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ChangeWave Research: Cancer Treatments – A Look at Monoclonal Antibodies

ChangeWave Research Report:Cancer Treatments – A New Look at Monoclonal Antibodies

Abstract

This report contains the findings from a recent ChangeWave Alliance research project on cancer treatments, along with a Roundtable on changes at the FDA.

A. Cancer Treatments

In March, we surveyed Alliance healthcare members on which cancer immunotherapy categories are most likely to succeed or fail, and why. A total of 72 members participated.

The March survey focused on five major cancer treatment categories – Monoclonal Antibodies, Anti-angiogenesis, Antibody-based, Anti-sense, and Interferon-based – to gain insight into which lines of attack harbor the greatest risks, and why. The survey results confirm that monoclonal antibody technology will be at the core of a new wave of successful cancer treatments.

In previous Alliance biopharma surveys, we also learned that trial design, safety, efficacy, and securing a major partner were all paramount for success. In the current survey, respondents delivered a similar message – with even greater urgency.

Bottom Line: (a) Monoclonal Antibodies are gaining traction with drug companies, regulators, and in clinical trials. (b) When it comes to overall predictors of cancer therapy success, red flags should shoot up when the potential risks of developing a therapy are out of balance with the potential payoffs. Excessive risks would include the inherent complexity of a cancer therapy, soaring scientific challenges in the clinical stages, and the sometimes titanic hurdle of obtaining FDA approval.

B. Changes at the FDA

In March, we also conducted an Alliance healthcare Roundtable to see whether, with a new commissioner on board, the FDA is entering a new era, or if we should expect business as usual.

Bottom Line: The new FDA director is a step in the right direction. In the coming year, the approval process should gradually speed up and new biotech drugs may be moved along slightly more aggressively – but revolution is definitely not in the air.

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Copyright ©2003 ChangeWave ResearchAll rights reserved.

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Table of Contents

Summary of Key Findings.............................................................................................3

A. Cancer Treatments.................................................................................................3

B. Changes at the FDA.............................................................................................13

ChangeWave Research Methodology........................................................................15

About ChangeWave Research....................................................................................16

Copyright ©2003 ChangeWave Research All rights reserved.

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I. Summary of Key Findings

A. Cancer Treatments

Overview

Research and development of cancer therapies and the challenges of commercialization are commanding the attention of the healthcare industry, Wall Street, and individual consumers. With the stakes so high, big pharma companies and many smaller biotech firms have invested, and are continuing to invest, tremendous resources to eradicate this multi-faceted disease.

Biological therapy, sometimes called immunotherapy, is a relatively new addition to a wide array of cancer treatments that also include surgery, chemotherapy, and radiation therapy. Biological therapies use the body’s immune system – either directly or indirectly – to combat cancer or to lessen the side effects caused by other cancer treatments.

During the week of March 25 – 30, 2003, we surveyed Alliance healthcare members on which cancer immunotherapy categories are likely to succeed or fail, and why. A total of 72 members participated.


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Factors Determining Success or Failure for Cancer TreatmentsEchoing previous Alliance surveys on pharmaceuticals and the FDA, respondents focused on several critical factors including:

Trial design Safety Efficacy Securing a Major

Partner

Monoclonal Anti- body Technology: The Core of a New Wave of Successful Cancer TreatmentsGaining traction with drug companies, regulators, and in clinical trials.

The science and industry are mature

The FDA is familiar with the science

IDEC Pharma and Johnson & Johnson, have competitive edge

Abginex and Genentech also have real-world prospects

Balancing Risk vs. Reward for Cancer ImmunotherapiesRed flags should shoot up whenever the risks of developing cancer therapies are out of balance with the payoffs. Excessive risks include: Complexity of the

therapy Soaring scientific

challenges in the clinical stages

At times, the titanic hurdles for obtaining FDA approval


Primarily, we looked at five cancer treatment categories – Monoclonal Antibodies, Anti-angiogenesis, Antibody-based, Anti-sense, and Interferon-based– to gain insight into which lines of attack harbor the greatest risks, and why. Of these, Monoclonal Antibodies has the longest track record, including about a dozen drugs now on the market (many for non-cancerous diseases). The other four, at varying stages of development, have so far achieved only sporadic success at best.

