Dublin, Ireland – May 17, 2011 –

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has signed an agreement to acquire Advanced BioHealing, Inc.

• Creation of a new strategic platform based on tissue regeneration using cell-based therapies complements Shire’s existing specialty focus and biologics manufacturing capability
• Strong strategic fit with ShireHigh medical need for symptomatic condition in growing and under-penetrated market, served by specialist physicians-A leading US marketed product for diabetic foot ulcers (DFUs)-Small specialised commercial team with a strong focus on customers and patients-Delivers value through satisfying high patient need
• Purchase price of $750 million in cash, financed from Shire’s existing cash resources
  -Closing of the transaction is subject to customary conditions, including obtaining anti-trust clearances
• Adds DERMAGRAFT to Shire portfolio – attractive US marketed product with further growth potential
  -A regenerative bio-engineered skin substitute indicated for use in the treatment of diabetic foot ulcers greater than six weeks in duration
  -Already achieved 5% patient share of the potential $3 billion slow healing DFU market; $146 million in US sales in 2010
  -Slow healing DFUs affect nearly 538,000(7) people annually in the US
  -Favorable reimbursement profile
  -Significant cost of not treating DFU effectively
  -Further growth prospects through potential expanded indication for Venous Leg Ulcers (VLU)
  -High regulatory, development and manufacturing hurdles for potential competitors
• Combines Advanced BioHealing’s world-class experience and commercial capability in regenerative medicine with Shire’s strengths and expertise in human cell biological manufacturing
• Opportunity to invest in and build
  -Leverage Shire’s biological manufacturing expertise to improve Advanced BioHealing’s manufacturing efficiency and expanding capacity
  -Improve disease awareness and prompt earlier medical intervention
  -Enhance Advanced BioHealing’s already impressive commercial success with Shire’s commercialisation expertise and international infrastructure
  Platform to potentially acquire additional regenerative medicine assets
• Value and growth enhancing. Shire confirms that its business continues to perform well.  Due to the modest short term financial effect of the acquisition this year, there will be no impact to our previously stated guidance for 2011

Mike Cola, President of Shire’s Specialty Pharmaceuticals business comments:

“This acquisition is a strong and complementary strategic fit for Shire.  We will invest in the strengths of Advanced BioHealing’s specialist commercial team, its manufacturing and its product development.  The potential to build on the success of DERMAGRAFT is attractive; it’s already a leading product providing a solution for a common complication suffered by diabetics in the US that, if not treated effectively, can lead to lower limb amputation and high cost to patients and society.  We believe there’s an opportunity to create more value from DERMAGRAFT and Advanced BioHealing’s proprietary technology and that with Advanced BioHealing’s team joining Shire, we can build Advanced BioHealing into an exciting new business providing regenerative medicine for patients’ unmet needs.”

Kevin Rakin, Chief Executive Officer of Advanced BioHealing, who will continue to lead this business within the Shire organization, comments:

“This is a very exciting opportunity for all of us at Advanced BioHealing to develop the business and deliver continued growth within a new environment that is highly complementary and will provide great leverage for us. We all look forward to being part of Shire.”

Strategic Rationale for the Transaction

Acquiring Advanced BioHealing brings both a US marketed product with opportunity for further growth and world-class expertise in regenerative medicine, enabling Shire to establish a new strategic business unit.

DERMAGRAFT treats a symptomatic condition, DFU, with a high level of medical need.  There are 538,000⁽⁷⁾ cases of slow healing DFU annually in the US. The condition is treated by specialist physicians (Shire’s core focus) in wound care centers, select physicians’ offices, Veteran Affairs (VA) Medical centers and clinics.

The World Health Organisation estimates an increase in incidence of diabetes of 43% in North America and 55% worldwide from 2007-2025 which could positively affect DERMAGRAFT growth prospects since diabetic patients have a 15%-25% lifetime risk of developing a DFU^(8,9).

DERMAGRAFT is a leading treatment in the slow healing segment of the DFU market and currently has a 5% share of that potential $3 billion market.

DERMAGRAFT has a strong value proposition to patients, physicians and payers; there are approximately 65,000⁽¹⁾ non-traumatic lower limb amputations in the US performed in people with diabetes annually. Comprehensive foot care programs that include foot-care education and preventive therapy, treatment of foot problems, and referral to specialists, can reduce amputation rates by 45% to 85%⁽¹⁾.

