Eagle Pharmaceuticals Inc

Eagle Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing injectable products utilizing the FDA's 505(b)(2) regulatory pathway. The company develops products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Its currently disclosed product portfolio includes two approved products and six advanced product candidates that together account for approximately $4 billion in peak U.S. branded reference drug sales.

For each of its products, the company intends to enter the market no later than the first generic drug, allowing it to substantially convert the market to its product while maintaining attractive pricing. The company believes it can further extend the commercial duration of its products through new intellectual property protection and/or orphan drug exclusivity and three years of regulatory exclusivity as provided under the Hatch-Waxman Act, as applicable.

Eagle Pharmaceuticals believes its strategy has been validated with the approval of its first product, EP-1101, a proprietary version of argatroban, which was approved by the FDA in June 2011. EP-1101 entered the market prior to the first generic version of argatroban and has captured a 28%, and growing, share of the overall argatroban market while maintaining attractive pricing.

Two of the company’s most advanced product candidates are proprietary presentations of bendamustine, which is currently marketed by Teva Pharmaceuticals, or Teva, under the brand name Treanda and indicated for the treatment of certain hematologic cancers. Bendamustine had 2012 U.S. branded sales of over $600 million, and based on recent market research the company anticipates sales to continue to grow substantially in 2013 and 2014, and estimates that sales could reach $800 million in 2015. Eagle believes its proprietary bendamustine products, EP-3101 and EP-3102, are improved products compared to Teva's Treanda because they are ready to dilute, or RTD, liquids with longer stability and also offer the potential for shorter infusion time. These attributes result in added benefits to nurses, patients and pharmacists, and improved economics to physicians and other stakeholders.

The company’s NDA for EP-3101 was filed with the FDA on September 6, 2013 and it believes EP-3101 will enter the market prior to generic competition and will capture a significant portion of the bendamustine market, as has been the case for its argatroban product.

The compant’s currently disclosed product portfolio also includes proprietary innovations of Alimta, Angiomax, and Dantrium (dantrolene), which together represent $3.4 billion in U.S. peak branded drug sales.

Eagle Pharmaceuticals was incorporated in Delaware in January 2007. Its corporate website address is www.eagleus.com.