Abbott Seeks Approval for CAT Arthritis Drug

[Guest guest]

Abbott Seeks Approval for CAT Arthritis Drug

Tue Apr 9, 5:28 AM ET

By Steenhuysen and Ben Hirschler

CHICAGO/LONDON (Reuters) - Abbott Laboratories Inc. said on Tuesday it

had filed for regulatory approval of a new rheumatoid arthritis drug,

developed by British biotechnology group Cambridge Antibody Technology

Plc.

If approved by U.S. and European regulators, the drug -- known by the

codename D2E7 -- will be the first fully human monoclonal antibody to

reach the market.

The injectable medicine is designed to intercept the process that causes

joint inflammation by targeting and blocking the activity of proteins

that regulate the body's inflammatory response.

In its fourth-quarter conference call, Abbott described it as a potential

blockbuster and industry analysts estimate it could generate peak sales

of between $500 million and $1 billion a year.

CAT will receive a royalty payment of around 3.5 percent on Abbott's

sales -- a relatively low rate reflecting the fact that CAT signed the

licensing deal when it was a private company with little negotiating

clout. D2E7 is CAT's most advanced product.

The timing of the regulatory filing was in line with expectations and CAT

shares were little changed following the announcement, adding eight pence

to 14.05 pounds by 0900 GMT.

The Cambridge-based company will not receive any milestone payment

following the filing but will get a fee if the drug is finally approved.

The strength of Abbott's regulatory submission is expected to become

clearer when Phase III clinical data on D2E7 is presented at a European

League Against Rheumatism meeting in Stockholm in June.

NEW DRUG CLASS

Most rheumatoid arthritis (RA) patients currently treat the disease with

a variety of anti-inflammatory drugs, but D2E7 is part of a new class of

drugs that uses monoclonal antibodies to inhibit inflammation-causing

proteins.

Monoclonal antibodies mimic naturally occurring antibodies. Current drugs

using monoclonal antibodies to treat RA are either man-made or made with

a portion of mouse protein.

But because D2E7 is the first monoclonal antibody made entirely from

human protein, it is essentially indistinguishable from antibodies

present in the human body. This should minimize adverse side effects.

Analysts believe the overall market for antibody drugs to treat RA could

reach $3 billion to $5 billion within the next few years. &

and Immunex Corp. already have competing drugs on the market.

Rheumatoid arthritis is a chronic disorder in which the immune system

attacks tissues, causing joint swelling and eventually eroding cartilage,

bones and ligaments. The disease afflicts about five million people

worldwide.

Abbott based its submissions in the United States and Europe on 23

clinical trials involving more than 2,300 RA patients in North America,

Europe and Australia. Patients received a dose of the drug every other

week.

http://story.news./news?

tmpl=story & u=/nm/20020409/sc_nm/health_abbott_dc_2 & cid=585

[Guest guest]

This is a drug very similar to Enbrel except that it is an injection once

every two weeks and it is made of human monoclonal antibodies

instead of mouse antibodies. At the most effective dose (40 mg), given

in combination with mtx, 66 percent of the patients who had D2E7 injected

weekly experienced a 20 percent improvement in their condition, while

54 percent reported a 50 percent improvement. Almost 27 percent

experienced 70 percent improvement.

Hopefully it will be approved soon and will help solve the problem with the

enbrel shortage.

a

[ ] Abbott Seeks Approval for CAT Arthritis Drug

> Abbott Seeks Approval for CAT Arthritis Drug

> Tue Apr 9, 5:28 AM ET

>

> By Steenhuysen and Ben Hirschler

>

> CHICAGO/LONDON (Reuters) - Abbott Laboratories Inc. said on Tuesday it

> had filed for regulatory approval of a new rheumatoid arthritis drug,

> developed by British biotechnology group Cambridge Antibody Technology

> Plc.

>

>

> If approved by U.S. and European regulators, the drug -- known by the

> codename D2E7 -- will be the first fully human monoclonal antibody to

> reach the market.

>

> The injectable medicine is designed to intercept the process that causes

> joint inflammation by targeting and blocking the activity of proteins

> that regulate the body's inflammatory response.

>

> In its fourth-quarter conference call, Abbott described it as a potential

> blockbuster and industry analysts estimate it could generate peak sales

> of between $500 million and $1 billion a year.

>

> CAT will receive a royalty payment of around 3.5 percent on Abbott's

> sales -- a relatively low rate reflecting the fact that CAT signed the

> licensing deal when it was a private company with little negotiating

> clout. D2E7 is CAT's most advanced product.

>

> The timing of the regulatory filing was in line with expectations and CAT

> shares were little changed following the announcement, adding eight pence

> to 14.05 pounds by 0900 GMT.

>

> The Cambridge-based company will not receive any milestone payment

> following the filing but will get a fee if the drug is finally approved.

> The strength of Abbott's regulatory submission is expected to become

> clearer when Phase III clinical data on D2E7 is presented at a European

> League Against Rheumatism meeting in Stockholm in June.

>

> NEW DRUG CLASS

>

> Most rheumatoid arthritis (RA) patients currently treat the disease with

> a variety of anti-inflammatory drugs, but D2E7 is part of a new class of

> drugs that uses monoclonal antibodies to inhibit inflammation-causing

> proteins.

>

> Monoclonal antibodies mimic naturally occurring antibodies. Current drugs

> using monoclonal antibodies to treat RA are either man-made or made with

> a portion of mouse protein.

>

> But because D2E7 is the first monoclonal antibody made entirely from

> human protein, it is essentially indistinguishable from antibodies

> present in the human body. This should minimize adverse side effects.

>

> Analysts believe the overall market for antibody drugs to treat RA could

> reach $3 billion to $5 billion within the next few years. &

> and Immunex Corp. already have competing drugs on the market.

>

> Rheumatoid arthritis is a chronic disorder in which the immune system

> attacks tissues, causing joint swelling and eventually eroding cartilage,

> bones and ligaments. The disease afflicts about five million people

> worldwide.

>

> Abbott based its submissions in the United States and Europe on 23

> clinical trials involving more than 2,300 RA patients in North America,

> Europe and Australia. Patients received a dose of the drug every other

> week.

>

>

> http://story.news./news?

> tmpl=story & u=/nm/20020409/sc_nm/health_abbott_dc_2 & cid=585

>

>

>

>

>