News and Trends—November 2013

| November 26, 2013

Apollo Endosurgery Announces Acquisition of Obesity Intervention Division from Allergan, Inc.
Leading weight-loss medical devices and access to global sales channel to fuel growth
AUSTIN, Texas—Apollo Endosurgery, Inc., a leading developer of medical devices and endoscopic surgical procedures, today announced that it has entered into a definitive agreement to purchase the obesity intervention division of Allergan, Inc. for up to $110 million. The total includes an upfront cash payment of $75 million, minority equity interest of $15 million, and up to $20 million in additional contingent consideration to be paid upon achievement of certain regulatory and sales milestones. The obesity intervention division is responsible for manufacturing and marketing the LAP-BAND® adjustable gastric band system and the ORBERA™ intra-gastric balloon system.

“The acquisition of the LAP-BAND® and ORBERA™ technologies will provide Apollo Endosurgery with a strong revenue stream that will enable us to expand our investment in innovative solutions that focus on improving patient outcomes in both the bariatric and endoscopic spaces,” said Dennis McWilliams, President and CEO of Apollo Endosurgery. “The addition of these devices will complement Apollo’s portfolio to include less invasive bariatric product offerings while expanding our domestic sales channel and increasing our global reach into more than 40 countries.”

LAP-BAND® adjustable gastric band is a proven, minimally invasive laparoscopic weight loss device with both US Food and Drug Administration (FDA) approval and broad-based insurance coverage, making it a preferred surgical solution for many patients. The device is an effective tool to help patients gradually lose weight and keep it off without any cutting, stapling or amputation of the stomach. ORBERA™ is a non-surgical alternative for the treatment of overweight and obese adults that is approved for sale outside the United States in over 40 countries.

“We are pleased to enter into a definitive agreement with Apollo Endosurgery regarding the sale of our obesity intervention business,” said David E.I. Pyott, Chairman of the Board and Chief Executive Officer, Allergan. “We are confident that Apollo Endosurgery has the management expertise, industry experience and commitment to innovation that will be essential to the continued clinical development and future advancement of the LAP-BAND® and ORBERA™ franchises.”

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. Goldman, Sachs & Co. served as exclusive financial advisor and Latham & Watkins LLP served as legal counsel to Allergan.

Additional terms of the transaction were not disclosed.
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 or you can contact Apollo by using the contact information provided below.
Apollo Endosurgery is a trademark of Apollo Endosurgery, Inc.

About Allergan

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 11,200 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and customers who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.
LAP-BAND and ORBERA are trademarks of Allergan, Inc.
Important LAP-BAND® System Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

It is indicated for use only in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis), who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions, or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Important: For full safety information please visit www.lapband.com, talk with your doctor, or call Allergan Product Support at 1-800-624-4261.

American Association of Clinical Endocrinologists, American College of Endocrinology and The Obesity Society Issue Comprehensive Healthy Eating Guidelines for Adults
Protocols Developed To Assist Physicians, Allied Health Care Personnel With Management and Prevention of Metabolic and Endocrine Disorders
JACKSONVILLE, Florida—The American Association of Clinical Endocrinologists (AACE), the American College of Endocrinology (ACE) and The Obesity Society (TOS) today published clinical practice guidelines to assist physicians and other health care personnel with the prevention and management of endocrine and metabolic disorders in adults.
The guidelines were jointly developed by the organizations to address the lack of large-scale, uniform standards for healthy eating and patient nutritional education.

“In issuing these guidelines, it is our intent to fill the medical gap that currently exists by defining evidence-based,  necessary and specific clinical strategies for the prevention and treatment of a broad range of metabolic disorders in adults,” said J. Michael González-Campoy, MD, PhD, FACE, who co-chaired the guidelines committee.

“These comprehensive recommendations effectively address patient standards of care while also providing a worthwhile framework for disease prevention,” he added.

Conditions addressed in the document include overweight and obesity, adiposopathy, diabetes mellitus, chronic kidney disease, hypertension, dyslipidemia, bone health, pregnancy and lactation, and nutrient deficiencies in older adults.

The complete guidelines are available for free and are published online at: https://www.aace.com/files/clinical-practice-guidelines.pdf.
About the American Association of Clinical Endocrinologists (AACE)
The American Association of Clinical Endocrinologists (AACE) represents more than 6,500 endocrinologists in the United States and abroad. AACE is the largest association of clinical endocrinologists in the world. The majority of AACE members is certified in endocrinology, diabetes and metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including obesity, diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, and hypertension. Visit our site at www.aace.com.
About the American College of Endocrinology (ACE)
The American College of Endocrinology (ACE) is the educational and scientific arm of the American Association of Clinical Endocrinologists (AACE). ACE is the leader in advancing the care and prevention of endocrine and metabolic disorders by: providing professional education and reliable public health information; recognizing excellence in education, research and service; promoting clinical research and defining the future of Clinical Endocrinology. For more information, please visit www.aace.com/college.
About The Obesity Society (TOS)
TOS is the leading professional society dedicated to better understanding, preventing and treating obesity. Through research, education and advocacy, TOS is committed to improving the lives of those affected by the disease. For more information please visit: www.Obesity.org.

