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AstraZeneca announced that the company has submitted applications in the European Union (EU) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets (quetiapine XR), seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy in adult patients using Mutual Recognition Procedure (MRP). This follows an sNDA submission for SEROQUEL XR in MDD in the U.S. in February this year.
Each year, around 33 million people will suffer from MDD in Europe1 - between 3 and 10% of the population2. Today, it is treated with generic or branded antidepressants, including SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors). Studies have shown at least one-third of patients fail to achieve a satisfactory response with current antidepressant therapy3. SEROQUEL XR is the first atypical antipsychotic medicine to be submitted in Europe for approval for the treatment of MDD. AstraZeneca has investigated its use in MDD as a potential new treatment option for patients who do not respond adequately to current treatments.
Data from eight randomized placebo-controlled studies of quetiapine XR at once-daily doses of 50, 150 and 300 mg in patients diagnosed with MDD support the submission announced today. These include four short-term monotherapy studies involving 2116 patients; two short-term adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to prior antidepressant therapy; a longer-term monotherapy maintenance study involving 1,854 patients and up to 78 weeks of treatment; and a further short-term study involving 338 elderly patients. The short-term studies used the Montgomery-?

Over 20 million people in the UK suffer from allergy at some point in their life and for the majority obtaining the help to know what is causing their problem is virtually impossible. Without the knowledge of what is causing a reaction allergy sufferers are unable to manage their condition properly and often go on to experience increasing health problems.
In response to continual demand from the public contacting Allergy UK requesting advice on where to obtain good credible allergy diagnosis Allergy UK announce today that from 19th May they will be introducing an allergy screening service which will be available through the local pharmacy.
"This is an exciting development for people with allergy and we have listened to those who contact us desperate for help. They want a local, affordable service where they can feel confident in the advice being given" said Muriel Simmons CEO of Allergy UK. "We are delighted to be working with the National Pharmacy Association to introduce this much needed service. The local pharmacy is often the first place that people turn to for advice with a health problem and it is therefore logical to establish a high quality allergy screening service within the pharmacy."
The service will offer a consultation during which a full clinical history will be taken by the pharmacist who will have undergone special training both by the Centre for Postgraduate Pharmacy Education at Manchester University and with the Clinical Director of Allergy UK. On-going support and information for the allergy sufferer will then be provided by Allergy UK.
"We needed to be sure that pharmacists received the best possible training to enable them to undertake the detailed clinical history required for good diagnosis. Any sufferer going to a pharmacist bearing the Allergy UK accreditation can be assured that the person they are seeing is a highly trained healthcare professional" said Jules Payne Deputy CEO and Head of Pharmacy Services for Allergy UK.
The Allergy Screening service will be a central part of the 2008 National Pharmacy Association ‘Ask your Pharmacist’ Campaign. It is planned that from May 19th (National Allergy Week) the service will be rolled out in selected pharmacies. Initially there will be 600 pharmacists around the UK wanting to introduce the service and we are working hard to deliver training to each of these. As at 19 May we will have at least one pharmacist delivering the service in 51 of the 152 PCT areas in England. Kaufen generishe cialis Our ultimate objective is to provide pharmacy based allergy screening services in every community in the UK with eventual roll out in Northern Ireland, Scotland and Wales.
John Turk, Chief Executive from the National Pharmacy Association said "I am delighted that our members will be able to offer a solution to those needing an allergy screening service. Pharmacists are in the right place and have the right training to provide improved access to this service."
Notes
- 1 in 3 of the population suffer from allergy at some point in their life.
- Asthma, Rhinitis and eczema have tripled in the last 20 years.
- 1 in 5 of the population suffer from asthma.
- 12 million people are allergic to cats.
- Peanut allergy has tripled in the last three year.10 years ago it was a very rare condition.
- 8% of healthcare workers suffer from latex allergy yet in 1979 only 2 cases were known.
- 40% of children suffer from allergy.
- 25% of all young people between the ages of 11 -21 suffer from hayfever.
- There is approximately only one consultant allergist for every 2 million of the population.
The National Pharmacy Association (NPA) was established in 1921 as the trade association of community pharmacy owners. Currently virtually all community pharmacy owners in the UK are in voluntary membership.
National Pharmacy Association
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Rexahn Pharmaceuticals, Inc. (AMEX:RNN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer, central nervous system disorders, sexual dysfunction and other unmet medical needs, announced that the Company has initiated a Phase II clinical trial for its lead clinical compound ZoraxelTM, for the treatment of Erectile Dysfunction (ED). ZoraxelTM is being developed as an orally administered, on-demand-use tablet.
