Gilead Sciences (GILD): Beginning August 1, 2007, Gilead Sciences will initiate an expanded access program1 to provide its investigational therapy, aztreonam lysine for inhalation, to patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (P. aeruginosa) infection who have limited treatment options and are at risk for disease progression. The expanded access program for aztreonam lysine for inhalation will be open to participating treatment centers in the United States.

The decision was based on results from two pivotal Phase 3 clinical studies, AIR-CF1 and AIR-CF2. Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aztreonam lysine by the end of 2007.

Data from AIR-CF1 study demonstrated improvement in respiratory symptoms for patients with CF.

Data from AIR-CF2 study demonstrated that aztreonam lysine for inhalation significantly improved the time to need for inhaled or intravenous (IV) antibiotics following a course of inhaled tobramycin.

Both studies also demonstrated improvements from baseline in respiratory function, as measured by relative improvement of forced expiratory volume in one second (FEV1) compared to placebo.

The most common treatment-emergent adverse events in these studies were cough, productive cough, nasal congestion, wheezing and sore throat. The incidences of these events were not significantly different between the placebo and the aztreonam lysine groups.

The Cystic Fibrosis Foundation, through its affiliate pharmacy, Cystic Fibrosis Services, Inc. will assist in drug distribution to the treatment centers.

The Program: The expanded access program will make aztreonam lysine for inhalation available to patients in the United States six years or older with CF who have P. aeruginosa present in expectorated sputum or throat swab culture within two months prior to consent. Patients with severe lung function impairment who are waitlisted or eligible for lung transplantation or who have completed participation in the open-label trial AIR-CF3 (CP-AI-006) will be eligible to participate. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program.

Physicians: To participate in the program, physicians will be required to evaluate patients at screening, at baseline, at Day 28 and at Day 56 visits, and then every two months thereafter. In this program, patients will receive aztreonam lysine for inhalation, administered via the PARI eFlow® Electronic Nebulizer, 75 mg three times daily, in 56-day cycles of therapy (28 days on drug followed by 28 days off) as provided by their physician until patients or physicians withdraw from participation in the study or the program is terminated by Gilead.

The Drug: Aztreonam lysine for inhalation is an antibiotic candidate currently being studied in Phase 3 clinical trials as a treatment for people with CF who have pulmonary P. aeruginosa. Aztreonam has potent activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is an FDA-approved agent for intravenous administration. Aztreonam lysine for inhalation is a proprietary inhaled formulation of aztreonam and has been designated with orphan drug status in the United States and Europe.

Gilead intends to expand the program to additional patient populations in defined stages. For more information regarding the expanded access program or to request registration materials, physicians may call 1-800-490-2697 or log on to www.EAPforCF.com.

1 Expanded access programs are part of an effort by the FDA and the pharmaceutical industry to make investigational drugs available during the later stages of clinical development for the treatment of serious or life-threatening diseases.

GILEAD: A SUCCESS STORY

Barron’s believes that shares of Gilead Sciences (GILD) could soar 20 percent to 25 percent on strong demand for its existing AIDS and flu drugs as well as from new products in the pipeline. Why not if the earnings are climbing by double digit every year and the journal believes it will climb another 25 percent this year to $1.50 to $1.55 per share. Barron’s quotes Chief Executive John Martin as saying, “For the past 20 years, I have been asked every year if the growth now will slow. It hasn’t and won’t. I continue to see developing value for stockholders. I continue to see a very exciting future for this company.”

GILD is a Prohost selection and resides in Prohost table since years. It is still there.

RNAi DRUG DEVELOPING IS WORTH BILLIONS

In other important news about another firm in Prohost selection comes from Alnylam (ALNY). Roche Holding has signed an agreement worth up to $1 billion with this RNAi specialized firm, giving it access to the U.S. firm’s skills in the new science of RNA interference. The agreement is the largest drug discovery partnership in the field to date. It validates the RNAi technology and drug development, in which Alnylam has become the most visible and most active.

Roche will pay Alnylam $331 million upfront in cash and equity investment, including a stake of 1.975 million Alnylam shares at $21.50 each, or just under 5 percent of Alnylam’s outstanding common stock. The pharmaceutical firm will get a non-exclusive license for Alnylam’s technology platform. The alliance will initially focus on oncology, respiratory diseases, metabolic diseases and certain liver diseases. Roche will also acquire Alnylam’s European research site at Kulmbach, Germany, which will become the Swiss group’s Center of Excellence for RNAi therapeutics discovery.

Novartis AG had bought a 19.9 percent stake in 2005 for $11.11 a share.

RNA interference, or RNAi, is a unique way of preventing diseases at their root origin, when feasible. It is a naturally occurring phenomenon where the body blocks RNA from manufacturing harmful proteins that are important parts of disease pathways. The technology seems to be more trusted than antisense and has attracted large pharmaceutical companies. Last year Merck paid $1.1 billion to buy the RNAi specialized firm Sirna. Also, RNAi was the basis for last year’s Nobel Prize in medicine. It has potential to block the chains of reactions that form pathways of many diseases, including cancer.

Last Friday AstraZeneca Plc signed a smaller RNAi deal, worth up to $400 million, with Britain’s Silence Therapeutics Plc (LSE:SLNL)

IS THIS TRUE?

A personalized Brain Cancer Vaccine To Reach The Swiss

NORTHWEST THERAPEUTICS (NWBO:OB)

Northwest Biotherapeutics (NWBO :OB) announced that it has received Authorization for Use to make its DCVax®-Brain commercially available for treatment of brain cancer patients in Switzerland. DCVax®-Brain is the first commercially available therapeutic vaccine for such cancers. The Company intends to begin making the product available to patients in Q3 2007.

Northwest Biotherapeutics has become the first company to market a personalized therapeutic vaccine for brain cancers, which has a bad prognosis for patients today.

Under the Swiss Authorization for Use, the Company is permitted to manufacture DCVax®-Brain in the US and make it available for the treatment of patients with brain cancer at select centers in Switzerland. The Authorization was granted in response to the Company’s application in mid-February, 2007. It was based upon the Company’s clinical data to date, and upon an extensive inspection by Swissmedic (the Swiss Agency for Therapeutic Products) on behalf of the BAG.

DCVax® works by mobilizing the full spectrum of immune response, both innate and adaptive, rather than just single immune agents such as antibodies alone or T cells alone. As such, DCVax® mobilizes the patient’s immune system to function in its normal, natural way. This leads to both improved efficacy and lack of problematic toxicities. Unlike conventional cancer drugs, DCVax® does not cause any debilitating side effects.

DCVax® products are personalized treatments, made by combining a patient’s own master immune cells (dendritic cells) with cancer biomarkers derived from or displayed by the patient’s own tumor. Precursors of the master immune cells are continuously circulating in a patient’s blood and are obtained through a blood draw. The master immune cells are then matured and activated through a series of proprietary steps, then “educated” by exposure to the patient’s tumor biomarkers, and injected back into the patient through a simple intradermal injection in the arm or thigh, consisting of just a few drops.

Unlike many personalized therapies under development, DCVax® products will be cost-effective. The key to their cost-effectiveness is a proprietary batch manufacturing process pioneered by NWBT, through over 10 years of development, under which a single manufacturing run is used to produce at least 3 years of personalized treatments for a particular patient. The treatments are stored frozen in single-dose vials, ready for use on an off-the-shelf basis for that patient. Such storage is highly reliable and low cost. By doing only one manufacturing run, and thereafter having the product available off-the-shelf, NWBT is able to keep the costs of its personalized vaccines at a level that can enable product pricing in a range comparable to other cancer drugs.

In parallel with making DCVax®-Brain commercially available to patients at selected medical centers in Switzerland, NWBT is also conducting a Phase II pivotal trial in 141 patients in the US. The trial began enrolling patients in December 2006, and is anticipated to conclude around the end of 2008. The Company plans to seek product approval in both the US and EU in early 2009, based upon the results of the Phase II pivotal trial.

DCVax®-Brain has been granted orphan drug status in both the US and the EU. Such status will afford DCVax®-Brain 7 years of market exclusivity in the US and 10 years in the EU, if DCVax®-Brain is the first product of its type to reach product approval.

Clinical trial data to date in brain cancer patients have shown that DCVax®-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1 months for newly diagnosed patients. DCVax®-Brain also extends these patients’ survival from 14.6 months to more than 33 months (and continuing — median not yet reached).

The DCVax® Technology platform is anticipated to be applicable to most cancers. NWBT is already at the Phase III, pivotal trial stage in prostate cancer, and has also received FDA clearance for clinical trials in five other cancers (including lung cancer, the leading cause of cancer deaths worldwide). Clinical trial data to date in hormone independent prostate cancer patients have shown striking results similar to the results in brain cancer.

The FDA approved Gilead’s (GILD) drug Letairis (ambrisentan) for pulmonary hypertension.

The disease: Narrowing and thickening of pulmonary (lung) arteries cause an elevation of the patients’ blood pressure. Among the symptoms are shortness of breath and exhaustion, which makes patients unable to exercise, or walk distances. The disease could cause heart failure and could be fatal if not treated.

The drug: Letairis belongs to a class of drugs called ERAs, or endothelin receptor antagonists. It relaxes the arteries, lowering blood pressure, hence, decreasing the extra load on the heart and lungs. In experimentation, the drug improved patients’ capacity to exercise. The drug is indicated as a once-daily treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO Functional Class II or III symptoms to improve exercise capacity and delay clinical worsening. Letairis will be available in the United States early next week. Because of the risks of liver injury and birth defects, the product will be available through the Letairis Education and Access Program (LEAP), a restricted distribution program designed to help patients learn about the risks of Letairis.

The drug’s label will carry strong cautionary language in a black box, as do other drugs of its class. Gilead says its studies show that incidence of liver damage is less with Letairis than with other products in this class. The company said Letairis will be available only through a special restricted program to educate patients and doctors about safe usage.

Price: Gilead said it has priced the drug at $3,940 a month, comparable with other oral drugs for the disease. Gilead said it established a program to ensure greater access to patients who are underinsured or face high co-payment requirements.

Incidence: Gilead said it estimates about 75,000 to 90,000 people in the US suffer from PAH, and 200,000 people worldwide, although fewer than half of them are currently believed to be diagnosed. The condition is often misdiagnosed as exercise-induced asthma or other respiratory ailments.

Marketing: Gilead in the US and GlaxoSmithKline PLC outside the U.S. Currently the drug is under regulatory review in Europe and Canada, and GlaxoSmithKline is doing studies in Japan aimed at getting approval there.

The Bad News

A drug developed by Encysive Pharmaceuticals (ENCY) for the same disease, i.e., pulmonary arterial hypertension, did not satisfy the requirements of the FDA for final approval. The agency issued its third approvable letter for the drug called Thelin, stating that Encysive’s development program did not demonstrate the evidence of effectiveness needed for approval.

Encysive said the FDA “encouraged the company to conduct an additional study” documenting that the drug improves exercise tolerance.

It is, indeed, bad news, especially, that in the same day, Gilead’s product was granted approval for the same disease.