67 WALL STREET, New York - September 13, 2013 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Health Care - Biotechnology and Pharmaceuticals - Biotechnology and Pharmaceutical Investing - Orphan Drug and Biologics Manufacturing - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Reimbursement Trends
Companies include: Aeolus Pharmaceuticals, Inc. (AOLS) and many more.
In the following excerpt from the Biotechnology and Pharmaceuticals Report, the President and CEO of Aeolus Pharmaceuticals, Inc. (AOLS), discusses company strategy and the outlook for this vital industry:
TWST: What is the agenda at this point? What are the priorities for the next 12 to 24 months, and what from your perspective would make that time frame a success?
Mr. McManus: I mentioned earlier that we have a contract with the federal government, and executing on that contract is our number-one priority. Our goal in that program is to generate the data necessary to drive a large purchase of our drug for the Strategic National Stockpile to protect our citizens from the effects of a nuclear event. We have $118 million five-year contract for development of AEOL 10150 with the Biomedical Advanced Research and Development Authority, or BARDA, which is part of the Department of Health and Human Services. BARDA's job is to develop and purchase drugs to protect citizens from the use of biological, radiological and chemical weapons. We entered into our contract with BARDA in February 2011, after winning a competitive request for proposal for a drug that protects lungs from radiation. Presently, we're about two and a half years into the five-year contract.
For medical countermeasures, you cannot test efficacy in humans, because obviously you can't expose people to radiation or chemicals, so you have to develop animal models that are blessed by the FDA that are used as a proxy for efficacy. We have completed that work and presented it to the FDA. They have given us their concurrence on our animal species and our models. Additionally, we have initiated a number of large efficacy studies in these models. We have three studies ongoing and several more scheduled to begin over the next few months.
Other significant accomplishments under the contract so far have been made in the manufacturing area. With our partners at Johnson Matthey Pharma Services, we have improved the manufacturing process for...
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