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GlaxoSmithKline and Myogen announce pulmonary arterial hypertension partnership
GlaxoSmithKline to commercialise ambrisentan in all territories outside of the US
Myogen receives Flolan rights in US and will launch commercial operations in Q2’06
Issued – Monday 6 March 2006, London, UK and Denver, Colorado
GlaxoSmithKline (LSE and NYSE: GSK) and Myogen, Inc. (Nasdaq: MYOG) today announced a two-part collaboration in Pulmonary Arterial Hypertension (PAH). Myogen licensed commercialisation rights for ambrisentan, Myogen’s selective endothelin receptor antagonist (ERA) currently in Phase 3 development to GlaxoSmithKline in all territories outside of the United States. Filing for marketing approval in the US and Europe is expected later this year. Simultaneously, GlaxoSmithKline and Myogen entered into a distribution agreement whereby Myogen will be responsible for the marketing and distribution of GSK’s Flolan (epoprostenol sodium) a life-saving medicine for many patients, used in the treatment of PAH, in the United States.
“We are pleased to be in this alliance with Myogen and view this collaboration as a continuation of our corporate pipeline expansion,” said Andrew Witty, President, Pharma Europe GlaxoSmithKline. “Myogen’s innovative approach to collaboration on ambrisentan has provided both companies with a potentially rewarding opportunity by giving GlaxoSmithKline access to a product candidate in an indication we know very well. At the same time, Myogen will be able to establish a commercial presence in the PAH market in the United States.”
“I believe that GlaxoSmithKline, one of the premier pharmaceutical companies in the world, is the ideal ex-US partner for ambrisentan” said J. William Freytag, President and Chief Executive Officer of Myogen. “They have been a pioneer in the treatment of PAH and, through their decade-long experience with Flolan, have a deep understanding of the PAH regulatory and market environments. Meanwhile, the Flolan distribution agreement is expected to underwrite the development of our own commercial organisation and marketing and field selling expertise in PAH, well in advance of the potential launch of ambrisentan. We believe this strategic development will accelerate our understanding of customer needs, reimbursement opportunities and market dynamics in general.”
Under the terms of the ambrisentan license agreement, Myogen will receive an upfront payment of $20 million and, subject to the achievement of specific milestones, will be eligible to receive up to an additional $80 million in milestone payments. In addition, Myogen will also receive stepped royalties on product sales with an estimated average royalty in the mid-20% range, which reflect the late stage development status and market potential of ambrisentan. Myogen will be responsible for the continued clinical development of ambrisentan. GlaxoSmithKline will be responsible for all regulatory and commercial expenses in its licensed territories. The companies will share the costs of certain additional clinical development activities for ambrisentan.
Under the terms of the Flolan distribution agreement, Myogen will build a commercial support team and field sales organisation beginning in the second quarter of 2006 dedicated to the marketing and distribution of Flolan in the United States. The distribution agreement is a three year agreement with an option to renew upon mutual consent.
About pulmonary arterial hypertension
PAH is a highly debilitating disease characterised by constriction of the blood vessels in the lungs, thereby increasing resistance to blood flow in the pulmonary tissues. The increased resistance makes it difficult for the heart to pump blood through the lungs to be oxygenated. Under this additional strain the heart responds by pumping harder and the pressure in the pulmonary artery rises, sometimes to very high levels.
Patients with PAH suffer from increasing shortness of breath as the heart has to work harder to pump against the elevated resistance from the blood vessels in the lungs. Left untreated, patients undergo an inexorable and rapid decline and ultimately may die of heart failure. PAH may occur without an apparent underlying cause, or it can occur secondary to diseases such as connective tissue disease, congenital heart defects, cirrhosis of the liver and HIV infection. PAH afflicts approximately 200,000 patients worldwide.
About ambrisentan
Ambrisentan is an investigational drug being developed as a once-daily oral therapy for patients with PAH and has been granted orphan drug designation for the treatment of PAH in both the United States and European Union. In December, Myogen announced positive top-line results from the ARIES-2 trial, the first pivotal trial evaluating ambrisentan in PAH. Top-line results of a second important trial (ARIES-1) are expected to be announced in April 2006, with FDA and EMEA filing targeted for Q4 this year.
Ambrisentan is a non-sulfonamide, propanoic acid-class, type-A selective endothelin receptor antagonist. Endothelin is a small peptide hormone that plays a critical role in the control of blood flow and cell growth. Elevated endothelin blood levels are associated with several cardiovascular disease conditions, including pulmonary arterial hypertension, chronic renal disease, coronary artery disease, hypertension and chronic heart failure. Agents that block the detrimental effects of endothelin may provide benefits in the treatment of these conditions.
Myogen and GSK believe ambrisentan, which is being developed for less severely ill PAH patients, would be complementary to Flolan which is usually used in later stages of PAH disease.
About Flolan (epoprostenol sodium)
Flolan was approved by the FDA in 1995 and is indicated for the long‑term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. Use of Flolan is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction. Flolan should not be used in patients who develop pulmonary oedema during dose initiation. Flolan is also contraindicated in patients with known hypersensitivity to the drug or structurally-related compounds. Flolan should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension. The diagnosis of PPH or PH/SSD should be carefully established. Please consult complete prescribing information for Flolan at www.gsk.com.
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 www.gsk.com.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery, development and commercialisation of small molecule therapeutics for the treatment of cardiovascular disorders. Myogen believes that their advanced understanding of the biology of cardiovascular disease combined with their clinical development expertise in cardiovascular therapeutics provide them with the capability to discover novel therapies, as well as identify, license or acquire products that address serious, debilitating cardiovascular disorders that are not adequately treated with existing therapies. Please visit the company’s website at
www.myogen.com
.
Safe harbor statement
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 ‘Operating and Financial Review and Prospects’ in the company’s Annual Report 2004.
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