DERMAGRAFT has a favorable reimbursement profile, with Medicare (100% coverage), more than 1,000 private plans, the Veteran’s Administration, and numerous Medicaid programs.

Generic or similar products to DERMAGRAFT would have to overcome high regulatory, development and manufacturing hurdles, including the performance of long, costly clinical trials, to enter the DFU market.

Shire and Advanced BioHealing believe there is potential to improve disease awareness and prompt earlier medical intervention. Shire will seek to build on Advanced BioHealing’s already impressive commercial success with Shire’s commercialisation expertise and international infrastructure.

With the acquisition Shire will own the global rights for DERMAGRAFT and will continue to invest in the development of new indications and new geographies, pending regulatory approvals.

Advanced BioHealing has fully enrolled multi-national trials (in US, Germany, Poland, Sweden, UK, Estonia and South Africa) to investigate DERMAGRAFT for the treatment of Venous Leg Ulcers (VLUs); data is due in Q4 this year with anticipated US filing in Q1 2012. In the U.S., VLUs account for the loss of 2 million working days and nearly $3 billion in treatment costs each year. Duration of treatment can last over a year in many cases, and frequently involves the use of significant healthcare resources, resulting in substantial costs for the U.S. healthcare system⁽²⁾.

DERMAGRAFT is approved but not yet marketed for DFU in Israel, S. Africa, and Singapore. An application was filed in Canada for DFU in March, 2011; undergoing dual review by both the biologics and medical device divisions.  Advanced BioHealing’s ongoing or planned submissions for DFU include Mexico, Saudi Arabia, United Arab Emirates and Malaysia.

About Advanced BioHealing

Advanced BioHealing is a privately held leading regenerative medicine company that develops, manufactures and commercializes living cell-based therapies for regenerative medicine.  Advanced BioHealing has over 400 full time employees based in the US, including an in-house commercial team of over 150 professionals comprising sales, marketing, reimbursement and policy professionals with backgrounds in the pharmaceutical, medical device and biotechnology industries.  The company, like Shire, focuses its small sales team on specialist physicians.

Shire intends to retain Advanced BioHealing’s expertise and to invest in building upon its world-class talent base to drive further value creation. The Advanced BioHealing business will become part of Shire’s Specialty Pharmaceuticals business, led by Mike Cola, and will leverage biologic manufacturing expertise from Shire’s Human Genetic Therapies business.

Advanced BioHealing has operations on three sites in the US: a manufacturing facility in La Jolla, California, corporate offices in Westport, Connecticut and research laboratories in Brentwood, Tennessee. In order to meet future demand, Advanced BioHealing, under Shire’s ownership, plans to expand its existing manufacturing capability and Shire will supplement Advanced BioHealing’s current manufacturing functions with Shire’s manufacturing process and quality assurance expertise.

About DERMAGRAFT

DERMAGRAFT is a regenerative bio-engineered skin substitute that assists in restoring damaged tissue.

DERMAGRAFT is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks in duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.  DERMAGRAFT should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot⁽⁶⁾.

DERMAGRAFT consists of living cells and a bio absorbable mesh scaffold. It is designed to stimulate healing in two ways: firstly, its mesh material is gradually absorbed and the human cells grow into place and replace the damaged skin and secondly, the living cells in DERMAGRAFT produce many of the same proteins and growth factors found in healthy skin, which help replace and rebuild the damaged tissue in the DFU.

Data from Advanced BioHealing’s 2001 pivotal clinical trial demonstrated that the weekly application of DERMAGRAFT and conventional therapy for up to eight weeks increased the proportion of DFUs of greater than six weeks duration that achieved 100% closure at 12 weeks by 64%, a statistically significant improvement, when compared to conventional therapy alone.

DERMAGRAFT is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus grafts, and in patients with known hypersensitivity to bovine products as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution. Adverse events observed in clinical trial included wound infection, osteomyelitis, and cellulitis⁽⁶⁾.

About Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs)

DFUs are open sores or ulcers on the feet that can occur in people with diabetes as a result of peripheral neuropathy, or damage to nerves, and can severely compromise a patient’s quality of life. Diabetic patients have a 15%-25% lifetime risk of developing a DFU^(8,9).

