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This Could Be Eli Lilly’s Long-Term Growth Driver

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About Galcanezumab

Galcanezumab is a monoclonal antibody under investigation that was created to fight calcitonin-related polypeptides alpha and beta. Galcanezumab has been developed for the prevention of migraine headaches.

In September 2017, Eli Lilly announced that a 12-month open-label study demonstrated the positive safety and tolerability profile of Galcanezumab in individuals with migraines.

In the 12-month study, patients on Galcanezumab demonstrated a statistically significant decrease in the number of a monthly migraine headache days. Patients on Galcanezumab 120 mg showed reductions in migraine headaches over 5.6 days, while patients on galcanezumab 240 mg showed a reduction over 6.5 days.

Eli Lilly (LLY) has plans to submit a BLA (Biologics License Application) for galcanezumab to the FDA (US Food and Drug Administration) in the 2H17.

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Clinical trials

In June 2017, Eli Lilly presented the results from the three phase-3 trials with Galcanezumab. Eli Lilly presented the detailed results of the phase-3 Evolve-1, Evolve-2, and Regain trials. In both the Evolve-1 and Evolve-2 trials, patients on galcanezumab 120 mg and 240 mg doses demonstrated a significant decrease in the average number of monthly migraine headache days compared with patients on placebo therapy.

Evolve-1 trial

In the phase-3 Evolve-1 trial, 60.3% and 60.9% of patients, respectively, on Galcanezumab 120 mg and Galcanezumab 240 mg demonstrated at least 50% reductions in the number of migraine headache days, compared with 38.6% of patients on placebo.

In the Evolve-1 trial, 38.8% and 38.5% of patients, respectively, on Galcanezumab 120 mg and Galcanezumab 240 mg demonstrated at least 75% reductions in the number of migraine headache days, compared with 19.3% of patients receiving placebo treatment. In the same trial, 15.6% and 14.6% of patients on Galcanezumab 120 mg and 240 mg, respectively, showed 100% reductions in migraine headache days, compared with 6.2% of patients on placebo treatment.

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Evolve-2 trial

In the phase-3 Evolve-2 trial, 59.3% and 56.5% of patients, respectively, on Galcanezumab 120 mg and Galcanezumab 240 mg demonstrated at least 50% reductions in the number of migraine headache days, compared with 36.0% of patients on placebo.

In the same trial, 33.5% and 34.3% of patients on galcanezumab 120 mg and galcanezumab 240 mg, respectively, demonstrated at least 75% reductions in the number of migraine headache days, compared with 17.8% of patients on placebo. Also, 11.5% and 13.8% of patients on Galcanezumab 120 mg and Galcanezumab 240 mg, respectively, showed 100% reductions in migraine headache days, compared with 5.7% of patients on placebo.

The Regain trial

In the phase-3 Regain trial, 27.6% and 27.5% of patients on Galcanezumab 120 mg and Galcanezumab 240 mg, respectively, achieved 50% reductions in the number of migraine headache days, compared with 15.4% of patients on placebo therapy.

This clinical trial data is expected to favor Eli Lilly in gaining regulatory approval around the world and build a strong commercialization capability. Eli Lilly’s peers in migraine drug market include Merck (MRK), Allergan (AGN), Bristol-Myers Squibb (BMY), and Amgen.  Notably, the Vanguard Total Stock Market ETF (VTI) invests ~0.33% of its total portfolio holdings in LLY.

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