China Biopharmaceuticals Holdings Completes All Clinical Trials Of Desloratadine For Hay Fever

China Biopharmaceuticals Holdings, Inc. (OTC Bulletin Board: CHBP), a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever. The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.

Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.

CHBP President and Chief Operating Officer Lufan An said, “We are pleased to have completed all the required clinical trials for Desloratadine for the SFDA’s review. We hope to have the SFDA’s approval to manufacture and market this drug by the end of 2007. If we are granted production approval, CHBP will be one of only four pharmaceutical companies producing Desloratadine tablets in China through 2010. This is the latest accomplishment of our R&D team which has submitted 15 drug applications to the SFDA during this calendar year.”

In a separate release, CHBP also announced today that it is one of only three companies that received authorization from the SFDA to initiate clinical trials to evaluate the safety and efficacy of Sofalcone for the treatment of digestive ulcers. CHBP also stated that the trials will be conducted in six hospitals throughout China and are expected to be completed within one year.

About China Biopharmaceuticals Holdings

China Biopharmaceuticals Holdings, Inc (CHBP) is a research driven pharmaceutical company dedicated to the discovery, development, manufacturing and marketing of small and large molecule pharmaceutical products, including medicines, vaccines, and active pharmaceutical ingredients for various categories of diseases. CHBP’s product portfolio includes 260 drugs already approved for manufacturing and marketing by the Chinese State Food and Drug Administration (SFDA). CHBP also has submitted 15 drug applications to the SFDA for its review during the calendar year of 2006. CHBP is a U.S.-listed public company with operating subsidiaries and senior management based in China. For further information, please visit our website at http://www.cbioinc.com.

Safe Harbor Statement

The statements contained herein that are not historical facts are “forward looking statements” within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In particular, our statements regarding the potential growth of the markets are examples of such forward- looking statements. The forward-looking statements include risks and uncertainties, including but not limited to, general economic conditions and regulatory developments, not within our control. The factors discussed herein and expressed from time to time in our filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed or implied by such statements. The forward looking statements are made only as of the date of this filing, and we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

China Biopharmaceuticals Holdings, Inc.
http://www.cbioinc.com

Alimera Sciences Receives FDA Approval To Market Alaway(TM) OTC For Up To 12 Hours Of Eye Itch Relief

Alimera Sciences Inc., an ophthalmic pharmaceutical company founded just three years ago, today announced that the U. S. Food and Drug Administration (FDA) has approved its ophthalmic solution Rx-to-OTC-switch new drug application (NDA) for Alaway(TM) (ketotifen fumarate ophthalmic solution 0.025%). Alaway(TM), a multiple action eye anti-allergic, is Alimera’s first NDA submission and the first to win approval. Indicated for the temporary relief of itchy eyes, Alaway(TM) will be marketed over-the- counter with the prescription strength active ingredient found in a prescription allergy eye drop.

An estimated 40 million people cope with itchy eyes associated with pollen, ragweed, grass, animal hair and dander — particularly during the spring and fall months. Unlike over-the-counter anti-itch eye drop products currently available, just one dose of Alaway(TM) offers eye itch relief within minutes and lasts up to 12 hours. Other over-the-counter products currently available offer no more than four hours of relief and require four doses per day. Alaway(TM), with its unique property of being both an antihistamine and a mast cell stabilizer addresses itchy eyes, the number one complaint among eye allergy sufferers.

“Developing Alaway(TM), submitting the application and achieving FDA approval for a three-year-old company is, indeed, an accomplishment of which Alimera is tremendously proud,” said Dan Myers, president and chief executive officer of Alimera Sciences. “The FDA’s approval of Alaway(TM) marks a milestone in Alimera’s overall strategy to consistently deliver innovative solutions to patient needs.

Alimera initially filed the NDA for Alaway(TM) in February of this year after completing a successful clinical study that showed it to be bioequivalent to Novartis’ Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%). Alaway(TM), in a 10mL bottle, is expected to be available to consumers in time to provide prescription strength relief for the spring 2007 allergy season.

About Alimera Sciences Inc.

Alimera Sciences Inc., a venture backed company, specializes in the development and commercialization of over-the-counter and prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences’ products address both the anterior (front) and posterior (back) segments of the eye. In August 2004, Alimera Sciences unveiled Soothe(R), the market’s first multi-dose, emollient-based artificial tear product, and in October 2005 initiated a Phase III clinical trial to study diabetic macular edema (DME) patients treated using Medidur(TM) with fluocinolone acetonide, the company’s pharmacologic treatment for DME.

Alimera Sciences Inc.
http://www.alimerasciences.com

CeRPTA Develops New Gluten-free Bread Of A Much Higher Quality Than Products Currently Available For Coeliacs

Researchers at the Food Technology Plant Special Research Centre (CeRPTA) have for the first time developed a completely gluten-free bread that is of a much higher quality than products currently available for coeliacs. The product was 100% successful in the tests carried out. The resulting product has an increased nutritional value, a longer useful life and a similar texture to traditional bread.

