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Roche Asthma Drug Meets Primary Endpoint In Phase II Study
Fox Business VX) Thursday said that a phase II study of its investigational asthma treatment lebrikizumab met its primary endpoint in a mid-stage trial. –Lebrikizumab isa humanized monoclonal antibody designed to block interleukin-13 (IL-13) cytokine. … IL-13 Blocker Helps Asthma Control Experimental Drug Promising Against Tough-to-Treat Asthma Roche asthma drug shows promise in mid-stage trial |
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 Mother Nature Network |
Gene Linked to High Asthma Risk in African-Americans Discovered
International Business Times Researchers found a gene, PYHIN1, and its variations may account for a large proportion of asthma risk in people of African descent. In particular, one polymorphism of the gene was 34 percent more likely found in African-American and Afro-Caribbean … Asthma Gene Unique To African Americans Asthma gene discovered unique to African-Americans Asthma gene found in African Americans |
View full post on asthma – Google News
 ThirdAge |
Gene Increasing Asthma Risk in African-Americans Identified
International Business Times Researchers have identified a new gene that increases the risk of asthma amongst the African-American population, the first gene variant found specific to asthma risk in blacks. The gene, PYHIN1, was rarely … Gene Variant Has Large Effect on Blacks' Asthma Risk Asthma gene found in African Americans Gene Variant Associated With Asthma Risk in Blacks |
View full post on asthma – Google News
Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that despite the implementation of U.S. Food and Drug Administration (FDA)-mandated label revisions to long-acting beta2 agonist (LABA)-containing drugs, the patient share among recently treated asthma patients of LABA/inhaled corticosteroids (ICS) combination drugs exceeded the patient share of single-agent ICS drugs in the fourth quarter of 2010. The label revisions seek to limit the use of LABA-containing drugs and state that physicians should attempt to step down patients to ICS therapies once asthma control is achieved.
“Additionally, specialists likely prefer the step-down approach to managing persistent asthmatics and will start an asthma patient on a LABA/ICS combination to control the disease and then back off treatment by returning to an ICS therapy.”
According to Treatment Algorithms in Asthma, among newly diagnosed patients, a similar percentage are using LABA/ICS as are using single-agent ICS agents in the first line of maintenance therapy within a year of diagnosis.
“The FDA advises that fixed-dose combinations of LABAs and ICSs be reserved for patients whose asthma remains uncontrolled despite treatment with single-agent ICSs. The presence of similar patient shares for these two drug classes in the first line of therapy for newly diagnosed patients suggests physicians are comfortable using LABA/ICS combinations as a first-line maintenance therapy and may not always follow these guidelines,” said Decision Resources Analyst Amanda Puffer, M.Sc. “Additionally, specialists likely prefer the step-down approach to managing persistent asthmatics and will start an asthma patient on a LABA/ICS combination to control the disease and then back off treatment by returning to an ICS therapy.”
Enhanced Service and Platform Now Available
The analysis is part of Decision Resources’ enhanced Treatment Algorithms series, which features a new online platform. Interactive, user-friendly and with more graphical data views, the new platform enables users to easily toggle between diseases and time cohorts, which ultimately allows for more in-depth analysis on each line of therapy. Treatment Algorithms analysis is now updated quarterly to provide ongoing trending of product utilization by line of therapy and new therapy initiations. Through examination of U.S. patient-level claims data, Decision Resources’ Treatment Algorithms series provides exceptional insight into physicians’ prescribing trends, from diagnosis through multiple courses of treatment, for a specific disease.
About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.
All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.
Contacts
Decision Resources
Lisa Osgood, 781-993-2606
losgood@dresources.com
or
Decision Resources, Inc.
Christopher Comfort, 781-993-2597
ccomfort@dresources.com
Today Phadia, the global leader of in vitro diagnostics for allergy, asthma, and autoimmune related diseases, announced that Dennis M. Flannelly has joined the company as Head of U.S. Marketing and Strategy.
Prior to joining Phadia, Mr. Flannelly spent his career at Merck where he held a number of progressively-responsible positions, rising from field sales to lead U.S. and international product launch planning and operational readiness for several targeted $1 billion compounds, including the migraine and insomnia franchises.
He also has extensive experience in respiratory care, having served as Marketing Manager for Merck’s Respiratory Business. In this capacity he defined the strategy and tactical execution for spring allergy campaigns, developed training plans for more than 1,800 sales representatives, and designed a multi-channel marketing program for back-to-school allergy and asthma season.
