Shire’s Lanadelumab Wows in Phase III Study
Shire’s $6.5 Billion Dyax Bet Pays Off as Lanadelumab Wows in Phase III Study
May 18, 2017
By Alex Keown, BioSpace.com Breaking News Staff
LEXINGTON, Mass. – Shire (SHPGY)’s 2015 bet on Dyax (DYAX) and its experimental drug to treat the rare illness, hereditary angioedema (HAE), is paying off. This morning the company revealed stellar Phase III data for lanadelumab that could transform the way HAE patients are treated.
Shares of Shire are spiking after the company said lanadelumab, a human monoclonal antibody designed to prevent angioedema in patients with hereditary angioedema, achieved “highly statistically significant and clinically meaningful results” for all three lanadelumab treatment arms compared to placebo. At the 300 mg dosing level administered every two weeks, patients saw “a statistically significant reduction in mean HAE attack frequency of 87 percent compared to placebo.”
Additionally, Shire said whether patients were dosed biweekly or monthly, a significantly higher proportion of patients, compared to placebo, were attack free throughout the entire 26-week study period.
The drug was well tolerated and no adverse events were reported.
Flemming Ornskov, Shire’s chief executive officer, said the company was encouraged by the Phase III data. Lanadelumab has already received both Orphan Drug Designation and Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Now the company plans to submit a biologics license application for evaluation by late 2017 or early 2018.
Early clinical data of lanadelumab, known as DX-2930, was one of the driving factors behind Shire’s $6.5 billion acquisition of Dyax in 2015. The purchase of Dyax bolstered Shire’s HAE pipeline, which included Cinryze and Firazyr. If approved, Shire executives believe lanadelumab can generate about $2 billion in annual revenue, although some analysts have predicted the drug will only generate between $1.1 and $1.5 billion.
HAE is a rare, genetic disorder estimated to affect about one in 10,000 to one in 50,000 people worldwide. The condition results in recurrent, localized edema (swelling). The areas of the body most commonly affected are the extremities, gastrointestinal tract, and upper airways. The swelling can be debilitating and painful, potentially impacting both work and education for people living with HAE. Swelling of the throat can be life-threatening due to asphyxiation.
“In the U.S., available treatment options include either injections for acute attacks or short-acting intravenous infusions administered twice a week. If approved, lanadelumab may offer patients a long-acting treatment option that significantly reduces HAE attacks when administered subcutaneously as infrequently as every four weeks,” Dr. Aleena Banerji of Massachusetts General Hospital and clinical trial investigator, said in a statement.
Dr. Marcus Maurer, a clinical trial investigator from Germany, said a new way to treat HAE could be transformative to the way patients live, as well as change how the disease is treated in the future. Shares of Shire are trading at $190.73 this morning.