Advanced BioHealing

Overview

Advanced BioHealing, Inc., a Shire company, specializes in the development and commercialization of life-altering regenerative medicine therapies. Advanced BioHealing currently manufactures and markets Dermagraft®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers, which assists in restoring damaged tissue and supports the body’s natural healing process.

History

Advanced BioHealing was founded in 2004 to develop and commercialize bioengineered tissue products. By 2005, the Company had raised two rounds of venture financing totaling $10.4 million to help fund product development.

In May 2006, Advanced BioHealing purchased the global rights to two cell-based products—Dermagraft and TransCyte—from U.K. based Smith & Nephew. Both products were already approved by the FDA for sale in the U.S.—Dermagraft for the treatment of diabetic foot ulcers, and TransCyte for the treatment of certain types of severe burns. While the two products provided Advanced BioHealing with an “instant” commercial opportunity, manufacturing and promotion of both Dermagraft and TransCyte had already been ceased.

Over the next nine months, Advanced BioHealing renovated and revalidated the original 70,000 square-foot manufacturing facility in La Jolla, California, and reinitiated manufacturing of Dermagraft. When operating at maximum capacity, this state-of the-art manufacturing facility can produce over 300,000 units of Dermagraft per year.

The Company shipped the first pieces of Advanced BioHealing-manufactured Dermagraft to U.S. customers on February 15, 2007.

Also in the first quarter of 2007, Advanced BioHealing finalized a Series C round of financing composed of $30 million in venture investment and $10 million in venture debt.

Since then, Advanced BioHealing has built a fully integrated, profitable regenerative medicine company marketing an FDA-approved living cell therapy with a dedicated sales force, scalable cell-based manufacturing, and established reimbursement.

In 2009, the Company initiated an ongoing multi-national pivotal trial of Dermagraft in patients with venous leg ulcers (VLUs) to assess the therapy’s safety and efficacy in the treatment of VLUs. The trial was completed in August 2011, and following preliminary analysis of the top-line results, the decision was made not to pursue the VLU indication.

On May 17, 2011, Shire Pharmaceuticals announced the acquisition of Advanced BioHealing. The deal, which made Advanced BioHealing the regenerative medicine business of Shire, closed on June 28, 2011.

In addition to the Company’s office, manufacturing and laboratory space in La Jolla, the Company also has its corporate headquarters in Westport, Connecticut, and office and laboratory space in Brentwood, Tennessee.

IMPORTANT SAFETY INFORMATION ABOUT DERMAGRAFT®

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Refer to Dermagraft Directions for Use for more information. Results may vary and not all patients will achieve complete wound closure with Dermagraft. In the pivotal trial, a 64% relative increase in complete wound closure was seen in the Dermagraft-treated patients; 30.0% of Dermagraft and 18.3% of conventional therapy patients achieved complete wound closure at 12 weeks. The most frequently reported adverse events experienced by patients in the Dermagraft group (terms ≥ 5%) included infection, accidental injury, skin dysfunction/blister, flu syndrome, osteomyelitis, surgeries involving study ulcer, wound enlargement/skin ulcer, cellulitis and peripheral edema/localized swelling. These adverse events were similar to those seen in the control group.

Important Safety Information About TransCyte®

TransCyte is indicated for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such as a covering prior to autograft placement.  TransCyte is also indicated for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. Results may vary with TransCyte and not all patients will achieve similar outcomes. In the pivotal trial, wounds treated with TransCyte were equivalent to or better than control (cryopreserved cadaveric allograft) with respect to mean percent take of the autograft at post autograft Day 14 (p=0.0001).  Mean percent take of 94.7% in TransCyte wounds was numerically higher than the 93.1% mean take in control wounds. The most frequently reported adverse events in the TransCyte group (terms ≥ 10%) included sepsis, pneumonia, respiratory disorder, infection not involving study wound, urinary tract infection, infection, death, pneumothorax, dyspnea, kidney failure and hyperglycemia.  These events are common in populations of the critically-ill burn patients and were not deemed related to TransCyte. One possibly related adverse event was reported: a study wound site-specific infection.  The infection was diagnosed by culture at the time of TransCyte removal with no clinical evidence of infection. Refer to TransCyte Directions for Use for more information.