ST. LOUIS–(BUSINESS WIRE)–The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA).

“We support the ACR treatment guidelines and believe topical NSAIDs, like PENNSAID, provide an effective option for reducing knee OA pain.”

the new guidelines, published in the April issue of Arthritis Care & Research, conditionally recommend that healthcare providers consider topical nonsteroidal anti-inflammatory drugs (NSAIDs) as one option for the initial management of knee OA, along with other treatments including acetaminophen, oral NSAIDs, tramadol and intraarticular corticosteroid injections. In addition, the guidelines strongly recommend the use of oral or topical NSAIDs or intraarticular corticosteroid injections in patients with an unsatisfactory clinical response to full-dose acetaminophen, and furthermore strongly recommend topical over oral NSAIDs in those patients aged 75 years or older initiating NSAID therapy.1

Commenting on the new guidelines, Marc C. Hochberg, MD, MPH, said, “Osteoarthritis is the most common form of arthritis affecting adults in the United States and is the principal cause of musculoskeletal pain, limitation in physical activity and reduction in health-related quality of life. it is important for all primary care providers and specialists taking care of patients with osteoarthritis to recognize that there is a lot that can be offered to the patient to reduce their pain and improve their function.” Dr. Hochberg is professor of medicine and epidemiology and public health, University of Maryland School of Medicine, Baltimore, and chair of the Task Force that developed the new ACR recommendations.

Knee OA is a chronic condition in which joint cartilage–the smooth tissue that cushions the bone and allows easy joint movement–breaks down, leading to pain and loss of physical function.2 Mallinckrodt LLC, a Covidien company, markets PENNSAID® (diclofenac sodium topical solution) 1.5% w/w, a topical NSAID. PENNSAID is the only U.S. Food and Drug Administration (FDA)-approved topical NSAID for the treatment of the signs and symptoms of knee OA, which demonstrated statistically significant differences in pain and physical function compared to placebo.

“Knee OA pain is one of the top five causes of disability in American adults,” said Alfredo Bozzini, Interim Chief Medical Officer, Pharmaceuticals, Covidien. “We support the ACR treatment guidelines and believe topical NSAIDs, like PENNSAID, provide an effective option for reducing knee OA pain.”

“The American College of Rheumatology osteoarthritis treatment guidelines propose to advance the use of topical NSAIDs beyond what the American Geriatric Society and American Academy of Orthopedic Surgeons recommend,” said Dr. Joseph Markenson, attending physician at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medical College. “The updated guidelines are helpful to physicians in their clinical practice, especially when seeing patients over 75 years of age.”

For Important Risk Information on PENNSAID, including boxed warning, see below.

About Osteoarthritis

OA is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints – such as knees, hands, elbows, wrists, ankles and feet – which allows for easy movement. When this cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. Today, an estimated 27 million Americans live with OA.2

the most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking. Despite the high prevalence of OA, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in affected patients.

About PENNSAID®

PENNSAID is the only FDA-approved topical NSAID for the treatment of knee OA which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC®), patient overall health assessment (POHA) and patient global assessment of knee OA.

INDICATION

PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

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WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

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Cardiovascular Risk

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• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. this risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

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• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.

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Gastrointestinal Risk

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• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

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IMPORTANT RISK INFORMATION

PENNSAID is also contraindicated in patients:

• with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID
• who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.

Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.

use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury.

use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.

should not be used in pregnant or lactating women and is not approved for use in pediatric patients.

Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

the most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).

do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use. Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.

you are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

PENNSAID is a registered trademark of Nuvo Research inc.

WOMAC is a registered trademark of Nicholas Bellamy.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. please visit covidien.com to learn more about our business.

1 Hochberg M, Altman R, et al. American College of Rheumatology 2012 Recommendations for the use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care & Research. 2012;64:465-474.

2 Arthritis Foundation. Osteoarthritis Fact Sheet. arthritis.org/media/newsroom/media-kits/Osteoarthritis_fact_sheet.pdf [Last Accessed January 10, 2012]

June 11, 2011 12:30 PM Eastern Daylight Time 

Results Presented at 16th Congress of the European Hematology Association

LONDON–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) announced today additional symptom improvement and quality of life (QoL) results from COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK inhibitor Treatment), a randomized, double-blinded, placebo-controlled Phase III trial of Incyte’s JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis (MF). the data, being reported at the 16th EHA Congress today, demonstrated that treatment with ruxolitinib resulted in significant reductions in spleen volume and improvements in Total Symptom Score (TSS) while placebo-treated patients experienced progressive splenomegaly (enlarged spleen) and worsening of symptoms, complementing clinical results presented recently at the 2011 ASCO Annual Meeting.

“Quality of life in patients with myelofibrosis can be severely compromised by massive splenomegaly and debilitating symptoms, and it is highly gratifying to see profound symptomatic improvement resulting in improved quality of life in MF patients.”

the findings are being reported at the EHA Congress in Poster #0912: Results Using the Modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0) in COMFORT-I: a Randomized, Double-Blind, Phase III Trial of JAK1/2 Inhibitor Ruxolitinib vs. Placebo in Myelofibrosis.1 the presenting author is Ruben A. Mesa, M.D., Professor of Medicine, Chair, Division of Hematology & Medical Oncology, Mayo Clinic, Arizona. Dr. Mesa is a leading expert on the symptomatic burden of myelofibrosis and has been instrumental in developing tools, such as the modified MFSAF, for measuring these symptoms.

these data demonstrated that the primary endpoint of a 35% reduction in spleen volume was clearly associated with reduction of abdominal symptoms (abdominal discomfort, pain under the ribs and feeling of fullness (early satiety)) associated with an enlarged spleen. Importantly, many patients with less than 35% reduction in spleen volume also had meaningful improvement in abdominal symptoms. Patient benefit also was assessed using the Patient Global Impression of Change (PGIC), which measures patients’ global assessment of change in their condition on a 7-point scale ranging from “very much worse” to “very much improved.” while more than two-thirds of ruxolitinib-treated patients graded their disease as “much or very much improved” based on the PGIC, nearly three-quarters of placebo-treated patients reported “no change” or “worsening” on that scale.

in addition, of patients who had a 50% or greater reduction in TSS (a key secondary endpoint), nearly 90% rated their disease as “much or very much improved” based on the PGIC scale. Also, over 50% of patients with a 25% to 50% TSS improvement rated their disease as “much or very much improved,” indicating that a significant proportion of these ruxolitinib-treated patients also had meaningful improvement in their disease. associated with these improvements were improvements in almost all sub-scales of the European Organization for Research and Treatment of Cancer Quality-of-Life 30 Questionnaire (EORTC QLQ-C30), a standard and well-validated measure of quality of life in cancer patients. A copy of the poster presentation can be viewed by clicking on the following link: EHA 2011 Ruben Mesa Poster.

Richard Levy, M.D., Incyte’s Executive Vice President and Chief Drug Development and Medical Officer, stated, “Quality of life in patients with myelofibrosis can be severely compromised by massive splenomegaly and debilitating symptoms, and it is highly gratifying to see profound symptomatic improvement resulting in improved quality of life in MF patients.”

as expected based on the mechanism of action of ruxolitinib, the most common adverse events occurring more frequently on ruxolitinib treatment than on placebo were anemia and thrombocytopenia. Both were manageable as evidenced by the low discontinuation rate as a result of these events (1 patient for each event in each arm of the study). Thrombocytopenia was managed with dose modifications and anemia was generally managed with transfusion. the prevalence of grade 3 and 4 anemia in ruxolitinib patients diminished over time as did the need for transfusion. among the most frequently reported non-hematologic adverse events in ruxolitinib treated patients were dizziness, headache and bruising and were generally of low grade, and self limited with continued therapy.

About COMFORT-I

COMFORT-I is a randomized (1:1), double-blind, placebo-controlled Phase III study comparing the efficacy and safety of ruxolitinib to placebo in 309 patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) and involved over 80 clinical sites in the US, Canada and Australia.

the primary endpoint was the proportion of patients achieving a reduction in spleen volume of 35% or more from baseline to week 24 as measured by MRI (or CT scan in applicable patients). Key secondary endpoints included duration of maintenance of a 35% or greater reduction in spleen volume from baseline and the proportion of patients with 50% or more reduction in symptom improvement as measured by the MFSAF v2.0 electronic diary.

the study met its primary end-point and will be presented by Srdan Verstovsek, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, University of Texas – MD Anderson Cancer Center and Principal Investigator for COMFORT-I in the Presidential Symposium, one of the two plenary sessions at EHA, on June 11.

COMFORT-II, which was conducted by Novartis in the EU as part of the Incyte-Novartis worldwide collaboration and license agreement, is a randomized (2:1), open-label Phase III study of ruxolitinib versus best available therapy. COMFORT-II enrolled 219 patients with primary MF, PPV-MF or PET-MF in 56 study locations in Europe.

