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 The leading web portal for pharmacy resources, news, education and careers May 28, 2017
Pharmacy Choice - Pharmaceutical News - Blog Coverage CytRx Announces FDA's Approval for New Drug Application - May 28, 2017

Pharmacy News Article

 4/20/17 - Blog Coverage CytRx Announces FDA's Approval for New Drug Application

Upcoming AWS CoverageonAlexion Pharmaceuticals Post-Earnings Results

LONDON, UK / ACCESSWIRE / April 20, 2017 /Active Wall St. blog coverage looks at the headline from CytRx Corp. (NASDAQ: CYTR) as the Company announced on April 19, 2017, that the US Food and Drug Administration (FDA) has agreed to a rolling submission for a New Drug Application (NDA) submission for the Company's aldoxorubicin drug for the treatment of soft tissue sarcomas (STS). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of CytRx's competitors within the Biotechnology space, Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN), announced on April 06, 2017, that it will report its financial results for the Q1 ended March 31, 2017, on Thursday, April 27, 2017, before the US financial markets open. AWS will be initiating a research report on Alexion Pharma in the coming days.

Today, AWS is promoting its blog coverage on CYTR; touching on ALXN. Get all of our free blog coverage and more by clicking on the link below:http://www.activewallst.com/register/.

505(b)(2) New Drug Application

A new drug application (NDA) under FDA's section 505(b)(2) is for a new drug containing similar active ingredients as a previously approved drug. According to the publication Regulatory Focus, a drug reviewed under 505(b)(2) represents a modified version of a previously approved product that requires additional clinical and nonclinical studies, other than bioavailability/bioequivalence studies, to demonstrate safety and efficacy. Such an application differs from a typical NDA in that the sponsor can rely on, at least in part, the FDA's findings of safety and/or effectiveness for a previously approved reference drug.

"We are very pleased to have achieved clarity from the FDA regarding CytRx's soft tissue sarcoma program," said Daniel Levitt, MD, PhD, Chief Operating Officer and Chief Medical Officer, "The FDA agreed that CytRx could use the application pathway for its filing that has been successfully used previously by the oncology drugs Abraxane, Doxil and Onivyde. Our interaction with the FDA was part of a continued collaborative and productive relationship with the Agency. We look forward to providing the study reports and analysis that can lead to the approval of aldoxorubicin for the treatment of patients with soft tissue sarcomas."

Future Opportunities

The Company's goal is to submit a rolling NDA under section 505(b)(2) to the FDA for STS in Q4 FY17. CytRx also plans to discuss with the European Medicines Agency (EMA) a path to filing a Marketing Authorization Application (MAA). The commercial launch of aldoxorubicin is still projected for 2018 in the United States. Aldoxorubicin has received Orphan Drug Designation by the FDA for the treatment of STS. Orphan designation provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.

CytRx stated that the proposed product label would include the treatment of soft tissue sarcomas. The Company noted that new data could allow future use of aldoxorubicin in neoadjuvant (pre-surgery) settings, as well as a replacement for doxorubicin in combinations. CytRx is also working on a market expansion strategy which could include other indications for aldoxorubicin including combinations with other chemotherapeutics and immunotherapies.

CytRx is under confidentiality agreements with a number of companies for a commercial partnership for the marketing of aldoxorubicin. The Company believes those active discussions may be further advanced by this latest news.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues, and connective tissue. It can arise anywhere in the body at any age. STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer. According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the US and approximately 5,000 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the US and Europe are part of a growing underserved market.

About Aldoxorubicin

Aldoxorubicin is a rationally engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS.

Stock Performance

At the close of trading session on Wednesday, April 19, 2017, following the announcement, CytRx's stock price surged 18.18% to end the day at $0.52. A total volume of 17.68 million shares were exchanged during the session, which was above the 3-month average volume of 1.04 million shares. The Company's share price has surged 23.81% in the past one month and 40.54% on YTD basis. The stock currently has a market cap of $61.08 million.

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