Endocrinologists Release List of Commonly Used Tests and Treatments to Question
List encourages physician and patient conversations by highlighting
potentially unnecessary—sometimes harmful—care in endocrinology
Chevy Chase, Maryland, and JACKSONVILLE, Florida—The Endocrine Society and the American Association of Clinical Endocrinologists (AACE) today released a list of specific tests or procedures that are commonly ordered but not always necessary in endocrinology as part of Choosing Wisely®,(http://www.choosingwisely.org) an initiative of the ABIM Foundation (http://www.abimfoundation.or). The list identifies five targeted, evidence-based recommendations that can support conversations between patients and physicians about what care is really necessary.
In their list, The Endocrine Society and AACE identified the following five recommendations:
1.    Avoid routine multiple daily self-glucose monitoring in adults with stable type 2 diabetes on agents that do not cause hypoglycemia.
2.    Do not routinely measure 1,25 dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function.
3.    Do not routinely order a thyroid ultrasound in patients with abnormal thyroid function tests if there is no palpable abnormality of the thyroid gland.
4.    Do not order a total or free T3 level when assessing levothyroxine (T4) dose in hypothyroid patients.
5.    Do not prescribe testosterone therapy unless there is biochemical evidence of testosterone deficiency.

“These recommendations give endocrinologists a platform to engage patients in important discussions about their health and the benefits of various treatment options,” said Endocrine Society President Teresa K. Woodruff, PhD. “We are pleased to be empowering patients and physicians to be true partners in determining the wisest course of care for each individual.”

“AACE/ACE is pleased to participate in these discussions, and reminds readers that these recommendations are not meant as guidelines or standards of care, but rather the observations of experts,” said American College of Endocrinology (ACE) President Daniel Einhorn, MD, FACP, FACE. “Each patient and encounter is unique, and there are many exceptions to each of the recommendations. Furthermore, the recommendations are likely to evolve over time as more is learned.”

The endocrinology Choosing Wisely list was developed after months of careful consideration and review, using the most current evidence about management and treatment options.

Members of The Endocrine Society along with representatives of AACE formed a joint task force to identify tests or procedures that should only be used in specific circumstances. With input from members of the Society’s Council, Clinical Affairs Core Committee and AACE’s Board of Directors and other leaders, the task force selected the final list based on the amount of evidence supporting each item, the value of the recommendation to practitioners, and the potential for cost savings.

“The Endocrine Society and AACE have shown tremendous leadership by releasing this list of tests and procedures they say are commonly done in endocrinology, but aren’t always necessary,” said Richard J. Baron, MD, president and CEO of the ABIM Foundation. “The content of this list and all of the others developed through this effort are helping physicians and patients across the country engage in conversations about what care they need, and what we can do to reduce waste and overuse in our health care system.”
First announced in December 2011, Choosing Wisely® is part of a multi-year effort led by the ABIM Foundation to support and engage physicians in being better stewards of finite health care resources. To date, more than 80 national and state medical specialty societies, regional health collaboratives and consumer partners have joined the conversations about appropriate care. Including new lists scheduled for release through March 2014, the campaign will have covered more than 250 tests and procedures that the specialty society partners say are overused and inappropriate, and that physicians and patients should discuss.

To learn more about Choosing Wisely and to view the complete lists and additional detail about the recommendations and evidence supporting them, visit www.ChoosingWisely.org.

New Road Map Guides Clinicians Through Medical Obesity Treatment Options
Aurora, Colorado—the American Society of Bariatric Physicians (ASBP) rolls out the first-ever comprehensive algorithm that navigates the physician’s role in medically treating and caring for patients affected by obesity.

The ASBP Obesity Algorithm—developed and written for the Society by a group of leading obesity medicine specialists—aims to give all physicians training and tools for prescribing and implementing obesity treatment plans for patients. Among these plans, changes in nutrition, exercise and behavior are included. Physicians may also recommend weight-loss medications or discuss surgical options for excess fat reduction.

“Physicians are now confronted with the need to understand what makes obesity a disease and how patients affected by obesity are best managed,” said ASBP President-elect and Algorithm Committee Co-chair Deborah Bade Horn, D.O., M.P.H., F.A.S.B.P. “They can benefit from the algorithm, which compiles the experience of researchers and clinicians who engage in obesity treatment on a day-to-day basis.”

The algorithm emphasizes patients’ overall health and reduction in risk of developing associated conditions, such as type 2 diabetes, hypertension, sleep apnea, cardiovascular disease and depression. Changes will only be recommended following an examination of the patient’s current lifestyle, family history, physical exam and laboratory testing. The algorithm will aid physicians in determining whether these results warrant a need for intervening obesity treatment and what that care would look like.

The algorithm also offers suggestions for affordable treatment options. Physicians can use the algorithm to create individualized treatment plans for patients, providing them with optimal obesity care at an affordable cost.
“This will help give physicians a better opportunity to manage patients affected by obesity in the most compassionate, scientifically sound and cost-effective way possible,” said ASBP Trustee and Algorithm Committee Co-chair Jennifer Seger, M.D.

Following the American Medical Association’s (AMA’s) decision in June to declare obesity a chronic disease state, more patients are seeking treatment options from their primary care providers. However, research studies indicate that primary care physicians want and need more help in discussing obesity with their patients. According to a study published in December 2012, primary care physicians have a perceivable need for additional education and training in order to improve treatment and care for patients affected by obesity. The U.S. Centers for Disease Control and Prevention reports that nearly 36 percent of U.S. adults and 17 percent of youth are affected by obesity. Obesity increases the risk of having heart disease, stroke, type 2 diabetes, and certain cancers, the leading causes of preventable death in the United States.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.

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