We also focused on off-label cancer treatments now gaining favor in the marketplace, the outlook for generic versions of cancer therapies, and the prospects for emerging cancer tests.

Background. In mid-2002, the Alliance told us cancer treatments that take an incremental approach are more likely to gain FDA approval. For example, chemotherapies for tumors and lung cancers that specifically target cancer cells without harming normal cell tissues.

Most importantly, the Alliance advised us that bold new therapies from bold new companies were probably going to fail, and only non-speculative cancer treatments that prove dramatically more effective would be placed at the head of the FDA queue.

With this in mind, we focused on the above five cancer therapy categories to learn which of these approaches are based on the most speculative science, have the biggest clinical hurdles, and are least amenable to the currently conservative FDA process.

Findings

The survey results confirm that monoclonal antibody technology will be at the core of a new wave of successful cancer treatments. This relatively old technology is getting serious traction with drug companies, regulators and in clinical trials – the problem is identifying winners and losers. As ChangeWave Research Director, Michael Shulman sees it, “So far, we see a bit more smoke than fire but also feel comfortable recommending investors take a hard look at a handful of companies already out in front of this wave.”

Question Asked: Which one or two of the following cancer treatment categories that are in early stage trial do you believe are most likely to lead to successful drug therapies getting to market? (Please Choose No More Than Two)

Anti-angiogenesis 50%Monoclonal Antibodies 49%Antibody-based 33%Anti-sense 18%Interferon-based 4%Don't Know 11%

Most Likely to Succeed. Respondents believe Anti-angiogenesis (50%) and Monoclonal Antibodies (49%) are the two categories of cancer treatments with the best chances of commercial success. Only 4% of respondents chose Interferon-based treatments.


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Question Asked: Which one or two of the following cancer treatment categories that are in early stage trial do you believe are least likely to lead to successful drug therapies getting to market? (Please Choose No More Than Two) Anti-sense 38%Interferon-based 28%Anti-angiogenesis 22%Antibody-based 11%Monoclonal Antibodies 7%Don't Know 21%

Tough Road Ahead. Respondents believe Anti-sense (38%) and Interferon-based (28%) treatments are least likely to succeed in the market. Interestingly, Anti-angiogenesis – the highest rated cancer treatment – garnered a relatively high negative rating.

Difference Score* for the Categories of Cancer Treatments:

Cancer Treatment Success Failure Net

Monoclonal Antibodies 49% 7% +42Anti-angiogenesis 50% 22% +28Antibody-based 33% 11% +22Anti-sense 18% 38% - 20Interferon-based 4% 28% - 24

*The Difference Score is the difference in the percentage of respondents who chose a cancer treatment category to be a likely "Success" and the percentage of those who picked a category to be a likely "Failure."

Monoclonal Antibodies Heads the List of Most Promising Cancer Therapies. The net difference score for Monoclonal Antibodies (+42) well exceeded that of the two nearest runner-ups, Anti-angiogenesis (+28) and Antibody-based (+22).

Poor Prospects for Interferon-based and Anti-sense Treatments. Interferon-based and Anti-sense treatments had the only negative net difference scores, and were overwhelmingly chosen as the most likely to fail in their efforts to obtain FDA approval and in the subsequent commercial stage.

Question Asked: Previous Alliance research shows poor trial design is often the reason why drug trials fail. The failure of Erbitux is a perfect example of this phenomenon. What cancer therapy(s) currently in trial is most likely to fail, either because of poor trial design or some other reason? In addition, why will this treatment category(s) fail to lead to successful drug therapies getting to market?

Respondents answered this question in two different ways. Alliance members in the first group approached the question more generally, with comments falling into one of three areas – safety and efficacy issues, trial design, and the disadvantages of cancer vaccines. Respondents in the second group focused on specific cancer treatment categories and addressed barriers and risks.