Coeliac disease is the permanent intolerance of gluten, forcing sufferers to follow a strictly gluten-free diet for their whole life. Gluten is a protein contained in certain cereals such as wheat, rye, barley, triticale (hybrid of wheat and rye) and possibly oats. Eating gluten produces atrophy to the villi in the intestine. Food is not absorbed, causing an inflammatory reaction. It affects genetically predisposed individuals, including children and adults.

It currently affects approximately 1% of the population. The number of coeliacs is growing rapidly, thus significantly increasing the number of consumers of gluten-free products.

The products are constantly improving, but coeliacs must continue adapting to a different taste that is not always pleasant. The work of the CeRPTA researchers aims to improve existing products, taking into account the growing needs of the direct and indirect coeliac population.

The aim was to develop a type of bread suitable for coeliacs with a similar taste and similar texture to bread made with wheat flour — that is, a spongy centre and a “normal” volume — as well as a unique taste that makes it stand out from existing products.

The researchers have focused on two areas: firstly, on producing a 100% gluten-free, high-quality product, and secondly, on the more demanding task of developing a 100% gluten-free product made entirely with plant products. The objective is to meet the needs of consumers with allergies to lactose and eggs.

This method allows modifications to be made and makes it possible, in the short-term future, to develop more similar products, providing coeliacs with the same choices of food as people without the disease.

The researchers have produced a 100% gluten-free product to meet these needs. The bread has a pleasant taste and texture and is of high-quality. It was produced with primary materials that are 100% gluten-free, is highly nutritional, and can be enjoyed both by coeliacs and by the general population.

Universitat AutГІnoma de Barcelona
www.uab.es

Seasonal Allergic Rhinitis – FDA Approves CLARINEX-D Gel 24 HOUR Prescription-Strength Once-Daily Nondrowsy Antihistamine

Unique Gel Control delivery system provides effective 24-hour relief – Schering-Plough Corporation (NYSE: SGP) today announced that the US Food and Drug Administration (FDA) has approved CLARINEX-D(R) 24 HOUR (desloratadine 5mg and pseudoephedrine sulfate USP 240 mg) Extended Release Tablets for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older. Available this April in time for spring allergy season, CLARINEX-D 24 HOUR will be the only once-daily prescription antihistamine and decongestant combination treatment on the market to provide 24-hour relief of nasal and non-nasal allergy symptoms.

“With the approval of CLARINEX-D 24 HOUR, physicians have a once-daily prescription allergy treatment that combines the proven efficacy and safety of CLARINEX with an established decongestant,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough.

According to a survey of 1,000 adults with allergies, 83 percent said they experience symptoms in the morning and more people indicated they suffer from nasal congestion, compared to other allergy symptoms, when they first wake up.(1)

CLARINEX-D 24 HOUR uses a Gel Control system to control the release of the pseudoephedrine component for consistent delivery. This ensures once-daily 24-hour efficacy, which allows people to wake up with their symptoms under control.

“My patients with allergies say that mornings are the toughest part of the day for dealing with their symptoms, and it often is their nasal congestion that finally makes them visit my office,” said William R. Lumry, M.D. of Allergy and Asthma Specialists in Dallas, Texas. “That’s why it is important for patients to have a one-dose option to help control their symptoms in the morning and all day long, even when congestion occurs.”

The FDA approved CLARINEX-D 24 HOUR based on results from two 2-week randomized, parallel group clinical trials involving 2,852 patients 12 to 78 years of age with seasonal allergic rhinitis, 708 of whom received CLARINEX-D 24 HOUR. In both trials, the antihistaminic efficacy of CLARINEX-D 24 HOUR, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than pseudoephedrine or CLARINEX 5 mg alone during the treatment period. And the decongestant efficacy of CLARINEX-D 24 HOUR, when measured by nasal congestion, was significantly greater than desloratadine during the treatment period.

CLARINEX-D(R) 24 HOUR Extended Release Tablets is contraindicated in patients with narrow-angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment.

It should generally be avoided in patients with hepatic insufficiency. It should also be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Pseudoephedrine hydrochloride may produce arrhythmias and cardiovascular collapse with accompanying hypotension or central nervous system stimulation with convulsions. Care should be taken in the concomitant administration of other sympathomimetic amines because combined effects on the cardiovascular system may be harmful to the patient.

The most commonly reported adverse events for CLARINEX-D(R) 24 HOUR Extended Release Tablets compared with desloratadine alone are dry mouth (8% vs 2%), headache (6% vs 5%), insomnia (5% vs 1%), fatigue (3% vs 3%), pharyngitis (3% vs 2%), and somnolence (3% vs 2%).

CLARINEX-D 24 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired.

About Allergies

Seasonal allergies affect an estimated 36 million people in the U.S. Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

About the CLARINEX Family

CLARINEX now is available in regular tablet, syrup and new decongestant combination tablet formulations.

