Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.
Althea Selected by Lorantis for Recombinant Protein Manufacturing Project
SAN DIEGO, CA – April 27, 2005 – Althea Technologies, Inc., a leading provider of innovative technologies for pharmaceutical services and manufacturing, announced today that it has been awarded a contract from Lorantis Ltd. to manufacture the protein component of HepVax, a hepatitis B therapeutic vaccine. Althea will produce the material in the company's cGMP manufacturing facilities in San Diego , California . Under the agreement Althea will provide a range of development and manufacturing services to Lorantis, enabling Lorantis to advance HepVax toward clinical evaluation.
Stefan Fischer, CEO of Lorantis said, “Working with Althea will allow us to rapidly advance HepVax forward towards an Investigational New Drug Application and is consistent with our aggressive timelines for bringing a high quality product to the clinic.”
Dr. Magda Marquet , co-President and co-CEO of Althea said, “We are very pleased to support Lorantis in the development of HepVax. We recognize the importance of this project and are committed to the high standards required for successful clinical evaluation of this exciting new product.” Rick Hancock , Sr. VP of Operations at Althea, said “Althea understands the importance of providing quality development and manufacturing support for recombinant protein products at the critical juncture of clinical trial material production.”
About Lorantis Ltd.
Lorantis, a privately held biotechnology company based in Cambridge UK , is pursuing immunology drug discovery and development programmes to address unmet medical need.Lorantis' most advanced product is HepVax, a therapeutic vaccine for the treatment of chronic hepatitis B. HepVax is composed of the Hepatitis B core particle in combination with Corixa's RC-529 adjuvant and is being co-developed by Lorantis and Corixa. IND filing is anticipated at the end of 2005, with commencement of Phase I trials in Q1 2006.
In addition, Lorantis has discovered a fundamental immune mechanism based on the Notch signalling pathway, by which the immune response can be selectively modulated, resulting in immune suppression in autoimmune disease and immune enhancement in cancer or infectious diseases. This new class of targeted medicines has the potential to transform the treatment of a broad range of major immunological disorders, including allergy, autoimmune disease and transplant rejection, as well as to greatly enhance the potential of cancer immunotherapy. It is anticipated that pre-clinical therapeutic data for Multiple Sclerosis, Allergic Asthma and Type I Diabetes will be available in the autumn of 2005. For more information, visit www.lorantis.com.
About Althea Technologies, Inc.
Althea Technologies, a leading San Diego-based pharmaceutical services firm, provides critical manufacturing and development services that support researchers worldwide in their advancement of novel therapies and efforts to apply new genomic information. Althea's services include cGMP contract manufacturing of recombinant proteins and DNA-based therapeutics and vaccines, aseptic filling, gene quantification using real-time PCR and gene expression analysis under GLP conditions. Additionally, Althea has introduced new services and technologies for the identification and understanding of gene signatures with innovative tools such as the company's proprietary eXpress Profiling℠. technology. For more information, visit www.altheatech.com.Contact:
| Althea Technologies, Inc. Alan Moore Executive Vice President & Chief Business Officer (858) 882-0205 amoore@altheatech.com |
Lorantis Ltd. Sean Marett VP Business Development +44 (0)1223 702 505 Sean.Marett@lorantis.com |
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