere technology – the proprietary particle that delivers insulin to the lungs. Pfeffer said during a J.P. Morgan Health Care conference in California last week that several partnerships were under discussions related to the particle.

Other possible applications for the delivery system, Pfeffer said, include Treprostinil, which is prescribed for pulmonary arterial hypertension, Palonosetron for chemotherapy-induced nausea and Epinephrine, which can treat Anaphylaxis, a life-threatening allergic reaction.

Shares of MannKind (Nasdaq: MNKD) fell 6 percent to 74 cents on Thursday. The stock, which was trading as high as $7.58 last February, lost more than 50 percent of its value earlier this month after the Sanofi announcement.

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Source: www.newstimes.com www.newstimes.com

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