Given A Choice, Arthritis Patients Take More Conservative Clinical Approach

A recent study suggests that increasing patient responsibility for making medical decisions may decrease their willingness to accept risky treatment options. Details of this proof-of-concept study appear in the December issue of Arthritis Care & Research, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.



According to the Centers for Disease Control and Prevention (CDC) nearly 1.1 billion visits to physician offices and hospital outpatient and emergency departments were made in the U.S. in 2006. A noval approach to doctor-patient interactions has emerged where both a patient and health care professional share information and jointly decide on course of treatment for the patient. This approach called shared-decision making (SDM) has been used in clincical settings to improve the quality of care for patients. Past studies have shown that increasing patient participation in decision-making decreases utiliztion of risky procedures. Other studies indicate that risk perception is increased under conditions that emphasize choice.



Liana Fraenkel, M.D., M.P.H., from Yale University School of Medicine and Ellen Peters, Ph.D., from Decision Research enrolled 216 participants in their medical decision making study. A demographic profile of the subjects showed that 70% were Caucasian, 62% were female, and the mean age was 59 years. Participants attending outpatient clinic appointments were asked to view a video in which a physician described the availability of a new medication associated with a rare risk of a serious side effect.



Video A discussed a new medication to prevent heart disease where patients have the rare risk of developing jaw necrosis. Video B described a new medication to treat chronic pain where there was a risk of progressive multifocal leukoencephalopathy relevant to patients with rheumatic diseases. Participants were provided 2 consecutive sets of instructions following the video viewing. The first set of instructions was designed to minimize choice, "The doctor decides that you should take this medication and she writes you a prescription for it." The second set of instructions maximized choice: "The doctor tells you that it is completely up to you whether or not you take this medication and then asks you to make a decision."



"We found that highlighting the perception of having a choice increases patients' worry about the risks of adverse events and decreases their willingness to accept treatment," said Dr. Fraenkel. Results showed the willingness of patients to take the proposed medication was lower. "Clinicians should be aware that promoting increased patient responsibility for decisions involving their health care may be associated with lower uptake of risky procedures or interventions," advised Dr. Fraenkel

Joint Distraction Promotes Structural Repair In Patients With Severe Knee Osteoarthritis

Joint distraction (the use of a surgical frame around a degenerated joint to strengthen and promote repair) promotes cartilage repair in severe end stage osteoarthritis (OA) of the knee, as demonstrated for the first time by data presented at EULAR 2008, the Annual Congress of the European League Against Rheumatism in Paris, France.



In the study, an external fixation frame, with springs, was used to bridge the knee joint in 19 relatively young osteoarthritis patients (







Osteoarthritis of the knee is twice as common in women as in men, mainly occurring in women over the age of 50. So far, no treatment has been available and end stage placement of a joint prosthesis is often inevitable. Delaying such joint replacement surgery and preserving the original joint, specifically in the light of the ageing population, offers significant social and economical potential.







Abstract number: OP0151




About EULAR
The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations.


The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.


Diseases of bones and joints, such as rheumatoid arthritis and osteoarthritis cause disability in 4 - 5 % of the adult population and are predicted to rise as people live longer.


As new treatments emerge and cellular mechanisms are discovered, EULAR 2008 brings together more than 12,000 experts - scientists, clinicians, healthcare workers, pharmaceutical companies and patients - to share their knowledge in a global endeavour to challenge the pain and disability caused by musculo-skeletal disorders.


To find out more information about the activities of EULAR, visit: eular/

Source: Rory Berrie


European League Against Rheumatism

FDA Clears The DPL (Deep Penetrating Light) Therapy System For Over-the-Counter - Home Use

LED Technologies, LLC announced today that the U.S. Food and Drug Administration (FDA) cleared their DPL™ Therapy System for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation. This clearance launches the way for the DPL™ Therapy System to bring temporary pain relief technology directly to the consumer without a prescription.


"This FDA clearance marks a considerable landmark for our company as we demonstrate our leadership in LED light-based science and develop innovative LED applications for the medical, professional and home use markets," commented Brent Safer, Director of Operations and designer of the DPL™ Therapy System.


