This Week in Biotechhttp://www.fool.com/investing/general/2013/08/17/this-week-in-biotech.aspx Sean Williams
August 17, 2013
With the SPDR S&P Biotech Index up 34% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
This week was definitely a mixed bag, with an FDA approval and plenty of positive clinical and preclinical data pushing some biotech companies to the upside, while new drug application filing delays and analyst comments soured others.
What's popping ...
GlaxoSmithKline (NYSE: GSK) also provided some pep in shareholders' step when it announced on Monday that the Food and Drug Administration had approved Tivicay (previously dolutegravir) for the treatment of HIV-1. In one trial in particular, Tivicay demonstrated a fully suppressed viral load (i.e., non-detectable levels of HIV-1 antibodies) in 63% of patients at 24 weeks. What's really intriguing about Tivicay is that it's approved to treat children as young as 12 (as long as they weigh 40kg and haven't taken a drug with the same action mechanism before) and can be used to treat patients that have taken HIV-1 medications before and treatment-naive patients. While I fully expect Gilead Sciences Stribild will remain the go-to drug in HIV-maintenance, Tivicay should fill the sub 18-year-old age gap and non-Stribild responsive patient gap perfectly.
Micro-cap synthetic cancer and infectious disease vaccine maker Inovio Pharmaceuticals (NYSEMKT: INO) also excited investors following a Thursday press release that its SynCon DNA vaccine for malaria delivered through its proprietary cellectra electroporation device, demonstrated effective and durable antibody and T-cell responses in non-human primates and small animals in a preclinical study. While some malaria vaccines have improved immune resistance to this infectious disease, certain age groups, like infants, remain quite vulnerable and open up a big market potential for Inovio. I'd still caution that this is but a preclinical trial that won't even move into human studies until next year, but it's a promising start.
What's dropping ...