CLARINEX Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older.(2)

CLARINEX Syrup provides relief from allergy symptoms caused by seasonal allergens such as ragweed, grass and tree pollens in patients 2 years of age and older and year-round allergens such as dust mites, animal dander and mold spores in patients 6 months of age and older. CLARINEX Syrup is also approved to treat the ongoing itching and rash due to hives from unknown causes in patients 6 months of age and older.(2)

Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue.(2)

Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.(2)

Please see full prescribing information at:
spfiles.com/piclarinex.pdf .

CLARINEX builds upon Schering-Plough’s heritage as a leader in discovery and development. Products from the company’s research efforts include the CLARITIN(R) (loratadine) family and NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg.*

About Schering-Plough Corporation

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people 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 Securities Litigation Reform Act of 1995, including the market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events and use words such as “may” and “estimate.” Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough’s business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering- Plough’s forward-looking statements. These factors include market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, timing of trade buying, the regulatory process for new products and new indications, and matters impacting patents on Schering-Plough products. 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 the 2004 third quarter 10-Q.

References:

(1) Roper Public Affairs and Media. Assessment of morning allergy suffering among adults with allergies. An Internet survey of 1,000 adults with diagnosed allergies, 2005. Margin of error +/- 2 percentage points.

(2) CLARINEX(R) Product Information. Schering Corporation.

*Calculated on the anhydrous basis.

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

Spring Allergies May Limit Attention Span and Impair Memory as Well as Cause Sniffles and Sneezes

Yet, New Study Finds That CLARITIN(R) Enables Allergy Sufferers to be as Alert and Focused as People Without Allergies –

In the first definitive clinical study to compare the cognitive function of symptomatic allergy sufferers to that of people who don’t have allergies, researchers found that CLARITIN can help allergy sufferers be as alert and focused as people who don’t have allergies.

This is significant news for the more than 50 million Americans who suffer from allergies,(1) said Jeffrey A. Wilken, Ph.D., director of the Washington Neuropsychology Research Group in Washington, DC, a lead researcher on the CLEAR (Cognitive effects of Loratadine: Effect on Allergy Response) Study, which was sponsored by Schering-Plough HealthCare Products.

Clinical studies have shown that untreated allergies can make it difficult to stay alert and focused and thus think clearly. CLEAR Study results went a step further. In the study, 300 people were given seven tests to measure attention, focus, and alertness. There were three groups of participants: people without allergies, allergy sufferers treated with placebo, and allergy sufferers who took the non-sedating antihistamine CLARITIN.

“What’s remarkable is that in seven out of seven tests, allergy sufferers who took a daily 10-milligram dose of CLARITIN performed no differently from people who did not have allergies,” said Dr. Wilken. “If you look at the findings of the study in terms of the real world, people who treat their allergies with CLARITIN will have an easier time than people with untreated allergies when focusing on a task that requires concentration and sustained attention-for example, proofreading, working on an assembly line, or driving.” Only CLARITIN has been clinically proven to make allergy sufferers as alert and focused as healthy people without allergies.

Not absent, but not fully present either

Allergies affect more than 50 million Americans(2) and cause an estimated 3.6 million lost workdays each year.(3) They contribute not only to absenteeism, but also to presenteeism — a new term that describes the phenomenon of being on the job but, because of illness or other medical conditions, not fully functioning. According to a recent Harvard Business Review article on presenteeism, researchers consider seasonal allergies to be a serious cause of this workplace problem.(4)

“When allergies affect people’s mental functioning, the quality and quantity of their work declines,” said workplace specialist Kent Peterson, MD, president of Occupational Health Strategies. “The more severe their allergies are, the greater the toll on their performance.”

About the CLEAR Study

The study included 200 allergy sufferers and 101 healthy subjects without allergies, all 18 years or older, who were exposed to a well-established and validated battery of objective tests that evaluated important aspects of cognitive function, including attention, concentration and working memory. The tests were conducted over a five-day period, and all functions were tested and scored each day. Half the allergy sufferers took Claritin during the study; the other half received a placebo.

Working memory: On a test that required subjects to remember information long enough to solve a problem based on that information, allergy sufferers taking Claritin achieved a mean score* that was statistically comparable to the healthy, allergy-free subjects’ score (119.1 +/- 20.4 vs. 123.0 +/- 20.5 [p=0.187]). The score of the allergy sufferers taking placebo was statistically worse (116.3 +/- 19.8 [p=0.024 vs. the allergy-free group]).

Concentration and sustained attention: On a math processing test that required subjects to remain focused and on task, allergy sufferers taking Claritin achieved a mean score* statistically comparable to the healthy, allergy-free subjects’ score (28.3.1 +/- 10.8 vs. 29.9.0 +/- 9.5 [p=0.218]). The placebo group’s score was statistically worse than that of the allergy- free subjects (27.3 +/- 6.2 [p=0.042]).

Visual analysis and discrimination: On a test that required good visual discrimination, allergy sufferers taking Claritin achieved a mean score that was statistically comparable to the healthy, allergy-free subjects’ score (51.1 +/- 19.5 vs. 54.7 +/- 15.9 [p=0.168]). The score of the allergy sufferers treated with placebo was statistically worse (47.6 +/- 19.4 [p=0.008 vs. the allergy-free group]).

