7/24/2014 7:27:24 AM
Ligand Partner GSK Announces Record Quarterly Promacta™/Revolade™ Revenue of $92 Million
Strong quarterly growth driven by sales in US, EU and Emerging Markets
SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner GlaxoSmithKline (GSK) plc has announced global revenue for Promacta™/Revolade™ for the second quarter ended June 30, 2014 of $92 million, up 31% from the second quarter of 2013. United States, European Union and the Emerging Markets all reported double-digit growth over the prior quarter, with United States up 17% and Emerging Markets up 50% versus first quarter 2014.
“Promacta continues to illustrate its value and importance in addressing major unmet medical needs,” said John Higgins, President and CEO of Ligand Pharmaceuticals. “GSK has maintained a global view of brand management and an ongoing commitment to maximizing the reach of Promacta/Revolade to patients in need. These impressive quarterly results clearly underscore GSK’s commitment to the product and represent the highest quarterly sales in the history of the drug and largest quarter-over-quarter growth in dollars.”
Recent Events Relating to Promacta/Revolade
In addition to quarterly global revenue for Q2 2014, GSK has also recently announced a number of other milestones or data events relating to Promacta/Revolade, including:
•Receipt of both Breakthrough Therapy Designation and Priority Review status for a supplemental New Drug Application (sNDA) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy. SAA is a rare disorder in which the bone marrow fails to make enough new blood cells. There are no approved therapies available for SAA patients who are unresponsive to initial immunosuppressive therapy (IST).
•Results of the Phase 3 PETIT2 study evaluating the efficacy of eltrombopag versus placebo in pediatric patients with chronic idiopathic thrombocytopenic purpura (cITP). The study met its primary endpoint, and GSK announced that it is moving forward with planned global regulatory submissions for a pediatric indication in cITP in 2014.
•Initiation of the global Phase 3 SUPPORT trial to evaluate the platelet supportive care effects of eltrombopag in combination with azacitidine (the current standard of care) versus placebo in combination with azacitidine in intermediate-1, intermediate-2 or high-risk patients with myelodysplastic syndromes (MDS). The study will assess the proportion of patients who do not require a platelet transfusion during the first four cycles of treatment.
•GSK and Novartis AG announced that Novartis is acquiring GSK’s oncology portfolio, including Promacta/Revolade, for an aggregate cash consideration of $16 billion, a sales multiple of approximately 10 times 2013 revenue. The deal leverages Novartis’ commercial capabilities in oncology, and Novartis projects significant growth over the coming years for the brands, including Promacta. The transaction is expected to be complete by the first half of 2015, subject to approvals.
About Eltrombopag (Promacta/Revolade)
Eltrombopag – marketed as Promacta™ in the U.S. and as Revolade™ in Europe and other countries around the world – works by interacting with the TPO receptor leading to increased platelet production. Eltrombopag is not approved or licensed anywhere in the world for use in patients with myelodysplastic syndromes.
For full U.S. Prescribing Information for Promacta® (eltrombopag), including Boxed Warning, please visit here. For the European Union (EU) Summary of Product Characteristics (SPC) for Revolade® (eltrombopag) in approved indications, please visit here.
Promacta and Revolade are trademarks of the GSK group of companies.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure. Ligand’s goal is to produce a bottom line that supports a sustainably profitable business. By diversifying our portfolio of assets across numerous technology types, therapeutic areas, drug targets and industry partners, we offer investors an opportunity to invest in the increasingly complicated and unpredictable pharmaceutical industry. In comparison to its peers, we believe Ligand has assembled one of the largest and most diversified asset portfolios in the industry with the potential to generate revenue in the future. These therapies address the unmet medical needs of patients for a broad spectrum of diseases including diabetes, hepatitis, muscle wasting, Alzheimer's disease, dyslipidemia, anemia, asthma and osteoporosis. Ligand’s Captisol platform technology is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline, Onyx Pharmaceuticals (a subsidiary of Amgen Inc.), Merck, Pfizer, Baxter International, Eli Lilly & Co. and Spectrum Pharmaceuticals. Please visit www.captisol.com for more information on Captisol. For more information on Ligand, please visit www.ligand.com. Follow Ligand on Twitter @Ligand_LGND.
This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand’s judgment as of the date of this release. These forward-looking statements include comments regarding eltrombopag, data analysis and evaluation of eltrombopag, utility or potential benefits to patients, the potential commercial market for eltrombopag and plans for continued development and further studies of eltrombopag. Actual events or results may differ from Ligand’s expectations. For example, there can be no assurance that other trials or evaluations of eltrombopag will be favorable or that they will confirm results of previous studies, that data evaluation will be completed or demonstrate any hypothesis or endpoint, that eltrombopag will provide utility or benefits to certain patients, that any presentations will be favorably received, that eltrombopag will be useful, that marketing applications will be filed or, if filed, approved, or that clinical or commercial development of eltrombopag will be initiated, completed or successful or that our rights to eltrombopag will not be successfully challenged. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
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