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TORONTO, MONTREAL — Hospital stays for psychiatric patients have fallen sharply in recent years, suggesting that people with mental-health problems are being discharged quicker and sicker than ever before, a trend that alarms physicians and consumer advocates.

A report released yesterday by the Canadian Institute for Health Information showed there are fewer mental-health patients admitted to hospital per capita than five years ago. For those who do seek treatment, the average stay has plummeted 55 per cent, to 16 days in 2005-06 from 36 days in 2000-01.

While the report did not include data to indicate levels of patient health at the time of release, it did reflect significant changes in the treatment of mental disorders, which have largely shifted from the realm of psychiatric-specific care facilities, where the most common length of stay is 26 days, to general hospitals, where the most common stay lasts eight days.

"If people don’t understand what’s behind the numbers, they’ll think this is a good-news story. That worries me," said Phil Upshall, national executive director of the Mood Disorders Society of Canada.

Patrick White, president of the Canadian Psychiatric Association, said the drop in patients’ length of stay reflects overall "pressure on the system." Because of hospital bed shortages - or inefficient use of beds allocated for psychiatric care - patients are being discharged more quickly even though they are sicker and more unstable than in the past, he said.

While 16 days may seem like a long time to spend in hospital, Dr. White, who runs the psychosocial, vocational and behavioural unit at Alberta Hospital in Edmonton, said for a patient with chronic schizophrenia who suffers a relapse, it is much too short.

"It should probably be a least 30 days, but there is pressure to free up the bed for someone else," he said.

Mental-health patients typically lose out to patients with physical illnesses in bed-shortage scenarios, Mr. Upshall said.

"Hospitals and hospital administrators have traditionally discriminated against mental-health conditions and people with them. That’s principally because of, in my view, the stigma attached to mental illnesses," he said.

"They’re discharging people into the community without the necessary supports. You would never discharge a patient with a broken back in need of a wheelchair without a wheelchair."

Dr. White said the decreases in hospital stays might be partly attributable to advances in medication used to treat psychiatric illnesses, which are now more effective and have fewer side effects, so patients have fewer relapses that require hospitalization.

According to the report, hospital readmission rates varied across the country, with the lowest being in Manitoba and Saskatchewan, and the highest in Prince Edward Island and British Columbia.

It also found that nearly 20 per cent of people discharged from hospital suffer some form of mental illness. Mood disorders such as depression and bipolar disorder made up the greatest proportion of mental-illness hospital admissions in every province. In the Northwest Territories and Yukon, substance-related disorders were the most common diagnoses.

David Goldbloom, vice-chair of the Mental Health Commission of Canada, a professor of psychiatry at the University of Toronto and the senior medical adviser of education and public affairs at the Centre for Addiction and Mental Health, said there is not enough patient-specific information in the report to speculate on what is driving the trends.

"What you can say on an optimistic level is maybe there are more resources in the community to provide care for people," Dr. Goldbloom said, adding: "All of this is a bit moot in the absence of crucial information on how people are doing."

TORONTO — Downing a morning glass of grapefruit or other juice may be a great way to get vitamin C. But for those taking certain medications, the common breakfast beverage could also do serious harm.

A Canadian study shows that drinking the juices can dramatically decrease the body’s ability to absorb certain drugs — including some taken for life-threatening conditions like cancer and heart disease.

Researchers at the University of Western Ontario in London found that subjects who took a particular antihistamine with grapefruit juice absorbed only half the drug compared to those who took the pill with water.

Other drugs that are absorbed in a similar way as the antihistamine would likely be affected in the same way, the researchers say.

“The concern is basically for a loss of effect for drugs, and particularly those … used in serious medical conditions,” principal researcher David Bailey said Tuesday from Philadelphia, where he presented the study’s findings at the national meeting of the American Chemical Society.

Mr. Bailey, a professor of clinical pharmacology, said an active ingredient in grapefruit juice appears to block a transporter protein that allows absorption of certain drugs from the small intestine into the bloodstream. Orange and apple juices contain similar ingredients.

The drugs include an anti-cancer agent, some beta blockers that can prevent a second heart attack and a medication to prevent rejection of transplanted organs, he said.