Zoraxel™ Phase II trial is a double-blind, placebo-controlled study. This multi-center trial is expected to be complete by the end of 2008.
Commenting on today’s news, Dr. Chang H. Ahn, Chairman and Chief Executive Officer of Rexahn, noted, "We are very pleased to announce the initiation of another Phase II trial. ZoraxelTM will prove itself a more effective, less toxic therapy for patients with erectile dysfunction."
About ZoraxelTM
ZoraxelTM is being developed as an immediate release tablet and has a well-established and excellent safety profile, different from current market leading PDE-5 inhibitors with many side effects (priapism, severe hypotension, myocardial infarction, sudden death, increased intraocular pressure and sudden hearing loss). Zoraxel™ is a dual neurotransmitter enhancer in the brain, and thus, acts through the central nervous system that regulates sexual functions, whereas the PDE-5 inhibitors work in the peripheral blood vessels and affect only erectile function. In the model studies, ZoraxelTM has been shown to significantly improve all three functions of sexual activity, i.e. sexual arousal, erection, and release. As such, ZoraxelTM may be a more effective ED treatment for patients who are both responsive and unresponsive to PDE-5 inhibitors.
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse. It is estimated to affect up to 30 million men in the United States, with 52% of men between the ages of 40 and 70 reporting difficulty with erectile function. By the year 2025, it is estimated that 322 million men worldwide will suffer from some degree of sexual dysfunction. Clinical management of ED has progressed substantially in recent years. The advancement of phosphodiesterase-5 (PDE-5) inhibitor therapeutics quickly followed the scientific understanding of the nitric oxide (NO) signaling mechanism in erectile tissue. Adverse events affecting the vascular system have been a major concern with drugs that regulate that response. Investigations into the neurotransmission involved in penile erection, hormone actions involved in this response, and biochemical signal transduction processes within the erectile tissue, are indicative of significant areas of scientific pursuit.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a biopharmaceutical company leveraging its proprietary technology platform to discover, develop and commercialize innovative treatments for cancer, central nervous system disorders, sexual dysfunction and other unmet medical needs. Rexahn’s compounds are designed to uniquely treat various disease states while significantly minimizing side effects in order to allow patients to regain their quality of life. For Additional information about Rexahn visit
Safe Harbor
This press release contains statements (including projections and business trends) that are forward-looking statements. Rexahn’s actual results may differ materially from the anticipated results and expectations expressed in these forward-looking statements as a result of certain risks and uncertainties, including, Rexahn’s lack of profitability, its auditor’s going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn’s development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn’s product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn’s claims; demand for and market acceptance of Rexahn’s drug candidates; Rexahn’s reliance on third party researchers and manufacturers to develop its product candidates; Rexahn’s ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. Buy synthroid pills These forward-looking statements are made as of the date hereof; Rexahn assumes no obligation to update these forward-looking statements.
Rexahn Pharmaceuticals, Inc.
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Protherics PLC "Protherics" or the "Company"), the international biopharmaceutical company focused on critical care and cancer, today announces that the first patient has been enrolled in a phase 2a study of its Angiotensin Therapeutic Vaccine (ATV) for the treatment of hypertension.
Hypertension is a major risk factor for serious and common cardiovascular diseases such as heart attacks and strokes and the global market for anti-hypertensive therapies is estimated to be worth around US$30 billion*. The majority of existing therapies are tablets which need to be taken on a daily basis, usually for the rest of a patient’s life. However, many patients with high blood pressure fail to take their medicines as prescribed, and it is estimated that approximately 70% of patients with hypertension do not have their blood pressure adequately controlled*. Therefore, a vaccine approach, which may require only three injections and a booster after six months rather than daily medication, should improve patient compliance with treatment.
The phase 2a, double-blind, placebo-controlled clinical study in 124 patients with mild to moderate hypertension has been initiated in the UK. Patients will be given a course of injections over six weeks. The study will assess the safety and tolerability of the vaccine, incorporating Protherics’ promising novel vaccine adjuvant, CoVaccine HT™. In addition both antibody response and effect on blood pressure will be assessed. The blood pressure results are expected in the first half of 2009.
Protherics has shown in a previous phase 2a study that a formulation of ATV, incorporating the vaccine adjuvant Alhydrogel®, modulated key hormones involved in regulating blood pressure in hypertensive patients. A new formulation of ATV has now been developed, incorporating the CoVaccine HT™ adjuvant, which has demonstrated a much stronger immune response in pre-clinical models.
CoVaccine HT™ and ATV are protected by extensive patents and applications in the US, EU and the rest of the world. The first US patent on ATV was granted in May 2008.
