Biotech Stock

Biotech Stocks Waiting FDA Approval

One sure way to gain in stock market is to bet on Biotech Stocks waiting on FDA Approval. Selling out just before FDA approval is a sure way of generating good profit.  Most of them sell out a portion just before the FDA decision. In case the decision goes against, still they are not in profit.  This is a strategy for Biotech investments for those who wants to play by safe.  For those who can afford to take the beating, just go full swing for the FDA Approval or rejection decision.  

Here is the list of stocks waiting FDA Approval in first half of 2010.

Isis Pharmaceuticals Mipomersen Affected by Side-Effect

The new cholesterol drug mipomersen of Isis Pharmaceuticals (Nasdaq: ISIS) and Genzyme’s (Nasdaq: GENZ) faces pressure as a consequence of side effect.  The drug potential will be severly reduced by this factor as the percentile of population willing to take this drug will be limitted.

Rumors about negative-safety results have pressured the stock this morning and this may be a a good opportunity for long-term investors to increase positions. Isis shares tumbled almost 15% on Thursday, following the released of mixed Phase III clinical data for its new cholesterol drug mipomersen. By our calculations, the efficacy results are significantly superior to the best available option for cholesterol treatment despite the sideeffects. 

Let’s start with the good news about the drug’s great efficacy data. Mipomersen is used in patients who have a genetic disorder that results in high cholesterol levels even while taking cholesterol-lowering drugs — like Pfizer’s (NYSE: PFE) Lipitor, AstraZeneca’s (NYSE: AZN) Crestor, Merck’s (NYSE: MRK) Zetia, and Abbott Labs’ (NYSE: ABT) Niaspan — mipomersen was able to reduce cholesterol by 28%. Patients taking placebo saw their cholesterol levels go up 5%.

The bad news is that increased liver enzymes continue to plague mipomersen — 14% of patients taking mipomersen saw liver enzyme levels at least three-times the normal level. Elevated liver enzymes are a sign of liver toxicity and a reason that many drugs die in clinical trials. Most of the patients only had one measurement that was high and there weren’t other signs of liver damage, which puts the companies in an awkward position. The side effects may not be severe enough to keep mipomersen from getting approved, but only the most severe patients may be willing to roll the dice given the side effect signal.

We should know a little more when the full data set is presented at a medical meeting. Here are the two most important things to look out for:

• The number of patients that rolled over to the open label study. After completion of the 26-week trial, both patients that got mipomersen and those on placebo are given the option of taking mipomersen, so the company can get long-term safety data from the patients. For investors, a high rollover rate indicates that doctors and patients think the benefits outweigh the risk.
• The results of MRIs looking at fat build up in the liver. Management said that there was an initial build up of fat, but they’re hoping images from later in the study show that the fat decreases over time like it does with other cholesterol drugs.

After the first trial, I said that investors might be overreacting.  The data to date is likely good enough to get past the FDA, but if mipomersen can only be used on the most severe patients, sales will be limited.

Cord Blood America Starts Vegas Operation

Cord Blood America was founded seven years ago in Southern California, with funding from Credit Card, CBAI now claims to have one of the largest stem cell cryogenic storage facilities in the nation.  CBAI recently acquired CorCell, “the first licensed private cord blood bank in the United States.”

Most people will remember stem cells for the great promise they hold for medicine, and the controversy over taking them from embryos. However, the stem cells at CBAI (and other cord blood banks) are taken from umbilical cords at birth.

 On 22nd Januavary they started their operation  in Las Vegas.  CBAI occupies a modern-looking 17,000 square-foot building just a short block south of East Sunset Road. During the ribbon cutting ceremony, there were short speeches by CBAI board member Joseph R. Vicente; Somer Hollingsworth, who is President and CEO of the Nevada Development Authority, working to bring economic diversity to Las Vegas; Nevada Lieutenant Governor Brian Krolicky; CBAI Lab Director Dr. Geoffrey O’Neill; and Matthew Schissler, CEO and co-founder of CBAI, who talked about the growth of the company over the past seven years.  Dr. O’Neill is the lab director who once worked with Robert A. Good who was the first physician to perform a successful human bone marrow transplant.

Cord Blood America Storage

Stem cells from cord blood can be beneficial for the child, can also be useful for the parents or relatives, and the possibilities don’t stop there. Stem cells may also be used for treating other people when the tissue type matches the recipient.  The collected Cord  Blood is stored in different liquid nitrogen storage tanks that can hold more than 20,000 samples each.  Each tank is insulated, and when the nitrogen level gets low the tank automatically sends a signal to the suppliers, in Los Angeles or Phoenix.

It may be a humble begining of another Amazon or eBay, who knows!

GenVec bags ASCO Foundation Merit Award

Research presented in the poster received a prestigious ASCO Foundation Merit Award. In addition, the poster received focused attention at the oral review session on esophageal cancer on January 22, 2010.

“This symposium brings together the greatest thought leaders in this area of oncology and we are pleased to be presenting this analysis at this event,” stated Mark Thornton, Ph.D., GenVec’s Senior Vice President of Product Development. “The encouraging increases in survival versus historical controls will warrant additional evaluation.”

The presented poster is available on GenVec’s website, www.genvec.com. To view the poster, click on “Investor Relations” then “Webcasts and Data.”

The poster, titled, “Long term survival analysis of multicenter clinical trial using endoscopy (END) and endoscopic ultrasound (EUS) guided fine needle injection (FNI) of antitumor agent (TNFerade Biologic (TNF)) in patients with locally advanced esophageal cancer,” reports on updated efficacy and survival data. In the 24 patients receiving TNFerade in combination with chemoradiation, the median survival was 47.7 months.  Median survival from other historical clinical trials in similar stage disease ranged from 9.7 to 34 months.

Cord Blood America Interview

Cord Blood America Interview Video