About Myelofibrosis (MF)

Myelofibrosis is a potentially life-threatening blood cancer characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms, such as fatigue, pruritus (severe itching), night sweats, bone pain and early satiety. MF is one of the Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), which also include polycythemia vera and essential thrombocythemia.2 Aberrant activation of the Janus kinase (JAK) pathway, which regulates blood cell production, has been associated with the development of the MPNs, including MF.3

Myelofibrosis is associated with poor prognosis and often results in a shortened survival. Up to 20% of patients can experience transformation to fatal secondary acute myelogenous leukemia within 10 years of diagnosis. currently, there are limited treatment options and no FDA-approved medicines for MF; the only potential cure is allogeneic stem cell transplant, for which a very small proportion of patients qualify.2

About Ruxolitinib

Ruxolitinib is Incyte’s lead internally developed JAK1 and JAK2 inhibitor that entered clinical trials in may 2007 and showed clinical activity in a number of hematologic disorders. This agent recently completed a global Phase III program (COMFORT) in myelofibrosis, and the new Drug Application is currently under review by the US Food & Drug Administration. Ruxolitinib also is in a global Phase 3 registration study, RESPONSE,4 in advanced polycythemia vera, a related hematologic neoplasm, as well as Phase 2 studies in patients with other hematologic malignancies and solid tumors. Other clinical studies evaluating ruxolitinib in patients with lymphoma and pancreatic cancer are planned.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, visit the Company’s web site at incyte.com.

Forward-Looking Statements

except for the historical information contained herein, the matters set forth in this press release, including statements regarding the presentation of the COMFORT-I results at one of the two plenary sessions at EHA on June 11 and other clinical studies evaluating ruxolitinib in patients with lymphoma and pancreatic cancer being planned, are all forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.

these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk and uncertainty associated with drug development and clinical studies, unanticipated developments in the efficacy or safety of ruxolitinib, the possibility that the outcomes for each of the planned clinical studies for ruxolitinib may not be favorable, the possibility that regulatory authorities may require additional clinical studies in order to support registration of ruxolitinib in any particular indication, the possibility that there may be other interpretations of the data produced in one or more of Incyte’s clinical studies, the results of further research and development, and other risks detailed from time to time in Incyte’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2011. Incyte disclaims any intent or obligation to update these forward-looking statements. Links to third-party websites or pages are provided for convenience only. each website is subject to its own terms of use, and we encourage you to consult these policy statements. Incyte has no control over third party sites and does not endorse or recommend these sites, and expressly disclaims any responsibility for the accuracy of content or opinions set forth in any third-party website or your use of that information.

References

1. Mesa RA, Verstovsek S, et al. Results Using the Modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0) in COMFORT-I: a Randomized, Double-Blind, Phase III Trial of JAK1/2 Inhibitor Ruxolitinib vs. Placebo in Myelofibrosis. Abstract #0912. 16th Congress of the European Hematology Association.

2. the Leukemia & Lymphoma Society. Idiopathic Myelofibrosis. 2007. available at lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/mpd/pdf/idiopathicmyelofibrosis. Accessed may 2011.

3. Vannucchi AM, Guglielmelli P, Tefferi A. Advances in understanding and management of myeloproliferative neoplasms. CA Cancer J Clin. 2009;59:171-191.

4. National Institutes of Health. Study of Efficacy and Safety in Polycythemia Vera Subjects who are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets versus Best available Care: the RESPONSE Trial. available at clinicaltrials.gov/ct2/results?term=%22The+RESPONSE+Trial%22. Accessed may 2011.

March 08, 2011 05:35 PM Eastern Daylight Time 

ROCHESTER, Minn.–(BUSINESS WIRE)–Here are highlights from the March issue of Mayo Clinic Health Letter. You may cite this publication as often as you wish. Reprinting is allowed for a fee. Mayo Clinic Health Letter attribution is required. Include the following subscription information as your editorial policies permit: Visit HealthLetter.MayoClinic.com or call toll-free for subscription information, 1-800-333-9037, extension 9771.

Getting Rid of Ulcer Pain

ROCHESTER, Minn. — There’s no need to put up with gnawing stomach pain due to ulcers. Most peptic ulcers can be cured in a matter of weeks, according to the March issue of Mayo Clinic Health Letter.

Peptic ulcers occur in the stomach or in the uppermost part of the small intestine (duodenum). The predominant symptom is a burning pain anywhere from the navel to the breastbone. Pain might last a few minutes to several hours. Typically, pain is worse when the stomach is empty and may flare at night. often, symptoms improve with eating food or by taking medication that reduces stomach acid.

Until 1980, doctors thought lifestyle factors such as stress and spicy foods caused ulcers. That’s not the case. It’s now known that the common bacteria Helicobacter pylori (H. pylori) often are the culprit behind ulcers. The bacteria damage the acid-tolerant lining of the stomach or duodenum, allowing stomach acid to reach more sensitive tissue underneath. The result is irritation and more tissue damage.

Regular use of anti-inflammatory pain medications is another common cause of ulcers. The medications can irritate and inflame the lining of the stomach, which can lead to ulcer development. Anti-inflammatory medications include celecoxib (Celebrex), diclofenac (Voltaren), ibuprofen (Advil, Motrin, others), naproxen (Aleve, Naprosyn) and ketoprofen. Aspirin also increases the risk of peptic ulcers.

an ulcer diagnosis is based on symptoms, medical history and imaging of the digestive tract. Blood tests, breath tests and stool samples may be used to check for H. pylori.

