Medical Health Center

Bayer Welcomes The Proposed EMEA Labeling Changes For Moxifloxacin

Bayer is pleased to announce that today theEuropean Medicines Agency’s (EMEA) Committee for Medicinal Products forHuman Use (CHMP) proposed a labeling change for oral moxifloxacin for thetreatment of Acute Exacerbations of Chronic Bronchitis (AECB), AcuteBacterial Sinusitis (ABS) and Community Acquired Pneumonia (CAP) in linewith official European clinical guidelines.

“We welcome the CHMP review which confirms the positive benefit-riskprofile of moxifloxacin as we believe this is an important treatment optionfor patients,” saidDr. Kemal Malik, member of the Bayer HealthCare Executive Committee andChief Medical Officer. “We would also welcome an EMEA assessment of otherantibiotics used for treatment of these infections in a similar fashion inthe interest of patient care.”

“Due to increasing resistance of Streptococcus pneumoniae in Europe,commonly used first line agents may not be appropriate in these countries.Oral moxifloxacin remains an important treatment option in theserespiratory tract infections”, said Prof. Hartmut Lode, Research Center forMedical Studies, Berlin.

On July 14, 2008, the European Commission granted a further indication formoxifloxacin tablets for the treatment of mild to moderate PelvicInflammatory Disease (PID) in all European countries.

About Moxifloxacin

Moxifloxacin is an antimicrobial in the fluoroquinolone class. It ismarketed under the brand names Avelox®, Avalox®, Izilox®, Actira®,Octegra®, Proflox®, Actimax®, Lapinix®, Havelox®, Avelon®, Megaxin® andPromira®. Moxifloxacin has been used in more than 98 million patientsworldwide.

About Bayer

The Bayer Group is a global enterprise with core competencies in the fieldsof health care, nutrition and high-tech materials. Bayer HealthCare, asubsidiary of Bayer AG,is one of the world’s leading, innovative companies in the healthcare andmedical products industry and is based in Leverkusen, Germany. The companycombines the global activities of the Animal Health, Consumer Care,Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals businessoperates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim isto discover and manufacture products that will improve human and animalhealth worldwide. Find more information at http://www.bayerhealthcare.com.

About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceuticalcompany. Its research and business activities are focused on the followingareas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’sHealthcare. With innovative products, Bayer Schering Pharma aims forleading positions in specialized markets worldwide. Using new ideas, BayerSchering Pharma aims to make a contribution to medical progress and strivesto improve the quality of life. Find more information athttp://www.bayerscheringpharma.de.

Forward-Looking Statements
This release may contain forward-looking statements based on currentassumptions and forecasts made by Bayer Group or subgroup management.Various known and unknown risks, uncertainties and other factors could leadto material differences between the actual future results, financialsituation, development or performance of the company and the estimatesgiven here. These factors include those discussed in Bayer’s public reportswhich are available on the Bayer website at www.bayer.com. The companyassumes no liability whatsoever to update these forward-looking statementsor to conform them to future events or developments.

View drug information on Avelox I.V..

NASONEX(R) Now Approved In Japan For The Treatment Of Allergic Rhinitis In Adult Patients

Schering-Plough Corporation (NYSE: SGP) announced that Schering-Plough K.K., the company’s country operation in Japan, has received marketing approval for NASONEX(R) (mometasone furoate monohydrate) Nasal Spray 50mcg for the treatment of allergic rhinitis in adult patients.(1) NASONEX is an intranasal steroid that significantly improves nasal allergy symptoms when taken once each day. NASONEX is the first intranasal steroid to be approved in Japan for once-daily administration. NASONEX is currently approved in over 100 countries worldwide and is anticipated to be available in Japan this fall.

“Allergies are a growing health problem in Japan,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “NASONEX provides physicians with an important treatment option for the relief of nasal allergy symptoms, especially for those patients looking for the convenience of a once-daily treatment.”

Allergic rhinitis, which encompasses the outdoor symptoms of seasonal allergic rhinitis (SAR) and the indoor symptoms of perennial allergic rhinitis (PAR), affects an estimated 18 to 23 million people in Japan. Nasal allergy symptoms classically include sneezing, nasal itching, nasal discharge and congestion. Japan is the world’s second largest market for prescription and over-the-counter medications for the treatment of allergies.

