Navigation Links
Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
Date:1/31/2008

SAN MATEO, Calif., Jan. 31 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. today announced it has entered into manufacturing agreements with Albemarle Corporation and Patheon Inc. The agreements provide for the large-scale clinical production of Varespladib (A-002), which is expected to be necessary in preparation for Anthera's Phase III clinical trials and planned New Drug Application submission to the Food and Drug Administration. Varespladib is Anthera's oral drug candidate for the treatment of cardiovascular disease.

Anthera believes the agreements position the company to:

-- Secure a cost-effective, long-term supply of Varespladib active

pharmaceutical ingredient (API) and tablets.

-- Quickly scale current manufacturing efforts to meet production

requirements, potentially accelerating Varespladib's time-to-market.

-- Reduce manufacturing related risks to the Varespladib clinical program.

-- Ensure a cost-effective transition to registration and commercial

production.

Building on the work done by Anthera's licensor, Eli Lilly, Albemarle will be responsible for process optimization and manufacture of cGMP quantities of the API. Patheon will be responsible for finished tablet production. The agreement also provides an option for the commercial production of Varespladib in the future. Financial terms were not disclosed.

"These agreements with Albemarle and Patheon provide Anthera with key supply chain resources for the manufacture of Varespladib," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "We are pleased to have secured outstanding technical organizations with significant commercial expertise that will contribute to the future success of the Varespladib program."

"We're delighted that Anthera has selected Albemarle as its API manufacturing supplier for its next phase of development," said David Clary, Albemarle Division Vice President of Fine Chemistry Services. "Our relationship with Anthera further demonstrates our proven abilities to support the chemistry and cGMP needs of emerging pharmaceutical companies."

"This agreement with Anthera illustrates our continued progress towards becoming the development and manufacturing partner of choice to global pharmaceutical and biotechnology companies," said Dr. Shabbir Anik, Patheon's President of Global Pharmaceutical Development Services. "We look forward to continuing to work with Anthera on the dosage form development and commercial scale up of Varespladib."

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly and Company and Shionogi & Co. Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase A2 (PLA2) family -- a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel upstream steps in the inflammation cascade and have the potential to address a variety of diseases. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases from Amgen. For more information, please visit http://www.anthera.com.

Contact: Anne Bowdidge (650) 218-6900

pr@anthera.com


'/>"/>
SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease
2. Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
3. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
4. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
5. Kosans Motilin Receptor Agonist, Licensed to Pfizer, Enters Phase 1 Clinical Trial in Gastroesophageal Reflux Disease
6. The Heart, Diabetes, And Weight Loss Centers of New York Introduce the New Science of Metabolic Diagnosis and Weight Management
7. CellCyte Genetics Corp. Enters Collaborative Research Agreement With Cleveland Clinic Foundation to Qualify Stem Cell Delivery in Damaged Heart Tissue
8. Cepheid Announces Termination of Contract With the Centers for Disease Control and Prevention to Develop Rapid Point of Care Test for Avian Influenza
9. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
10. Concentra Medical Centers Gears Up for Flu Season to Keep Area Workforce Healthy
11. Ambrx Enters FGF-21 Type 2 Diabetes Drug Discovery Collaboration with Merck and Co. Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 If ... Leaders Scholarship is any indication, the future is in ... at www.diabetesscholars.org by the Diabetes Scholars Foundation ... the way of academic and community service excellence. ... since 2012, and continues to advocate for people with ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (United States, China, Japan, Brazil, United Kingdom, Germany, France, ... Surgical Procedure Volumes: ... provides surgical procedure volume data in a geographic context. ... analysis of growth drivers and inhibitors, including world population ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(Date:6/24/2016)... ... , ... People across the U.S. are sharpening their pencils and honing their ... in which patients and their families pay tribute to a genetic counselor by nominating ... of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, ...
(Date:6/24/2016)... Las Vegas, Nevada (PRWEB) , ... June 24, ... ... their Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and ... The Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer ...
(Date:6/24/2016)... ... 24, 2016 , ... Venture Construction Group (VCG) sponsors Luke’s Wings ... 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. ... service members that have been wounded in battle and their families. Venture Construction Group ...
Breaking Medicine News(10 mins):