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Avid Bioservices Announces Manufacturing Supply Agreement for the Production of a Therapeutic Monoclonal Antibody Intended for Phase III Clinical Trials.


Business Editors/Health & Medical Writers

BIOWIRE2K

TUSTIN, Calif.--(BW HealthWire)--March 13, 2002

Avid Bioservices, Inc. (Avid), a wholly-owned subsidiary of Peregrine Pharmaceuticals (Nasdaq: PPHM PPHM Peregrine Pharmaceuticals, Inc (stock symbol)
pphm Parts Per Hundred Million
), today announced that it has signed a manufacturing supply agreement with a biotechnology company for the current Good Manufacturing Practices (cGMP) production of a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing  anticipated to be used in an upcoming Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  clinical study.

The client has requested the details of this project remain confidential.

"We are very happy to be working with this company and look forward to manufacturing its promising new therapeutic compound," said Steven King Steven King is the name of:
  • Steven King (documentary producer), the producer of
  • Steven King (hockey player)
  • Steven King (footballer)
  • Steve King, a United States politician
See also
  • Stephen King, horror fiction author
, Avid's president. "Since announcing the formation of Avid in January, there has been tremendous interest in Avid's development and production capabilities. We have already had a number of on-site client audits, and the reviews of the facilities and capabilities at Avid have been very positive. We look forward to signing additional supply agreements in the future."

"We expect that Avid will commence generating revenues during the ensuing quarter and will continue to generate revenues for the foreseeable future," stated Paul Lytle, Avid's chief financial officer. "These revenues will assist Avid in expanding its operations over the coming years to meet anticipated demand."

The biotechnology and biopharmaceutical industries are currently facing a worldwide shortage of manufacturing facilities for monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies").  and other recombinant proteins Since human recombinants have replaced the animal version in human therapeutics, the prefix of "rh" for "human recombinant" appears less and less in the literature Human recombinants that replaced animal or harvested from human types
. Based on the number of non-monoclonal antibodies biopharmaceutical companies currently have in the pipeline, industry experts estimate that over the next three to five years, manufacturing capacity will fall short by two to three times what is required. The current shortfall is even more severe for monoclonal antibodies where the requirement is likely to be five to six times current capacities. There is a critical need for increased manufacturing capacity or many of these potential new and life saving biological drugs will be significantly delayed. Due to the cost and time required to build new manufacturing facilities and the expertise required to manage operations, an increasing number of companies are switching from in-house manufacturing to outsourcing with contract manufacturing facilities.

About Avid Bioservices

Avid Bioservices provides a full range of cGMP manufacturing services for the biotechnology and biopharmaceutical industries. The company's comprehensive package of services includes highly specialized cell culture, process and analytical development work, in addition to full-scale manufacturing, purification, bulk packaging, and regulatory support. For more information about Avid, please visit www.avidbio.com.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Actual events or results may differ from the company's expectations as a result of risk factors discussed in Peregrine's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, the company's report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended April 30, 2001 and on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended October 31, 2001.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 13, 2002
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