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By: AMRI via PR Newswire
April 03, 2012 at 08:00 AM EDT
AMRI Signs Exclusive Option to License its Tubulin Inhibitor Program for Cancer
Agreement Demonstrates AMRI's Commitment to Value Creation from its Proprietary Portfolio of Compounds and Programs

ALBANY, N.Y., April 3, 2012 /PRNewswire/ -- AMRI (Nasdaq: AMRI), a global contract healthcare services organization spanning the entire R&D continuum, announced today that it has signed an exclusive option to enter a license agreement with Bessor Pharma, LLC, a translational drug development company led by industry veteran Barry A. Berkowitz, Ph.D., for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer.

Under the terms of this agreement, AMRI will receive an undisclosed option fee and reimbursement for certain costs associated with the intellectual property related to ALB 109564(a).  The option period is approximately eight months, during which time Bessor Pharma will conduct further due diligence, engage in the required fund raising and coordinate with AMRI a technology transfer and advanced development plan. Upon exercising the option, Bessor Pharma will receive an exclusive license to the ALB 109564(a) intellectual property, and be solely responsible for all related research and development and patent costs.  Under the terms of the license, AMRI will receive royalties on sales of any ALB 109564(a)-related drug that is commercialized, in addition to the potential to earn additional revenue as the manufacturer of the drug itself.  In the event that the option is not exercised, all rights to ALB 109564(a) will revert to AMRI.

AMRI Chairman and CEO Thomas E. D'Ambra, Ph.D. said, "We are very pleased with this commercialization opportunity for our tubulin inhibitor program. We believe this novel compound offers good potential to advance the effectiveness of treatment against certain types of cancer in humans, and Dr. Berkowitz and his team have a proven track record of success in drug development.  The tubulin program is one of the assets that we have developed from our past R&D investments.  As we have stated previously, we will continue to pursue strategic opportunities to enable AMRI to advance the clinical development of our other compounds or programs to create near and long-term value for the company."

Dr. Berkowitz, President and CEO of Bessor said, "AMRI has built a strong initial program around ALB 109564(a), providing an early indication that it may offer clinically relevant activity distinct from other tubulin inhibitors. AMRI's decision to select Bessor to advance this compound is an important further endorsement of our development team and approach."  Dr. Berkowitz added, "Bessor is acquiring a portfolio of translational stage compounds and advancing them to key value points through an integrated pharmaceutical network and a team of top drug development and clinical experts. We look forward to working with AMRI and its strengths in drug discovery and API manufacture on this project and potentially other future projects as part of our network."

About ALB 109564(a) and Oncology
ALB 109564(a) is a novel analog from an established and marketed class of tubulin inhibitors, which is designed to kill cancer cells by preventing cell mitosis. The discovery of ALB 109564(a) leveraged AMRI's unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities. ALB 109564(a) has significant benefits compared with existing tubulin inhibitors in the same class. AMRI's Phase I study of ALB 109564(a) involved intravenous administration of ALB 109564(a) to cancer patients with advanced solid tumors. The study was designed to evaluate the compound's safety, tolerability, and pharmacokinetic profile and document effects on tumor growth.  Previously announced results from the Phase I clinical dose-escalation study indicate that ALB 109564(a) is well tolerated at the doses tested and shows preliminary evidence of clinical activity in disease types not typically treated with approved vinca alkaloids.

About AMRI
AMRI is a global contract research and manufacturing organization with more than twenty years experience providing customers fully integrated drug discovery, development, and manufacturing services. AMRI supplies a broad range of services and technologies that support the discovery and development of pharmaceutical products and the manufacturing of API and drug product for existing and experimental new drugs. With locations in the United States, Europe, and Asia, AMRI maintains geographic proximity and flexible cost models. AMRI has successfully partnered certain programs and is actively seeking to out-license its remaining programs to strategic partners for further development.

About Bessor Pharma
Bessor Pharma LLC, founded by a team of R and D and pharmaceutical business leaders, has created and is utilizing a new model for drug development and value creation, with a focus on translating drug discovery/development opportunities from universities and other organizations to key value points, typically IND readiness and for select projects, clinical proof-of-concept. The company has developed a flexible, project-oriented, capital efficient approach that attacks key drug development and financing challenges while advancing an innovative portfolio of product candidates. Bessor operates as a semi-virtual organization with a top team of pharmaceutical R&D and business experts and set of partners that function as a fully-integrated pharmaceutical network.

AMRI Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties.  Readers should not place undue reliance on our forward-looking statements.  The company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company's control.  Factors that could cause such differences include, but are not limited to: (a) Bessor Pharma's ability to raise funding for the ALB 109564(a) research and clinical trial program; (b) the results of Bessor Pharma's due diligence; (c) problems or delays which may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead  Bessor to discontinue development; (d) positive information about early stage clinical trial results is not necessarily indicative of clinical efficacy and does not ensure that later stage or larger scale clinical trials will be successful, for cancer or any other indication; (e) the planned timing of initiation and completion of clinical trials for ALB-109564(a) are subject to the ability of the Company to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved; (f) delay or denial of regulatory approvals from the FDA resulting from, among other things, adverse FDA decisions or interpretations of data that differ from AMRI's or Bessor's interpretations and that may require additional clinical trials or potential changes in the cost, scope and duration of clinical trials; and those factors discussed in the company's Annual Report on Form 10-K for the year ended December 31, 2011 as filed with the Securities and Exchange Commission, and the company's other SEC filings. The company does not undertake any obligation to and does not intend to update any forward-looking statements contained in this press release.

Contacts:

Investors – Mark Frost, AMRI Chief Financial Officer, 518-512-2211
Media – Gina Monari, AMRI Communications, 518-512-2512

For Bessor Pharma – Robert Gottlieb, RMG Associates, 857-891-9091

SOURCE AMRI

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