Mannkind picks up Pfizer’s Exubera facility
pharmafile | March 16, 2009 | News story | Manufacturing and Production |Â Â Mannkind, diabetesÂ
The demise of Pfizer's inhaled diabetes treatment Exubera cast a pall over the prospects for inhaled insulin therapy, but has afforded one company still working in the area a manufacturing shortcut.
California-based Mannkind has entered into an agreement to buy a facility in Frankfurt, Germany, that Pfizer had kitted out to manufacture the bulk insulin ingredient for Exubera.
The agreement includes property rights, production equipment, a quantity of bulk insulin and a license to manufacture bulk insulin for use in pulmonary delivery.
The purchase price is $33 million, with just $3 million of that in upfront cash, according to a Mannkind statement, which said the remainder of the figure is likely to be in stock.
Mannkind chief executive Alfred Mann said the facility would "make an excellent counterpart" to the company's existing fill-and-finish facility in Danbury, Connecticut.
Pfizer gave up on Exubera in October 2007, less than a year after its launch, after diabetics proved reluctant to switch to the inhaled product even if it meant reducing the number of self-injections.
Patient dissatisfaction with the inhaler device, concerns about long-term safety and a reluctance by insurers to reimburse the product because of unclear compliance benefits have all been cited as reasons for the flop. Faced with Pfizer's failure, two rival inhaled insulin products – from Eli Lilly and Novo Nordisk – were also shelved.
Mannkind, though, remains committed to developing an inhaled insulin product and has taken its Afresa product through phase III development. On February 26, Mannkind said it was due to file for approval of Afresa in the USA within three weeks.
Not all elements of the purchase are straightforward, however, as Mannkind and Pfizer need to secure agreement from Sanofi-Aventis.
Sanofi-Aventis has first refusal rights to acquire the property rights as a legacy from the two firm's co-development of Exubera, which started in 1998. In January 2006 Pfizer paid Sanofi-Aventis $1.3 billion for full rights to the product.
The deal also hinges on getting a green light from Infraserv, which operates the Industriepark Hoechst in Frankfurt where the facility is located. The deadline for getting that approval is April 3.
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