Para compra kamagra puede ser visto como un desafío. Aumenta Smomenta, y todos los que se poco a poco abrumado, como es lógico, cada vez más hombres están diagnosticados con disfunción eréctil.
Microsoft word - omthera company formation release 3.8.10final
FOR IMMEDIATE RELEASE
Makovsky + Company
Omthera Pharmaceuticals, Inc. Closes a $6.5M Series A led by Sofinnova Partners to
Advance Epanova™, a Prescription Omega 3 Therapy
Dyslipidemia Experts Jerry Wisler and Michael Davidson, M.D. Co-Found New Pharmaceutical
Company Developing a Prescription Omega 3 Treatment of High Triglycerides
NEW YORK – March 8, 2010 – Omthera Pharmaceuticals, Inc., an emerging specialty pharmaceutical
company focusing on the clinical development of new dyslipidemia therapies, today announced
commencement of operations in Bedminster, New Jersey. Omthera’s lead product candidate,
Epanova™, an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA), has shown promising results in lowering triglycerides in earlier clinical
trials, as well as an excellent safety and tolerability profile. The Omthera management team includes drug
development and commercialization expert Jerry Wisler, president and chief executive officer, and
cardiologist and clinical expert Michael Davidson, M.D., chief medical officer.
“Under the leadership of Mr. Wisler and Dr. Davidson, Omthera Pharmaceuticals is poised to elevate the
treatment of dyslipidemia, beginning with its lead product candidate Epanova for the treatment of very
high triglycerides,” said Graziano Seghezzi, member of Omthera’s board of directors and partner at
Sofinnova Partners, a leading European venture capital firm who led the initial financing for Omthera. “Dr.
Davidson’s clinical expertise in cardiovascular disease treatment along with Mr. Wisler’s track record of
commercialization of cardiovascular therapies will help Omthera bring new and innovative therapies to the
Jerry Wisler brings 25 years of pharmaceutical industry experience to Omthera, including his most recent
role as co-founder, president and CEO of Aegerion Pharmaceuticals, Inc., a biopharmaceutical company
focused on the development and commercialization of pharmaceuticals to treat dyslipidemia. While at
Aegerion he was actively involved in clinical trial design, fundraising, business development and general
management. Prior to his role at Aegerion, Mr. Wisler served as vice president of marketing for Novartis.
Mr. Wisler held numerous positions during his 20 years with Merck, including vice president of marketing
with responsibility for the atherosclerosis franchise. He led Merck’s Zocor® team during a period of robust
growth, with annual revenues growing from $1.8 billion in 1997 to $5.3 billion in 2002. Mr. Wisler was also
involved in various lifecycle management activities for Zocor, providing commercial input into the decision
to enter into a Joint Venture with Schering-Plough for Zetia® and Vytorin®.
“The prescription Omega 3 market is already over $1.5 billion in annual worldwide revenues and is
positioned for tremendous growth,” said Mr. Wisler. “I am excited to be working with Dr. Davidson, whom
I have collaborated with over the past 12 years. We are assembling a strong team of employees and
external consultants to develop Epanova and bring it to market over the next few years.”
Michael Davidson, M.D. has more than 20 years of experience in the development of drugs for the
treatment of lipid disorders and continues to serve as clinical professor and director of Preventive
Cardiology at the University of Chicago. He was previously founder, president and CEO of the Chicago
Center for Clinical Research, acquired by Pharmaceutical Product Development (PPD) in 1996, and later
sold to Radiant Research. His studies on statins, novel lipid-lowering drugs, and nonpharmacologic risk
factor reduction have established him as a key opinion leader in this area. A prolific author and lecturer
on lipid disorders, nutrition, and atherosclerosis, Dr. Davidson has coordinated more than 700 clinical
trials in the area of preventive cardiology and published more than 200 articles for leading medical
journals. Dr. Davidson earned his medical degree from The Ohio State University College of Medicine in
Columbus and fulfilled his residency in internal medicine at Rush-Presbyterian-St. Luke’s Medical Center
in Chicago, where he later completed a fellowship in cardiology.
Epanova, Omthera’s lead product candidate, a free fatty acid form of Omega 3, is expected to provide
unique absorption characteristics and bioavailability versus the ethyl ester form found in prescription
Omega 3s currently available. Absorption characteristics of Epanova are further enhanced via a
proprietary capsule and capsule coating that delays absorption to the small intestine with superior release
kinetics. The delivery of Omega 3 to the small intestine is also expected to result in improved GI
Omthera plans to initiate comparative bioavailability trials for Epanova in mid-2010 and begin Phase III
trials of Epanova in patients with severe hypertriglyceridemia (TG >500 mg/dL) in late 2010 or early 2011.
The compound is also expected to enter Phase III trials in combination with statin therapy in 2011.
“An estimated five million people in the U.S. have triglyceride levels greater than 500 mg/dL and
according to a recent National Health and Nutrition Examination Survey (NHANES) analysis, that number
is growing,” said Dr. Davidson. “Epanova has potential to provide these patients with a ’best in class’
therapy to get their triglyceride levels under control and reduce their risk of heart disease. I am very
pleased to be leading the clinical trial efforts for this important product.”
About Sofinnova Partners
Sofinnova Partners is an independent venture capital firm based in Paris, France. For over 35 years, the
firm has backed nearly 500 companies at different stages of development – pure creations, spin-offs, as
well as turnaround situations – and worked alongside Europe’s key entrepreneurs in the technology, life
sciences and cleantech sectors. With €1.1 billion of funds under management, Sofinnova Partners’
experienced team and hands-on approach in building portfolio companies through to exit have created
market leaders, from landmark historical investments including Genentech, Actelion and Vistaprint to
more recent successes such as CoreValve, Novexel, Fovea and Sensitive Object. With a global mindset,
the firm has a sister organization in San Francisco, California.
About Omthera Pharmaceuticals, Inc.
Omthera Pharmaceuticals, Inc. is a specialty pharmaceuticals company with an experienced team of
experts in drug development focusing its efforts on the clinical development of new therapies for
dyslipidemia. The lead product candidate is Epanova™, an Omega 3 fatty acid containing a novel
formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omthera holds worldwide
rights to Epanova. For more information visit www.omthera.com.
Drug Name -- Buspar Alternate Names – Buspirone Manufacturer – Bristol-Myers Squibb Type – Prescription (not controlled). Pregnancy Issues – FDA Pregnancy Class B. Buspar is not expected to cause harm to a fetus or to cause birth defects. This, however, has not been proven over time. It is not known whether or not Buspar is transplacental. It is not known whether or not
ALL-TRANS-RETINOIC ACID LOADED OCULAR MICROSPHERES: PREPARATION AND IN-VITRO CHARACTERIZATION Y. Çirpanli1, N. Ünlü1, S. Çalis1, A.A. Hincal1 1 Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, ABSTRACT Preparation of PLGA (50:50) with solvent evaporation technique. In-vitro Microspheres technique. For this purpose, 10 mg retinoic