THUNDER BAY — As the winds that blow off the northern shores of Lake Superior grow colder, the streets and trees of Thunder Bay become more bare.
It’s a natural passing of the seasons, but in a community long plagued by unemployment, drug use and doctor shortages, health officials have expressed concern that the winter season may strengthen the storm of invasive Group A streptococcus, also known as IGAS, that has reached this northern community.
About 75 people in the area surrounding and including this city of about 109,000 have become infected and at least 10 have died. Health officials have known of the outbreak of contagious bacteria for months but informed the public only last week.
The eye of the strep storm has sat over the city’s south core, where drug users take shelter from the cold in abandoned buildings.
In those crowded dens on Simpson Street, where bathrooms, needles and pipes are shared, IGAS can spread like wildfire and the Thunder Bay District Health Unit has defended its silence about the outbreak by saying the risk of infection was concentrated there, not among the general population.
Lee Sieswerda, Thunder Bay District Health Unit’s epidemiologist, has said about 38 per cent of those infected were intravenous drug users, and 15 per cent were “underhoused.”
But according to Elizabeth Alvarez, who was the health unit’s associate medical officer of health until June, when her contract wasn’t renewed, the decision not to go public was initially based on the widespread group of people who’d become infected, which included children and the elderly. She said there were concerns that an announcement would create larger crowds in the city’s only emergency room, which has the largest volume of patients in Ontario.
“I felt that we should have gone earlier to the media, I’m a big believer in getting things out. But others worried that there was nothing to pinpoint a cause or a source,” she said recently in an interview from her new home in Hamilton.
The heart of the city’s south core is an aging mall, the Victoriaville Centre. Rows of discount clothing stores bathed in yellow light lead to a central food court where the elderly, mothers with strollers, drug dealers and drug users converge at square tables that have been bolted to the ground.
Blocks away, the grandest houses in Thunder Bay – large brick three-storey edifices with ornate porches – sit among old spruce and maple trees.
In this city that has hemorrhaged jobs and money over the past decade with the decline of the lumber industry, discarded syringes are a commonplace sight.
Sean Lee, a 30-year-old drug user, can recall the weekend he contracted a strep infection. It was August and he was “slumming it” on Simpson Street, injecting his veins with cocaine.
“I wish I’d known, I would have been more careful,” he said recently, seated at one of those square tables in the Victoriaville Centre. The strep ravaged his body for weeks and he lost so much weight his skin encases to his 6-foot-2 frame like cling-wrap.
But Annette Swerdelyk will likely never know how she caught the infection that nearly took her leg, and her life. The 52-year-old mother of two plays over and over again in her head the day in late May when she grazed her knee outside a laundromat. She had no idea an aggressive strain of streptococcus was moving through the area, as health officials had decided that the bacteria posed a low risk to members of the “general population” like Ms. Swerdelyk.
Her knee swelled for several days before she went to the emergency room, where doctors told her they were “gridlocked” with patients and sent her home with a prescription for painkillers and antibiotics. She returned the next day, her knee swollen to twice its size, the pain unbearable. She was admitted to hospital and quarantined.
“I thought I was going to die, I’m lucky I didn’t,” she said recently, seated on a couch in her home gingerly touching the large purple scar above her knee-cap. “They were talking about amputating my leg at the hip. I was … [in my] hospital bed crying like a baby.”
Ms. Swerdelyk spent nearly two weeks in hospital and was sent home with a pick-line that injected antibiotics directly into her bloodstream.
A faint purple tinge lingers on her left leg, a sense of betrayal lingers in her mind: It was only days ago that she picked up a local newspaper and realized she’d been part of an outbreak.
“When you have something that serious going on, the public needs to know,” she said, her brown eyes narrowing. “They’re stereotyping who gets this disease and it’s not true.”
Streptococcus is a fairly common bacteria, but the underlying causes of IGAS outbreaks remain unknown, Dr. Alvarez said. When she left the investigation, the health unit was researching whether residents of northern communities had increased susceptibility to the infection, she said, but like Ms. Swerdelyk, it is likely the Thunder Bay region will never know why it was struck.
With a report from Canadian Press
Dating when you have an incurable sexually transmitted infection is a fraught business, with sufferers facing ignorance, humiliation and rejection. Three women talk to Louise Millar about their experiences – and an initiative that offers new hope
Dating can be complicated enough at the best of times. Add to that the worry of having to tell a new partner that you have an incurable sexually transmitted infection and it can become almost inconceivable. When should you tell your date - and how? How do you know they won’t tell anyone? And what judgement will they make about you?

