|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.
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and a...
Sep. 4, 2015 04:15 PM EDT Reads: 529
Contrary to mainstream media attention, the multiple possibilities of how consumer IoT will transform our everyday lives aren’t the only angle of this headline-gaining trend. There’s a huge opportunity for “industrial IoT” and “Smart Cities” to impact the world in the same capacity – especially during critical situations. For example, a community water dam that needs to release water can leverage embedded critical communications logic to alert the appropriate individuals, on the right device, as...
Sep. 4, 2015 04:00 PM EDT
Manufacturing connected IoT versions of traditional products requires more than multiple deep technology skills. It also requires a shift in mindset, to realize that connected, sensor-enabled “things” act more like services than what we usually think of as products. In his session at @ThingsExpo, David Friedman, CEO and co-founder of Ayla Networks, will discuss how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the ...
Sep. 4, 2015 04:00 PM EDT
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, will introduce the technologies required for implementing thes...
Sep. 4, 2015 03:45 PM EDT Reads: 142
Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is designed for their business. In 2015, organizations such as United Airlines, Sony...
Sep. 4, 2015 03:30 PM EDT Reads: 544
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.
Sep. 4, 2015 03:30 PM EDT Reads: 979
Any Ops team trying to support a company in today’s cloud-connected world knows that a new way of thinking is required – one just as dramatic than the shift from Ops to DevOps. The diversity of modern operations requires teams to focus their impact on breadth vs. depth. In his session at DevOps Summit, Adam Serediuk, Director of Operations at xMatters, Inc., will discuss the strategic requirements of evolving from Ops to DevOps, and why modern Operations has begun leveraging the “NoOps” approa...
Sep. 4, 2015 03:30 PM EDT Reads: 469
While many app developers are comfortable building apps for the smartphone, there is a whole new world out there. In his session at @ThingsExpo, Narayan Sainaney, Co-founder and CTO of Mojio, will discuss how the business case for connected car apps is growing and, with open platform companies having already done the heavy lifting, there really is no barrier to entry.
Sep. 4, 2015 03:00 PM EDT Reads: 227
To assist customers with legacy Windows Server 2003 that is no longer supported by Microsoft, Racemi has introduced fixed price packages for upgrading and migrating Windows Server 2003 servers to either Windows 2008 R2 or Windows 2012 R2 and the choice of Amazon Web Services (AWS) or SoftLayer cloud. "We're extending a lifeline by upgrading the legacy servers to more modern Windows Server platforms while taking advantage of cloud computing," said James Strayer, vice president of product managem...
Sep. 4, 2015 02:12 PM EDT
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Learn what is going on, contribute to the discussions, and e...
Sep. 4, 2015 02:00 PM EDT Reads: 232
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
Sep. 4, 2015 02:00 PM EDT Reads: 271
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...
Sep. 4, 2015 01:45 PM EDT Reads: 651
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
Sep. 4, 2015 12:30 PM EDT Reads: 121
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, 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. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of tech...
Sep. 4, 2015 12:00 PM EDT Reads: 297
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
Sep. 4, 2015 12:00 PM EDT Reads: 110