NASONEX

In the United States, NASONEX is indicated to treat nasal symptoms of seasonal and perennial allergic rhinitis in patients 2 years of age and older, as well as nasal polyps in adults 18 years of age and older.(2) NASONEX is also proven to help prevent most seasonal nasal allergy symptoms in adults and children 12 years of age and older when NASONEX is started 2 to 4 weeks prior to allergy season.(2) NASONEX is nonsedating and not addictive when used as directed.(1) Side effects were generally mild and included headache, viral infection, sore throat, nosebleeds and coughing.(2)

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 http://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 NASONEX. 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 I, Item IA. “Risk Factors” in Schering-Plough’s 2008 Q1 10-Q.

References:

1. NASONEX(R) Package Insert. Schering-Plough K.K.

2. NASONEX(R) (summary of product characteristics). Schering Corporation.

Schering-Plough Corporation
http://www.schering-plough.com

View drug information on Nasonex Nasal Spray.

IRX Therapeutics To Present Phase 2 Results At 7th International Conference On Head And Neck Cancer

IRX Therapeutics, a privately-held company dedicated to the discovery and development of proprietary therapies for the treatment of cancer and viral diseases, today announced that a symposium on findings from its Phase 2 clinical trial of IRX-2 will be held on July 22, 2008 at 6:30 am (PDT) during the 7th International Conference on Head and Neck Cancer at the San Francisco Marriot Hotel. The American Head and Neck Society’s International Conference on Head and Neck Cancer has been the world’s pre-eminent meeting for head and neck cancer since its inception in 1984. Approximately 1,600 surgeons, oncologists, scientists and allied health professionals are expected to attend.

The symposium, chaired by Dr. Gregory T. Wolf, current President of the American Head and Neck Society, titled, “New Paradigm for the Treatment for Head and Neck Cancer” will include three presentations:

Arlene A. Forastiere, M.D., will present “Overview of Current Therapies for Head and Neck Cancer.” Dr. Forastiere is Professor of Oncology, Otolaryngology, Head and Neck Surgery and Radiation Oncology at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University.

Theresa L. Whiteside, Ph.D. will present “Overcoming Immunosuppressive Effects in Head and Neck Cancer.” Dr. Whiteside is Professor of Pathology, Immunology and Otolaryngology and is Director of the Immunologic Monitoring and Cellular Products Laboratory at the University of Pittsburgh School of Medicine.

Gregory T. Wolf, M.D., F.A.C.S., the Principal Investigator for the Phase 2 trial of IRX-2, will present “IRX-2: Promising New Immunotherapy for Head and Neck Cancer.” Dr. Wolf is the Professor and Chair, Department of Otolaryngology and Head and Neck Surgery at the University of Michigan as well as Director of the University of Michigan Head and Neck Oncology SPORE Program.

Following the presentations there will be a panel discussion moderated by Dr. Wolf on the role of immunotherapy in head and neck cancer.

IRX Therapeutics will also be sponsoring an exhibit booth at the Conference highlighting the upcoming INSPIRE trial, a global Phase 3 clinical trial of IRX-2 in head and neck cancer.

About Head and Neck Cancer

Head and neck cancer is a deadly disease that often goes undiagnosed until it is at an advanced stage. There are 500,000 new cases worldwide each year, with about 45,000 new cases in the United States. Head and neck cancer is associated with high rates of recurrence and mortality and is understood to be highly immunosuppressive. The current standard of care for newly diagnosed head and neck cancer is primarily curative surgery followed by radiation therapy or, in some cases, chemoradiation. For patients indicated for curative surgery, there is no approved neoadjuvant therapy. The immunosuppressive nature of head and neck cancer creates a potential role for immunotherapy as a neoadjuvant intervention in the treatment of this disease.

About IRX Therapeutics

IRX Therapeutics is a privately-held immunotherapy company founded by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology. The Company’s product platform seeks to restore an effective cellular immune response for the treatment of advanced cancers and viral diseases by correcting both dendritic cell and T-cell defects. An effective immune response is essential for the eradication of viruses and tumors.

The Company’s lead product, IRX-2 (citoplurikin), received Fast Track designation by the Food and Drug Administration. Phase 1/2 and Phase 2 clinical trials in late-stage head and neck cancer patients have been completed.