“These are three serious medical conditions for which the drugs simply have to work properly.”

In 1990, Mr. Bailey reported on the first known food-drug interaction, when his team discovered that grapefruit juice boosted the potency of the high blood pressure drug felodipine, leading to toxic levels of drug in the blood.

Since then, other researchers have identified about 50 medications that are subject to the so-called “grapefruit juice effect.” Some prescription drugs now carry warning labels against consuming the juice or fresh grapefruit while taking the medications to avoid overdose.

The new study shows that grapefruit, orange and apple juices — and also the whole fruits — can have the opposite effect, by limiting absorption.

To date, the fruit juices have been shown to lower the absorption of the anti-cancer agent etoposide; the beta blockers atenolol, celiprolol and talinolol; the anti-rejection drug cyclosporine; and the antibiotics ciprofloxacin, levofloxacin and itraconazole.

“This is just the tip of the iceberg,” said Bailey. “I’m sure we’ll find more and more drugs that are affected this way.”

Commenting on the research, Dr. David Juurlink of Sunnybrook Health Sciences Centre in Toronto said there are probably dozens of transporter proteins that pump drugs in and out of tissues all over the body that could be affected by what we ingest.

“And we have only a very rudimentary understanding of what these pumps do and what drugs they affect and what other drugs or foods might modulate these pumps,” said Dr. Juurlink, Sunnybrook’s head of clinical pharmacology and toxicology.

“There’s a lot of uncertainty in terms of what the implications are for the average person.”

Mr. Bailey said patients should check with their doctor or pharmacist before taking a drug with grapefruit or other fruits and juices. As a general rule, he suggests avoiding consumption for about four hours before and after taking a pill.

“The best thing to do in general to get the most consistent effect of your drug … is to take it with a glass of water on an empty stomach.”

Dr. Juurlink said that while the four-hour window is reasonable advice, there’s too little known about the complexity of food-drug interactions to come up with a hard-and-fast rule for all patients and all medications.

“It’s hard to formulate a generic recommendation that fits everybody, other than be aware of the fact that food — and grapefruit in particular — can influence how your body handles drugs.”

LAVAL, QUE. — The natural next step for Canada’s health system is allowing more private delivery, which will give patients more choice, and better access to care, the new president of the Canadian Medical Association says.

“My whole career has been about resolving access issues. This is my battle horse,” said Robert Ouellet, who takes over Wednesday as president of the CMA.

“Private delivery is an accepted practice everywhere in the world and it’s time Canada accepted this reality.”

A radiologist by training, Dr. Ouellet, 62, owns and operates five medical imaging clinics in suburban Montreal. He is an unabashed promoter of private-sector delivery of medical care and keen to introduce more competition into Canada’s health-care system, and he knows this will make him a lightning rod for criticism.

A team of researchers from Canada and the United States has taken an important step toward harnessing the healing power of menstrual blood.

They used stem cells isolated from the menstrual blood of two women and cloned by a San Diego company to save the legs of eight severely injured mice.

University of Western Ontario surgeon Hao Wang injected the menstrual stem cells into mice that had had the blood vessels to their legs blocked and the nerves tied. The mice that received the injection immediately after they were injured recovered, although two of them limped. But the legs of the mice in the control group turned black and fell off after 10 days, Dr. Wang said. All of the mice in the experiment were male.

The findings, reported yesterday in the Journal of Translational Medicine, are preliminary, but offer a glimpse into the potential of stem cells derived from menstrual blood in treating human patients, male and female.

Thomas Ichim, CEO of Medistem Laboratories, the company that cloned the stem cells, is hoping they will prove to be an effective treatment for both men and women with a condition known as critical limb ischemia - serious obstruction of arteries that leads to decreased blood flow to hands, legs and feet. The condition causes 150,000 amputations a year in the United States.

Dr. Ichim is keen to begin a small human trial if he can get approval from the U.S. Food and Drug Administration and also hopes to investigate whether cells might also help people with multiple sclerosis and liver failure.

Dr. Ichim and one of the other authors of the paper, Neil Riordan, are both shareholders and managers at the publicly traded company. Dr. Wang and the other scientists are not shareholders. He says it is promising that the human stem cells worked so well in mice.

