Feds Subpoena Vertex Documents Regarding Laboratory Practices

Published: Nov 02, 2015

November 2, 2015
By Alex Keown, BioSpace.com Breaking News Staff

BOSTON – Vertex Pharmaceuticals received a subpoena from the United States Department of Justice related to the company’s marketed medicines during the third quarter of 2015, the company reported in a filing to the U.S. Securities and Exchange.

According to the brief in its 10-Q filing Vertex said the Department of Justice is requesting “documents relating primarily to our Good Laboratory Practices in a bioanalytical laboratory.” Bioanalytical labs measures drug levels in biological samples, specifically in blood and urine, Reuters reported.

Vertex said it is cooperating with the subpoena and is in the process of responding to the federal request. Vertex did not indicate what may have prompted the federal government to issue the subpoena. Nor did Vertex indicate where the laboratory in question was located, nor if the blood is from humans or animals.

Good Laboratory Practices are governed by the federal Food, Drug, and Cosmetic Act and Public Health Service Act. Good Laboratory Practices are defined by the U.S. Food and Drug Administration (FDA) as “the minimum basic requirements for study conduct, personnel, facilities, equipment, written protocols, operating procedures, study reports, and a system of quality assurance oversight.” A Vertex spokesperson told Reuters the subpoena from the Department of Justice “will not impact the safety, effectiveness and commercialization of the company's existing drugs or those in development.” The same spokesperson, Zach Barber, told the Boston Business Journal that Vertex “does not view the U.S. Attorney’s request as material to (its) business.”

“We also do not see any impact on the research, development and commercialization of any of our medicines,” Barber told the Journal.

Vertex’s stock is up more than 2 percent this morning, currently trading at $127.17 per share. The stock has a 52-week high of $143.45 per share.

Data collected by the federal government’s request are used to answer several questions regarding toxicity profile of test articles, risks associated with clinical studies involving humans or animals and level of use that can be approved.

The Department of Justice’s subpoena’s comes hot on the heels of a research collaboration struck between Vertex and CRISPR Therapeutics focusing on gene editing research targeting cystic fibrosis and sickle cell anemia.

Vertex saw approval of its newest cystic fibrosis treatment Orkambi earlier this year. Analysts predict the newest treatment could earn $5 billion by 2018. The drugmaker also has Kalydeco, another treatment of cystic fibrosis, which earned approximately $250 million in the first half of the year. Orkambi is predicted to have a wider reach than Kalydeco. The company expects 3,900 patients to be eligible to take Kalydeco by the end of the year, but Orkambi will “be able to treat 20,500 cystic fibrosis patients in the EU and U.S. older than 12 with the F508del mutation.” The company is continuing to develop other cystic fibrosis drugs for its pipeline, including VX-661. Last month the company reported the benefits to lung function in the 39-patient trial seemed to decline slightly over time, although Leiden said there “was no statistical or consistent downward trend.

Earlier this year Kalydeco, the first drug designed to counter the genetic cause of cystic fibrosis, was touted by the White House during the State of the Union Address. During his talk to the nation, President Barack Obama pointed out a guest of the first lady who is taking Kalydeco. Kalydeco was approved in 2012 and is aimed at a “select few” of the genetic mutations that can cause cystic fibrosis.

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