Minor pain is becoming all to common as our active and aging population become more prone to sports injuries, arthritis and the muscle and joint pain that accompanies the aging process. The American Pain Society estimates that 45% of the population seeks medical help for persistent pain sometimes in their lives. Medical economists estimate that pain costs the U.S. more than $100 billion every year, including over 500 million workdays lost and 40 million doctor visits.


The future of the DPL™ Therapy System is extremely bright as its applications expand beyond the minor pain relief field. Currently, LED Technologies, LLC is developing new DPL™ (Deep Penetrating Light) treatments for wrinkle reduction, TMJ, Fibromyalgia, Acne and a variety of other pain and wound healing applications.


"LED Technologies, LLC is committed to being the leader in LED light based therapy by bringing new and affordable medical applications to the consumer marketplace," stated Ron Ferguson Director of Sales and Marketing for the company. "Our research shows great demand for effective and affordable medical applications that the individual can use in the privacy of their own homes." The DPL™ Therapy System is a non-invasive, drug free therapy which can be utilized for a person's individual needs.


LED Technologies, LLC was established in 2004 and has a Patent Pending on its proprietary design, consisting of two LED panels containing 154 880nm Infrared and 20 660nm Red LEDS. The DPL™ two panel system projects the largest surface area LED exposure in the home-based marketplace with a 9"X14" (126 sq. inches) footprint. The system also includes a stand for use on the face and an easily adjustable strapping system which helps you place the panels almost anywhere on your body.


LED Technologies, LLC

Study Showed Half Of Patients Treated With Enbrel(R) (etanercept) Plus Methotrexate Can Achieve DAS Clinical Remission

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Amgen (NASDAQ:AMGN) announced the publication of data from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) trial demonstrating that half of patients treated with the combination of ENBREL and methotrexate achieved Disease Activity Score (DAS) clinical remission and nearly all had no progression of joint damage. These findings were published online on July 15 by The Lancet, a leading global medical journal.


According to study results at one year, 50 percent of patients (n = 265) with active early moderate-to-severe rheumatoid arthritis who received a combination of ENBREL and methotrexate therapy achieved DAS clinical remission (DAS28 less than 2.6) versus 28 percent (n = 263) of those treated with methotrexate alone. DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a modified measure of the DAS44, which is a validated tool used in clinical trials and serves as the basis for the European League Against Rheumatism (EULAR) response criteria.


"We hope that these data encourage physicians to use clinical remission as a new standard for evaluating symptom control in the treatment of early RA," said Paul Emery, M.D., lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK. "Clinical remission is highly relevant to patients' daily lives as they cope with their symptoms."


Additionally, at one year, 80 percent of patients (n = 246) receiving ENBREL and methotrexate had no evidence of progression of joint damage as seen on x-ray, compared to 59 percent (n = 230) of those treated with methotrexate alone.


Combination therapy with ENBREL plus methotrexate also helped patients remain more functionally active. Based on the Health Assessment Questionnaire (used to assess certain daily life activities), 61 percent (n = 256) of patients treated with combination therapy demonstrated improvement in their functionality versus 44 percent (n = 241) of those treated with only methotrexate. Further, the COMET trial showed that patients who were treated with combination therapy had a nearly three-fold reduction in work stoppage compared with those who received methotrexate alone.


"It's important for people living with a chronic disease like moderate to severe rheumatoid arthritis to be able to continue with their daily life activities," said Dr. Emery. "These data show that if patients receive combination treatment early, they are more likely to be able to continue with their daily activities, including going to work, than those treated with methotrexate alone."















American College of Rheumatology (ACR) scores were also assessed in the COMET study and were comparable to the DAS clinical remission data. Nearly half of patients receiving ENBREL plus methotrexate achieved an ACR 70 score, versus 28 percent of the methotrexate-only group. The percentage of patients who achieve an ACR 70 score represent those who achieve a 70 percent improvement in select RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician disease assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.