IRX Therapeutics

Rates Of Oesophageal Cancer In UK Among The Worst In Europe,

Call for national research study to investigate the causes of oesophageal cancer

The Barrett’s Oesophagus Foundation would like to support the Chief Medical Officer’s recommendation for a large scale national research study to investigate the risk factors associated with the rising rate of cancer of the oesophagus. This was included in his Annual Report published recently, which raised grave concern over the sharp rise in oesophageal (gullet) cancer over the last two decades.

Barrett’s Oesophagus is a condition which occurs in patients with a long history of heartburn and acid reflux. People with Barrett’s oesophagus are up to 125 times more likely to develop cancer of the oesophagus than the average person. The Barrett’s Oesophagus Foundation is the only charity dedicated to the prevention of cancer from this condition.

Sir Liam Donaldson’s other recommendations include better educational programmes to improve public awareness of the symptoms of oesophageal cancer and research into better diagnostic techniques.

Dr Rebecca Fitzgerald, Trustee of Barrett’s Oesophagus Foundation and an expert on cancer of the oesophagus, says: “Further research and greater awareness could save many lives. We hope that Sir Liam’s recommendations are taken seriously.”

Oesophageal cancer is the sixth most common cause of cancer deaths in England and Wales and kills over 6,000 people a year. England has some of the highest rates of oesophageal cancer in Europe. Over the last 20 years, the rate of new cases in England has gone up by 86% for men and 40% for women, whereas the rate has sharply decreased in other European countries, such as France. The reasons for this are unknown.

For more information visit http://www.barrettsfoundation.org.uk

Notes

1. Spokespeople and case studies are available for interview

2. To speak directly with Dr Rebecca Fitzgerald, please contact the numbers above

3. The Barrett’s Oesophagus Foundation was established in 1999 as a national charity with the principal aims of:

- securing the long term future of The UK National Barrett’s Oesophagus Registry (UKBOR)
- establishing a patient support group for Barrett’s sufferers and their families
- funding research projects into the causes, prevention and treatment of Barrett’s oesophagus and oesophageal cancer

Barrett’s oesophagus (Barrett’s) is an abnormal lining of the oesophagus (otherwise known as the gullet), which occurs in patients with a long history of heartburn and reflux (acid and bile moving into the gullet). In a minority of people Barrett’s oesophagus may progress through a series of stages (dysplasia) to cancer.

4. PROBE is the patient support network of the Barrett’s Oesophagus Foundation with three key aims: to provide a network of support and information to Barrett’s patients: to raise funds for research: to raise awareness of the condition and its implications

http://www.barrettsfoundation.org.uk

SinuCleanse Introduces Kids Mist

Makers of the SinuCleanse® line of nasal washing products, today announced a product for children, the Kids Mist ™. With the recent ban by the Food and Drug Administration on many over-the-counter cough and cold medicines for children, parents have been left with few options for easing kids’ sinus symptoms. The Kids Mist from SinuCleanse is safe and all-natural and is available at Walgreens and online at http://www.sinucleanse.com.

Diane Heatley, M.D., a pediatric ENT physician with the University of Wisconsin-Madison, created the Kids Mist for her patients who weren’t old enough to use a neti pot or squeeze bottle on their own.

“For newborns and children under the age of six, products to help with nasal congestion and other sinus or allergy-related symptoms are very limited,” said Heatley. “The Kids Mist from SinuCleanse fills that void.”

The Kids Mist from SinuCleanse delivers a super-fine saline mist, much finer than anything else on the market. Each kit delivers 200 doses and refills are available online and at select retailers.

“The mist gently moisturizes the inside of a child’s nose, thinning nasal secretions and clearing them from the nose and sinuses,” said Heatley. “It’s a very comfortable treatment to ease your child’s suffering. Since is it all natural, there are no concerns about interactions with other prescription medications your child might be taking and no worry about side-effects.”

The Kids Mist from SinuCleanse is comprised of a pump spray bottle with a slender tube attached. The tube is placed at the base of the child’s nose. “From there, it’s very easy to operate,” says Heatley.

Parents simply plunge the bottle top down for one squirt of the fine saline mist. “Each squirt delivers a consistent, accurate dosage,” says Heatley. “The design prevents germs from being drawn into the bottle from the nose, so the Kids Mist doesn’t become contaminated like other saline mist sprays. And, because of the tube, nothing is being inserted fully into the nose, preventing irritation of the inside of the nose.”