VLUs are common in patients with a history of leg swelling, varicose veins, or a history of blood clots in either the superficial or the deep veins of the legs. VLUs affect 500,000 to 600,000 people in the United States every year and account for 80 to 90 percent of all leg ulcers⁽¹⁰⁾.They are treated in the same wound center and hospital locations as patients with DFU.

Closing of the transaction is subject to customary conditions, including obtaining anti-trust clearances.

Barclays Capital is acting as financial adviser to Shire.
BofA Merrill Lynch acted as financial adviser to Advanced BioHealing, Inc.

For further information please contact:

Investor Relations
Eric Rojas (erojas@shire.com)
+1 781 482 0999

Sarah Elton-Farr (seltonfarr@shire.com)
+44 1256 894157

Media
Jessica Mann (jmann@shire.com)
+44 1256 894 280

Matthew Cabrey (mcabrey@shire.com)
+1 484 595 8248

Notes to editors

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

References

⁽¹⁾ Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
⁽²⁾ Drug Discovery & Development, Nexagon Greatly Reduces Venous Leg Ulcer Size, July 13, 2010.
⁽³⁾ Lavery, et al. Evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes management cohort. Diabetes Care. 2006;26:1435-1438.
⁽⁴⁾ Ramsey et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22:382–387.
⁽⁵⁾ Diabetic Foot Ulcer (DFU) Therapeutics – Pipeline Assessment and Market Forecasts to 2017, GlobalData, April 2011.
⁽⁶⁾ DERMAGRAFT Prescribing Information.
⁽⁷⁾ Margolis, et al. Diabetic healing of neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999; 22(5):692-695.
⁽⁸⁾ Sanders LJ. Diabetes mellitus: prevention of amputation. J Am Podiatric Assoc. 1994;84:322-328.
⁽⁹⁾ Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217-28.
⁽¹⁰⁾ Cleveland Clinic website, Lower Extremity (Foot and Leg) Ulcers.

His father, a diabetic, had a foot ulcer that resulted in the amputation of his left leg, which contributed to his death, his son said.

“He became a statistic,” Schwegman said. “He was one of the 50% of people that died within five years after having an amputation.”

Diabetic foot ulcers, or DFUs, are usually located on the ball of the foot, the bottom of the big toe or sides of the feet. They can be a result of neuropathy, or nerve damage which leads to a loss of feeling.

Although prevention is key, simply not treating an ulcer can lead to infection, particularly in the bone, and eventual loss of a limb.

“If you have a DFU that leads to a major amputation, your risk of death in five years is greater is higher than that of breast cancer and prostate cancer combined,” Schwegman said.

“This is a very, very serious health problem that has very serious risks if not dealt with properly and quickly,” the doctor said. “In order to do that, we really need to get the word out to both the patients and the physicians.”

That’s where the Save a Leg, Save a Life Foundation , or SALSAL, comes in. On Saturday, Schwegman, along with the Atlanta chapter of the national group, are offering free foot screenings as part of the American Diabetes Association’s Health Expo.

You can find an expo near you by visiting the American Diabetes Association’s calendar for 2011. Diabetics can be screened for cuts, blisters, discoloration of feet, and any signs of bacteria or infections, conditions that can lead to foot ulcers.

Right now, 18.8 million adults and children in the U.S. have diabetes. The Centers for Disease Control and Prevention estimates that 7 million people have undiagnosed diabetes and 79 million are prediabetic.

Diabetics need to know that treating the ulcer early is the best way to get  it healed.

“If we’re not treating them aggressively, the chances that they heal is actually very, very low,” Schwegman said.

An important part of the evaluation of a person with a diabetic foot ulcer is a thorough vascular exam, since diabetics have a higher risk of having peripheral arterial disease. The condition results when circulation to the legs and feet is blocked or narrowed by calcifications. The poor blood flow can cause pain and discoloration in the feet- an increase in a red color, a dusky bluish color or sometimes the toes turn black and result in amputation.

Dr. Desmond Bell, a wound care specialist and founder of SALSAL, recommends going straight to a podiatrist or wound care specialist if a cut, sore or wound does not heal in a week or two. Those with a history of diabetic foot ulcers should see a specialist immediately.

Bell said several newer treatments are available to treat these wounds. None are a “silver bullet” for every single wound.

SALSAL hopes to educate both physicians and the general public about them in order to prevent unnecessary amputations. Of the thousands of products available, only these three have evidence that they have increased wound healing rates:

-Advanced skin cell substitutes include Dermagraft and Apligraf. These are similar in that they are derived from neonatal foreskins.
-A growth factor gel, Regranex.

Hyperbaric oxygen therapy can also heal wounds and treat infections.

Most exciting, Bell said, is peripheral revascularization, in which cardiologists and others, go into the groin similar to an angioplasty for the heart. Through this new procedure, doctors can open up blockages in the leg and restore blood flow.

“It requires lots of doctors often times and it requires a motivated patient,” Schwegman said. “By saving their leg, it really does save their life.”

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Today’s Wound Clinic (TWC): When was your company founded and where is the company located?
Dean Tozer (DT): Advanced BioHealing was founded in 2003. The company maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Brentwood, Tenn.

TWC: How long have you personally been in the wound care section of healthcare and how did you get into this area of specialty?
DT: Over the past 20 years, I have been involved with the design and execution of global development and commercial strategies for pharmaceutical, molecular diagnostic, and biomedical device product portfolios. My involvement in the wound care section of healthcare began about five years ago when ABH was looking to acquire the assets to Dermagraft® from Smith and Nephew. Canaan Partners, who were early investors in ABH, brought me in to assist with the due diligence. Upon researching Dermagraft and the potential market, I found that the product was based on strong science, it addressed a significant unmet medical need, and although it hadn’t been successfully commercialized, it looked like an interesting business opportunity. That’s when I decided to join ABH as an executive and subsequently helped lead the reintroduction of Dermagraft into the U.S. wound care market.

TWC: What do you find most rewarding about providing products to medical directors and wound care clinicians?
DT: To patients who face amputation if their diabetic foot ulcer doesn’t heal, advanced therapies like Dermagraft, can provide hope during the treatment process. We continually see diabetic foot ulcers that make tremendous progress in wound closure after just two to three applications of Dermagraft. It’s pretty amazing when a patient comes back a week after their Dermagraft application and the physician or nurse takes off the wound dressing. Many times you can literally see the healing occur in front of your eyes. We believe Dermagraft is helping the body regenerate the cells that surround the edge of the wound bed and allowing those cells to start filling in over this temporary dermis, which is what Dermagraft is. With Dermagraft, we are making a huge impact on people’s lives. This approach to healing wounds is a prime example of the potential of the emerging field regenerative medicine.

TWC: How many different types/series of products do you make? Please list your most popular ones.
DT: Advanced BioHealing markets and manufactures Dermagraft, a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioresorbable scaffold. Dermagraft is approved by the FDA and is indicated for use in the treatment of full-thickness diabetic foot ulcers. It has been applied more than 250,000 times in over 1,000 wound care centers and outpatient clinics nationwide.

TWC: What would you say makes your company unique in the wound care setting?
DT: One of our company’s most distinguishing factors is that we manufacture and market Dermagraft, an advanced wound care product that contains living human fibroblast cells. Dermagraft incorporates patented technology that was developed through many years of research, and it is a safe and effective bio-engineered skin substitute that heals diabetic foot ulcers faster than standard treatment. Advanced BioHealing is one of a few companies in healthcare, not just wound care, that are successfully providing cell-based therapies to physicians and patients.

TWC: Please tell our readers something about your company that they may not know?
DT: Advanced BioHealing is dedicated to supporting clinicians and patients by raising awareness about diabetic foot ulcers—one of the most common and most serious co-morbidities of diabetes—and aims to help the thousands of people across the nation who are at risk of developing this condition.
In an effort to do so, Advanced BioHealing developed Heal2gether, a community health education program, to provide patients and their families with the resources they need to understand diabetic foot ulcers, why they need to take special care of their feet, how to identify the early warning signs, and how to prevent them in the future.