The COMET study is a 24-month, double-blind, randomized, parallel group, multicenter, outpatient study. The data published in The Lancet represent the results of the first year of treatment, in which patients were randomly assigned to receive combination ENBREL 50 mg plus methotrexate therapy, or methotrexate alone, once a week for 52 weeks. The population under study had less than two years (median seven months) of moderately to severely active disease.


At one year, there were no differences in rates of serious infections or malignancies among patients in the ENBREL plus methotrexate group compared with the methotrexate-only group. No cases of tuberculosis or demyelinating disease were reported. No new safety signals were identified.


In other RA clinical trials of ENBREL, the most common adverse events were injection site reaction, infection, and headache. Rare cases of tuberculosis and demyelinating diseases have been reported in post-marketing surveillance.


ABOUT ENBREL


ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor and has 16 years of collective clinical experience with an established safety profile. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severe plaque psoriasis in adults.


ENBREL indications in the U.S:


-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.


-- ENBREL is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.


-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.


-- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.


-- ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.


Important Safety Information


What important safety information do I need to know about taking prescription ENBREL?


ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.


Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.


Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).


In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.


Tell your doctor if you:


-- Think you have, are being treated for, have signs of, or are prone to infection


-- Have any open sores


-- Have or have had TB or hepatitis B


-- Have ever been treated for heart failure


-- Have ever had or develop a serious nervous system disorder


-- Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL


Common side effects in adult clinical trials were injection site reaction, infection and headache.


In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder.


If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA.


About Amgen and Wyeth


Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.


Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit amgen.


Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.


Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. To learn more, visit wyeth.


Amgen Forward-Looking Statement


This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of July 15, 2008, and expressly disclaims any duty to update information contained in this news release.


No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and products liability claims. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.


In addition, sales of Amgen's products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtain patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.


The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.


Wyeth Forward-Looking Statement


The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


Wyeth

wyeth



View drug information on Enbrel.

Emisphere Announces Initiation Of Phase III Clinical Program Of Oral Calcitonin For The Treatment Of Osteoarthritis

Emisphere
Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) has been notified that
Novartis Pharma AG and its development partner Nordic Bioscience have
initiated the Phase III clinical program of oral calcitonin (referred to as
SMC021) for the treatment of osteoarthritis, a chronic, irreversible and
degenerative condition. The oral calcitonin product is a new drug candidate
with potential to be the first disease-modifying drug for
osteoarthritis(i),(ii).


The salmon calcitonin is formulated in tablet form using Emisphere's
novel eligen(R) delivery technology. Emisphere's technology creates the
potential for salmon calcitonin to be available as a convenient oral
medication for the first time.



"We are pleased to announce the initiation of Phase III trials for oral
calcitonin, which may represent the first disease-modifying drug for the
treatment of osteoarthritis," said Michael V. Novinski, President & CEO of
Emisphere. "Currently, there are no available treatment options for
osteoarthritis that actually help prevent disease progression or joint
damage, and we are excited to be at the leading edge of research in this
area. An unmet need facing osteoarthritis patients and physicians today is
the lack of any proven disease-modifying drug for osteoarthritis. Oral
Calcitonin would help prevent structural damage in at-risk joints, or the
progression of structural damage in joints already affected. Current
treatment options for osteoarthritis provide only symptomatic relief"(iii).



In osteoarthritis, oral calcitonin may stimulate a protective effect
that helps maintain the quality of cartilage and reduce the progression of
joint space narrowing(iv). Oral calcitonin also has been shown to protect
against cartilage breakdown in animal models.



The Phase III clinical program is being conducted by Nordic Bioscience
both in the European Union and in the US, and is planned to include more
than 2000 patients.



In 2000, Emisphere and Novartis Pharma AG entered into a license
agreement for the development of oral salmon calcitonin for the treatment
of osteoarthritis and osteoporosis. The Phase III clinical trial of oral
calcitonin for the treatment in osteoporosis started also early this year.
The two companies entered into additional license agreements for the
development of oral human growth hormone and an oral form of parathyroid
hormone (PTH) fragment 1-34 in 2004 and 2006, respectively.



