Healthcare Industry News: valproic acid
News Release - October 4, 2007
Hyperion Therapeutics, Inc. Announces Senior Management Team and $15M Financing EventSOUTH SAN FRANCISCO, Calif., Oct. 4 (HSMN NewsFeed) -- Hyperion Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of gastrointestinal and hepatology therapies that address underserved patient populations or unmet medical needs today announced key senior management appointments and closing of up to $15 million in debt financing from Comerica Bank and Life Sciences Capital. Joining Co-Founder Chris Rivera (President and CEO) are Marvin Garovoy, M.D. (Senior Vice President (SVP), Clinical Development), Sharron Gargosky, PhD (Chief Scientific Officer and SVP of Corporate Development), Klara Dickinson (SVP, Regulatory Affairs and Compliance), Kevin Weber (SVP, Global Strategy and Operations), Wayne Davis, PhD (Vice President, Clinical Operations), Hoi Leung, PhD (Vice President, Biostatistics), George Jue (Vice President, Finance and Controller), and James Kaser (Vice President, Global Sales).
"The build out of our senior management team and infusion of additional financial capital provides a solid foundation for Hyperion to fulfill its commitments and capitalize on the opportunity presented by our recently announced strategic collaboration with Ucyclyd Pharma, Inc., a subsidiary of Medicis Pharmaceutical Corporation," said Chris Rivera, President and CEO. "This team brings a unique and proven track record of developing, gaining regulatory approval and building orphan and specialty markets. I look forward to working with them to build a leading biopharmaceutical company and to make a difference in patients' lives."
About the Management Team
Chris E. Rivera, President and CEO, co-founded Hyperion Therapeutics in 2006, and led the execution of the Ucyclyd Pharma collaboration agreement. Prior to joining Hyperion, Mr. Rivera was Senior Vice President of Commercial Operations at Tercica where he was responsible for developing and overseeing Tercica's global commercialization strategies and was intimately involved in the development and consummation of the Ipsen cross-licensing collaboration. As Senior Vice President, Genzyme Therapeutics, Mr. Rivera was largely responsible for building the company's U.S. renal business and assisted in the launch of Renagel® (sevelamer hydrochloride) globally. Earlier in his career, Mr. Rivera also helped build the initial commercial organizations at Centocor and Cephalon.
Marvin R. Garovoy, MD, Senior Vice President, Clinical Development, has held numerous industry positions over the past several years, including Vice President of Clinical Science at Xoma (US) LLC where he was the clinical lead working in collaboration with Genentech on the development of Raptiva® (efalizumab) from Phase I through FDA approval. Dr. Garovoy was most recently at Arriva Pharmaceuticals, where he held the position of Chief Medical Officer. Dr. Garovoy is a transplant physician by training, and has held multiple teaching positions at Harvard Medical School and at UCSF where he was Professor of Surgery, Medicine and Laboratory Medicine.
Sharron E. Gargosky, PhD, Chief Scientific Officer and Senior Vice President of Corporate Development, was most recently Executive Director of Ucyclyd, Research and Development at Ucyclyd Pharma Inc., a subsidiary of Medicis Pharmaceutical Corporation. In this role, she was responsible for the NDA approval of AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%. Dr. Gargosky was previously Vice President of Business Development for Diagnostic System Laboratories where she was responsible for business expansion through evaluation and implementation of new growth opportunities and patent portfolio management. Dr Gargosky's prior positions include Clinical Director for Pharmacia and Assistant Research Professor in the Endocrinology Division at Oregon Health State University.
Klara A. Dickinson, Senior Vice President, Regulatory Affairs and Compliance, was previously Vice President of Regulatory Affairs and Healthcare Compliance Officer at CoTherix, Inc. In this role, Ms. Dickinson led the filing of the NDA and label negotiations for the company's initial product, Ventavis® (iloprost) Inhalation Solution, an orphan drug. Prior to CoTherix, Ms. Dickinson was at Scios, Inc. as Associate Director of Regulatory Affairs where she was instrumental in securing regulatory approval for Natrecor® (nesiritide). From 1993 to 1997, she held several positions in the Quality Control and Regulatory Affairs departments at DEY Laboratories.
Kevin D. Weber, Senior Vice President Global Strategy and Operations, joined Hyperion Therapeutics from Ucyclyd Pharma, Inc, a subsidiary of Medicis Pharmaceuticals Corporation, where he was Vice President, General Manager. Mr. Weber's 22 years of pharmaceutical experience includes management positions with Rhone-Poulenc Rorer, VHA and Medicis Pharmaceuticals. He has successfully launched and managed several pharmaceutical brands in a variety of therapeutic areas including gastrointestinal (Maalox®), dermatology (Dynacin®), respiratory (Azmacort®, Intal®, and Orapred®) and rare metabolic disorders (AMMONUL and BUPHENYL® (sodium phenylbutyrate)).
