A Medical Device Daily

Nektar Therapeutics (San Carlos, California) reported it is restructuring to complete its transition from a drug delivery service provider to a drug development company.

The move follows the decision by Pfizer (New York) last October to abandon further sales of Exubera, an inhaled insulin product (Medical Device Daily, Oct. 22, 2007). Nektar had partnered with Pfizer to develop the inhaled form of the drug and the inhaler system to deliver it.

“We are transforming Nektar into a world-class drug development company and these changes are a natural progression on the path to achieving this vision,” said Howard Robin, president/CEO of Nektar. “This restructuring aligns the organization with the future direction of our company and strengthens our ability to drive programs rapidly through the clinic.”

About 150 positions have been eliminated with the restructuring, although Nektar said it has preserved the necessary technical and manufacturing personnel and capabilities to forge a new partnership for its inhaled insulin programs.

Nektar recently initiated Phase 2 clinical trials for its two PEGylated small molecule programs, NKTR-102 (PEG-irinotecan) for solid tumors and NKTR-118 (oral PEG-naloxol) for opioid bowel dysfunction. NKTR-061 (inhaled amikacin), which is being co-developed with Bayer AG to treat hospital-acquired pneumonia, is expected to enter Phase 3 trials this year.

Pfizer cited low sales as a reason for abandoning the drug, blaming, in part, the patient-unfriendliness of the inhaler device developed by Nektar.

Pfizer later agreed to pay Nektar $135 million to resolve all contractual obligations between the firms (MDD, Nov. 7, 2007).

The device’s bulkiness — about the height of a tennis ball can, though somewhat slimmer — and user-unfriendliness, were among the reasons given by some observers for poor uptake of the product.

Exubera was once predicted to produce up to $10 billion annually, with Nektar to have received 10% to 20% in sales and royalties, but had garnered only a slim 1% of the insulin market.

Given approval in 2006, Exubera was the first inhaled insulin on the U.S. market (MDD, Jan. 31, 2006).