About the SinuCleanse® Family of Nasal Washing Products

The SinuCleanse neti pot was created in 1997 as an all-natural defense for adults and children who suffer nasal problems. It was created by an ear, nose and throat physician and is clinically proven to reduce sinus symptoms and features a full line of products for every member of the family. This drug-free treatment can be used as often as needed and is safe for every sinus sufferer, including pregnant women, people on multiple medications and children. The SinuCleanse line has expanded and now includes three easy-to-use applications: the original neti pot, the SinuCleanse Squeeze™ and the new Kids Mist™.

The SinuCleanse® line of products is available at Walgreens, CVS, Rite Aid and other fine retail locations, as well as online at http://www.sinucleanse.com.

SinuCleanse

Ear, Nose, And Throat Physicians Hail Efforts Of Congress To Pass Medicare Legislation

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) applauds the efforts of the U.S. Senate and the U.S. House of Representatives to preserve access to quality healthcare for the nation’s seniors and veterans by halting cuts to physicians’ Medicare payments. By overwhelmingly passing H.R. 6331, the Medicare Improvements for Patients and Providers Act of 2008, Congress has sent a strong message to President Bush that preserving Medicare is a critical priority for our nation.

The AAO-HNS is also humbled and grateful for the critical role played by Sen. Edward Kennedy (D-MA) in helping this bill pass in the U.S. Senate. Sen. Kennedy has long staked his reputation on ensuring that healthcare remains a priority in the Senate, and his dramatic appearance on the Senate floor to cast the decisive vote hammered home the importance of ensuring critical access to healthcare for our nation’s seniors and veterans.

H.R. 6331 halts a 10.6 percent cut to physician Medicare payments that took effect July 1, 2008. It also provides a 1.1 percent positive update for 2009, ensuring that physicians who see Medicare patients can continue to provide seniors with access to quality healthcare.

The AAO-HNS now urges President Bush to immediately sign H.R. 6331 into law and join Congress in supporting physicians and the patients they treat.

About the AAO-HNS

The American Academy of Otolaryngology - Head and Neck Surgery, one of the oldest medical associations in the nation, represents more than 12,000 physicians and allied health professionals who specialize in the diagnosis and treatment of disorders of the ears, nose, throat, and related structures of the head and neck. The Academy serves its members by facilitating the advancement of the science and art of medicine related to otolaryngology and by representing the specialty in governmental and socioeconomic issues. The organization’s mission: “Working for the Best Ear, Nose, and Throat Care.”

American Academy of Otolaryngology - Head and Neck Surgery

SinoFresh Announces “Next Step” In Program To Attack “Super-Bug” MRSA

SinoFresh HealthCare, Inc. (OTCBB: SFSH), the makers of SinoFresh Nasal Spray, announced the next step in a research and development program expected to lead to a nasal spray product for attacking MRSA — the so-called “super bug” — reservoirs in the nasal passage. These nasal reservoirs are believed by public health experts to be a significant source of MRSA infections. “This continuation of an earlier study is a concrete expression of SinoFresh’s commitment to exploring ways to protect and promote nasal and upper respiratory health and hygiene,” according to Charles Fust, CEO of SinoFresh. In July 2005, SinoFresh announced it had achieved positive results in an in vitro study conducted at the Public Health Research Institute under the direction of Dr. Barry Kreiswirth who is the director of the institute’s Tuberculosis Center and Hospital Infections Program.

MRSA (methicillin resistant staphylococcus aureus) is a growing concern in the health care community. This is due to both the virulence of the infections which it causes and to the fact that it is highly antibiotic resistant, making infections difficult to treat. Staphylococcus aureus is a common bacterium found on skin and most strains usually do not produce disease or infection. The MRSA strain, however, produces toxins which attack tissues. It harbors in the nasal passages (as do most S. aureus strains) and is transferred to skin by hand contact. Under certain circumstances it can then produce a virulent infection of the skin and underlying tissues which can lead to disfigurement and sometimes death.

According to Dr. John Todhunter, an outside consultant to SinoFresh, there is an apparent consensus in the health care community that having a high nasal load of MRSA is associated with increased rates of MRSA infection. There are approximately 2 - 3 million persons in the U.S. at any time carrying MRSA around in their nasal passages. As a result, eradication of nasal MRSA colonies is seen as a potentially important weapon in reducing the spread of MSRA. The antibiotic Mupirocin is currently the treatment of choice for reducing nasal MRSA loads. In recent years it is becoming less effective as MRSA’s resistance to yet another antibiotic has emerged. “SinoFresh’s approach to controlling nasal MRSA does not depend on any specific antibiotic and it is expected to have less chance of the bug finding a way to defeat it,” said Dr. Todhunter. “This could be a significant improvement in how MRSA reservoirs are controlled.”

