On Drugs and BioTechs
This week, we have a special feature article contributed by our friend and colleague, Edward Kenna. "NEW VISTAS IN CANCER TREATMENT: INTRODUCTION" is the first part of a series of articles that will detail how modern biotechnology is being brought to bear on cancer treatment and prevention. Some exciting strides have been and are being made on this front, and we should expect to see even broader progress with new cancer treatment modalities advancing in human clinical trials. The current article presents a timely and clearly written introduction to the cancer treatment arena, and sets the stage for the next article, which will focus on the use of antibodies for treating cancer.
We strongly encourage readers to take time out to watch a PBS television special series on life, called "Intimate Strangers: Unseen Life on Earth" which is airing as a four-part series this month. The first part ("The Tree of Life") was shown on Tuesday, and focused on how all forms of life share the same basic heritage and machinery. Fascinating analogies were made between genomes and musical scores, with an organism's genome containing a "recorded history" of that organism's genetic heritage. Dr. Craig Venter, President of Celera Genomics (CRA), was among a number of scientists interviewed, and commented on the significance of knowing the entire human genome sequence. For schedule of upcoming programs, go to the PBS web site: pbs.org. For more information about the series, go to: pbs.org
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1. BRISTOL-MYERS SQUIBB AND MILLENNIUM: CANCER ALLIANCE
PRNewswire -- BRISTOL- MYERS SQUIBB (BMY: $77, +1, +2%) and Millennium Predictive Medicine, Inc., known as MPMx, a majority-owned subsidiary of MILLENNIUM PHARMACEUTICALS, INC. (MLNM: $77, unchanged), today announced they have entered into a unique alliance in the emerging field of cancer pharmacogenomics. This is the use of genetic information to develop new anticancer therapies to treat specific patient populations or tumor types, or to tailor existing therapies to individual patients. Bristol-Myers Squibb, the world leader in cancer therapies, is collaborating with MPMx, a world leader in the new field of predictive medicine, to apply this exciting new research approach to some of Bristol-Myers Squibb's oncology drugs in development and to marketed products.
The Bristol-Myers Squibb/MPMx collaboration is the first integrated application of cancer pharmacogenomics utilizing new medicines and existing therapies. The alliance will coordinate the development of therapeutic products and pharmacogenomic tests. Therapeutic products resulting from this alliance will be brought to market by Bristol-Myers Squibb. Pharmacogenomic tests will be brought to market by one or more leading diagnostics companies, selected by MPMx and Bristol-Myers Squibb.
During the five-year term of the alliance, Bristol-Myers Squibb will provide MPMx with $32 million in license fees, annual fees, and research funding. This is believed to be one of the largest pharmacogenomics alliances to date.
The goal of the partnership is to identify and validate oncology clinical markers - genes or proteins - that can help predict patients' responses to specific cancer treatment regimens and aid the development of new cancer therapies. By integrating clinical markers and genomic technology into the treatment of cancer, therapies could be tailored to individual patients, thereby boosting efficacy and reducing side effects.
COMMENT: This newly-announced alliance exemplifies the trend toward personalization of medicine at the genetic level. Much is to be gained by studying the relationship between an individual's specific genetic makeup and response to cancer chemotherapy. The key concept is that therapies could be tailored to individual patients. This same sort of pharmacogenomic approach can be developed for other diseases, such as those caused by infectious agents. Both Bristol-Myers Squibb (BMY) and Millennium Pharmaceuticals (MLNM) are in The Bull Market Drug and Biotech Portfolio.
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2. AMGEN: LONGER ACTING VERSION OF KEY DRUG
AMGEN (AMGN: $88, +2, +2%) announced data from a phase 3 clinical trial of its Novel Erythropoiesis Stimulating Protein (NESP). These data suggest that NESP, a new molecule with a prolonged biological half life which stimulates production of red blood cells, safely maintained hemoglobin levels (number of red blood cells) as effectively as recombinant epoetin alfa (EPO) with less frequent dosing (weekly or once every two weeks compared to 1-3 times per week).
