Theratechnologies and Ferrer Announce a Distribution & Licensing Agreement for Tesamorelin in Europe
03 February 2011 - 10:55PM
Marketwired Canada
Theratechnologies (TSX:TH) and Ferrer Internacional S.A. ("Ferrer") announced
today that they have entered into a distribution and licensing agreement
providing Ferrer with the commercialization rights to tesamorelin in Europe,
Russia, South Korea, Taiwan and certain central Asian countries for the
treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
Ferrer is a privately-held international pharmaceutical company based in
Barcelona, Spain, which operates in over 60 countries.
Terms of the Agreement
Under the terms of the agreement, Ferrer will be responsible for conducting all
regulatory and commercialization activities in connection with tesamorelin for
the treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy in the territories subject to the agreement. Theratechnologies
will be responsible for the manufacture and supply of tesamorelin to Ferrer.
Ferrer will purchase tesamorelin at a transfer price equal to the higher of a
significant percentage of the net selling price and a predetermined floor price.
Theratechnologies has the option to co-promote tesamorelin for the reduction of
excess abdominal fat in HIV-infected patients with lipodystrophy in the
territories. Theratechnologies has kept all development rights to tesamorelin
for other indications and will be responsible for conducting research and
development for any additional programs. Ferrer has the option to enter into a
co-development and commercialization agreement using tesamorelin relating to any
such new indications. The terms and conditions of such a co-development and
commercialization agreement will be negotiated based on any additional program
chosen for development.
"With signed partnerships in the major markets, we have met our corporate
objectives and have positioned Theratechnologies extremely well for future
growth," commented Mr. John-Michel T. Huss, President and CEO of
Theratechnologies. "In 2010, Ferrer had over $1 billion in sales and was amongst
the fastest growing pharmaceutical companies in Europe with a 16% growth rate in
international sales," continued Mr. Huss. "Furthermore, Ferrer's regulatory
expertise has resulted in many European active registration dossiers which I
believe will be an important driver to the future success of tesamorelin in
Europe. Undoubtedly, Ferrer's dynamism and strong collaborative spirit will be
important in the commercial success of tesamorelin in these regions. I am
assured that with Ferrer at our side, patients in these territories will have
access to tesamorelin as rapidly as possible," concluded Mr. Huss.
"Market trends are clear," said Jordi Ramentol, CEO of Ferrer, "the future will
be determined by the ability of new treatments to address unmet clinical needs
and tesamorelin is an excellent example of such an approach. We are excited
about this opportunity to sign this agreement with Theratechnologies for the
commercialization of tesamorelin in these territories," commented Mr. Ramentol.
"It is also of great pride to be able to offer tesamorelin, upon approval, to
healthcare professionals and patients," concluded Mr. Ramentol.
Conference Call and Webcast
The Company will hold a conference call and webcast February 3 at 8:30 a.m. to
discuss this strategic agreement. To participate, please dial: 1-416-981-9017 or
1-800-738-1032 (toll free). Please dial-in five minutes prior to the
teleconference in order to ensure your participation. The webcast will be
available on the Company's website at http://www.theratech.com or at
http://www.gowebcasting.com/2192. A replay of the conference call will be
available from 10:30 a.m. today, February 3, 2011, until February 17, 2011 at
11:59 p.m. at the following number: 1-416-626-4100, pass code 21510203# or
1-800-558-5253, pass code 21510203#. The webcast will be posted for 15 days at
the link indicated above.
About tesamorelin
Tesamorelin is an analogue of the human growth hormone releasing factor ("GRF")
shown to reduce excess abdominal fat in HIV-infected patients with
lipodystrophy. GRF is a hypothalamic peptide that acts on the pituitary cells in
the brain to stimulate the synthesis and release of endogenous growth hormone.
Tesamorelin is approved for sale for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy in the United States alone and in no
other country, including Canada. Tesamorelin is being exclusively commercialized
in the United States by EMD Serono under the brand name EGRIFTA(TM).
About HIV-Associated Lipodystrophy
Several factors, including a patient's antiretroviral drug regimen and the HIV
virus itself, are thought to contribute to HIV-associated lipodystrophy, which
is characterized by body composition changes. The changes in body composition
may include accumulation of excess abdominal fat accumulation, which is known as
abdominal lipohypertrophy.