Regardless of the cause, treatment focuses on protecting the stomach or duodenum from stomach acid. A physician will likely prescribe one or more acid-reducing medications. if H. pylori is the cause, antibiotics also may be prescribed. Ideally, patients refrain from taking any anti-inflammatory medications.

With proper treatment, ulcers usually heal within a few weeks. While lifestyle factors aren’t the primary causes of ulcers, they can contribute to worsening symptoms. to encourage healing, it’s important to manage stress, stop smoking and avoid alcohol.

Mayo Invention Depicts Stiffness of Organs, Helps Doctors Diagnose Liver Disease

ROCHESTER, Minn. — A new diagnostic imaging tool invented at Mayo Clinic helps doctors know how internal organs feel to the touch, according to the March issue of Mayo Clinic Health Letter.

Called magnetic resonance elastography (MRE), the technology merges the age-old diagnostic practice of using touch — known as palpation — with high-tech magnetic resonance imaging (MRI).

MRE uses sound waves to vibrate soft tissues within the body, then captures and analyzes the characteristics of how the tissues vibrate. that information is used to create an image that depicts the relative stiffness of the body tissues and organs.

Mayo Clinic and other select medical centers are using MRE to diagnose early stages of liver disease. A healthy liver is soft and supple. Early liver disease causes a stiffening of the liver tissues from fibrosis, which can be detected quickly and painlessly with MRE. When diagnosed early, fibrosis can be halted or reversed with proper treatment. Advanced fibrosis can only be treated with liver transplant.

Previously, the only way to diagnosis liver fibrosis was by taking tissue samples (biopsies) using needles. This approach didn’t always produce accurate results. The sample could have come from healthy areas of a diseased liver.

Mayo Clinic researchers are studying MRE as a tool to aid in the diagnosis of other diseases and conditions, including breast cancer, brain injury, Alzheimer’s disease and musculoskeletal diseases.

Telomeres — the end Caps to Chromosomes — Provide Hints about Benefits of Healthy Living

ROCHESTER, Minn. — new findings about the protective end caps to DNA-filled chromosomes suggest that healthy lifestyles might influence a person’s genetic code, according to the March issue of Mayo Clinic Health Letter.

The research focuses on telomeres, end caps present on every DNA-filled chromosome. Telomeres often are likened to the plastic ends on a shoelace that prevent unraveling. Likewise, telomeres keep DNA within a chromosome from unraveling, becoming damaged or from accidentally linking to another chromosome.

Researchers have looked at both telomere length and changes over time. When healthy cells divide to facilitate healing or renew tissue, the DNA-containing chromosome within the cell nucleus divides, too. each division shortens the telomeres. Cells with shortened telomeres may lead to damaged chromosomes or may spark tumor growth. as a result, telomere length is emerging as a marker for the process of aging. But related research has found that the telomere shortening process can be slowed, stopped or even reversed with the enzyme telomerase.

Preliminary research shows that a healthy lifestyle increases telomerase activity. One three-month study found a 29 to 84 percent increase in telomerase activity among participants who ate a plant-based diet, walked briskly 30 minutes a day and underwent stress management therapy.

so far, there’s no known cause-and-effect relationship between telomeres and disease. But telomere health appears to be most enhanced by a healthy diet, exercise and stress management. these new discoveries suggest that a healthy lifestyle may be protective down to an individual DNA strand.

Mayo Clinic Health Letter is an eight-page monthly newsletter of reliable, accurate and practical information on today’s health and medical news. to subscribe, please call 1-800-333-9037 (toll-free), extension 9771, or visit HealthLetter.MayoClinic.com.

March 16, 2011 08:01 AM Eastern Daylight Time 

MORRISTOWN, N.J.–(BUSINESS WIRE)–Intendis, Inc., part of the Bayer Group, which makes Finacea® (azelaic acid) Gel, 15%, has developed the first Smartphone application (app) designed specifically for those with mild to moderate rosacea. The Rosacea App provides information, support and helpful tools that can be used to learn more about rosacea and to help manage its signs and symptoms. The Rosacea App is available free of charge to anyone who has an iPhone, Blackberry or Android Smartphone.

The Rosacea App provides instant access to an abundance of helpful information about the many issues faced by people with rosacea. Not only does it serve as a source of information, it also acts as a personal daily journal. A rosacea flare up can be caused by any number of triggers – from the weather, to different foods, to alcohol, to skin care products. it is important to keep track of potential triggers so that steps can be taken to help avoid them. The Rosacea App features a Trigger Tracker tool that can be used to track and manage these triggers. it also delivers daily Weather Alerts to inform users of a possible weather trigger. The Rosacea App is also equipped with a Substitution Finder that provides alternative suggestions for foods and drinks that can be used in place of those that may be triggering a rosacea flare up. The Rosacea App offers an Assessment Tool that helps one identify whether they may suffer from rosacea. it also provides answers to many of the Frequently asked questions about rosacea and provides an overview of the treatment options available – including a discussion about Finacea® (azelaic acid) Gel, 15% and its effectiveness in treating the bumps, pimples and associated redness of mild to moderate rosacea.