About Salmon Calcitonin



Calcitonin is a polypeptide hormone secreted by the parafollicular
cells of the thyroid gland. Calcitonin enables the bone to retain more of
its mass and functionality by inhibiting the bone-tissue resorbing activity
of specialized bone cells called osteoclasts. Calcitonin is involved in the
regulation of calcium and the decrease of bone loss and fractures.
Calcitonin derived from salmon is estimated to be about 30 times more
potent than the human versioni.(iv) Synthetic salmon calcitonin, which is
identical to the natural salmon calcitonin, is currently available only as
nasal spray or as an injectable therapy.
















About the eligen(R) Technology



Emisphere's broad-based oral drug delivery technology platform, known
as the eligen(R) technology, is based on the use of proprietary, synthetic
chemical compounds, known as EMISPHERE(R) delivery agents, or "carriers".
These molecules facilitate or enable the transport of the therapeutic
macromolecules across biological membranes such as those of the
gastrointestinal tract, and exert their desired pharmacological effect.
Emisphere's eligen(R) technology makes it possible to orally deliver a
therapeutic molecule without altering its chemical form or biological
integrity.



About Oral Calcitonin



Oral calcitonin is a novel drug under clinical development for the
potential treatment of both osteoarthritis and osteoporosis. It has a dual
method of action that could provide the unique benefit of protecting bones
and preserving cartilage in patients with osteoarthritis and osteoporosis,
all in one medication(v).



Oral calcitonin is formulated with a novel new technology that for the
first time facilitates the convenient oral dosing of calcitonin. The oral
calcitonin compound consists of the peptide hormone (calcitonin) and
5-CNAC, a delivery agent for increasing gastrointestinal absorption, and
uses Emisphere Technologies' eligen(R) technology, which is an advanced
drug delivery system that facilitates the oral delivery of active
calcitonin without altering the drug's biological characteristics or
benefits(vi).



Calcitonin is a natural hormone secreted by the thyroid gland that is
important for bone formation and maintenance. It helps regulate normal
blood calcium levels and inhibitors cells that are responsible for bone
degradation(iv). Synthetic calcitonin has been used as an injectable
medication for more than 30 years and as an intranasal formulation since
1987.



About Osteoarthritis



Osteoarthritis is the most common form of arthritis, affecting 20
million people in the U.S. alone. Osteoarthritis, also called degenerative
joint disease, is the most common type of arthritis. It is associated with
a breakdown of cartilage in joints and can occur in almost any joint in the
body. It most commonly occurs in the weight bearing joints of the hips,
knees and spine. It can also affect the fingers, neck and large toe. It
rarely affects other joints unless prior injury or excessive stress is
involved. Cartilage is a firm, rubbery material that covers the ends of
bones in normal joints. Its main function is to reduce friction in the
joints and serve as a "shock absorber." The shock-absorbing quality of
normal cartilage comes from its ability to change shape when compressed
(flattened or pressed together). Osteoarthritis causes the cartilage in a
joint to become stiff and lose its elasticity, making it more susceptible
to damage. Over time, the cartilage may wear away in some areas, greatly
decreasing its ability to act as a shock absorber. As the cartilage
deteriorates, tendons and ligaments stretch, causing pain. If the condition
worsens, the bones could rub against each other.



About Emisphere Technologies, Inc.



Emisphere Technologies, Inc. is a biopharmaceutical company pioneering
the oral delivery of otherwise injectable drugs. Emisphere's business
strategy is to develop oral forms of injectable drugs, either alone or with
corporate partners, by applying its proprietary eligen(R) technology to
those drugs or licensing its eligen(R) technology to partners who typically
apply it directly to their marketed drugs. Emisphere's eligen(R) technology
has enabled the oral delivery of proteins, peptides, macromolecules and
charged organics. Emisphere and its partners have advanced oral
formulations or prototypes of salmon calcitonin, heparin, insulin,
parathyroid hormone, human growth hormone and cromolyn sodium into clinical
trials. Emisphere has strategic alliances with world-leading pharmaceutical
companies. For further information, please visit the Emisphere website,
emisphere.