In the developing embryo, stem cells have an endless capacity for self-renewal and give rise to every type of cell in the body - skin, muscle, bone, heart, liver, kidney, brain and more than 250 other kinds of specialized cells. In adults, stem cells are far more rare, and provide the replacement cells to keep our bodies healthy and working well.

Scientists around the world are working to harness the regenerative power of stem cells to repair the human body.

Using embryonic stem cells is controversial because some come from aborted fetuses (some also come for umbilical cords). Many scientists are now trying to side step the ethical debate by reprogramming mature cells back to their embryonic state.

Getting stem cells from menstrual blood is another approach. The lining of the uterus is shed every month when a woman has her period. Research suggests the endometrium, or lining of the uterus, is rich in adult stem cells.

In 2007, researchers announced that cells taken from the menstrual blood of two women could be coaxed into becoming nine different types of cells, including muscle, nerve and bone.

It is those cells that Medistem Laboratories has cloned, Dr. Ichim said. The company calls them endometrial regenerative cells. The next step, said Dr. Wang, is to figure out exactly what these stem cells did to save the legs of the mice that had been injured.

It may be, Dr. Ichim said, that they produced growth factor that stimulated mouse stem cells to repair the damage.

People who have contracted West Nile virus - even those with some serious neurological complications - can take heart that they will fully recover over time, Canadian researchers say.

In a study of 156 Canadians afflicted with West Nile virus disease, including some who developed potentially fatal meningitis and encephalitis, the average time to recovery was about a year, said principal investigator Mark Loeb, an infectious-disease specialist at McMaster University in Hamilton, Ont.

"If they’re infected with West Nile, where they have West Nile fever or they have West Nile virus meningitis or encephalitis, these data can tell them what to expect, that gradually over about a year their mental and physical function generally and on average will return to normal," Dr. Loeb said.

While there is always some variation among individual patients, Dr. Loeb said, "I think at least it helps patients and physicians and their families to know what to expect over time."

MONTREAL — Some of the worst discrimination and stigma faced by people suffering from mental illness comes from their health-care providers, the chairman of the Mental Health Commission of Canada says.

Michael Kirby exhorted Canada’s doctors yesterday to "demonstrate a commitment to healing" by tackling head-on the myths and stereotypes about people with mental illness.

"I challenge you to help us change public attitudes, to help reduce stigma and discrimination. You can play an invaluable role in improving the lives of people living with mental illness by becoming a community leader on the stigma issue," he said in an address to the 141st annual meeting of the Canadian Medical Association, taking place this week in Montreal.

The Mental Health Commission of Canada, created last year, has among its priorities the development of a national mental-health strategy and a long-term stigma-reduction campaign.


Recent

  • Stigma of mental illness pervasive: CMA head 

We ask the experts to settle common questions we’ve all wondered about. If you’ve got a question, send it to seriously@globeandmail.com. Be sure to include your hometown and a daytime contact number so we can follow up with any queries.

QUESTION I hear my partner snoring at night and I am worried that it might be sleep apnea - how can I tell and what should we do?

ANSWER Although an overnight study performed at the sleep clinic by a medical professional is the most reliable way to determine whether someone suffers from obstructive sleep apnea, there are indicators of this condition that are frequently reported by sufferers or their sleeping partners. Snoring is one.

But not everyone who snores has OSA. OSA affects 2 to 5 per cent of people over 30 and is much less common than snoring, but there are similarities in these two conditions. Both snoring and sleep apnea occur more often in men than women (the ratio is 2:1) although this difference disappears after menopause.


From the archives

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Tadalafil Shows Promise for Relief of Lower Urinary Tract Symptoms Associated With BPH

NEW YORK, August 19, 2008 – Men with signs of benign prostatic hyperplasia (BPH) can be helped with a daily dose of erectile dysfunction drug tadalafil (Cialis®) to relieve associated lower urinary tract symptoms (LUTS), according to a new study published in the October 2008 issue of The Journal of Urology. Researchers from the University of Texas Southwestern Medical Center at Dallas, Northwestern University and Lilly Research Laboratories report on a randomized, double-blind, placebo-controlled study of over 1000 men in ten countries.

