Wired News – FDA Granted Approval to Eagle Pharma’s Bendamustine Hydrochloride RTD Solution in a 500ml Admixture
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LONDON, UK / ACCESSWIRE / May 18, 2018 / If you want access to our free research report on Eagle Pharma, Inc. (NASDAQ: EGRX) ("Eagle"), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=EGRX as the Company's latest news hit the wire. On May 16, 2018, the Company announced that the US Food and Drug Administration (FDA) has granted final approval to the Company's ready-to-dilute (RTD) bendamustine hydrochloride (HCl) solution in a 500ml admixture for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Eagle's bendamustine HCl injection does not require reconstitution and is administered as a 500ml admixture over 30 or 60 minutes. The Company has 13 US patents covering different bendamustine formulations and methods.
Eagle Pharma Intends to Launch its Ready-to-Dilute Product with its Internal Sales Force
Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals, stated that this approval expands the Company's bendamustine product offering, is complementary to BENDEKA®, and enables it to provide value to a cost-conscious segment of the market that the Company is uniquely positioned to fill.
Scott added that Eagle intends to launch its ready-to-dilute product with its internal sales force. Aditionally, based upon the Company's view of the market, it anticipates over time achieving up to a 12% market share, increasing the Company's overall profitability.
Eagle's Vasopressin ANDA Accepted for Filing by the FDA
On April 16, 2018, the FDA accepted for filing the Company's abbreviated new drug application (ANDA) for vasopressin injection, 1ml. This product is the generic version of Endo International PLC's original Vasostrict® formulation, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Vasostrict had approximately $400 million in brand sales in 2017.
Chronic Lymphocytic Leukemia and Indolent B-Cell Non-Hodgkin Lymphoma
CLL is a type of cancer in which the bone marrow makes too many lymphocytes. Early on there are typically no symptoms. Later non-painful lymph nodes swelling, feeling tired, fever, or weight loss for no clear reason may occur. Enlargement of the spleen and anemia may also occur, which worsens gradually. CLL results in buildup of B cell lymphocytes in bone marrow, lymph nodes, and blood. These cells do not function well and crowd out healthy blood cells.
NHL is a group of blood cancers that includes all types of lymphoma except Hodgkin's lymphomas. Symptoms include enlarged lymph nodes, fever, night sweats, weight loss, and tiredness. Other symptoms may include bone pain, chest pain, or itchiness. Some forms are slow growing while others are fast growing.
About Eagle Pharmaceuticals, Inc.
Founded in 2007 and headquartered in Woodcliff Lake, New Jersey, Eagle Pharma 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.
Stock Performance Snapshot
May 17, 2018 - At Thursday's closing bell, Eagle Pharma's stock climbed 1.27%, ending the trading session at $68.59.
Volume traded for the day: 281.87 thousand shares, which was above the 3-month average volume of 256.23 thousand shares.
Stock performance in the last month – up 22.79%; previous three-month period – up 5.77%; past six-month period – up 24.35%; and year-to-date - up 28.40%
After yesterday's close, Eagle Pharma's market cap was at $934.88 million.
Price to Earnings (P/E) ratio was at 19.72.
The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry. This sector was up 0.1% at the end of the session.
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