Relovair COPD and asthma filings on track despite more mixed trial results – The Pharma Letter


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Relovair COPD and asthma filings on track despite more mixed trial results
The Pharma Letter
For asthma, the company plans to file for approval in Europe in mid-2012 and will continue discussions with the US Food and Drug Administration on the regulatory requirements for a US asthma indication. GSK is looking to replace its top-selling drug
Relovair on track for filing in mid-2012, says GSKPMLiVE
GSK, Theravance Report Mixed Bag of Data for Relovair in COPD, AsthmaGenetic Engineering News
GSK and Theravance Announce Completion of the Relovair(TM)* Registrational MarketWatch (press release)
Reuters –MedCity News –FierceBiotech
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GSK and Theravance to file COPD/asthma drug – The Pharma Letter


Telegraph.co.uk

GSK and Theravance to file COPD/asthma drug
The Pharma Letter
For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the Food and Drug Administration on the regulatory requirements for a US asthma indication. Despite some mixed clinical trial results with Relovair
GSK, Theravance report completion of Relovair studies in COPD and asthmaPharmaceutical Business Review
GSK and Theravance Announce Initial Outcomes From Pivotal Phase III Studies MarketWatch (press release)
Theravance Falls Most in 3 Years After Glaxo Drug FailsBusinessWeek
Zenopa –TheStreet.com –Evening Standard
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AstraZeneca takes option on Prosidion diabetes assets; advances asthma drug – The Pharma Letter


Financial Times

AstraZeneca takes option on Prosidion diabetes assets; advances asthma drug
The Pharma Letter
Separately, Dynavax Technologies (Nasdaq: DVAX) and AstraZeneca yesterday announced their decision to advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into Investigational New Drug-enabling preclinical toxicology studies.
The Market Just Spanked My Stock!Motley Fool

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Asthma and COPD Treatment in the UK Could Improve Says New Study

Asthma and COPD Treatment in the UK Could Improve Says New Study by the Organisation for Economic Cooperation and Development (OECD)

The Pharma Times is reporting that survival rates for different cancers are improving in the UK, but most of the other 33 nations of the Organisation for Economic Cooperation and Development (OECD) achieve higher rates, says a new report.

Also, while the UK does well in avoiding hospital admissions for people with uncontrolled diabetes, it could improve the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD), according to the OECD’s annual Health at a Glance report.

The five-year relative survival rate for breast cancer in the UK during 2004-9 was 81%, up from 75% during 1997-2002, but still lower than the OECD average of 84%, says the study. For cervical cancer the rate was 59%, also lower than the OECD average of 66%, and for colorectal cancer the UK’s five-year survival rate during 2004-9 was 54% for female patients and 53% for males, compared with an Organisation average of 62% for women and 60% for men.

Also, avoidable hospital admissions for asthma complications and COPD are higher in the UK than the OECD average; for asthma admissions the rate was 74 per 100,000 adults in 2009 (OECD average 52) and for COPD it was 213 (OECD average 198).

On the other hand, admissions in the UK for uncontrolled diabetes are less than half the OECD average, at 24 versus 50 admissions per 100,000 population.

The report also notes that in 2009, for the first time, the share of Gross Domestic Product (GDP) allocated to health in the UK exceeded the OECD average, reaching 9.8% compared with an average of 9.6%.

The share of GDP allocated to health has increased strongly in the UK over past decade, particularly during the 2008-9 recession, rising from 8.4% in 2007 to 9.8% in 2009, it comments.

UK spending on health per person in 2009 was US$3,487, adjusted for purchasing parity, which is also slightly higher than the OECD average of $3,233, and per capita spending grew 4.8% in real terms in the UK during 2000-9 (Organisation average 4%).

84% of health spending in the UK was funded by public sources in 2009, which is well above the Organisation average of 72% and among the highest share in OECD nations.

Overall, the new edition of Health at a Glance says that medical care is improving in OECD member countries, but better prevention and management of chronic diseases is needed to reduce costs.

Some Asthma Drugs Kill More People Than Asthma: Why Is Big Pharma Allowed to … – AlterNet

Some Asthma Drugs Kill More People Than Asthma: Why Is Big Pharma Allowed to
AlterNet
Big Pharma and the FDA have known for years that some asthma drugs can cause asthma deaths, especially in children and African Americans. Sign up to stay up to date on the latest Personal Health headlines via email. Big Pharma has been accused of

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Acton Pharma Says Trial Of Asthma Therapy Aerospan Shows No Growth Suppression – RTT News

Acton Pharma Says Trial Of Asthma Therapy Aerospan Shows No Growth Suppression
RTT News
(RTTNews) – Privately-held Acton Pharmaceuticals Inc. Tuesday reported the publication of results of the Phase IIIb trial of Aerospan, a long-term asthma therapy, which said no suppression of growth and bone maturation was found in prepubescent
Acton Pharmaceuticals, Inc. Announces Publication of AEROSPAN(R) (Flunisolide MarketWatch (press release)

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Nycomed to collaborate with Orion on Easyhaler for asthma and COPD

Nycomed and Orion Corporation to collaborate on Easyhaler for asthma and COPD

Companies to co-market Easyhaler® combination products in major European markets Nycomed to market Easyhaler® products in MENA under exclusive licensing agreement Significant strengthening of Nycomed’s fast-growing Respiratory portfolio

Nycomed announced today that it has entered into a collaboration agreement with Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) for the co-marketing of Easyhaler® combination products for the treatment of asthma and COPD in the major European countries and an exclusive license and distribution arrangement for the Middle East and North Africa region (MENA). Both companies will commercialise Easyhaler combination products under their own brands accompanied by the Easyhaler umbrella brand.

The agreement covers Orion’s new Easyhaler combination products for treatment of asthma and COPD (chronic obstructive pulmonary disease). Orion is developing a budesonide-formoterol formulation that combines budesonide as an anti-inflammatory agent and formoterol as a long-acting bronchodilator. In addition, Orion has another Easyhaler® research programme in progress to develop a fluticasone-salmeterol formulation. In this formulation fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Both these combination products are included in the co-marketing agreement.

Respiratory is a key strategic area for Nycomed, including the COPD treatment Daxas® (roflumilast), Alvesco® (ciclesonide) for asthma, and Omnaris® (ciclesonide) for allergic rhinitis. The collaboration with Nycomed reinforces Orion’s presence throughout Europe and is in line with Orion’s strategy to strengthen its marketing position in Europe and the sales coverage through partnerships. The co-marketing area – in which both companies present their own product brands under the Easyhaler umbrella brand – covers the major European countries including Austria, the Benelux countries, France, Germany, Greece, Italy, Poland, Portugal, Spain and Switzerland. Orion will retain exclusive marketing rights for the Nordic countries, U.K. and Eastern Europe where the company is currently promoting single molecule Easyhaler products. Orion will exclusively manufacture the Easyhaler combination products covered by the agreement.

Dr. Liisa Hurme, Senior Vice President of Orion’s Proprietary Products division, commented: “I am excited about the collaboration agreement and look forward to having such a strong partner focusing on the treatment of asthma and chronic obstructive pulmonary disease. The collaboration creates a momentum for Easyhaler products in Europe and strengthens Orion’s strategic objective to become a stronger player in the field of respiratory medication.”

Guido Oelkers, Executive Vice President Commercial Operations, Nycomed, commented: “We are very pleased to have signed this collaboration agreement with Orion. We see great potential in these high quality Easyhaler products in major European countries and the MENA region. They will significantly enhance Nycomed’s fast-growing Respiratory portfolio.”

About Easyhaler®

Orion’s portfolio of proprietary products includes Easyhaler®, an in-house developed dry-powder inhaler. Orion has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances (salbutamol, beclometasone, budesonide, formoterol) used in the treatment of asthma and COPD. At the moment under development are new combined formulations of budesonide-formoterol, and fluticasone-salmeterol for the treatment of asthma and COPD.

About Orion

Orion is an innovative European R&D-based pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. Orion’s pharmaceutical R&D focuses on the following core therapy areas: central nervous system drugs, cancer and critical care drugs, and Easyhaler® pulmonary drugs.
The Group’s net sales in 2010 amounted to approximately EUR 850 million. The Company invested EUR 85 million in research and development. At the end of 2010, the Group had a total of approximately 3,100 employees, of whom 2,450 worked in Finland and 650 in other countries. Orion’s A and B shares are listed on NASDAQ OMX Helsinki. For more information visit: www.orion.fi/en

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a diversified portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. A range of OTC products completes the portfolio.
Its R&D is structured around collaborations. In-licensing and expanding in emerging markets are cornerstones of the company’s growth strategy.

Nycomed employs 12,500 associates worldwide, and its products are sold in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, Latin America, Asia and the Middle East. In the US and Japan its products are available through best in class partners.

Headquartered in Zurich, Switzerland, the company generated total sales of € 3.2 billion in 2010 and an adjusted EBITDA of € 851 million.

SOURCE: Nycomed

Nycomed and Orion to sell generic Advair and Symbicort – Pharma Times

Nycomed and Orion to sell generic Advair and Symbicort
Pharma Times
The firms have signed an agreement which covers Orion's combination products for the treatment of asthma and chronic obstructive pulmonary disease, delivered by its new Easyhaler dry powder inhaler. In particular, Orion is developing copies of GSK's
Nycomed and Orion Corporation to collaborate on Easyhaler® for asthma and COPDReuters (press release)

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Ventura bags major US partner for COPD/asthma combo copy – Pharma Times

Ventura bags major US partner for COPD/asthma combo copy
Pharma Times
division of an undisclosed leading international pharmaceutical company" for VR315, a combination therapy for chronic obstructive pulmonary disease and asthma that is widely thought to be a generic version of GlaxoSmithKline's blockbuster Advair.
Vectura Signs Up US Partner For VR315 Lung DrugNASDAQ
Vectura signs US license agreement for VR315 productStock Market Wire
Vectura gets new US partner for copy of lung drugReuters
The Pharma Letter –Pharmaceutical Business Review
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