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Claus G. Roehrborn, MD, Professor of Urology, University of Texas Southwestern Medical Center, states, “Since reports of erectile dysfunction (ED) incidence, pathophysiology and treatment have shown a possible link between BPH LUTS and ED. PDE5 inhibitors like tadalafil (Cialis®) have received increased attention for treating BPH LUTS, although they are currently only approved for ED. The half-life of tadalafil is 17.5 hours, making it suitable as once daily therapy. Although the precise mechanism of action by which PDE5 inhibitors may alleviate LUTS is not completely understood, several putative mechanisms are currently under investigation.”

Men with signs of BPH may experience LUTS, such as urinary frequency, urgency, intermittence, nocturia, straining, incomplete emptying or a weak urinary stream. LUTS increase with age with an overall prevalence of greater than 50% in men 50 years or older. Drugs currently used to treat these symptoms can produce unwanted side effects, including dizziness, low blood pressure and sexual dysfunction.

Participants in the tadalafil study were required to have at least a 6-month history of LUTS secondary to BPH. Subjects with a high PSA (more than 10 ng/ml) were excluded, as were subjects with other complicating conditions or conflicting drug treatments. Anyone who had undergone treatment for erectile dysfunction or other BPH treatments underwent a 4-week treatment-free screening period. All participants then received placebo for 4 weeks prior to randomization. The 1056 subjects were then divided randomly into 5 groups that received a placebo, or doses of 2.5, 5.0, 10.0 or 20.0 mg/day of tadalafil.

Using the International Prostate Symptom Score (I-PSS), a validated seven-item questionnaire about LUTS occurring within the last month, the researchers found that all doses of tadalafil were superior to placebo for relieving LUTS, with statistically significant effects at 4, 8 and 12 weeks. The treatments decreased I-PSS scores from 3.9 to 5.2 points in the different dosage groups, a clinically meaningful improvement according to the guidelines of the American Urological Association. Of the doses studied, 5 mg per day improved the I-PSS by 4.9 points and provided the best risk-benefit profile.

 

###

The article is “Tadalafil Administered Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Dose Finding Study” by Claus G. Roehrborn, Kevin T. McVary, Albert Elion-Mboussa and Lars Viktrup. It appears in The Journal of Urology, Volume 180, Issue 4 (October 2008) published by Elsevier.

Contact: Linda Gruner
l.gruner@elsevier.com
212-633-3923
Elsevier Health Sciences

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Video: Asmanex Twisthaler 110 MCG (Mometasone Furoate Inhalation Powder) is Now Available Nationwide for the Maintenance Treatment of Asthma in Children Ages 4 to 11

ASMANEX is the first and only once-daily inhaled corticosteroid inhaler approved for children as young as age 4

KENILWORTH, N.J., August 19, 2008 /PRNewswire-FirstCall/ — Schering-Plough Corporation announced today that ASMANEX(R) TWISTHALER(R) 110 mcg (mometasone furoate inhalation powder) is now available in pharmacies nationwide. ASMANEX is indicated for the maintenance treatment of asthma as prophylactic therapy in patients four years of age and older, and is the first and only once-daily inhaled corticosteroid inhaler approved for this use in children as young as 4. ASMANEX was approved for children ages 4 to 11 by the U.S. Food and Drug Administration (FDA) in February 2008. It is not indicated for the relief of sudden asthma symptoms or in children less than 4 years of age.

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 To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/asmanex/34590/ 

ASMANEX provides physicians with a new treatment option to help manage children’s asthma as back-to-school season approaches. Studies show that asthma attacks increase in the back-to-school months, and that asthma emergency room and hospitalization rates spike in September.(1) With asthma affecting more than one child in every 20 in the United States(2), physicians need to help parents and their children be prepared to face the obstacles of managing asthma symptoms during the new school year.

“In my practice, I see an increase in pediatric asthma patients this time of year as children return to school and become exposed to a new environment with new allergens or irritants that may aggravate their symptoms,” said Kevin R. Murphy, M.D., board certified pediatric pulmonologist and director of allergy, asthma and pulmonary research at Boys Town National Research Hospital, Omaha, Nebraska. “It is important for parents and their children’s physicians to be aware of safe and effective daily treatment options, such as ASMANEX, to treat their child’s asthma and prevent symptoms before they start.”

When taken every day, maintenance inhalers like ASMANEX can help prevent asthma symptoms, such as coughing, wheezing and shortness of breath.(3) According to updated guidelines from the National Asthma Education and Prevention Program, inhaled corticosteroids are the preferred foundation therapy for initiating long-term control treatment in children with persistent asthma.(4) Daily use of ASMANEX helps manage asthma in patients with persistent asthma, and its automatic dose counter helps patients track remaining doses.

“As the back to school season approaches, it is important for parents to monitor their child’s asthma symptoms and work with their physician to determine an appropriate asthma management plan,” said Nancy Sander, founder and president of the Allergy & Asthma Network Mothers of Asthmatics. “A once-daily treatment is a useful option to help parents establish a regular routine for their children when taking asthma medication.”

Asthma symptoms can occur at any time, so in addition to use of a quick relief inhaler to treat sudden asthma symptoms and managing asthma with a maintenance inhaler, it is also important for parents to work closely with their child’s doctor to identify asthma triggers that can exacerbate a child’s asthma symptoms during school.(5) For example, classrooms may contain indoor allergens like dust mites and molds, as well as irritants including chalk dust and strong odors.(6) Additionally, children may experience difficulty breathing outside during recess or before and after school, as a result of exposure to outdoor allergens, weather changes and diesel exhaust created by school buses.(6, 7)

About Pediatric Asthma

Asthma is a chronic disorder characterized by inflammation of the air passages, resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.(3, 2) Asthma symptoms, such as coughing, wheezing, and shortness of breath, can occur and can impact multiple aspects of patients’ lives.(3) Asthma is the most common chronic condition among children, and it is the cause of almost three million physician visits and 200,000 hospitalizations among children each year in the United States.(2, 8) It is also the third leading cause of hospitalization among children.(2)

About ASMANEX(9)

ASMANEX 110 mcg has not been demonstrated to be effective in treating asthma symptoms caused by specific asthma triggers.

The U.S. Food and Drug Administration (FDA) approved the use of ASMANEX 110 mcg for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age in February 2008. The approval was based in part on results from a 12-week placebo-controlled trial of 296 patients 4 to 11 years of age who had been diagnosed with mild to moderate persistent asthma for at least six months. Results showed significant improvement in percent predicted FEV1 (forced expiratory volume in one second) from baseline to endpoint in patients treated with ASMANEX 110 mcg once-daily, in the evening, compared to placebo (P=0.002). In this study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of the efficacy of ASMANEX. The only approved dose for children 4 to 11 is 110 mcg (1 puff) administered once daily in the evening.

ASMANEX was discovered and developed by Schering-Plough Research Institute and is currently approved for asthma treatment in more than 40 countries. ASMANEX offers an effective inhaled corticosteroid to help manage asthma symptoms in a device that was awarded the DuPont Award for innovation in packaging. The ASMANEX TWISTHALER employs an inhalation-driven device that does not use a propellant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.

ASMANEX is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. ASMANEX is not indicated for the relief of sudden asthma symptoms or in children less than 4 years of age. It is available in two dose strengths, 110 mcg for children between 4 and 11 years old, and 220 mcg for patients 12 and older.

ASMANEX is not a rescue inhaler and should not be used to treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma symptoms.

ASMANEX should not be used to treat acute asthma episodes (including status asthmaticus) where extra measures are required.

ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone or any of the ingredients in ASMANEX. There have been cases of hypersensitivity, allergic reactions, facial swelling, hives, and throat tightness reported.

Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX.

It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider as the dosage of ASMANEX should be reduced slowly.

If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.

Avoid coming in contact with measles, chicken pox virus, tuberculosis, or any other infections before or while using ASMANEX. Contact your health care provider immediately if you or your child have been exposed.

Patients who use inhaled steroids, including ASMANEX, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.

Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient’s dose to the lowest dose that effectively controls his/her symptoms.

ASMANEX may increase the risk of some eye problems such as cataracts, glaucoma, and increased intraocular pressure. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.

Use ASMANEX as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.

The most common side effects with ASMANEX in patients 4-11 years old include fever, allergic rhinitis, abdominal pain, vomiting, urinary tract infection, and bruise.

The most common side effects with ASMANEX in patients >12 years old include headache, allergic rhinitis, sore throat, and upper respiratory infection.

 

 Full prescribing information is available at: http://www.spfiles.com/piasmanex.pdf 

About Schering-Plough Corporation

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to potential market for ASMANEX TWISTHALER 110 mcg. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Part II, Item 1A. “Risk Factors” in Schering-Plough’s 2008 10-Q for the quarterly period ended June 30, 2008, filed August 1, 2008.

References:

1. Johnston, NW et al. The September Epidemic of Asthma Hospitalization: School Children as Disease Vectors. Journal of Allergy and Clinical Immunology. March 2006. Vol. 117(3); 557-562.

2. “Asthma Facts and Figures.” Asthma and Allergy Foundation of America, 2005. http://www.aafa.org/display.cfm?id=8&sub=42

3. “What is Asthma?” National Heart Lung and Blood Institute, May 2006. http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html

4. “National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma.” National Institutes of Health. National Heart Lung and Blood Institute, 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf

5. “Topic of the Month: August 2005: Preparing for School with Allergies and Asthma.” American Academy of Allergy Asthma & Immunology. http://www.aaaai.org/patients/topicofthemonth/0805/

6. “Managing Asthma: A Guide for Schools.” National Asthma Education and Prevention Program, July 2003. http://www.nhlbi.nih.gov/health/prof/lung/asthma/asth_sch.pdf

7. Wargo, John. Children’s Exposure to Diesel Exhaust on School Buses. Environment & Human Health, Inc. February 2002. http://www.ehhi.org/reports/diesel/dieselintro.pdf

8. “Tips to Remember: Childhood Asthma.” American Academy of Allergy Asthma & Immunology, May 2007. http://www.aaaai.org/patients/publicedmat/tips/childhoodasthma.stm

 

 9. Asmanex Twisthaler [package insert]. Kenilworth, NJ: Schering Corporation. 2008. Press Contact: Julie Lux 908-298-4774 Gail Thornton 908-298-5313 Investor Contact: Janet Barth Joe Romanelli 908-298-7436 

CONTACT: Press, Julie Lux, +1-908-298-4774, or Gail Thornton,+1-908-298-5313; or Investors, Janet Barth or Joe Romanelli,+1-908-298-7436, all for Schering-Plough Corporation

Web site: http://www.spfiles.com/piasmanex.pdf/http://www.schering-plough.com/

Ticker Symbol: (NYSE:SGP)

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Nycomed: Moving Ahead – Strong Results in Second Quarter 2008

   

  • Strong sales in key home markets
  • Core products continue to develop very well
  • Veltuzumab in-licensing significantly strengthens pipeline
  • Oncology sale successfully closed

 

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The financial results reported in this press release are related to Nycomed S.C.A. SICAR and comprise all of the Nycomed Group’s operations. A full interim report is attached.

 

ZURICH, Switzerland, Aug. 18, 2008–In the first six months of 2008, Nycomed’s adjusted EBITDA increased by 4.9% to € 653.7 million compared to € 623.3 million in the first six months of 2007, benefiting from the cost decreasing effects of last year’s restructuring and as a result of the successful integration. Most of Nycomed’s markets and key products have performed well for the first half year of 2008 and provided a counterweight to the decreasing sales of Pantoprazole in the US.

 

Total net turnover decreased by 3.4% to € 1,714.5 million compared to € 1,774.0 million in the first six months of 2007 primarily due to the negative effect of “at-risk” launches of generic Pantoprazole in the US and positively impacted by the execution payment from the out-licensing agreement with Sepracor. Adjusting for these effects and the loss of the imaging business from Bracco, total net turnover in the first half year increased by 3.1% compared to the same period in 2007.

 

“We are pleased to report that the second quarter of 2008 has been very satisfactory for Nycomed. Our home markets, especially the Western European key markets, continue to trade significantly above our expectations,” said Håkan Björklund, Nycomed’s Chief Executive Officer.

