AMRI Signs Agreement for Exclusive License of its Tubulin Inhibitor Program for Cancer

ALBANY, N.Y., Feb. 11, 2013 /PRNewswire/ -- AMRI (NASDAQ: AMRI) announced today that it has signed an exclusive license agreement with Chai Therapeutics, LLC for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer. This agreement follows the exercise of an option to license the intellectual property, which was granted in March 2012 by AMRI to Bessor Pharma, LLC, a translational drug development company. Chai Therapeutics is an affiliate of Bessor Pharma, LLC.

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Under the terms of the license agreement, AMRI received an undisclosed license fee and reimbursement for certain costs associated with the intellectual property related to ALB 109564(a). Chai Therapeutics received an exclusive license to the ALB 109564(a) intellectual property, and will be solely responsible for all related research and development and patent costs going forward; AMRI will receive a share of future consideration from the further development and sales, if any, of any ALB 109564(a)-related drug that may be developed, licensed and/or commercialized.

"We are very pleased to continue to work with Bessor on the further development of AMRI's novel tubulin inhibitor," AMRI Chairman and CEO Thomas E. D'Ambra, Ph.D. said. "The recent formation of Chai Therapeutics to focus on the development of our compound is a strong statement by our partners of the potential benefit that this technology could ultimately deliver to cancer patients. Dr. Berkowitz and his team have a proven track record of success in drug development and we are confident in their ability to move this program forward."

D'Ambra continued, "The tubulin inhibitor program is an asset 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 and programs to create near- and long-term value for the company."

Barry A. Berkowitz, Ph.D., President and CEO of Bessor said, "In AMRI's work to date, ALB 109564(a) has shown significant promise as a next generation tubulin inhibitor for the treatment of cancer. Through our integrated network of drug development and clinical experts and the flexible structure afforded by Chai, we plan to advance the clinical program to further define the compound's potential.  ALB 109564(a) is one of several translational projects in Bessor's growing portfolio that it is advancing to key value points."

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. This proprietary program, as well as AMRI's other available pipeline programs in the therapeutic areas of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), cognitive impairment and schizophrenia, were each created with business strategies aimed at differentiating them from existing standards of care.

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

Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization offering customers fully integrated drug discovery, development and manufacturing services. For over 21 years, AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have undergone tremendous change in response to multiple challenges. This experience, a track record of success and locations in the United States, Europe and Asia now provides our customers with SMARTSOURCING™, a full range of value-added opportunities providing customers informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI has also successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).

About Bessor Pharma and Chai Therapeutics

Bessor Pharma LLC and its affiliate, Chai Therapeutics, LLC, founded by a team of R&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 and  Chai Therapeutics' ongoing ability to raise funding for the ALB 109564(a) research and clinical trial program; (b) problems or delays which may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead Bessor and Chai to discontinue development; (c) 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; (d) the planned timing of initiation and completion of clinical trials for ALB-109564(a) are subject to the ability of Bessor and Chai to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved; (e) 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, Bessor or Chai'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 AMRI'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.

SOURCE AMRI