TWC: Please describe the mission/vision of your company in wound care and any of your goals that you would like to highlight.
DT: Our grand vision is to become a global leader in the field of regenerative medicine. To accomplish this goal, Advanced BioHealing is focused on developing and commercializing living cell-based therapies that repair damaged human tissue and enable the body to heal itself.
Specifically with regard to diabetic foot ulcers, Advanced BioHealing is committed to producing and distributing Dermagraft, a breakthrough product for this debilitating condition—an underserved market for which we believe we haven’t even begun to tap the potential. The company will continue to concentrate on commercialization, and leveraging its expertise in the manufacturing, reimbursement and sales and marketing of living cell-based therapies to expand Dermagraft into additional indications and geographies. Clinical trials for a potential venous leg ulcer indication are currently underway.
&nbspOverall, the company is dedicated to the business of science, which not only enabled the company to identify, re-introduce to market and commercialize Dermagraft, but also outlines an approach and discipline for evaluating future opportunities to expand its role as one of the premier regenerative medicine companies in the world.

TWC: Looking ahead, what are some things that the company is working on for 2011 and beyond?
DT: The number of patients with diabetic foot ulcers is expected to grow as the number of people with diabetes increases worldwide.
Advanced BioHealing plans to maintain its sharp focus on expanding the market for Dermagraft through penetrating the underserved diabetic foot ulcer market. In addition, Dermagraft is currently the focus of an ongoing pivotal trial to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers.

TWC: Do you have any advice for clinicians who are unsure about what products/services are best for their wound care clinic?
DT: As many clinicians know, if not treated properly, diabetic foot ulcers can result in serious complications, including amputation. Given the severity of this condition, doctors and nurses trained as wound care specialists and other experts within the field of wound care are advocating for the use of evidence-based medicine. Advanced
BioHealing is committed to advancing the standard of care for the treatment of diabetic foot uclers, and advises clinicians to adopt advanced therapies to accelerate wound healing and decrease complications in non-healing wounds. Advanced therapies include living skin equivalents, like Dermagraft; topical gels, hyperbaric oxygen therapy, and negative pressure wound therapy.
Each wound is unique and clinicians have a lot of different options in products/services. By taking an evidence-based approach to wound healing and using clinically proven advanced therapies, they will have the best chance of helping their patients to close their chronic wounds.

TWC: How can wound care clinicians get in touch with a representative to learn more about your company and products?
DT: Wound care clinicians can learn more by visiting www.dermagraft.com or by calling our customer service department at 1.877.DERMAGRAFT (337.6247).

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Given those drivers, it’s no surprise that the regenerative medicine session of Biotech Showcase™ 2011 in San Francisco attracted an overflow crowd.

Alan Trounson, Chairman of the California Institute for Regenerative Medicine concurred, citing promising results in diabetes, cancer, neurodegenerative disease and other conditions. He admitted, however, that much of the work is in early clinical trials. “In animal studies, we have a cure for HIV,” he said. “In diabetes, we expect to file an IND application in about two years.”“People view regenerative medicine as a far-off objective, but that is not true. There’s a tremendous amount of ongoing work,” noted Gil Van Bokkelen, Chairman and CEO of Athersys, and Chairman of the Alliance for Regenerative Medicine.

The goal for Richard Insel, CSO of the Juvenile Diabetes Research Foundation, is to find a cure for diabetes by accelerating discovery and development. The Foundation is funding projects to restore beta cell function, either by transplanting encapsulated stem cells, or alternatively, by regenerating the beta cells in the hosts themselves. He reported that one of the programs the Foundation supports is producing beta cells at the same rate as mature cells, and this is reversing diabetes.

Geron focuses on embryonic stem cells and, according to Tom Okarma, President and CEO, “We have robust animal data for glial cells, cardiomyocytes, dendritic cells, etc.” For example,  GRNOPC1, a potential therapy for spinal cord injury, is in human trials where it has induced new blood vessels and myelination, and improved locomotor activity. The progenitor cells expand ten to fifteen fold in animal models, and migrate. “They’ve been injected up to two weeks after the initial injury,” he pointed out.

To recoup the USD 45 million spent to generate the data for an IND involving six animals, Okarma said Geron will expand this platform for Alzheimer’s disease and thrombotic stroke applications.

Advanced BioHealing has launched perhaps the largest trial ever for venous leg ulcers, involving 500 patients in seven countries, Dean Tozer, Senior VP, said. His technology relies upon seeding neonatal fibroblasts onto biodegradable scaffolds. It also applies to diabetic foot ulcers.

