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Gilead, Dendreon, Seattle Genetics And Great News For CLL Patients. Who Confused Investors?

Prohost Biotech - Friday, August 12, 2011

It was crazy. During the market’s dive, Gilead’s (GILD) stock was oversold. The stock experienced a selloff after having been snubbed for years never mind it has contributed to turning a killer virus into a tamed manageable disease, or that its revenues and incomes have exceeded Wall Street exaggerated expectations.     

Comparing between how AIDS patients looked, how much they used to suffer and how long they lived when the disease was first discovered, and how they look, live and survive now, makes us wish that Gilead would have been specialized in many other devastating diseases in addition to HIV/AIDS. The improvement in the management of HIV/AIDS in just two decades has no equal in any approach that meant to improve the management of other life-threatening diseases cancer included. This is the reality in spite of the billions of dollars spent on programs aimed at fighting these diseases since the end of WW2.

Gilead is a model innovative biotech firm. Its engines seem not to pause. The firm designs its future visions and acts on them instantaneously. With sharp eyes, it looks around and tries to figure out, which of the scientists, organizations, or companies it would love to have among the teams it is assembling for future plans. Without wasting a moment, it brings the selected people, or companies into its projects. That’s exactly what Gilead has done to develop Complera, the newly approved combo drug. It picked Tibotec and signed a collaborative agreement that was immediately put into effect.

Combo tablets have reduced the number of pills to be taken by HIV infected patients. The new mode of administration made a big difference in the lives of patients, mentally and psychologically. It played a big role in improving compliance, quality of patients’ life and in infected patients’ capability to live a normal active life and regain their social activities, including returning back to work.

Our appreciation does not emanate solely from an approval of a drug every now and then, but from the firm’s scientific and technological capability and its determination to accomplish its programs. As we observe, Gilead’s programs include closing in on HIV and defeating it, a goal we believe will be achieved sooner or later.

Complera’s approval is just an important milestone in the continuous efforts aimed at rendering HIV treatments less risky, less painful and more tolerated. Otherwise, the drug is not a cure for HIV-1 infection or preventive from viral contamination. Also, the pill is not without adverse effects and toxicities, which do exist and warrant Boxed Warnings in the package insert, about the possibility of developing serious side effects.

Dendreon’s (DNDN): Some commentators are insinuating that DNDN’s selloff has led investors to reconsider their enthusiasm for Seattle Genetics (SGEN) and other developing-stage firms at the verge of putting breakthrough cancer products on the market. These implications are untrue and misleading to investors. It is the hinting itself that scared investors and made them sell excellent stocks. There is in fact nothing common between Dendreon and SGEN or the other firms. Provenge is a therapeutic vaccine, while the other firms’ products are targeted conjugated monoclonal antibody therapeutics and targeted small molecule drugs. All have demonstrated safety and superior efficacy that went beyond existing products’ limitations. Moreover, Dendreon’s vaccine has passed the clinical trial tests. The problem is not the vaccine, but pricing it.  As we wrote in our Dendreon article, the selloff of the stock was exaggerated  READ THE ARTICLE.

Witnessing a huge revolution: We are living at a time when the evolution and advancement in molecular biology and biotechnology began to display its fruits in the medical laboratory and the clinic. In the past few days, news announced that the advancement in gene-transfer techniques and in the knowledge about the immune system’s pathways and functions might have created a breakthrough approach to curing advanced chronic lymphocytic leukemia (CLL). The study, which is published the New England Journal of Medicine and Science Translational Medicine is small, yet, the results are very promising. As a matter of fact, the results have stunned some of the researchers who contributed to, or witnessed the whole show.

Three patients with refractory chronic lymphocytic leukemia (CLL) responded following infusion of autologous T-cells with genetically modified antigen receptor. The receptor-modified T-cell population increased by more than 1,000-fold from initial engraftment and remained at high levels for six months in one of the patients. The approach used has successfully killed a large number of cancer cells in the three patients who had no hope other than bone marrow transplants, which are lengthy procedures, costly and carry 1 in 5 chance of death and 50% chance of a getting a cure after escaping death from the transplants themselves.

The gene transfer processes for therapeutic uses have been in the making for the past 20 years. They consist of removing patients' own T cells, modifying them genetically in Penn's vaccine production labs in Penn Hospital University in Pennsylvania, and then returning them back to the patients' bodies after chemotherapy. Those on top of the trial said that the general scene was of genetically modified versions of the patients T cels turning into "serial killers", hunting down and obliterating cancer cells in a massacre kind of invasion. The results:  Sustained remissions of up to one year to date.

The senior author of the study Dr Carl June, director of Translational Research and a professor of Pathology and Laboratory Medicine in the Abramson Cancer Center and his team believe the same protocol can be used in developing treatments for ovarian cancers, lung cancers, multiple myeloma, melanoma and, probably other cancers. The notion is that the treatment has worked better than the team thought it would: "Within three weeks, the tumors had been blown away in a way that was much more violent than we ever expected." Said Dr. June to the press.

Short Selling: The story should be exciting to physicians, patients and believers in the rapid advancement in the biotech industry, which is struggling in a market that advocates shorting each and every successful firm’s stock without discrimination. Those who keep building wealth on the demise of the biotech sector took advantage of DNDN huge dive to create unrealistic scenarios that exist only in their minds. If they don’t believe those who criticize them, then what about believing The European Securities and Markets Authority? On Thursday night, this Authority, which coordinates the European Union’s markets policies, announced that short sales would be curtailed in France, Belgium, Italy, and Spain effective Friday. There is already a temporary short-sale ban in Greece and Turkey.

At a time when computer tools for trading stocks become extremely sophisticated and powerful,  putting them in the wrong hands could destroy large countries’ economic systems. Imagine the consequences of using the same against emerging technologies that have proven throughout history that they were the only saviors of ailing economies?

We Long GILD and SGEN

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