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Isotechnika Pharma Inc IPHAF



GREY:IPHAF - Post by User

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Post by go4futureon Nov 13, 2008 8:56am
907 Views
Post# 15582964

Big Pharma should just make the...

Big Pharma should just make the...investment in newer drugs like Voclosporin that may provide a much better safety & efficacy profile than spending more money on maintaining websites and marketing information on decades old drugs cited numerous times by FDA, carry severe warning labels and FDA issued watch on anti-TNF class drugs in general (Remicade, Humira etc) for long-term use and potential cancer/tumor issues. I know Remicade (J&J) is a biologic, is expensive, has to be injected, can provide some good benefits and is a cash cow for J&J. However, I saw one study that mentioned that a there are a handful of FDA approved drugs that are responsible for an abnormal amount of deaths/severe symptoms and it mentioned that Remicade was the 3rd highest. Is it not time for big pharma to step up and provide drugs that improve safety & efficacy profiles...?     

MEDVERSATION(TM) Website Launched by Centocor to Facilitate Physician-Patient Dialogue About Drug Benefits and Risks
12 Nov 2008 - ACQUIREMEDIA
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HORSHAM, Pa., Nov. 12 /PRNewswire/ -- Centocor, Inc. announced today the launch of MEDVERSATION(TM) (www.medversation.com), an extensive web-based resource designed to facilitate more-informed conversations between U.S. physicians and their patients about the efficacy and safety of REMICADE(R) (infliximab).

This interactive web application, in development for the past three years and the first in its therapeutic class, provides physicians general information about the progression of certain inflammatory diseases. In addition, physicians can access detailed summaries of REMICADE clinical data and interactive tools to manage and customize information for discussions with patients.

"We recognize that health care conversations have become increasingly complex over the past few years, with physicians being faced with an escalating volume of information about drug benefits and risks from numerous sources," said Thomas Schaible, Vice President, Medical Affairs, Centocor, Inc. "We hope MEDVERSATION will play a role in helping physicians access information on disease states and clinical data about REMICADE, to enable them to more readily participate in dialogue with an increasingly more informed and empowered patient population. We want all patients to receive treatment that it is right for them, regardless of whether or not the treatment may be ours."

Centocor created MEDVERSATION with the belief that informed conversations between health care professionals and patients diagnosed with serious inflammatory diseases are essential to quality care. To that end, Centocor has attempted to construct a useful resource for physicians to consider the multiple dimensions of individual medical decisions that involve our therapies now and in the future.

Content within MEDVERSATION is organized into four main sections, paralleling the core dimensions of a medical conversation:

    --  Natural History of Disease: Provides a wide array of research on and        data for rheumatoid arthritis, Crohn's disease, ulcerative colitis        and psoriasis.    --  Benefits of Treatments: Provides extensive clinical data, including data        from Phase IV trials, about the benefits of REMICADE.    --  Risks of Treatments: Provides extensive clinical data and post-marketing        experience regarding the potential risks of REMICADE.    --  Benefit:Risk Analysis: Helps physicians interpret and better understand        benefit and risk information.

In addition to these four content areas, MEDVERSATION offers:

    --  Content update email alerts.    --  Customizable handouts about disease progression and the benefits and        risks of treatment.    --  Consumer-friendly content.    --  A personal library where physicians can bookmark and organize articles        and topics of interest from across the website.

MEDVERSATION will be frequently updated to provide new data and information as it becomes available. Currently, MEDVERSATION includes information regarding REMICADE and its approved uses in the treatment of Crohn's disease, rheumatoid arthritis, ulcerative colitis and psoriasis; information for additional approved uses in the treatment of ankylosing spondylitis, psoriatic arthritis and pediatric Crohn's disease will be added over time. In addition, pending the approval of investigational therapies from Centocor, new content will be added to MEDVERSATION.

For more information about MEDVERSATION, please visit www.medversation.com.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and is approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE has demonstrated broad clinical utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE have been well established in clinical trials over the past 14 years and with more than one million patients treated worldwide through commercial experience.

In the U.S., REMICADE is approved for the following indications:

    --  Reducing signs and symptoms, inhibiting the progression of structural        damage and improving physical function in patients with moderately to        severely active RA, when administered in combination with methotrexate.    --  Reducing signs and symptoms in patients with active AS.    --  Reducing signs and symptoms and inducing and maintaining clinical        remission in adult and pediatric patients with moderately to severely        active CD who have had an inadequate response to conventional therapy.    --  Reducing the number of draining enterocutaneous and rectovaginal        fistulas and maintaining fistula closure in adult patients with        fistulizing CD.    --  Reducing signs and symptoms, inducing and maintaining clinical remission        and mucosal healing, and eliminating corticosteroid use in patients with        moderately to severely active UC who have had an inadequate response to        conventional therapy.    --  Reducing signs and symptoms of active arthritis, inhibiting the        progression of structural damage and improving physical function in        patients with PsA.    --  Treatment of adult patients with chronic severe plaque PsO who are        candidates for systemic therapy and when other systemic therapies are        medically less appropriate.

REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. REMICADE is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year.

Important Safety Information

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Children and young adults who have been treated for Crohn's disease with REMICADE have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6-mercaptopurine. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet, or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE and discuss it with your doctor.

About Centocor

Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.

The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

For more information about Centocor, please visit www.centocor.com.

SOURCE Centocor, Inc.

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