Chris Calhoun, CEO of Cytori Therapeutics, reported on the regenerative potential of using stem cells from fat tissues to reconstruct breasts after lumpectomies. “With three needle sticks, we can reconstruct the breast in one hour,” restoring normal appearance to a situation not otherwise served.The question broached by Mark Monane, Managing Director of Equity Research Biotechnology and Life Sciences at Needham & Company, was, “What are we getting?” Despite new therapies and even a few blockbusters, “There’s a less than optimal return on investment,” he concluded.

That said, “One of every three patients could be helped by regenerative medicine,” Monane continued. Therefore, to increase the potential return, he advised companies to develop and leverage platforms to reduce the risk and thereby attract investors. “Regenerative medicine companies are founded on hope, but Wall Street wants deliverables.”

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From January 2003 until December 2009, O’Boyle served as the CFO of NuVasive Inc., a medical device company focused on spinal applications, which completed its initial public offering in May 2004.

ABH develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. It maintains its corporate office in Westport, Conn., with additional sites in La Jolla, Calif., and Nashville, Tenn.

ABH has grown revenue from zero in 2006 to more than $130 million in 2010 and employs more than 350 professionals, the company said in a news release. The company attributes the growth to growing demand for its FDA-approved product Dermagraft for the treatment of diabetic foot ulcers.

Kevin C. O’Boyle has been senior vice president and CFO for Advanced BioHealing Inc., which opened and office and lab space in Brentwood earlier this year. The company is trying to expand the market for Demragraft, a synthetic skin graft which is used to treat diabetic foot ulcers.

“Kevin has an outstanding track record as CFO of companies executing high-growth strategies, focused on both organic and external opportunities, and accessing the equity markets,” said KevinRakin, Chairman and Chief Executive Officer for ABH.

ABH has grown revenue from zero in 2006 to over $130 million in 2010 and today employs more than 350 professionals. These strong results are based on growing demand for its FDA-approved product Dermagraft for the treatment of diabetic foot ulcers.

“I am excited about joining the exceptional team at Advanced BioHealing,” said O’Boyle. “Advanced BioHealing is a well-established leader in the field of regenerative medicine with the ability to improve patient lives with its cell-based therapy. I look forward to bringing my leadership experience to the company as it moves into its next phase of commercial growth.”

O’Boyle has 15 years experience in the healthcare industry. From January 2003 until December 2009, O’Boyle served as the Chief Financial Officer of NuVasive, Inc., a medical device company focused on spinal applications, which completed its initial public offering in May 2004. He joined NuVasive when it had less than $30 million in annual revenue and was a key member of the management team that grew the business to more than $400 million in annual revenue.

Prior to that time, O’Boyle served in various positions during his six years with ChromaVision Medical Systems, Inc., a publicly-held medical device company specializing in the oncology market, including as its Chief Financial Officer and Chief Operating Officer. O’Boyle currently serves on the boards of GenMark Diagnostics, Inc., a publicly traded molecular diagnostics company, and Tornier, BV, a privatelyheld global orthopedics company.

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Exact regulations governing the manufacture of a convergent technology — or “combination product” — such as a biologic and delivery device depend on the primary designation applied to that product by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Different regulatory agencies have different requirements, so companies must establish manufacturing processes that comply with the strictest regulations for which they intend to seek approval.

A Few Examples

The Dermagraft bioengineered skin substitute, for example, consists of human fibroblast cells embedded in a bioabsorbable mesh for the treatment of diabetic foot ulcers. It is regulated by the FDA as a medical device, reimbursed by the Centers for Medicare and Medicaid Services as a biologic, and would be regulated by the EMEA as an advanced therapy medicinal product. The product’s manufacturer must adhere to all applicable device and biologic standards and regulations. Doing so can pose a challenge, especially when companies try to define what requirements are applicable.

Another example is the INFUSE bone graft, which consists of a recombinant version of a naturally occurring protein (BMP-2) that is combined with a collagen-based carrier for delivery. It is approved for use in multiple indications including spine fusion, treatment of open tibia fractures, and certain oral and maxillofacial applications. Although BMP-2 is a protein biologic, combining it with a collagen sponge requires regulation as a medical device.

Drug-eluting stents are a type of device–drug combination that has had a profound impact on the practice of medicine. Regulated as medical devices, they provide an immediate mechanical benefit through placement of a stent to help keep coronary arteries open following an angioplasty procedure. The drug component that’s coated onto the stent helps prevent restenosis from occurring in the months following such a procedure.

