MultiCell Technologies Inc. (OTC:MCET) is working on a stent that combines two drugs aimed at reducing restenosis ’ salicylate, aspirin’s active ingredient, and sirolimus. This polymer stent will be designed to dissolve completely over the course of a year.

A coronary stent is a tube placed in the coronary arteries that supply the heart, to keep the arteries open in the treatment of coronary heart disease.

One of the drawbacks of vascular stents is the potential for restenosis via the development of a thick smooth muscle tissue inside the lumen, the so-called neointima. Development of a neointima is variable but can at times be so severe as to re-occlude the vessel lumen (restenosis), especially in the case of smaller diameter vessels, which often results in reintervention. Consequently, current research focuses on the reduction of neointima after stent placement. Considerable improvements have been made, including the use of more bio-compatible materials, anti-inflammatory drug-eluting stents, resorbable stents, and others. Restenosis can be treated with a reintervention using the same method.

Recently, Abbott Laboratories received CE Mark approval in the European Union for its Absorb bioresorbable vascular stent for treating blocked coronary arteries. The device, like other stents, works by opening up and providing support to clogged arteries. Unlike its metal counterparts, however, the device is designed to dissolve within approximately two years after implantation there by reducing Restenosis.

MultiCell Technologies, Inc. engages in the research, discovery, development, and commercialization of therapeutics using its proprietary cell-based systems and immune system modulation technologies. It involves in the research and development targeting degenerative neurological diseases, including multiple sclerosis and cancer. They are currently working on

• MCT-125, a Phase IIb clinical trial therapeutic candidate for the treatment of primary multiple sclerosis-related fatigue.
• MCT-465, a preclinical adjuvant therapeutic candidate for the treatment of TLR3+ cancers.
• MCT-475, a preclinical therapeutic candidate for the treatment of TLR3+ breast cancer.
• Research and development of Sybiol technology( synthetic bio-liver therapeutic liver assist device).

Shares of Amag Pharmaceuticals Inc. soared by 13% on Monday after the drugmaker said it reached an agreement with regulators on an updated product label for the anemia drug Feraheme.

The company said the updated label it agreed to with the Food and Drug Administration(FDA) does not include a boxed warning. But, it does include bolded warnings for problems that have been reported after the intravenous injection is administered. That includes life-threatening hypersensitivity reactions and clinically significant hypotension.

The updated product label also includes an increased observation period to 60 minutes from 30 minutes to observe patients for signs of hypersensitivity.

Amag CEO Dr. Brian J.G. Pereira said in a statement from the company they were pleased to put to put the uncertainty behind them.

A Brief History: Amag said late last month it would slash 24 percent of its work force due to declining sales and safety concerns surrounding Feraheme, its only marketed product. Sales of Feraheme fell on a quarter-to-quarter basis because of a decline in provider demand in the dialysis market. Demand also fell in the non-dialysis market because of safety concerns.

Feraheme is approved for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapeutic iron compounds to treat iron deficiency anemia (IDA) in the United States, Europe, and Japan. It also provides novel imaging agents to aid in the diagnosis of cancer and cardiovascular diseases. It offers Feraheme, an iron replacement therapeutic for the treatment of IDA in adult patients with chronic kidney disease; and GastroMARK used for delineating the bowel in magnetic resonance imaging (MRI). The company is also developing Feraheme, which is in Phase II clinical trials for use as a vascular-enhanced MRI agent for the assessment of peripheral arterial disease. AMAG Pharmaceuticals has collaborative agreements with 3SBio Inc. for the development and commercialization of Feraheme as an IV iron replacement therapeutic agent in China; Guerbet S.A; Takeda Pharmaceutical Co. Ltd.; and Covidien for marketing GastroMARK in the United States, Canada, and Mexico. The company was founded in 1981 and is based in Lexington, Massachusetts.

Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) recently announced that it anticipates initiating multi-national, Phase 3 trial of voreloxin in the second half of 2010. What could be the target price of Sunesis Pharmaceuticals (SNSS) if Voreloxin is approved? Let’s evaluate SNSS for this purpose.

Biotech Stock Evaluation involves analyzing the different points. A fair evaluation is to be made before investing in any biotech stocks.

1. Competitor (Existing and other drugs in the Pipeline) : Voreloxin is used for treating Acute Myeloid Leukemia. CYCC is is the main competitor for SNSS. Sapacitabine (CYC682) is also in the Phase II trial stage. What will be the market share of Voreloxin? This will depend of the performance of CYC682 and Voreloxin. However if the drug is approved, we can count on at least 30% market share. (If the drug is so bad, then FDA will not approve the drug.)