When Jessica, then a 35-year-old single mother of two, was diagnosed with genital herpes, she found herself facing all of these questions. With one man she decided to leave it two weeks before telling him. His reaction left her traumatised. ‘He said, “Why did you not tell me at the start? How do I know I can trust you now? For all I know, if we had slept together, I might have woken up and found my wallet and car keys missing.” I was distraught and broken-hearted.’
Jessica’s experience is not unusual. With visits to British genito-urinary medicine clinics doubling to 1.8 million between 2002 and 2006, and rises in the recorded cases of genital herpes, human papilloma virus (HPV) and HIV, increasing numbers of women are having to navigate the complex world of dating with a sexually transmitted infection (or STD, sexually transmitted disease, as it is also known).
Jessica contracted herpes from a long-term partner who had omitted to tell her about his condition. ‘We always used condoms, then one day he asked me if we could stop. I found out afterwards he was desperate to experience sex without a condom again. That far into our relationship it didn’t occur to me that he might have herpes.’
Almost immediately, Jessica experienced the stigma that can be attached to the disease. ‘Even my GP was ignorant about the condition. He told me [wrongly] that I couldn’t share soap or towels with my children. It frightened the life out of me. I went home and burst into tears. I felt dirty and contaminated and disgusted with myself. When I started dating again I realised that this kind of ignorance was everywhere. People were like, “Oh, my God, I don’t want [to date] one of them.” I felt nobody wanted to touch me. It was like having leprosy.’
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Now 51, Jessica is single again, having spent 15 years dating with herpes. ‘What other personal thing would you tell people so early on in a relationship? I’ve tried telling people at the start and seen them walk away. The other option is to have protected sex then tell them afterwards, but that seems underhand.’
Fortunately, however, there is now a breakthrough for women like Jessica. New dating websites are springing up designed to give a choice to single people with STIs. The idea is that, along with your favourite films and hair colour, you now also list your condition. By the time a potential date gets in contact, you can be sure he already knows about it.
‘We set up our site in September 2006, after recognising the issues that people were facing,’ says Sheelagh Caygill from Gateshead, a co-founder of the first website for British people with STIs, datepositive.net. ‘But we had no idea how much demand there was. Within hours of a small story appearing in a newspaper, the website went crazy. Now we have 3,000 members and it’s growing all the time.’
Some of Caygill’s female members told her about their fear of rejection. ‘Many have been judged harshly - more so than men,’ she says, ‘and even been accused of being “loose women”. There was almost a sense of “It serves you right for sleeping round.” There is still that double standard in society.’
Christine Webber, a psychotherapist and relationships expert, explains. ‘You can’t, in a couple of generations, fly in the face of all the conditioning that has existed for thousands of years. Until the pill in the 1960s, most women strenuously avoided having sex outside marriage because it had dire economic, career and relationship consequences, and in many ways those old stereotypes still exist today.’
Caygill says her website aims to remove those pressures. ‘You move right past your STI. Otherwise, you can get stuck on “Oh, herpes - can I get it from your towel?” and so on. It opens up a new world to people. It allows them to return to that time in their life when they could date without having to think about it.’
Specialist dating websites can also eliminate the stress of worrying about infecting a partner during sex. Sarah, 33, a care worker from Oxfordshire, joined Date Positive after making the decision to date only men who shared her condition. ‘I was diagnosed with HIV in 2001,’ she explains. ‘It was a real shock. I had maybe five or six boyfriends in my twenties and didn’t always practise safe sex. You never think it’ll happen to you. When I was diagnosed it turned out I’d had it a long time. As a result, I never knew who I had contracted it from.’
FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US
LONDON, Oct. 10, 2008–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. SEROQUEL XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.
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Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition that consists of recurring episodes of depression and mania. Approximately eight million American adults may be affected by bipolar disorder.
“When people think about bipolar disorder it is important to remember how debilitating the depressive episodes of the disease can be. In fact, in the long term, patients with bipolar disorder experience depressive symptoms three times longer than manic symptoms,” said Dr. Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Stanford University Medical Center and VA Palo Alto Health Care System. “With the approval of SEROQUEL XR for the treatment of bipolar depression and mania, we have a once-daily treatment that has been proven to help control the depressive and manic symptoms of bipolar disorder.”