* All scores reflect performance in terms of speed and accuracy.

The study was conducted at 14 research centers across the United States and was commissioned by Schering-Plough HealthCare Products.

About CLARITIN(R)

CLARITIN(R) is the most successful “prescription-to-OTC” switch in history. Immediately after its launch in December 2002, CLARITIN became the #1 OTC antihistamine brand (in total sales dollars), and has remained in this top position to date.(5)

Schering Laboratories received U.S. Food and Drug Administration (FDA) approval on November 27, 2002, for the OTC sale of all five formulations of the CLARITIN(R) brand, each at its original prescription strength: CLARITIN(R) Tablets, a once-daily formulation; CLARITIN(R) RediTabs(R) Tablets, a novel once-daily formulation in an orally disintegrating tablet; CLARITIN-D(R) 24 Hour Extended Release Tablets, a once-daily formulation with a decongestant; CLARITIN-D(R) 12 Hour Extended Release Tablets, a twice-daily formulation with a decongestant; and CLARITIN(R) Syrup, a liquid formulation with directions for use in children 2 years of age and older. In 2003, the FDA approved CLARITIN Hives Relief(TM) tablets as the first-ever indication for the OTC relief of itching due to hives, a common skin condition. For more information on allergies and treatment, visit http://www.CLARITIN.com.

Schering-Plough HealthCare Products is the U.S. over-the-counter (OTC) and consumer products business unit of Schering-Plough Corporation (NYSE: SGP).

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people 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 Securities Litigation Reform Act of 1995, including the market for CLARITIN. Forward-looking statements relate to expectations or forecasts of future events and use words such as “may,” “will” and “estimate.” Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough’s business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough’s forward-looking statements. These factors include current and future branded, generic and over-the-counter competition, manufacturing issues, and timing of trade buying. 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 the company’s 2004 annual report on Form 10-K.

1. American Academy of Allergy, Asthma and Immunology. The Allergy Report. Vol. I. Rochester, NY: Academic Services Consortium, University of Rochester; 2000.

2. American Academy of Allergy, Asthma and Immunology. The Allergy Report. Vol. I. Rochester, NY: Academic Services Consortium, University of Rochester; 2000.

3. Crystal-Peters J; Crown WH; Goetzel RZ; Schutt DC. The Cost of Productivity Losses Associated With Allergic Rhinitis. Medstat Group, Washington, DC 20008, USA. Am J Manag Care 2000 Mar; 6(3): 375

4. “Presenteeism: At Work, But Out of It.” Harvard Business Review, Oct. 2004: 49-58.

5. AC Nielsen: dollar sales, week ended 12/14/02, and cumulative weeks 12/14/02 through 02/26/05

CONTACT: Media, Julie Lux, +1-908-298-4774, Mobile, +1-908-216-0370, or Mary-Frances Faraji, +1-908-298-7109, Mobile, +1-908-432-2404, or Investor Contacts, Alex Kelly, or Janet Barth, +1-908-298-7436, all of Schering-Plough Corporation

http://www.schering-plough.com
http://www.CLARITIN.com

People with Peanut Allergy at Risk of Allergic Reaction to Lupin Flour

A report in this week’s issue of The Lancet concludes that adults and children with an allergy to peanuts could also be allergic to lupin flour – a substance that is used in some European countries as a potential replacement for soya flour. Food manufacturers in these countries are using it in certain specialty breads, bakery goods and catering foods, and a small number of these are finding their way into the UK. The authors suggest that people with a peanut allergy should avoid all products containing lupin flour until they can be specifically tested to see if they are susceptible.

The report details the case of a 25-year-old woman who, in August 2004, had an allergic reaction after eating a restaurant meal of chicken, French-fried potato, and onion rings. The woman knew she had a severe allergy to peanuts after a reaction to a peanut sweet when she was 15. However, peanut contamination of her food was considered unlikely. Lupin flour, an ingredient of the onion ring batter, was eventually identified as the cause of her attack.

The authors note that the prevalence of lupin allergy has increased markedly in some countries, especially France, where in 1997 the addition of lupin flour was first permitted to wheat flour. Although the food use of lupin has been permitted in the UK since 1996, few lupin-containing foods are so far on sale; the main source appears to be imported bakery and catering goods.

A new directive on food labelling came into force in Europe in November 2004, requiring food manufacturers to specifically list 12 potential allergic ingredients. Lupin flour is not included on this list despite recommendation from the UK based Institute of Food Science and Technology.

