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NEW YORK, N.Y., Oct. 17, 2002 — Manhattan Research, a healthcare marketing information and services firm, recently announced the release of the Cybercitizen Health v2.0 study and associated data set.

Building on eight years of trended data, the recent findings illustrate the continued evolution of the Internet and how it is being integrated into the healthcare delivery system for a growing number of consumers, health plans, and health professionals.

Key trend findings:

* “Zone of Influence” expands: The impact of the Internet in health extends well beyond the individual Internet user accessing online health information and resources into their “zone of influence” — which often includes their children, spouses, and elderly parents. In fact, while the current data show that 63.3 million Americans are actively using online health resources, 124.7 million are directly, or indirectly, influenced by e-health in total.
* Online drug information seekers have doubled: The population of consumers seeking drug information online surged ahead in 2002, with 24.7 million consumers stating they have searched for drug information online in the last three months. This dramatic increase is driven in part by the growing number of online resources, and by general consumer advertising (i.e., television, print) driving consumers to the Web for more information.
* Search engine use remains strong: Consumers primarily rely on search engines to start their online journey when seeking health information, as opposed to going directly to the targeted Web site. Although the use of leading health portals, such as WebMD, increases each year, consumers are placing a high level of importance on search engines, such as Yahoo! and Google, as they travel to their final online destination.
* E-health consumers twice as likely to request a prescription: In addition to their increased tendency to search for additional information after seeing an offline advertisement for a prescription medication, e-health consumers are much more likely to take action offline (e.g., visit a physician, consult with a pharmacist, call an 800 number, etc.). In fact, the latest data show that e-health consumers are 2.3 times more likely than offline consumers to request a prescription drug by name from their physician.

Stan Bernard, Adjunct Professor of eHealth at The Wharton School of Business and a pharmaceutical industry consultant, said: “The recent Manhattan Research report shows that the Internet has moved from Wall Street to Main Street. Online consumers now rely more on the Internet for health information than any other source except physicians.”

“Last year, the focus was on the evolution of e-health. This year, the mantra is integrating e-health back into healthcare,” said Mark Bard, President of Manhattan Research. “From the point of view of the consumer, the Internet has already become a critical resource when researching health information, making decisions about treatment options, and interacting with health professionals and organizations.

“However, many health and life sciences organizations, pharmaceutical companies included, have yet to realize the full potential of marketing to this disproportionately valuable segment of the population, and the competitive advantage of integrating the online component back into the overall business.”

NEW YORK, N.Y., October 23, 2002 -� New research from independent market analysis company Datamonitor finds that the Internet is emerging as a valuable tool for consumers to look for health-related information by greatly expanding the amount of available health information.

Online health resources have allowed consumers to become more active in their own healthcare, particularly in terms of learning about their condition and treatment options. As the burden of knowing about both the disease and developments in treatment has become increasingly shared, a deeper level of interaction between patients and physicians is now possible.

More and more patients are using information they find online to generate discussions with their doctors about diseases, symptoms and treatment options.

While the fact that patients are taking a more proactive role in their healthcare is no doubt good news, the Internet does carry with it the risk that not all information is necessarily accurate, or indeed that patients can convince themselves that they are suffering from a disease having read the symptoms profile online, when in reality they may well not be. This can be both time-consuming and frustrating for doctors, who then need to re-educate the patient and convince them that they have been misinformed.

Irrespective of the quality of content offered, the Internet has served to increase the dialogue between physicians and their patients.

In the future, consumers would like to take this increased level of interaction a step further with almost 50% of both U.S. and European consumers, who use the Internet, stating that they would like to be able to email their doctor, schedule appointments online and receive prescriptions by email. While such initiatives are very much in their infancy, they would no doubt be well received by busy consumers who find current facilities inconvenient.

Datamonitor conducted a survey of 4,531 consumers across Europe and the U.S. in June 2002. Results from this survey show that as many as 43% of US consumers (32% in Europe) have looked for health-related information, both on- and offline in the last year.

In addition to traditional resources such as doctors, books and magazines, 66% of these consumers in the U.S. (36% in Europe) have used the Internet as a means to search for health-related information. These consumers stated that they are more likely to use health information websites sponsored by companies such as Yahoo! or the BBC, than websites which are connected to a pharmaceutical company, the government or medical institutions. In addition, women emerged as being 12% more likely than men to use the Internet to search for health information.

More than 1 in 5 U.S. consumers who have looked for information online have asked their doctor about a disease symptom/diagnosis having read something on the Internet. Online resources have allowed consumers to become more proactive in their healthcare, particularly in terms of learning about their conditions and treatment options.

