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Peptech / Abbott Labs / DE27

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    Abbott's Rheumatoid Arthritis Drug Looks Good In Tests

    CHICAGO -(Dow Jones)- Early data on Abbott Laboratories' (ABT) potential
    blockbuster rheumatoid arthritis drug D2E7 appear favorable, showing it to
    be as or more effective than other drugs that treat the disease, analysts
    said Tuesday.
    The data, from abstracts of a presentation Abbott will make in June at the
    European League Against Rheumatism in Stockholm, revealed that the drug is
    safe for human use.
    "The data presented is impressive, with D2E7 showing response rates that are
    on par or better than Enbrel or Remicade," said Dan Lemaitre, analyst with
    Merrill Lynch, referring to competing drugs. "In all studies, D2E7
    demonstrated a sustained effect and patients tolerated the drug very well."
    Enbrel is made by Immunex Corp. (IMNX) and Wyeth (WYE), and Remicade is made
    by Johnson & Johnson (JNJ).
    Abbott spokeswoman Cindy Resman said, "We're excited about the data," but
    declined to comment more specifically.
    Rheumatoid arthritis is a chronic, debilitating and incurable disease that
    erodes the bones and cartilage and attacks the joints, with 2 million
    sufferers in the U.S. Treatment can alleviate the pain and inflammation as
    well as slow the disease's progression and prevent the destruction of
    cartilage and bone.
    Analysts say inflammation-fighting D2E7 can represent an advance in
    treatment of the disease compared with Remicade and Enbrel. In rheumatoid
    arthritis and other inflammatory diseases, patients have a high level of a
    protein called tumor necrosis factor alpha, or TNF-alpha. By binding this
    protein, inflammation is stopped and the progress of the disease halted.
    Abbott believes worldwide sales of the drug, approval of which is expected
    sometime next year, could eventually top $1 billion annually.
    Remicade is an antibody made from a mouse and must be given intravenously
    every few weeks. While it's effective in fighting rheumatoid arthritis,
    patients must also take the pill methotrexate with the infusion so the body
    doesn't reject the foreign antibody.
    Enbrel is more advanced. Though it isn't an antibody, Enbrel acts like one
    in keeping TNF-alpha away, and it doesn't need methotrexate to suppress the
    body's immune system. However, because Enbrel is not an antibody, it doesn't
    circulate in the body for long and must be taken more frequently. Enbrel is
    injected every few days.
    Abbott's D2E7 is the first fully human monoclonal antibody, making it
    virtually indistinguishable from an antibody a human body would naturally
    create if it were able to design one targeting TNF-alpha, Abbott says.
    Therefore, no methotrexate is required.
    Also, D2E7 circulates in the body for weeks before being cleared. Patients
    don't need to take frequent doses, and can inject themselves every two
    No Worriesome Side Effects Noted
    When rheumatoid arthritis patients in one study took D2E7 alone, at six
    months at the highest and most frequent dose, 18% achieved a 70% improvement
    in their American College of Rheumatology (ACR) criteria for measuring
    response. The ACR criteria include reduction in swollen or tender joints
    along with five other variables.
    Thirty-five percent of the patients in the study achieved a 50% improvement
    in their ACR score, and 53% of patients achieved a 20% improvement, analysts
    said. The results were similar to those of Enbrel and Remicade.
    D2E7 demonstrated a sustained effect and patients tolerated the drug well.
    Results of Abbott's 636-patient safety trial show no statistically
    significant differences between D2E7 and a placebo in terms of severe side
    effects or serious infections.
    "These adverse events are of particular concern because they were reported
    in Enbrel and Remicade patients," wrote Ted Huber, of Banc of America
    Securities, in a research note. "The abstract stated specifically that D2E7
    patients did not experience tuberculosis or opportunistic infections, which
    is a real positive."
    In addition, efficacy appears to be sustained over the long term, which is
    key because rheumatoid arthritis is a chronic condition. Data showed that
    the six months' efficacy of the drug is sustained at one year. After one
    year, 26% of patients achieved 70% improvement in their ACR. Just over 50%
    of patients achieved a 50% improvement, and 71.2% of patients achieved a 20%
    improvement. These results again are similar to Enbrel and Remicade, but
    D2E7 could prove competitive due to its more convenient dosing schedule,
    Huber said.
    There did appear to be a more pronounced response rate when D2E7 is dosed
    weekly as a monotherapy, rather than every two weeks, Lemaitre noted.
    Huber said D2E7 should "sail through the FDA," referring to the U.S. Food
    and Drug Administration, which must approve the drug. The data support
    Abbott's assertion that it has a strong filing with the FDA and that D2E7
    will be approved worldwide by mid-2003, generating revenue of $150 million
    next year, he added.
    Indeed, the timing and strength of the D2E7 filings, he said, hint at even
    earlier approvals and possible upside to the revenue forecast.
    Abbott, of Abbott Park, Ill., is assuming a 10-12 month FDA review, which
    could set the launch for early 2003, Lemaitre said. But he questioned
    whether that was realistic.
    "Review times for biologics are in the 15-16 month vicinity and D2E7 does
    not appear to have expedited review status," Lemaitre wrote in a research
    note. " Moreover, with two compounds already on the market, there may not be
    an urgency to rush the drug through the agency."
    If approval comes in late 2003 rather than earlier in the year, it could
    provide Enbrel's makers the time to ramp capacity and possibly augment the
    label to once-a-week dosing vs. twice-a-week today, Lemaitre said.
    Further down the road, Abbott may face competition from the CDP870 drug made
    by Pharmacia Corp. (PHA) and Celltech Group PLC (CLL), which could be out in
    2005 with once-a-month dosing, Lemaitre wrote.
    Abbott's share price rose a bit early Tuesday, changing hands at $53.78, up
    64 cents, or just over 1%.
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