Wayne B. Davis, PhD, MBA, Vice President, Clinical Operations joins Hyperion from SuperGen, Inc. where he most recently served as Senior Vice President, Clinical Research. During his tenure, Dr. Davis led the project team for SuperGen's first targeted anti-cancer therapeutic, MP470, resulting in the IND filing in March, 2007 and the initial enrollment of the first-in- human clinical study in July. Prior to SuperGen, Dr. Davis served as Vice President, Operations at PRA International, Executive Vice President Global Operational Services and Director General, North America at CroMedica, Inc. and Vice President, Operations for the Infectious Disease and Immunology Therapeutic Unit of Quintiles Transnational Corp.
Hoi M. Leung, PhD, Vice President, Biostatistics, most recently served as Director, Biometrics at XOMA (US) LLC. Prior to XOMA, Dr. Leung was Senior Director, Biostatistics at Quintiles for the Infectious Disease, Medical Device, and Immunology Therapeutic Unit. Dr. Leung has extensive experience in the design, analyses and interpretation of clinical trials with regulatory perspective. From 1979 to 1997 he served with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in various capacities including Statistical Reviewer of New Drug Applications, Group Leader and Team Leader in the Division of Biometrics.
George T. Jue, Vice President Finance and Controller most recently served as Vice President, Finance at VaxGen. From 2005 to 2006, he served as the Vice President, Finance and Corporate Controller at PDL BioPharma, where he was responsible for the integration of a $500 million acquisition. His previous roles include Corporate Controller at Scios/Johnson & Johnson, Director of Finance for the Urology Division at Roche BioScience, Senior Group Controller at Genentech Inc. and Associate CFO at Lawrence Berkeley National Laboratory.
James A. Kaser, Vice President, Global Sales was most recently the Vice President of Sales for Tercica Inc. In this capacity, he created and implemented a national sales program for the start-up biotechnical firm. Before working at Tercica, Mr. Kaser was a Regional Business Director for Corixa Corporation and spent seven years at Genzyme Corporation where he progressed through positions of increasing responsibility in sales including his role as Senior Regional Business Director. He began his career in a sales capacity at the Merck Sharpe and Dohme Company.
About the Financing Event
Hyperion has closed $15 million in venture debt from Comerica Bank and Life Sciences Capital. This funding, in addition to the recently announced $40 million in Series B financing, will enable the Company to advance clinical trials of GT4P for potential use in urea cycle disorder (UCD) and hepatic encephalopathy (HE) and AMMONUL for potential use in acute HE. Further, the funds will be used to invest in the U.S. sales and marketing efforts of the only two FDA-approved compounds for the treatment of UCD, AMMONUL and BUPHENYL.
About Hyperion Therapeutics
Hyperion Therapeutics is a specialty therapeutics company focused on becoming a global leader in gastrointestinal (GI) and hepatology therapeutic programs and products that address underserved patient populations or unmet medical needs. The company has assembled a seasoned executive team with extensive industry experience developing and commercializing specialty pharmaceutical products. Hyperion is headquartered in South San Francisco, CA. For additional information, visit: http://www.hyperiontx.com.
AMMONUL is indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. The most common adverse reactions are vomiting (9%), hypokalemia (7%), hyperglycemia (7%), convulsions (6%), and mental impairments (6%). Do not administer to patients with known hypersensitivity to sodium phenylacetate or sodium benzoate. Acute symptomatic hyperammonemia should be treated as life-threatening. Uncontrolled hyperammonemia can result in brain damage or death. Dialysis may be required, preferably hemodialysis, to remove a large burden of ammonia. Administration must be through a central line; use of a peripheral line may cause burns. Do not administer undiluted product. Because of prolonged plasma levels achieved by phenylacetate in pharmacokinetic studies, repeat loading doses should not be administered. Use caution when administering to patients with hepatic or renal insufficiency. AMMONUL may cause nausea and vomiting. An antiemetic may be administered during infusion. See the prescribing information for a complete listing of warnings, precautions, and drug interactions.
BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase(CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). BUPHENYL should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation. The most common adverse reactions associated with BUPHENYL were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these drugs have been reported to increase blood ammonia levels, and probenecid may affect the kidneys' excretion. Use with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.
AMMONUL and BUPHENYL are registered trademarks of Ucyclyd Pharma, Inc.
Full Prescribing Information for AMMONUL® and BUPHENYL® are available at http://www.Ammonul.com and http://www.Buphenyl.com, respectively, or by contacting Hyperion Therapeutics, Inc.
Source: Hyperion Therapeutics
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