Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX), will hold a conference call to discuss its newly-disclosed license agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product. Interested parties may access the call as follows:
| Date | Tuesday, February 17, 2015 | |||||
| Time | 8:30 a.m. Eastern Standard Time | |||||
| Telephone | 877-876-9176 (U.S.) or 785-424-1667 (International) | |||||
| Conference ID: | EGRX21715 | |||||
| Webcast (live and archive) | ||||||
A replay of the conference call will be available for one week after the call's completion by dialing 800-695-0715 (US) or 402-220-1423 (International). The webcast will be archived for 30 days at the aforementioned URL.
Eagle has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. The Company’s strategy is to utilize the FDA's 505(b)(2) regulatory pathway. The Company currently markets Ryanodex® (dantrolene sodium) in the U.S. for the treatment of malignant hyperthermia. Additional information is available on the company’s website at www.eagleus.com.
Forward-Looking Statements
This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: acceptance for filing by the FDA of the NDA for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen; the decision of the FDA on Eagle’s request for Priority Review for this NDA; success in gaining timely FDA approval of the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen; the timing and level of success of a future launch of the rapid infusion bendamustine product by Teva; the success of Eagle’s commercial arrangement with Teva and the parties’ ability to work effectively together; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended September 30, 2014, and its other filings with the U.S. Securities and Exchange Commission. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to: whether the FDA will accept Eagle’s NDA for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen; whether the FDA will grant Priority Review of the NDA or whether the FDA will ultimately approve the NDA, at all; whether Teva will be successful at commercializing the rapid infusion bendamustine product; whether Eagle and Teva will successfully perform each of their respective obligations under the exclusive license agreement; and other risks described in Eagle’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Ryanodex® is a registered trademark of Eagle Pharmaceuticals, Inc.
For Eagle Pharmaceuticals, Inc.
In-Site Communications, Inc.
Lisa M. Wilson, 212-452-2793
President