Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Osiris Therapeutics, Inc. (OSIR), GlaxoSmithKline plc (ADR) (GSK), Forest Laboratories, Inc. (FRX): This Week in Biotech

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 …

Perhaps the most exciting news of the week comes from small-cap biotech company Osiris Therapeutics, Inc. (NASDAQ:OSIR), which reported absolutely stunning top-line results from its late-stage therapy Grafix to treat diabetes-related foot ulcers. In trials, Grafix achieved 62% primary wound closure at 12 weeks, compared with just 21.3% for the current standard of care, easily meeting its primary endpoint and the pre-specified stopping point to end the trial early because of overwhelming efficacy. In addition, Osiris Therapeutics, Inc. (NASDAQ:OSIR) had far fewer adverse events than the current standard of treatment and completely closed 80% of wounds in patients that crossed over from the initial standard of care after it proved ineffective. As I said … stunning! Shares ended the week higher by 86%.

Osiris Therapeutics, Inc.

GlaxoSmithKline plc (ADR) (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 Inc (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 Pharmaceuticals Inc (NYSEMKT:INO). 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 …

Just when you thought that Forest Laboratories, Inc. (NYSE:FRX) was getting its act together, it went and fumbled at the goal line. With patent expirations expected to wipe away a significant chunk of Forest Laboratories, Inc. (NYSE:FRX)’ revenue by 2015, many eyes were looking at its co-developed COPD maintenance combo drug, aclidinium/fomoterol, to make a dent in the COPD space. Instead, Forest Laboratories, Inc. (NYSE:FRX) and partner Almirall will delay their new drug application filing until 2014 to address chemistry, manufacturing, and control issues raised by the FDA in a pre-NDA filing meeting. In the meantime, GlaxoSmithKline plc (ADR) (NYSE:GSK) and Theravance have already brought Breo Ellipta to market and also have Anoro Ellipta being reviewed by the FDA for long-term COPD maintenance. Forest Laboratories, Inc. (NYSE:FRX)’ window of opportunity in gaining COPD market share may have already closed.

DOWNLOAD FREE REPORT: Warren Buffett's Best Stock Picks

Let Warren Buffett, George Soros, Steve Cohen, and Daniel Loeb WORK FOR YOU.

If you want to beat the low cost index funds by 19 percentage points per year, look no further than our monthly newsletter.In this free report you can find an in-depth analysis of the performance of Warren Buffett's entire historical stock picks. We uncovered Warren Buffett's Best Stock Picks and a way to for Buffett to improve his returns by more than 4 percentage points per year.

Bonus Biotech Stock Pick: You can also find a detailed bonus biotech stock pick that we expect to return more than 50% within 12 months.
Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.