Do Your Homework

To fulfill conflicting requirements on such complex products, development companies must not only comply with regulations governing safety and efficacy, but also the vast array of regulations covering product manufacturing, packaging, facility validation, consistency and safety of materials, sterility of the product, and (where appropriate) sterilization and viral inactivation procedures.

Regulatory requirements for manufacturing can vary greatly among international regulatory agencies. As such, guidelines that meet one agency’s requirements may be insufficient for another’s. Thus, it is essential to cultivate an early understanding of the regulatory requirements for all potential markets in which a product may be sold. Because the regulatory environment is ever changing and requirements are increasingly stringent, it is critical for combination product manufacturers to continuously assess their manufacturing processes and accreditations to ensure that they remain in compliance with current regulations.

To demonstrate compliance with different regulatory agencies, companies should seek certifications and accreditations relevant to their products’ specific technology categorization and within specific geographies. For example, a company with a medical device product for the EMEA market may seek ISO 13485 certification, a quality-management standard for medical device manufacturing as established by the International Organization for Standardization. Similarly, a US company with a cellular therapeutic product may apply for accreditation by the American Association of Tissue Banks (AATB), affirming that the company’s product manufacturing meets or exceeds all AATB safety standards with regards to handling, processing, labeling, packaging, storage, and distribution of tissue.

A thorough understanding of the manufacturing and regulatory guidelines and requirements for development of convergent technologies will help ensure a company’s success in meeting the challenges it will face in bringing new products to market.

Author Details

Kathy McGee is vice president and general manager, and Andrea Loewen-Rodriguez is executive director for regulatory affairs at Advanced BioHealing, Inc., 36 Church Lane, Westport, CT 06880; 1-858-754-3700.

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But, that’s precisely what’s happening, experts warn.

“I believe it’s happening quite a bit. In some cases, people aren’t aware of these other wounds. They may automatically assume that every wound is a pressure ulcer, which just is not the case,” says Dr. James Spahn, a retired head and neck surgeon who now serves as CEO/founder of EHOB Inc., an Indianapolis-based manufacturer of pressure ulcer prevention and treatment products.

Statistics reveal that the prevalence of non-pressure ulcer skin breakdown is indeed significant. Collectively, more than 600,000 new cases of leg ulcers are diagnosed each year across the general population, experts say.

Meanwhile, the prevalence of venous wounds in adults is 1% to 2% of the U.S. population and can be as high as 3.4% in those over age 80, according to the American College of Phlebology. The prevalence rate for arterial leg wounds can range from 0.12% to 1.8%, according to researchers, and those rates may be conservative because only 25% of Americans over age 65 who have peripheral arterial disease are treated for the condition.

Incontinence-related dermatitis, which affects at least 6% of long-term care residents, also must not be overlooked, along with the 1.5 million skin tears that occur in institutionalized adults each year, many of them stemming from wheelchair injuries, transfers and falls. Finally, with roughly 23% of those age 60 or older being diabetic (many of them undiagnosed), diabetic foot ulcers are another major concern. These wounds account for up to 25% of all diabetic hospital admissions in the United States. They also are credited for more than 60% of all non-traumatic lower limb amputations, according to the National Diabetes Education Program.

“Each type of wound can be a real challenge and requires careful attention. Prevention and early diagnosis is key, and neither will occur without proper training that elevates caregiver knowledge,” notes Chris Cashman, CEO of Sanuwave, Alpharetta, GA. Sanuwave is a manufacturer of regenerative wound healing technologies.

Stopping the bleeding

The first and perhaps most critical element of successful wound management and prevention is a comprehensive, proactive care plan that combines ongoing physiological and risk assessments.

“If we don’t take the time to really get to know each resident and their history, we won’t know the risk factors and won’t be able to prevent some of these wound problems in the first place,” Spahn stresses. “Regardless of the wound type, it does really come down to education. Without it, we’re in trouble.”

Effective wound management also requires a multidisciplinary approach to ensure that all aspects of a resident’s care are represented.

“You have to treat the whole [resident], not just the hole in the [resident],” Jackie Todd, RN, CWCN, clinical education specialist for Medline Industries Inc.’s Atlantic Division, reasons. “There are nine body systems and they all intertwine and affect each other. Everything has to be evaluated for impact on healing.”

