Millennium Resumes Clinical Program For MLN0002/Ulcerative Colitis

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Millennium Resumes Clinical Program For MLN0002

Article Date: 18 May 2007

Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the

initiation of patient dosing in a clinical program designed to

evaluate the safety, tolerability, pharmacokinetics and

pharmacodynamics of MLN0002 derived from a newly engineered,

commercially scaleable cell line. MLN0002 is a novel monoclonal

antibody that binds to the T-cell integrin alpha 4 beta 7 with

potential in a variety of gastrointestinal diseases, including

ulcerative colitis.

" MLN0002 is differentiated by its unique mechanism of action that

selectively inhibits trafficking of inflammatory cells to the

gastrointestinal tract. This innovative approach has the potential to

increase the level of efficacy and reduce the risk of unwanted side

effects seen with currently available therapies, " said

Simonian, M.D., Chief Medical Officer, Millennium. " The return of

MLN0002 to clinical trials is exciting for Millennium and ulcerative

colitis patients. MLN0002 is one of only a few novel product

candidates being investigated as alternatives to anti-TNF and other

immunosuppressive therapies for ulcerative colitis and potentially

other inflammatory bowel diseases. "

" There is clearly a need for new therapeutic options as a substantial

percentage of ulcerative colitis patients either do not respond to

current therapies or have concerns regarding the safety of these

therapies, " said Feagan, M.D., Professor of Medicine at the

University of Western Ontario, London, Canada and a leading expert in

inflammatory bowel disease. " Based on the positive experience of

patients in the previous Phase II trial, we are enthusiastic about

moving this novel product candidate forward in the hopes of

delivering a new and effective option to patients for whom ulcerative

colitis remains inadequately managed. "

The new clinical program for MLN0002 consists of two studies: a Phase

II dose-ranging trial in ulcerative colitis patients and Phase I

study in normal healthy volunteers. These studies were initiated

following favorable results from a previous randomized Phase II trial

involving 181 ulcerative colitis patients. In that trial, MLN0002,

derived from an earlier cell line, was well tolerated and achieved a

statistically significant improvement in clinical remission, the

trial's primary endpoint, compared to placebo. Serious adverse events

were mainly related to exacerbations of underlying ulcerative

colitis, which occurred in 15 percent of patients in the treatment

groups, compared to 10 percent in the placebo group. The results of

this trial were published in the June 16, 2005 issue of the New

England Journal of Medicine.

About MLN0002

MLN0002 is a novel monoclonal antibody that selectively binds to

alpha 4 beta 7, a T-cell integrin. Its mechanism of action inhibits

the migration of T-cells specifically to the gastrointestinal tract,

as demonstrated in non- clinical studies. Increased gut T-cell

trafficking is believed to play a role in the pathogenesis of

inflammatory bowel diseases (IBD), including conditions such as

ulcerative colitis and Crohn's disease.

MLN0002 is part of a robust pipeline and a component of Millennium's

2007 goals of accelerating several key assets.

About ulcerative colitis

Ulcerative colitis is an IBD, the general name for a group of chronic

disorders that cause inflammation in the gastrointestinal tract. The

disease can be difficult to diagnose because its symptoms are similar

to other intestinal disorders and to another type of IBD called

Crohn's disease.

Ulcerative colitis causes inflammation and sores, called ulcers, in

the lining of the rectum and colon or large intestine. Inflammation

in the colon also causes the colon to empty frequently, causing

diarrhea. Other typical symptoms include lower abdominal pain, rectal

irritability and fecal incontinence.

Annually, ulcerative colitis develops in approximately 24,300

patients in the U.S. The prevalence in the U.S. is 671,000.

Ulcerative colitis can occur in people of any age, but it usually

starts between the ages of 15 and 30, and less frequently between 50

and 70 years of age. It affects men and women equally and appears to

run in families, with reports of up to 20 percent of people with

ulcerative colitis having a family member or relative with ulcerative

colitis or Crohn's disease. A higher incidence of ulcerative colitis

is seen in Caucasians and people of Jewish descent.

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company

based in Cambridge, Mass., markets VELCADE, a novel cancer product,

and has a robust clinical development pipeline of product candidates.

Millennium's research, development and commercialization activities

are focused in two therapeutic areas: oncology and inflammation. By

applying its knowledge of the human genome, understanding of disease

mechanisms and industrialized drug discovery platform, Millennium is

developing an exciting pipeline of innovative product candidates.

Millennium's website is http://www.millennium.com.

This press release contains " forward-looking statements, " including

statements about the Company's growth and development of products.

Various important risks may cause the Company's actual results to

differ materially from the results indicated by these forward-looking

statements, including: adverse results in its drug discovery and

clinical development programs; failure to obtain patent protection

for its discoveries; commercial limitations imposed by patents owned

or controlled by third parties; the Company's dependence upon

strategic alliance partners to develop and commercialize products and

services based on its work; difficulties or delays in obtaining

regulatory approvals to market products and services resulting from

its development efforts; product withdrawals; competitive factors;

difficulties or delays in manufacturing the Company's products;

government and third-party reimbursement rates; the commercial

success of VELCADE and INTEGRILIN® (eptifibatide) Injection;

achieving revenue consistent with internal forecasts; and the

requirement for substantial funding to conduct research and

development and to expand commercialization activities. For a further

list and description of the risks and uncertainties the Company

faces, see the reports it has filed with the Securities and Exchange

Commission. The Company disclaims any intention or obligation to

update or revise any forward- looking statements, whether as a result

of new information, future events or otherwise.

Millennium Pharmaceuticals, Inc.

http://www.millennium.com