Safe Harbor Statement Regarding Forward-Looking Statements



The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or potential
outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency
of Emisphere's cash and other capital resources) are forward-looking
statements that involve risks and uncertainties, including, but not limited
to, the likelihood that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize
products using Emisphere's drug delivery technology, Emisphere's ability to
fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and
Exchange Commission, including those factors discussed under the caption
"Risk Factors" in Emisphere's (Commission File no. 1-10615) Annual Report
on Form 10-K (File 000-17758) filed on March 6, 2007 and our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2007.



References


i. Kardsal MA, Sondergaard BC, Madsen SH, Wulf, H. Sumer EU, Olsen AK,
Qvist P, Christiansen C, Nordic Bioscience, Herlev, Denmark, CCBR
Ballerup, Denmark. "Induction of cAMP levels switches chondrocytes
phenotype from catabolic to anabolic - Implications for novel
treatments of osteoarthritis." Abstract Control/Tracking Number: #
06- A-1085-ASBMR, presented at ASBMR 28th Annual Meeting,
Philadelphia, April 19, 2006.


ii. Karsdal MA, Sondergaard BC, Sims NA, Gooi JH, Qvist P, Christiansen
C, Nordic Bioscience, Herlev, Denmark, SVIMR, Melbourne, Australia,
CCBR Ballerup, Denmark. "Calcitonin directly modulates chondrocyte
activity in vitro and abrogates collagen type II degradation in
vivo." Abstract Control/Tracking Number: # 06-A-1049-ASBMR,
presented at ASBMR 28th Annual Meeting, Philadelphia, April 19, 2006.


iii. Datamonitor, March 2006.


iv. Azria M. The Calcitonins: Physiology and Pharmacology. Basel, Karger.
1989.


v. 2 Oct Briefing new BF Head/ Milka Bedikian/ October 24, 2006.


vi. Emisphere Technologies, Inc. Available at
emisphere/ot_tet.asp. 2007.


Emisphere Technologies, Inc.

emisphere

Hyperuricemia Rates Remain High Among U.S. Adults And Senior Citizens Placing Them At Risk For Developing Gout

Hyperuricemia rates among the nation's adults and senior citizens remain substantially high, putting them at greater risk for developing gout, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.


Hyperuricemia is an abnormally high level of uric acid in the blood that can lead to gout a painful and potentially disabling form of arthritis that has been recognized since ancient times. Initial symptoms of gout usually consist of intense episodes of painful swelling in single joints, most often in the feet (especially the big toe). Gout occurs when excess uric acid (a normal waste product) accumulates in the body, and needle???like crystals deposit in the joints. This may happen because either uric acid production increases or, more often, the kidneys are unable to remove uric acid from the body adequately.


Previous studies have confirmed that there is a direct link between serum urate levels and the risk of gout, making serum levels an accurate indicator of how to monitor the disease. Based on this information, researchers recently estimated the increasing trend of hyperuricemia among adults and senior citizens in the United States.


They reviewed National Health and Nutrition Examination Survey (a group of surveys used to assess the health and nutrition of American adults and children) data from 1999-2008 and analyzed 24,693 participants who were at least 20 years old of which 11,816 were men and 12,877 were women. Data was used to estimate the average serum urate level and prevalence of hyperuricemia (defined, for this study, as having serum urate level greater than 7.0mg/dL in men and greater than 5.7 mg/dL in women) among both gender and age groups and was compared to U.S. population estimates from the Census Bureau. Participant blood samples were also collected during home interviews or doctor examinations and tested for blood uric acid levels.


The researchers found that an estimated 31.9 million (20.1 percent) U.S. adults have hyperuricemia. More specifically, they also noted hyperuricemia among 16.1 million men and 15.8 million women. They also found that the prevalence of hyperuricemia increased with age with those participants ages 20 to 29 years being at a lower prevalence than those who are 80 years or older. Moreover, the study determined that prevalence of hyperuricemia among U.S. adults age 65 and older to be 8.4 million, or 31.3 percent of the population.