As Head of Marking and Strategy for Phadia, Mr. Flannelly will oversee all marketing efforts for ImmunoCAP®, the market leader for in vitro allergy testing; develop and execute a broad, multi-channel launch plan for ImmunoCAP Allergen Components, a next-generation allergy test that was cleared by the FDA in June 2011; and develop in-depth marketing efforts to drive accelerated growth for EliA®, the emerging leader and future gold standard for autoimmune testing. This will include expansion of Phadia’s extensive physician and consumer education efforts and healthcare reform initiatives.
David Esposito, President and General Manager of Phadia U.S., said, “Phadia has substantial growth plans in the U.S. to continue our trajectory for ImmunoCAP and seize upon our recent FDA approval for ImmunoCAP Allergen Components, which is the first allergy test to provide visibility into the specific molecules of the allergen that is driving the allergic reaction. In addition, we have just begun our efforts to drive significant growth in the autoimmune market, third largest disease category in the U.S., with our EliA® test offerings. As we continue to build our team, Dennis Flannelly brings a depth of experience from his years at Merck that will serve us well. He has consistently demonstrated the kind of leadership, business acumen, and strategic marketing insight that we need at this time to execute our growth plans.”
Dennis Flannelly added, “I have long admired Phadia and I have seen firsthand the benefits of ImmunoCAP testing from my days leading several initiatives with Merck’s marketing efforts for Singulair®. With Phadia’s recent FDA clearances for next-generation allergy tests, I believe there is a significant opportunity to not only grow the business domestically, but to improve patient care, reduce healthcare costs, and enhance quality of life for people who have allergies or asthma. I’m looking forward to working with David Esposito and his team during this exciting time in Phadia’s history.”
Mr. Flannelly holds a bachelor’s degree in marketing from Villanova University and a master’s in marketing from St. Joseph’s University. He is a Six-Sigma Black Belt and has won several awards for his innovative marketing programs from Merck.
About Phadia
Phadia AB is a global leader in allergy, asthma and autoimmunity diagnostics. Phadia develops, manufactures and markets complete blood test systems to manage and support clinical diagnosis. Phadia has marketing companies in more than 20 countries and distributors in more than 60 countries. For more information please visit www.phadia.com.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6797224&lang=en
Contacts
Phadia
Media Contacts:
Michelle Larkin, 610-228-2117
michelle@gregoryfca.com
or
Katie Nicolai, 610-228-2128
katien@gregoryfca.com
 Fox News |
Botox could not only cure wrinkles but Asthma as well
International Business Times AU Asthma patients can now find relief for their condition and have a wrinkle-free voice box at the same time. Australian doctors are trying a radical new treatment for patients with severe asthma by injecting botox into the larynx in an effort to relax … Asthma sufferers to have Botox injected into voice box Botox bid to iron out asthma How to get rid of those voice-box wrinkles and breathe easier |
View full post on asthma – Google News
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Asmacure Ltee to Present at the 2011 BIO Business Forum During the Annual BIO …
PR Newswire (press release) QUEBEC CITY, June 22, 2011 /PRNewswire/ — Asmacure Ltee, a clinical-stage biopharmaceutical company focused on the development of nicotinic receptor agonists for the treatment of asthma and other inflammatory diseases, announced today that CEO Martin … |
View full post on asthma – Google News
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Research and Markets: the Asthma, COPD & Allergic Rhinitis Market Outlook to …
Business Wire (press release) The global respiratory market was valued at $44.0bn in sales in 2010 with asthma/COPD drugs being the key revenue drivers of the therapeutic segment. Of respiratory indications, asthma represents the main area of R&D interest for pharmaceutical … |
View full post on asthma – Google News
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GSK gets good news on asthma drug
Triangle Business Journal GlaxoSmithKline (NYSE: GSK) announced statistically significant Phase 3 results for Relovair, an asthma treatment that the British drug giant is developing with partner Theravance Inc. (NASDAQ: THRX). Relovair is a once-daily inhaled treatment for … Glaxo Drug Gets Positive Trial Results Theravance, Glaxo Lung Drug Passes Two Pivotal Trials; Two More to Go Glaxo reports positive results for inhaler drug |
View full post on asthma – Google News
AstraZeneca (NYSE:AZN) today announced results from a long-term study comparing SYMBICORT® (budesonide/ formoterol fumarate dihydrate) Inhalation Aerosol 160/4.5 mcg with budesonide pressurized metered-dose inhaler (pMDI) 160 mcg in self-reported African American patients with moderate to severe persistent asthma. The data demonstrated that SYMBICORT treatment resulted in significant improvement in lung function compared to treatment with budesonide alone, and safety results indicated that patients in the SYMBICORT group had fewer exacerbations over the randomized study period compared to patients treated with budesonide.1-2 The incidence of adverse events (AEs) was similar between the two groups.2 The results were presented in a poster at the 2011 American Thoracic Society (ATS) International Conference in Denver.
