News and Trends—December 2013

| December 27, 2013

Apollo Endosurgery Completes Acquisition of Allergan Inc.’s Obesity Intervention Division
AUSTIN, Texas, (PRNewswire)—Apollo Endosurgery, Inc., a leading developer of medical devices for endoscopic surgical procedures, today announced the completion of the acquisition of the obesity intervention division of Allergan, Inc., which manufactures and sells weight loss solutions comprised of the LAP-BAND® adjustable gastric banding system and the ORBERA™ intra-gastric balloon system.

“With worldwide obesity numbers reaching epidemic levels, the acquisition of the LAP-BAND and ORBERA™ technologies places Apollo Endosurgery in a leadership position to provide surgeons and patients with innovative and less invasive solutions in the fight against obesity,” said Dennis McWilliams, President and CEO of Apollo Endosurgery. “By expanding both our product portfolio and adding talent to our team, this acquisition will be a catalyst for growth as we continue to advance technologies in the fields of bariatric and minimally invasive surgery.”

About the Acquisition. Apollo announced the acquisition on October 29, 2013, for a purchase price of up to $110 million. This total includes an upfront cash payment of $75 million, a minority equity interest in Apollo by Allergan of $15 million, and up to $20 million in additional contingent consideration to be paid upon achievement of certain regulatory and sales milestones.

Piper Jaffray & Co. served as exclusive financial advisor and Cooley LLP served as legal counsel to Apollo Endosurgery in connection with the transaction. Current Apollo investors PTV Sciences, H.I.G. BioVentures, Remeditex Ventures, Novo A/S and CPMG, Inc. provided the equity financing of the acquisition. Debt financing was led by Oxford Finance LLC, who was joined by MidCap Financial, LLC and EastWest Financial Services.

About Apollo Endosurgery, Inc. Apollo Endosurgery, Inc. is dedicated to revolutionizing patient care through the adoption of less invasive bariatric and endoscopic surgical solutions. Apollo Endosurgery was cofounded with the Apollo Group, a unique collaboration of physicians from the Mayo Clinic, Johns Hopkins University, Medical University of South Carolina, the University of Texas Medical Branch and the Chinese University of Hong Kong. This collaboration developed a broad portfolio of patents in the field of endoscopic surgery that became the foundation of Apollo Endosurgery. For more information regarding Apollo Endosurgery, go to www.apolloendo.com.

Apollo Endosurgery, LAP-BAND, and ORBERA are trademarks of Apollo Endosurgery, Inc.

Extent of Obesity Not Strongest Factor for Patients when Choosing Type of Weight Loss Operation—Journal of the American College of Surgeons study finds that patients choose a bariatric surgical procedure based primarily on their own preferences and behaviors.

CHICAGO, Illinois—A new study investigating why obese patients choose one type of weight loss operation over another reveals that the main factors influencing decision making are whether patients have type 2 diabetes (T2D), how much weight they want to lose, and their tolerance for surgical risk to achieve their ideal weight. Unlike findings from previous studies the patient’s body mass index (BMI), or measure of obesity, does not play a significant role in the decision-making process according to study results published in the December issue of the Journal of the American College of Surgeons.

“BMI alone was not an important determinant, suggesting that patients and their surgeons considered the whole patient and what was important to him or her,” according to principal investigator Christine C. Wee, MD, MPH, associate professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, Boston.

“This finding was reassuring,” said Dr. Wee, who also is associate section chief for research in the Division of General Medicine and Primary Care at Boston’s Beth Israel Deaconess Medical Center, one of the sites where the study was conducted.

However, Caroline Apovian, MD, the lead author of the study, said, “One unexpected and concerning finding was that patients who reported having more uncontrolled eating were actually more likely to undergo the less effective laparoscopic banding procedure than gastric bypass.”

Dr. Apovian is professor of medicine and pediatrics at Boston University School of Medicine and director of Nutrition and Weight Management Center at Boston Medical Center, which served as a second study site. She speculated that patients who have poorer control over their eating patterns choose the banding procedure because it is reversible, and gastric bypass typically is not.

Laparoscopic gastric banding makes the stomach smaller by wrapping a band around part of the stomach. The surgeon can later adjust the band to allow less or more food intake, or even remove the band altogether. Surgeons use small incisions during a laparoscopic procedure. Roux-en-Y gastric bypass, one of the most common bariatric surgical procedure in the United States,1 removes part of the stomach and reroutes the digestive tract so that food bypasses most of the stomach, thus limiting absorption of calories. Surgeons perform gastric bypass with either an “open” surgical approach or, more often, a laparoscopic approach.
Gastric bypass produces greater and more sustainable weight loss over time than other weight loss procedures but involves a slightly higher risk of complications, said coauthor Daniel B. Jones, MD, MS, FACS, a bariatric surgeon at Beth Israel Deaconess Medical Center (BIDMC) and professor of surgery at Harvard.
At the time of the study, gastric banding was the second most common bariatric procedure, according to Dr. Jones. A newer procedure, laparoscopic sleeve gastrectomy, was uncommon when the operations in the study were performed (between June 2008 and October 2011),2 but is now more popular than gastric banding because it generally provides better results, he explained.