As the responsibility for knowing about the disease and developments in treatment has become more shared between patients and their doctors, a deeper level of interaction is possible and patients are now far more likely to approach their doctors with information, rather than taking a passive role in their treatment and diagnosis.

Datamonitor’s survey found that 28% of the U.S. consumers who had searched for health information online (21% in Europe), have asked their doctor about a specific medication because of something they have read on the Internet. A similar number had asked their doctor about disease symptoms/diagnosis having read something online.

The ability to print information, rather than trying to remember it, is also proving popular, with increasing numbers of patients bringing along printed information from the Internet when they visit their doctor. This is useful not only for the patient but also the doctor, because, provided that the information is from a reputable source, it can serve to highlight additional information about a given disease and its treatment options to doctors.

There is a risk that patients may find inaccurate information online which can be time-consuming and frustrating for doctors. Forty-eight percent of US consumers (almost 40% in Europe) told Datamonitor that they would like to discuss information that they find on the Internet with their doctor. A downside to patients taking this initiative lies in the fact that not all information available online is necessarily accurate.

Furthermore, there is the concern that a patient may convince themselves that they have a particular disease having recognized symptoms they have read on a health website, when in reality they may well be unrelated.

Online health resources are of greatest value when the information provided is, first and foremost, veritable and useful in diagnosis or treatment. When the information presented by a patient is incorrect, the doctor has the task of re-educating him/her, which can be time-consuming and undermine the doctor’s authority. However, by the same token, if the online information is valid, less time may be required to inform the patient about the disease, thus freeing up more time which can be spent on diagnosis or discussing different treatment options.

All aspects of the patient/doctor relationship could without doubt be improved if the patient uses online resources containing high quality information, however, the sheer volume of information available online does unfortunately hinder the chances of each and every website being 100% accurate.

David Deon, eHealthcare analyst at Datamonitor, comments: “Currently consumers have access to a plethora of online information, varying in the levels of accuracy they provide. Understandably, many doctors question the value of the Internet, particularly when their patients bring in or talk about inaccurate information found online. Given the demand for health-related information among consumers and the skepticism of some doctors, there is a huge opportunity for companies to provide reliable online resources, perhaps under a recognized quality standard scheme that could be approved by an independent body.”

Surveyed consumers told Datamonitor that they want online services that make communication with their doctor faster and more convenient. An average of 54% of US consumers (average of European consumers was 45%) would like to be able to email their doctor and a further 55% in the US (46% in Europe) would like their doctors to be able to send prescriptions by email. This facility would no doubt prove invaluable for busy consumers who need repeat prescriptions for medication such as the contraceptive pill, but struggle to find the time to visit their doctor to collect these prescriptions.

Consumers would also like to schedule doctor’s appointments on the Internet, with 33% in the US (average 44% in Europe) stating that they would like to see this facility.

The pharmaceutical industry is presently one of the key providers of health information online. Through websites, companies are offering information about their products and the relevant conditions as well as other useful tools. Some sites also provide features that may be printed and used by patients during doctor’s visits. These materials can include diagnosis tools, talking points on the disease and treatments as well as product-specific information.

The provision of product information, such as additional evidence of efficacy, may serve to inform physicians of another therapeutic option. By facilitating the patient-physician relationship, pharmaceutical companies can foster corporate brand loyalty and indirectly present relevant information to time-poor physicians.

Mobile technology, such as mobile phones and handheld computers will serve to expand the accessibility of online information greatly. Using such technology, patients will potentially be able to present information to their doctors using their phone or handheld, instead of having to print it out. The convenient access to the Internet at the point-of-care should serve to drive patients presenting information they find online at doctor’s visits.

The rate-limiting factor in the use of mobile technology for this purpose is the level of penetration of Internet-enabled devices. At present, a greater proportion of consumers in surveyed European countries than in the US access health information through Internet-enabled technology.

David Deon comments: “The Internet has served to empower patients in their interactions with physicians by providing them with convenient access to disease and product information. There is a significant opportunity for the pharmaceutical industry to provide consumers with accurate and reliable online resources that foster the patient-doctor relationship.”

SAN ANTONIO, TEXAS, Nov. 15, 2002 — An overwhelming number of physicians say prior drug authorization may lead to less than optimal treatment, more emergency room visits, and potential risk to patients’lives, according to survey results announced at the American College of Allergy, Asthma and Immunology (ACAAI) annual meeting.

