Orexo announces the approval of Abstral® in Japan Uppsala,

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
Orexo announces the approval of Abstral® in Japan

Uppsala, Sweden – September 20, 2013 – Orexo AB today announced the approval of Abstral® (fentanyl) sublingual tablets in Japan, where the product has been registered and will be sold by Kyowa Hakko Kirin Co., Ltd. Based on the agreement, the approval will trigger a milestone payment to Orexo. Kyowa Hakko Kirin and its subsidiaries have the rights for Abstral in all markets except the US, where the rights are held by Galena Biopharma, Inc. In Japan, Abstral will be distributed jointly by Kyowa Hakko Kirin and Hisamitsu Pharmaceutical Co., Inc. The two companies are well established in the field of treatment of cancer pain. Kyowa Hakko Kirin and Hisamitsu Pharmaceutical are jointly selling Fentos® Tape (fentanyl citrate transdermal absorption product) since June 2010. “With this approval, Abstral has now successfully been developed in the three major pharmaceutical markets in the world. The approval in Japan demonstrates again the capability of our organization as well as the value recognized by the regulatory authorities from new and advanced pharmaceutical sublingual formulations that improve treatment of patients. The approval in Japan is an exciting opportunity for Abstral and for Orexo and we are convinced that Kyowa Hakko Kirin is well positioned to successfully launch Abstral in Japan.” said Nikolaj Sørensen, President and CEO of Orexo. Abstral is the leading rapid acting fentanyl product in Europe, where it achieved full year sales of EUR 41 million (US$54 million) in 2012. In the first half of 2013, sales exceeded EUR 24 million (US$32 million) corresponding to 27% growth period for period. For further information, please contact: Nikolaj Sørensen, President and CEO Tel: +46-18-780 88 00, Email: ir@orexo.com About Abstral® Abstral is a rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl, a well-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for chronic pain. Abstral is approved in the US, EU and Canadian markets. About Orexo AB Orexo is an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology and commercial operations in the United States. The company is commercializing its proprietary product, Zubsolv® (buprenorphine and naloxone), for maintenance treatment of opioid dependence, in the United States. Zubsolv is a novel formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Orexo has a portfolio of two approved and revenue generating products currently marketed under license in the EU and US. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX and OTC market in the US (ORXOY). The largest shareholders are Novo A/S and HealthCap. For information about Orexo AB, please visit www.orexo.com. About Kyowa Hakko Kirin Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology and immunology/allergy. Kyowa Hakko Kirin leverages antibody-related leading-edge technologies to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world. For more information, visit www.kyowa-kirin.com. Orexo is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at 09:15 am CET on September 20, 2013.

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Zoomlion Boosts Mining Gear Amid Global Revenue Surge

Updated Category News Views 6

An Ambitious Expansion Overhaul Alright, let's talk Zoomlion Heavy Industry Science & Technology Co., Ltd. They're not just making a splash; they're wading knee-deep into expanding their mining machinery operations and taking charge in international markets. You see, in the first half of 2026, this Chinese behemoth saw its mining machinery business skyrocket by over...

Continue Reading
AI in Music: CITY JAM Focuses on Human Creativity

Updated Category News Views 6

Breaking Down the AI Music Race In the wild world of music production, AI's making waves. Here's the thing though—it's all about how fast and how much it can churn out. Now, won't lie to you, that's impressive, but not the full picture. Pat Villaceran, the brain behind CITY JAM, is adamant that the real gold isn't just speed. It's the unique sound each artist brings to...

Continue Reading
Tchah Sup Kim: A Retrospective at KCCNY in 2026

Updated Category News Views 4

A Glimpse into Tchah Sup Kim's Legacy Stumble into the world of Tchah Sup Kim (1940–2022) this fall at the Korean Cultural Center New York. Kim's posthumous retrospective, "The Key to a New World," brings together over 130 of his works alongside archival materials, offering a comprehensive dive into a mind that spent decades between New York and Korea. The exhibit,...

Continue Reading
Young Visionaries Win Junior Medals at STARMUS VIII

Updated Category News Views 8

Fresh from the Canary Islands' shores, STARMUS VIII has lifted the veil on two young powerhouses shaping tomorrow—Valeria Corrales and Aneeshwar Kunchala. These two have snagged coveted honors, crowning them as champions of their generation. Igniting Passion for Science and the Environment Valeria Corrales isn't just another face in the crowd; she’s the force behind a...

Continue Reading
New Docs Spotlight Psychiatry on World Mental Health Day

Updated Category News Views 7

Unmasking Mental Health on the Global Stage Hold onto your hats, folks. The Scientology Network is cranking up the heat this World Mental Health Day. On October 10, they’re rolling out a program that puts the spotlight on CCHR’s crusade against what they see as dark forces in the psychiatric industry. It’s a marathon of documentaries that dives into allegations of...

Continue Reading
Jiangxi Dialogues: Youths Forge Global Ties in 2026

Updated Category News Views 5

Bringing Global Youth to the Table In the heart of Jiangxi, China, young minds from across the globe gathered not just to chat but to shape the future. A bunch who only a decade ago might have been ignored in such circles are now leading discussions, and they’ve kicked off their powwow on September 22, 2026, with a bang in Nanchang. What’s the Agenda? Imagine more...

Continue Reading
Kailas Campaign Binds Climbers with Gear, Trust

Updated Category News Views 5

Embracing the Spirit of Climbing Connections Alright, so when's the last time you saw a brand digging into the human side of one rugged sport like climbing? That's where Kailas steps in, pulling us beyond gear talk into the trust and camaraderie that defines climbing. Their latest effort—dubbed “Stay Warm, Stay Together”—goes beyond mere technical prowess by...

Continue Reading
Kexing Biopharm Expands Global Reach at CPHI Milan

Updated Category News Views 11

Kexing Biopharm's Showstopper Moment in Milan Call it a strategic blowout or just audacious timing—Kexing Biopharm's move at the CPHI Milan 2026 has painted a clear picture. From October 6th to 8th, Milan was the stage where Kexing rolled out its showcase, bragging about a pipeline that screams innovation and possibility. And let’s be honest, their timing couldn’t...

Continue Reading
Haag-Streit Debuts Innovative Octopus 910 Perimeter at AAO

Updated Category News Views 3

Now here's something that'll tickle your ophthalmologist's fancy—Haag-Streit USA has rolled out the Octopus 910, a slick piece of kit set to shake up visual field testing for glaucoma management. This time, they're getting in front of the competition, unveiling it at the Association for Research in Vision and Ophthalmology's 2026 shindig in New Orleans. With this new...

Continue Reading
Buying Land in Greeneville: Avoiding Costly Mistakes

Updated Category News Views 5

Diving Headfirst into Raw Land Purchases Buying land isn't like your typical house flip in Greeneville, Tennessee. It's a whole different ballgame out there. You might think you're just purchasing a piece of Mother Earth, but you got to know there's more beneath the surface—quite literally—before you sign anything. You can go from a promising adventure to a...

Continue Reading

Top 5 Most Recently Viewed Articles

Fathom and Move Concierge Join Forces for Enhanced Relocation

Updated Category News Views 146

Fathom Holdings Inc. and Move Concierge's Strategic Alliance Fathom Holdings Inc. (NASDAQ: FTHM), a prominent real estate services platform utilizing innovative technology, has forged a strategic partnership with Move Concierge. This collaboration aims to enhance the moving experience for both Fathom agents and their clients, ultimately simplifying what can often be a...

Continue Reading
Above Food Ingredients Achieves Key Compliance Milestones

Updated Category News Views 195

Above Food Ingredients Achieves Key Compliance Milestones Above Food Ingredients Inc. (NASDAQ: ABVE) continues to mark its progress by successfully meeting significant compliance requirements set by The Nasdaq Stock Market LLC. The company acknowledges that they have resolved previous issues surrounding the market value of publicly held shares, which is a substantial step...

Continue Reading
Trump's Comments Spark Concerns for Taiwan Semiconductor Amid Trade Tensions

Updated Category News Views 243

Trump's Critique of Taiwan Semiconductor on Podcast Republican presidential candidate Donald Trump has taken a pointed stance against Taiwan Semiconductor Manufacturing Company (TSM). During a discussion on the Joe Rogan podcast, he accused Taiwan of negatively impacting America's chip industry. This accusation marks his second focused attack on the semiconductor giant....

Continue Reading
Parents Fear Financial Dependence of Kids Beyond Adulthood

Updated Category News Views 268

Parents are in the hot seat when it comes to worrying about their children’s financial futures. A recent survey from U.S. Bank lays bare that nearly one in four parents is fretting over this concern, and for Generation X parents, that number spikes to an eye-watering 50%. What’s the deal here? These aren’t just idle fears—this reflects a seismic shift in how...

Continue Reading
Revolutionary Mailbox Alert System Enhances Daily Convenience

Updated Category News Views 140

Innovative Mailbox Alert System Transforms Mail Delivery Experience Many people have experienced the hassle of repeatedly checking their mailbox, only to be disappointed when there’s no mail. One inventive thinker aimed to tackle this common nuisance by creating a product known as the MAIL ALERT. This ingenious device is designed to give homeowners a visual indication...

Continue Reading