Medical technology firm Smith & Nephew plc, of London, picked up Fort Worth, Texas-based cell therapy company Healthpoint Biotherapeutics for $782 million in cash. Healthpoint markets Collagenase Santyl ointment, and has a cell therapy product, HP802-247, in Phase III testing for wound healing.
Healthpoint's prior Phase IIb trial, published in The Lancet, showed the product achieved 83 percent wound closure in patients with venous leg ulcers. The product was also well tolerated, with adverse events including skin ulcers, cellulitis, wound infections and skin irritation.
Speaking in an investor conference Wednesday morning, Smith & Nephew CEO Olivier Bohuon emphasized the importance of biologics to the company's growing business. "As a leader in the wound market, we must also be a leader in the area of bioactives," Bohuon said.
Healthpoint earned $200 million in net revenue in 2012 from products including its Collagenase Santyl Ointment Oasis Wound Matrix, Oasis Ultra Tri-Layer Matrix and Regranex (becaplermin) Gel 0.01 percent.
Smith & Nephew is a global medical technology business with an interest in orthopedics reconstruction, wound care, sports medicine and trauma.
Bohuon said the acquisition of Healthpoint would give Smith & Nephew a strong position in the use of bioactive products for wound management, and would complement its existing wound care portfolio, which includes Allevyn wound dressing, Cica-Care silicone gel sheet, Secura preventive skin care and a negative pressure wound therapy device, among others.
The company has been very active within the past year in the wound care and biologics space. In May, it acquired device company Kalypto Medical Inc., which was developing a portable, ambulatory negative pressure wound therapy system.
Earlier this year, Smith & Nephew launched a joint venture with Essex Woodlands to spin out its orthopedic biologics division into a company focusing on drugs and devices. That venture became Bioventus LLC, of Durham, N.C.
Roger Teasdale, president of advanced wound management for Smith & Nephew, noted that the market for bioactive products in wound care is growing rapidly, compared to traditional wound therapies.
Between 2006 and 2010, the traditional wound therapy market grew 6.5 percent. "Bioactive therapies grew over 50 percent," Teasdale said.
Healthpoint's Santyl is a collagenase debrider in a petroleum base. "We've seen strong growth of the Santyl brand," Teasdale said. "It's the sole reimbursed enzymatic debrider."
Teasdale also saw growth potential in Healthpoint's Oasis Ultra, a natural extracellular matrix derived from porcine small intestinal submucosa. The product promotes angiogenesis by incorporating three layers of tissue into the wound.
Smith & Nephew also will be gaining Regranex Gel (becaplermin), a product Healthpoint acquired from Systagenix in 2011. It is marketed for diabetic foot ulcers.
The acquisition gives Smith & Nephew a firm foothold in North America, expanding its operations and personnel beyond its European home base.
Its U.S. sales force will grow from 260 to more than 700 reps, Teasdale said.
Smith & Nephew said it intends to continue investing, optimizing its joint capabilities in North America and elsewhere in the world, and it expects some revenue synergies.
Adrian Hennah, chief financial officer for Smith & Nephew, said the $782 million transaction would be "broadly neutral by 2015 and accretive thereafter."
That is largely due to Healthpoint's marketed products, especially Santyl. Smith & Nephew attributed only modest value to the existing pipeline in its formal financial evaluation, but less formally, the company said it believes HP802-247 could be a very profitable product.
Healthpoint began a Phase III trial of HP802-247 in September 2012. The trial is expected to enroll 440 subjects over the age of 18 who have had venous leg ulcers for at least six weeks, but not more than 24 months. (See BioWorld Today, Sept. 12, 2012.)
Participants will receive HP802-247 or placebo every 14 days. The product is a fibrinogen and thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts derived from neonatal foreskins. It has two parts: one with fibrinogen, and the other with thrombin and the cells.
When the two products are combined, they form a gel and sequester the cells on the surface of the wound. There, the cells secrete endogenous growth factors that promote healing.
Venous leg ulcers affect about 2.5 million in the U.S., and typically require a prolonged course of treatment, frequently complicated by setbacks.
Previous in vitro studies showed that HP802-247 releases growth factors and cytokines into the wound, which are thought to interact with the patient's cells to stimulate wound healing.
The product faces little competition in the marketplace. Dermagraft (human fibroblast-derived dermal substitute, Shire plc) was developed by Advanced Biohealing Inc. for diabetic foot ulcers, but it failed to show superiority to compression therapy for venous leg ulcers, and as a result is not approved for that indication.
Apligraf, by Organogenesis Inc. is approved for venous ulcers and diabetic foot ulcers.