Author Dr Michael Radcliffe (Royal Free Hospital, London, UK) states: “Further work will be required to establish the prevalence and significance of lupin allergy. Meanwhile those with peanut allergy, around 1% of the UK population including 250 000 pre-school children, appear to be at particular risk as up to half may be pre-sensitised. They should be advised to avoid all products containing lupin until they can be specifically tested.”

http://www.thelancet.com

Astelin(R) Nasal Spray Provided Greater Improvement in Relieving Nasal Allergy Symptoms Than Zyrtec(R)

A new head-to-head, peer-reviewed clinical trial demonstrated that ASTELIN(R) Nasal Spray(R) (azelastine HCl), marketed by MedPointe Pharmaceuticals, provided 25 percent greater reduction in nasal symptoms than top-selling prescription antihistamine Zyrtecпѓ’ (cetirizine HCl), marketed by Pfizer Inc. The new data, published in the May 2005 issue of Clinical Therapeutics, also showed that ASTELIN offered significantly greater improvements in allergy patients’ quality of life, compared to Zyrtec.

“Patients with chronic allergies are often frustrated with allergy medications that do not work as well as they had hoped,” said lead investigator, Jonathan Corren, MD, Allergy Research Foundation, Inc. “This study provided clear evidence that ASTELIN offered patients more relief from nasal symptoms than Zytrec and improved their overall quality of life.”

The ACT I study (Azelastine Cetirizine Trial) directly compared the efficacy of ASTELIN versus Zyrtec in patients with moderate-to-severe allergic rhinitis in order to determine which prescription antihistamine was more effective in improving nasal symptoms of seasonal allergic rhinitis. The ACT I study examined the efficacy of ASTELIN or Zyrtec against common allergy symptoms, including runny nose, sneezing, nasal itching and nasal congestion. These symptoms collectively were directly measured as the Total Nasal Symptom Score (TNSS). In the ACT I study, patients experienced improvements in TNSS while taking either Astelin or Zytrec; however, patients taking ASTELIN showed an overall greater improvement in TNSS compared to those taking Zyrtec. The average improvement in TNSS for ASTELIN was 5.56 (29.3%) compared with 4.32 (23.0%) with Zyrtec, which was significant (P = .015).

In the assessment of onset of action over four hours, the TNSS was significantly improved from baseline in both treatment groups 15 minutes after initial administration (P
Using the Rhinitis Quality of Life Questionnaire (RQLQ), the standard tool of measurement, the ACT I study showed that ASTELIN offered statistically significant improvements (P = 0.049) in quality of life benefits compared with Zyrtec.

“This study once again confirms the efficacy of ASTELIN and reaffirms the benefit of a topically administered antihistamine,” said Paul Edick, President of MedPointe Pharmaceuticals.

ACT I Study Design

Conducted during the 2004 fall allergy season at 20 investigational centers in major geographic regions throughout the U.S., the ACT I trial was a two-week, randomized, double-blind study involving 307 patients with moderate-to-severe allergic rhinitis. Participants were males and females 12 years of age and older with a two-year history of seasonal allergic rhinitis and a documented positive allergy skin test during the previous year. Following a one-week placebo lead-in period, patients were randomized to ASTELIN two sprays per nostril twice daily plus placebo tablets or Zyrtec 10-mg tablets once daily plus placebo (saline) nasal spray for the two-week, double-blind treatment period. Patients recorded symptoms twice daily in diary cards during the two-week treatment period.

Both ASTELIN and Zyrtec were well tolerated in the ACT I study. The most common adverse event, or side effect, experienced with ASTELIN was bitter taste (3.3 %). The most common side effect of Zyrtec was drowsiness (2.6%).

Impact of Allergies

Allergic rhinitis is the fifth most prevalent chronic disease in the United States, affecting up to 40 million adults and children each year. Allergic rhinitis costs the nation approximately $5.3 billion in direct and indirect costs (including time lost from work and school) and accounts for about 10,000 absences from school.

Twenty percent of the U.S. population suffers from seasonal allergies, which are caused by pollen, spores, and other allergens. Millions of Americans suffering from seasonal allergies also may be sensitive to environmental triggers such as air pollution, cigarette smoke, and cleaning solutions. It is critical that patients seek proper diagnosis with physicians to determine which type of allergies they suffer from to determine the best treatment options.

Additional Information About ASTELIN

ASTELIN, the only prescription antihistamine approved by the Food and Drug Administration to treat symptoms of seasonal allergic rhinitis and nonallergic vasomotor rhinitis, is the fastest-growing antihistamine in new prescriptions in the past year.

ASTELIN is indicated for the treatment of the symptoms of seasonal allergic rhinitis (in patients 5 years of age and older) and nonallergic vasomotor rhinitis (in patients 12 years of age and older). ASTELIN is well tolerated and relieves the full range of rhinitis symptoms, including difficult-to-treat nasal congestion. The most commonly reported adverse events in seasonal allergic rhinitis and nonallergic vasomotor rhinitis patients 12 years of age and older were bitter taste, headache, somnolence, and nasal burning. The adverse event profile in seasonal allergic rhinitis patients 5 to 11 years of age was similar to that in the adult population.

For additional information and/or full Prescribing Information on ASTELIN, please call 1-800-598-4856 or visit www.astelin.com.