In a randomized controlled study of 522 hemodialysis and peritoneal dialysis patients conducted in Europe and Australia, maintenance of hemoglobin level, weekly dose requirement and the frequency of dose changes in the NESP and EPO groups were similar regardless of route of administration, even among NESP patients treated every other week. Due to its three-fold longer half-life compared to EPO, NESP permits longer dosing intervals. Amgen is completing worldwide clinical trials of NESP in chronic renal failure patients on dialysis as well as patients with chronic renal insufficiency, a condition in which patients' kidney function is compromised but does not yet require dialysis treatment. Amgen is also conducting clinical trials of NESP in oncology.
COMMENT: Epoetin alfa (EPO) has been a huge drug for Amgen. NESP could be a key follow-up drug to EPO. Reduced frequency of dosing is particularly helpful with injectable drugs.
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3. PFIZER MAY PURSUE HOSTILE WARNER-LAMBERT TAKEOVER BID
PFIZER (PFE, $35, unchanged) said it may take its $75 billion all-stock bid for WARNER-LAMBERT (WLA) directly to shareholders as Warner-Lambert stood by its plan to merge with American Home Products (AHP). Pfizer has to decide whether to launch an exchange offer or a proxy fight. Pfizer last week made an unsolicited bid to take over Warner-Lambert just hours after Warner-Lambert had unveiled plans to merge with American Home Products in a $70 billion stock deal.
COMMENT: In the opinion of a few well known money managers, the battle shaping up may only be in the early stages. We expect them to raise their bid. WLA at $92 may look cheap in a few days.
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4. AMERICAN HOME PRODUCTS: VACCINE FOR CHILDREN
A new vaccine to prevent a major cause of meningitis, pneumonia and other infections in children won the endorsement of a U.S. Food and Drug Administration panel Friday. The vaccine, called Prevenar and made by American Home Products (AHP: $55, +1, +2%), aims to stop infection by pneumococcus, a common bacterium that can cause a variety of serious illnesses. A panel of vaccine experts deemed Prevenar safe and effective, calling it an important weapon against infections that kill more than a million children worldwide every year and which are growing resistant to antibiotics.
A Centers for Disease Control and Prevention panel has recommended the vaccine be given to all healthy infants under age five. Prevenar would likely be an important product for AHP, drug industry analysts said. Revenues from Prevenar sales are expected to reach several hundred million dollars in the near future.
For Prevenar, a study of more than 38,000 children in found the vaccine was 97 percent effective in preventing infections from the seven strains of pneumococcus that the vaccine targets. Those strains cause more than 80 percent of pneumococcal infections, including serious bloodstream infections, pneumonia, meningitis and middle-ear infections. Recommended administration is four doses of Prevenar given at two, four, six and 12-15 months.
COMMENT: Prevenar is a very important new vaccine that has the potential to save a large number of lives every year.
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5. NEW VISTAS IN CANCER TREATMENT: INTRODUCTION By Edward Kenna
Nearly thirty years ago, with the nation flush from the success of its lunar landings, President Nixon announced a national initiative and increased funding to find a cure for cancer. As the years went by, expectations for quick success in this "War on Cancer" were shown to have been naive. Frustratingly little was known about the fundamental nature of cancer. Just what made a cancer cell different from a normal cell? What caused the myriad forms of cancer? How were they different from each other? Why were some harder to treat than others? What was the genetic makeup of cancer? Back in the early 1970's, researchers had only vague clues and advances in our knowledge brought more questions than answers.
But now, as the turn of the century is upon us, the labor of thousands of doctors and researchers has revolutionized our understanding of these dreaded diseases known collectively as cancer. Just as electrical engineers and physicists have brought computers and wireless technologies into our lives that would have seemed magical only 10 years ago, so too biologists and chemists have been making advances in understanding the human body and its diseases, in many cases literally molecule by molecule. Today the battle against cancer is being waged on at least five different fronts, with the pace of progress quickening every day. It's conceivable that by the second decade of the next century, nearly all cancers will be, if not curable, then at least manageable diseases.