The researchers at BIDMC, along with colleagues at Boston Medical Center and the Center for Survey Research at the University of Massachusetts, Boston, conducted the Assessment of Bariatric Surgery, or ABS, Study.
This study included 536 adults who had either gastric bypass (297 patients) or gastric banding (239 patients) and who completed a one-hour telephone interview within the 18 months prior to the operation. Study subjects answered interview questions about perceptions, such as their ideal weight as well as about factors that motivated them to decide to have a bariatric surgical procedure. They also reported how willing they were to accept the risks to lose weight.

In addition, participants rated their quality of life and their level of emotional eating and uncontrolled eating. Information about patients’ demographic characteristics, BMI, and obesity-related diseases came from their medical records. The researchers analyzed the data by accounting for patients’ demographics, such as age and BMI, as well as for patient preferences and eating behaviors.

Patients who opted for gastric bypass over gastric banding were more likely to have T2D, poorer quality of life, a higher weight loss goal, and greater tolerance for assuming risk related to treatment, the investigators reported.
Those who exhibited a higher degree of uncontrolled eating were more likely to choose gastric banding. Although patients who underwent banding had a lower average BMI, meaning they were less obese than those who had gastric bypass, the authors reported that this difference was not statistically significant after adjustment for patient preferences and eating behavior.

Dr. Wee said the study results suggest that behavioral characteristics and patient preferences may be as, or more, influential than BMI in the decision-making process.

“It is important that patients talk to their surgeons about their values, weight loss goals and concerns, such as aversion to risk, the level that obesity has adversely affected their quality of life, and their potential challenges to losing weight, including their eating behaviors,” Dr. Wee said. “This information will help the surgeon better guide the patient in choosing a weight loss operation.”

Other study authors included Karen W. Huskey, MPH; Sarah Chiodi, MPH; Donald T. Hess, MD, FACS; Benjamin E. Schneider, MD, FACS; and George L. Blackburn, MD, PhD, FACS.

The Assessment of Bariatric Surgery Study is funded by the National Institutes of Health. (R01DK073302, PI Wee). Dr. Wee is also supported by an NIH Midcareer Mentorship Award (K24DK087932).
Citation: Journal of the American College of Surgeons, December 2013: 217(6) 111–81125.

The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 79,000 members and is the largest organization of surgeons in the world. For more information, visit www.facs.org.

References
1.    Nguyen NT, Masoomi H, Magno CP, et al. Trends in use of bariatric surgery, 2003-2008. J Am Coll Surg 2011 ;213:261-266.
2.    Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg 2013; 216:252-257.

Covidien Announces Definitive Agreement to Acquire Given Imaging
DUBLIN, Ireland & YOQNEAM, Israel (BUSINESS WIRE)—Covidien and Given Imaging Ltd. announced a definitive agreement under which Covidien will acquire all of the outstanding shares of Given Imaging for $30.00 per share in cash, for a total of approximately $860 million, net of cash and investments acquired. This transaction provides Covidien additional scale and scope to serve the multibillion dollar global gastrointestinal (GI) market and supports the Company’s strategy to comprehensively address key global specialties and procedures.

Given Imaging provides one of the broadest technology platforms for visualizing, diagnosing and monitoring the digestive system, including its flagship PillCam®, an innovative swallowed capsule endoscope.

“We believe GI is one of the most attractive specialty procedure areas. Acquiring Given will enable Covidien to significantly expand its presence in a $3 billion GI market,” said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. “Adding Given’s portfolio of diagnostics to our portfolio accelerates Covidien’s strategy of providing physicians with products that support the patient along the care continuum from diagnosis to treatment. It also confirms our leadership in developing less-invasive screening, diagnosis and treatment solutions that can improve patient outcomes and lower healthcare costs.”

“Given Imaging revolutionized GI diagnostics over 12 years ago with the launch of PillCam and created an entirely new diagnostic category—capsule endoscopy. The combination of Covidien’s established global presence and Given Imaging’s innovative capabilities has the potential to transform this market,” said Homi Shamir, President and CEO, Given Imaging Ltd. “After thoroughly evaluating our strategic options we determined that this transaction is in the best interests of Given Imaging, its shareholders and employees and provides unique benefits to patients globally.”

Given Imaging is dedicated to developing innovative diagnostic and monitoring technologies for the digestive system. The company’s broad portfolio includes the PillCam, a minimally-invasive, non-sedation, swallowed optical endoscopy technology for the small bowel, esophagus and colon. In total, Given Imaging has seven product lines across 21 GI disease states. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z monitoring and SmartPill® motility monitoring systems.