In addition, nearly 90 percent of respondents from the general public say they prefer treatment decisions to stay with their physicians. And, in fact, these respondents cite their lack of trust in health plans or state Medicaid programs to choose the best medical course of action.

The survey, conducted on behalf of the ACAAI, is the first to examine the potential impact of limiting patient access to physician-recommended treatments by state legislatures and managed care organizations through a process called prior authorization. The process requires that these groups review medical treatments for coverage.

Depending on the outcome of the review, treatments might have to obtain prior approval before an attending physician may prescribe it.

The survey found that most physicians and members of the general public believe the practice of prior drug approval is seriously flawed.

Of particular concern among respondents are treatments for such urgent medical situations as an asthma attack, which require therapies called acute care or rescue medications. The largest group affected by prior approval for drug treatment is Medicaid recipients — which includes over 36 million people.

“For people with life-threatening diseases, like asthma, delaying prescribed treatment can have devastating consequences,” stated Bob Lanier, MD, president of ACAAI. “This is very clear to the medical community and the population at large, as reported in this survey. This ought to be clear to the government, insurance companies or managed care organizations as well.”

The topic of prior drug approval, including those for emergency treatments, is being debated state by state.

Additional survey findings among physicians:

* More than nine out of ten primary care physicians (92 percent) agree that “requiring prior authorization is bad policy for the simple reason that it takes the decision of what is the most appropriate medication for a patient in an emergency situation out of the hands of their physician — the individual in the best possible position to determine what is best for a given patient in a given situation.”
* Nearly all primary care physicians feel that prior authorization will have a negative impact on the overall health of patients who need acute care or rescue medications, and that patients won’t have access to the best available treatment (92 and 95 percent, respectively).
* The majority of primary care physicians feel that prior authorization will have a substantial impact on the overall health of more acutely ill patients, low-income patients and elderly patients, with the greatest effect on the health of more acutely ill patients (67, 55, 49 and 54 percent, respectively).
* Nine out of ten primary care physicians (92 percent) also agree that “even if prior authorization might make sense for chronic condition medications, it doesn’t make sense for “acute care or rescue” medications where many patients will not have such medication on hand when an emergency arises and will therefore have no time to seek prior authorization.”

Additional findings among the general public:

* Nine out of ten adults agree (90 percent) that “even if requiring prior authorization might make sense in non-emergency situations, it’s hard to see how it makes sense when it discourages doctors who are dealing with a medical emergency from using the medicine they think is best.”
* Nine out of ten adults also agree (90 percent) that “prior authorization sounds like a bad idea because it will, in effect, take the decision of what medication is best for a patient out of the hands of the physician, who knows the patient best.”
* Eight out of ten adults agree (82 percent) that “it’s easy to imagine a physician — faced with the requirement of prior authorization for the drug they think is best for their patient — choosing to avoid the delay and hassle of getting approval and, instead, prescribing an alternative medication.”
* A policy of prior authorization to use acute care or rescue medications is foolhardy and moreover, potentially deadly,” claims Dr. Lanier. “Allergic asthma is a significant medical problem that demands serious attention by patients, employers, insurance companies, and state Medicaid programs.”

The survey, conducted on behalf of ACAAI, includes responses from 315 primary care physicians and 2,464 adults over 18 years. The survey took place online from November 5 through November 6, 2002.

Source: American College of Allergy, Asthma and Immunology

SAN ANTONIO, TEXAS, Nov. 15, 2002 — The American College of Allergy, Asthma and Immunology (ACAAI) has announced the roll-out of a “Get Smart About Allergies” national education campaign.

In response to growing evidence that allergies interfere with life and can cause serious health consequences, the campaign will inform allergy sufferers about how to better manage their disease with help from a family physician or an allergy specialist.

The ACAAI says it is following through on its call-to-action issued in August, after finding that 94 percent of allergy sufferers believe their quality of life — often including their work productivity, sleep, concentration and even their sex lives — is affected by allergies. The program will provide allergy sufferers with tools to “get smart” about allergies, including a free consumer brochure offering advice about when to see a doctor and information on the potential risks of over-the-counter medications.

The campaign also features an easy-to-navigate website and a public service announcement.

“Because allergies often last a lifetime, it’s never too soon or too late for individuals to ’get smart about allergies’ and see an allergy specialist or family physician about their condition,” said Dr. Bobby Lanier, President of ACAAI. “Our campaign goal is to alleviate the needless suffering that allergy patients deal with on a daily basis. With the help of a healthcare professional, this disease can be managed and other potential health complications — such as sinus or ear infections, asthma and sleep problems — can be minimized.”

