Antibodies Show Higher Success Rates than Small-Molecule Drugs, with More Predictable Pharmacology and More Predictable Toxicity Profiles

Wall Street Transcript

67 WALL STREET, New York - May 3, 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 - Executive Officer Interviews - Biotechnology and Pharmaceutical Investing - Orphan Drug and Biologics Manufacturing - Biotechnology and Pharmaceutical Companies Valuation

Companies include: Medicines Co. (MDCO), Cubist Pharmaceuticals Inc. (CBST), Regeneron Pharmaceuticals Inc. (REGN), Seattle Genetics Inc. (SGEN), Immunogen Inc. (IMGN), Merck & Co. Inc. (MRK), Pharmacyclics Inc. (PCYC), Johnson & Johnson (JNJ), Gilead Sciences Inc. (GILD), Infinity Pharmaceuticals, Inc. (INFI), Celgene Corporation (CELG), Amgen Inc. (AMGN), Biogen Idec Inc. (BIIB) and many more.

In the following excerpt from the Biotechnology and Pharmaceuticals Report, an expert analyst discusses the outlook for the sector for investors:

TWST: You expect a new wave of antibiotic approvals. What is happening in the regulatory environment that supports your hypothesis? And which companies do you expect to benefit and over what time frame?

Dr. Kantor: Over the past half decade or so, the FDA has been particularly difficult when it comes to approving new antibiotics. It's gotten to the point where Congress is actually taking action; recently they passed something called the GAIN Act. This is a piece of legislation designed to provide incentives for companies to develop antibiotics.

There are a number of antibiotics that went to the FDA four or five years ago and were subsequently all denied approval. Almost all of these drugs have now come back, completed new sets of Phase III trials per new FDA guidelines and are now getting ready to be refiled with the agency, so the expectation is that with better guidance from FDA, with increased legislative pressure and with the whole wave of new positive Phase III read-outs, that we are going to see FDA act and approve a number of new antibiotics.

In terms of the companies that we are talking about, there are several - one is Durata, (DRTX), another Trius (TSRX), Medicines Company (MDCO), Cubist (CBST). All of these companies have new antibiotics, which have completed or are soon to complete Phase III and could potentially have FDA approvals starting in 2014.

TWST: Antibiotics aside, how would you describe the current regulatory environment for the rest of your group?

Dr. Kantor: Investors like to think of the FDA in terms of waves of being favorable or unfavorable. And there is some truth to that. However, the FDA responds to...

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