NEKTAR THERAPEUTICS (NASDAQ:NKTR) Files An 8-K Other Events
Item 8.01 Other Events.

Nektar Therapeutics, a Delaware corporation (“Nektar”), has royalty rights to Bayer AG’s (“Bayer”) Ciprofloxacin Dry Powder for Inhalation (DPI) drug candidate. Bayer has sole responsibility for all aspects of the development and commercialization of Ciprofloxacin DPI. 

The Phase III clinical trial program for Ciprofloxacin DPI, called RESPIRE, was designed and conducted solely by Bayer and was comprised of two pivotal trials with identical study designs to evaluate the efficacy and safety of Ciprofloxacin DPI in adult patients with non-cystic fibrosis bronchiectasis (NCFB). The data from RESPIRE 1 were presented at the 26^th International Congress of European Respiratory Society in September 2016. In the 14 days on/off regimen, the RESPIRE 1 trial met its primary endpoints of significantly prolonged time to first exacerbation and significantly reduced frequency of exacerbations versus placebo. On April 5, 2017, an abstract with data from the RESPIRE 2 trial was published by the American Thoracic Society in connection with the American Thoracic Society 2017 International Conference. The abstract had been previously submitted by Bayer in accordance with ATS submission guidelines. The RESPIRE 2 trial showed a positive trend of Ciprofloxacin DPI efficacy for both the 14 and the 28 days on/off regimens, but did not reach statistical significance. A pooled analysis of the primary efficacy results of RESPIRE 1 and RESPIRE 2 is positive. The data of both RESPIRE 1 and RESPIRE 2 indicated that Ciprofloxacin DPI has a positive safety profile. Top-line results of RESPIRE 2 will be presented at the upcoming American Thoracic Society 2017 International Conference.

Patients with NCFB suffer from frequent and severe exacerbations of their disease, so there is a significant unmet medical need for long-term treatment options. Bayer has informed us that they plan to discuss next steps with regulatory authorities on the basis of the findings from RESPIRE 1 and RESPIRE 2.

About NEKTAR THERAPEUTICS (NASDAQ:NKTR)

Nektar Therapeutics is a biopharmaceutical company. The Company is engaged in the development of a pipeline of drug candidates that utilize its PEGylation and advanced polymer conjugate technology platforms, which are designed to enable the development of new molecular entities that target known mechanisms of action. The Company’s pipeline consists of drug candidates for therapeutic areas, including oncology, pain, anti-infectives and immunology. The Company’s drugs include MOVANTIK (naloxegol) tablets, MOVENTIG, AdYnoVATE, NKTR-102 (next-generation topoisomerase I inhibitor), BAY41-6551 (Amikacin inhale, formerly NKTR-061), NKTR-181 (orally-available mu-opioid analgesic molecule), NKTR-102, NKTR-214 and MoVAnTiK fixed-dose combinations (opioid/naloxegol combinations). Its drugs also include Neulasta (pegfilgrastim), PEGASYS (peginterferon alfa-2a), PEG-INTRON (peginterferon alfa-2b), Somavert (pegvisomant) and Macugen (pegaptanib sodium injection).

NEKTAR THERAPEUTICS (NASDAQ:NKTR) Recent Trading Information

NEKTAR THERAPEUTICS (NASDAQ:NKTR) closed its last trading session down -1.28 at 21.08 with 1,911,962 shares trading hands.