67 WALL STREET, New York - April 25, 2014 - 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 - Orphan Drug and Biologics Manufacturing - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Biotechnology and Pharmaceutical Companies Valuation - Genetic and Cell Therapies
Companies include: Evoke Pharma, Inc. (EVOK) and many more.
In the following excerpt from the Biotechnology and Pharmaceuticals Report, the Co-Founder, President and CEO of Evoke Pharma, Inc. (EVOK) discusses company strategy and the outlook for this vital industry:
TWST: What stage of testing is EVK-001 in now?
Mr. Gonyer: We're preparing to start Phase III now. We've developed the drug from formulation optimization, Phase I, Phase II and meetings with the FDA, and we're beginning Phase III shortly.
TWST: Can you estimate how long the Phase III trial is likely to last?
Mr. Gonyer: We estimate enrollment to be about 12 months, and we expect to have data in mid to late 2015.
TWST: Are there any other companies who are working on new treatments for gastroparesis, and if so, how do their methodologies compare to your intranasal spray approach?
Mr. Gonyer: Right now, from what we can determine from what's available publicly, there are three products in development in addition to ours. They're all in early-stage Phase II development. One is a subcutaneous delivery, which is interesting to us, because it's a nonoral route. The other two products are oral medications that we believe will be difficult for these patients to absorb effectively, but as I said, they're in early Phase II, and they're all new chemical entities that have to go through very long clinical and safety development programs moving forward. So they're years behind us from what we can tell.
The other interesting point is our product, metoclopramide, has a dual mechanism of action. It has a peripheral effect on the GI tract, meaning it gets the stomach moving. It also has a central effect that helps relieve the symptoms of nausea and vomiting directly. These other products in development are drugs that are helping to improve the movement of the stomach only. The idea there is, if you can get the stomach moving, to get the food and drug out, then you'll relieve the symptoms, but that doesn't always occur. Other products that have been in development in gastroparesis, trying the same approach, have failed in Phase II studies.
TWST: How big is the market for this kind of treatment?
For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.