I can only say,,,, I wish....
Harv

Drug patents run  for 20 years, and Enbrel is more complex since it is
a Biologic drug.  Read on below:

Sen. Jay Rockefeller, D-W.Va., will wade into a $10 billion
free-for-all Tuesday when he takes the first tentative step toward
creating a legal framework for how the United States should regulate
generic versions of biotech medicines.

Generics have been saving U.S. consumers money since 1984, when
Congress passed the Hatch-Waxman Act, giving generic drugmakers an
easier way to get copycat drugs on the market after the patent
protections on the original had expired.

But Hatch-Waxman said nothing about biotechnology. That's not
surprising, given that there were only two biotech medicines on the
market in 1984, and their patents were still young.

Fast-forward to the present. Three biotech medicines came off patent
in 2001. Three more lose protection this year. One recent financial
report listed 17 biotech medicines, worth more than $10 billion in
sales in 2000, that will be fair game for generics by 2006.

Biotech firms in Canada, Europe and Asia, as well as a few generic
wannabes in the United States, are all hungering after this lucrative
pie.

Yet Congress has never told the U.S. Food and Drug Administration how
it should regard generic proteins, enzymes and antibodies -- which are
harder to make than chemical pills.

Tuesday, Rockefeller will toss a pebble into this unregulated pond
when he introduces legislation that, among other things, would direct
the Institute of Medicine to report back to Congress within a year
with suggestions on how to create an expedited review process for
generic biologics.

Rockefeller's tiptoe into generic biologics will probably be
overlooked by most media. The thrust of his bill is aimed at closing
perceived loopholes in Hatch-Waxman that name-brand drug makers have
exploited to keep generics off the market. That is a big issue for
consumers, and hence for lawmakers.

But Rockefeller's efforts to bring the rule of law to biogenerics
should be of prime concern out here in the biotech industry's
heartland.

Patients and health care payers should also cheer rules that would
inject competition into the pricing of biotech medicines.

"The pressure for action is building," said Stephen Bent, a
Washington, D.C. , attorney who has been tracking the biogeneric
issue. "You have all these biologics coming off patent at a time when
drug prices have really gotten everyone's attention."

But regulating biogenerics isn't likely to prove as easy as regulating
generic pills, for reasons that have to do with the different ways the
two kinds of medicine are made.

The pills in your medicine chest are made through chemical processes
that have been refined for 100 years and have become relatively
foolproof. Think of following the instructions on a box of cake mix.
Whip in the egg and the milk in the proper proportions and your cake
will probably rise.

Because of the relative simplicity of making chemical pills,
Hatch-Waxman said generic manufacturers did not have to repeat the
three phases of clinical trials required to prove the safety and
efficacy of new drugs.

Instead, they simply feed their knockoff pill to healthy adults and
take blood tests to determine how the medicine is absorbed into the
bloodstream of these human guinea pigs. If the generic is absorbed in
the same fashion as the name brand, it is deemed "bioequivalent" --
the magic word leading to FDA approval of a generic pill.

But none of these concepts apply to biotech proteins, enzymes or
antibodies.

Biotech isn't about mixing chemicals, it's about growing molecules.
Biotech medicines are made by splicing genes into fast-growing
organisms such as bacteria, which multiply to produce quantities of
the desired medicine. It's a process akin to winemaking. Subtle
factors such as the type of wood in the casks influence the flavor of
a wine.

So making biotech medicines is as much an art as it is a science.

Moreover, it is not possible to test biogenerics for bioequivalency,
because unlike chemical pills, they are not swallowed. Biotech
medicines are injected or infused directly into the bloodstream. Since
they are by definition immediately delivered to the bloodstream, other
tests must be devised to determine whether a biogeneric has the same
therapeutic effect as a name-brand biologic.

The Biotech Industry Organization argues that making biologics is
still so complex that generic firms should have to prove their safety
and effectiveness,

almost as if they were creating new medicines. Shortcuts to the
three-phase approval process, of the sort that Hatch-Waxman made
possible for pills, would be risky for the patients, a lobbyist for
the organization, Stephan Lawton, argues.

"Maybe we'll be there in five years, maybe 10," Lawton said.

But the organization's position is undercut by the fact that at least
some elements inside the FDA believe that the agency already has the
authority and know-how to create a shortcut to approval for generic
insulin.

I recently met with representatives of Cangene Corp., a Canadian firm
that is developing a generic insulin.

Cangene spokesman Mark Langstaff said that, based on FDA guidance, his
company has run a small clinical trial comparing its generic against
the Eli Lily insulin that comes off patent in 2002. Langstaff declined
to provide any details other than to say that Cangene, which already
manufactures several other biotech products, plans to seek FDA
approval in December to sell its generic insulin in the United States.

Steve Bende, lobbyist for the Generic Pharmaceutical Association, said
the FDA has also been writing guidelines for generic human growth
hormone, which would compete with a Genentech product coming off
patent next year, but that industry pressure has delayed release of
those rules.

Bende said that generic-makers believe the FDA has the authority to
create expedited review processes for biogenerics, but that they
expect any medicine approved under such a homespun policy would be
challenged in court.

"The cleanest way to do this would be to have explicit directions from
Congress," he said.

So far, the biotech industry has shown little interest in helping to
write the rules that would address the safety concerns that arise from
the differences in manufacturing pills and proteins.

