Navigation Links
Elusys Therapeutics and Lonza Extend Manufacturing Agreement for Anthim, a New Anthrax Treatment in Late-Stage Development
Date:7/15/2010

PINE BROOK, N.J. and BASEL, Switzerland, July 15 /PRNewswire/ -- Elusys Therapeutics and Lonza today announced an agreement for the scale-up and commercial production of Anthim, a therapeutic monoclonal antibody in late-stage development for the treatment of inhaled anthrax. Under the new contract, Lonza will provide process scale-up, technology transfer, validation, and commercial manufacturing at one of its facilities in the USA. The manufacturing process for Anthim was optimized for full scale production by Lonza under a separate agreement announced in 2009. The Anthim manufacturing process uses Lonza's GS Gene Expression System.

(Logo: http://photos.prnewswire.com/prnh/20090420/NY01624LOGO )

(Logo: http://www.newscom.com/cgi-bin/prnh/20090420/NY01624LOGO )

"Elusys is pleased to extend its relationship with Lonza for the commercial production of Anthim, an anti-toxin that has been highly effective in treating anthrax infected animals," said James Porter, Vice President of Development and Manufacturing at Elusys. "Anthim has the potential to deliver significant therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency and therefore, we believe that partnering with Lonza provides Elusys the manufacturing experience and large-scale capacity needed to ensure commercial quantities of Anthim long-term. As the world's leading contract manufacturer of monoclonal antibodies and recombinant proteins, Lonza has considerable experience in large-scale manufacturing and a well-established reputation with regulatory agencies for the production of licensed products."

In 2009, Elusys was awarded a contract totaling up to $143 million from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services to complete the final development, commercial manufacturing and licensure of Anthim. This contract represented one of the largest awarded by BARDA for advanced product development.

"Working with the team at Elusys on such a novel new antibody therapy has been very rewarding," said Dr. Stephan Kutzer, Head of Lonza Custom Manufacturing. "We are excited about continuing our successful relationship and look forward to supporting Elusys in the launch and long-term commercial supply of Anthim."

Anthim Background

Based on extensive testing, which included multiple models of anthrax infection, Anthim has demonstrated excellent potential as an effective, single dose therapeutic for the treatment of people infected by or exposed to anthrax spores. These study results showed Anthim prevented death in 70 – 100% of animals treated with a single dose of drug.

Anthim is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins. It is being developed for prevention and treatment of inhaled anthrax following a biowarfare attack.

This project is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000026C, and the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), the Department of Health and Human Services (HHS) and BARDA under Contract No. HHSN272200700035C.

About Elusys Therapeutics

Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and contracts totally up to $177 million in government funding.  Anthim, a highly effective anthrax anti-toxin, is in late-stage development and is a strong candidate for future procurement into the Strategic National Stockpile.  For more information, please visit www.elusys.com.

About Lonza

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690 billion. Further information can be found at www.lonza.com.


'/>"/>
SOURCE Elusys Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Niaid / Barda Awards Elusys a $12 Million Contract to Further Develop Anthim, the Companys Anthrax Therapeutic
2. Elusys Anthrax Anti-Toxin, Anthim(TM), Enters Second Phase I Clinical Study
3. Elusys Presents Data From Anthim(R) Anthrax Anti-Toxin Studies at the HHS Stakeholders Workshop 2009 & BARDA Industry Day
4. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
5. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
6. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
7. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
8. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
9. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
10. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
11. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... -- SI-BONE, Inc., a medical device company that pioneered the use of ... (MIS) device indicated for fusion for certain disorders of the sacroiliac ... Administrative Contractor (MAC) covering the states of Connecticut ... Massachusetts , Minnesota , ... Rhode Island , Vermont ...
(Date:2/12/2016)... , Feb. 12, 2016 On Thursday, ... Robotic Surgery at St. David,s North Austin Medical Center ... Vinci ® Xi ® Surgical System with ... 7000dV. Thiru Lakshman , M.D., colorectal surgeon ... total proctocolectomy utilizing Integrated Table Motion technology, which seamlessly ...
(Date:2/12/2016)... , Feb. 12 2016  OMS Supply, a ... and medical practitioners, announced today the recent launching of ... visitors a variety of features that enhance the user ... surgery supplies. --> ... a fairly new company that started in early 2016, ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... ... a new initiative—the Siemens Foundation-PATH Ingenuity Fellowships—to develop the advanced skills needed ... top students from U.S. universities who will draw from Siemens’ deep knowledge ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... 29, 2016 — 1:30 p.m. – 3:00 p.m. EST, http://www.fdanews.com/fixeddosecombination ... the life cycle of pharmaceutical products, garnering increased attention from all stakeholders in ...
(Date:2/12/2016)... ... February 12, 2016 , ... Coco Libre, the maker of coconut water beverages ... GRAMMY’s Style Lounge Event. Coco Libre will offer musicians and celebrities the company’s signature ... event. The invitation-only gifting suite, held this year at the W Hollywood Hotel, has ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... (WaaS), today announced the integration of Clarity Intelligence Platform (CIP) into Cielo®, a ... offer real-time business intelligence (BI) to their small and medium business (SMB) clients. ...
(Date:2/12/2016)... ... February 12, 2016 , ... AssureVest Insurance Group, a locally owned insurance firm ... that will raise funds earmarked to purchase computers and software for Mrs. Harrison’s 2nd ... school is in a low-income area and has more than 60 2nd and 3rd ...
Breaking Medicine News(10 mins):