Nektar/Bayer Agree To Develop Inhaled Amikacin For Hospital-Acquired Pneumonia

Product combining Nektar’s deep-lung delivery technology and amikacin formulation could reach market in 2010-2011 timeframe, Nektar COO tells “The Pink Sheet” DAILY.

Bayer HealthCare and Nektar Therapeutics will collaborate on further development and commercialization of Nektar's inhaled aminoglycoside antibiotic amikacin for treatment of hospital-acquired Gram-negative pneumonias in a deal worth up to $175 million in regulatory and commercialization milestone payments plus royalties, the companies announced Aug. 6.

Bayer will pay San Carlos, Calif.-based Nektar $50 million up front, as well as tiered performance royalties up to a maximum of 30 percent for sales outside the U.S.; the two firms will co-promote the product and share profits on U.S. sales.

"Bayer has 52 percent; we have 48 percent," Nektar Chief Operating Officer Hoyoung Huh said during a same-day interview with "The Pink Sheet" DAILY. "Essentially, it's very close to a 50/50, but I think it was important to [Bayer] to maintain one or two percentage points on the controlling side."

Under the agreement, Bayer will take over global clinical development, regulatory strategy, manufacturing and marketing of the specially formulated antibiotic, with Nektar participating in "all aspects of decision making and governance," the companies said.

"Bayer is basically funding the majority of the clinical trials, but we have an ownership stake in both the development and the commercial decisions," said Huh.

The deal is the first under a strategy of partnering rather than outlicensing to improve the company's long-term financial health Nektar announced in May (¹ (Also see "Nektar Reorganizes To Position Pegylated, Pulmonary Units For Future Development" - Pink Sheet, 24 May, 2007.)). "Especially in the areas where we were strategically very interested in investing further, such as this one, we wanted to have commercial rights and direct access to the market," Huh said.

Nektar is investigating amikacin in combination with its proprietary pulmonary technology as an inhaled adjunct to systemic antibiotics to treat Gram-negative pneumonias in ventilated patients.

"Amikacin is a very effective drug for Gram-negative pneumonia; however, it has severe toxicities in the IV setting, so leveraging our formulation and device platforms, we are able to deliver this drug to the site of infection, which is the deep lung, without creating the toxicity profile that the IV drug confers," Huh explained.

"There really isn't any good standard of care therapy for Gram-negative infections in this patient setting, and at the same time there aren't many other programs in development that address this unmet need."

Data from a Phase IIb trial testing the efficacy of the therapy is anticipated by the end of the year, and Nektar is meeting with Bayer to go over plans for a Phase III trial it hopes to launch in the first half of 2008, Huh said.

Part of the Phase III design discussion will center on finding statistically significant ways of demonstrating the experimental therapy's potential for cutting down on antibiotic resistance.

"One of the other issues with IV therapy is you have lower levels of the drug getting to the bug, and so the bug mutates and resistance ensues - especially in the Gram-negative setting," Huh said. "The fact that we can confer higher concentration to the site of infection, we believe can strongly impact the resistance profile, and so we're now trying to figure out how [to] measure that in a fashion that demonstrates it in a statistically significant manner."

Multiple firms, including Hospira and Teva, market generic injection formulations of amikacin sulfate in the U.S.

- Shirley Haley ([email protected])