Andrew Heath, Chief Executive of Protherics, commented:
"We are excited about the prospects for ATV, a potential value driver for the company. A vaccine approach to the treatment of high blood pressure promises to address the issue of poor patient compliance with daily medication and thus reduce the incidence of stroke and heart attacks. With data expected within a year, this could be a major outlicensing opportunity."
*Company estimates
About Protherics
Protherics (LSE: PTI, NASDAQ: PTIL) is a leading international biopharmaceutical company focused on specialist products for critical care and cancer.
Protherics has produced two FDA approved biologics for critical care use which are currently sold in the US: CroFab™, a North American pit viper antivenom and DigiFab™, a digoxin antidote. Protherics reported revenues of ??26.1 million for its year ended 31 March 2008 and a strong cash balance of ??37.7 million. The Company’s strategy is to use the revenues generated from its marketed and out-licensed products to help fund the advancement of its broad, late stage pipeline.
Protherics has two major development opportunities in its portfolio. CytoFab™ is being developed by AstraZeneca, for the treatment of severe sepsis, following a major licensing deal announced in December 2005. AstraZeneca is conducting an additional phase 2 programme following changes to the commercial manufacturing process. A new formulation of Angiotensin Therapeutic Vaccine, for the treatment of hypertension, has today commenced a phase 2a study. Protherics also has four novel products being developed in a range of cancer indications where it intends to undertake the sales and marketing in the US and/or the EU.
With headquarters in London, the Company has approximately 300 employees across its operations in the UK, US and Australia.

About Angiotensin Therapeutic Vaccine
Angiotensin Therapeutic Vaccine (ATV) is a conjugate vaccine containing a peptide analogue of the hormone angiotensin I cross linked to the carrier protein keyhole limpet haemocyanin (KLH). ATV is designed to treat hypertension by stimulating the immune system to neutralise angiotensin I, a peptide hormone that plays a key role in the regulation of blood pressure.
Protherics has previously shown in hypertensive patients that a first generation formulation of ATV modulates key hormones involved in regulating blood pressure. An improved formulation of ATV has now been developed, incorporating a novel vaccine adjuvant, CoVaccine HT™, which has shown evidence of stimulating a much stronger immune response in pre-clinical models. CoVaccine HT™ was acquired by in June 2006 by Protherics from CoVaccine BV.
A vaccine approach to the management of hypertension is expected to improve patient compliance with therapy, which is a major problem in achieving control of high blood pressure with current therapy. Because of its envisaged slow onset and sustained effect, ATV has the potential to be used on its own, or in combination with existing high blood pressure medications, to improve the control of hypertension. For more information, visit
here.
About Hypertension
Hypertension is one of the most common medical conditions in developed countries and is a risk factor associated with heart attacks, heart failure, blood vessel problems and kidney damage. Buy levitra without prescription Current treatments are tablet based, requiring daily doses, often for life, and patient compliance is often poor. The pharmaceutical market for high blood pressure treatment is the largest single therapeutic sector in the world, with global sales exceeding US$30 billion per annum.
Protherics
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acheter cialis soft mastercard A randomized controlled trial performed by researchers of the University of Amsterdam evaluates writing therapy in posttraumatic stress disorder in the March issue of Psychotherapy and Psychosomatics.
Writing assignments have shown promising results in treating traumatic symptomatology. Yet no studies have compared their efficacy to the current treatment of choice, cognitive behavior therapy (CBT). This study evaluated the efficacy of structured writing therapy (SWT) and CBT as compared to a waitlist control condition in treating acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). A randomized controlled trial was conducted at an outpatient clinic. Participants (n = 125): (a) satisfied DSM-IV criteria for ASD or PTSD, (b) were 16 years or older, (c) were sufficiently fluent in Dutch or English, (d) had no psychiatric problems except ASD or PTSD that would hinder participation or required alternative clinical care, and (e) received no concurrent psychotherapy. Treatment consisted of five 1.5-hour sessions of CBT or SWT for participants with ASD or acute PTSD and ten 1.5-hour sessions for participants with chronic PTSD. Outcome measures included the Structured Clinical Interview for DSM-IV, Impact of Event Scale, Beck Depression Inventory, State-Trait Anxiety Inventory and the Dissociative Experiences Scale. At posttest and follow-up, treatment was associated with improved diagnostic status and lower levels of intrusive symptoms, depression and state anxiety, while a trend was noted for the reduction of avoidance symptoms. Treatment did not result in lower levels of trait anxiety or dissociation. No differences in efficacy were detected between CBT and SWT. At the end of the study, the Authors confirmed the efficacy of CBT for ASD and PTSD and identified SWT as a promising alternative treatment.
PSYCHOTHERAPY AND PSYCHOSOMATICS

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