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(Note: This question focused only on which cancer treatments will fail and why).

a. General Reasons Why Cancer Therapies Will Fail

Sample of Alliance Member Responses:

i. Safety and Efficacy Issues

WIL5353 writes, “I do not believe problems will be with poor trial design but with side effects versus efficacy issues. Will delay unless and until someone comes up with an agent that has superior efficacy and acceptable side effects for the tumor involved (must be clearly superior to current standard of care for significant tumor).”

GUI5093 writes, “Lack of specificity and failed delivery.”

ABC3984 writes, “Failure of drug trails is most often due to poor efficacy of a given drug. Cancer is a very complicated disease.”

DDU7628 writes, “It is a very complicated issue. Normally, all trials are carefully designed. Drug discovery and development are a very risky and unpredictable business. There are a lot of unknown factors.”

COB6520 writes, “Most of all because treating cancer with pharmacology and trying to get the body well by introducing a foreign, man-made substance is the wrong approach.”

MLJ7088 writes, “High toxicity or long term toxic effects of the drug.”

ii. Trial Design

FER6743 writes, “The limited number of cases is the limiting factor in most trials.”

MLJ7088 writes, “Poorly run trials – it is a responsibility of the drug company to comply with rigid FDA guidelines. This is not always cost effective or takes way too much time. The consumer often suffers because of the long delays and repeated testing necessary. Research money and grants run out.”

CLI1209 writes, “Those being studied without adequate controls, with too few patients, and those where the FDA has not been consulted in advance of Phase II trials. In each case, these are examples of defective study design and/or management.”

CLE2459 writes, “In-vitro model does not seem to carry forward to in-vivo successes, probably due to anatomical/structural differences of tumor behavior in the test tube versus the body.”

iii. Disadvantages of Cancer VaccinesCopyright ©2003 ChangeWave Research

All rights reserved.6


JUD1157 writes, “All cancer vaccines – extremely difficult to design a meaningful protocol.”

WSU8151 writes, “The much anticipated cancer vaccines have hit a major unrecognized problem. This involves a protein B7-H1 that may be responsible for this dilemma because it is produced by many tumors (lung, ovarian, colon, and melanoma). Previously it was noted only on macrophages because it regulated/killed T lymphs to prevent autoimmune disorders. This means that the tumor itself can kill sensitized T cells to that tumor, making a vaccine seem ineffective. However, if an anti B7-H1 drug is found, the whole area of vaccines will take off. P.S., the most successful anticancer vaccine so far is the Hepatitis B vaccine – it prevents cirrhosis and hepatomas.”

b. Reasons Specific Categories of Cancer Treatment Will Fail


i. Interferon-based

ABG4789 writes, “Interferon-based has far too many effects (targets) to be used against malignant cells - i.e. it is too non-specific in its action.”

ii. Anti-sense

JEF7251 writes, “Anti-sense - the technology is too immature, and it is difficult to deliver the agent in meaningful doses to the target (inside the cancer cells). It (Anti-sense) may eventually lead to successful approvals, but will lag the others. HuMAB's, for instance, are amenable to modification with small molecules and other payloads, and bind to a target on the cell surface, not inside, and have approved drugs on the market (Enbrel, Herceptin, etc.).”

WID2493 writes, “Any potential therapy can fail and will fail if design is inadequate. Too many companies try to hit homeruns with treatment modalities when a single is enough. Trying to design a drug for all types and looking at a cure for multiple cancers is not much of a real possibility; however, companies attempt this because of the potential market returns on their expensive investments. This leads to failure and Anti-sense therapies are, in my estimation, a long way off.”

BIO9114 writes, “Any stand-alone treatment will have a harder time of succeeding in trials. Drugs that are tested to enhance chemotherapy will have the best chance of success. I don't believe Anti-sense drugs will be effective in human trials, even if combined with chemo. Anti-sense drugs try to target specific RNA/DNA sequences to prevent transcription of important proteins in the tumor cells, and therefore make the tumor cells stop growing, etc. Too many things have to go right for this to happen.”


