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Brief Marketplace Overview

2Q, 2005

Maxalt trails market leader Imitrex in new prescription share, with Zomig closely following.  Relpax, previously ascending as a competitive threat, has recently displayed growth stabilization.  Axert and Frova have garnered significantly less overall marketplace interest.

Metamorphosis of Industry sales force strategies continues, as exemplified by Bristol-Myers Squibb’s shift to specialist targeting and Pfizer and Merck reevaluation relating to recent COX-2 developments.  AstraZeneca, Sanofi-Aventis and Novartis remain focused upon primary care targeting.  Pfizer’s ex-US sales force is more than double the size of their 12,000 representative US force, while AstraZeneca retains 50% more representatives ex-US as compared to US markets.  Merck focuses upon a strong US presence, with approximately equivalent sales force size to that of JNJ.   AstraZeneca’s US force is comparatively smaller, and Merck’s ex-US force remains comparatively under-staffed. 

Detailing return on investment has declined in recent years for most of the major competitors.   During the past decade, the mean number of details per day for each sales representative Industry-wide has diminished by 43%, in contrast to progressively ascending total Industry force size and overall number of details.  Manufacturer cost for each primary care sales representative exceeds $150,000, with salary signifying the greatest component, closely followed by administration, promotional costs, and, to a lesser extent, advertising and distribution.  Specialty sales force costs, exceeding $300,000 per representative, are driven by the necessity for intensive initial and ongoing training .  Resulting enhanced knowledge and sales capability equates with greater contact efficacy and higher yields when objectively analyzed.

Merck’s recent pipeline failures and COX-2 difficulties have motivated aggressive job cuts affecting 5100 employees throughout the company in an effort to reduce costs.  Maxalt, although stable in new prescription share, remains a distant second to Imitrex.  Strategic sales methodologies include superior efficacy at lower dosage and fewer cumulative number of tablets utilized per episode.  Migraine sales force strategies, structure, and positioning are currently undergoing reevaluation and reorganization.

Axert sales performance has been inconsistent with corporate expectations.  Aggressive investment and prioritized promotion of Topamax in Migraine prevention is planned by Ortho-McNeil for 2005.  Industry sources project an enthusiastic marketplace response. 

In recent years, AstraZeneca has shifted their sales force strategy toward leadership enhancement, incentive realignment, and expansion of sales representative interaction time for district managers.  Coordination of overlapping clinician target strategy objectives between various brand reps has yielded enhanced sales revenue.

AstraZeneca outlicensed U.S. Zomig promotional rights to Medpointe as of late 3Q, 2003, with complete franchise promotional exclusivity commencing January 1, 2004, following the 4Q, 2004 co-promotional period.  Despite efforts by the 650 member Medpointe sales force, minimal alteration in market share resulted.  AstraZeneca terminated the outlicensing agreement as of April 1, 2005 and will resume exclusive marketing in the US.  Sales rep sources are currently focusing upon a smooth transition, utilizing a public relations approach in assuring customers that the change in franchise management was unrelated to corporate discord or product deficiency.

Pfizer sales rep sources at the recent American Academy of Pain Medicine meeting stated that Celebrex promotion was on hold pending FDA determination following the recent Advisory Committee recommendations.  In announcements scheduled for April 5, 2005, Pfizer, as a result of Merck’s COX-2 travails and Pfizer’s expiring patents, may reduce their sales force size. 

Relpax is marketed by the Pfizer Neurology sales force in conjunction with Aricept and Zoloft.   Positioning of Relpax in comparison to Imitrex includes mention of 3 head-to-head studies demonstrating, according to sales representative sources, superior efficacy based upon one hour post-dose severity, 2 hour post-dose severity, and patient functionality at 24 hours.  Lipophilic side chains promote fast onset of action, according to their portrayal, with high receptor specificity.  Pharmacoeconomic considerations include positioning as the least costly triptan for those without insurance coverage.  Pfizer’s DTC advertising program for Relpax is ongoing.

The Migraine pipeline includes Pfizer’s Bextra in Preregistration, and two Pozen compounds deemed non-approvable by the FDA.  MT100 will be reviewed at the upcoming May 4th  Peripheral And Central Nervous System Drugs Advisory Committee meeting, while MT300 resubmission to the FDA is planned for 2H, 2005.  Sirenade’s SRN 001 and SRN 002 are in early Phase development, the latter in the German market.  Pfizer is currently developing Neurontin, their marketed post-herpetic neuralgia and partial seizure anticonvulsant, as well as PNU 142633F, a backup compound, both in Phase II, for Migraine.  Eisai’s anticonvulsant Zonegran is currently in Phase II for Migraine.  Civamide is progressing in Phase II/III for Migraine and as well as Cluster Headache.

Axert is under evaluation in a currently enrolling Phase IV trial, designed to determine efficacy within one hour of migraine onset.  Myobloc continues in Phase II for adult migraine intervention.  The currently enrolling trial targets adults with 2 – 15 migraines per month, comparing 5,000 units vs. 2500 units vs. placebo. 

The currently ongoing Phase III Depakote ER teenage migraine trial is enrolling those age 12 – 17 with a minimum of 2 migraines per month.  Initial dosing of 500 mg qd is advanced to 1000 mg qd after 15 days and for the remainder of the trial.  After 9 follow-up visits during the 1 year trial, participant data is evaluated for endpoint efficacy, defined as a decrease in the frequency or severity of migraine episodes.

Menstrually-Associated Migraine remains an area of competitor interest, representing an opportunity for continued marketplace expansion.

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