Navigation Links
Amira Pharmaceuticals and GlaxoSmithKline Enter Global Agreement for FLAP Inhibitor Program

Deal follows positive phase I data from novel product candidate AM103 for

the oral treatment of respiratory disease

SAN DIEGO, Feb. 4 /PRNewswire/ -- Amira Pharmaceuticals and GlaxoSmithKline today announced they have entered into a worldwide exclusive agreement to develop, manufacture and commercialize FLAP (5-Lipoxygenase Activating Protein ) inhibitors for the treatment of respiratory and cardiovascular disease.

Under the terms of the agreement GSK will be granted an exclusive, worldwide license to develop, manufacture and commercialize Amira's FLAP inhibitors, including AM103 and other compounds within the current development program. In the event that all potential development and regulatory milestones are successfully achieved, Amira could receive up to US $425 million in upfront and milestone payments. In addition, Amira will be entitled to receive tiered royalty payments based on worldwide net sales and commercial sales milestones.

Initial development activities will focus on candidate compound AM103, for the treatment of asthma. Positive data, from a phase I study completed in November 2007, show AM103 has the potential as a once-daily, oral, non-steroidal asthma treatment. In this study the compound was also well-tolerated.

Peppi Prasit, Chief Scientific Officer and Co-Founder Amira said: "To have identified such a positive drug candidate and progressed to the completion of phase I clinical trials just two years after the company was founded is a tremendous achievement for the team at Amira. We are delighted that GlaxoSmithKline will be taking this asset into full development. With their experience and expertise in this area we hope that AM103 will become the first FLAP inhibitor available to patients worldwide to treat symptoms of asthma and possibly other inflammatory diseases."

"This is a momentous day in the young life of Amira," said Bob Baltera, Chief Executive Officer, Amira. "This deal validates the abilities and expertise in Amira to expedite the delivery of novel medicines. We are particularly pleased to have partnered with GSK, one of the leading pharmaceutical companies in the world, and a company that has a strong heritage in the treatment of respiratory diseases."

About respiratory diseases

The prevalence of asthma is increasing globally and despite the success of inhaled beta-agonist and corticosteroid therapy there is still a significant need for alternative therapies. Although other therapies are available that target the leukotriene pathway, a FLAP inhibitor has the potential to inhibit a broad spectrum of leukotrienes. FLAP inhibitors are also being investigated for use in other respiratory indications, including rhinitis, as well as having potential for the treatment of other inflammatory and cardiovascular diseases.

The global non-steroidal market for the treatment of asthma and rhinitis is currently worth in excess of US $4 billion; prescriptions for the treatment of rhinitis contribute 15% to total worldwide sales of non-steroidals. A FLAP inhibitor with improved efficacy and equal or improved safety and tolerability to existing leukotriene receptor antagonists, in both asthma and rhinitis, would likely capture a significant portion of this market.

About the agreement

Commenting on the agreement, Dave Allen, SVP Respiratory Centre of Excellence in Drug Discovery, GlaxoSmithKline said: "The role of anti-leukotriene agents has been well validated in the treatment of respiratory diseases. We are very excited at entering into this global agreement with Amira to deliver novel therapies to patients based on this mechanism."

In addition Moncef Slaoui, Chairman R&D, GSK said: "As leaders in the development, manufacture and marketing of medicines for respiratory diseases GSK is pleased to be introducing this treatment to our product pipeline. We believe AM103, a novel FLAP inhibitor, has the potential to offer patients a convenient and effective alternative treatment for respiratory diseases including asthma and rhinitis."

About FLAP Inhibitors

FLAP (5-lipoxygenase activating protein) is a key component early in the leukotriene pathway, a complex signaling process that exerts control over biological processes, such as inflammation and immunity. Excessive production of leukotrienes exacerbates inflammatory diseases, such as asthma; the FLAP gene has also been linked to a significant increase in the risk of myocardial infarction and stroke. AM103 binds to FLAP, inhibiting the synthesis of leukotrienes that cause inflammation.

