Last week, AstraZeneca PLC (AZN) announced top-line results from two Phase 3 trials and one safety extension trial for naloxegol, an oral drug in development for patients with opioid-induced constipation from taking opioids for non-cancer related pain. The results of the two pivotal trials, KODIAC-04 and KODIAC-05, evaluated naloxegol in 12.5 mg and 25 mg doses across 12 weeks of once-daily therapy. The 12-week extension study, called KODIAC-07, was part of a long-term safety trial.
In total, the KODIAC study was comprised on four late-stage clinical trials.
The trials showed naloxegol to be well tolerated and safe, with no severe adverse events attributed to the drug. In KODIAC-04, both doses delivered statistically significant results in improving spontaneous bowel movements, although in KODIAC-05, only the higher dose achieved a statistically significant response for the primary endpoint.
The drug is designed to block opioids from binding with opioid receptors in the gastro-intestinal tract (the cause of constipation) without impacting the opioid receptors in the brain (the benefit of the drugs).
Naloxegol is aiming to be the first approved once-daily oral peripherally-acting mu-opioid receptor antagonist, or “PAMORA,” for patients with opioid-induced constipation, a common side effect of prescription opioids.
The drug was developed using the oral small molecule polymer conjugate technology of Nektar Therapeutics (NKTR) through a partnership established in September 2009. Under the agreement, Nektar can receive up to $235 million in aggregate payments upon the achievement of certain regulatory milestones, as well as additional tiered sales milestone payments of up to $375 million if the product achieves considerable levels of commercial success. Nektar is also eligible to receive double-digit royalty payments on net sales of naloxegol worldwide.
Nektar said on Tuesday that the U.S. Food and Drug Administration has accepted the New Drug Application for naloxegol, triggering a $70 million milestone payment to Nektar. AstraZeneca filed the NDA in mid-September. The payment, due within five days, exceeds the $60.9 million that Nektar generated in revenue during the third quarter, which also got a lift from the advancement of naloxegol.
The MAA filing for naloxegol in Europe and NDS in Canada have been accepted by the respective regulatory agencies. The acceptance of the MAA in Europe resulted in a $25 million milestone payment to Nektar last quarter.
A $10 million milestone payment also came to Nektar via Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer AG (BAYRY) , initiating a Phase 3 trial evaluating Amikacin Inhale in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia patients receiving antibiotics. Bayer’s drug candidate utilizes a Pulmonary Drug Delivery System developed by Nektar.
Shares of NKTR had nearly doubled in value in 2013 until news in September that NKTR-181 failed to hit endpoints in a Phase 2 trial in patients with chronic pain from osteoarthritis of the knee caused the stock price to sink more than 30 percent. Trying to recover, shares have climbed back up to close on Monday at $11.01 to keep the stock ahead by about 50 percent in 2013. No shares have traded in pre-market activity on Tuesday following the news release.
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