MannKind CEO Alfred Mann said Monday that the company has held talks with “a number of very significant” drugmakers about a potential partnership to market its inhaled insulin product Afresa, which is currently under review by the FDA. Mann indicated that the interested companies are “very qualified to take this to market.”

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Rodman & Renshaw analyst Simos Simeonidis commented that he expects MannKind to enter into a worldwide partnership for Afresa during the summer, and he said it is likely the product will be approved by the FDA next spring. In addition, the analyst stated that late-stage results for Afresa presented recently at the annual meeting of the American Diabetes Association “solidify our view that Afresa can be a product that could take market share away from injectable insulins and become [a] significant player in the diabetes space.” Simeonidis suggested that Afresa has the potential to achieve sales of $1 billion or more.

Shares in MannKind rose as much as 15 percent on the news.

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MannKind will purchase Pfizer’s insulin facility in Frankfurt for $33 million. The agreement also includes the acquisition of assets related to the production of bulk insulin, including the relevant real property rights, the production equipment, a quantity of bulk insulin, and a license to manufacture bulk insulin for use in pulmonary delivery.

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Upon the closing of this transaction, MannKind intends to retain more than half of the current workforce and plans to operate the facility at a production level commensurate with the company’s present needs for recombinant human insulin.

In the event some or all consents are not obtained, only the bulk insulin, the license to manufacture bulk insulin for use in pulmonary delivery and, potentially, certain removable equipment will be transferred to MannKind at closing.

“The insulin plant in Frankfurt is a state-of-the-art insulin production facility that would make an excellent counterpart to our formulation, fill-and-finish facility for Afresa in Danbury, Connecticut,” notes Alfred Mann, chairman and CEO of MannKind. “Upon the closing of this transaction, we will obtain an immediate supply of insulin and the ability to supply our insulin needs for the future even if we are unable to acquire the facility itself.” Afresa is an ultrarapid-acting insulin product that has completed Phase III trials.

Source: GEN News

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