The transaction is subject to customary closing conditions, including Given Imaging shareholder approval and the receipt of certain regulatory approvals, and is expected to be completed by March 31, 2014. The Boards of Directors of both companies have approved the transaction, and the Boards of Directors of DIC, Elron and Rdc, owners of 44 percent of Given’s outstanding shares, have approved voting in favor of the transaction. DIC has also entered into a customary voting agreement with Covidien.

Financial Highlights. Covidien intends to finance the transaction through cash on hand and will report Given Imaging within the Medical Devices business segment. Upon closing of the transaction, Covidien expects Given Imaging will add between $40 and $50 million per quarter in incremental revenue to the Medical Devices segment.

On a reported U.S. GAAP basis, the transaction is expected to be dilutive to both operating margin and earnings per share (EPS) in fiscal 2014. On an adjusted basis, excluding one-time items and transaction costs, management expects the transaction to be neutral to both operating margin and EPS in fiscal 2014. The transaction is expected to be accretive to operating margin and EPS both on a U.S. GAAP and on an adjusted basis in fiscal 2015 and beyond. From a “cash earnings” standpoint, which excludes the impact of amortization, the transaction is expected to be accretive immediately after it closes.
Covidien management is not changing any of its guidance as a result of this transaction.
Supporting materials are now available on the Investor Relations section of Covidien’s website: http://investor.covidien.com

News from the American Society of Bariatric Physicians

Physicians Receive Recognition for Service from National Medical Society Focused on Clinical Obesity Treatment
DENVER, Colorado—The American Society of Bariatric Physicians (ASBP) recently recognized and honored six individuals for their service to the Society and dedication to furthering obesity medicine.
•    David Bryman, D.O., MPH, FASBP (Scottsdale, Ariz.)
Designation as an ASBP Fellow to recognize a physician member for excellence in obesity medicine and service to the Society.
•    Richard Lindquist, MD, ABFM, FAASP (Seattle)
Bariatrician of the Year to recognize a physician who has done the most to advance the field of bariatric medicine and the Society.
•    Ethan Lazarus, MD (Denver)
Dr. Vernon B. Astler Award to recognize efforts of an ASBP member to advance the Society’s place and purpose to the media, government and medical community, as Dr. Astler did in helping guide the society to secure a seat in the American Medical Association House of Delegates.
•    Ed Hendricks, MD, FASBP (Roseville, Calif.)
Raymond E. Dietz Award to recognize an individual who has made continuing contributions to the Society as did the award’s namesake who was one of the pioneers of the organization.
•    Justin Puckett, DO (Kirksville, Mo.)
Steelman-Seim Educator Award to recognize an individual who has exhibited excellence in advancing the cause of health care through education and teaching.
•    Krishna Doniparthi, MD (Milton, Ga.)
Task Force Award to recognize exceptional accomplishments while serving on a task force working to further one or more strategic initiatives of the Society.

The honorees were recognized during the ASBP Annual Awards Luncheon on Oct. 12 at the Arizona Biltmore in Phoenix.

Physicians Installed to New Positions on Board of Trustees of  National Medical Society Focused on Clinical Obesity Treatment
DENVER, Colorado—The American Society of Bariatric Physicians (ASBP) recently installed five officers and three new trustees to its Board of Trustees for the 2013-2015 term:
•    Eric C. Westman, MD, MHS (Durham, N.C.)
President
•    Deborah Bade Horn, DO, MPH, FASBP (Houston)
President-elect
•    Wendy Scinta, MD, MS (Fayetteville, N.Y.)
Vice President
•    Craig Primack, MD, FACP, FAAP (Scottsdale, Ariz.)
Secretary/Treasurer
•    David Bryman, DO, FASBP (Scottsdale, Ariz.)
Chairman
•    Crystal Broussard, MD
(The Woodlands, Texas)
Trustee
•    Ursula Inge Ferguson, DO, FACOI (Las Vegas)
Trustee
•    Ethan Lazarus, MD
(Denver)
Trustee
•    William McCarthy, MD (Woodbridge, Va.)
Trustee

The newly elected trustees join two other trustees who will be completing the second year in their current two-year term: Richard Lindquist, MD, ABFM, FAASP (Seattle) and Jennifer Seger, MD (San Antonio).
The installation took place during the ASBP Annual Awards Luncheon on Oct. 12 at the Arizona Biltmore in Phoenix.

The American Society of Bariatric Physicians (www.asbp.org) is the leading association for clinical physicians and other providers dedicated to the comprehensive medical treatment of patients affected by obesity and associated conditions. Many ASBP-member physicians also hold certification from the American Board of Obesity Medicine. Physicians may download a free copy of the ASBP Obesity Algorithm at www.ObesityAlgorithm.org. Individuals can search for obesity medicine specialists in their own area at www.FindObesityTreatment.org.

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