Healthcare :: Innovative pulmonary & PEGylation-based therapeutic product dev. drives business strategy of Nektar

Innovative pulmonary and PEGylation-based therapeutic product development is the focus of two new business units recently created at Nektar Therapeutics (Nasdaq: NKTR), the company announced today.

Nektar also announced the creation of a new global communications team to expand and fortify investor and analyst relations.

“We have focused our strongest leaders on our core technologies to accelerate the development of breakthrough pulmonary and PEGylation-based therapeutics to help patient and medical professionals,” said Nektar President and Chief Executive Officer Howard W. Robin. “And we have hired two experienced communications professionals, who have strong ties with the investment, analyst, medical and media communities, which will not only improve transparency with these stakeholders but also enable us to better articulate our value proposition and corporate developments.”

Nektar PEGylation Platform

Nektar PEGylation technology can enhance the properties of therapeutic agents by increasing drug circulation time in the bloodstream, decreasing immunogenicity and dosing frequency, increasing bioavailability and improving drug solubility and stability. It is a technique in which non-toxic polyethylene glycol (PEG) polymers are attached to therapeutic agents, and it is applicable to most major drug classes, including proteins, peptides, antibody fragments, small molecules, and other drugs.

Nektar is pioneering new applications for its PEGylation platform technology, including the PEGylation of small molecules to reduce blood brain barrier penetration. The first product that the company is developing using this platform is NKTR-118 (PEG-naloxol oral) which applies the company?s advanced PEGylation technology to address opioid-induced constipation, a debilitating side effect of opioid treatments. NKTR-118 combines Nektar?s Advanced PEGylation technology with naloxol, a derivative of the opioid-antagonist drug naloxone. A Phase 1 study indicates that NKTR-118 may have the potential to mitigate the constipation side effect from opioid use, without hampering the painkilling properties of opioid drugs in the central nervous system by reducing blood brain barrier penetration.

In addition, Nektar is developing NKTR-102 (PEG-irinotecan), a PEGylated small molecule invented by Nektar using its leading PEGylation technology. It is a PEGylated form of irinotecan, a chemotherapeutic agent used for the treatment of solid tumors. In preclinical studies in tumor-bearing mice, NKTR-102 resulted in significantly higher reduction in tumor growth than irinotecan in colon, lung and breast tumors. Furthermore, preclinical studies revealed that NKTR-102 was well-tolerated with significant reduction of neutropenia and diarrhea, two debilitating side effects of non-PEGylated irinotecan.

Nektar PEGylation Technology is also used in eight additional approved partnered products in the U.S. or Europe today, including Roche?s PEGASYS? for hepatitis C and Amgen?s Neulasta? for neutropenia.

Nektar Advanced Pulmonary Technology

Nektar Pulmonary Technology uses innovative molecular formulations and novel delivery devices designed for ease-of-use to improve or enable administration of medicines to and through the lungs for both lung diseases and systemic conditions. The cornerstone of the pulmonary technology is the development of fine, aerodynamic drug particles for efficient dispersibility and reproducible delivery. As a noninvasive alternative to injection, the pulmonary delivery route offers opportunities for improved and innovative drug delivery and greater patient compliance. In addition, pulmonary delivery offers rapid onset of action and more efficient and targeted treatment of lung disorders.

Partnered with Pfizer, Nektar developed the core technologies used for Exubera(r)(insulin human [rDNA origin] Inhalation Powder), including the formulation and particle engineering for the insulin powder, the filling and packaging techniques for the insulin blister, and the Exubera Inhaler with its components. Exubera is the first approved inhaled insulin and is considered an important advancement in the treatment of diabetes that could help adult patients manage their disease. Nektar manufactures the Exubera Inhalers and supports the manufacturing of the powder processing for the insulin powder.

The company also has a proprietary inhaled anti-infective product currently in clinical development and four additional pulmonary products in the clinic with strategic partners, including tobramycin inhalation powder in phase 3 trials for lung infections in cystic fibrosis patients by Novartis AG. In addition, Nektar is developing NKTR-061 (inhaled amikacin) is under development for patients with hospital-acquired pneumonia that need mechanical ventilation or patients on ventilators who contract ventilator-associated pneumonia who have high morbidity and mortality rates, in spite of available broad spectrum intravenous antibiotics to treat these infections. This anti-infective platform is designed to treat pneumonias in this difficult-to-treat ventilated patient population.