Notable Achievements

Negotiated terms for a research collaboration between the Global Alliance for TB Drug Development (TB Alliance) and the Institute of Microbiology (IMCAS), a member institute of the Chinese Academy of Sciences, for a partnership to discover and develop promising, novel anti-tuberculosis agents from natural sources, including microbial metabolites and traditional Chinese medicines. A pilot screen conducted by IMCAS identified 24 natural product extracts as having potential anti-tubercular activity. IMCAS and the TB Alliance will collaborate to further test these extracts, purify and identify the active components, and develop those that prove most promising. Read Press Release.

Negotiated terms for a research collaboration between the Global Alliance for TB Drug Development (TB Alliance) and Rutgers, The State University of New Jersey to identify new small-molecule inhibitors of Mycobacterium tuberculosis RNA polymerase (RNAP) with the intent of developing new and improved TB treatments. RNAP is a proven target for anti-tuberculosis therapy with the uncommon ability to kill both active and dormant TB bacteria when the enzyme is inhibited. A class of antibacterial compounds known as rifamycins, which also target RNAP, are used as first-line treatment of TB and are the only current treatments that can relatively rapidly reduce populations of TB bacteria to undetectable levels. Read Press Release.

Negotiated terms for a research collaboration between the Global Alliance for TB Drug Development (TB Alliance) and The Johns Hopkins University (JHU) for combination testing of current and potential tuberculosis (TB) drugs in mice. This marks the first time such a large set of TB drugs will be tested comprehensively in an animal model of TB. The results will form the basis and rationale for selecting new, and potentially lifesaving, drug combinations to be studied in humans for their potential to treat both drug-sensitive and drug-resistant TB. Read Press Release.

Negotiated terms for a research collaboration between the Global Alliance for TB Drug Development (TB Alliance) and the Novartis Institute for Tropical Diseases (NITD) for a five-year research collaboration designed to yield new medicines for TB, including drug-resistant TB. The partnership is a milestone toward the development of faster TB drug regimens that treat all forms of TB, are easier for patients to complete, and can be used safely in patients with HIV/AIDS. Read Press Release.

Negotiated terms for a research collaboration between the Global Alliance for TB Drug Development (TB Alliance) and the Infectious Disease Research Institute (IDRI), a Seattle-based non-profit scientific research institute, to study which of the many proteases in M.tb might make the best targets for TB drugs. The first priority will be proteases that are essential for M.tb's survival in animals as several proteases seem to be important for M.tb to stay alive in low oxygen or low nutrient conditions. Survival under these circumstances is thought to be critical for the persistence of M.tb in humans, so drugs that prevent this survival have a good chance of shortening TB treatments. Read Press Release.

Negotiated terms for a research partnership between the Global Alliance for TB Drug Development (TB Alliance) and the Institute of Materia Medica (IMM), a member of the Chinese Academy of Medical Sciences, to develop promising, novel anti-tuberculosis agents. The TB Alliance and IMM will work together on the design, synthesis and evaluation of a class of compounds known as riminophenazines. The class was discovered in the 1950s and developed to work against tuberculosis, but has not been used for TB due to some side effects. Because researchers see potential in the class, the goal of the research partnership is to deliver novel compounds from the riminophenazine class - without the side effects - that could improve TB treatment. The collaboration will utilize IMM's expertise and integrated capabilities in chemistry, pharmacology and manufacture along with the TB Alliance's research experience. Read Press Release.

Negotiated terms for a joint program between the Global Alliance for TB Drug Development (TB Alliance) and Cumbre Pharmaceuticals on the design, synthesis and optimization of two different classes of multi-functional antibiotics. The collaboration will utilize Cumbre’s unique antibiotic discovery and development technical platform to deliver novel antibiotic compounds. The TB Alliance will have exclusive rights to these compounds for the treatment of tuberculosis and other neglected diseases, while Cumbre will retain the rights to pursue compounds for use in other infectious disease areas. Read Press Release.

Negotiated terms for a partnership between the Global Alliance for TB Drug Development (TB Alliance) and Bayer HealthCare AG to coordinate a global clinical trial program to study the potential of moxifloxacin to shorten the standard 6-month treatment of tuberculosis (TB). Moxifloxacin is an orally active fluoroquinolone that has been approved in 104 countries for the treatment of bacterial respiratory and skin infections. The Phase II clinical program will evaluate whether substitution of moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) eliminates TB infection faster than current standard therapy. The trials will be run in Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the United States and Zambia and close to 2,500 TB patients will be enrolled. The partnership is committed to making the product affordable and accessible in developing countries where patients need it most. Read Press Release.

On September 13, 2006, the Licensing Executives Society (LES) Industry/University and Government Laboratory Transactions Industry Sector presented the TB Alliance and Bayer its Deals of Distinction Award which recognizes worthy transactions involving licensing and transfer of intellectual property and promote creative and innovative solutions to business issues. This deal was recognized as an excellent example of a public-private partnership between a major pharmaceutical company and a not-for-profit organization which balances the competing needs and issues inherent with expanded drug development of a marketed medicine for new uses. It won the award because (1) it was the first in which a company allowed a currently marketed drug to be studied for a disease that is most prevalent in the developing world; (2) the partnership engaged a Big Pharma company with a not-for-profit, public-private partnership in the testing of a drug for a new use; and (3) if successful, the collaboration envisions registering moxifloxacin for a TB indication. Read LES Press Release and TB Alliance Press Release.

