PORT WASHINGTON, N.Y., March 30, 2017 – ACETO Corporation (NASDAQ:ACET), an international company engaged in the development, marketing, sale and distribution of Human Health products, Pharmaceutical Ingredients and Performance Chemicals, today announced that Rising Pharmaceuticals, Inc., its finished dosage form generics subsidiary, has launched Zileuton Extended Release Tablets, 600 mg, a generic version of Zyflo CR® Tablets from Chiesi USA. Rising Pharmaceuticals received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the chronic treatment of asthma and should be taken regularly as prescribed.
Rising is a leading supplier of generic medicines in the U.S., and the launch of Zileuton Extended Release Tablets, 600 mg, adds to the company's significant human pharmaceutical franchise. Zileuton Extended Release Tablets, 600 mg, had U.S. sales of approximately $75 million for the 12 months ending December 2016, according to IMS Health.
Rising Pharmaceuticals has built a commercial portfolio of over 110 products currently in the U.S. market. Additionally, it has a development portfolio of more than 80 ANDAs filed with the FDA or pending launch, representing over $10 billion in addressable market value, using recent IMS sales data. Rising develops and brings high-quality products to the market in collaboration with select development and finished dosage form manufacturing partners, under the Rising label.
ACETO Corporation sells generic prescription products and over-the-counter pharmaceutical products under its Rising label to leading wholesalers, chain drug stores, distributors and mass merchandisers.
ACETO Corporation, incorporated in 1947 and with offices and operations in 10 countries, is engaged in the development, marketing, sale and distribution of Human Health products (finished dosage form generics and nutraceuticals), Pharmaceutical Ingredients (pharmaceutical intermediates and active pharmaceutical ingredients) and Performance Chemicals (specialty chemicals and agricultural protection products).
FORWARD LOOKING STATEMENTS
This news release contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking statements contained in this news release may not occur. Generally, these statements relate to our business plans or strategies, projected or anticipated benefits or other consequences of ACETO’s plans or strategies, financing plans, projected or anticipated benefits from acquisitions that ACETO may make, or a projection involving anticipated revenues, earnings or other aspects of ACETO’s operating results or financial position, and the outcome of any contingencies. Any such forward-looking statements are based on current expectations, estimates and projections of management. ACETO intends for these forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements. Words such as "may," "will," "expect," "believe," "anticipate," "project," "plan," "intend," "estimate," and "continue," and their opposites and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the Company’s strategic initiatives including selling finished dosage form generic drugs, and statements regarding the prospects for long-term growth. ACETO cautions you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many of which are beyond ACETO’s control, which may influence the accuracy of the statements and the projections upon which the statements are based. Factors that could cause actual results to differ materially from those set forth or implied by any forward-looking statement include, but are not limited to, risks and uncertainties discussed in ACETO’s reports filed with the Securities and Exchange Commission, including, but not limited to, ACETO’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016 and other filings. Copies of these filings are available at www.sec.gov.
Any one or more of these uncertainties, risks and other influences could materially affect ACETO’s results of operations and whether forward-looking statements made by ACETO ultimately prove to be accurate. In addition, periodic high-margin product sales may have a positive material financial impact in a given quarter that may be non-recurring in future quarters, thereby rendering one quarter's performance not useful as a predictor of future quarters' results. ACETO’s actual results, performance and achievements could differ materially from those expressed or implied in these forward-looking statements. ACETO undertakes no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise.
Investor Relations Contact: