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 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 PROS AND CONS OF KEY PHASE III PIPELINE PRODUCTS
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.
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.
US DRUG MARKET MS DRUG REVENUE BY CLASS (IN THOUSANDS)
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
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 firstname.lastname@example.org
. Requests for copies of AVOS's MS Therapeutic Market Outlook report can be e-mailed to email@example.com