For Immediate Release

2015.03.20

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/

Daiichi Sankyo Signs Agreement with AstraZeneca to Co-commercialize MOVANTIK™ in the US

PARSIPPANY, NJ, March 19, 2015 – Daiichi Sankyo, Inc. today announced a co-commercialization agreement with AstraZeneca for MOVANTIK™ (naloxegol) in the US, in line with the Daiichi Sankyo strategy to expand its US portfolio through strategic alliances, in addition to internal R&D and acquisitions.  MOVANTIK is a first-in-class, once-daily, oral, peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

 

MOVANTIK was approved by the US Food and Drug Administration in September 2014. It was descheduled by the US Drug Enforcement Administration in January 2015 and is no longer labelled as a controlled substance. The launch of MOVANTIK in the US is planned for early April 2015.  

 

Under the terms of the agreement, Daiichi Sankyo, Inc. will pay a $200 million up-front fee and subsequent sales-related payments of up to $625 million. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo, Inc. Both companies will be jointly responsible for commercial activities.

 

Ken Keller, President, US Commercial, Daiichi Sankyo, Inc., said: “We are proud to bring our proven primary care and specialty expertise to this collaboration with AstraZeneca. 

MOVANTIK represents an opportunity to help patients manage one of the most common conditions arising from widely used pain medications, as well as an opportunity to continue to build the Daiichi Sankyo US portfolio of medicines in this therapeutic area.”

 

Paul Hudson, Executive Vice President, North America, AstraZeneca said: “We are delighted to collaborate with Daiichi Sankyo to expand our commercialization efforts  in the US in order to get this important medicine to the large number of patients suffering with opioid-induced constipation. Our agreement reflects our evolving business model by creating value from our portfolio through externalization activity. Together, we will grow the potential of this important treatment, while we retain our significant interest in the long-term commercial success of MOVANTIK in our largest market.”

  

About MOVANTIK (naloxegol) tablets

MOVANTIK (naloxegol) tablets is the first FDA approved once-daily oral PAMORA specifically designed for the treatment of OIC in adult patients with chronic non-cancer pain. In the phase 3 clinical studies, MOVANTIK was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal tract.

 

MOVANTIK is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar’s oral small-molecule polymer conjugate technology.

About OIC

OIC is a condition caused by prescription opioid pain medicines. Millions of patients are treated with opioids each year. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC.

 

Important Safety Information for MOVANTIK

・MOVANTIK is contraindicated in:

 ・Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction due to the potential for GI perforation

 ・Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms

 ・Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients

・Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops

・Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone in the clinical trials were observed to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients.

・The most common adverse reactions with MOVANTIK in clinical trials were: abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)

 

About Daiichi Sankyo, Inc.

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a ‘Hybrid Business Model’ to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.

 

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

 

CONTACTS

 

Kimberly Wix (US)

Daiichi Sankyo, Inc.

+1 973 944 2338

kwix@dsi.com

 

Minobe Yasuki (Japan)

Daiichi Sankyo Co., Ltd.

+81 362 25 1126

minobe.yasuki.eg@daiichisankyo.co.jp