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Auriga Laboratories, Inc. (OTCBB: ARGA), a specialty pharmaceutical company, announced today the launch of Extendryl® PEM and Extendryl® GCP. The two new products will be marketed under the Extendryl brand name which consists of prescription products to treat various cough, cold, and allergy symptoms.
The prescription respiratory market is valued at more than 8 billion dollars in sales and more than 68 million prescriptions are written annually in the US. Extendryl® PEM (phenylephrine HCl 30 mg; methscopolamine nitrate 1.25 mg) Tablets combine two compounds; a decongestant with an anticholinergic/drying agent in an extended release format to provide 8 to 12 hours of relief of symptoms for adults suffering from nasal congestion and mucosal drainage associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma. Extendryl® GCP Oral Solution combines three compounds (100 mg/5 mL guaifenesin; 15 mg/5mL carbetapentane citrate; 5 mg/mL hydrochloride), and is indicated for temporary relief of non-productive cough accompanying respiratory tract congestion associated with the common cold, influenza, sinusitis, and bronchitis.
Extendryl® PEM and Extendryl®GCP will be launched in March 2008. "These new products further solidify Auriga’s commitment to enhance the Extendryl product line, and the launch is well timed to coincide with the start of Spring allergy season. These new additions to the Extendryl family will be a highly synergistic addition to Auriga’s current promotional efforts," said Frank Greico, Chief Executive Officer of Auriga.
Extendryl is contraindicated in patients who are sensitive to any of the ingredients or related compounds, and in patients with glaucoma, hypertension, cardiac disease, hyperthyroidism, urinary retention, peptic ulcer, patients on MAO inhibitor therapy and during an asthmatic attack. Extendryl GCP is contraindicated in women who are pregnant and/or nursing. Extendryl PEM is contraindicated in children under 6 years of age. See individual product package inserts for full prescribing information.
About Auriga Laboratories™
Auriga Laboratories is a specialty pharmaceutical company building an extensive product portfolio of prescription brands targeting high growth therapeutic categories in the respiratory, dermatology, and psychiatry markets, which have combined annual revenues of more than fifteen billion dollars in the United States. The company’s high-growth business model combines driving revenues through a primarily variable cost commission-based sales structure, acquisition of proven brand names, introduction of new brands, and a strategic development pipeline, all of which designed to enhance its growing direct relationships with physicians nationwide. Auriga’s exclusive prescription and over-the-counter product portfolio includes Aquoral™ for the treatment of Xerostomia, Akurza™, Xyralid™, Zytopic™, and Coraz™ dermatology products, and the Zinx™ Extendryl ®, and Levall ® Families of products for relief of symptoms associated with a range of acute respiratory diseases. For more information, visit
Forward-Looking Statements
The information contained herein includes forward-looking statements. These statements relate to future events or to the company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to its operations, results of operations, growth strategy and liquidity.
The company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Generic zithromax pills no prescription Statements regarding the company’s ability to increase its sales force and the success of such sales force in selling its products in light of competitive and other factors, the regulatory status and/or regulatory compliance of its products, the development of additional products, its ability to sustain market acceptance for its products, its dependence on collaborators, the company’s exposure to product liability claims, and the company’s prices, future revenues and income and cash flows and other statements that are not historical facts contain predictions, estimates and other forward-looking statements. Although the company believes that its expectations are based on reasonable assumptions, it can give no assurance that its goals will be achieved and these statements will prove to be accurate. Important factors could cause actual results to differ materially from those included in the forward-looking statements.
Auriga Laboratories
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NicOx S.A.
(Eurolist: COX) announced that Merck & Co., Inc. has initiated the
first in a series of planned clinical studies, in mild to moderate
hypertensive patients, under the companies’ collaborative agreement to
develop new nitric oxide-donating antihypertensive agents using NicOx’
proprietary technology. Three drug candidates have now been selected from
the companies’ joint research program, of which two have completed initial
dose ranging studies in healthy volunteers under the exploratory clinical
study paradigm with encouraging results.
Merck plans to conduct a number of clinical studies in hypertensive
patients involving single and multiple ascending dosing, prior to the
selection of a compound to be advanced into phase 2. The most advanced
candidate is now being evaluated in the first of these studies, which is a
single ascending dose trial in mild to moderate hypertensive patients. The
main objectives of this study are to assess the efficacy, safety,
tolerability and pharmacokinetics of single ascending doses of this
candidate. Subsequent studies will assess multiple ascending doses.