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WLU8236 writes, “There are several reasons: 1) Cost of Anti-sense, certainly for systemic and prolonged treatments, 2) Typically limited effect on gene expression (decreases by 50-70%), 3) Heterogeneity of most tumors, and 4) Selection of resistant tumor cells from the total population in a patient.”

iii. Antibody-based

TJL1121 writes, “Tumor-activated-prodrug (antibody-based) Immunogen. Trials are too small and no big pharma leadership.”

iv. Anti-angiogenesis

NIZ9560 writes, “Small molecule anti-angiogenesis inhibitors have been difficult to validate in humans.”

GLE3274 writes, “Most anti-angiogenics are going to prove to cure cancer quite well. Unfortunately, no one cares about curing cancer in mice. Pharmaceutical companies are targeting pathways they don't understand yet. Typical run-before-you-can-walk failure.”

v. Monoclonal Antibodies

HAN5261 writes, “Therapies based on humanized monoclonal antibodies, even those claimed to be fully human. Non-human glycosylation of these humanized antibodies leads to rapid clearance from the body and also interferes with cell mediated responses (T cell responses).”

VAN2268 writes, “Monoclonal antibody therapy such as Zevalin, which is already approved. The hospital cost for the therapy drug is over $20,000 for a dose and physicians will be reluctant to use it.”

Question Asked: Many cancer treatments are considered "off-label" - i.e., they are used without the blessing of a formal FDA label. Are you aware of any off-label cancer treatments that are currently gaining favor in the marketplace?

Seeking Alternatives. Once again, Alliance members responded in one of two ways. The first group identified pharmaceutical therapies for certain cancer treatments that are not specifically approved by the FDA. Respondents in the second group were 'au naturale,' so to speak – they chose a variety of alternative and holistic cancer therapies.

Interestingly, vitamin-based therapies garnered more mentions than any single drug therapy. This is consistent with our findings from a January 2003 Alliance report on Off-Label Drug Use. In that report, we found “Biotech drugs will not generate meaningful revenues from off-label use in their first two to three years on the market, and insurance companies will be slower to pay for off-label use than they have in the past.”


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a. Pharmaceutical Therapies GRE3148 writes, "Temodar for gliomas other than anaplastic gliomas." PET4075 writes, "Thalidomide." WID2493 writes, "Breast cancer products for lung cancer." YON8043 writes, "Navelbin for breast cancer." CLI1209 writes, "Gleevec for indications not yet approved." WSH1329 writes, "Chronic Lymphocytic Leukemia (CLL)."

b. Alternative and Holistic Therapies HAN5261 writes, "Vitamin C in super dosages." MLJ7088 writes, "Alternative and holistic therapies." FER6743 writes, "Shark cartilage." COB6520 writes, "Coxey treatments available only in Mexico which uses high

dose intravenous vitamins and special herbal cocktails."

Question Asked: PSA testing has revolutionized the treatment of prostate cancer. Today, physicians feel far more comfortable in trying relatively new treatments because they can closely monitor the progress of the disease. Are you aware of any other tests on the horizon that could be as successful as PSA testing? Testing the Waters. Prostate cancer, the most commonly diagnosed cancer in men in the U.S., is the second leading cause of deaths among U.S. males. Fortunately, the widespread use of Prostate-Specific Antigen (PSA) Testing is saving numerous lives because of its ease of use and effectiveness. Given PSA’s success, we asked Alliance members if they knew of any comparable tests in the pipeline.

Respondents identified tests for several kinds of cancers. A few respondents mentioned Free PSA testing, which is a more specific immunoassay than the basic PSA. Another test highlighted was CEA (Carcinoembryonic Antigen). As ZSA8198 puts it, "CEA is an important test for monitoring the treatment of colorectal cancer.”

Genetic testing was also noted by a number of Alliance members, without mention of specific applications. As JEF7251 points out, "There are many cancer diagnostics and monitoring tools in development, some of which depend on multi-marker testing."

Question Asked: Some analysts believe the market for generic cancer drugs is poised to grow significantly over the next few years. Others are not so sure. Do you believe that - when available - generic versions of cancer therapies will be readily accepted in the marketplace?

