Welcome!

News Feed Item

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 efficacy profile.

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 commercial launch".

"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.

About Bilastine

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®(ii) (diclofenac potassium for oral solution), Bezalip®(i) SR (bezafibrate), Soriatane®(i) (acitretin), NeoVisc® (1.0% sodium hyaluronate solution) Uracyst® (sodium chondroitin sulfate solution 2%) and Collatamp G®(iii) in the Canadian market. Additionally, NeoVisc® and Uracyst® are commercially available and are sold globally through various international partnerships.

For further information on Tribute visit the Company's website: www.tributepharma.com.

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, Inc.

(iii)Collatamp G® 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
    (9); 1257-1269. 
ii. Ibid 
iii.Ibid 
iv. Ibid 
v.  Ibid 
vi. The Canadian Allergy, Asthma and Immunology Foundation n.d., Allergies
    Asthma Our research is helping your loved ones., pamphlet. 

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
"We host and fully manage cloud data services, whether we store, the data, move the data, or run analytics on the data," stated Kamal Shannak, Senior Development Manager, Cloud Data Services, IBM, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, discussed how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a practic...
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, will discuss some of the security challenges of the IoT infrastructure and relate how these aspects impact Smart Living. The material will be delivered i...
SYS-CON Events announced today that Ocean9will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, will provide a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services ...
Imagine having the ability to leverage all of your current technology and to be able to compose it into one resource pool. Now imagine, as your business grows, not having to deploy a complete new appliance to scale your infrastructure. Also imagine a true multi-cloud capability that allows live migration without any modification between cloud environments regardless of whether that cloud is your private cloud or your public AWS, Azure or Google instance. Now think of a world that is not locked i...
SYS-CON Events announced today that Auditwerx will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Auditwerx specializes in SOC 1, SOC 2, and SOC 3 attestation services throughout the U.S. and Canada. As a division of Carr, Riggs & Ingram (CRI), one of the top 20 largest CPA firms nationally, you can expect the resources, skills, and experience of a much larger firm combined with the accessibility and atten...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...