The Rosacea App provides a coupon for Finacea® that can be used at the pharmacy, directly from the Smartphone. It also gives the user the opportunity to register for special offers or to sign up for a monthly newsletter. By completing the built in questionnaire in The Rosacea App, the user will gather important information about their condition that they can take and discuss with their healthcare provider. The Rosacea App has been created with the special informational and educational needs of the sufferer of mild to moderate rosacea in mind.

INDICATION & USAGE

FINACEA is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

IMPORTANT SAFETY INFORMATION

FINACEA is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use. FINACEA is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. In clinical trials, sensations of burning/stinging/tingling occurred in 29% of patients, and itching in 11%, regardless of the relationship to therapy. Post-marketing safety – Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure to the eye. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with a dark complexion, these patients should be monitored for early signs of hypopigmentation.

other than FINACEA, Intendis, Inc. (part of the Bayer group) does not promote or endorse any products or recommendations made by third parties. all products and brand names listed are the property and responsibility of their respective trademark and copyright holders.

please see full Prescribing Information for FINACEA at finacea-us.com.

FINACEA is a registered trademark of Intendis, Inc.

Intendis is part of the Bayer Group.

About Intendis

Intendis Inc. is an U.S. based affiliate of Intendis GmbH, a fully integrated pharmaceutical company based in Berlin, Germany. As part of the Bayer Group, Intendis is dedicated to Dermatology and focuses on the development and marketing of high quality, innovative topical therapies, targeted to treat skin disorders. Intendis’ objective is to become a leading partner in the field of dermatology.

Find out more at intendis-us.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. these factors include those discussed in Bayer’s public reports which are available on the Bayer website at bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Data suggest the drug could address the most important unmet medical need in schizophrenia

PRINCETON, N.J.–(BUSINESS WIRE)–Nov 30, 2010 – Cyrenaic Pharmaceuticals inc. (“Cyrenaic”), a private drug development company focused on the treatment of CNS disorders, today announced Phase IIa clinical results for CYR-101, its novel investigational drug for the treatment of schizophrenia. the results from the study showed that the drug alleviated the symptoms of the disease, including the negative and cognitive symptoms.

Schizophrenia affects approximately 1% of the general population and is characterized by three major symptom classes: positive symptoms, such as hallucinations and delusions; negative symptoms, such as apathy and emotional flattening; and cognitive symptoms, including impaired memory and attention deficit. Most patients experience some degree of cognitive symptoms during the course of their disease, even during the prodromal phase. furthermore, if left untreated negative symptoms often lead to poor patient compliance with existing medications and poor control of disease burden.

Whilst existing medications primarily target positive symptoms but have no direct efficacy on other symptoms of this disease, there are currently no approved treatments for the specific treatment of negative or cognitive symptoms. a treatment for these symptoms therefore remains a major unmet medical need in schizophrenia. Despite these shortcomings, the global market for existing antipsychotics was estimated at $16 billion in 2008.

Commenting on the Phase IIa study results, Geoff race, Strategic Advisor to Cyrenaic, said: “We are very encouraged by the results of this study. We believe CYR-101 has the potential to deal with the important aspects of schizophrenia, including those symptoms currently not managed by existing therapies.

“These results confirm the promising efficacy signal that was observed in relevant animal models and open the door to treatment alternatives not only in schizophrenia but also in a number of other debilitating neurological and psychiatric diseases, suggesting a large spectrum of additional potential indications for CYR-101”.

The double-blind, randomized, placebo-controlled, multicentre study was conducted in Europe in 100 patients diagnosed with schizophrenia or schizoaffective disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders (Edition IV-TR). the most salient result observed after treatment with CYR-101 was a reduction of negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) compared to placebo. CYR-101 also improved cognition as measured by the Brief Assessment of Cognition in Schizophrenia instrument (BACS). Confirming the benign safety profile observed in four previously completed Phase I clinical studies, CYR-101 was well tolerated with no evidence of the side-effects associated with typical and atypical antipsychotics, including weight gain, prolactin increase and extrapyramidal symptoms.

Cyrenaic’s CYR-101 studies have been conducted by Forenap Pharma, an international leader in the field of neuroscience and psychiatric clinical trials.

-ends-

About Cyrenaic Pharmaceuticals Cyrenaic is focused on the development of CYR-101, an innovative antipsychotic in development for the treatment of schizophrenia that has the potential to treat all symptoms of the disease. the Company was established through a joint investment by Care Capital and Index Ventures in 2007. Cyrenaic is headquartered in Princeton, new Jersey, USA. Cyrenaic’s clinical studies are being conducted by French neuroscience CRO Forenap Pharma based in Rouffach, France.

