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News Breaks
June 12, 2014
16:20 EDTAZN, NKTRNektar: U.S. AADPAC recommends no cardiovascular trial for pamora class
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the majority of US FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist class of drugs, which includes MOVANTIKTM, an investigational treatment for opioid-induced constipation for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act date set by the FDA for MOVANTIK is September 16.
News For NKTR;AZN From The Last 14 Days
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September 1, 2015
08:33 EDTAZN, NKTRNektar receives $40M milestone payment from first commercial sale of Moventig
Nektar (NKTR) announced that it has received a $40M cash payment under a license agreement with AstraZeneca (AZN). The payment was triggered by the first commercial sale of MOVENTIG (naloxegol) in Germany. MOVENTIG is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication approved in the European Union for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. MOVENTIG is marketed in the U.S. by AstraZeneca as MOVANTIK and is the first once-daily oral PAMORA medication indicated for the treatment of OIC in adult patients with chronic, non-cancer pain. MOVENTIG/MOVANTIK is part of the exclusive worldwide license agreement announced on September 21, 2009 between AstraZeneca and Nektar Therapeutics. Under the terms of the agreement, in addition to the $40 million milestone payment announced today, Nektar received a $100 million milestone payment upon first commercial sale of MOVANTIK in the U.S. in March of 2015. Nektar is also entitled to royalties on worldwide net product sales and up to $375 million in sales milestones. The royalty rate in the U.S. starts at 20% and escalates. The royalty rate in Europe and the rest of the world starts at 18% and escalates. Under the agreement, AstraZeneca is responsible for all sales and marketing activities for MOVANTIK worldwide.
05:33 EDTAZNValeant, AstraZeneca to partner on brodalumab
Valeant Pharmaceuticals (VRX) announced that its affiliate has entered into a collaboration agreement with AstraZeneca (AZN) under which Valeant was granted an exclusive license to develop and commercialize brodalumab. Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Under the agreement, Valeant will hold the exclusive rights to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin under a prior arrangement with Amgen Inc., the originator of brodalumab. Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in U.S. and EU for brodalumab in moderate-to-severe psoriasis is planned for Q4. Under the terms of the agreement, Valeant will make an up-front payment to AstraZeneca of $100M, as well as additional pre-launch milestones of up to $170M and further sales-related milestone payments of up to $175M following launch. After approval, AstraZeneca and Valeant will share profits.
August 27, 2015
07:51 EDTAZNRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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August 24, 2015
05:13 EDTAZNAstraZeneca to collaborate with Peregrine on cancer immunotherapy clinical trial
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August 23, 2015
12:35 EDTAZNBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 20, 2015
11:33 EDTAZNLeerink major pharmaceuticals analyst holds an analyst/industry conference call
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09:23 EDTAZNAdvaxis, MedImmune begin enrollment in axalimogene filolisbac Phase I/II study
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