Peptech / Abbott Labs / DE27

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
weeks.
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%.