Unique Collaboration Between TB Alliance and Tibotec To Accelerate Tuberculosis Drug Development
PRNewswire 06.17.09

The two organizations will share their expertise and resources in the development of TMC207, which could become the first TB drug with a new mechanism of action in 40 years. The interim data from an ongoing Phase II study of TMC207 were recently published in the New England Journal of Medicine. In the placebo-controlled study of 47 patients with multidrug-resistant TB (MDR-TB), it was found that 48 percent of patients receiving TMC207 in combination with standard treatment converted to negative sputum culture after eight weeks compared with 9 percent of those who received placebo and standard treatment.

The collaboration will maximize the expertise and resources from both the public and private sectors with the intent to improve the treatment of one of the world's oldest and most deadly diseases. Increased efforts and resources to develop new and improved TB drugs are sorely needed. Among infectious diseases, tuberculosis is the second most common cause of adult deaths worldwide. The World Health Organization (WHO) estimates approximately one-third of the world's population is infected with Mycobacterium tuberculosis (M.tb), the bacillus that causes TB, and the disease is responsible for nearly 5,000 deaths per day, worldwide. MDR-TB, which is characterized by resistance to at least two of the most powerful medicines in today's standard, four-drug regimen for drug-susceptible TB, is of particular concern given the rapid rise in the number of cases throughout the world and the difficulties in treating it. There were an estimated 510,000 incident cases and 130,000 fatalities due to MDR-TB in 2007. The Pacific Health Summit is focusing on MDR-TB at this year's conference because of the growing public health threat it poses.

"We see tremendous potential in this collaboration and in the future of TMC207 as part of a critically-needed new TB regimen," said Dr. Mel Spigelman, TB Alliance President and CEO. "Since the TB Alliance was founded, we have assembled the largest pipeline of new TB drugs in history, but this progress is only possible with the commitment of our partners. Tibotec has tremendous scientific prowess, a commitment to fighting infectious diseases, and is an essential long-term partner in our fight to end one of the greatest epidemics of our time."

Under the terms of the agreement, Tibotec will continue to develop TMC207 for the treatment of MDR-TB, and on approval, will establish an access program to ensure the compound reaches those in developing countries who are in need. The agreement grants the TB Alliance a royalty-free license for the worldwide development and access to TMC207 in the field of drug-susceptible TB. In addition, Tibotec will collaborate with the TB Alliance on a discovery research program to identify new compounds for the treatment of TB. The rights for the newly discovered compounds for the treatment of tuberculosis will belong to the TB Alliance under a royalty free license. Costs for the development of TMC207 will be shared.

"To make a meaningful contribution to the global fight against TB, we knew we had to take a novel approach. Our collaboration with the TB Alliance represents a major step forward in the fight against TB as the two organizations combine their expertise and resources in the quest to make new TB treatments available," said Dr. Paul Stoffels, Global Head of Pharmaceutical Research and Development, Johnson & Johnson. "With MDR-TB becoming a growing, global health threat, and hundreds of thousands of unnecessary deaths from drug-susceptible TB occurring, we are committed to accelerating the development of new drug regimens for tuberculosis."

This announcement marks the first collaboration initiated by the newly created Tibotec Global Access and Partnerships Program. The program is creating a sustainable portfolio of medicines -- both marketed and in development -- that are designed to address major health challenges in resource-poor countries. Ben Plumley, Vice President of Global Access and Partnerships said, "The future of successfully tackling neglected diseases, such as TB, will be through joint development initiatives between companies and product development partnerships, such as the one we are announcing today with the TB Alliance."

Product development partnerships (PDPs), such as the TB Alliance, build partnerships linking the public, private, academic, and philanthropic sectors. The TB Alliance combines the research and development proficiency of its own staff with the skills and resources of its partners to streamline and optimize TB drug development.

TMC207

TMC207 was discovered by scientists at Janssen Pharmaceutica N.V., which signed the collaboration agreement with the TB Alliance, and is being developed by its affiliate Tibotec. In vitro studies show that it is highly active against Mycobacterium tuberculosis (M.tb). TMC207 has a unique mechanism of action targeting adenosine triphosphate (ATP) synthase, which M.tb, requires to generate its energy supply. Currently, TMC207 is being studied in a Phase II clinical trial in people with MDR-TB. The safety and efficacy of TMC207 has not yet been established.

Global Alliance for TB Drug Development

The TB Alliance is a not-for-profit, product development partnership accelerating the discovery and development of new TB drugs that will shorten treatment, be effective against susceptible and resistant strains, be compatible with antiretroviral therapies for those HIV-TB patients currently on such therapies, and improve treatment of latent infection.

Working with public and private partners worldwide, the TB Alliance is leading the development of the most comprehensive portfolio of TB drug candidates in history. It is committed to ensuring that approved new regimens are affordable, adopted and available to those who need them.

The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs (DGIS), the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID). For more information on TB drug development and the TB Alliance, please visit www.tballiance.org

Tibotec Inc.

Tibotec Inc., based in Yardley, Pa., USA, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

Janssen Pharmaceutica N.V.

Janssen Pharmaceutica N.V. is a worldwide centre of excellence for integrated R&D, production and general services. The company has three sites in Belgium (Beerse, Geel and Olen), which together employ some 4200 people. The company is active in very diverse therapeutic areas, such as psychiatry and neurology, internal medicine, cancer, and pain management.

Tibotec Inc. and Janssen Pharmaceutica N.V. are subsidiaries of Johnson & Johnson.

Forward looking statements:

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Tibotec Inc.'s, Janssen Pharmaceutica N.V.'s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Tibotec Inc., Janssen Pharmaceutica N.V. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

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(II) World Health Organization. Tuberculosis Fact Sheet. Accessed from http://www.who.int/mediacentre/factsheets/fs104/en/index.html

(III) The Global Plan to Stop TB 2006-2015." Accessed from http://www.stoptb.org/globalplan/assets/documents/GlobalPlanFinal.pdf

(IV) World Health Organization. "Global Tuberculosis Control 2009." Accessed from http://www.who.int/tb/publications/global_report/2009/en/index.html

(V) World Health Organization. Tuberculosis Fact Sheet. Accessed from http://www.who.int/tb/publications/2008/factsheet_april08.pdf

(VI) Andries et al. A Diarylquinoline Drug Active on the ATP Synthase of Mycobacterium tuberculosis Science 14 January 2005: Vol. 307. no. 5707, pp. 223 - 227.

Media Contacts:
Global Alliance for TB Drug Development Tibotec
Joanna Breitstein Karen Manson
kmanson@its.jnj.com
joanna.breitstein@tballiance.org

SOURCE Tibotec Inc.; TB Alliance