 

“The in-licensing agreement with Immunomedics on veltuzumab is a significant addition to our pipeline. Veltuzumab offers an excellent strategic fit with Nycomed’s other programs in the field of autoimmune and inflammatory diseases,” he added.

Key figures

 

Q2 2008

(m€)

Q2 2007

(m€)

Change

2008 YTD

(m€)

2007 YTD

(m€)

Change

Net turnover

884.2

900.5

-1.8%

1,714.5

1,774.0

-3.4%

Gross profit

margin

681.6

77.1%

655.1

75.6%

+4.0%

+2.0%

1,295.8

75.6%

1,287.2

75.4%

+0.7%

+0.2%

Operating income

178.7

149.9

+19.2%

261.7

199.4

+31.3%

EBITDA

margin

335.9

38.0%

293.7

32.6%

+14.4%

+16.5%

634.6

37.0%

523.9

29.5%

+21.1%

+25.3%

Adjusted EBITDA

margin

349.6

39.5%

337.0

37.4%

+3.8%

+5.7%

653.7

38.1%

623.3

35.1%

+4.9%

+8.5%


Markets

Most markets have performed well for the first six months of 2008. Sales in Russia/CIS grew by 18.0% (37.0% in local currency) while sales in Germany developed satisfactorily despite significant price reductions. Pantoprazole sales in Canada and Spain were impacted by generic competition and price reductions respectively.

 

In Europe, sales in the first six months remained stable compared to the same period 2007. Most of the Scandinavian and Central European countries are characterised by a stable demand with single-digit market growth. In Italy, sales in the second quarter have increased considerably, showing a 28.8% growth compared to the same period in 2007. Excluding the imaging business, sales in Germany increased by 6.2% for the six-month period. The markets in Eastern Europe showed double-digit growth compared to first half 2007, notably Czech Republic and Croatia, while Romania and Greece nearly doubled net turnover.

 

In the Latin America, Canada and South Africa region (Argentina, Brazil, Mexico, Canada and South Africa) total net turnover decreased by 6.9% for the first six months compared to the same period in 2007. The declining growth is mainly caused by considerably lower Pantoprazole sales in the second quarter of 2008 in Canada as a result of the entry of generics. Sales in Argentina are showing very positive trends. June year-to-date sales in Brazil were slightly above sales for the first six months of 2007 in local currency, whereas sales in Mexico and South Africa have slightly decreased in local currency compared to the previous year.

 

In Russia /CIS, Nycomed’s fastest growing region, sales increased by 18.0% for the first six months of 2008 compared to the same period in 2007. However, adjusting for the unfavourable impact from exchange rates, sales growth was approximately 37.0% in local currency for the first six months. Sales growth, in local currencies, was approximately 28.0% for the second quarter.

 

Total sales of Nycomed US, a specialty business focusing on dermatology and emergency care in the United States, increased by 14.4% for the first six months. This result was impacted by the acquisition of Bradley. Adjusting for this and for the unfavourable impact of the US dollar, sales increased by 3.0% for the first six months of 2008 compared to 2007.

 

For the total International Sales/Export business, excluding Australia, product sales for the first six months decreased approximately 7.0% compared to the same period in 2007 mainly due to lower sales of Pantoprazole and a few other products in Asia.

 

Contract production grew by 18.9% to € 35.4 millions for the first six months of 2008 due to increased demand related to Nycomed´s contract manufacturing agreements.


Products and pipeline

Sales of Nycomed’s top-earner Pantoprazole were adversely affected by the “at-risk” launch of generic Pantoprazole tablets in the United States. Other core products such as Calcium, TachoSil®, Preotact® and Alvesco® continue to develop very well.

 

In January 2008, Nycomed and Wyeth launched an own generic version of Pantoprazole in the United States. While this own generic has had some success in the market, its sales have not and cannot offset the substantial harm caused by the launch of infringing generics. Nycomed and Wyeth remain convinced of the validity and enforceability of their patent and will continue to vigorously pursue litigation.

 

In mid-April, Nycomed launched its nasal corticosteroid Omnaris™ in Canada. In the United States, business partner Sepracor launched the product mid-April.

