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

 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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