Ideally, a multidisciplinary team should include a healthcare provider, such as a physician or advance practice nurse; administrator and bedside clinicians, dietitians, physical therapists, staff nurses, occupational therapists, infection control, and educators.

“All should have clearly defined roles,” adds Diane Maydick, director of clinical affairs, Derma Sciences, Princeton, NJ.

Asking the right questions also is essential, as is diligent documentation and communication to ensure that all members involved in resident care are well versed on risks, changes to physiological and cognitive status, and adjustments to medication and other treatment protocols.

Dodging disasters

Taking a proactive approach through detailed assessments, personalized care plans and a team approach also will reduce the likelihood for wound misdiagnosis—and subsequent mistreatment that can prove catastrophic.
One example might be a resident with recurrent venous stasis disease, bordering on lymphedema. Compression must never be applied without first ruling out arterial involvement and a history of congestive heart failure.
“If peripheral vascular disease exists, or if CHF is a possibility, compression could exacerbate [the condition] and possibly cause death,” Todd warns.

Using therapies that increase microcirculation in residents who are misdiagnosed with vascular complications also is dangerous, adds Cashman. “You really need to know what you’re dealing with if you’re going to be increasing blood supply.”

Another line of caution when managing arterial wounds: Never raise the foot.

“About the worst thing you can do with an arterial wound is prop it up, which can cause the toes to rot,” and lead to amputation, Spahn explains.

Diabetic foot ulcers present their own set of challenges. In some cases, these are misdiagnosed as pressure ulcers—even though a prior diabetes diagnosis and location of the foot ulcer (typically on the plantar aspect of the metatarsal heads and the heel, and over the dorsal portion of the toes), serves as a reliable tip-off. In other cases, DFUs aren’t given the attention they deserve because caregivers may assume that they are unavoidable.

“In my opinion, it seems that many people just don’t understand how serious diabetic foot ulcers are, so they’re not being as serious about treating them,” says Dean Tozer, senior vice president, Advanced BioHealing Inc., Westport, CT. ABH manufacturers Dermagraft, a bio-engineered skin substitute for the treatment of diabetic foot ulcers.

And DFUs are serious. Diabetics who develop one have up to a 25% risk for lower limb amputation. There also is a 45% chance of death within five years, if not properly managed.

With a diabetic resident, it’s imperative not only to keep their blood sugar in check, but also to identify decreased sensation due to diabetic neuropathy and then take appropriate preventive measures to reduce the risk of diabetic-related ulcers. Such measures may include use of properly fitting stockings and shoes, and inspection of shoes for foreign objects or potential areas of pressure prior to the resident placing them on their feet, to prevent traumatic injury, explains Laura Popkes, clinical services manager for McKesson Medical-Surgical Extended Care Medimart, Minneapolis, MN.

Caregivers also must be aware that peripheral arterial occlusive disease is four times more prevalent in diabetics than in non-diabetics.

Paper power

Regardless of the type of skin ulcer being treated, detailed, ongoing documentation of risk factors, comorbidities, wound types, and care and treatment protocols becomes paramount.

“It is imperative to accurately document wound types and patient characteristics. Inaccurate documentation can lead to legal issues,” stresses Maydick.

Even more importantly, however, thorough documentation allows caregivers to better monitor wound care progress and make necessary care plan adjustments based on past treatment and prevention successes and failures. With a diabetic foot ulcer, for example, documentation creates a vital timeline to monitor standard therapies and determine when advanced modalities may be in order. Above all, documentation helps ensure that treatment and prevention are tailored to each resident.

“What works on one [resident] will not necessarily work for everyone, even if it is the same type of wound with basically the same underlying etiology and comorbid conditions,” Todd reasons.

Being fully aware of underlying conditions, additional risk factors and primary and secondary interventions–along with how long the interventions have been in place and their degree of effectiveness–will go a long way toward improving wound management.

“In order to achieve quality healed outcomes in the shortest amount of time, we have to step back, look from that 10,000-foot vantage point, and take a common sense approach to wound care,” Todd continues.

“Wound care is not rocket science and even though we may be given challenging wounds to deal with, we can achieve wound healing and not break the bank.”

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