The “Get Smart About Allergies” brochure offers guidelines on managing the disease and explains when patients should see a physician or an allergy specialist. It outlines the risks of not seeking medical advice and describes the potential dangers associated with over-the-counter allergy medications.

The brochure is available through the ACAAI and at selected doctors’ offices. Consumers can download an online version of the brochure by visiting www.smartaboutallergies.com. Visitors to the Website also can gather information on allergies and review the results of the ACAAI survey, which provides insight into the way allergy sufferers feel about their condition.

Another element of this campaign is a 30-second educational Public Service Announcement (PSA) that will illustrate the impact mismanaged allergies have on a person’s life. The PSA aims to motivate patients to seek professional advice for optimal care and will be featured on broadcast and in print media throughout 2003.

“It is imperative that anyone who suffers — or thinks they may be suffering — from allergies seek the advice of an allergy specialist for proper diagnosis and treatment,” said Dr. William Berger, president-elect of ACAAI. “Optimal treatment may require avoidance strategies, immunotherapy or prescription medications, including oral non-sedating antihistamines or topical nasal sprays.”

DUBLIN, CAL., Nov. 15,2002 — SuperGen Inc. announced that it has received approval from the FDA to market Mitozytrex (MitoExtra), the company’s proprietary version of the generic drug mitomycin, for use in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed.

Mitozytrex becomes the first approved drug based on SuperGen’s patented ’supergenerics’ Extra technology platform.

“We are very pleased to have received FDA clearance to market Mitozytrex. This approval marks a milestone as it is the first New Drug Application - from beginning to end - that the company has seen through to approval,” said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen.

“Receiving approval for MitoExtra is extremely gratifying, from both a personal and professional standpoint, as SuperGen was founded on the concept of the Extra technology,” added Dr. Rubinfeld. “It is our belief that this could lead to a whole new generation of improved generics, or supergenerics, and we intend to develop the leading anticancer generics into Extra compounds.”

Most anticancer drugs are cytotoxic; in addition, most must be administered intravenously. If a vein is missed on injection, the drug can extravasate, or leak, to surrounding tissue, causing ulceration that sometimes requires even plastic surgery to correct. SuperGen’s Extra technology is designed to ’shield’ the drug from the injection site, thus providing the patient with protection from tissue ulceration.

“In addition to their so-called shielding benefit, the Extras could offer other important advantages over existing generics, such as increased solubility, stability and shelf life,” said Dr. Rubinfeld.

PRINCETON, N.J., and TOKYO, JAPAN, Nov. 18, 2002 -� The FDA has approved Abilify (aripiprazole), a new antipsychotic medication indicated for the treatment of schizophrenia.

Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. will jointly market Abilify in the United States. The companies anticipate that Abilify tablets will be widely available in pharmacies within two weeks.

Clinical studies involving 1,238 patients with acute relapse of schizophrenia demonstrated that treatment with Abilify provided significant improvements in the positive and negative symptoms of schizophrenia.

Importantly, treatment with Abilify was associated with minimal weight change, minimal extrapyramidal symptoms (EPS is a group of involuntary muscle movement disorders) and a modest difference in sedation compared to placebo (11% vs. 8%). Additionally, the incidence of QTc interval prolongation with Abilify treatment is not different from placebo.

“Abilify represents an important new treatment for schizophrenia,” said Jeffrey Lieberman, M.D., vice chairman of psychiatry, professor of psychiatry and pharmacology, University of North Carolina at Chapel Hill. “Clinical data show that patients treated with Abilify experience significant improvement of their symptoms, and the medication demonstrated an excellent safety and tolerability profile.

“Given that a large percentage of patients discontinue or switch antipsychotic medication due to inadequate response or side effects, the addition of Abilify to our armamentarium is very exciting.”

Schizophrenia affects more than two million Americans, and about one percent of the population worldwide. Schizophrenia interferes with a person’s ability to think clearly, manage emotions, make decisions and relate to others.

This illness tends to manifest itself in early adulthood and is characterized by positive symptoms, such as hallucinations, delusions, and paranoia, as well as negative symptoms, such as social withdrawal and emotional flatness. While there is no cure for schizophrenia, it is a treatable illness.

As with other drugs having efficacy in schizophrenia, the mechanism of action of Abilify is unknown. However, it has been hypothesized that Abilify works differently from other antipsychotics.

Specifically, it is proposed that the efficacy of Abilify is mediated through a combination of partial agonist activity at dopamine D2 receptors and serotonin 5HT1A receptors, and antagonist activity at serotonin 5HT2A receptors. Partial agonism refers to the ability to both block a receptor if it is overstimulated and to stimulate a receptor when activity is needed.

