Biopol Allergy Immunotherapy Manufacturing Facility, Idaho, USA

Biopol Laboratory, which is a subsidiary of the ALK-Abelló Group – one of the largest producers of pharmaceuticals for allergy immunotherapy, is building a new manufacturing and research and development facility in Post Falls, Idaho, US.

The new facility is expected to occupy a 12.5-acre site in Riverbend Commerce Park, south of Interstate 90. The site will be the main office and the largest production site of raw materials for the company's allergy immunotherapy products.

With an initial investment of around $30m, the facility is expected to provide approximately 50 jobs when completed in 2009.

Miles Guralnick, president of Biopol Laboratories, commented on the project: "We are excited to be moving to this new dynamic region in Northern Idaho. Through the planning and design phases we have built very good relations with the Idaho and regional governments and business communities, and I expect these relations to develop into a mutually beneficial cooperation."

CURRENT FACILITIES

Biopol Laboratory, which has been producing immunotherapy drug compounds since 1977, currently operates out of five facilities in and around Spokane, Washington and has use of a 600-acre farm in Plummer, Idaho, just south of Kootenai County, where it grows a variety of grasses and other plants to produce pollens used as raw materials for allergy immunotherapy products.

The idea behind the new plant is to rationalise and centralise production of raw materials at one site to increase efficiency. Biopol will relocate its lab, offices, manufacturing facilities, and associated in-process and finished product warehouses to the new site. The new facility was planned in October 2006 and construction was started in July 2007.

COMPOUND PRODUCTION

The initial phase of construction for the plant will cover ALK-Abelló’s raw material needs for its immunotherapy tablets for grass and house dust mite allergies as well as some of the existing subcutaneous and sublingual immunotherapy products for the US and European markets.

A second phase is expected to include raw material for future products such as a tablet immunotherapy for ragweed pollen allergy which is currently in early clinical development in collaboration with ALK-Abell's US partner, Schering-Plough.

CONSTRUCTION

In July 2007 following permissions granted at city, county and state level, Integrated Project Services (IPS) broke ground for the new facility. IPS is providing design, product development and process engineering services and ensuring validation in accordance with latest cGMP and cGLP requirements.

The new facility will increase the production capacity for Biopol's products and will allow scale-up for production of its allergen source materials.

The site also includes new pollen and mite processing buildings, as well as energy efficiency for process and utility systems, odours / dust control systems and waste treatment.

Miles Guralnick said: "IPS is the perfect partner for Biopol. They have a high level of competency and the experience required for the detailed design of this bulk pharmaceutical facility… the Post Falls facility offers the additional space and increased capacity to enable us to continue to provide an uninterrupted supply of quality allergenic biological source materials. We look forward to a good collaboration and to a very successful project."

GRAZAX

Grazax is the first tablet-based sublingual immunotherapy treatment for grass pollen allergy to be developed for approval across Europe. The drug is currently involved in a special clinical trial called GT-08 for patients with a greater than two-year history of seasonal allergic rhinitis.

In June 2006 the GT-08 study made preliminary findings and reported highly significant results (P < 0.0001), with reduction in rhinoconjunctivitis symptoms (43%) and use of symptomatic medications (68%) from the very first day of the first grass pollen season with Grazax treatment compared with a placebo.

In addition, 82% of patients treated with Grazax responded to the treatment, a 49% increase compared with the placebo group. The study found that the treatment dramatically reduced rhinoconjunctivitis symptoms such as sneezing and eye and nose irritation and, importantly, most participants considered the treatment to be convenient.

Professor Dr Claus Bachert of the ENT Department, The University of Ghent commented: "We are very excited by these important results from GT-08. While symptomatic medications for treating the eye and nose symptoms of allergy are generally available to grass allergy sufferers everywhere, the accessibility to causal immunotherapy has been limited.

The widespread variations in the availability of specialist allergy services across Europe have limited access to effective treatment for grass allergy to only very few people with many waiting in line. With Grazax, we now have a treatment that can be quickly and simply administered at home by the patient."