About MedPointe Pharmaceuticals

MedPointe Pharmaceuticals is a privately held, specialty pharmaceutical company located in Somerset, New Jersey. MedPointe specializes in respiratory, allergy, central nervous system, cough-cold, and pediatric products. The company maintains a manufacturing facility in Decatur, Illinois. For more information on MedPointe, visit http://www.medpointepharma.com.

Zyrtec is a registered trademark of Pfizer Inc.

Lifesaving Allergy Drug, Epinephrine, Out of Reach for Many in Need

Self-injectable epinephrine – used for treating anaphylaxis, a severe allergic reaction – is unavailable for adults and children in many countries, unavailable in doses for infants anywhere in the world and where it is available, it may be inadequately administered in some adults, especially women.

These findings were published in this month’s Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI).

Based on a survey of 75 allergists-immunologists in the 2003 to 2005 World Allergy Organization (WAO) House of Delegates, F. Estelle R. Simons, M.D., University of Manitoba, Winnipeg, Canada, finds that many areas of the world have no supplies of epinephrine kits for patients at risk of anaphylaxis, and nowhere in the world is there a autoinjector with a dose suitable for use in infants.

Anaphylaxis is a life threatening, often unexpected, allergic reaction that affects many parts of the body at once. Like other allergic reactions, anaphylaxis is the body’s overreaction to a foreign substance that ordinarily is harmless. Symptoms of anaphylaxis include hives, swelling and flushing, difficulty breathing and wheezing, a swelling of the tongue, throat and nose, dizziness and a dangerous drop in blood pressure, nausea and cramping.

Epinephrine injections are first-line therapy for anaphylaxis and should be provided to all patients at risk of subsequent episodes of anaphylaxis according to new medical guidelines developed by the Joint Task Force on Practice Parameters of the ACAAI, the American Academy of Allergy, Asthma and Immunology (AAAAI), and the Joint Council on Allergy, Asthma and Immunology (JCAAI). The guidelines indicate that more than one dose is needed for approximately one third of individuals with anaphylaxis.

In Dr. Simons’ survey, widespread availability of epinephrine autoinjectors for emergency self-treatment of anaphylaxis in the United States, Europe, Canada and Australia contrasted with limited availability in Asia, South America and Africa. Survey results revealed the cost for epinephrine autoinjectors were reported to range from U.S. $30 to U.S. $110, and could vary 2-fold within the same country. The purchase cost in some countries is equivalent to a month’s salary for many patients.

The most common triggers of anaphylaxis worldwide are foods, as well as insect stings or bites, latex rubber, medications and exercise. In some world regions, unique anaphylaxis triggers are of relatively high importance, according to Dr. Simons. In the Asia-Pacific region, food triggers include buckwheat, bird’s nest soup and royal jelly (ingested bee product), and sting and bite triggers include jellyfish, triatomid bugs and green ants.

The investigation also raises concerns for individuals at risk of anaphylaxis who may develop an anaphylaxis episode when traveling internationally, use their epinephrine, and subsequently be unable to obtain prescription refills.

Epinephrine injected by an autoinjector in the lateral aspect of upper thigh is the standard of care in the emergency self-treatment of anaphylaxis. The current recommendation includes both subcutaneous and intramuscular administration. The most widely used epinephrine product for self-administration in the United States is the EpiPen autoinjector.

In a separate report, Ted T. Song, D.O., Walter Reed Army Medical Center, Washington, D.C., and colleagues investigated whether EpiPen autoinjector, with a needle length of 1.42 cm, is sufficient for intramuscular delivery of epinephrine in men and women. Their findings showed that, since the distance from skin to muscle in the thigh is greater in women compared with men, the epinephrine autoinjector needle may not be long enough to deliver the drug to the intramuscular tissue in many women.

Recent studies have shown that intramuscular administration of epinephrine gives shorter time to maximal concentration compared with the subcutaneous route, but data is not available to establish one route as being superior over the other.

Investigators note that the increasing trend in obesity may mean that even fewer women would receive epinephrine adequately with the EpiPen autoinjector and that more men would also be affected. Physicians should be aware that many women and obese men will likely get the drug in their subcutaneous tissue and not in their intramuscular tissue.

Patient information on allergic diseases and anaphylaxis is available by calling the ACAAI toll free number at (800) 842-7777 or visiting its Web site at http://www.acaai.org, or the Food Allergy & Anaphylaxis Network (FAAN) at http://www.foodallergy.org.

The ACAAI is a professional medical organization comprising nearly 5,000 qualified allergists-immunologists and related health care professionals. The College is dedicated to the clinical practice of allergy, asthma and immunology through education and research to promote the highest quality of patient care.

Citations:

Simons, FE. Lack of worldwide availability of epinephrine autoinjectors for outpatients at risk of anaphylaxis. Ann Allergy Asthma Immunol 2005;94:534-538.

Song, TT, et al. Adequacy of the epinephrine autoinjector needle length in delivering epinephrine to the intramuscular tissues. Ann Allergy Asthma Immunol 2005;94:539-542.

Reference: Lieberman, P, et al. The diagnosis and management of anaphylaxis: An updated practice parameter. J Allergy Clin Immunol 2005; 115:S483-523.

