67 WALL STREET, New York - October 20, 2009 - The Wall Street Transcript has just published its Biotechnology Report offering a timely review of the sector to serious investors and industry executives. This 70-page feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Heightened M&A Activity - Trend Toward Orphan Disease Drug Development - Generic Drug Competition - Current Length Of FDA Approval Process - Ownership Ego Preventing Shareholder Returns - IPO And Secondary Offering Window Opening - Big Pharma R&D Pipeline - Decreased Clinical Development Risk - Impact Of Health Care Reform - Convergence Of Large-Cap Biotech And Pharmaceutical Companies - Easier Credit For Small Cap Biotech Companies - Developments In Cancer Chemotherapeutics - Gene Delivery Technology
Companies include: ADVENTRX (ANX); Abbott Labs (ABT); Advaxis (ADVX); Amedisys (AMED); Amgen (AMGN); Amylin Pharmaceuticals (AMLN); Antares Pharma (AIS); BioDelivery Sciences (BDSI); Biogen Idec (BIIB); Biomarin (BMRN); Boston Scientific (BSX); Bristol Myers (BMY); CVS Caremark (CVS); Celgene (CELG); Cerner (CRN); Cerus (CERS); Coke (KO); CombiMatrix (CBMX); Coventry Health Care (CVH); DARA (DARA); Eisai (ESALY); Eli Lilly (LLY); GenVec (GNVC); Gilead (GILD); GlaxoSmithKline (GSK); Health Management Associates (HMA); Human Genome Sciences (HGSI); Inspire Pharmaceuticals (ISPH); Intellect Neurosciences (ILNS.OB); InterMune (ITMN); International Stem Cell (ISCO.OB); Javelin Pharmaceuticals (JAV); Johnson & Johnson (JNJ); Keryx Biopharmaceuticals (KERX); Kraft (KFT); MAP Pharmaceuticals (MAPP); Medco (MHS); Merck (MRK); Merit Medical (MMSI); Novartis (NVS); Novelos (NVLT.OB); Novo Nordisk (NVO); Nutrisystem (NTRI); OSI Pharmaceutical (OSIP); Orexigen (OREX); Pepsi (PEP); Pfizer (PFE); Rite Aid (RAD); Schering-Plough (SGP); Takeda (TKPHF); Teva Pharmaceuticals (TEVA); Viropro (VPRO.PK); Walgreens (WAG); Wyeth (WYE); XOMA (XOMA); ZIOPHARM (ZIOP).
In the following brief excerpt from the 70-page report, Thomas Moore, CEO of Advaxis, Inc., discusses the outlook for the sector and for investors.
TWST: Tell us about the products you currently have in development and their indications?
Mr. Moore: Our lead product works against HPV, Human Papillomavirus-caused cancer, which has progressed through Phase I human trails. HPV causes virtually all cervical cancer, and between 30 and 50% of head and neck cancers. It's also being investigated as a possible factor in small-cell lung cancer, but that's in early stages. It also causes the vast majority of cases of penile cancer and anal cancer because HPV virus is the number one sexually transmitted virus and disease worldwide. We believe our construct will work against all of these cases of HPV-caused cancer, and our initial human trail was against cervical. The next one in line is the breast cancer construct. It works against the HER2/neu receptor, which is what Herceptin works against. We attack it from both inside and outside the cell, which is a somewhat broader attack. Herceptin technology loses effectiveness over time, whereas what we've demonstrated - again in animal testing - is the ability to eliminate tumors, in this case over 70% of the time. Again, we cannot get the mice to get restarted with cancer. They just won't take it if we attempt to reintroduce it. That's ready for human trial. We have a joint grant proposal with the Department of Defense and their immunology division there. The Department of Defense actually spends a great deal of money researching breast cancer because the incidents of breast cancer is higher among women in the military than in the civilian population. They've done a great deal of work on the immunotherapy side, and they were interested in taking our compound forward. We should learn more about that in the next couple of months, but we are hopeful that we'll be able to go forward with that. That will be our second construct in human trials. The next is the prostate cancer construct that I've already talked about. That too is ready for human trials, and we are negotiating right now to have an investigator begin the research on it. The last one is a construct which reduces the ability of cancer tumors to increase their blood supply by creating new blood vessels to provide them with blood. Cancer cells, as you know, grow very fast. They need a lot of blood to fuel that growth, and this technology would shut that fuel off. Those are the four lead constructs we have. We have an additional seven or so that are in development, two in concert with the City of Hope, which is a non-profit research center, but other ones as well. One of the great things about this is it's an extremely flexible platform technology. We can adapt it to attack various kinds of cancers and also to work against infectious disease. At some point in future, we hope to get into looking at techniques like this against things like hepatitis C, possibly influenza and the like. Because it uses the immune system, it bypasses the blood-brain barrier, which frustrates many other therapies against brain cancer. We are beginning early development on something that would potentially work against glioma.
TWST: Are you looking to raise additional funding at this time?
Mr. Moore: Right now we are looking to raise other money. We announced the closing of just under $1 million worth of debt a couple months ago, and we are continuing to raise money and look at ways of raising money.
TWST: What should investors know about Advaxis?
Mr. Moore: To compress it into a succinct story, this is genuinely different technology from anything else out there. We think our animal results are the best that you are going to find anywhere. The human results, while on a small study, are really very encouraging. Additionally, we have a very experienced team that has a lot of experience in pharmaceuticals in their regulatory work, and so we are a capable group that carries this off. The capital expense to manufacture the technology is minimal and so there is no capital risk for this company going forward. We don't need to construct a $200 million plant to enter the market. So from that standpoint it's a pretty good investment. Every dollar that investor puts in is going to go against advancing the clinical program for these constructs. With a very broad program like the one we have, we think our chances of success are good and the chances of having a single accident to mess us up are low. So we are excited and we think we have a very strong program.
The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This 70-page special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online .
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