Note the comments on "rather stunning clinical results" Looks like
several more drugs are in the pipeline.
UPDATE 1-Reuters Summit-Roche says arthritis new business pillar
Wednesday 9 November 2005, 1:12pm EST
By Ben Hirschler
NEW YORK, Nov 9 (Reuters) - Roche Holding AG (ROG.VX: Quote, Profile,
Research) expects rheumatoid arthritis to become a key plank of its
drugs business in the future, driven by sales of two products now
nearing the market, its head of pharmaceuticals said on Wednesday.
"This will be an emerging area of strength for Roche," William Burns
told the Reuters Health Summit in New York via a telephone interview.
"Is it likely to be as big as oncology? Maybe that is a tall order.
But if you take where we are in hepatitis and transplant, it is going
to be probably larger than that."
Strong clinical trial data on MRA and MabThera, which is already an
established anti-cancer treatment, will be presented at a medical
conference in San Diego next week, he added.
Both MRA and MabThera are antibody-based products that must be given
by injection. But the Swiss-based company is also preparing to start
mid-stage Phase II clinical tests on a compound that would be the
world's first oral anti-TNF arthritis drug, Burns said.
Anti-TNF agents work by blocking the inflammation-causing protein
tumor necrosis factor.
There are three existing injectable products in the class -- Amgen
Inc.'s (AMGN.O: Quote, Profile, Research) Enbrel, Johnson & Johnson's
(JNJ.N: Quote, Profile, Research) Remicade and Abbott Laboratories
Inc.'s (ABT.N: Quote, Profile, Research) Humira -- all of which are
big sellers.
An oral version of the drug that could be given as a pill would be a
boon for patients. "We believe we are on journey toward making a
significant contribution with an oral anti-TNF drug," Burns said.
UNMET NEED
Anti-TNF drugs have transformed the treatment of rheumatoid arthritis
but they do not work for all patients, leaving a considerable unmet
medical need that MRA and MabThera -- which is also known as Rituxan
-- could address.
Roche and its partners will present "rather stunning" clinical data on
the efficacy of the medicines at the American College of Rheumatology
annual meeting next week, Burns said.
MRA was originally discovered by Roche's Japanese associate, Chugai
Pharmaceutical Co. Ltd. (4519.T: Quote, Profile, Research), while
Genentech Inc. (DNA.N: Quote, Profile, Research) and Biogen Idec Inc.
(BIIB.O: Quote, Profile, Research) are partners on MabThera.
Some industry analysts have predicted that both MRA and MabThera could
generate annual sales in excess of $1 billion as treatments for
rheumatoid arthritis. Burns declined to give sales projections.
Roche enjoys a premium rating within the pharmaceutical sector, driven
primarily by its large pipeline of promising new medicines,
particularly for cancer, where it is global market leader.
The company also has an unusual business model, which combines
medicines with diagnostics -- something Burns said would help Roche
leverage its position in the arthritis market in the medium term.
Because of the growing range of treatment options for rheumatoid
arthritis, Burns said it would be "extraordinarily useful" to have a
test that predicted how different patients might respond to different
drugs.
Roche plans to develop such a diagnostic kit, he said, although it is
likely to be several years before the product reaches market.
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nikki - 14 Nov 2005 14:03 GMT
> Both MRA and MabThera are antibody-based products that must be given
> by injection. But the Swiss-based company is also preparing to start
[quoted text clipped - 3 lines]
> Anti-TNF agents work by blocking the inflammation-causing protein
> tumor necrosis factor.
I thougth dna-jp1 already past all clinical tests and is waiting to get
formal
approval??
Dna-jp1 is an oral anti-TNF drug hence it would be the first oral
anti-TNF drug?
So Burns isn't right about that?
Nikki
nikki - 14 Nov 2005 14:16 GMT
oh, I'm sorry,
forget about the part "is waitin for formal approval".
As I understand Androclus and University are waiting to start Phase III
trials now.
Maybe some of you didn't exactly know what procedures are in Clinical
trials, here's what I found:
Phase I clinical trial - "The initial set of drug studies in humans,
which are generally designed to evaluate the safety of a new drug in a
small number of patients or normal volunteers."
Phase II clinical trial - Small-scale drug studies in patients that are
designed to characterize a drug's effects on a particular disease.
These studies usually evaluate more than one drug dose and generally
compare the new drug to therapy that is already known to be effective.
Phase III clinical trial - These studies are the definitive trails
conducted to demonstrate the safety and effectiveness of a new drug for
the diagnosis or treatment of a disease.
Phase IV clinical trial - Continuing studies that occur after the
product has been approved for market.
Nikki
>> Both MRA and MabThera are antibody-based products that must be given
>> by injection. But the Swiss-based company is also preparing to start
[quoted text clipped - 11 lines]
>
> Nikki