Thu, Apr. 2, 12:00 PM
- AstraZeneca's (AZN -0.2%) U.S. launch of Movantik (naloxegol) triggers a $100M milestone payment to developer Nektar Therapeutics (NKTR -0.8%) as stipulated in their license agreement signed in September 2009. It will also receive an initial royalty rate of 20% on net sales that will escalate as sales ramp up.
- Nektar is also entitled to a $40M milestone payment upon the first Movantik sale in Europe with a royalty rate of 18% that will escalate as sales increase. Total sales-based milestones could reach as high as $375M.
- AstraZeneca has responsibility for all sales and marketing activities for Movantik worldwide. Movantik is indicated for the treatment of opioid-induced constipation in adults with chronic, non-cancer pain.
Tue, Mar. 31, 9:39 AM
- AstraZeneca (AZN -2%) launches Movantik (naloxegol) in the U.S., a once-daily oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.
- Opioids work by binding to mu-receptors in the brain and other parts of the central nervous system. Unfortunately, mu-receptors also exist in the bowel which leads to OIC. Movantik is mu-opioid receptor antagonist.
- Movantik will be co-promoted in the U.S. by Daiichi Sankyo (OTCPK:DSNKY).
- Previously: AstraZeneca inks U.S. co-commercialization deal for OIC med (March 19)
- Related tickers: (NKTR -1%)(PGNX +0.5%)(CBST)(SLXP +0.1%)(SGYP -2.4%)
Thu, Mar. 19, 12:14 PM
- AstraZeneca (AZN -0.2%) and Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) pair up to commercialize the former's Movantik (naloxegol) in the U.S. for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Under the terms of the agreement, Daiichi will pay an upfront fee of $200M and subsequent sales-related payments of up to $625M. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi. Both firms will sell the product. There is no change in AZN's previously announced financial guidance. The deal is emblematic of AZN's evolving business model to drive value through externalization activity. The launch in the U.S. is planned for early April.
- AZN licensed naloxegol from Nektar Therapeutics (NKTR -4.2%) in 2009. It was approved by the FDA in September. The U.S. Drug Enforcement Agency (DEA) removed it from its Schedule II list in January citing its lack of abuse and dependence potential.
- Opioids relieve pain by binding to mu-receptors in the central nervous system. Unfortunately, they can also bind to mu-receptors in the bowel which results in OIC. The incidence of OIC in patients taking prescription opioid medicines for chronic pain is believed to be as high as 81%.
- Previously: DEA removes naloxegol from Schedule II list (Jan. 26)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
Wed, Mar. 18, 12:45 PM
Wed, Mar. 18, 9:12 AM
Tue, Mar. 17, 6:29 PMNektar's NKTR-102 fails to demonstrate a significant increase in overall survival in breast cancer patients in Phase 3 study; shares off 15% after hours
- A Phase 3 trial (BEACON) evaluating Nektar Therapeutics' (NASDAQ:NKTR) NKTR-102 (etirinotecan pegol) as monotherapy in patients with advanced breast cancer who were heavily pre-treated with a median of three prior therapies failed to show a statistically significant increase in median overall survival (OS) compared to the active control arm of a single chemotherapy agent of physician's choice (TPC).
- In a top-line analysis of 852 patients, treatment with NKTR-102 showed a 2.1-month improvement in median OS (12.4 months vs. 10.3 months) compared to TPC (p=0.08) but the difference failed the test of statistical proof.
- The study also failed to achieve statistical significance in the secondary endpoints of objective response rate (ORR) and progression-free survival (PFS).
- In a pre-specified subgroup analysis of patients with a history of brain metastases, treatment with NKTR-102 increased median OS 5.2 months (10.0 months vs. 4.8 months) compared to TPC (p<0.01). The proportion of patients with brain metastases with 12-month survival was 44.4% compared to 19.4% for the TPC arm.
- In a pre-specified subgroup analysis of patients with baseline liver metastases at study entry, patients receiving NKTR-102 showed an improvement of 2.6 months in median OS (10.9 months vs. 8.3 months) compared to TPC (p<0.002). The proportion of these patients with 12-month survival was 46.9% in the NKTR-102 arm versus 33.3% in the TPC arm.
- Nektar's analysis of the data is ongoing. The results will be submitted for presentation at an upcoming medical meeting.
- Shares are down 15% after hours on robust volume.
Tue, Feb. 24, 5:39 PM
Tue, Feb. 24, 4:18 PM| Comment!
Mon, Feb. 23, 5:35 PM
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Mon, Jan. 26, 8:47 AM
- Citing its lack of abuse and dependence potential, the U.S. Drug Enforcement Agency (DEA) removes naloxegol from its list of Schedule II drugs.
- Naloxegol was developed by Nektar Therapeutics (NASDAQ:NKTR) for the treatment of opioid-induced constipation. It is marketed under the brand name Movantik by AstraZeneca (NYSE:AZN).
Dec. 9, 2014, 7:14 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives. It is the first once-daily oral peripherally -acting mu-opioid receptor agonist (PAMORA) approved in the EU.
- Moventig is part of an exclusive worldwide license agreement initiated in 2009 with Nektar Therapeutics (NASDAQ:NKTR). The product utilizes Nektar's oral small molecule polymer conjugate technology.
- Previously: Ad Comm supports approval of Moventig for OIC (Sept. 26, 2014)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
- OIC-related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Dec. 3, 2014, 12:45 PM
Nov. 6, 2014, 5:36 PM
Nov. 6, 2014, 4:45 PM| Comment!
Nov. 1, 2014, 6:19 PM
Oct. 16, 2014, 9:52 AM
- In conjunction with development partner Actavis (ACT -0.5%), Ironwood Pharmaceuticals (IRWD -0.7%) initiates a Phase 2 clinical trial (~240 patients) to assess the safety and efficacy of linaclotide for the treatment of adults with opioid-induced constipation (OIC). Data is expected in 2H 2015.
- Linaclotide is currently FDA-approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.
- OIC-related tickers: (SLXP -0.6%)(PGNX +1.9%)(NKTR -0.5%)(AZN -2%)(CBST +0.1%)(SGYP +0.7%)(SCMP -0.3%)
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Nektar Therapeutics Inc is a clinical-stage biopharmaceutical company. The Company develops a pipeline of drug candidates that utilizes its PEGylation and polymer conjugate technology platforms that are designed to developmolecular entities.
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