The Mess in MS - Pharmaceutical Executive

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The Mess in MS
Multiple sclerosis remains a mysterious disease for patients, doctors, and researchers alike. The leading treatments are already a decade old, and break through drug Tysabri has upset the market in more ways than one. How will the pipeline improve the outlook over the next decade?

Pharmaceutical Executive


Meanwhile, Bayer Schering and Genzyme are co-developing Campath (alemtuzumab), a biologic similar to Tysabri. Industry buzz about the drug centers on Campath's potential for short, intermittent doses to put MS into remission for a period ranging from five to 20 years. If such claims are valid, Campath will represent a milestone in the treatment of MS. On track for a 2013 launch, the MAb, which must be infused, is likely to enter a crowded MS market of orally administered competitors.

Even with the MS market's many unmet needs, novel treatments will increasingly be required to meet higher standards of safety and prove their value before they can gain wide market acceptance (see "Key Phase III Pipeline Products").

Comparing the Meds, Valuing the Market


THE PROS AND CONS OF KEY PHASE III PIPELINE PRODUCTS
The success of next-generation MS drugs will be based chiefly on their mechanism of action—and efficacy—with oral delivery a secondary feature. Interviews by AVOS with a diverse set of MS specialists revealed that they were split in their prioritizing of ease of administration. Some physicians indicated that they and their patients are eager to obtain the first oral MS therapy and abandon injections, while other physicians expressed wariness about sacrificing stability and slowed disease progression for the sake of dosing convenience. Weaker efficacy will not be tolerated; oral treatments must prove at least as effective and safe as the beta-interferons to gain any credibility.

The oral medications are likely to be adopted initially as second or even third line treatment options. They will have to prove their utility and value in patients for whom other drugs have failed before moving to first line status. Physicians reported that they would handle patient requests to switch from injectables to orals on a case-by-case basis, but generally were not inclined to switch stable patients before long term data and usage are available—a dynamic already evidenced in the prescribing pattern of Tysabri.


US DRUG MARKET MS DRUG REVENUE BY CLASS (IN THOUSANDS)
Which compounds in the MS pipeline will deliver on their promise over the next seven years? What specific criteria will determine their success? To answer these questions, AVOS examined efficacy, safety, and administration data from the most recent clinical trials for five late-stage candidates with unique mechanisms of action, comparing the attributes to those of Avonex, the market leader and benchmark. The analysis determined that Bayer's Campath, Sanofi-Aventis' teriflunomide, and Novartis' FTY720 appear to be superior to Avonex, while Merck Serono/Teva's cladribine and Teva's laquinimod fell below the benchmark. Both Campath and FTY720 displayed better efficacy, but were marred by severe safety concerns, which are likely to require additional trials and delay their launch. The three other drugs, all orals, demonstrate weaker efficacy than that of Campath or FTY720, but fared better on administration and safety.

These new therapies will increase overall MS market growth through 2014. AVOS estimates that total revenues in the US will jump from $3.9 billion in 2008 to $5.9 billion in 2014. The worldwide market, largely identical in product offerings, will experience 67 percent revenue growth over the same period—split evenly between the US and other high-prevalence areas such as Europe and Canada. The global MS market value in 2014 is estimated to be about $10 billion (see "US Market's MS Drug Revenue by Class").

Interestingly, no precedent exists by which to predict how a market characterized solely by injectable biologics will react when oral pills are first introduced. The convenience of a pill is not sufficient incentive for oral therapies to change the therapeutic market overnight, the way the arrival of generics treatments do. Pricing power will also resist any massive reductions associated with the introduction of oral drugs. As long as doctors view oral formulation attributes as secondary when making a prescribing decision, an oral's ability to be priced at a premium and garner higher reimbursement rates will be dependent upon a superior clinical profile. Tysabri's significant price premium ($27,000 a year) reflects the drug's better efficacy. Convenience alone will not be the key determining factor in awarding price premiums or discounts.

Yet it's important to remember that the success rate of bringing new MS treatments to market is poor. Only 5 percent of all MS compounds that entered clinical trials in 1995 or later won FDA approval—that's significantly less than the industry average of 12 percent. And the agency's increasingly conservative safety approach may not bode well for drugs like FTY720 and Campath that have already displayed questionable safety records marred by patient deaths in trials.

Multiple sclerosis remains a poorly understood disease. While its mechanisms are increasingly identified, yielding more advanced disease-modifying agents, the causal question (Why does the body's immune system start attacking the brain's myelin sheath in the first place?) continues to baffle researchers. On the bright side, the field is well funded, and the sheer volume of MS products in the pipeline (14 in Phase III and 18 in Phase II) is a strong signal that at least one new product will enter the market by 2014. Further delays, setbacks, and disappointments are inevitable, though, and the next significant treatment breakthrough in MS is still waiting to be found.

Jim Wahl is an associate at AVOS Life Sciences, a management consultancy and research products firm in Research Triangle Park, NC. He can be reached at
. Requests for copies of AVOS's MS Therapeutic Market Outlook report can be e-mailed to


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