Novel Ulcerative Colitis Treatment

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Date Joined Apr 2007
Total Posts : 459
   Posted 12/14/2007 4:57 PM (GMT -6)   


Serono and Swedish Biotech Company InDex Pharmaceuticals Sign Worldwide Agreement to

Develop and Commercialize Novel Ulcerative Colitis Treatment

 Agreement for novel gastroenterology therapy currently in Phase II

 ENEVA and STOCKHOLM, Sweden, Feb. 23 /PRNewswire-FirstCall/ -- Serono
(virt-x: SEO; NYSE: SRA) and InDex Pharmaceuticals AB ("InDex") announced
today that they have signed an agreement under which Serono receives exclusive
worldwide rights to develop and commercialize InDex' product Kappaproct(R) for
the treatment of ulcerative colitis and potentially other inflammatory
diseases. Kappaproct(R) is an antisense inhibitor of the p65 protein, a key
activator of the pro-inflammatory NF-kappa B pathway.
    Under the terms of the agreement, InDex will receive an initial fee upon
the effective date of the agreement and potential milestone payments related
to development progress, regulatory submissions and approvals, as well as
research and development funding. If Kappaproct(R) is successfully developed
and registered worldwide in at least one indication, the aggregate amount of
these payments could reach USD35 million. InDex will also receive undisclosed
royalties on sales of Kappaproct(R).
    "Ulcerative colitis is a severe debilitating disease and represents a high
unmet medical need," said Franck Latrille, Serono's Senior Executive Vice
President Global Product Development. "Kappaproct(R) has the potential to be a
significant breakthrough by inducing clinical remission in patients with
active ulcerative colitis without compromising safety."
    "As one of the world's leading biotechnology companies, Serono has an
impressive track record in the development and marketing of innovative
therapeutics," said Svante Rasmuson, CEO of InDex Pharmaceuticals. "We are
confident that in Serono we have found a strong and committed partner for
completing development of this novel approach to the treatment of ulcerative
    Kappaproct(R) is currently being tested in a Phase II clinical trial for
active ulcerative colitis which will involve 150 patients. In a completed
proof-of-concept, double-blind placebo-controlled clinical trial in patients
with therapy-resistant inflammatory bowel disease, it was shown that the
majority of these patients responded positively to a single dose of
Kappaproct(R). Patients receiving Kappaproct(R) experienced only mild adverse
    Kappaproct(R) is being developed for the treatment of ulcerative colitis,
a chronic inflammatory condition involving the large bowel. This disease
mainly affects young people, with disease onset typically occurring between
the ages of 20 and 30 years. The most common symptoms of ulcerative colitis
are abdominal discomfort and frequent loose stools. Patients may also
experience fatigue, weight loss, loss of appetite, rectal bleeding, loss of
body fluids and nutrients. Severely affected patients experience fever, bloody
diarrhea, nausea, and abdominal cramps. Ulcerative colitis may also cause non-
intestinal problems such as arthritis, inflammation of the eye, liver disease
and anemia. Disease management is a long-term commitment for both patient and
physician, since there is currently no cure for this condition. In a majority
of cases, the disease may be controlled with conventional drugs, including
5-aminosalicylic acid (5-ASA) and glucocorticosteroids. However, between 25
and 40 percent of ulcerative colitis patients are unresponsive to such
treatment, and ultimately require surgical resection of the colon. Patients
with long-standing ulcerative colitis disease are at considerable risk of
developing colorectal cancer.

    Some of the statements in this press release are forward looking. Such
statements are inherently subject to known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements
of Serono S.A. and affiliates to be materially different from those expected
or anticipated in the forward-looking statements. Forward-looking statements
are based on Serono's current expectations and assumptions, which may be
affected by a number of factors, including those discussed in this press
release and more fully described in Serono's Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission on April 17, 2003.  These
factors include any failure or delay in Serono's ability to develop new
products, any failure to receive anticipated regulatory approvals, any
problems in commercializing current products as a result of competition or
other factors, our ability to obtain reimbursement coverage for our products,
and government regulations limiting our ability to sell our products. Serono
has no responsibility to update the forward-looking statements contained in
this press release to reflect events or circumstances occurring after the date
of this press release.

    about Serono
    Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive(TM) (Luveris(R) is not approved in the
USA). In addition to being the world leader in reproductive health, Serono has
strong market positions in neurology, metabolism and growth. The Company's
research programs are focused on growing these businesses and on establishing
new therapeutic areas. Currently, there are approximately 30 ongoing
development projects.
    In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a
net income of US$390.0 million, making it the third largest biotech company in
the world. Its products are sold in over 90 countries. Bearer shares of Serono
S.A., the holding company, are traded on the virt-x (SEO) and its American
Depositary Shares are traded on the New York Stock Exchange (SRA).

    about InDex Pharmaceuticals
    InDex Pharmaceuticals develops antisense therapeutics and
diagnostic/prognostic tools for unmet medical needs within inflammation and
cancer. The company, located at Karolinska Institutet in Stockholm, was
incorporated in December 2000 and has currently a staff of 26 people. Main
shareholders are SEB Foretagsinvest and Life Equity Sweden.
    The company's corporate mission is to break new ground in innovative
therapies and thus become a preferred R&D partner to large industry players in
the biopharmaceutical area. The first product Kappaproct(R), developed for the
treatment of inflammatory bowel disease, has entered into phase II clinical
trials for active ulcerative colitis.
    Research activities are focused on development of antisense drugs.
Antisense represents an expansion of conventional pharmacology in combination
with new findings within molecular biology. Consequently, a new class of drugs
has been created with a different approach, but the antisense technology
itself also implies a more rational design of new drugs.


Veteran Member

Date Joined Dec 2005
Total Posts : 3238
   Posted 12/14/2007 5:00 PM (GMT -6)   
Next time can you post the link? It is actually against forum rules to post long articles. Thanks!
Tabitha (Tab)

100mg Azathioprine, 2 Fibercon, Colazal-9 a day, Acidopholis Pearls, Nexium
Co-Moderator UC Forum

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