Licensind and acquisitions

Nycomed signed two significant licensing agreements in the second quarter 2008 and successfully finalised the divestment of its oncology portfolio by transferring it to Bayer Schering Pharma and 4SC AG.

 

Veltuzumab. On 14 July 2008, Nycomed and Immunomedics announced a collaboration and licensing agreement on Immunomedics’ veltuzumab. Under the agreement, Nycomed will receive the exclusive, worldwide rights to develop, manufacture and commercialise the subcutaneous formulation of veltuzumab for the treatment of all non-cancer indications. Veltuzumab presents a significant enhancement to Nycomed’s autoimmune and inflammation pipeline, and Nycomed will develop veltuzumab in rheumatoid arthritis (RA) as the primary indication.

 

Atimos®. In late June, Nycomed Canada Inc. announced a licensing agreement with Chiesi Farmaceutici SpA to market Atimos® (formoterol), a treatment anticipated for asthma and chronic obstructive pulmonary disease (COPD).

 

Oncology Projects. Following the introduction of its new research and development (R&D) strategy in 2007, Nycomed reviewed all drug development projects. In order to focus its resources on its core therapeutic areas, Nycomed decided to discontinue its cancer research activities and sell the related projects.

 

Nycomed agreed with 4SC AG, Germany, on the sale of a major part of Nycomed’s R&D projects in the field of oncology. Eight projects in the preclinical and first clinical stage have been transferred to 4SC. The company, based in Martinsried, will assume full ownership of the eight projects, while Nycomed retains rights to research, develop and commercialise outside the scope of the patents sold. The transaction closed on 31 July 2008. Nycomed received a total payment of € 14 million.

 

As the second step in the divestment of its Oncology portfolio, Nycomed signed a contract with Bayer Schering Pharma on 24 July 2008. This agreement comprises two potential drug candidates and an extensive back-up program for which Bayer Schering Pharma will assume full development and commercialisation rights. Nycomed will receive an initial reward, as well as payments upon completion of agreed preclinical and regulatory milestones. Overall compensation could total € 52 million.

 

Bradley. Nycomed successfully completed the acquisition of Bradley Pharmaceuticals, a company focused on niche therapeutic markets in the United States making Nycomed US a leader in the US dermatology market, with combined annualised dermatology sales of US $ 450 million. In the second quarter of 2008, the synergies from the integration were even greater than expected, resulting in a positive effect on cost savings in marketing, sales and administration.

Outlook for 2008

Based on the current market conditions and exchange rate movements, we expect an adjusted EBITDA for the year of 2008 of approximately € 1,160.0 billion.

Financial background

Adjusted EBITDA and EBITDA are key figures used in order to have a more comprehensive analysis of our operating performance and of our ability to service our debt.

 

Adjusted EBITDA means net earnings before net financial items, income taxes, depreciation of tangible assets and amortization of intangible assets, adjusted for certain unusual or non-recurring items.

 

In connection with Nycomed’s acquisition of Altana Pharma AG on 29 December 2006, a new holding structure became effective by way of a share exchange between the private equity investors of Nycomed A/S (the former holding company of the Nycomed Group) and the new holding company, Nycomed S.C.A. SICAR, Luxembourg. At that date, Nycomed S.C.A. SICAR became the ultimate parent company in the Nycomed Group. Comparison figures are presented as if Nycomed S.C.A. SICAR had always been the ultimate parent company.

 

 

About Nycomed

Nycomed is a privately owned pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

 

The company is active in a range of therapeutic areas, focusing on gastroenterology, respiratory, inflammation, pain management, osteoporosis and surgical management. New products are sourced both, from its own research and from business partners.

 

Nycomed is European based with a presence in over 50 countries worldwide and an increasing emphasis on fast growing markets.

 

The combined group employs 12,000 people. In 2007, it had annual sales of € 3.5 billion and an adjusted EBITDA of € 1.2 billion.

 

For more information visit www.nycomed.com

For further information

Investors:
Christian B. Seidelin, Vice President Controlling, Treasury and Insurance
Phone +41 44 555 11 04

 

Media:
Tobias Cottmann, Director External Communications
Phone +41 44 555 15 10

 

 

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