About bipolar disorder
Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterised by one or more manic or mixed episodes, often with one or more episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode. Patients with bipolar I disorder experience depressive symptoms – approximately three times longer than manic symptoms. Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania. Bipolar disorder is typically managed through a treatment strategy with several phases – including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.
-ENDS-
10 October 2008
Notes To Editors
Media Enquiries:
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Investor Enquiries UK:
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Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
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About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
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FDA Continues Review of Takeda’s New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
OSAKA, Japan, October 10, 2008 /PRNewswire/ — Takeda Pharmaceutical Company Limited (”Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
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“In our most recent discussion with the FDA, it indicated that due to internal resource constraints it will not be able to complete the alogliptin review by the PDUFA date,” said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. “Additionally, the FDA did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA. Takeda remains confident in alogliptin’s potential as a new treatment option for people suffering from type 2 diabetes and we will work with the FDA as they continue this NDA review.”
Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. In December, 2007 Takeda submitted its NDA for alogliptin for the treatment of type 2 diabetes. This submission enhances Takeda’s position as a global leader in type 2 diabetes - one of Takeda’s core therapeutic areas.
The alogliptin NDA submission included six Phase 3 clinical trials involving more than 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was generally well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.
DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase-4 (DPP-4), which selectively metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). By maintaining the blood levels of GLP-1 and GIP, DPP-4 inhibitors are a new type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels. GLP-1 and GIP are excreted in the digestive tract following food intake, and stimulate the beta-cells in the pancreas — thereby stimulating increased insulin secretion — and it has also been confirmed that they improve the functioning of the beta cells themselves. Furthermore it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed and appetite is suppressed as well.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, .
CONTACT: Matt Kuhn, +1-224-554-5609, or Seizo Masuda, +011-81-3-3278-2037,both of Takeda
Web site: http://www.takeda.com/
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Injection-drug users who are incarcerated are less likely to kick their habit than those who remain in the community, new Canadian research shows.
In fact, there is strong evidence that addicts who end up in jail are more likely to stay hooked longer and less likely to be treated for addiction, according to the research published in the medical journal Addiction.
“The simple explanation is that by incarcerating people, you limit their access to help,” Evan Wood, a researcher at the B.C. Centre for Excellence in HIV-AIDS, said in an interview.
“While it may be politically popular to jail injection-drug users, it’s not a very effective public health measure,” he said.
The study followed 1,603 intravenous drug users in Vancouver for almost a decade. During the study period, 842 of them (just over half) stopped injecting drugs for a period of at least six months.
The data were derived from the Vancouver Injection Drug User Study, which has been ongoing since 1996. Two-thirds of the users spent time in jail at some point, mostly for drug-related crimes.
Researchers also tried to determine the effect of incarceration on drug use by focusing on the minority of IV drug users - one in five - who were incarcerated for the first time during the study period.
Incarceration was defined as “being in detention, prison or jail overnight or longer in the previous six months.”
The paper showed that pre- and post-incarceration drug use was virtually the same. In other words, jailing drug addicts did not help them overcome addiction.
Researchers found that those who were jailed were 57 per cent less likely to give up drugs for a period of six months or more, compared with those who were not jailed.
The study also found that IV drug users with access to methadone programs (methadone is a drug used to wean heroin users from their addiction) were 62 per cent more likely to kick their drug habit for a period of six months or more. Methadone programs are available in the community but not in prison.
“This is a simple research paper, but it has an important message,” Dr. Wood said.
“We need to look at the most effective solutions for dealing with drug crime,” he said. “Locking up drug addicts is ineffective.”According to the paper, 30 per cent of female prisoners and 14 per cent of male prisoners in Canadian federal penitentiaries are serving sentences for drug-related offences. The numbers are probably higher in provincial jails, but there are no good data.
Dr. Wood said the vast majority of people in the study were jailed for petty crimes, mostly related to theft as a means of getting money to feed their addiction.
The researcher said incarceration is very expensive and that money would be better spent on addiction treatment and rehabilitation programs.
“It’s appealing to the public that there is an element of punishment when crimes are committed, but the public can also recognize that addiction is a health issue,” Dr. Wood said.
He stressed that “no one is suggesting that violent criminals should not be locked up,” but said the vast majority of drug addicts are, at worst, petty thieves.
