ALS Therapy Development Institute Signs Manufacturing Agreement with Microbix
Tuesday October 16, 10:05 am ET


TORONTO, Oct. 16 /CNW/ - Microbix Biosystems Inc.(TSX: MBX - News) announced today that it has been selected by the ALS Therapy Development Institute (ALS TDI) in the U.S. to manufacture a series of adenoviruses that will be used in research aimed at fighting the disease Amyotrophic Lateral Sclerosis (ALS), often called Lou Gehrig's disease.



The ALS Therapy Development Institute (ALS TDI), based in Cambridge, Mass., is a leading research organization that works to discover and develop drugs that are potential treatments for ALS and related disorders such as Alzheimer's, Parkinson's and Huntington's diseases. "The production of high titer adenoviral constructs required for animal testing requires specialized manufacturing expertise that only recognized leaders in the field like Microbix can deliver," says Steve Perrin, Chief Scientific Officer at the ALS TDI. "Patients and families should be excited about this collaboration for a couple of reasons. High quality, high volume manufacturing of gene therapies will allow us to switch genes on and off at an unprecedented pace. We're scaling this project to get to the answer no matter how many genes we've got to modulate. It might be gene 1 or gene 300 that controls the disease so we need to keep marching until we find it," said Sean Scott, president of ALS TDI.

Under the terms of the one-year contract, Microbix will use its proprietary technology to produce, purify and characterize various adenoviruses created to carry therapies to sites of ALS pathology. The preparations will then be returned to the Institute, allowing them to further their research into this debilitating disease. Adenoviruses are non-pathogenic viruses that can deliver specifically selected genes to key sites in the body or to cultured cells for therapeutic purposes.

Approximately 3,000 people in Canada and 30,000 people in the U.S. currently have ALS, and some 8,000 new cases are diagnosed in North America each year. ALS is a progressive neuromuscular disease that attacks motor neurons in the brain and spinal cord. Eighty per cent of people with ALS die within two to five years of diagnosis - unable to breathe or swallow. There is currently no cure or effective treatment for ALS.

"We are honoured to have been chosen by the Institute for this critical component of their program," said William J. Gastle, CEO of Microbix. "This contract recognizes our leadership position in adenovirus production, and fits well into our near term plan to expand our core virology business into therapeutic applications."

Microbix specializes in developing proprietary biological technologies and commercializing them through global partners. The Company currently has three large-market technologies at various stages in the product pipeline - its VIRUSMAX(TM)Technology which significantly boosts the yield of influenza virus from eggs; Urokinase, a thrombolytic biologic that can be used as a catheter clearing drug and has potential in new cancer drug combination; and the Semen Sexing Technology(TM). Established in 1988, Microbix is headquartered in Toronto.

This press release contains forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These forward-looking statements represent the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.

For further information

visit www.microbix.com or contact William J. Gastle, CEO, Microbix Biosystems Inc., (416) 234-1624 x 230
James Long, CFO, Microbix Biosystems Inc., (416) 234-1624 x265



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Source: Microbix Biosystems Inc.

Contract manufacturing news in brief

By Kirsty Barnes


17/10/2007 - Microbix Biosystems, PacificGMP and Insulet have all recently announced new contract manufacturing news.

ALS Therapy Development Institute has forged a one-year manufacturing deal with Microbix Biosystems who will purify and characterise a series of adenoviruses for the research firm.

Adenoviruses are non-pathogenic viruses that can deliver specifically selected genes to key sites in the body or to cultured cells for therapeutic purposes and in this instance they will be created to carry therapies to sites of amyotrophic lateral sclerosis (ALS) pathology.

The firm will then use these adenoviruses in its research to discover a treatment for ALS, otherwise known as Lou Gehrig's disease - a progressive neuromuscular disease that attacks motor neurons in the brain and spinal cord and is largely fatal. Currently there is no cure or effective treatment for ALS.

"The production of high titer adenoviral constructs required for animal testing requires specialised manufacturing expertise that only recognised leaders in the field like Microbix can deliver," says Steve Perrin, chief scientific officer at ALS.

In other news, PacificGMP has been hired by BD Biosciences to create and store master and working cell banks and manufacture antibodies to good manufacturing practice (GMP) standards on its behalf.

Master and working cell banks are a two-level storage system of mammalian cells, which are used in the production of biopharmaceuticals. No terms of the deal were disclosed.

Recently Insulet announced a new arrangement to outsource the production of its insulin pump to contract engineering firm Flextronics International.

US-based Insulet called in for reinforcements after it was unable to make enough of the insulin devices, called Omnipod, to keep up with market demand.

There are only a few insulin pumps on the market, but the Omnipod device reportedly uses an advanced pump technology and is disposable and wireless, making it, according to some, cheaper and easier to use than competing products.

Meanwhile, Arbor Pharmaceuticals has announced that it has recruited Pharmaceutical Sciences Institute of North Carolina's Campbell University to help it develop a novel drug formulation for ear infections in children.

Arbor is a small specialty pharmaceutical company that focuses on paediatric drugs and this is to be the company's second product.

http://www.outsourcing-pharma.com/ne...-manufacturing