“Data from this year-long study of SYMBICORT supports our understanding of the product’s efficacy and safety in African American patients.”
SYMBICORT is a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol). It is indicated for the treatment of asthma in patients 12 years of age and older not adequately controlled on a long-term asthma control medication, such as an ICS, or whose disease severity clearly warrants initiation of treatment with both an ICS and LABA.3
“African American patients are disproportionately affected by asthma – asthma prevalence is higher for African Americans than for Caucasians,” said Dr. Ubaldo Martin, Director of Clinical Research at AstraZeneca. “Data from this year-long study of SYMBICORT supports our understanding of the product’s efficacy and safety in African American patients.”
There have been few prior studies evaluating combination asthma treatment in specific ethnic populations at higher risk for asthma prevalence. Results from this 52-week study are consistent with safety and efficacy data from the TITAN study, a 12-week study of SYMBICORT in African American patients, and with previous SYMBICORT studies conducted among predominantly Caucasian patients.4-6
About the Study
The 52-week, randomized, double-blind Phase III study included 742 self-reported African American patients 12 years of age and older with moderate to severe persistent asthma. After two weeks of receiving two inhalations, twice daily of budesonide 160 mcg, patients were randomized to receive two inhalations, twice daily of SYMBICORT 160/4.5 mcg or two inhalations, twice daily of budesonide 160 mcg.2
Results from the study showed:
Fewer patients receiving SYMBICORT (7.7%) compared to budesonide (14.0%) had ?1 asthma exacerbation (oral/systemic corticosteroid use, an asthma-related hospitalization, or emergency room/urgent care visit) (P=.006) 2
The time to first asthma exacerbation was longer in patients treated with SYMBICORT compared to budesonide (P=.018) 2
Similar percentages of patients had ?1 AE, the most common AEs were headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection2
Treatment with SYMBICORT resulted in significantly greater improvements in predose forced expiratory volume in one second (FEV1), predose forced vital capacity (FVC), and morning peak expiratory flow (AM PEF) compared to budesonide1
Improvements in predose FEV1 were observed after two weeks of randomized treatment with SYMBICORT, without diminution of effect relative to budesonide during the treatment period1
No new safety concerns were identified with SYMBICORT during the course of the study. The most common adverse events for patients receiving SYMBICORT or budesonide were headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection.2
About Asthma in African Americans
African Americans are more likely to be diagnosed with asthma in their lifetime, and asthma prevalence is higher in African American patients compared to Caucasians.7
Important Safety Information, including boxed WARNING3
WARNING: ASTHMA RELATED DEATH
Important Safety Information, including boxed WARNING
WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids
SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason.
Due to possible immunosuppression, potential worsening of infections could occur; a more serious course of chickenpox or measles can occur in susceptible patients.
Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients.
As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.
Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.
Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.
In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.
SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.
The most common adverse reactions ?3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.
Indications
SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see boxed WARNING).
SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.
Please see full Prescribing Information, including boxed WARNING, and visit www.MySYMBICORT.com
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
References:
1. Brown, R.W. Differential Long-term Pulmonary Function Outcomes of Budesonide/Formoterol Pressurized Metered-Dose Inhaler pMDI and Budesonide pMDI in African-American Patients with Asthma. [poster]. American Thoracic Society, May 13-18, 2011, Denver, CO. Abstract #17354.
2. Brown, R.W. Long-term Safety of Budesonide/Formoterol Pressurized Metered-Dose Inhaler Budesonide pMDI in African-American Patients with Asthma: Asthma Exacerbation Adverse Events. American Thoracic Society, May 13-18, 2011, Denver, CO. Abstract #17354.
3. Symbicort Prescribing Information. AstraZeneca.
4. Spector, S., Martin, U., Uryniak, T., O’Brien, C. Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler Versus Budesonide Dry Powder Inhaler on Pulmonary Function in Black Adolescents and Adults with Moderate to Severe Persistent Asthma [oral presentation]. American College of Chest Physicians Annual Meeting, October 30-November 4, 2010. Vancouver, BC, Canada.
5. Spector, S., Martin, U., Uryniak, T., O’Brien, C. Safety and Tolerability of Budesonide/Formoterol (BUD/FM) Pressurized Metered-Dose Inhaler (pMDI) in Black Adolescents and Adults with Moderate to Severe Persistent Asthma. [oral presentation]. American College of Chest Physicians Annual Meeting, October 30-November 4, 2010. Vancouver, BC, Canada.
6. Noonan, Michael. Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma.
7. American Lung Association. Epidemiology & Statistics Unit, Research and Program Services. Trends in Asthma Morbidity and Mortality, February 2010. Accessed April 27, 2011: http://www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf