FDA Approval for Abstral (Fentanyl) Sublingual Tablets - US launch planned for Q1 2011

FDA Approval for Abstral (Fentanyl) Sublingual Tablets - US launch
planned for Q1 2011

Uppsala, January 10, 2011 - Orexo AB (STO: ORX) announces today that its
partner ProStrakan Group plc (LSE: PSK) has received approval from the
US Food and Drug Administration (FDA) for Abstral®. Abstral® is licensed
for the treatment of breakthrough pain in cancer patients, 18 years of
age and older, who are already receiving, and are tolerant to, opioid
analgesics for their underlying persistent cancer pain. “This is an
important step for patients with cancer pain to have options for the
treatment of their breakthrough pain,” said John Jenkins, M.D., director
of FDA's Office of New Drugs in the Center for Drug Evaluation and
Research.

ProStrakan expects to launch Abstral® in the US during Q1 2011. Launch
preparations are at an advanced stage and sales teams have already
completed a significant level of training. Abstral® will be the only
fast-acting sublingual tablet for breakthrough cancer pain on the US
market, where the overall annual market value for fast-acting fentanyl
products is $550m. (Source: Wolter Kluwers, August 2010. MAT).

Abstral® is the first product to be approved in the US with the FDA
mandated class Risk Evaluation and Mitigation Strategy (REMS) for
transmucosal immediate release fentanyl products. The Abstral® REMS
allows appropriate prescriptions to be filled at retail pharmacies as
well as providing access to Abstral® within hospitals. “This approval is
also a significant step toward reducing the burden on the health care
system of implementing REMS programs,” added Dr. Jenkins. “When fully
implemented, FDA expects that prescribers, pharmacies, and distributors
of all immediate release transmucosal fentanyl products will be able to
use standardized materials and a single shared system to implement the
REMS.”

Abstral is a fast-acting and rapidly disintegrating sublingual tablet
formulation of fentanyl citrate designed for oral transmucosal delivery.
The product offers an alternative therapeutic choice to patients and
clinicians with a simple, patient friendly and predictable way of
delivering fentanyl transmucosally while retaining the individualised
dose titration aspects required for optimal treatment of breakthrough
pain.

Breakthrough pain is an acute and often severe flare of pain,
experienced by patients suffering from cancer, which occurs even though
a person may be taking opioid pain relief medicine regularly for their
persistent pain. It is known as breakthrough pain because it "breaks
through" a regular pain medicine schedule. It may be caused by the
cancer itself or it may be related to cancer treatment.

Abstral® has been a significant driver of growth for ProStrakan in
Europe. The product is now marketed by ProStrakan across the principal
European markets - UK, Germany, France, Spain, Italy and Sweden. By June
2010 the product had gained an average share of 24% of the fast-acting
fentanyl market across these countries (Source: IMS, June 2010), and
recorded Europe-wide sales of £14.1m in the first 10 months of 2010.

Torbjörn Bjerke, President and CEO of Orexo
“This US approval of Abstral® is very good news not just for Orexo, but
also for the population of cancer patients experiencing very severe
pain. This will enable us, through our partner ProStrakan, to provide
these patients with very fast, and effective relief from pain in a
responsible and managed way. Abstral® is already making a big difference
to patients throughout Europe and will soon be launched in other
countries as well. Orexo is receiving between 25-30 percent royalties on
net sales of Abstral® in Europe and will receive between 23-28 percent
royalties on net sales in the US. This is another important step towards
making Orexo a specialty pharmaceutical company.”

Peter Allen, Chairman & Acting Chief Executive of ProStrakan, said:
“FDA approval of Abstral® is another significant step forward for
ProStrakan, enabling us to launch our second major oncology support
product in the US, the world's largest pharmaceutical market. Abstral®
is already being prescribed for patients across Europe who suffer the
debilitating effects of breakthrough cancer pain and we believe that the
benefits of Abstral's rapid pain relief will be recognised by both
clinicians and patients in the US.”

To the editors

Contact details:
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 708 66 19 90
Email: torbjorn.bjerke@orexo.com (torbjorn.bjerke@orexo.com)

Thomas Lundqvist, EVP and Head of Pharmaceutical R&D, Orexo AB
Tel: +46 705 31 83 41
Email: thomas.lundqvist@orexo.com (thomas.lundqvist@orexo.com)

Robin Wright, EVP and CFO, Orexo AB
Tel: +44 7720 300025
Email: robin.wright@orexo.com (robin.wright@orexo.com)

About Abstral®

  · Abstral® is a fast-acting and rapidly disintegrating tablet for
sublingual (under the tongue) administration of fentanyl intended for
the management of breakthrough pain in cancer patients who are already
receiving opioid analgesics for their underlying persistent cancer pain.
  · Abstral® was launched in the principal European markets during the
course of 2009 and generated sales of £14.1m in the first ten months of
2010 in Europe.
  · In the top four European markets (Source: IMS data June 2010).
Abstral® achieved in June 2010 a 24% market share by tablet volume of
short-acting fentanyl products. (Source: IMS data June 2010).