2. Market for the drug. : AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. Estimated AML market is $900mm a year. 30% of 900mm = 270mm

3. No of Shares outstanding.: 110mm shares outstanding as of today. By the time the drug is approved, number of shares is most likely to go up to another 25% (to be safe). So for our calculations we will consider 110 * 1.25 = 137.5 mm

4. Gross margin: 40 % to be fair
270 * .4 = 108

5. Operating expenses: 50mm per year for new trial and research expense.

6. Profit after operating expense 108 – 50 = 58 million

7. Assume a P/E ration of 20 gives = $1.16billion

8. Price per Share will be 1160/ 137.5 = 8.43

9.Now what is the chance of approval, taking a 50% chance of FDA approval will bring the value down to $4.215.

10. Approval will be at least 2 year away. For each year discount at least 20%.
     4.215 – .843 = 3.372
     3.372 – .6744 = 2.69

So we have calculated targeted value as $8.43. However we can say that now it is $2.5 stock.

Note:  We take no responsibility for the loss or gain made by individual investor. Investors should do their own research before  investing the money in the stock.

Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) recently announced that it anticipates initiating multi-national, Phase 3 trial of voreloxin in the second half of 2010. Sunesis completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its lead compound, voreloxin, in acute myeloid leukemia (AML). Sunesis has received feedback and guidance from the FDA in response to proposed plans for further development of voreloxin in the treatment of AML. Based on the development clarity achieved as a result of these meetings, Sunesis intends to proceed with its plan to conduct a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. This trial will evaluate the overall survival of voreloxin in combination with cytarabine, a widely used chemotherapy in AML, compared to cytarabine with placebo, in patients with relapsed or refractory AML.

Sunesis also reported today that, as part of its global development strategy, a pre-submission meeting has been scheduled for the current calendar quarter with the European Medicines Agency (EMA) to obtain EMA’s scientific advice on the development program for voreloxin, including the proposed Phase 3 trial.

“We are very pleased by the outcomes of these milestone meetings with the FDA and are looking forward to initiating our multi-national Phase 3 trial,” stated Daniel Swisher, Chief Executive Officer of Sunesis. “We believe that voreloxin’s novel anti-leukemic properties and encouraging Phase 2 clinical data hold significant potential in a patient population with few treatment options. As we evaluate how best to fund our voreloxin development program, including our planned Phase 3 trial, we are continuing discussions with potential pharmaceutical partners.”

Best biotech stock can give more than 500% gain with in a short period.  When we say Biotech Stocks most of you should be remembering the recent gains made  some Biotech companies like HGSI and CTIC.  Few months back CTIC was going below .05 cents  and now it is riding at about $1.50. 

The Buzz Word “Biotech”

What are Biotech firms? Biotech firms primarily use genetic engineering.  Most of these companies are started with some solid idea to come up with some winning product.  Examples are cure for Cancer, AIDS etc…  There are different points to analyze a biotech company.  This is different from analyzing common stock like Microsoft or GE. 

Every Biotech or pharmacy company has to pass many hurdles before they come up with a successful product in the market. If you take the history of Biotech companies, most of them had been at the brink of Bankruptcy at one point of their life.  This is primarily due to the lack of income during the research and development stage of the product. It takes long to successfully develop, get approved by FDA and successfully market the product.

Food and Drug Administration (FDA).

All new drugs must go through a lengthy testing and approval process supervised by the Food and Drug Administration (FDA). Each drug must complete three sets of clinical trials called Phase I, Phase II, and Phase III, typically running 18 months, two years, and three to four years, respectively. Products successfully completing the clinical trials are submitted to the FDA for marketing approval, a process usually taking one or two years to complete.

Given these timeframes, it’s best to focus on companies with at least two products in phase III trails or awaiting final FDA approval. More is better, and you want companies with a steady stream of products in all testing stages.

Burning Cash

Most biotech firms have few, if any, products already on the market generating income. Companies without income to cover expenses are said to be “burning cash.” Analysts often compare a company’s assets to its “burn rate” to determine how long the company can survive before running out of cash. They say it’s better to stick with companies with a least two years supply of cash on hand.

Partners

Most biotech products sound promising. However, it’s difficult to know if there are better competing products in the pipeline and the size of the potential market even if the product is successful. Small biotech companies usually form partnerships with large pharmaceutical firms to market their products. The existence of these partnerships means these in-the-know companies think highly enough of the product’s prospects to take on the marketing.

A last point to mention is beware of companies which are family business.  I have to add some negative marks for them!