The study notes that drug use fell while people were in prison but it did not stop. (It is widely acknowledged that drugs like heroin, cocaine and crack are available in prison.) In fact, researchers concluded that there are no major differences in drug consumption patterns between those who were jailed and those not jailed.
The big difference was that IV drug users who remained in the community were more likely to get treatment and stop using drugs, at least temporarily.
There is also evidence that those who had been imprisoned engaged in more risky behaviours such as needle sharing. (There are no needle-exchange programs in Canadian prisons, though activists have been demanding them for years.) Earlier research showed that about 30 per cent of all new infections with HIV-AIDS occur in prison.
A”good” fat found in abundance in olive oil may provide one of the keys to appetite control and weight loss.
Oleic acid, a type of monounsaturated fat, suppresses hunger pangs and so can help prevent snacking between meals, according to researchers at the University of California, Irvine.
In a study involving lab mice, the researchers found that when oleic acid reaches the small intestine it is converted into a hormone called oleoylethanolamide, or OEA. This hormone, in turn, sends hunger-dampening signals to the brain. That means you can go longer without eating.
The findings, published in the journal Cell Metabolism, could open up new strategies for helping people lose weight, said Daniele Piomelli, who led the research effort.
Dr. Piomelli noted that previous studies have found that protein also plays a pivotal role in appetite control. And, in particular, a high-protein meal tends to be very filling and quickly sates the desire for food.
“If we can mix appropriate amounts of protein and fat [containing high levels of oleic acid], the net result could be very advantageous,” Dr. Piomelli said in an interview. “You would consume less in a single meal … and prolong the interval between eating.”
He also suggested that new medications could be developed to mimic the appetite-suppressing effects of oleic acid.
Avocados, soybeans, canola oil and a variety of other foods also contain oleic acid. But olive oil, which is one of the cornerstones of the heart-healthy Mediterranean diet, is especially rich in the stuff, Dr. Piomelli said.
NEW AND IMPROVED?
Newer is not necessarily better when it comes to schizophrenia medications.
Researchers recently tested three drugs on a group of children and adolescents diagnosed with schizophrenia. Two of the drugs, olanzapine (brand name Zyprexa) and risperidone (Risperdal), come from a newer class of medications known as atypical anti-psychotics. The third drug, molindone (Moban), is an older anti-psychotic.
The results, published in the American Journal of Psychiatry, surprised the researchers. The newer and more expensive drugs were no more effective at treating young people with schizophrenia than the older medication was. About 46 per cent of those prescribed risperidone, and 34 per cent on olanzapine reported an improvement. That compared with a 50-per-cent improvement rate for patients taking molindone.
What’s more, the newer drugs had a higher risk of causing certain side effects, including weight gain. Some study participants put on as much as 15 pounds in eight weeks.
Linmarie Sikich, who led the study at the University of North Carolina at Chapel Hill, said older medications are seldom used today because of the commonly held belief that the newer drugs are much better. “When we started the study, a lot of people really thought we were verging on the edge of unethical to treat kids with one of the older drugs.”
Dr. Sikich conceded that the older drugs are far from perfect and also carry the risk of serious side effects, including muscle stiffness, involuntary movements and feelings of restlessness.
But she said the study shows that the older medications should be tried more often, possibly as a first line of treatment.
BAD AIR, PAINFUL APPENDIX
A surprising new study has uncovered a possible link between air pollution and elevated rates of appendicitis.
The researchers reviewed the cases of 5,000 Calgary residents who were admitted to hospital for appendicitis between 1999 and 2006. These data were matched up with daily air pollution records.
The study found that hospital admissions for the painful condition rose by 15 per cent on the summer days that had the highest concentrations of nitrogen dioxide and ozone in the atmosphere, said the lead researcher, Gilaad Kaplan of the University of Calgary.
“I would call it a modest effect, meaning that it doesn’t explain every case of appendicitis we see, but it may explain a subset of them,” said Dr. Kaplan, who presented his findings in Orlando, Fla., this week at a scientific meeting of the American College of Gastroenterology.
Previous studies have found that air pollution poses a health risk to patients with pre-existing respiratory and heart conditions. But how could foul air inflame the appendix - an organ without apparent purpose that has mystified doctors for years?