For more information, please visit cyrenaicpharma.com

About CYR-101 CYR-101 is a small molecule new Molecular Entity with a novel mechanism of action that was in-licensed from a leading Japanese pharmaceutical firm. it shows potent antagonistic effects at 5-HT2A and sigma-2 receptors in vivo and in vitro and is devoid of direct modulatory activity on dopamine transmission.

About schizophrenia Schizophrenia is a chronic, severe and disabling mental disorder affecting 2.4 million Americans (approx. 1.1% of the U.S adult population) and approximately 5 million people globally. While there is no cure for the disease, correct medication and treatment is able to keep the disorder in check. According to Datamonitor, the global schizophrenia market was valued at US$16 billion in 2008. the symptoms of schizophrenia are broadly categorized as positive, negative, and cognitive symptoms. Positive symptoms are psychotic behaviors not seen in healthy people, such as hallucinations and delusions. Negative symptoms are associated with disruption to normal behavior and emotion, such as a lack of ability to sustain planned activity or a lack of pleasure in everyday life. Cognitive symptoms include problems with working memory and trouble focusing or paying attention.

Contact: Media enquiries College Hill Life Sciences Nicole Yost and Jayne Crook Email: cyrenaic@collegehill.com Ph: +44 (0)20 7866 7855 or Corporate enquiries Geoff race Email: geoff@cyrenaicpharma.com Ph: (+44) 7968 961 275 or US: Care Capital – Dr. Lorenzo Pellegrini Email: lorenzopellegrini@carecapital.com Ph: (+1) 609-683-8300 or Europe: Index Ventures – Dr. Michele Ollier Email: michele@indexventures.com Ph: +41 (0)22 737 00 00

Posted: November 2010

Press Release Source: A place of Hope.com on Wednesday December 29, 2010, 6:00 am EST

EDMONDS, Wash.–(BUSINESS WIRE)– Caring Online, an online resource for eating disorders such as anorexia, bulimia and binge eating, provides a free eating disorder survey, among other self-assessment tools, that helps survey takers determine whether they might have an eating disorder.

The survey consists of 101 questions and value statements about users’ eating habits and feelings toward food as well as their mental and physical health. Survey items include “Are you obsessed or preoccupied with what you are eating and with dieting?” and “I feel I must do things perfectly or not at all.” those taking the survey are asked to indicate how often they experience these feelings or engage in these behaviors or to what extent they agree or disagree with these statements.

“The survey is designed to help those who might be suffering from an eating disorder realize that they might have a troubled relationship with food and encourage them to seek the proper treatment,” said Dr. Gregory Jantz, author of the best-selling “Hope, Help and Healing for Eating Disorders” and founder of A place of Hope, a whole-person treatment center for eating disorders.

after submitting the confidential survey, each user is given a score that indicates the likelihood that an eating disorder is present based on the answers provided in the survey. Users are also given the option to have a representative from A place of Hope contact them with more information about treatment options.

in addition to the survey, Caringonline.com provides a wealth of resources on eating disorders, including a list of symptoms, treatment options, news and studies, as well as recommendations for informative books, videos, magazines and other websites on the subject.

To take the eating disorder survey or to get more information about eating disorders, please visit Caringonline.com.

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Gynesonics, Inc., a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids, announced today that the company has received the CE mark for its VizAblateTM system. The VizAblateTM system is intended to provide gynecologists with an incision-less procedure for the treatment of uterine fibroids associated with heavy menstrual bleeding. The VizAblateTM system is a transcervical device that combines ultrasound image guidance with radiofrequency ablation to treat fibroids in an outpatient setting. Symptoms from uterine fibroids have been reported to affect as many as 24 million women in the European Union.

“The VizAblateTM transcervical procedure is straightforward to perform and requires no incisions, making it appealing to gynecologists and their patients, especially when the primary option may be a hysterectomy.”

“The CE mark is an important milestone for the VizAblateTM system,” said Darrin Uecker, President and CEO of Gynesonics. “We are very pleased with our progress throughout 2010, and the CE mark positions us to expand our clinical base and begin commercialization in the European Union where there is strong demand from gynecologists for our product.”

“The VizAblateTM system provides gynecologists with a unique solution for treating uterine fibroids,” said Jose Gerardo Garza-Leal MD, Professor at the Universidad Autónoma de Nuevo León in Monterrey, Mexico and Principal Investigator for the VizAblateTM clinical studies that were completed in support of the CE mark. “The VizAblateTM transcervical procedure is straightforward to perform and requires no incisions, making it appealing to gynecologists and their patients, especially when the primary option may be a hysterectomy.”

as many as 3 out of 4 women will have fibroids during their reproductive life and, though not all will experience symptoms, it has been estimated that up to 30% will. Symptoms associated with fibroids include heavy menstrual bleeding, pelvic pain and pressure and urinary dysfunction. The most frequent surgical treatment for symptomatic uterine fibroids is hysterectomy, with approximately 250,000 hysterectomies being performed in the United States each year alone for fibroids.