Our traditional means of fighting cancer are being improved. The use of computer technology is making radiation treatments more effective and less onerous. Liposomal formulations of conventional chemotherapy drugs such as cisplatin and doxorubicin are moving through clinical trials; these formulations may offer lower toxicity and increased efficacy. Other researchers have put chemotherapy drugs into films and gels; these are then implanted at the disease site after surgery or injected into tumors. This delivers a higher concentration of drug to the tumors while decreasing systemic side effects. Other new forms of chemotherapy including topoisomerase inhibitors, which interfere with DNA replication in rapidly dividing cells, and antisense compounds that block the activity of key genes or enzymes in certain cancers, are also advancing through clinical trials.
The likelihood of successful cancer treatment has always been enhanced by early detection. Most of the forms of cancer that can now be treated successfully, such as melanoma, breast, and cervical, are diagnosed before they have metastasized, or spread. New means of early detection, such as scanning procedures for imaging the lung and new blood tests that detect proteins made by cancer cells before the cancer would even be visible to the eye, are just beginning to appear. Earlier detection of many types of cancers will save thousands of lives.
But the real promise of biotechnology for the treatment of cancer is in three other areas that are raising the hopes of oncology researchers and gaining the attention of the investment community. They are: 1) antibodies specifically created to combat different types of cancer cells; 2) cancer vaccines designed to make the body produce its own immune response against cancer; and 3) angiogenesis inhibitors, which interfere with the blood supply to solid tumors. There are literally dozens of companies working in these areas, hoping to create a blockbuster drug which will be much more important to cancer patients than any incremental advance in chemotherapy or radiation - and also make fortunes for themselves and their investors.
All five of these areas, particularly the last three, merit our attention as long-term investors in drug and biotech companies. It would be impossible to cover all of the important work being done in any one of them, let alone all five. Also it's important to remember that much of the research going on in oncology is secret - large drug companies have all the money they need for research and have no reason to reveal what they're doing, whereas many biotech companies are constantly trying to raise money and are thus eager to tell their story to the public. But given those limitations, I'd like to discuss some of the major activity in these areas. Next week, I will give an overview of efforts to use antibodies to treat cancer.
Edward Kenna is an investment professional with Access Securities. He has broad knowledge and experience in biotechnology investment.
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6. DRUG AND BIOTECH PORTFOLIO SCORECARD; UPCOMING ARTICLES
Today's scorecard for the Drug and Biotech Investor Portfolio:
Name Symbol Last Chg. %Chg.
Affymetrix AFFX 77 -1 -1 Amgen AMGN 88 +2 +2 Biomira BIOM 2.6 0 -1 B-M Squibb BMY 77 +1 +2 Celera Genomics CRA 39 +1 +2 Genentech DNA 76 -1 -1 Gilead Sciences GILD 47 0 0 Human Genome HGSI 92 +4 +4 ImClone Systems IMCL 28 0 -1 Medimmune MEDI 103 +3 +3 Millennium MLNM 77 0 0 Merck MRK 78 0 -1 Pfizer PFE 35 0 0 Viropharma VPHM 19 -1 -5
We will continue to discuss new approaches to cancer treatment including immunotherapy, vaccines, and anti-angiogenesis in upcoming issues. In a few years' time, we expect that these and other developments will revolutionize the treatment of cancer.
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Eddy Arnold invites comments or feedback about The Bull Market Drug and Biotech Investor and can be reached by e-mail at BiotechInvestor@Bull-Market.com.
Dr. Eddy Arnold is a Professor of Chemistry at Rutgers University and a Resident Faculty Member at the Center for Advanced Biotechnology and Medicine in Piscataway, NJ. He works in research areas in biochemistry, chemistry, and medicine, with an emphasis on enhancing drug and vaccine development through fundamental scientific studies, and a particular focus on diseases caused by viruses including AIDS and the common cold.
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Disclaimer: Dr. Eddy Arnold invests in many of the stocks described in The Drug and Biotech Investor. He has consulted with and collaborated with a number of the companies in the portfolio. All of the material provided here is obtained from documents in the public domain.
The Bull Market Report, LLC is not a registered Investment Adviser or a Broker/Dealer. Readers are advised that the report is issued solely for informational purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy. The opinions and analyses included herein are based from sources believed to be reliable and written in good faith, but no representation or warranty, expressed or implied is made as to their accuracy, completeness or correctness.
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(C) Copyright 1999 The Drug and Biotech Investor and The Bull Market Report, LLC.
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