Abilify is administered as a once-daily oral tablet. The effective dose range of Abilify is 10 to 30 mg. The recommended starting and target dose of 10 or 15 mg daily enables physicians to initiate therapy at an effective dose without the need to titrate. Dosage can be subsequently adjusted to optimize individual patient response.

Tablets may be administered at any time of the day, with or without food. Abilify is available in 10 mg, 15 mg, 20 mg and 30 mg tablets.

FORT COLLINS, COLORADO, September 4, 2002 — Atrix Laboratories announced the US launch of Eligard(TM) 22.5mg (leuprolide acetate suspension for injection), a new proprietary product for the palliative treatment of advanced prostate cancer. Eligard 22.5mg utilizes Atrix’s innovative drug delivery system, Atrigel, to deliver leuprolide acetate over a three-month period.

“The availability of both one-month and three-month Eligard provides new alternatives to current prostate cancer therapy,” said David R. Bethune, Atrix’s chairman and chief executive officer. “The Eligard products have attributes and features that may be beneficial to patients and caregivers alike. We foresee potential benefits to the physician who wants an effective treatment for the advanced prostate cancer patient; to the patient who uses this therapy; and to the nurse who administers the treatment.”

The launch of Eligard 22.5mg prostate cancer product coincides with the start of National Prostate Cancer Awareness Month. According to the National Cancer Institute, a majority of advanced prostate cancer patients receive leutenizing hormone releasing hormone (LHRH) therapy during the course of their treatment.

The American Cancer Society lists prostate cancer as the most common cancer, excluding skin cancers, in American men. It is estimated that approximately 189,000 new cases of prostate cancer will be diagnosed in the United States this year and approximately 30,200 men will die of the disease. Approximately one man in six will be diagnosed with prostate cancer during his lifetime.

Atrix received approvals from the FDA for its Eligard 7.5mg one-month product and Eligard 22.5mg three-month product in January and July 2002, respectively. In April 2002, Atrix submitted a New Drug Application (NDA) for Eligard 30mg, a four-month sustained release product, which is currently under FDA review.

Eligard 22.5 mg, like other LHRH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment.

NEW YORK, N.Y., September 3, 2002 — Marjorie Powell, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA) and Bernie Horn, JD, Policy Director, Center for Policy Alternatives will present their perspectives on current legislation regarding government price controls and rebates that reduce drug prices for State Medicaid programs, seniors and the uninsured, when they keynote the Institute for International Research’s (IIR) 7th Annual Conference on the Medicaid Drug Rebate Program, September 25-27, 2002 in Chicago.

Together, they will address the litigation landscape, and speculate on the ongoing issues plaguing state legislatures and PhRMA in 2003.

A second pair of keynote presenters, James G. Sheehan, Assistant US Attorney, Chief, Civil Division, US Department of Justice and Michael Loucks, Health Fraud Chief, US Attorney’s Office, Boston, will address enforcement initiatives, resolution and ongoing compliance with price reporting and rebates.

Day Three highlights the PHS 340B Program, HIPAA and dispute resolution.

CORONA, CA., September 3, 2002 — Watson Pharmaceuticals announced that on August 30 it had resubmitted a New Drug Application (NDA) to the FDA for Oxytrol (oxybutynin transdermal system), the company’s transdermal oxybutynin therapy for which Watson is seeking an indication for the treatment of overactive bladder with symptoms of urge incontinence, urgency and frequency.

The NDA amendment includes new clinical data from the Oxytrol Phase IIIb trial, which evaluated the safety and efficacy of Oxytrol and tolterodine tartrate extended-release capsules (Detrol LA(R)) compared to placebo.

In addition, results from a pharmacodynamic study comparing Oxytrol to 10 mg/day Ditropan XL, which assessed the effects of oxybutynin and its active metabolite (n-desethyoxybutynin) on saliva production, were submitted. Results from both trials were recently presented at the 32nd meeting of the International Continence Society in Heidelberg, Germany.

“We have been working hard over the last few months on our Oxytrol NDA amendment,” stated Allen Chao, Ph.D., Chairman and Chief Executive Officer of Watson Pharmaceuticals. “We listened to the FDA’s requests and resubmitted our NDA for Oxytrol to the FDA incorporating new data from the Phase IIIb trial. We believe our NDA package is sound and that the amendment should address the FDA’s concerns. We continue to view Oxytrol as a key product that will help position Watson as a leader in the branded pharmaceutical sector.”

 

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