The VizAblate SystemTM is currently available for investigational use only in the United States.

Gynesonics, Inc. is a privately-held company with venture capital investors Abingworth, ATV Capital, and Interwest Partners. The company has offices in Redwood City, CA.

For additional information visit Gynesonics.com or contact:

Darrin UeckerPresident and CEOGynesonics, Inc.Phone: 650-216-3860

Results demonstrate FFR-guided treatment offers cost-saving benefits to the U.S. healthcare system

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the publication of results from an economic evaluation of the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which confirmed FFR-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease improves patient outcomes and offers cost-saving benefits to the U.S. healthcare system.

“This study also reflects the benefits this technology has on patient care and the advantages it offers to the healthcare system as a whole.”

the one-year results, published in Circulation, demonstrate that treatment guided by St. Jude Medical’s FFR measurement system was cost-saving, finding mean overall costs associated with the FFR-guided group significantly lower than the group guided by angiography alone. mean overall costs for FFR-guided treatment was $14,300, compared to $16,700 for angiography-guided treatment, with cost savings occurring during both the initial procedure, primarily due to a decrease in unnecessary drug-eluting stent use, and during follow-up as a result of a decrease in re-hospitalization and fewer major adverse cardiac events (MACE). Results further indicated that MACE, such as death, myocardial infarction (heart attack) and repeat revascularization, occurred in 13.2 percent of patients who received FFR-guided treatment, compared to 18.3 percent of patients who received angiography-guided treatment.

“Economic evaluation of the FAME study reveals that FFR-guided percutaneous coronary intervention in patients with multivessel coronary disease is one of those rare situations in which a new technology not only improves outcomes but also conserves resources,” said William F. Fearon, M.D., associate professor, Stanford University Medical Center. “This study also reflects the benefits this technology has on patient care and the advantages it offers to the healthcare system as a whole.”

Current data show that physiological assessment using FFR prior to placement of coronary stents helps physicians to better optimize clinical outcomes by determining which specific lesion or lesions are responsible for a patient’s ischemia (a deficiency of blood supply to the heart caused by blood restriction). in addition, data have demonstrated that FFR measurements can be useful as an alternative to noninvasive functional testing, and to help assess an abnormal narrowing in a coronary artery for patients with anginal symptoms such as chest pain.

“St. Jude Medical believes FFR provides tremendous value to patients, physicians and hospitals,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “Not only is it clinically effective, but it is clear that it is a cost-effective treatment option for hospitals. we will continue to provide physicians with data that further demonstrate the significant benefits this technology offers for patients and healthcare systems around the world.”

the FAME study is a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. the study compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. the 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of MACE were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone. Based on its large size, multicenter nature, and randomized prospective design, the economic evaluation of the FAME trial further strengthens the evidence supporting the health economic advantage to performing FFR-guided percutaneous coronary intervention.

Two-year results, presented as a late-breaking trial during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference, demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent risk reduction of death or heart attack.

the St. Jude Medical FFR measurement system portfolio includes both the PressureWire™ Certus and the PressureWire Aeris™. the PressureWire Certus was the only FFR guidewire used in the FAME trial; the PressureWire Aeris is the industry’s only wireless technology available, which requires no additional equipment or cabling in the cardiac catheterization laboratory.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries as measured by PressureWire Certus and PressureWire Aeris. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients’ heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. the company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. for more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. the statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. these risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended October 2, 2010. the Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Press Release Source: BG Medicine, inc. On Tuesday November 23, 2010, 8:00 am EST

WALTHAM, Mass.–(BUSINESS WIRE)– BG Medicine, inc., a U.S.-based life sciences company, announced today that the U.S. Food and Drug Administration has cleared the company’s Galectin-3 test for use in conjunction with clinical evaluation as an aid to assess the prognosis of patients diagnosed with chronic heart failure. this marks the first time the FDA has cleared a test to measure galectin-3 blood levels, and is the first novel cardiac test cleared by the FDA in five years.

Galectin-3 is a protein that has been shown to play an important role in the development and progression of heart failure in approximately 30% of the patients diagnosed with heart failure.i this galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart’s ability to pump.ii the role of galectin-3 in heart failure was first established in 2004iii, and the clearance of the company’s Galectin-3 blood test now for the first time allows physicians to use this product in the evaluation of patients diagnosed with heart failure.