Yes 69%No 15%Don't Know / NA 16%

Copycats Looking Good. Respondents echoed the sentiment of our previous ChangeWave Alliance surveys on the generic drug industry. More than two-thirds (69%) of respondents expect generic versions of cancer therapies will be readily accepted


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once available for market. This is not startling news, as other studies and our own research show that lower-priced generics can be expected to gain 80%-85% market share after a relatively short time on the market.

To put this in context, Michael Shulman recently stated that, "The [generics] industry represents the single best market segment for investment in the entire market for equities." Based on the Alliance’s research, generics will continue to win over proprietary drugs in head-to-head competition.

Importantly, several forces are working together to propel generics, including legislative, regulatory and judicial factors; a marketplace favoring the acceleration of sales of generics; and competition (big pharma) that is unprepared to do battle.

Summary and Analysis

1. Complexity and Risk in Cancer Therapies. In previous Alliance biopharma surveys, we learned that trial design, safety, efficacy, and securing a major partner were all paramount for success. In the current survey on cancer therapies, respondents delivered a similar message – with even greater urgency.

According to survey participants, the challenge for companies working on cancer cures is heightened because of the complexity of the disease and the associated learning curve. As ABC3984 puts it, "Cancer is a very complicated disease." Since cancer manifests in so many configurations, and little is still understood about its chemistry, the road from lab to marketplace is riskier in comparison to many other bioventures.

2. Monoclonal Antibodies Keep Rolling Along. Unlike many other categories of cancer therapies, MOABs have established a track record with some notable successes. Rituxan and Herceptin are two examples of MOABs that have been approved by the FDA, and researchers continue to test MOABs in clinical trials to treat many types of cancer.

3. Other Cancer Treatment CategoriesCopyright ©2003 ChangeWave Research

All rights reserved.10

About Monoclonal Antibodies: The key word in monoclonal antibody therapy is “antibody”. Antibodies are proteins transported via the bloodstream by “B lymphocytes” or white blood cells that are the worker bees and soldiers of the immune system (do you remember how they attacked poor Raquel Welch in Fantastic Voyage?). Antibodies are produced when the immune system senses substances that are found in the viruses and bacteria that typically cause disease. Antibodies roam around and identify foreign substances for attack by cells that are part of the immune system. While there are a myriad of antibodies – many highly specialized – the immune system antibodies able to fight cancer are quite weak.

A monoclonal antibody focuses on a very particular component of a specific protein or other substance associated with a disease. Monoclonal antibodies are mass produced with the use of immune cells grown in the laboratory..


Anti-angiogenesis: Promising, But Watch Out For Mousetraps. Like Anti-sense, anti-angiogenesis technologies have demonstrated exciting potential in early clinical stages. The problem is that success in mice is not carrying over to humans. However, with increased understanding of the pathways, Anti-angiogenesis could eventually prove to be beneficial for humans.

Anti-sense is a Long Shot. Anti-sense drug design is faster, simpler, and more efficient than the traditional drug design directed at protein targets – and they can be designed to treat a wide range of diseases beyond cancer. Unfortunately, Anti-sense is plagued by a host of limitations including immaturity of technology, the potentially high cost of treatment, and the inclination of Anti-sense biotech firms to swing for homeruns.

Interferon-based Therapies Hold Little Promise. In its early days, Interferon-based therapies caused great excitement as a possible magic bullet against cancer. Today, the prospects for these proteins to battle cancer are dim. As ABG4789 writes, "Interferon-based has far too many effects (targets) to be used against malignant cells…it is too non-specific in its action.”

Investment Thesis

Monoclonal antibodies have an excellent chance of being the core of a new generation of cancer treatments for the following reasons:

The science and the industry are mature -- while the “anti-angiogenesis” or “anti-sense” components of the biotech industry are easy to identify, monoclonal antibodies have been around for more than a generation, having been discovered by British researchers in 1975. There are, for example, at least 20 significant suppliers (at the very minimum) of monoclonal antibodies for laboratory and clinical trial use; mass production techniques of these materials is well understood with clear regulatory guidelines and a handful of drugs are on the market, notably Rituxan from IDEC Pharmaceutical.

The science is well understood by the FDA.

There are two well-known therapies on the market and reasonably well known to people in the industry.