The TB Alliance-Bayer deal was also one of six finalists for the Scrip 2006 Best Partnership Alliance Award. Scrip Awards are designed to recognize new standards of excellence and celebrate the very best achievements that reflect cutting-edge science and the intellectually exciting and socially rewarding nature of the industry. The Best Partnership Alliance award recognizes the importance of partnerships involving pharmaceutical and/or biotech companies, focusing on deals that require strong strategic input from both partners, are mutually beneficial, hold promise to address an unmet medical need and demonstrate strategic potential as well as an innovative business model.

Negotiated terms for a Research Agreement for the Global Alliance for TB Drug Development for a supplemental program to develop analogs of PA-824 with researchers at the University of Auckland in New Zealand. This program is being conducted in tandem with the existing analog program already underway at the Novartis Institute of Tropical Diseases working with U.S. National Institute of Allergy and Infectious Disease (NIAID).

Negotiated terms for a joint drug discovery program between the Global Alliance for TB Drug Development and GlaxoSmithKline. The program consists of a portfolio of four projects intended to yield new compounds that attack Mycobacterium tuberculosis (M. tb) on multiple levels to improve the treatment of tuberculosis. The research program includes the pleuromutilins, a novel class of antibiotics, and two target-based projects, isocitrate lyase (Icl) and InhA. The fourth project will screen GSK’s antimicrobial libraries for novel compounds that have the ability to kill M. tb. Read Press Release.

Negotiated terms for a Letter of Intent between the Global Alliance for TB Drug Development and the Novartis Institute for Tropical Diseases, a unit of Novartis AG, for a joint research program to identify the next generation of nitroimidazopyran compounds related to PA-824, one of the lead compounds in the TB Alliance portfolio that is on track to enter Phase I clinical trials in 2005. Read Press Release.

Negotiated a two-year Sponsored Research Agreement for the Global Alliance for TB Drug Development with the University of Illinois at Chicago Institute for Tuberculosis Research to develop novel macrolide antibiotics for the treatment of tuberculosis. The primary goal of the research project is to optimize the anti-TB activity of macrolides through the synthesis of chemically modified erythromycin derivatives. Read Press Release.

On behalf of the Arizona Disease Control Research Commission, exclusively out-licensed a novel disulfone bis-phosphonate reagent to incorporate a disulfone and/or a disulfone phosphate moiety into potential phosphate dependent enzyme inhibitors. Several novel compounds have been synthesized and found to be inhibitors of HIV integrase. The technology was developed at The University of Arizona.

Assisted the Global Alliance for TB Drug Development to conclude an Agreement with the Korea Research Institute of Chemical Technology (KRICT). Under the terms of the Agreement, KRICT will synthesize several hundred novel quinolones and the compounds will then be biologically evaluated, both in vitro and in vivo, at the Yonsei University College of Medicine in Seoul. In addition, the lead compound in the family, KRQ-l0018, will be further evaluated for efficacy in animal models. Read Press Release.

Negotiated a worldwide exclusive License Agreement to allow the Global Alliance for TB Drug Development to develop Chiron Corporation's new preclinical stage compound PA-824 for the treatment of tuberculosis. Under grant-back provisions, Chiron retained the right to participate in later-stage development, manufacture and marketing of the product in selected countries. Read Press Release.

Obtained over $650,000 from a major pharmaceutical company for sponsored research on Parkinson's disease under a two year Option Agreement that included provisions for a university client to receive an additional $2.8 million from a license execution fee and milestone payments upon exercise of the option.

Negotiated terms of a worldwide exclusive License Agreement with a major multi-national company that provided a university client with more than $4.5 million in license fees and royalty income.

Out-licensed a university discovered niche cardiovascular compound to a U.S. based start-up pharmaceutical development company.

Re-negotiated an exclusive License Agreement with a start-up company on behalf of a university client that more than doubled the university’s initial equity position in the company in lieu of future royalties on net sales of a specific potential product.

Located a library of small molecule compounds at a major pharmaceutical company and negotiated a Screening Agreement for an industrial client to evaluate selected compounds for potential utility in a novel therapeutic area.

Located novel synthetic organic chemistry process technologies at U.S. universities with the potential to enable a U.S. based bulk drug manufacturer to improve the synthetic procedure and significantly reduce the cost of preparation of several generic drugs.

Identified novel microencapsulation technologies at several academic laboratories and research institutes that resulted in an industrial client entering into Confidentiality Agreements and receiving written research proposals from six different investigators.

Identified a compound for the treatment of atopic dermatitis in Phase II clinical trials at a small start-up company for an industrial client with a large franchise in skin care products.

Identified several compounds with a specific mechanism of action that were in late stage clinical trials at major pharmaceutical companies, determined the availability for license in a patentably distinct therapeutic area and then arranged for introductory meetings with a start-up pharmaceutical company client.

Identified a novel compound in Phase I clinical trials that was available for licensing and co-development by an industrial client. Arranged for the client to visit the company's research facilities and receive a scientific presentation with an outline of potential licensing terms.

Evaluated novel cardiovascular technology and provided a university client with a detailed written report describing potential commercialization strategies.

Reviewed biological data on a series of novel compounds and provided a university client with several potential commercial options.

Reviewed various technologies and prepared more than 50 detailed Evaluation Reports for an academic client.

Analyzed marketing data from a business plan for a university client that was in the process of starting a company based upon novel university discovered technology.

Reviewed Invention Disclosures and rendered a licensing opinion for several other university clients.