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Veloxis Pharmaceuticals A/S and Athena Drug Delivery Solutions Pvt. Ltd. announce partnership to develop, manufacture and commercialize its investigational drug AtorFen™ (Fenofibrate-Atorvastin fixed dose combination)

23-12-11 kl. 23/12 2011 04:59 | Veloxis Pharmaceuticals 0,90 (+4,65%)

Company Announcement no. 16/2011





To: NASDAQ OMX Copenhagen A/S Hørsholm,
Denmark, December 23, 2011



Veloxis Pharmaceuticals A/S and Athena Drug Delivery Solutions Pvt. Ltd.
announce partnership to develop, manufacture and commercialize its
investigational drug AtorFen™ (Fenofibrate-Atorvastin fixed dose combination) in
certain emerging markets


Veloxis Pharmaceuticals A/S (OMX: VELO) and Athena Drug Delivery Solutions Pvt.
Ltd. today announced an alliance whereby Athena will obtain exclusive rights in
certain emerging market territories to manufacture and, with third parties,
develop, register and commercialize Veloxis’ AtorFen™ (Fenofibrate
Atorvastatin fixed dose combination).


AtorFen™ will contain the lowest fully effective dose of fenofibrate and is a
combination of two effective dyslipidemia treatments in one tablet thereby
potentially improving patient compliance. The product has been developed by
Veloxis through Phase II in the US. Results showed significant improvements in
HDL-C, triglycerides, VLDL and fibrinogen compared with atorvastatin alone
(Lipitor® 40 mg) as well as significantly greater effect on non-HDL-C, LDL-C,
triglycerides and total cholesterol compared with fenofibrate alone (Tricor®
145 mg).


Under this alliance, Athena will establish and fund AtorFen™ manufacturing
capabilities in India and through partnerships with regional and country level
pharmaceutical companies develop and, once approved, commercialize the product.
Veloxis will transfer its technology for manufacturing of AtorFen™ to Athena,
with all expenses funded by Athena, and Veloxis will retain 70% of all revenues
generated (subject to a minimum royalty rate). Veloxis will retain the right to
re-claim major territories or regions where third party distributors are not
established by Athena within certain time intervals.


”This alliance will enable Veloxis to establish a competitive presence for
AtorFen™ in emerging markets.” said William Polvino, M.D., chief executive
officer of Veloxis. ”Substantial future growth in the pharmaceutical industry
is expected to come from this region where cardiovascular morbidity is on the
rise. We’re delighted to have the opportunity to work with Athena, a company
that is well positioned in emerging markets. This agreement is part of our
strategy to out-license our cardiovascular portfolio to partners who can
realize the full value of these assets.”

Financial guidance

The content of this release will have no influence on the company’s financial
guidance for 2011 which was provided on 1 March 2011 in connection with the
release of the financial results for 2010.

For more information, please contact:

Veloxis Pharmaceuticals A/S William Polvino
Johnny Stilou President and CEO
CFO Phone: (+1) 732 321 3202
Phone: (+45) 21 227 227 Email: [email protected]
Email: [email protected]


About Veloxis Pharmaceuticals A/S


Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis
Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company.
Clinical development is the core of Veloxis’ efforts to develop a product
portfolio which includes the Company’s lead product candidate, LCP‐Tacro™, for
immunosuppression, specifically organ transplantation, and products to combat
certain cardiovascular diseases. Veloxis adapts new technologies on a fast
commercial timetable. Veloxis’ unique, patented delivery technology, MeltDose®,
can improve absorption and bioavailability ‐ at low‐scale up costs ‐ not only
for a broad spectrum of drugs already on the market but also for new chemical
entities. Veloxis has a lipid lowering product, Fenoglide®, currently on the
U.S. market and a diversified near and medium term pipeline with three clinical
stage product candidates and a number of projects in preclinical development.
Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX:
VELO.


For further information, please visit www.veloxis.com.




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