SinoFresh’s approach is based on the potent ability of an ingredient in their product to destroy bacterial cell walls and membranes. This is by physical means rather than by an effect on bacterial metabolism which is how antibiotics work. “Since bacteria can in effect change their metabolism to be resistant to antibiotics but can’t very well change the laws of physics the chances for development of resistance to SinoFresh’s product are much lower,” said Dr. Todhunter.

According to William Wilferth, VP for Research and Development at SinoFresh, “We are continuing on an exciting and promising path but are doing so methodically, with this model study currently being set up and then progressing to clinical studies, depending on what the data tell us.”

Mr. Fust stated that “This is a potentially very large market for SinoFresh with a potential for 80 to 100 million treatments annually. We’re obviously excited to have pulled the trigger on this development effort and have reason to be cautiously optimistic that it will develop into a product for this market.”

About SinoFresh HealthCare, Inc.

SinoFresh HealthCare, Inc. (OTCBB: SFSH) is a developer and marketer of innovative upper respiratory system therapies. The company is researching broad-spectrum antiseptic approaches to reducing viral, bacterial and fungal organisms that are suspected to cause pathogenesis of the mouth, nose and throat. The company’s lead product, SinoFresh™ Nasal and Sinus Care, is a hygienic cleansing spray that kills germs and removes other nasal-sinus irritants. The company is also researching how antiseptic cleansing may alleviate chronic sinus distress, a condition that may affect 37 million Americans annually. SinoFresh™ products are available in major retail outlets nationwide.

http://www.sinofresh.com

Child’s Ability To Taste And Smell Measured By New Combination Of Tests

Researchers have developed a series of tests that for the first time accurately measure the normality of taste (gustatory function) and smell (olfactory function) in young children, according to a new study published in the July 2008 edition of Otolaryngology - Head and Neck Surgery.

The study, authored by researchers in Australia, determined that most children age 5-7 can identify a majority of 16 different test odorants that can measure smell function, along with four common tastes that describe taste function. The identifiable odorants include: floral, orange, strawberry, fish, chocolate, baby powder, paint, cut grass, sour, minty, onion, Vicks Vapo-rub, spicy, Dettol (liquid antiseptic), cheese, and gasoline (petrol). The identifiable tastes represented each section of the tongue palate: salty, bitter, sour, and sweet. As a result, a series of three tests, the Wholemouth Taste Test, the Regional Taste Test, and the Odor Identification Test, are able to offer sufficient information to diagnose the level of function of both taste and smell in young children.

Previously, the ability to measure a child’s capacity for smell and taste was neglected across the world because no suitable clinical test existed (many similar tests used for adults are too lengthy for a child, and test for smells and tastes that may not be well known to the majority of children). With the development of such a test, physicians can now consider chemosensory dysfunctions in a diagnosis. The loss of taste and smell can be caused by a number of diseases and medications, along with disorders ranging from nasal and sinus disease to head trauma to middle ear surgery and infections.

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Article adapted by Medical News Today from original press release.
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Otolaryngology - Head and Neck Surgery is the official scientific journal of the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS). The study’s authors are David G. Laing, PhD; Carolina Segovia, MSc; Therese Fark; Olga N. Laing; Anthony L. Jinks, PhD; Julia Nikolaus; and Thomas Hummel, MD. They are associated with the University of New South Wales, in Kensington, Australia.

About the AAO-HNS

The American Academy of Otolaryngology - Head and Neck Surgery (http://www.entnet.org/), one of the oldest medical associations in the nation, represents nearly 12,000 physicians and allied health professionals who specialize in the diagnosis and treatment of disorders of the ears, nose, throat, and related structures of the head and neck. The Academy serves its members by facilitating the advancement of the science and art of medicine related to otolaryngology and by representing the specialty in governmental and socioeconomic issues. The organization’s mission: “Working for the Best Ear, Nose, and Throat Care.”

Source: Matt Daigle
American Academy of Otolaryngology, Head and Neck Surgery