About Theratechnologies
Theratechnologies (TSX:TH) is a biopharmaceutical company that discovers and
develops innovative therapeutic products, with an emphasis on peptides. The
Company targets unmet medical needs in specialty markets where its
commercialization strategy is to retain all or part of the commercial rights to
its products. Its most advanced compound, tesamorelin, an analogue of the human
growth hormone releasing factor, was recently approved by the U.S. Food and Drug
Administration as the only treatment for excess abdominal fat in HIV-infected
patients with lipodystrophy. Tesamorelin is being exclusively commercialized in
the United States by EMD Serono for the treatment of excess abdominal fat in
HIV-infected patients with lipodystrophy under the brand name EGRIFTA(TM).
Theratechnologies granted the exclusive distribution rights to tesamorelin in
Latin America, Africa and the Middle East to sanofi-aventis for the treatment of
excess abdominal fat in HIV-infected patient with lipodystrophy.
For more information on Theratechnologies, please visit www.theratech.com
About Grupo Ferrer
Grupo Ferrer is a privately-held European R&D-based pharmaco-chemical and
medical device company headquartered in Barcelona, Spain. Founded in 1959, the
group encompasses today 45 companies developing its activities in Europe, Latin
America, Africa, Middle East, Asia and the United States. In total, Ferrer's
human healthcare products are being commercialized in 93 countries through 26
direct subsidiaries (including Joint Ventures) and 70 partners and distributors.
Ferrer carries out activities throughout the full value chain of the pharma
business, from R&D to international marketing, including fine chemicals
development and both raw material and pharmaceutical product manufacturing. For
this purpose, Ferrer Grupo has research centres in Spain and Germany, as well as
manufacturing sites in Europe and Latin America.
Ferrer's regulatory expertise has resulted in more than 400 active registration
dossiers in Europe, including high added-value products for orphan and
life-threatening diseases.
The aim of Ferrer's corporate strategy is to establish alliances and long-term
relationships with biotechnology and pharmaceutical companies within its
strategic therapeutic areas. The company holds a long track record of agreements
signed with big multinationals as well as with medium size pharmaceutical
companies and small biotech or R&D base companies.
Ferrer also has in its portfolio a range of products that provide an excellent
level of synergy with tesamorelin. In the area of HIV, the company currently
commercializes Targretin (bexarotene) and Panretin (alitretinoin), in
respiratory, Oslif (indacaterol) for COPD and Aeriseal for emphysema, and
various products in metabolism (diabetes, bone metabolism and dyslipidemias).
The company has experience with high value-added products, for very specific
indications (i.e., Remodulin for PPH) that may have specific requirements in
terms of administration (injectables, subcutaneous pumps, etc.) and that require
a cold chain distribution (i.e. Aeriseal).
For more information on Ferrer, please visit www.ferrergrupo.com.
Theratechnologies' Forward-Looking Information
This press release contains certain statements that are considered
"forward-looking information" within the meaning of applicable securities
legislation. This forward-looking information includes, but is not limited to,
information regarding the growth of Theratechnologies, the regulatory approval
of tesamorelin for the reduction of excess abdominal fat in HIV-infected
patients with lipodystrophy in Europe and in the other territories mentioned
herein, and the commercialization of tesamorelin in Europe.
Forward-looking information is based upon a number of assumptions and is subject
to a number of risks and uncertainties, many of which are beyond the Company's
control that could cause actual results to differ materially from those that are
disclosed in or implied by such forward-looking information. The assumptions
used in making such forward-looking information include, among others, that
regulatory agencies in countries outside of the United States will approve
tesamorelin for the treatment of excess abdominal fat in HIV-infected patients
with lipodystrophy, and that Ferrer will be successful in the commercialization
of tesamorelin in Europe for the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy. These risks and uncertainties include,
but are not limited to: the risk that tesamorelin is not approved by regulatory
agencies outside of the United States, or even if approved, the risk that
tesamorelin is not accepted by the marketplace where it will be commercialized
and as such, results in weak sales of the product which may impact the Company's
growth.
The Company refers potential investors to the "Risks and Uncertainties" section
of its Annual Information Form (the "AIF") dated February 23, 2010. The AIF is
available at www.sedar.com under the Company's public filings. The reader is
cautioned to consider these and other risks and uncertainties carefully and not
to put undue reliance on forward-looking statements. Forward-looking information
reflects current expectations regarding future events and speaks only as of the
date of this press release and represents the Company's expectations as of that
date.
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