American College of Allergy, Asthma and Immunology (ACAAI)
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States
http://www.acaai.org

New food allergy research consortium focuses on peanut allergy

The only advice doctors can give to the 4 percent of Americans with potentially life-threatening food allergies is to avoid the culprit food, often nuts or shellfish. But that may change as researchers in a new Food Allergy Research Consortium, announced today, strive to develop therapies to treat and prevent food allergy.

The consortium, led by Hugh Sampson, M.D., at the Mount Sinai School of Medicine in New York City, will receive approximately $17 million over five years from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In addition, a five-year NIAID grant totaling approximately $5 million to the Emmes Corporation, of Rockville, MD, will fund a statistical center to support the consortium.

“The expertise of the Food Allergy Research Consortium provides a unique opportunity to investigate basic immunologic mechanisms associated with food allergy in animal models and humans, and, ultimately, to test novel therapies to treat food allergy,” says Daniel Rotrosen, M.D., director of NIAID’s Division of Allergy, Immunology and Transplantation.

The consortium will conduct basic, clinical and epidemiological studies, and develop educational programs aimed at parents, children and healthcare providers.

The consortium’s first project will be a clinical study to evaluate a potential peanut allergy therapy. This potential therapy is expected to work in much the same fashion as allergy shots in which allergic individuals are given increasing doses of an allergen. The shots stimulate an immune response that protects against future allergic reactions. The existing approach, however, cannot be used in people with peanut allergies due to the risk of life-threatening reactions. To overcome this barrier, Dr. Sampson and Wesley Burks, M.D., of Duke University, Durham, NC, developed modified versions of peanut allergens that have been shown to be safe and effective in animal models. The consortium will evaluate these modified allergens in human clinical trials led by Robert Wood, M.D., of the Johns Hopkins University School of Medicine, Baltimore.

The consortium’s second project is an observational study that will enroll 400 infants who have allergies to milk or eggs. Such children are at higher risk of developing peanut allergy, but the vast majority will lose their allergies to those foods as they grow up. The study will follow the children for at least five years and study immunologic changes that accompany the loss of allergy to foods and the development of allergy to new foods. This study will be led by Scott Sicherer, M.D., at Mount Sinai School of Medicine.

The clinical and observational studies will take place at five clinical sites:

— Mount Sinai School of Medicine, New York; Principal Investigator: Hugh Sampson, M.D.

— Johns Hopkins University School of Medicine, Baltimore; Principal Investigator: Robert Wood, M.D.

— Duke University School of Medicine, Durham, NC; Principal Investigator: Wesley Burks, M.D.

— University of Arkansas Children’s Hospital Research Institute, Little Rock; Principal Investigator: Stacie Jones, M.D.

— National Jewish Medical and Research Center, Denver; Principal Investigator: Donald Leung, M.D., Ph.D.

For information about participating in the Food Allergy Research Consortium’s clinical and observational studies, please call the Mount Sinai School of Medicine Pediatric Allergy Division at 212-241-5548.

The consortium’s third project will conduct basic immunobiology research to determine the biological mechanisms of peanut allergy in mice. This knowledge will provide insights into allergic mechanisms in humans, which will lead to the identification and development of potential strategies to treat and prevent food allergies in humans. This research will be led by Kim Bottomly, Ph.D., of Yale University, New Haven, CT, in collaboration with Dr. Sampson and Lloyd Mayer, M.D., at Mount Sinai School of Medicine.

In addition, the consortium will conduct a two-pronged educational program to teach parents and children how to avoid food allergens, and train pediatric health care professionals to treat and prevent food allergy.

NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Contact: Linda Joy
ljoy@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov

FDA Approves Orally Disintegrating Prescription Antihistamine, Re-Formulated CLARINEX(R) (desloratadine) REDITABS(R) Tablets

REDITAB Dissolves Without Water to Treat Indoor and Outdoor Allergies and Hives of Unknown Cause –

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved re-formulated CLARINEX(R) (desloratadine 2.5 mg and 5 mg) REDITABS(R) tablets for the treatment of allergy symptoms caused by both perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria (CIU), or hives of unknown cause, in adults and children 6 years of age and older. The tablet disintegrates orally, is taken once-daily for 24-hour relief, and now comes in a new “tutti frutti” flavor. This convenient new formulation will be available in both a 2.5 mg and a 5 mg dose, and will be in pharmacies nationwide in September 2005.

“The CLARINEX REDITABS formulation offers my patients a new, convenient treatment option for their allergies,” said William Berger, M.D., a clinical professor in the Division of Allergy and Immunology at the University of California, Irvine. “An orally disintegrating tablet allows my patients the convenience to take their medication anytime and wherever they are even without water, and the once-daily dose helps them start each day with their symptoms under control.”

The tablet dissolves rapidly allowing allergy sufferers to take their medication when it is convenient for them, even when they do not have access to water. Patients who have active lifestyles or dislike swallowing pills may prefer REDITABS for their allergy treatment. Options like REDITABS, make it possible to identify the most appropriate allergy treatment for each patient given their lifestyle and preferences.

