Orexo provides US commercialization progress update and direction for 2013 financial outlook
ET | Source:Orexo AB
Orexo AB (Orexo) today informs about the progress towards becoming a full
-fledged specialty pharmaceutical company with a US commercial presence. Orexo
also announced the company project it will turn profitable in late 2013, with
the current assumptions on regulatory timing and launch of Zubsolv™ in September
Zubsolv™ and Abstral® to be commercialized in partnership
Orexo have in the ongoing review of its strategic options for how to establish a
US commercial infrastructure to drive sales of Zubsolv and Abstral reached
important conclusions; both the Zubsolv and Abstral product lines in the US will
provide healthy risk adjusted returns to Orexo and its shareholders. However,
from an industrial point of view the products should ideally be commercialized
by different sales forces, and should be commercialized in a partnership
structure and not by Orexo alone.
During the coming months, Orexo will explore optimal deal and partnership
models, which will secure Orexo a commercial presence in the US, without
exposing the company to the full financial risk of commercializing both products
on a stand-alone basis.
To secure sufficient time to identify the optimal partnership for Abstral, the
agreement with the current license holder for Abstral in the US, ProStrakan Inc,
has been extended until July 1st2013. This matches the expected approval
timelines for Zubsolv in US, which is in the beginning of July 2013. Orexo
expects agreements to be finalized for both Zubsolv and Abstral in advance of
Trade name for Zubsolv, acceptable to the FDA
On December 11thOrexo received notice from the FDA that the proposed trade name
Zubsolv™ was acceptable to the agency. The final approval of trade name is
pending the final approval of the Zubsolv label, which is standard practice from
the FDA. The acceptance of the trade name is an important milestone for the
tactical launch planning of this product.
Share buy-back program
Orexo launched a share buy-back program in July 2012, which initially was
stopped as the company entered into a black-out period in advance of announcing
the Q3-results. With the current partnering discussions showing good interests
for our commercial assets, and a new black-out period emerging, the Board of
Orexo do not consider it prudent to run this program now, and it will therefore
not be resumed in the near term.
Orexo project profitability late 2013 - with current assumptions of a regulatory
timing for Zubsolv outlined by FDA
Orexo has so far not provided guidance on its future financial performance,
despite this has been a strong wish from the investor community. The Board of
Orexo is for 2013 still not able to do so. The key reasons are the inherent
timing risks associated with US regulatory drug approvals and timing of the
commercial launch of Zubsolv. However, Orexo has a good financial position and
the continuing ex-US royalties on Abstral provides a solid future revenue base
for Orexo. Directionally, and based on the assumption of a regulatory approval
timing for Zubsolv as outlined by FDA with subsequent launch of Zubsolv in
September, it is projected that Orexo will turn profitable in late 2013 and will
have a positive cash flow in 2014.
A letter to shareholders has today December 19th, 2012, been sent to
shareholders of Orexo AB and is an update of Orexo transformation and progress
to a full-fledged specialty pharmaceutical company by the Chairman of Orexo,
Martin Nicklasson. The letter is also available on Orexo’s home page at
For further information, please contact:
Anders Lundström, President and CEO
Tel: +46 706-67 22 66, E-mail: firstname.lastname@example.org
Zubsolv is a novel sublingual formulation of buprenorphine and naloxone using
Orexo’s extensive knowledge in sublingual technologies. Zubsolv is intended for
maintenance treatment of people suffering from opioid dependence. Through
application of its proprietary technologies Orexo has increased the
bioavailability of the active ingredient, accelerated dissolve time, reduced
tablet size and improved taste resulting in a preference of Zubsolv in
comparison with Suboxone tablet. Zubsolv has the potential to be the first new
entrant into a growing USD 1.5 billion market, with more than five million
patients suffering from opioid dependence and where a majority of patients are
not adequately treated today. Market potential for Zubsolv is at peak estimated
at above USD 500 million in sales annually.
Abstral is the novel, 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 EU, US
and Canadian markets.
Orexo AB is an emerging specialty pharma company developing improved treatments
using proprietary drug delivery technology. Orexo’s expertise is within the area
of reformulation technologies and especially sublingual formulations. The
company has a portfolio of revenue-generating US and EU approved products
currently marketed under license and a pipeline of several reformulations of
approved compounds for areas of unmet medical need. Orexo also has collaboration
projects with several international pharma companies. Orexo AB, with its
headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are
Novo A/S and HealthCap.
For more information about Orexo please visit www.orexo.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 10:00 am CET on December 19, 2012.
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