A FLAP inhibitor is active at a point higher in the leukotriene pathway than a CysLT1 receptor antagonist, enabling it potentially to inhibit the production of all leukotrienes. Leukotrienes, prostaglandins and other arachidonic acid-derived lipids make up the eicosanoid family of inflammatory mediators.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit

About Amira

Founded in 2005 and headquartered in San Diego, Amira Pharmaceuticals is a small molecule pharmaceutical company focused on the discovery and early development of compounds to treat inflammatory disease linked to the eicosanoid pathway.

The company combines the rigor of a big pharmaceutical company with the ingenuity and energy of a small company, creating an environment for efficient and effective pre-clinical and clinical program decisions. Its scientific founders have successfully worked together for more than a decade and were pivotal in the discovery of a number of inflammatory drugs, including Singulair(R). The drug hunters at Amira are now actively leveraging their history of success to create high-value compounds for the future.

In January 2006, Amira signed a collaboration with Roche to establish a research alliance and an option for Amira to license two clinical-stage compounds from Roche. Amira has yet to exercise its option.

Amira has raised $40 million to date from investors including Novo A/S (Copenhagen, Denmark), Avalon Ventures (San Diego, CA), Prospect Ventures (Palo Alto, CA) and Versant Ventures (Menlo Park, CA). For more information, visit

GlaxoSmithKline Forward-Looking Statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Business and Prospects in the company's Annual Report on Form 20-F for 2006.

SOURCE Amira Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Amira Pharmaceuticals Appoints First Vice President of Development
2. Amira Pharmaceuticals Announces Favorable Phase 1 Clinical Trial Results for Lead Product Candidate AM103 and Initiates Clinical Studies for the 2nd Entry Molecule for the Treatment of Respiratory and Cardiovascular Disease
3. Poniard Pharmaceuticals Announces Upcoming Conference Participation
4. Webcast Alert: Oscient Pharmaceuticals Announces Date for Release of Fourth Quarter Financial Results
5. Jazz Pharmaceuticals, Inc. Announces Submission of Complete Response to FDA Approvable Letter for LUVOX(R) CR
6. Acura Pharmaceuticals, Inc. Announces Approval to List Shares on NASDAQ and Effective Feb. 4, 2008 a New Trading Symbol: ACUR
7. Tigris Pharmaceuticals Appoints Pedro Granadillo to Board of Directors
8. Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE
9. Arena Pharmaceuticals to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
10. MAP Pharmaceuticals to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
11. Transcept Pharmaceuticals to Present at the 2008 Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
Post Your Comments:
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... the largest, most successful and prominent nonprofit healthcare organizations in the country. They ... involvement with various organizations, and helped advance the healthcare industry as a whole ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at ... Michigan, have come together on Thanksgiving Day to share the things that they ... on the Serenity Point YouTube channel, patients displayed what they wrote on index ...
(Date:11/26/2015)... ... November 26, 2015 , ... The Catalent Applied Drug ... need to integrate dose form selection in early phase drug development. The first ... supporting and bringing together the UK’s emerging life sciences companies, corporate partners, and ...
(Date:11/26/2015)... CA (PRWEB) , ... November 26, 2015 , ... ... a new set of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This newly ... options. These classically-influenced trailer titles work with any font, giving users limitless opportunities ...
(Date:11/25/2015)... ... November 25, 2015 , ... As part of ... Empowerment ™ attracts volunteers together who want to combine talents and resources to ... stakeholders in the process. The non-profit launched its first major fundraiser on November ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... -- The total global healthcare industry is expected to grow at ... America has the highest projected growth at 12.7%, ... ), is second with growth projected at 11.5%. ... expenditure. In 2013-2014, total government funded healthcare was nearly 68%. ... 41.2% in 2013-2014. In real terms, out of pocket expenditure ...
(Date:11/25/2015)...  The American Academy of Pediatrics (AAP), American ... March of Dimes cheered today,s signature into law ... of 2015 (S.799), which takes much-needed strides ... to drugs, such as opioids, and to improve ... organizations have worked together leading advocacy efforts for ...
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
Breaking Medicine Technology: