HERTFORDSHIRE, England and PITTSBURGH, Feb. 12, 2019 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced the launch of the first FDA-approved therapeutically equivalent, substitutable generic of ADVAIR DISKUS®, Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), approved by the U.S. Food and Drug Administration (FDA) through the Abbreviated New Drug Application (ANDA) pathway. Wixela Inhub is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
All three strengths of Wixela Inhub will be offered at a wholesale acquisition cost* 70% less than ADVAIR DISKUS and 67% less than GSK's authorized generic version which launched on Feb. 8. The wholesale acquisition costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively.
Mylan's Chief Commercial Officer Tony Mauro commented, "We've had numerous discussions with customers about the need for a unique launch strategy for the first substitutable generic of ADVAIR DISKUS that increases affordability to all in our healthcare system. We trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the U.S. healthcare system overall."
In addition, Mylan will offer patient services to provide training and education about the treatment and device.
Wixela Inhub is indicated for the twice daily treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.
*The WAC does not necessarily reflect the price paid by consumers, pharmacies, or third-party payers.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to statements that: Mylan is launching Wixela™ Inhub™, the first generic of ADVAIR DISKUS®, at a list price 70% less than the brand; unique pricing of Wixela Inhub will immediately benefit patients and reduce overall cost to the U.S. healthcare system; all three strengths of Wixela Inhub will be offered at a wholesale acquisition cost of 70% less than ADVAIR DISKUS and 67% less than GSK's authorized generic version launched on Feb. 8; the wholesale acquisition costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively; we trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the U.S. healthcare system overall; and Mylan will offer patient services to provide training and education about the treatment and device. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights; risks associated with international operations; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.
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