|By Marketwired .||
|May 13, 2014 05:00 PM EDT||
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.
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.
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Jul. 30, 2015 07:30 PM EDT Reads: 1,383
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Jul. 30, 2015 07:15 PM EDT Reads: 288
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Jul. 30, 2015 06:30 PM EDT Reads: 877
Malicious agents are moving faster than the speed of business. Even more worrisome, most companies are relying on legacy approaches to security that are no longer capable of meeting current threats. In the modern cloud, threat diversity is rapidly expanding, necessitating more sophisticated security protocols than those used in the past or in desktop environments. Yet companies are falling for cloud security myths that were truths at one time but have evolved out of existence.
Jul. 30, 2015 06:00 PM EDT Reads: 1,795
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
Jul. 30, 2015 05:00 PM EDT Reads: 1,081
Public Cloud IaaS started its life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in adop...
Jul. 30, 2015 04:00 PM EDT Reads: 2,196
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Jul. 30, 2015 03:45 PM EDT Reads: 440
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
Jul. 30, 2015 03:00 PM EDT Reads: 1,734
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Jul. 30, 2015 03:00 PM EDT Reads: 476
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with ...
Jul. 30, 2015 02:30 PM EDT
The Cloud industry has moved from being more than just being able to provide infrastructure and management services on the Cloud. Enter a new era of Cloud computing where monetization’s services through the Cloud are an essential piece of strategy to feed your organizations bottom-line, your revenue and Profitability. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed how to easily o...
Jul. 30, 2015 01:45 PM EDT Reads: 373
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Jul. 30, 2015 01:45 PM EDT Reads: 259
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Jul. 30, 2015 01:30 PM EDT
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. The DevOps approach is a way to increase business agility through collaboration, communication, and integration across different teams in the IT organization. In his session at DevOps Summit, Chris Van Tuin, Chief Technologist for the Western US at Red Hat, will discuss: The acceleration of application delivery for the business with DevOps
Jul. 30, 2015 12:45 PM EDT Reads: 1,111
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, S...
Jul. 30, 2015 12:00 PM EDT Reads: 2,045