Nabi has received the approval letter from the Food and Drug Administration (FDA) to manufacture Nabi-HB [Hepatitis B Immune Globulin (Human)] in its biopharmaceutical manufacturing facility in Boca Raton, Florida.
"This approval letter completes the last major step in bringing the Boca Raton facility on-line and is a landmark event in Nabi's transition to becoming a vertically integrated biopharmaceutical company," said David J. Gury, Chairman, Chief Executive Officer and President of Nabi. "We can now directly control the quality and supply of Nabi-HB from the point of vaccinating donors and collecting plasma at our nine antibody collection centers, through fractionation and purification in our own manufacturing facility, and on to the marketing of the product through our sales force. Moreover, this event confirms that Nabi has both the capability and capacity to manufacture its current and pipeline antibody-based products for U.S. markets and eventually for markets world-wide."
In addition to the production of Nabi-HB, Nabi will continue to manufacture clinical lots of other immune globulin products at the Boca Raton facility, including the company's investigational therapeutics Altastaph and Civacir. When these products are approved for marketing, Nabi expects to use the Boca Raton facility for their commercial manufacture.
Nabi also announced that Douglas Waddell has joined the company as Senior Director, Therapeutics Manufacturing and is responsible for all aspects of the manufacturing of its specific antibody products. Mr. Waddell joins Nabi from Bayer Corporation where he most recently directed manufacturing operations at their Clayton, North Carolina fractionation facility. C. Thomas Johns, Nabi's Senior Vice President, Manufacturing Operations, commented, "Doug Waddell brings a wealth of knowledge and practical experience to Nabi as we begin commercial production of our own product. His expertise will be instrumental in assuring a reliable supply of Nabi's products for the patients who depend on them."
Nabi's Boca Raton manufacturing plant is a highly specialized facility. During the production of therapeutic antibody products, plasma, which has been screened and tested for viruses, is purified, processed and separated into components, or fractions. Nabi's facility was designed as a multi-product facility to be effective and efficient in producing specific antibody products used to treat or prevent diseases such as hepatitis and staphylococcal infections.
"During the construction period, regulatory oversight of plasma fractionation in the U.S. was intensified," commented Gury. "This is the first new plant of its kind in the U.S. to go through the approval process since the FDA implemented these more stringent requirements and inspection standards."
Based on receipt of the approval letter, Nabi will now begin depreciating the capitalized cost of the manufacturing facility. Initially the production of Nabi-HB will not fully utilize the plant's capacity. Earlier this year, Nabi announced a contract manufacturing agreement with Acambis that is expected to utilize some of the plant's excess capacity in 2002. Nabi is actively pursuing additional contract manufacturing opportunities to produce clinical and commercial lots of material for other companies, until production of its own products fully utilizes the plant 's capacity. The company expects to be successful in these efforts based on the industry-wide need for FDA licensed manufacturing facilities, and the number of plasma-based products in development which require the specialized manufacturing capabilities offered by Nabi.