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LONDON, UK / ACCESSWIRE / September 11 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Eli Lilly and Co. (NYSE: LLY), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=LLY. The Company announced on September 8, 2017 positive safety results for Galcanezumab in its 12-month Phase-3 study. As a part of the study, treatment with self-administered Galcanezumab for up to 12 months revealed a positive safety and tolerability profile in patients suffering with migraines - a result that is consistent with previous studies. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Detailed results from the 12-month, open-label Phase-3 study were presented at the 18th Congress of the International Headache Society (IHC) in Vancouver on Friday, September 08, 2017.
What is Galcanezumab?
Galcanezumab is a monoclonal antibody which has been designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP). It is believed that CGRP plays an important role in migraine and cluster headache. Galcanezumab is basically an investigational once-monthly, self-administered injection. Currently, its effectiveness for treating migraines and cluster headaches, along with its side effects, are being evaluated.
Plan to Submit Biologics License Application to the US FDA
Christi Shaw, President of Eli Lilly Bio-Medicines, stated that the long-term results of the study are very important for the millions of Americans suffering with migraines. The results reaffirm the efficacy and safety profile of Galcanezumab and support its potential use as a self-administered, monthly injection. He also mentioned that after over two decades of research, the Company is now ready to submit Galcanezumab to the FDA as a potential treatment option for providing more migraine-free days to people with migraines.
Eli Lilly intends to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Galcanezumab in the latter half of 2017. This would also be followed by submissions to other regulatory agencies around the world.
Details About the Study Design
It is a 12-month, randomized, open-label study intended to evaluate the safety and effectiveness of two doses of Galcanezumab administered subcutaneously (i.e. 120 mg or 240 mg once-monthly, following a 240 mg starting dose) in 270 patients with episodic and chronic migraine. The study was conducted on patients who had an average of 10.6 migraine headache days per month at baseline. The primary endpoints comprised the percentage of patients who discontinued Galcanezumab treatment.
Study Results and Implications
- As mentioned above, 270 patients were randomized to treatment with Galcanezumab 120 mg or Galcanezumab 240 mg once monthly for 12 months. A certified healthcare provider oversaw the initial dose of the injection, while the subsequent doses were self-administered by the patient via prefilled syringe or auto-injector pen.
- In the 12-month study period, Galcanezumab was associated with a statistically significant reduction in the number of monthly migraine headache days with both doses. It was 5.6 days for 120 mg and 6.5 days for 240 mg, with p < 0.001 for both dosing groups
- Injection site pain, nasopharyngitis, and upper respiratory tract infection were some of the common adverse events (≥10%) reported by the both the dosing groups. To be precise, three patients in the 120 mg dosing group and seven patients in the 240 mg group reported serious adverse events.
- In fact, approximately 4.8% of the total patients in the study discontinued the treatment due to adverse events. However, there was no clinically meaningful difference in the rate of adverse events between Galcanezumab 120 mg and 240 mg dosing groups.
- The Company will submit these findings for publication in a peer-reviewed journal in the coming year.
Migraine Affects Around 36 million Americans
Migraine is a disabling neurological disease which affects over 36 million Americans. Three times more women have migraines compared to men. It is characterized by recurrent episodes of severe headache accompanied by other symptoms such as nausea, vomiting, sensitivity to light and sound, and changes in vision.
The Migraine Research Foundation estimates that healthcare and lost productivity costs associated with migraine in the US are approximately $36 billion annually. Despite that, the disease remains under-recognized and under-treated.
Last Close Stock Review
Eli Lilly's share price finished last Friday's trading session at $82.92, advancing 1.69%. A total volume of 3.95 million shares have exchanged hands, which was higher than the 3-month average volume of 3.57 million shares. The Company's stock price advanced 0.42% in the last one month, 2.32% in the past three months, and 3.79% in the previous twelve months. Additionally, the stock surged 12.74% since the start of the year. Shares of the Company have a PE ratio of 35.94 and have a dividend yield of 2.51%. The stock currently has a market cap of $90.40 billion.
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