GILD, ALNY AND NWBO:OB? - The Road Towards Success
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.