“This new formulation, along with the currently available CLARINEX family of products, helps physicians tailor the treatment regimen to patients’ specific needs and allows them to provide a variety of safe and effective allergy treatments for both children and adults,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough.

CLARINEX is the only prescription nonsedating antihistamine approved for patients as young as 6 months old and is available in different forms to accommodate patient preference and symptoms. The CLARINEX family of products includes CLARINEX (0.5 mg per 1 mL) Syrup for children as young as 6 months old, CLARINEX REDITABS for both adults and children starting at 6 years of age and CLARINEX (5 mg) Tablets and CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/pseudoephedrine 240 mg) Extended Release Tablets for patients 12 years of age and older. CLARINEX-D 24 HOUR combines an antihistamine with a decongestant for patients suffering from nasal congestion associated with seasonal allergic rhinitis.

CLARINEX also is the only prescription nonsedating, 24-hour antihistamine approved for the treatment of indoor and outdoor allergies and hives of unknown cause. The efficacy and safety of CLARINEX in outdoor allergies has been established in four double-blind, randomized, placebo-controlled studies involving more than 2,300 patients with seasonal allergies. CLARINEX was also studied in indoor allergies in two double-blind, randomized, placebo-controlled studies involving more than 1,300 patients with perennial allergies. A single 5 mg dose of CLARINEX taken once daily provides 24-hour nonsedating relief from nasal and non-nasal symptoms of indoor and outdoor allergies. The approval for CLARINEX in chronic idiopathic urticaria (CIU) was based on two double-blind, randomized, placebo-controlled studies involving more than 400 patients.

In clinical trials, CLARINEX provided significantly greater symptom relief than placebo. Also, CLARINEX provided powerful morning symptom relief with significant improvement in morning symptom scores over placebo.(1) The most common side effects in allergic rhinitis were sore throat, dry mouth and fatigue, with an incidence rate similar to placebo. In CIU studies, the most common side effects were headache, nausea and fatigue.

About Allergies and Hives

Seasonal allergies affect an estimated 36 million people in the U.S.2 Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

Chronic idiopathic urticaria (CIU) refers to ongoing outbreaks of hives that last longer than six weeks, with no known cause. They can develop anywhere on the body and are usually associated with itching. The itchy, red spots appear quickly and usually disappear within 24 hours and may reappear elsewhere on the body.(2)

About the CLARINEX Family of Products(3)

CLARINEX is available in a regular tablet, an orally disintegrating tablet, as syrup and in combination with a decongestant.

CLARINEX Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older. CLARINEX REDITABS tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 6 years of age and older. CLARINEX Syrup, available in a bubblegum flavor, is approved for the relief of symptoms of outdoor allergies in children two years and older, and indoor allergies and hives of unknown cause in children as young as six months. CLARINEX-D(R) 24 HOUR Extended Release Tablets is a once-daily prescription antihistamine and decongestant combination treatment which provides 24-hour relief of nasal and non-nasal symptoms of outdoor allergies in patients 12 years of age and older.

Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue.

Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.

Due to its pseudoephedrine component, CLARINEX-D 24 HOUR Extended Release Tablets should not be taken by patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, severe high blood pressure, or severe heart disease, or by patients who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen (14) days. Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver or kidney problems; or enlarged prostate should check with their health care provider before taking CLARINEX-D 24 HOUR Extended Release Tablets. Care should be used if CLARINEX-D 24 HOUR Extended Release Tablets is taken with other antihistamines and decongestants because combined effects on the cardiovascular system may be harmful. The most commonly reported adverse events for CLARINEX-D 24 HOUR Extended Release Tablets were dry mouth, headache, insomnia, fatigue, sore throat, and drowsiness.

Please see full prescribing information at: spfiles.com/piclarinex.pdf.

CLARINEX builds upon Schering-Plough’s heritage as a leader in discovery and development. Products from the company’s research efforts include the CLARITIN(R) (loratadine) family and NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg. *

* Calculated on the anhydrous basis

About Schering-Plough Corporation

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people 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 Securities Litigation Reform Act of 1995, including information relating to the market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events and use words such as “may” and “estimate.” Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering- Plough’s business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough’s forward-looking statements. These factors include market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, timing of trade buying, the regulatory process for new products and new indications, and matters impacting patents on Schering-Plough products. 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 the first quarter 2005 10-Q.

References:

(1) Meltzer E.O., Prenner B.M., Nayak A., and the Desloratadine Study Group. “Efficacy and tolerability of once-daily 5 mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons.” Clin Drug Invest (2001) 21:25-32.

(2) Natahn, R.A., Meltzer, E.O., Selner, J.C., Storms, W. “Prevalence of Allergic Rhinitis in the United States.” Journal of Allergy and Clinical Immunology (1997) 99:S808-14.

(3) CLARINEX(R) Product Information. Schering Corporation.

http://www.schering-plough.com