Bayer HealthCare's New Sterile Fill Facility Receives EMEA, FDA Licenses

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Oct 2008 - 6:00 PDT

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The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer) for its new sterile filling facility (SFF) on its Berkeley, Calif. campus. The approval closely follows authorization already given by the U.S. Food and Drug Administration in August 2008. Together, these licenses from the regulatory bodies ensure this state-of-the-art facility is ready to support the supply of Bayer's Kogenate® FS/ KOGENATE® Bayer (Antihemophilic Factor [Recombinant]) line of products in its largest markets (U.S. and EU). The forward-looking technology and design of the new SFF represent a key investment by Bayer, already one of the top-10 biotech companies in the world, in further strengthening its bio-manufacturing operations on the West Coast of the United States. The facility will be utilized in the late-stage production processes of filling and lyophilization (freeze-drying) for Bayer's Kogenate® FS/ KOGENATE® Bayer line of products, a leading treatment for hemophilia A.

"These regulatory approvals for the Berkeley SFF represent a significant milestone for us and come at an opportune time given the continued expansion of the Kogenate product line in existing and new markets around the world," said Joerg Heidrich, Senior Vice President & Global Head of Product Supply Biotech, Bayer HealthCare. "As we look toward the future and the promise of true therapeutic advancements reflective of our strong product pipeline, it is crucial that our biotech facilities, infrastructure and processes are in line with the bold vision we have as an organization for developing therapeutic solutions for disease areas where there are still high unmet medical needs."

The 44,000 square foot SFF significantly increases the product output, or capacity, and supports larger lot sizes. It also features a new automated loading and unloading system (ALUS). The high level of automation within the facility further minimizes the risk of external contamination and provides even greater assurance of product quality, as it requires fewer personnel to operate. This capacity increase, product reproducibility and reliability will support the Kogenate product line's significant growth in several emerging markets.

"This facility is truly state-of-the-art, and represents the latest, most reliable freeze-drying technology available, launching us ahead of other SFF facilities on the U.S. West Coast," said Johannes Schweppenhaeuser, Director, Final Product Manufacturing, Bayer HealthCare Pharmaceuticals. Bayer is the second largest biotech employer in California's major biotech hub, the San Francisco Bay Area. "The high level of automation, in conjunction with Bayer's rigorous process standards, results not only in higher output, but most importantly, further risk reduction," continued Schweppenhaeuser. "The safety of our patients is a top priority, and any steps we take to further ensure the quality, safety and reliability of our products are of critical importance."

The increased capacity of the new SFF comes at a momentous time for Bayer as the company continues to expand its hemophilia portfolio with new development candidates in clinical trials. For example, Bayer is the only company with a long-acting recombinant Factor VIII product in late-stage clinical trials. Kogenate formulated with liposomes is currently in Phase II clinical development and may represent a true breakthrough for the hemophilia community by allowing once-weekly infusions in prophylaxis. Bayer is preparing Phase I clinical trials with its recently-acquired recombinant Factor VIIa for treating patients who develop inhibitors to FVIII and FIX treatment.

Bayer continues licensure activities for the SFF to ensure it can supply product for all markets of the world. Regulatory agencies from Canada and other countries are in the final stages of inspections and application reviews. Pending these additional approvals, Kogenate products will continue to be manufactured at the existing approved filling and freeze-drying facility on the Berkeley, Calif. campus.

About Kogenate® FS

Kogenate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage. The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials (frequency ≥ 4% of patients) were skin associated hypersensitivity reactions (rash, pruritus, urticaria), inhibitor formation in previously untreated or minimally treated patients, infusion site reactions, and central venous access device (CVAD) line-associated infections.

Kogenate FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

Please see the full prescribing information for important risk and use information at http://www.kogenatefs.com.

About Hemophilia A

Hemophilia A, also known as factor VIII deficiency or classic hemophilia is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is the most common type of hemophilia and is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately 400,000 people around the world have hemophilia A.

About Bayer HealthCare LLC

Bayer HealthCare LLC is an affiliate of Bayer HealthCare AG. Bayer HealthCare AG is one of the world's leading, innovative companies in the healthcare and medical products industry, and based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology, Primary Care, and Specialty Medicine, which includes Hematology, Oncology, and Multiple Sclerosis. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.

Bayer HealthCare Pharmaceuticals is the second largest biotechnology employer in the San Francisco Bay Area. Currently, more than 2000 people dedicated to every field of biotechnology, including research, clinical and process development, manufacturing and commercialization work at the Bayer HealthCare Pharmaceuticals facilities in Berkeley, Emeryville, and Richmond, California and Seattle, Washington. http://www.bayer.com

Forward-looking statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports filed with the Frankfurt Stock Exchange. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Source
Sreejit Mohan
Director, Public Policy & Communications
Bayer HealthCare LLC
and
Cathy Keck Anderson
Deputy Director, Public Policy & Communications
http://www.bayer.com

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