“The availability of a galectin-3 test to identify high risk patients with cardiovascular disease and myocardial fibrosis represents another step toward the goal of enabling more efficient targeting of therapeutic approaches to reduce fibrosis in patients with chronic heart failure,” said Bertram Pitt, M.D., F.A.C.C., professor of internal medicine, Division of Cardiology, University of Michigan School of Medicine.

Heart failure is caused by a combination of factors that reduce blood flow and damage or overwork the heart muscle, so that it cannot circulate blood efficiently to meet the needs of other body organs.iv Heart failure may lead to serious medical complications and is a leading cause of death. According to the American Heart Association, heart failure affects an estimated 5.8 million Americans with 670,000 new diagnoses each year. the estimated direct and indirect cost of this condition in the U.S. is $39.2 billion.v

“In recent times many major medical conditions have been redefined from a classical definition based on signs and symptoms to a science-based definition taking into account the underlying biology. With the introduction of our Galectin-3 test, we are offering physicians the first opportunity to identify those patients with higher levels of galectin-3. Galectin-3 has been implicated in important biological processes in heart failure, including myofibroblast proliferation, fibrogenesis, and cardiac remodeling,” indicated Pieter Muntendam, M.D., president and chief executive officer of BG Medicine. “It is an important step towards improved medical management in heart failure.”

the BGM Galectin-3 test is based on the common ELISA format using the standard microtiter plate presentation. BG Medicine is currently finalizing its commercialization plans with LabCorp, one of the world’s largest clinical laboratories, in order to make the BGM Galectin-3 test available within 45 days of the FDA clearance.

BG Medicine has also entered into agreements with Abbott Laboratories (NYSE:ABT – News), Alere inc. (NYSE:ALR – News), and bioMérieux SA (EURONEXT:BIM – News) for the development and commercialization of automated versions of the BGM Galectin-3 test for Abbott’s Architect immunochemistry instrument platform (i1000SR and i2000SR), Abbott’s hand-held i-STAT System, Alere’s Triage Meter Pro and the bioMérieux VIDAS/miniVIDAS systems.

BG Medicine is a life sciences company focused on the discovery, development, and commercialization of novel diagnostics to improve patient outcomes and contain healthcare costs. for further information about galectin-3 and the BGM Galectin-3 test, visit galectin-3.com.

i BGM Galectin-3 Product Insert.

ii de Boer, Rudolf A. et al. “Galectin-3: A novel Mediator of Heart Failure Development and Progression,” European Journal of Heart Failure. 2009; 11: 811–817.

iii Sharma, Umesh C. et al. “Galectin-3 marks Activated Macrophages in Failure-Prone Hypertrophied Hearts and Contributes to Cardiac Dysfunction,” Circulation, Journal of the American Heart Association. 2004;110:3121-3128.

iv hearthub.org/hc-heart-failure.htm. Accessed on October 25, 2010.

v Heart Disease and Stroke Statistics, 2010 Update. American Heart Association.

DURHAM, N.C.–(BUSINESS WIRE)–An article published recently in Psychosomatic Medicine 72:(November) 897-904) showed that the Williams LifeSkills video training program can reduce stress in individuals who care for a relative with Alzheimer’s disease. The impact of the 5-week video training was significant: depressive symptoms, perceived stress, anxiety and blood pressure were all reduced. These improvements were maintained or even enhanced six months after the video training was delivered. in this controlled study, caregivers were alternately assigned to two groups: one that participated in a video-delivered plus telephone coaching coping skills training program and another group that was wait-listed and received the training later.

“People who care for the 5 million Americans afflicted by Alzheimer’s disease are usually family members and they have been found to be at increased risk of developing both physical and mental health problems”

“People who care for the 5 million Americans afflicted by Alzheimer’s disease are usually family members and they have been found to be at increased risk of developing both physical and mental health problems”, commented Virginia Williams, President of Williams LifeSkills, the developer of the program and lead author on this paper. “These individuals are extremely stressed, and usually don’t have the time or the financial resources to attend more formally delivered coping skills programs. The advantage of the Williams LifeSkills video training is that is not only less costly, but can be viewed and studied in their home at times most convenient for the caregiver”.

Redford Williams, a co-developer of the training program and Professor of Psychiatry and Medicine at Duke University, added, “few stress reduction programs for caregivers have been shown to produce improvements in both psychological and biological stress markers. in this study, 116 caregivers were recruited over a 2-year period and were assessed before and up to six months later for both psychosocial and biological markers of stress. Compared to those in the wait list group, caregivers receiving video coping skills training not only reported lower levels of anxiety, perceived stress and depression, but were also found to have clinically meaningful reductions in blood pressure.”

Williams LifeSkills is a North Carolina based company that develops coping skills training programs to reduce physical and emotional stress in a wide variety of populations, including medical personnel, cardiac patients, teens and law enforcement officers. more information about Williams LifeSkills and its coping skills programs can be found at williamslifeskills.com

Reference: Psychosomatic Medicine 73:000–000 (2011)