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Pill
or Inhaler soon to be out!
Early Trial Results of Teva's Oral
MS Drug Disappointing
NEW YORK (Reuters Health) Sept 17 - Israeli drugmaker Teva Pharmaceutical
Industries Ltd. on Monday announced that interim clinical trial results on an
oral formulation of the company's approved injectable multiple sclerosis (MS)
drug Copaxone (glatiramer acetate) has failed to achieve statistical endpoints.
In early morning trading on the NASDAQ, shares of Teva dropped
5.98 to 61.07, a decline of almost 9%.
According to Teva, an independent Data Safety Monitoring
Committee (DSMC) has recommended that the trial still continue to completion,
expected by October, due to the favorable safety profile of the drug. Henry
McFarland, chairman of the DSMC, noted, however, that there was little chance
that the final results of the study would differ from the interim results.
Although disappointed, Teva executives said during a Monday
morning conference call that they intend to continue pursuing an oral MS
treatment.
They added that since the early results of the oral Copaxone
trial showed a trend for a treatment effect in favor of the higher dose, future
studies of the oral formulation are expected to use much higher doses.
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Pill
or Inhaler soon to be out!
By
Beth M. Mantz
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Swallowing a pill or breathing through an inhaler is
much easier and less painful than getting an injection.
With that in mind, a number of drug companies - Teva Pharmaceutical
ndustries Ltd. (TEVA), Schering AG (SHR), Biogen Inc. (BGEN) and Genzyme
Corp-General Division (GENZ) - are racing to develop multiple-sclerosis treatments in these
forms in the hope that the added convenience will win a big share of the potential $2.1 billion world-wide market.
Currently, the only treatments available are injections like the weekly
shot of Biogen's Avonex Valerie Millerick receives for her MS. Millerick, a
56-year-old nurse from Valley Cottage, N.Y., who founded and runs a
$2-million-a-year dialysis services business, is eager for a pill or inhaler.
"Oral medication wins out over injection every time," says Millerick.
"Once there is an oral drug, the rest of the industry should just pack up
their bags and go home."
In MS, the body's immune system turns on itself. The disease attacks the
nerves and brain and slowly strips away the protective sheath coating the
nerves called myelin. Symptoms range from numbness and tingling to paralysis and
blindness. Of the 350,000 Americans that live with this potentially
crippling and nonfatal disease, 70% share Millerick's diagnosis:
relapsing-remitting MS where the disease worsens in acute episodes and then
recovers.
While sufferers don't number in the millions, treating MS can be a
lucrative venture. To date, Avonex leads the market reaping first-quarter
world-wide sales of $220 million with more than half coming from the U.S.
Another treatment, Betaseron, generated sales of $145 million for Schering and
sales of $20 million for Chiron Corp. (CHIR) during the first quarter. Barred
from sale in the U.S., Serono SA's (SRA) Rebif commanded $83 million in sales
while Teva's Copaxone logged $74 million in sales during the first
quarter.
These medicines can stave off the frequency and severity of the
neurological attacks in many relapsing-remitting MS sufferers. Some studies have
demonstrated these drugs can trim the number of exacerbations by one-third.
They may slow the disease, but they can't stop it, let alone repair the damage.
"The ideal drug for relapsing-remitting MS is one that stops all relapses,
prevents exacerbations and recovers disabilities," says Stephen Reingold,
vice president of research at National Multiple Sclerosis Society. "We have
nothing close to that." Injections Underused Neither are these
injections ideal treatments. Various drawbacks limit their use to as few as
70,000 patients of the estimated 350,000 who could benefit from them. Some
sufferers claim their illness does not warrant treatment. Many refuse therapy
because they fear needles or they don't want to disrupt their lives with routine
injections. Some patients begin treatment and then stop because of adverse
side effects like rashes. Others want the medicine but their insurance
either doesn't cover the injections or charges a higher copayment.
However, an oral MS drug - even if it just matched an injectable's
efficacy and safety - could improve the standard of care in treating MS and
surmount these obstacles.
Teva, Schering, Biogen, and Genzyme are hoping their oral or inhalable MS
medications can capitalize upon the injections' shortcomings. Each
anticipates
its version will be the one to convert patients who refuse current medicines,
says Salomon Smith Barney analyst Elise Wang. A pill or inhalant could be priced
lower or might prompt managed-care companies to add these new MS medicines to
the list of drugs they cover, adds Wang. Teva has made the most progress
with a pill, a version of its current MS treatment Copaxone, or glatiramer
acetate. The compound releases cells that block proteins called cytokines in
order to suppress inflammation.
The Israeli
drug maker is halfway through tests comparing two dosage forms of the daily pill
against a dummy pill in 1,650 relapsing-remitting MS patients around the world.
Set to last 14 months, the "Copaxone Oral," or CORAL, study should
enroll its last patient by this fall. Biogen does not intend to let its
competitors eat into its Avonex market share and in fact hopes to leapfrog oral
MS treatments. "A non-injectable form would provide a great advantage to our product, even if it already the market leader,
and would help increase our market share even more," says Nancy Sinomian,
senior director of medical research. The Cambridge, Mass., biotechnology company
partnered with Inhale Therapeutic Systems Inc. (INHL), of San Carlos, Calif., to
develop an inhalable version of Avonex, whose safety and tolerability in healthy
volunteers are under examination in early-stage studies, slated to end in the
third quarter. If those results are encouraging, Biogen aims to begin dosing and
further safety tests early next year, and aggressively developing this version
for currently approved for Avonex users, the relapsing-remitting MS sufferers.
Betting On New Drugs Unlike some rivals, Schering is not betting on
an oral form of its current treatment Betaseron because it does not
believe an oral form of the beta interferon product would survive the
stomach and intestines. Instead, the German drug maker is working on three
different pills that would be at least as effective, if not more, than current
therapies. It wants these pills to cut the frequency and severity of MS attacks
by at least 30%, says Steffen Stuerzebecher, vice president of clinical
development for central nervous system therapeutics.
Its two most advanced projects are in phase II tolerance trials: Mesopram
and an unnamed compound that block proteins spurring inflammation in the central
nervous system. The third drug, a CCR1 antagonist that targets certain immune
cell responses, is undergoing early-stage safety tests and should begin phase
II studies by the middle of next year. Schering plans to wait for data from all
three programs before proceeding to massive testing in relapsing-remitting
patients.
Genzyme, a relatively new player, is intent on creating an oral MS
medicine that is significantly more effective than the treatments currently
available.
"I don't think Genzyme or (Chairman and Chief Executive) Henri (Termeer)
are looking for incremental effect," says Frederic Vinick, senior vice
president of drug discovery at the Cambridge, Mass. biotechnology company.
"We want to see a definitive clinical event - a profound effect like 60% to
70% reduction in attacks or remissions within 12 to 18 months."
With nearly six early-discovery and development projects in the
queue, Genzyme is studying how these compounds may work alone or in combination
to
affect the various molecular pathways of the disease.
Even if oral and inhalable MS drugs become blockbusters, many experts
believe, injectable MS treatments will survive. They expect the most severely
debilitated patients will receive the injections or MS sufferers, as a
whole, will use a panoply of medicines including both orals and injections
to fight the neurological disease on a variety of fronts.
-By Beth M. Mantz, Dow Jones Newswires; 201-938-5287;
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