MannKind Will Help Patients Switch from "Exubera" to "Technosphere Insulin"

Valencia, CA (Sep. 16)-MannKind and Pfizer (New York) agreed that the former company will help patients who need inhaled insulin switch from Pfizer’s “Exubera” medicine to MannKind’s “Technosphere Insulin” drug. Technosphere Insulin is an investigational product that recently completed Phase III clinical trials.

In October 2007, Pfizer announced that it would stop marketing its inhaled Exubera product because it did not meet patients’ needs or Pfizer’s financial expectations. Exubera patients have been switching to other diabetes therapies since then, and a small number of patients must continue to take inhaled insulin for medical reasons. Pfizer began discussions with MannKind to give these patients access to Technosphere Insulin, and Pfizer will reimburse some of MannKind’s costs relating to helping patients switch therapies.

In a company press release, Peter Richardson, MannKind’s chief scientific officer, said, “For some Exubera patients, continued treatment with inhaled insulin is needed. These patients generally fall into two categories: those with severe needle-phobia or a very poor response to subcutaneous insulin. This small number of patients represents a group with particularly high medical need who will benefit from using an inhaled insulin such as Technosphere Insulin.”

In related news, Kalorama Information released a report stating that government regulations banning chlorofluorocarbon (CFC) in inhalers are dramatically changing the respiratory-disposables and reusable-respiratory-accessories market. Kalorama published the report, titled “World Market for Respiratory Equipment and Disposables,” on Sept. 9, 2008.

Asthma afflicts about 181 million people worldwide, and chronic obstructive pulmonary disease affects 44.2 million people worldwide. Incidence rates for the diseases continue to increase. Inhalers represent 45% of the $36-billion market for respiratory devices and are expected to grow at a rate of 9.8% through 2012. The growth will be spurred partly by new product innovations in response to a ban on CFC-based inhalers.

In 2005, the US mandated that ozone-depleting CFC propellants must be removed from inhalers by Dec. 31, 2008 to abide by international environmental guidelines. CFC is to be replaced with hydrofluoroalkane (HFA).

The new, non-CFC inhalers will not face generic competition until their patents begin to expire in 2010. Joe Constance, a Kalorama analyst, said, “Compliance [with the ban] could be a blessing in disguise for inhaler companies,” in a company press release.

“Until December 2007, companies with CFC-based products were allowed to market their product, so they have had sufficient time to take the necessary steps to shift towards HFA based products. And the companies did not need to make any significant changes in their manufacturing processes in order to abide by this new government regulation,” said Constance.

Inhaler equipment suppliers and pharmaceutical companies have been preparing themselves by installing the capabilities to perform stability testing and product-compatibility tests for HFA-based products.

Kalorama Information provides independent market research in the life sciences.

For more information, see “FDA Urges Early Switch to HFA-Propelled Albuterol Inhalers.”