October 19, 2015
By Alex Keown, BioSpace.com Breaking News Staff
LEXINGTON, Mass – The U.S. Food and Drug Administration (FDA) will not approve Shire PLC ’s new drug application for the dry eye treatment lifitegrast without additional clinical studies, the company announced late Friday.
Ireland-based Shire, which is managed from offices in Massachusetts, was expecting a ruling on its dry eye treatment on Oct. 25, but on Friday U.S. regulators issued a “complete response letter,” a notice the FDA sends to companies to inform them the marketing application for the drug will not be approved in its current form.
Philip J. Vickers, head of research and development at Shire, said the company will work quickly to address the FDA’s requests, which includes a request for more information on market quality. He said the company wants to get the drug to market to deliver “a new prescription treatment option for the 29 million adults in the U.S. living with the symptoms of this chronic and progressive disease.” The new drug application for lifitegrast included data from four randomized, controlled clinical trials with more than 1,800 patients, Shire said.
The FDA’s move was not unexpected. The Boston Globe said David Evans, an analyst at UBS AG in London predicted in a research note earlier this month the FDA would seek more data before approving lifitegrast.
The FDA’s additional requirement came after the company completed a Phase III study of ifitegrast, dubbed OPUS-3, which is expected to be the basis of Shire‘s response to the FDA’s letter. Results are not expected to be available until November, but in a statement, the company said if the data is positive, it will include it as parts of its resubmission to the FDA in the first quarter of 2016.
Although the stock may have been dinged immediately following the announcement, currently Shire’s is up more than 2 percent, trading at $213.57 per share.
Chronic dry eye, which is estimated to affect 25 million people in the United States, is a disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea. One type of chronic dry eye is caused by decreased tear production due to inflammation. Analysts predicted ifitegrast could reach peak sales of $1 billion annually, The Telegraph of London reported.
Dry eye medications can be big business and promising drugs are attractive targets for acquisition. In July,Allergan PLC backed up its dry eye treatment drug Restasis by adding another dry eye care treatment to its portfolio with the $125 million-plus acquisition of U.S. –based Oculeve, a development stage medical device company. Oculeve‘s lead dry eye development treatment OD-01, is a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease. Allergan plans to conduct two additional pivotal trials prior to FDA submission, which is expected in 2016 with potential commercial launch in 2017. Restasis is expected to bring in more than $1 billion in sales this year, the Boston Globe reported.
With ifitegrast being pushed back, analysts at Bank of America Merrill Lynch, told The Telegraph, they believe the FDA’s decision could have a negative impact on its $30 billion bid for Baxalta. In July, Shire offered to acquire Baxalta in an all-cash transaction of about $45.23 per Baxalta share, a total of about $31 billion. Baxalta is a new company, having spun off from Baxter International on July 1, 2015. Shire went public with its offer in late July after it had not received a response from Baxalta. On Aug. 4, Wayne Hockmeyer, chairman of the Baxalta board, wrote, “The Board today reaffirmed its conclusion that Shire’s proposal significantly undervalues Baxalta and its attractive prospects for growth and value creation, and that a merger at this time would be severely disruptive at this very early stage of Baxalta’s existence as a public company and presents a significant and real risk to value creation for our shareholders.”
Additionally, there were rumors circulating earlier this month that Shire had been planning a deal to acquire U.S. drugmaker Radius Health .