Insurance companies have shown a willingness to pay for expensive treatments based on monoclonal antibodies if usage is backed up by clinical trials.

MOABs have unique roles in therapies that will afford them greater patent protection than other drugs.


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Winners in this segment will be those companies most able to benefit from these factors in the marketplace.

Drug companies, notably IDEC Pharmaceuticals and Johnson & Johnson, enjoy a large competitive advantage by having a drug on the market that is successful, and by creating large patient pools that can be used for future clinical trials to expand usage of these drugs. IDEC has more than 200 trials underway. Abginex and Genentech also have real-world prospects.

Clinical trials have not been necessary for previous, non-biologic cancer treatments prescribed off-label, but according to a November ChangeWave survey, they are vital to off-label use of expensive, biologic based anti-cancer treatments. Survey respondents said that insurers would not pay unless a new treatment is backed by an FDA label and/or strong clinical trial results. Institutions and physicians will be reluctant to pursue off-label use due to tort liability.

According to Shulman, this means the strong and successful (those companies with drugs on the market and many new usages in trial) have a very large jump on companies without drugs on the market.

These drugs will maintain their pricing (they are very expensive) for they are prescribed for terminally ill or severally ill people with terrible maladies – cancer, severe arthritis, severe Crohns’s disease and so on.

Proper insurance reimbursement also means expensive drugs do not need a large patient population to become $1BN drugs – but rather, strong clinical trials showing the efficacy of the drug and a hefty price tag.


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B. Changes at the FDA

Overview

The Food and Drug Administration (FDA) and its new commissioner, Dr. Mark McClellan, face a host of big challenges ahead. The Agency, which regulates products that account for 25 cents of every consumer dollar spent, is under increasing pressure to make the drug-review process quicker and more efficient.

Last year, the FDA approved only 21 truly new drugs, compared with 44 in 1996. The decrease reflects a sharp slowdown of new applications from the drug industry, which is struggling with the rising costs of drug development.

Over the past year, the Alliance has provided clear guidance on the FDA's criteria for reviewing Phase II and Phase III clinical trials. Recently (March 2003), we conducted an Alliance Roundtable on “Changes at the FDA,” to gain insight into whether the FDA is moving in a new direction, and if so, to find out what is driving the change.

For an organization that is perpetually overextended and under-funded, we wanted to learn what – if anything – has changed in recent months at the FDA. Has the appointment of a new FDA commissioner helped or hurt the review process? In particular, is the agency loosening up its criteria for considering a trial's results?

Additionally, has the shift in the review of biotech drugs – from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER) – had any effect on the review process?

Summary and Analysis

New FDA Commissioner is a Good Start. The FDA was headless for a year until Dr. McClellan took over the helm in November. Many analysts believed the agency was hindered as a result of the lack of a director, claiming that the FDA was facing heightened challenges which required strong leadership.

Most Alliance members were positive about the appointment of the new FDA commissioner. As JEF8057 writes, "I think that the most significant change is having a head in charge of the organization. This reduces the uncertainty of dealing with FDA processes….at least there is someone steering the ship at this point."

The commissioner’s professional background is seen as a plus for the biopharma industry. Dr. McClellan is a businessman as well as a physician, and a few Alliance members pointed out his apparent sensitivity to corporate needs. Others said they expect the agency to become more efficient and proactive in a number of areas as a result of his appointment.

After recently hearing a talk by Dr. McClellan, DAV7781 writes, "He went to great lengths to discuss ways that FDA was going to expedite the approval of new drugs. He


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plans to make the process quicker and less costly, and hopes to eliminate multiple reviews.”

JBU2588 concurs that more timely reviews are in store, but raises an important issue about the balancing act of safety, efficacy and economics at a time when sensitivity to costs is extremely high:

"He [McClellan] also may require more efficacy data than what's previously been acceptable to the agency. Safety is critical, but in an environment where reimbursement is a huge issue, efficacy is, too. Given the cost of therapies, it also has to provide some measurable benefit or outcome. My guess is that pharmaco-economic studies will receive more attention, especially for supplemental indications."

