Click here to close now.

SYS-CON MEDIA Authors: Elizabeth White, XebiaLabs Blog, Liz McMillan, David Sprott, Carmen Gonzalez

News Feed Item

Bioniche Life Sciences Inc. Regains Sponsorship of Urocidin™

BELLEVILLE, Ontario, April 1, 2013 /PRNewswire/ --

Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that sponsorship of its Phase III bladder cancer product - Urocidin™ - has been returned to the Company from former development/marketing partner, Endo Pharmaceuticals (Endo).

It was announced in December, 2012 that Bioniche and Endo had come to an agreement whereby Endo would return global rights to Urocidin™. Since that time, Bioniche and Endo have been working together to ensure a smooth transition. Endo has completed all termination activities related to the original license agreement between the two companies and sponsorship has now been officially returned to Bioniche.

"This is an important milestone for Urocidin™," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "With sponsorship back in our hands, we will endeavor to schedule meetings with North American regulatory agencies. With Health Canada, we will discuss the potential for approval of a regulatory submission under its Notice of Compliance with Conditions policy. With the U.S. Food and Drug Administration (FDA), we will propose a revised clinical development plan to achieve U.S. registration."

"The urology community recognizes the urgent need for complementary and/or alternative treatments for non-muscle-invasive bladder cancer that fails to respond to BCG," said Dr. Alvaro Morales, Professor Emeritus, Department of Urology, Queen's University (Kingston, Ontario). "A number of research teams around the world are actively studying a variety of agents, some of which are showing significant promise. Currently, Urocidin™ is the only one that has completed a Phase III trial."  Dr. Morales was the Principal Investigator in the Phase I and II clinical trials, as well as the Phase III clinical trial with Urocidin™.

If the Company is successful in obtaining access to the Canadian market under the Notice of Compliance with Conditions (NOC/c) policy, a new drug submission could be made to Health Canada before the end of 2013. Approximately one year of review would follow and, if Health Canada is satisfied with the submission, an approval under NOC/c could follow before the end of 2014.

An early registration in Canada would generate revenues from commercial sales to offset the cost of additional clinical trial work that may be required for the U.S. and other jurisdictions.

The Company is also actively in discussions with potential new development/partners who are interested in obtaining rights to Urocidin™ in certain jurisdictions. Such partnerships are expected to generate up-front payments, milestones, development support, and licensing revenues.

The Company recently announced the establishment of a new wholly-owned private Human Health subsidiary - Bioniche Therapeutics Corp. The subsidiary is a standalone unit, and the new structure will allow direct external investment to support research and development activities, commercialization activities and acquisition opportunities, which may result in accretive value to the parent company. A search is ongoing for a Chief Executive Officer for the new subsidiary.

About Urocidin[TM]

Urocidin™ is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin[TM] is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.

About the First Phase III Clinical Trial with Urocidin™ 

The Company's first Phase III trial was a 129-patient open label, single-arm trial, meaning there was no comparator therapy used in the trial. The trial was designed to assess the safety and efficacy of Urocidin[TM] as a treatment of non-muscle-invasive bladder cancer in patients whose cancer had not responded positively to prior treatment with BCG therapy. This trial enrolled its first patient in November, 2006 and the last patient was enrolled in April, 2009. The last patient's last dose was administered in April, 2011 and the last patient's last visit occurred in December, 2011.

Preliminary results, reported at urology association meetings in March, May and June, 2011, showed that, after 12 months, there was a 25% overall disease-free survival rate and the product was well-tolerated by patients with most adverse events considered "mild to moderate".

About Bladder Cancer

Bladder cancer is one of the leading causes of death among men and women and an estimated 357,000 bladder cancer cases occur worldwide each year. It is estimated that 72,570 new cases of bladder cancer and‎ 15,210 deaths from bladder cancer will occur in the United States in 2013. In Canada, an estimated 7,800 (5,800 men; 2,000 women) new bladder cancer cases were expected in 2012, with 2,100 expected deaths. Bladder cancer is the 4th most common cancer in men and the 12th most common cancer in women in North America. The prevalence of non-muscle-invasive bladder cancer is ten times its incidence and creates a major economic burden on healthcare systems. As measured on the basis of cumulative per patient cost from the time of diagnosis until death, bladder cancer is the most expensive cancer to treat.

Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin™ is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and One Health. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.

For more information, please visit http://www.Bioniche.com.

Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

For further information:
Jennifer Shea, Vice-President, Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: +1(613)966-8058; from Australia: 0011-1-613-966-8058
Cell: +1(613)391-2097; from Australia: 0011-1-613-391-2097
[email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
WSM International is launching a DevOps services division that offers assessment, consulting and implementation to large enterprises and organizations with complex infrastructures. This is the first independent services company to create a dedicated practice to help organizations looking to transition to the DevOps model. The concept of DevOps is to blend information technology (IT) software development with operations to optimize the computing infrastructure according to the specific needs of ...
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborat...
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Modern Systems announced completion of a successful project with its new Rapid Program Modernization (eavRPMa"c) software. The eavRPMa"c technology architecturally transforms legacy applications, enabling faster feature development and reducing time-to-market for critical software updates. Working with Modern Systems, the University of California at Santa Barbara (UCSB) leveraged eavRPMa"c to transform its Student Information System from Software AG's Natural syntax to a modern application lev...
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
Hosted PaaS providers have given independent developers and startups huge advantages in efficiency and reduced time-to-market over their more process-bound counterparts in enterprises. Software frameworks are now available that allow enterprise IT departments to provide these same advantages for developers in their own organization. In his workshop session at DevOps Summit, Troy Topnik, ActiveState’s Technical Product Manager, will show how on-prem or cloud-hosted Private PaaS can enable organ...
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 ...
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed...
Business as usual for IT is evolving into a “Make or Buy” decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud busi...
Businesses are looking to empower employees and departments to do more, go faster, and streamline their processes. For all workers – but mobile workers especially – utilizing the cloud to reconnect documents and improve processes without destructing existing workflows can have a dramatic impact on productivity. In his session at 16th Cloud Expo, Mark Grilli, vice president of Acrobat Solutions marketing at Adobe Systems Incorporated, will outline new ways that the cloud is changing the way peo...
Sonus Networks introduced the Sonus WebRTC Services Solution, a virtualized Web Real-Time Communications (WebRTC) offer, purpose-built for the Cloud. The WebRTC Services Solution provides signaling from WebRTC-to-WebRTC applications and interworking from WebRTC-to-Session Initiation Protocol (SIP), delivering advanced real-time communications capabilities on mobile applications and on websites, which are accessible via a browser.
SYS-CON Events announced today that Aria Systems, the leading innovator in recurring revenue, has been named “Bronze Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Proven by the world’s most demanding enterprises, including AAA NCNU, Constant Contact, Falck, Hootsuite, Pitney Bowes, Telekom Denmark, and VMware, Aria helps enterprises grow their recurring revenue businesses. With Aria’s end-to-end active monetization platform, g...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes ...