Tribute Pharmaceuticals and Faes Farma Announce Exclusive License Agreement in
Canada for Bilastine, a New Treatment Option in the $120
million Allergic Rhinitis and Urticaria Market
MILTON, ONTARIO AND MADRID, SPAIN -- (Marketwired) -- 05/13/14 --
Tribute Pharmaceuticals Canada Inc. ("Tribute") (OTCQB: TBUFF)(OTCBB:
TBUFF)(PINKSHEETS: TBUFF) (a Canadian specialty pharmaceutical
company) and Faes Farma, S.A. ("Faes") (BME: FAE), a Spanish
pharmaceutical company, announced today the signing of an exclusive
license agreement that grants Tribute the exclusive right to sell
Faes's Bilastine product for the treatment of Allergic Rhinitis and
Chronic Idiopathic Urticaria (hives) in Canada, following receipt of
regulatory approval from Health Canada for such product. The
exclusive license is inclusive of prescription and non-prescription
rights for Bilastine, as well as adult and paediatric presentations
in Canada. Terms of the agreement were not disclosed.
Allergic rhinitis and urticaria are both allergic disorders that can
adversely affect quality of life to the extent that work or school
productivity may be impairedi. The characteristic symptoms of
allergic rhinitis are nasal itching, congestion, rhinorrhoea and
sneezingii. For urticaria, characteristic symptoms include itchy skin
lesions with a central swelling (wheals) and painful areas of deeper
swelling involving the skin and mucous membranes (angioedema)iii.
Both types of allergies are common, with a global prevalence of
10-30% for allergic rhinitis and of greater than 20% for urticariaiv.
Even though the cost of care for individuals with allergic disorders
is low, the total global cost is high, predominantly because these
disorders are so highly prevalentv. According to the Canadian
Allergy, Asthma and Immunology foundation, Allergic Rhinitis affects
20% to 25% of Canadiansvi.
IMS Health reports that the Canadian oral antihistamines market had
sales of approximately $120 million in 2013. Upon approval by Health
Canada, Bilastine will be the first new oral antihistamine approved
in Canada since 2001. Bilastine will provide Allergists,
Immunologists, Dermatologists, Family Medicine and General
Practitioners a new treatment option for allergic rhinitis and
chronic idiopathic urticaria with a clinically proven safety and
Mariano Ucar, President and CEO of Faes commented, "Faes shall have
the opportunity to provide Canadian patients direct access to the
innovative Bilastine drug, in the allergy and dermatology fields. The
Canadian pharmaceutical business is a top 10 pharmaceutical market
globally. Bilastine is an excellent fit with Tribute's sales and
marketing infrastructure and presence in Canada. We have found an
excellent partner for Canada and look forward to a successful
"We are excited to have the opportunity to launch a globally
recognized product like Bilastine in Canada, and to further
strengthen our dermatology and primary care portfolio," said Rob
Harris, President and CEO of Tribute. "Bilastine has been approved in
48 countries worldwide and we look forward to introducing this new
and innovative product to Canadian physicians. Furthermore, the
execution of this agreement underscores Tribute's commitment to
expanding its business in Canada with licensed, long-term,
patent-protected, revenue generating products like Bilastine, while
also acquiring and licensing mature products in Canada. Bilastine is
a great opportunity for Tribute because it also provides us with the
ability to maximize a longer-term revenue source with an
over-the-counter strategy as well."
Tribute plans to host a conference call on Thursday, May 15, 2014 at
11:00 AM EDT or 8:00 AM PDT to further discuss the Bilastine license
in conjunction with a review and discussion of the Company's results
for the first quarter ending March 31, 2014. Details of this call
were announced on May 8, 2014.
Bilastine is a non-sedating H1-antihistamine for symptomatic
treatment of Allergic Rhinitis and Urticaria in adults and children
older than 12 years of age. It is an innovative and patent protected
new molecule developed by Faes in Spain. Bilastine, as a new active
substance in Canada, will be granted a minimum of 8 years market
exclusivity upon Health Canada approval. Bilastine has been studied
in over 30 clinical trials including 5 pivotal Phase III trials in
Allergic Rhinitis or Urticaria. Bilastine has been licensed for 126
countries worldwide and is marketed by Faes (BME: FAE), Menarini,
GlaxoSmithKline, Pfizer, Takeda, Pierre Fabre, Merck KGaA, Hikma
Taiho and Vianex.
About Faes Farma S.A.
Faes Farma was established in Bilbao, Spain in 1933. Today, Faes
remains a Spanish company with a global focus that researches,
manufactures and markets pharmaceutical products and raw materials in
over 60 countries worldwide. Faes has offices, R&D and manufacturing
facilities in Spain and Portugal as well as sales and marketing
infrastructure in Latin America. In 2013, Faes employed over 700
people and had sales revenues of approximately EUR180 million. For
further information about Faes, visit http://www.faes.es.
About Tribute Pharmaceuticals Canada Inc.
Tribute is a Canadian specialty pharmaceutical company focused on the
acquisition, licensing, development and management of pharmaceutical
and healthcare products with its primary focus on the Canadian and US
markets. Tribute markets Cambia(R)(ii) (diclofenac potassium for oral
solution), Bezalip(R)(i) SR (bezafibrate), Soriatane(R)(i)
(acitretin), NeoVisc(R) (1.0% sodium hyaluronate solution) Uracyst(R)
(sodium chondroitin sulfate solution 2%) and Collatamp G(R)(iii) in
the Canadian market. Additionally, NeoVisc(R) and Uracyst(R) are
commercially available and are sold globally through various
For further information on Tribute visit the Company's website:
Tribute Pharmaceuticals Forward Looking Statement
This press release contains certain forward-looking statements about
Tribute as defined in the Private Securities Litigation Reform Act of
1995, which statements can be identified by the use of
forward-looking terminology, such as "may", "will", "expect",
"intend", "anticipate", "estimate", "predict", "plan" or "continue"
or the negative thereof or other variations thereon or comparable
terminology referring to future events or results. Forward- looking
statements, by their nature, are subject to risks and uncertainties,
Tribute's actual results could differ materially from those
anticipated in these forward looking statements as a result of
numerous factors, including general economic conditions, the ability
of Tribute to successfully integrate operations, and the timing of
expenditures and expansion opportunities, any of which could cause
actual results to vary materially from current results or anticipated
future results. Specifically in respect of this release there is no
certainty that Tribute will be able to obtain Health Canada approval
for Bilastine or, if approved, that Tribute will be able to
successfully market Bilastine. See Tribute's reports filed with the
Canadian Securities Regulatory Authorities and the U.S. Securities
and Exchange Commission including Tribute's Form 10-K for the fiscal
year ended December 31, 2013, which contains cautionary statements
identifying important risk factors with respect to such
forward-looking statements, including certain risks and uncertainties
that could cause actual results to differ materially from results
referred to in any forward-looking statements. Tribute assumes no
obligation to update the information contained in this press release
to update forward-looking statements to reflect changed assumptions,
the occurrence of anticipated events or changes in future operating
results, financial condition or business over time.
(i)Soriatane and Bezalip are registered trademarks and under license
from Actavis Group PTC ehf
(ii)Cambia is a registered trademark and under license from Depomed,
(iii)Collatamp G(R) is a registered trademark and under license from
EUSA Pharma (Europe) Limited.
i. Carter N J, Bilastine In Allergic Rhinitis and Urticaria. Drugs 2012; 72
vi. The Canadian Allergy, Asthma and Immunology Foundation n.d., Allergies
Asthma Our research is helping your loved ones., pamphlet.
Tribute Pharmaceuticals Canada Inc.
Nuwa Group LLC
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