Biotech industry lobbyists have expressed suspicion about
Rockefeller's mild study proposal, considering the senator too close
to the generic industry.

The bio lobby has been mounting a whisper campaign, warning that
biogeneric makers are setting up plants in Hungary, the Czech Republic
and Russia -- glossing over the fact that there are Canadian and U.S.
firms poised to compete once the patents lift and the rules are
clarified.

Eventually competition will come to biotech medicines, and when it
does, consumers will benefit just as they have from the price pressure
that generics have put on the makers of pills. The only question for
the biotech industry is whether it wants to remain part of the problem
or become part of the solution.

Visit my website:
http://www.mzuschlag.com

Hi Barbara,

I don't know, I posted before about a trial with dna-jp1. Costs are
estimated around  150 a year, and they are pills, much more convenient
than Enbrel with all the needle-hassle(although very grateful Enbrel
exists!)
If I understand correctly phase 3 (dna-jp1) will be completed end of
september 2005. That would probably mean it could be on the market
somewehere next year? I can hardly wait.

Nikki

p.s. Go to development programs (left)

nikki wrote:

mentioned in my previous posting with no succes.

now and then, here's the right url.

to go all the way to undo all previous agreements about me working from
home. I have been working from home for 12 hours a week and 8 hours in
the office. That way I can handle the fatigue and still make sure I have
a much needed income.

the manufacturer ( www.androcolus.com )

all about RA, apparently they now think it might work for MS and such as
well.

Rheumatoid Arthritis Clinical Trial Results

clinical trial results of its AT-001 (dnaJP1) compound for treatment of
rheumatoid arthritis (RA) in Proceedings of the National Academy of
Sciences*.  The product, developed at University of California, San
Diego, demonstrated biological efficacy, with no significant side
effects observed.

with disease-specific immunomodulatory activity.  It is a revolutionary
biologic that is intended to induce tolerization of the autoimmune
process in patients with RA, thus inhibiting disease-related
inflammation without affecting patient’s immunity to infection or cancer.

AT-001 orally for 6 months.  The peptide caused no side effects and
induced a change from proinflammatory to regulatory T cell function.
Peptide-induced T cell production of IL-4 and IL-10 increased
significantly as a result of the treatment, while peptide-induced T cell
proliferation and production of IL-2, interferon-gamma and TNF-alpha
decreased significantly.  Responses to unrelated antigens did not
change, confirming the antigen-specific nature of this treatment.  The
trial design was open-label and a placebo control was not included.  In
this open-label context, both physician- and patient-generated clinical
scores showed marked improvement from baseline.

trial for RA, sponsored by NIH.

in delaying or possibly abolishing the need for disease modifying
antiarthritic drugs (DMARDs), which provide significant improvements in
RA but have potentially serious side effects.  Compared to the current
generation of anti-inflammatory biologics, AT-001 is intended to have
specific and not broadly immunosuppressive action, is oral and has
to-date demonstrated a very favorable side-effect profile.

California, San Diego by Salvatore Albani, M.D., Ph.D., Professor of
Medicine and Pediatrics and coworkers.  The discovery was supported by
previous studies by Dr. Albani and Dr. Dennis Carson, UCSD Professor of
Medicine.  The University of California has licensed to Androclus
Therapeutics exclusive rights to further develop such immunomodulation
therapies for RA and other indications.  Dr. Albani is the scientific
founder of Androclus Therapeutics.

the treatment of a broad range of autoimmune diseases.  Androclus is
currently developing therapeutics for the treatment of multiple
sclerosis and inflammatory bowel disease, with Phase I/IIa clinical
trials expected to start in early 2005.

mission to discover, develop and bring to commercial fruition novel
products and technologies for treatment of diseases involving the immune
system, such as autoimmunity, cancer and infectious diseases.
Androclus’ revolutionary technology platform enables up- or
down-modulation of patients’ immune responses, without the broad
immunosuppression associated with currently marketed anti-inflammatory
drugs.  Androclus’ R&D portfolio includes oral therapeutic peptides for
the treatment of rheumatoid arthritis, multiple sclerosis and
inflammatory bowel disease.

Scavulli, A. Amox, S. Roord, I. De Kleer, D. Bonnin, P. Lanza, C. Berry,
M. Massa, R. Billetta, and S. Albani. 2004. Epitope-specific
immunotherapy induces immune deviation of pro-inflammatory T cells in
Rheumatoid Arthritis. Proceedings of the National Academy of Sciences,
March 23, 2004, Vol. 101, No. 12, pages 4228-4233.

Albani’s laboratory at UCSD and has successfully completed a Phase I/IIa
open-label clinical trial, demonstrating biological efficacy and
evidence of clinical efficacy, with no significant side effects.  Phase
I/IIa results were published in the Proceedings of the National Academy
of Sciences in March 2004.  AT-001 is currently the subject of a
multi-center Phase II clinical trial at UCSD, Stanford, Mayo Clinic,
Johns Hopkins and other centers, to be completed in Q3 2005.  Androclus
has strategically partnered AT-001 with a large biotechnology company.

develop therapeutics for the treatment of MS and IBD.  Pre-IND
discussions with the FDA have been completed regarding the MS compound.
 INDs for both MS and IBD compounds are planned within 1 year.

biotechnology company for RA and psoriatic arthritis indications.  Phase
I/IIa results published in PNAS in March 2004.  Phase II will be
completed in Q3 2005.