Struggling with Inertia. Today, the FDA is faced with the weight of its own track record. It has a well-earned reputation of acting too slowly in the review and approval process – and being too conservative, particularly on cutting edge therapies.

Many Roundtable participants believe modest changes in the approval process will happen, but argue that lasting progress is a delicate business. As DJA1991 writes, "The FDA has such a horrendous reputation for delaying drug reviews that it will likely overcompensate and try to over-expedite. I would anticipate faster and faster approvals and reviews until someone gets burned and there is another backlash in the other direction."

Others are even less optimistic, as CEN6529 puts it, "I don't think the FDA's review and approval process has changed much. The FDA still takes longer to review results nowadays than it used to, and the agency is still 'gun-shy' about biotech drugs in particular."

CLI5003 concurs on the slowing of biotech drug approvals, and sees the switch of biologics hindering the review of new, complex agents until the reviewers adjust to the new arrangement. “After all,” he says, “it really depends on the people, just like anything else." Alternatively, MTA0602 believes the new review process for biotechs will have a positive impact. He writes, "Having biotechs with the rest of the drugs in the same committee is going to avoid different criteria and reduce the ‘off label’ problem.”

Bottom Line: The new FDA director is a step in the right direction. In the coming year, the approval process should gradually speed up and new biotech drugs may be moved along slightly more aggressively – but revolution is definitely not in the air.


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II. ChangeWave Research Methodology This report presents the findings from two recent ChangeWave Alliance research projects on cancer treatments (March 2003; n=72), and changes at the FDA (March 2003; n=13).

The Alliance’s proprietary research and business intelligence gathering system is based upon the systematic gathering of valuable business and investment information directly over the Internet from accredited members.

ChangeWave surveys its Alliance members on a range of business and investment research and intelligence topics, collects feedback from them electronically, interprets and reconciles the information in a cohesive manner and converts the information into valuable quantitative and qualitative reports. The Alliance has assembled its membership team from senior technology and business executives in leading companies of select industries. Nearly 3 out of every 5 members (58%) have advanced degrees (e.g., Master’s or Ph.D.) and 94% have at least a four-year bachelor’s degree.

The business and investment intelligence provided by the Alliance provides a real-time view of companies, technologies and business trends in key market sectors, along with an in-depth perspective of the macro economy – well in advance of other available sources.


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III. About ChangeWave Research

ChangeWave Research, of Phillips International, Inc. is a market research intelligence network powered by thousands of accredited and organized front-line professionals – the ChangeWave Alliance.

ChangeWave is the alternative to traditional “sell-side” investment research. The company publishes ChangeWave Investing, the investment advisory service for individual investors dedicated to researching and discovering growth stocks that profit from radical change, and Weekly WaveWire, a free e-mail newsletter distributed to over 200,000 investors.

ChangeWave has a very unique asset in its 3,900-member Alliance. We have assembled our membership team from a broad cross section of more than 20 vertical markets such as Internet e-commerce, semiconductors, data storage, and biotechnology, along with a wide range of professional disciplines including CIOs, IT managers, executive management, scientists, engineers and sales personnel.

The ChangeWave Alliance is composed of senior technology and business executives in leading companies – credentialed professionals who spend their everyday lives working on the frontline of technological change.

ChangeWave Research Reports provide a real-time view of companies, technologies and business trends in key market sectors along with an in-depth perspective of the macro economy – well in advance of other available sources. ChangeWave surveys its 3,900 Alliance members on a wide range of investment research topics and converts the findings into valuable investment and business intelligence reports. ChangeWave delivers its products and services on the Web at www.ChangeWaveResearch.com

ChangeWave Research does not make any warranties, express or implied, as to results to be obtained from using the information in this report. Investors should obtain individual financial advice based on their own particular circumstances before making any investment decisions based upon information in this report.

For More Information:

ChangeWave Research Telephone: 301-279-42009420 Key West Avenue, 4th Floor Fax: 301-610-5206Rockville, MD 20850 www.ChangeWaveResearch.comUSA [email protected]

Helping You Profit From A Rapidly Changing World ™www.ChangeWaveResearch.com


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