“We really don’t have a good grasp of the root causes of appendicitis,” said Dr. Kaplan. He speculated that air pollution might somehow weaken the immune system, leaving a person vulnerable to infection.
BREAST MILK DRUG RISK
Health Canada has issued a warning about the risks posed to breastfed babies whose mothers are using medications that contain codeine.
Codeine is converted into morphine by the body. Some mothers’ bodies perform this biological function faster than others, producing a rapid spike in the amount of morphine in their breast milk. That means their babies could suffer a lethal morphine overdose.
Although such cases are rare, Health Canada says mothers should talk to their doctors before taking pain and cough medications containing codeine.
Canadian Vaccine Manufacturer Able to Deliver Doses Ahead of Schedule
From Canada Newswire English (October 9, 2008)
MISSISSAUGA, ON, Oct. 9 /CNW/ - GlaxoSmithKline Inc. (GSK) today announced that it has begun shipment of FLUVIRAL(R) (Influenza Virus Vaccine) to Canadian private market customers for the 2008-2009 influenza season, having met and exceeded the contractual timelines for public market deliveries.
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With the majority of doses already delivered to provinces across Canada, GSK has also begun to ship vaccine to direct customers, including physicians and clinics, which will allow customers to begin immunizing patients as soon as possible.
“We are pleased to be able to quickly supply influenza vaccine in Canada for the 2008-2009 season,” said Dr. Tjark Reblin, Vice President Medical and Chief Medical Officer, GlaxoSmithKline Inc. “We are excited to play an integral part in helping Canadians protect themselves against this serious infection.”
Production of influenza vaccine this year was complicated by the introduction of three new influenza strains for the 2008-2009 season: A/Brisbane/59/2007 (H1N1)-like strain, A/Brisbane/10/2007 (H3N2)-like strain and B/Florida/4/2006-like strain. Fortunately, this factor did not result in any delays in delivering doses for the season.
About Seasonal Influenza
Influenza, or “the flu,” is a respiratory illness that affects millions of Canadians each year, primarily during the winter months. The flu typically starts with a headache, chills and cough, followed rapidly by fever, loss of appetite, muscle aches and fatigue, running nose, sneezing, watery eyes and throat irritation. Nausea, vomiting and diarrhea may also occur, especially in children.
While the majority of those who become sick will recover, influenza results in an average of 20,000 hospitalizations and 4,000 deaths in Canada each year. According to the Public Health Agency of Canada, the influenza vaccine - combined with regular hand washing and proper cough etiquette - provides the best protection for oneself and others against the influenza virus.
About FLUVIRAL(R)
FLUVIRAL(R) conforms to the current requirements of the World Health Organization (WHO). FLUVIRAL(R), split-virion influenza vaccine, is used for active immunization against influenza disease caused by the influenza subtypes A and type B contained in the vaccine. FLUVIRAL(R) is indicated for the active immunization against influenza caused by influenza virus in adults and children 6 months of age or older.
Important Safety Information
Soreness at the injection site that can last up to 2 days is a common side effect in adults, but rarely interferes with your daily activities. Flu vaccines are safe and well tolerated in healthy children, but mild local reactions, primarily soreness occurs in 7% of cases in children below 3 years of age. Post-vaccination fever may be observed in 12% of children 1 to 5 years of age. A flu vaccine may be contraindicated if you are allergic to eggs or if you have acute febrile illness.
GlaxoSmithKline: A Canadian Vaccines Leader
GlaxoSmithKline is the leading Canadian influenza vaccine manufacturer, and will supply the majority of the Canadian government’s seasonal influenza vaccines purchases until 2010. GlaxoSmithKline also has a contract with the Government of Canada for the development and production of a pandemic influenza vaccine, and to provide the infrastructure and capacity to produce sufficient pandemic vaccine for Canadians in the event of an influenza pandemic. GlaxoSmithKline maintains two state-of-the-art manufacturing facilities dedicated to the production of innovative vaccines in Quebec City and Laval, Quebec. GlaxoSmithKline’s Laval site also serves as a research and development hub for North America, providing activities related to research projects in early development, as well as the implementation of technological platforms supporting the pre-clinical and clinical development of candidate vaccines.
GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
<< (R) Fluviral is a registered trademark, used under license by GlaxoSmithKline Inc. >>
Media inquiries: Peter Schram, (905) 819-3363
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Omrix Biopharmaceuticals Provides Update On Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moderate Bleeding
NEW YORK–(BUSINESS WIRE)–Oct 9, 2008 - Omrix Biopharmaceuticals, Inc. (”Omrix”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that the Fibrin Pad U.S. Phase II clinical trial in mild to moderate bleeding was suspended yesterday afternoon to investigate an incident of post-operative bleeding. The Company will provide an update once additional information is available.
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About the Fibrin Pad
The Fibrin Pad builds on the Company’s aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.
About Omrix Biopharmaceuticals, Inc.
Omrix is a fully integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products. Omrix’ biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. The Company’s passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential biodefense applications. For more information, please visit www.omrix.com.
Safe Harbor Statement
This news release contains forward-looking statements. Forward-looking statements provide the Company’s current expectations or forecasts of future events. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The Company’s actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the Company’s filings with the Securities and Exchange Commission (SEC), including sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form 10-K as filed with the SEC on March 17, 2008, and the Company’s most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the Company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this news release.
Contact
Omrix Biopharmaceuticals, Inc.
Francesca M. DeMartino, 212-887-6510
Senior Director, Investor Relations
francesca.demartino@omrix.com
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AstraZeneca’s Purplepill.com Tops the List of Most Visited Pharmaceutical Brand Web Sites in Q2 2008
AstraZeneca’s Purplepill.com Tops the List of Most Visited Pharmaceutical Brand Web Sites in Q2 2008
Ramped Up Marketing Efforts and FDA Activity Drive Growth at Top Brand.com Sites
RESTON, Va., October 09, 2008 /PRNewswire-FirstCall/ — comScore, Inc. , a leader in measuring the digital world, today released a study of the top pharmaceutical brand Web sites in Q2 2008. The study revealed that purplepill.com, AstraZeneca’s Web site for its heartburn treatment Nexium, generated the most site traffic in Q2 2008 with more than 1 million unique visitors, up 55 percent from year ago. Also showing substantial growth versus last year was diabetes drug Actos, ranking second with 855,000 unique visitors. Insomnia medication Ambien CR, ranked third with 756,000 unique visitors.
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“AstraZeneca has aggressively marketed Nexium this year, running approximately twice as much online display advertising in Q2 as either of its major competitors, Prevacid and Aciphex,” said John Mangano, senior director, comScore Pharmaceutical Marketing Solutions. “This additional marketing muscle appears to have helped generate strong site visitation, a very important marketing step in the competitive pharmaceutical industry.”
Top 10 Pharmaceutical Brand Web Sites by Unique Visitors Q2 2008 vs. Q2 2007 Total U.S. -- Home/Work/University Locations Source: comScore, Inc. Unique Visitors (000) Web Site Q2 2007 Q2 2008 Percent Change Nexium (purplepill.com) 659 1,021 55 % Actos (actos.com) 34 855 2399 % Ambien CR (ambiencr.com) 1,949 756 -61 % Gardasil (gardasil.com) 912 722 -21 % Lexapro (lexapro.com) 530 549 3 % Veramyst (veramyst.com) N/A 538 N/A Januvia (januvia.com) 118 507 329 % Lyrica (lyrica.com) 368 501 36 % Topamax (topamax.com) 361 498 38 % Seroquel (seroquel.com) 359 447 24 %
Some highlights from the study include:
– Takeda Pharmaceuticals substantially increased marketing for the Actos brand beginning in the third quarter of 2007, helping build actos.com into the second most visited site in the category in Q2 2008 versus year ago.
– Merck’s diabetes treatment Januvia increased marketing activity beginning in the second half of last year, resulting in a nearly 330-percent increase in visitors to januvia.com.
– Pfizer has ramped up marketing and public relations efforts for Lyrica since the third quarter of 2007, when the product received FDA approval to be marketed for the treatment of fibromyalgia. The site, lyrica.com, has seen a 36-percent increase in unique visitors.
– With a number of migraine treatments nearing patent expirations, the makers of popular migraine treatment Topomax launched a heavy online display ad campaign to bolster awareness, resulting in a 38-percent increase in Q2 2008 versus year ago.
– Merck’s highly publicized HPV vaccine Gardasil was approved by the FDA in the second quarter of 2006. Although the number of site visitors has declined 21 percent during the past year since the company’s initial marketing and public relations push, the site still ranks among the top 5 most visited sites with 722,000 visitors.