"These findings from the latest nationally representative sample of U.S. adults suggest that the prevalence of hyperuricemia is substantial, particularly among older individuals," explains Yanyan Zhu, PhD; research assistant professor at the Boston University School of Medicine and an investigator in the study. "This burden could be explained by recent increase in obesity and associated conditions (such as metabolic syndrome and hypertension) as these conditions can raise uric acid levels," says Dr. Zhu, whose research team also recently completed a study showing that gout rates and related cases of hyperuricema have increased over the past two decades. This study will also be presented at this ACR's Annual Scientific Meeting this week.


Source: American College of Rheumatology (ACR)

NICE Must Rethink Denying Abatacept, Says Patient-voice Organisation Arthritis Care, UK

In a snub to thousands of people with rheumatoid arthritis, the National Institute of Health and Clinical Excellence (NICE) has published final guidance stating that the drug abatacept (Orencia) is not cost effective for the NHS and should be refused.


The drug for severe rheumatoid arthritis (RA) was only launched in the UK in June. Manufacturers Bristol-Myers Squibb said at the time that it promised long-term efficacy for people with RA who have not responded positively to anti-TNF therapy.


Abatacept is licensed in the UK for use in combination with methotrexate for adults with active moderate to severe RA, who have responded poorly to other disease modifying anti-rheumatic drugs (DMARDs), and to at least one anti-TNF.


'It's a huge blow. This decision will dash the hopes of thousands. The fact that the new-generation drug rituximab (MabThera) was approved recently doesn't mean that all people failed by anti-TNFs will be suitable for it. Abatacept was a bright, new hope for them, and to put it beyond their reach will seem catastrophic', said Arthritis Care's spokesman Jane Spence.


'People qualified to receive anti-TNF treatment already have serious, active rheumatoid arthritis. It's very debilitating and destructive, and if not properly treated, those with the severest form of the condition can kiss goodbye to hopes of halting their disease's damaging progress', she added.


'This harsh ruling means there's no place left to go if you've been failed by rituximab, or the anti-TNF treatments. Whilst NICE is obliged to make its decisions on NHS cost-effectiveness, the narrow focus merely robs Peter to pay Paul. Instead of funding abatacept, now the taxpayer will foot the bill for expensive orthopaedic and palliative care for people who might do well on the drug, if allowed it. Many may end up on disability or incapacity benefits as well', said Spence.


The final NICE guidance, published recently, states that abatacept is not recommended for treatment on the NHS of people with rheumatoid arthritis. However, it says the small number of people who are currently receiving it may continue until they and their clinicians consider it appropriate to stop.
'Arthritis Care speaks up for people with arthritis and we'll make a robust appeal against this ruling. We'll urge NICE to revisit the evidence and reverse its decision, which, if allowed to stand, will deny many who potentially qualify for this treatment, the benefits it offers', said Spence.


The launch of abatacept in the UK followed the grant of its European Commission licence on May 21, 2007. NICE guidance applies to England and Wales. Decisions in Northern Ireland usually mirror NICE's lead. In September, the equivalent body in Scotland, the Scottish Medicines Consortium (SMC), also refused to recommend abatacept.


Arthritis has some 200 forms. It is the UK's biggest single cause of physical disability, affecting around nine million Britons. About 400,000 Britons of all ages have rheumatoid arthritis, a disease in which the immune system does not protect the body, but appears to ravage it with a chemical called Tumour Necrosis Factor (TNF). Some 10% (40,000) of these have severe RA, and it is people within this group who could benefit from abatacept.


Arthritis Care, established in 1947, is the UK's largest voluntary organisation committed to supporting people with arthritis. It celebrates its Diamond Jubilee this year.


Predating the NHS by one year, the charity works to represent people with arthritis, and to lobby decision-makers on their behalf. It has over 300 branches UK-wide, a free, confidential information helpline; it produces a range of information booklets plus the award-winning Arthritis News, and it actively campaigns locally, nationally and internationally for people with arthritis.


arthritiscare.uk


View drug information on Orencia.