Cubist Pharmaceuticals and Hydra Biosciences Announce Plans to Begin Phase 1 Clinical Trial for Novel TRPA1 Modulator to Treat Acute Pain

LEXINGTON, Mass. & CAMBRIDGE, Mass.--()--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Hydra Biosciences, Inc. today announced plans to begin a Phase 1 clinical trial for a small molecule antagonist of the human Transient Receptor Potential Ankyrin repeat 1 (TRPA1) ion channel discovered in a collaboration between Cubist and Hydra. This Phase 1 trial is the first step in a clinical development program designed to evaluate the potential of this TRPA1 investigational product to treat acute pain and certain inflammatory conditions. Under the collaboration, the companies recently identified and completed preclinical testing on a potent, selective TRPA1 antagonist, CB-625 (full name CB-189,625), and filed for regulatory approval to initiate human clinical studies. The open-label, dose-escalation study to assess the safety and pharmacokinetics of CB-625 in healthy volunteers will be conducted in the Netherlands and is expected to start in the first quarter of 2012.

“This is an important milestone in our innovative R&D partnership with Hydra, and marks meaningful progress in our ongoing goal to become a global leader in the acute care and hospital environment,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “Through focus and disciplined execution, we are delighted to have taken this exciting acute pain program from program initiation into the clinic in just over two years.”

Russell Herndon, President and Chief Executive Officer of Hydra Biosciences said, “We are excited about the progression of CB-625 into the clinic, as we believe this drug candidate may one day have the ability to impact the way doctors manage peri-operative pain, reducing reliance on opioids, which carry an excessive number of side effects.”

The regulatory filing to initiate Phase 1 clinical studies triggered a $5 million milestone payment from Cubist to Hydra.

About CB-625

Ion channels are transmembrane proteins that facilitate the flow of ions (positively and negatively charged molecules) into and out of the cell. The Transient Receptor Potential (TRP) channel family comprises a novel group of non-selective cation channels that are distinct from classical sodium, calcium or potassium voltage-gated channels and provide the potential to develop selective and safer ion channel drugs. Ion channels have been implicated in many diseases, including hypertension, cardiac arrhythmias, gastrointestinal disorders, cystic fibrosis and pathological pain.

CB-625 is a novel small molecule antagonist of the human TRPA1 channel. This unique mechanism of action in peripheral pain fibers distinguishes this drug from all other classes of analgesics. Opioids are the mainstay of treatment of acute perioperative pain. Although excellent analgesics, the opioids are fraught with side effects including centrally mediated respiratory depression, nausea and/or vomiting, and peripherally mediated constipation. CB-625 blocks peripheral TRPA1 channels and attenuates surgically induced and inflammatory mediated pain in animal models. This unique mechanism represents a novel, non-opioid method of treating peri-operative pain.

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.

Cubist is a registered trademark of Cubist Pharmaceuticals, Inc.

About Hydra Biosciences

Hydra Biosciences, a biopharmaceutical company based in Cambridge, Massachusetts, develops drugs to treat pain, inflammation, anxiety and other diseases using its expertise in novel ion channels. Hydra Biosciences’ proprietary platforms enable the company to identify and develop drug candidates that address significant unmet medical needs. More information about Hydra Biosciences is available at: www.hydrabiosciences.com.

Cubist Safe Harbor Statement

This press release contains forward-looking statements regarding the clinical development of CB-625, including plans to initiate a Phase 1 clinical trial for this compound in healthy volunteers and the therapeutic potential of CB-625. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: CB-625 may not show an acceptable safety profile in the Phase 1 clinical trial or may not show sufficient therapeutic effect or an acceptable safety profile in any subsequent later stage clinical trials; CB-625 may not act in the way expected based on pre-clinical trials; clinical trials of CB-625 may not be successful or initiated or conducted in a timely manner and the timing of initiation and conduct of subsequent trials is dependent on our ability to successfully work with regulatory authorities, including the FDA on the design of the trials, among other things; the commercial market for the intended use of CB-625 may not be as large as Cubist anticipates; technical difficulties or excessive costs relating to the manufacture or supply of CB-625; we, and Hydra, which has an interest in the intellectual property protecting CB-625, may not be able to maintain and enforce such intellectual property; and we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of CB-625. Drug development involves a high degree of risk. Success in pre-clinical trials does not mean that later stage trials will be successful. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent periodic filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. These statements speak only as of the date of this release, and Cubist undertakes no obligation to update or revise these statements, except as may be required by law.

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Contacts

Cubist Contacts:
INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Cubist Pharmaceuticals, Inc.
Francis McLoughlin, 781-860-8777
Director, Corporate Communications
or
Hydra Contacts:
CORPORATE:
Hydra Biosciences
Russell Herndon, 617-494-5230 x3352
President and Chief Executive Officer
or
MEDIA:
LaVoie Group
Leah Monteiro, 978-745-4200 x111
Senior Account Executive
lmonteiro@lavoiegroup.com

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Contacts

Cubist Contacts:
INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Cubist Pharmaceuticals, Inc.
Francis McLoughlin, 781-860-8777
Director, Corporate Communications
or
Hydra Contacts:
CORPORATE:
Hydra Biosciences
Russell Herndon, 617-494-5230 x3352
President and Chief Executive Officer
or
MEDIA:
LaVoie Group
Leah Monteiro, 978-745-4200 x111
Senior Account Executive
lmonteiro@lavoiegroup.com