These industry insights along with an analysis of other relevant online health trends will be presented during a complimentary webinar conducted by comScore and ePharma Summit entitled, Internet Trends and Usage in 2008 and Beyond, on Thursday, October 16 from 2 to 3 p.m. EDT.
To register for the webinar visit https://www1.gotomeeting.com/register/831770879 and mention priority code G1P1406W2COM.
For more information on comScore Pharmaceutical solutions, please visit: http://www.comscore.com/solutions/info_req.asp?industry=pharma.
About comScore
comScore, Inc. is a global leader in measuring the digital world and preferred source of digital marketing intelligence. For more information, please visit http://www.comscore.com/boilerplate.
CONTACT: Andrea Vollman of comScore, Inc., +1-312-775-6646, press@comscore.com
Web site: http://www.comscore.com/http://www.purplepill.com/
Ticker Symbol: (NASDAQ-NMS:SCOR)
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A United Business Media Company
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Abbott Opens New Research Facility and Pilot Plant in Ludwigshafen
LUDWIGSHAFEN, Germany, October 09, 2008 /PRNewswire-FirstCall/ — Abbott today announced the opening of new development laboratories and a pilot plant facility that will research groundbreaking technologies and test large-scale production of newly developed drug formulations. The expansion is part of Abbott’s global drug delivery business, SOLIQS, which is based in Ludwigshafen.
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“Abbott is committed to advancing scientific innovation and bringing new medicines to patients,” said John M. Leonard, M.D., senior vice president, Pharmaceuticals, Research and Development, Abbott. “Innovative drug formulation is critical to the development of effective new treatments that make a difference for patients.”
“Nearly 40 percent of pharmaceutical compounds never reach the clinical study phase because they cannot be absorbed in the human body,” said Jorg Breitenbach, Ph.D., senior director of drug product development and head of SOLIQS. “The SOLIQS expansion builds on Abbott’s expertise in drug delivery technology and addresses the rising demand for innovative, patient-focused formulations.”
The facility will evaluate new processes to complement its current proprietary technologies — Meltrex(TM), Xellex(R), NanoMorph(R) and smartCrystals(R) — that target the formulation of soluble complex pharmaceutical substances. Using the Meltrex(TM) technology, Abbott developed a new tablet formulation of its leading protease inhibitor lopinavir/ritonavir (known as Kaletra(R)), which is the first and only co-formulated protease inhibitor tablet that does not require refrigeration and can be taken with or without food — two important advances in delivering HIV medicine, especially in developing countries where disease prevalence is highest. The tablet formulation also offers the increased dosing convenience of fewer pills (a total daily dose of four tablets, instead of six soft-gel capsules).
Hendrik Hering, State Minister for Economic Affairs of Rhineland-Palatinate, joined Abbott at today’s opening ceremony to recognize the company’s continued commitment to investing in research in Germany. In addition to a new Formulation Development Center, which opened earlier this year at the company’s headquarters, the SOLIQS expansion is part of Abbott’s global investment in facilities and resources to advance its pipeline.
Scientific Innovation at Abbott
Abbott was founded on the idea that using new technologies and treatment approaches could dramatically improve the quality of care for patients. Today, Abbott’s 7,000 scientists around the world are focused on using breakthrough science to develop effective treatments and solve unmet medical needs. Abbott’s global pharmaceutical research and development organization is focused on the discovery and development of novel molecular targets and new drug candidates in the areas of immunology, oncology, virology, central nervous system/pain and dyslipidemia.
About SOLIQS
SOLIQS is Abbott’s global drug delivery business unit focused on improving the oral bioavailability of poorly soluble substances and the developing pharmaceuticals with a tailored dissolution profile. Based in Ludwigshafen, SOLIQS also works on behalf of third parties.
About Abbott Germany
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.
Abbott Germany headquarters are in Wiesbaden with around 4,000 staff located at the Wiesbaden, Ludwigshafen, Rangendingen and Wetzlar sites
For more information about Abbott, visit http://www.abbott.de and http://www.abbott.com.
CONTACT: German Media, Franziska Theobald, 06122 - 58 3331, or All OtherMedia, Tracy Sorrentino, +1-847-937-8712, or Financial, Lawrence Peepo,+1-847-935-6722, all of Abbott
Web site: http://www.abbott.com/http://www.abbott.de/
Ticker Symbol: (NYSE:ABT)
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A United Business Media Company
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