Key Developments For Nektar Therapeutics
Nektar Therapeutics (NKTR.O) (Nasdaq)
Nektar Therapeutics Raises High End Of Prior FY 2009 Revenue Guidance-Conference Call
Nektar Therapeutics revises fiscal 2009 revenue guidance and expects revenue to be in the range of between $65-$95 million. According to Reuters Estimates, analysts on an average are expecting the Company to report revenue of $75 million for the same period.
Nektar Therapeutics And AstraZeneca PLC Announce Phase 2 Data From Oral NKTR-118
Nektar Therapeutics and AstraZeneca PLC announced data from a phase II study that demonstrated oral NKTR-118 improved lower gastrointestinal dysfunction by increasing the frequency of bowel movements in patients with opioid-induced constipation, while simultaneously preserving opioid-mediated analgesia. NKTR-118, an oral peripherally-acting opioid antagonist, is an investigational product candidate in clinical development for the treatment of opioid-induced constipation. In the phase II double blind, randomized, placebo-controlled study of 208 patients with opioid-induced constipation, NKTR-118 achieved the primary endpoint of change from baseline in spontaneous bowel movements (SBMs). Patients receiving either 25 mg or 50 mg of oral NKTR-118 once daily had a significantly greater change from baseline in SBMs during the first week of treatment than patients receiving placebo. The mean change from baseline in SBMs per week for patients receiving 25 mg NKTR-118 was 3.6 versus 1.9 in the placebo group (p= 0.002). Patients receiving 50 mg NKTR-118 had a mean change from baseline in SBMs per week of 4.4 versus 1.9 in the placebo group (p=0.0001). The increase from baseline in SBMs versus placebo averaged over the four-week treatment period was significant for both the 25 mg (p=0.002) and 50 mg (p<0.0001) dose groups. Results for the 5 mg dose of NKTR-118 were not significant.
Nektar Therapeutics Shows Encouraging Anti-Tumor Activity In Ovarian Cancer in Phase 1 and Preclinical Data
Nektar Therapeutics announced the favorable data on lead oncology program, NKTR-102, demonstrating encouraging Phase 1 and preclinical anti tumor activity of the investigational compound in ovarian cancer. These data were presented at the European CanCer Organisation (ECCO) and the European Society for Medical Oncology (ESMO) 2009 Joint Multidisciplinary Congress in Berlin, Germany. In the preclinical studies presented, NKTR-102 was evaluated at three dose levels and compared to three equivalent dose levels of irinotecan in a platinum resistant 2780 ovarian cancer mouse model. NKTR-102 showed clear superiority over irinotecan at all dose levels, with 100% of animals demonstrating partial or complete tumor regression with NKTR-102 compared to only one of 10 animals with a partial response at the highest irinotecan dose. NKTR-102 was also better tolerated than irinotecan at all doses tested. Data were also presented on patients with recurrent ovarian cancer from the Phase 1 dose escalation study of single agent NKTR-102. Of five patients with ovarian cancer in the study, two were evaluable for efficacy. Both patients showed anti-tumor activity, including tumor reductions of up to 37% and a decrease in CA-125 marker levels of up to 80%. Pharmacokinetic data from this same Phase 1 study showed increased and sustained SN38 exposure with administration of NKTR-102 compared to expected SN38 levels following irinotecan administration.
AstraZeneca PLC And Nektar Therapeutics Signs Worldwide Agreement For Drug Development Programmes
AstraZeneca PLC and Nektar Therapeutics announced that they have entered into an exclusive worldwide license agreement for two drug development programmes: NKTR-118, a late stage investigational product being evaluated for the treatment of opioid induced constipation, and the NKTR-119 programme, an early stage programme that is intended to deliver products for the treatment of pain without constipation side effects. Both programmes were developed by Nektar, utilizing their proprietary small molecule advanced polymer conjugate technology platform. Under the terms of the agreement, AstraZeneca will assume the responsibility for the continued development of both the NKTR-118 and NKTR-119 programmes, including the initiation of late-stage clinical studies for NKTR-118. AstraZeneca expects completion of the design of the phase III programme in the near term, and anticipates filing the drug with regulators in 2013. AstraZeneca will also be responsible for global manufacturing and marketing for both programmes. Under the agreement, Nektar will receive an upfront payment of $125 million for both NKTR-118 and NKTR-119.
Nektar Therapeutics Announces Data Demonstrating Favorable Oral Bioavailability and Drug-Drug Interaction Profile for NKTR-118
Nektar Therapeutics announced clinical study data demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug interactions. NKTR-118, an oral peripherally-acting opioid antagonist, is in clinical development for the treatment of opioid-induced constipation. A human pharmacokinetic study conducted in 20 healthy subjects demonstrated the comparative bioavailability of NKTR-118 in tablets and solution, confirming the drug's rapid absorption profile in both formulations and demonstrating the bioequivalence of the oral tablet formulation to solution. In vitro studies demonstrated the high metabolic stability of NKTR-118 compared to naloxone. Results of in vitro testing indicate that NKTR-118 has a low potential for clinically important drug-drug interactions, thereby facilitating the combination of NKTR-118 with a wide range of drugs in clinical development. Nektar also announced results from a separate Phase 2 clinical trial of NKTR-118. Topline data from this Phase 2 study showed that NKTR-118 met the primary endpoint of increase in spontaneous bowel movements over the baseline period in a double-blind, randomized, placebo-controlled study in 208 patients with opioid-induced constipation, while preserving the analgesic effect of opioid by reducing the blood-brain barrier penetration.
