mandy.jackson@informausa.com

Shire is expanding its regenerative medicine business with added production capacity for Dermagraft, its bio-engineered skin substitute for diabetic foot ulcers, and for future acquired assets with construction of a new 150,000-square-foot manufacturing facility for Advanced BioHealing, which it bought last year for $750 million (scripintelligence.com, 18 May 2011).

Advanced BioHealing leased 28 acres of land in the Sorrento Mesa area of San Diego from BioMed Realty Trust that could accommodate up to 800,000 square feet of office and manufacturing space for several hundred new employees, according to Kathy McGee, senior vice president of operations at Advanced BioHealing.

"Our long-term strategic growth plan involves an assessment of available clinical products that could allow for growth in the regenerative medicine field in the future. Our initial requirement for expanded capacity is to meet future growth for our lead product Dermagraft," Ms McGee said.

Advanced BioHealing will continue to manufacture Dermagraft at its existing 115,000-square-foot production facility in the Torrey Pines area near the University of California, San Diego. That operation has the capacity to meet the projected demand for Dermagraft into 2015.

Shire reported $48.8 million in Dermagraft sales for the first quarter of 2012, which was 10% more than Advanced BioHealing reported for the first three months of 2011.

"By 2015, we need to have expanded manufacturing capacity as well as the capacity to handle additional products as they become available," Ms McGee said.

Shire and Advanced BioHealing intend to pursue new indications and additional markets for Dermagraft, which was approved by the US FDA for diabetic foot ulcers lasting for more than six weeks in 2001. However, Shire said last year that it would no longer pursue a venous leg ulcer indication after Dermagraft failed to achieve the primary endpoint of complete healing required in Phase III testing by the FDA and the European Medicines Agency (scripintelligence.com, 25 August 2011).

But in terms of new assets, Ms McGee said Advanced BioHealing's expansion in San Diego also will support Phase II clinical development of Vascugel, an endothelial cell-based therapy for blood vessel repair meant to improve haemodialysis access for patients with end-stage renal disease. Shire announced its acquisition of substantially all assets owned by the investigational product's developer, Pervasis Therapeutics, in April (scripintelligence.com, 13 April 2012).

"As additional products and indications become available to us, we will have the ability to do a multi-phase expansion as we add assets into the portfolio," Ms McGee said of Advanced BioHealing's new campus in San Diego.

Joseph Panetta, president and CEO of the local biotechnology industry association Biocom, said Shire's decision to expand in San Diego shows that the region is ideal for companies that are making the transition from research and development to commercial operations. "The Southern California life sciences industry has been known for our innovation, and now we are starting to be known as a great place for companies to expand and stay in the long term," Mr Panetta said.

Advanced BioHealing expects to begin construction in Sorrento Mesa in 2013 with the first building slated to open in mid- to late-2014 with about the same number of employees as the Torrey Pines manufacturing operation, which has about 250 workers.