About Breakthrough Cancer Pain
Breakthrough pain (“BTP”) is an acute and often severe flare of pain,
experienced by patients treated with round the clock opioid analgesics
for their underlying chronic cancer pain. It is known as breakthrough
pain because it "breaks through" a regular pain medicine schedule. For
some patients, breakthrough pain occurs during certain everyday
activities, such as walking or dressing. For others, it occurs
unexpectedly without any apparent cause.

In a recent survey of patients with cancer BTP:

  · 89% stated that BTP negatively affected their quality of life
  · 73% stated that BTP wakes them from a deep sleep at least once a
month
  · 76% stated that BTP affects their ability to perform everyday
household chores
  · 75% stated that BTP is one of the most challenging effects of having
cancer
  · 35% stated that BTP affects their relationships with their family
members
  · 82% stated that BTP negatively affects their emotional health

The American Pain Foundation. Breakthrough Cancer Pain Survey Fact
Sheet.
Available at:
http://www.painfoundation.org/learn/programs/spotlight-on-cancer-pain/br
eakthrough-pain/btcp-survey-fact-sheet.pdf (http://www.painfoundation.or
g/learn/programs/spotlight-on-cancer-pain/breakthrough-pain/btcp-survey-
fact-sheet.pdf)

About the Abstral Risk Evaluation and Mitigation Strategy (REMS)
The Abstral® REMS program will allow the dispensing of Abstral in retail
pharmacies across the US, once they are enrolled in the program.
ProStrakan has partnered with Relay Health to develop and deliver an
innovative REMS program for Abstral® that is designed to integrate with
the pharmacy management system to automatically verify that all REMS
requirements have been met prior to the pharmacist dispensing Abstral®.
The Abstral® REMS program has been designed to minimise burden on
prescribers and pharmacies and allow appropriate patient's access to
Abstral®.

The goals of the Abstral® REMS are to mitigate the risk of misuse,
abuse, addiction, overdose and serious complications due to medication
errors by:

•   Prescribing and dispensing Abstral® only to appropriate patients,
which includes use only in opioid-tolerant patients.
•   Preventing inappropriate conversion between fentanyl products.
•   Preventing accidental exposure to children and others for whom it
was not prescribed.
•   Educating prescribers, pharmacists, and patients on the potential
for misuse, abuse, addiction, and overdose.

The FDA has requested that all immediate-release fentanyl products are
brought within a single REMS model and then within a single REMS system
within 2011. It is anticipated that the Abstral® REMS will be very
similar to the class-wide REMS for all immediate-release fentanyl
products.

As part of the approval, ProStrakan has agreed to conduct a
post-approval clinical study of Abstral® in children.

Common adverse reactions to Abstral® include nausea, constipation,
drowsiness and headache. Serious adverse reactions, including deaths,
have occurred with other immediate-release fentanyl products. Deaths
have occurred because of improper selection of patients and/or incorrect
dosing.

A full copy of the FDA press release related to the approval of Abstral®
can be found at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239490.htm 
(http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239490.htm
).

About Orexo
Orexo is a pharmaceutical company focusing on developing treatments for
pain and inflammation. Orexo is developing proprietary products based on
its proven reformulation technologies, targeted at the Specialty
Pharmaceutical market. Orexo intends to commercialise some of these
products itself in one or more major markets. Its development activity
builds on Orexo's core competences in R&D, which have previously
resulted in several successful products, currently out-licensed through
worldwide partnership agreements to larger pharmaceutical companies.
Today, Orexo has four products on the market of which Abstral® is a
leading product for the treatment of breakthrough pain in cancer
patients in most of Europe. Orexo also has three significant
partnerships with major pharmaceutical companies for research and
development programs: discovery stage collaborations with Ortho-McNeil
Janssen and Janssen Pharmaceutica in respiratory inflammation and with
Boehringer Ingelheim for inflammation and pain, both within the
arachidonic acid cascade and a clinical stage development agreement with
Novartis for the treatment of gastrointestinal disorders. Orexo's head
office is located in Uppsala, Sweden.
More information can be found at www.orexo.com (http://www.orexo.com/).

About ProStrakan
ProStrakan Group plc is a rapidly growing specialty pharmaceutical
company engaged in the development and commercialisation of prescription
medicines for the treatment of unmet therapeutic needs in major markets.
ProStrakan's head office is located in Galashiels in Scotland. The
company's development capabilities are centered in Galashiels and
Bedminster, New Jersey, USA. Sales and marketing of ProStrakan's
portfolio of products are handled by commercial subsidiaries in the UK,
US, France, Germany, Spain, Italy and other EU countries.
You can learn more about ProStrakan at
www.prostrakan.com (http://www.prostrakan.com/).

Note:
This is information that Orexo AB (publ.) is required to disclose
pursuant to the Swedish Securities Markets Act. The information was
provided for public release on January 10, 2011 at 08:00 a.m. CET.