"The initiation of this series of clinical studies in hypertensive
patients is a very important step towards delivering a new treatment
paradigm for hypertension, where the medical need remains significant,"
commented Jacques Djian M.D., NicOx’ Cardiometabolic Area Leader. "We
believe these drug candidates have considerable potential as improved
antihypertensive agents based on their nitric oxide-donating properties and
we hope they will deliver a major advance in antihypertensive treatment for
patients worldwide."
In July 2007, NicOx announced the initiation of the first in a series
of studies in healthy volunteers for the selected candidates (see press
release of July 16, 2007). Merck is responsible for funding and performing
the development of these compounds going forward.
To date, NicOx has received euro 19.2 million from Merck under this
agreement. NicOx also stands to receive potential additional milestone
payments of euro 269 million and industry standard royalties on the sales
of products which result from the agreement. Furthermore, NicOx has the
option to co-promote resulting products, on a fee-for-detail basis, to
specialist physicians in the United States and certain major European
countries.
"We are delighted that less than one year after the first drug
candidate entered human testing, we now have three drug candidates
identified and that the first of these has started patient dosing," said
Buy generic diflucan Michele Garufi, Chairman and CEO of NicOx. "We look forward to continued
rapid progress in our collaboration with Merck and to the future
introduction of a new anti-hypertensive class on the market."
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx
is applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of NCEs in the therapeutic areas of inflammatory and
cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary
NCE and the first compound in the Cyclooxygenase Inhibiting Nitric
Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase
3 clinical studies for the treatment of the signs and symptoms of
osteoarthritis, with final phase 3 results anticipated in 2008.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric
oxide-donating NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent
and underserved diseases, such as atherosclerosis, hypertension, glaucoma
and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext
Paris Stock Exchange (Compartment B: Mid Caps).
This press release contains certain forward-looking statements.
Although the Company believes its expectations are based on reasonable
assumptions, these forward-looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially
from those anticipated in the forward-looking statements.
For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of NicOx S.A. to
differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the Document de
Reference filed with the AMF, which is available on the AMF website
() or on NicOx S.A.’s website
().
NicOx S.A.

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With the peak grass pollen season approaching, scientists can reveal that a daily dose of probiotic can change the immune status of people with hay fever.
In the first human study of its kind, scientists at the Institute of Food Research found that probiotic bacteria in a daily drink can modify the immune system’s response to grass pollen, a common cause of seasonal hay fever.
But they are not recommending that sufferers rush to the supermarket shelves just yet. The changes found may not have an immediate effect on symptoms.
"This was a pilot study based on small numbers of patients, but we were fascinated to discover a response", says research leader Professor Claudio Nicoletti. "The probiotic significantly reduced the production of molecules associated with allergy."
Hayfever is an allergic reaction to pollen or fungal spores, most commonly grass pollen. The immune system mistakes the spores for harmful invaders and produces excessive amounts of the antibody IgE to bind to them and fight them off.
IgE stimulates the release of histamine to flush out the spores, and this irritates the airways making them swell and producing the symptoms of hayfever.
In this study, volunteers with a history of seasonal hay fever drank a daily milk drink with or without live bacteria over 5 months. The study was double-blinded and placebo controlled, so neither the volunteers nor the scientists knew who had been assigned the probiotic drinks. The probiotic drinks contained Lactobacillus casei, a bacterial species that has been widely studied for its health promoting properties.
Blood samples were taken before the grass pollen season, then again when it was at its peak (June), and 4 weeks after the end of season. There were no significant differences in levels of IgE in the blood between the two groups at the start of the study, but IgE levels were lower in the probiotic group both at the peak season and afterwards.
At the same times, levels of the antibody IgG were higher, a type of antibody that in contrast to IgE is thought to play a protective role against allergic reactions.
"The probiotic strain we tested changed the way the body’s immune cells respond to grass pollen, restoring a more balanced immune response", says Dr Kamal Ivory, a senior member of the group.
The changes observed may also reduce the severity of symptoms, but clinical symptoms were not measured in this study. That is one aim of further research.
"Generic viagra pills no prescription These are really interesting results", says Dr Linda Thomas, head of science at Yakult UK, who provided the drinks and some of the funding. "We are delighted that independent scientists found evidence of this biological activity. The project was part of ongoing research into the benefits of our probiotic strain. The Institute of Food Research is well positioned to do this kind of fundamental research, as it is unique in having the right combination of expertise in microbiology, immunology, flow cytometry and human nutrition research."
Professor Nicoletti’s group intend to perform a similar study in the near future to see if the immunological changes translate into a real reduction in the clinical symptoms of hayfever. They would also like to examine the mechanisms involved.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Notes: Full reference: Clinical and Experimental Allergy, 2008. Oral delivery of Lactobacillus casei Shirota modifies allergen-induced immune responses in allergic rhinitis. Kamal Ivory, Stephen J. Chambers, Carmen Pin, Elena Prieto, Juan L. Arqu?©s, Claudio Nicoletti
Funding was provided by Yakult and through IFR’s Core Strategic Grant from the BBSRC.
The mission of the Institute of Food Research () is to undertake international quality scientific research relevant to food and human health and to work in partnership with others to provide underpinning science for consumers, policy makers, the food industry and academia. It is a company limited by guarantee, with charitable status, grant aided by the Biotechnology and Biological Sciences Research Council ().
Click here for more on IFR’s research on commensal bacteria.
Flow cytometry allows the rapid analysis of thousands of single cells and can detect rare events. It brings the power of physics to bear on important biological questions by using laser light to measure the characteristics of thousands of individual cells suspended in a stream of fluid.
Yakult () was developed in 1935 by Dr Shirota, at Kyoto University in Japan. Yakult has almost 75 years in bacteriological research and has achieved global recognition in the use of friendly bacteria in foods, cosmetics and pharmaceuticals. Research continues at the Yakult Central Institute in Japan and the company also works closely with scientific and medical communities to increase understanding of the role of friendly bacteria in health. Today Yakult is consumed by 25 million people in 31 countries and territories world-wide.
Source: Zoe Dunford
Norwich BioScience Institutes
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Older adults with low blood levels of vitamin D and high blood levels of a hormone secreted by the parathyroid glands may have a higher risk of depression, according to a report in the May issue of Archives of General Psychiatry, one of the JAMA/Archives journals.
About 13 percent of older individuals have symptoms of depression, and other researchers have speculated that vitamin D may be linked to depression and other psychiatric illnesses, according to background information in the article. "Underlying causes of vitamin D deficiency such as less sun exposure as a result of decreased outdoor activity, different housing or clothing habits and decreased vitamin intake may be secondary to depression, but depression may also be the consequence of poor vitamin D status," the authors write. "Moreover, poor vitamin D status causes an increase in serum parathyroid hormone levels." Overactive parathyroid glands are frequently accompanied by symptoms of depression that disappear after treatment of the condition.
Witte J. G. Hoogendijk, M.D., Ph.D., and colleagues at VU University Medical Center, Vrije Universiteit Amsterdam, the Netherlands, measured blood levels of vitamin D and parathyroid hormone and assessed symptoms of depression among 1,282 community residents age 65 to 95. Buy propecia pills Of those individuals, 26 had a diagnosis of major depressive disorder, 169 had minor depression and 1,087 were not depressed. The average blood vitamin D level was 21 nanograms per milliliter and the average parathyroid hormone level was 3.6 picograms per milliliter.
Blood vitamin D levels were 14 percent lower in individuals with major and minor depression (average, 19 nanograms per milliliter) compared with non-depressed participants (average, 22 nanograms per milliliter). In addition, parathyroid hormone thyroid levels were an average of 5 percent higher in those with minor depression (average, 3.72 picograms per milliliter) and 33 percent higher in those with major depressive disorder (average, 4.69 picograms per milliliter) than in those who were not depressed (average, 3.53 picograms per milliliter).
The findings may be important to patients because both low blood vitamin D levels and high parathyroid hormone levels can be treated with higher dietary intake of vitamin D or calcium and increased sunlight exposure. "Moreover, the clinical relevance of the present study is underscored by our finding that 38.8 percent of men and 56.9 percent of women in our community-based cohort had an insufficient vitamin D status," they conclude. Additional studies are needed to determine whether changes in levels of vitamin D and parathyroid hormone precede depression or follow it.
Arch Gen Psychiatry. 2008;65[5]:508-512.
This study was supported by a clinical fellow grant from the Netherlands Organisation for Scientific Research.
Archives of General Psychiatry
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