Tobira Therapeutics Completes Senior Management Team With Key Strategic Hires in Finance, Clinical and Pharmaceutical Sciences

Experienced Team in Place to Drive Late-Stage Development of Innovative Single-Tablet Regimens for HIV Infection

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Tobira Therapeutics, Inc., developer of innovative antiretroviral therapies for HIV, announced the addition of three highly accomplished executives in the finance, clinical and pharmaceutical sciences functions. Joining the company are Caroline Loewy as Executive Vice President and Chief Financial Officer, Jeff Enejosa, M.D., as Senior Director, Clinical Research, and Mark Menning as Director, Pharmaceutical Sciences. These key hires complete Tobira’s experienced team, capable of advancing its lead compound, cenicriviroc (CVC or TBR-652), rapidly through the final stages of clinical development. Cenicriviroc is a novel, oral, once-daily, fixed-dose combinable, dual inhibitor of chemokine receptors CCR5 and CCR2. Tobira is currently evaluating cenicriviroc in a Phase 2b trial for the treatment of HIV-1 infection.

“In the past 18 months, we have built a world-class team of drug development and business executives whose expertise will drive Tobira’s future growth. Together, our team is uniquely qualified to complete the ongoing Phase 2b study of cenicriviroc and execute our comprehensive Phase 3 development program.”

“We believe cenicriviroc has the potency, safety and properties to become a key component of innovative, once-daily, single-tablet complete regimens for HIV,” said Andrew Hindman, Tobira’s President and Chief Executive Officer. “In the past 18 months, we have built a world-class team of drug development and business executives whose expertise will drive Tobira’s future growth. Together, our team is uniquely qualified to complete the ongoing Phase 2b study of cenicriviroc and execute our comprehensive Phase 3 development program.”

Ms. Loewy brings more than 20 years of strategic, operational and financial experience, serving as Chief Financial Officer at two publicly traded biotechnology companies and as a Wall Street equity research analyst covering the biotechnology industry. While a CFO, she successfully raised approximately $300 million of investment capital to support Phase 3 development programs. In her new role, Ms. Loewy will oversee financial operations and, as a member of Tobira’s leadership team, contribute to the company’s strategic direction reporting directly to Mr. Hindman.

Dr. Enejosa joins Tobira with more than 18 years of clinical and pharmaceutical industry experience in designing and executing clinical trials for antiviral therapeutics and treating patients as a Board-certified Internal Medicine physician with specialty in HIV medicine. Dr. Enejosa was Director, Clinical Research at Gilead Sciences, where he supervised and led Phase 1-3 clinical trial planning and execution in HIV and chronic hepatitis B, including pivotal studies supporting successful U.S. and European regulatory approvals of Viread^®, Truvada^® and Atripla^®. As Senior Director, Clinical Research, Dr. Enejosa will report to Tobira’s Chief Medical Officer, Eric Lefebvre, M.D.

Mr. Menning brings more than 15 years pharmaceutical development expertise to Tobira. Most recently, he served as Senior Research Scientist, Formulation and Process Development at Gilead Sciences where he led the co-formulation and process development of multiple fixed-dose combination products for the treatment of HIV. He is a co-inventor of the Truvada^®, Atripla^®, Complera^® and Stribild™ tablets. Mr. Menning will report to Sean Dalziel, Ph.D., Vice President, Technical Operations.

Cenicriviroc is a novel dual inhibitor of the CCR5 and CCR2 chemokine receptors, in development for treatment of HIV-1. While CCR5 is a well-validated therapeutic target that prevents entry of HIV into immune cells, cenicriviroc has the potential to be the first once-daily, dual chemokine inhibitor that is combinable into either fixed-dose combination therapies or complete single-tablet regimens. In May 2012, Tobira completed enrollment in an ongoing Phase 2b study of cenicriviroc in antiretroviral treatment-naïve patients infected with CCR5-tropic HIV-1. Tobira plans to present twenty-four week dose response data from this clinical trial at a scientific meeting in the first quarter of 2013.

About Tobira Therapeutics

Tobira Therapeutics is a privately-held biopharmaceutical company developing innovative therapies for treatment of HIV infection. The company’s lead development candidate is cenicriviroc (CVC or TBR-652), a novel, oral, once-daily, fixed-dose combinable, dual inhibitor of chemokine receptors CCR5 and CCR2 being evaluated for the treatment of HIV infection. Cenicriviroc has demonstrated potent antiretroviral activity and good tolerability in a Phase 2a trial¹. Tobira is currently conducting a randomized, double-blinded, double-dummy and controlled Phase 2b study of cenicriviroc in treatment-naive HIV-infected individuals with CCR5-tropic virus. Tobira has financial backing from a syndicate of leading life science investors including Domain Associates, Frazier Healthcare Ventures, Montreux Equity Partners, Novo Ventures and Canaan Partners. Learn more at www.TobiraTherapeutics.com.

¹ Lalezari, J., et al, “Safety, Efficacy, and Pharmacokinetics of TBR-652, a CCR5/CCR2 Antagonist, in HIV-1–Infected, Treatment-Experienced, CCR5 Antagonist–Naive Subjects.” J Acqir Immune Defic Syndr. 2011 June; 57(2)