From The Editor | August 4, 2017

Clinical News Roundup: LabCorp To Acquire Chiltern

Source: Clinical Leader
Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

LabCorp has announced it will acquire Chiltern pursuant to a definitive agreement with Chiltern’s shareholders in an all-cash transaction valued at approximately $1.2 billion. Once the transaction is complete, Chiltern will become part of LabCorp’s Covance segment.

“This acquisition strengthens our position as a leading life sciences company that delivers innovative diagnostics and drug development solutions to improve health and improve lives,” said David P. King, chairman and CEO of LabCorp. “Our acquisition of Covance has demonstrated the value of combining diagnostic and CRO capabilities, expertise, data, and leadership. The addition of Chiltern furthers our strategy and will provide us with enhanced capabilities across a broader client base as we continue to innovate and grow.”

Chiltern has a 35-year track record of growth as a provider of clinical services and solutions in multiple key therapeutic areas, with engagement models for biopharmaceutical and medical device companies. It has more than 4,500 employees around the world, including Asia-Pacific, and has conducted more than 1,800 studies across 87 countries in the last 5 years. Chiltern is a leading CRO among emerging-to-mid biopharma customers, with forecasted 2017 revenue of approximately $550 million.

“Joining LabCorp and Covance will allow Chiltern to expand its collaborative approach to bring better, more personalized therapies to market for patients every day,” said Jim Esinhart, Ph.D., CEO of Chiltern. “Customers will benefit from the expanded capabilities this provides and our employees will have a greater opportunity to propel research into the future with strong, supportive partners.”

INC Research and inVentiv Health Announce Completion of Merger
INC Research Holdings and inVentiv Health announced the successful completion of their previously announced merger. The combination creates a fully-integrated biopharmaceutical solutions organization, including an end-to-end CRO and CCO (contract commercial organization). The combined company will be known as INC Research/inVentiv Health on an interim basis until a relaunch under a new brand in 2018.

Alistair Macdonald, CEO, INC Research/inVentiv Health, said, “The closing of this deal marks the beginning of an industry-changing new company, purpose-built to achieve the singular goal of accelerating biopharmaceutical performance. INC Research/inVentiv Health will address new market realities through shared clinical and commercial expertise, data, and insights to meet the needs of biopharmaceutical companies of all sizes. This strategic combination enhances our ability to facilitate approvals and product launches in multiple markets worldwide and the value we offer to employees, customers, and our shareholders.”

Michael Bell, executive chairman of the board of directors and president, Commercial Division, INC Research/inVentiv Health, added, “With the industry’s most comprehensive clinical and commercial solutions continuum, the Board and I are confident in the company’s ability to meet the needs of biopharmaceutical companies who are navigating an increasingly complex marketplace. Customers will benefit from enhanced global scale, deep therapeutic alignment, and integrated solutions, including market access and real-world evidence. We are pleased with transition progress to date, look forward to supporting our talented management team, and are committed to enabling our customers to speed the delivery of therapies to the patients who need them most.”

Senate Passes FDA Reauthorization Act Of 2017
The Senate has voted to pass the FDA Reauthorization Act of 2017. The bill was passed by the House in June and will now head to the desk of President Trump. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” read a statement from Senate Energy and Commerce Committee chairman Greg Walden, R-OR; ranking member Frank Pallone, Jr., D-NJ; Health Subcommittee chairman Dr. Michael Burgess, R-TX; and Health Subcommittee ranking member Gene Green, D-TX). “This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

The bill’s passage immediately drew praise from the industry, including Stephen Ubl, president and CEO of the PhRMA (Pharmaceutical Research and Manufacturers of America). “PhRMA applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts,” Ubl said. “PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the FDA with new tools and resources to keep up with the latest scientific advances. By strengthening the FDA and improving efficiency in the drug review process, we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, the FDA, and patients.”

The Biotechnology Innovation Organization (BIO) also weighed in, saying the bill contained provisions that would help accelerate and incentivize the entry of generics and biosimilars to the market.

“[The bill] ensures the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development,” said James Greenwood, BIO president and CEO. “The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”

Senate Passes “Right-To-Try” Legislation
The Senate passed via unanimous consent (there was not a vote) a bill that claims to improve terminal patients' access to experimental drugs. However, opponents remain unconvinced the legislation, if passed in the House and signed into law, would actually help patients. Additionally, the legislation may further burden and undermine the FDA.

The bill is part of what's known as the "Right-To-Try" movement, which has been sweeping across state legislatures (37 states now have such laws), and is part of a bid to increase access to experimental therapies for terminally ill patients while skirting around FDA, which regulates the use of investigational medical products outside of clinical trials under its expanded access program.

According to experts, the main barrier for patients trying to access such investigational treatments is the companies running the clinical trials for these therapies. Many believe "Right-To-Try" legislation does not address this barrier. FDA, meanwhile, signs off on more than 99% of expanded access requests, as the agency allows such use after a company gives its OK.

At the heart of the revised Senate bill is a section on whether FDA can use clinical outcomes from trials in which the use of an investigational drug led to safety events that might delay or cause FDA to reject its approval.

The bill, a previous version of which barred FDA from even considering such data, now says that FDA can use the data if "that use of such clinical outcome is critical to determining the safety of the eligible investigational drug." If such a determination is made, an agency director at FDA would have to provide "written notice of such determination to the sponsor, including a public health justification for such determination."

The bill also makes clear companies, prescribers, dispensers, and others will not be held liable regarding "any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act."

Consumer Group: Clinical Trial Fails To Disclose Risk Of Death
A clinical trial testing blood transfusion therapies for heart attack patients may place participants in danger of death or a repeat heart attack without fully disclosing those risks. That allegation has been made by Washington, DC-based consumer advocacy group Public Citizen. In a letter, the group asked federal health officials to immediately suspend enrollment in the study, which is recruiting patients at dozens of hospitals.

The nonprofit consumer advocacy group claims the clinical trial, which is designed to compare two red blood cell transfusion strategies for heart attack patients with anemia, fails to inform participants of prior studies that strongly suggest one method is more likely to result in death or a repeat heart attack.

“Those are serious end points,” said Michael Carome, a physician and director of Public Citizen’s health research group. “This isn’t measuring what your appetite is or how far you can walk. This is measuring serious outcomes that have tremendous importance for the subjects.”

Carome added that the patient consent form should explicitly state the risk of death, repeat heart attack or cardiac surgery as a result of participating in the study. “The consent form is completely silent on that,” he said.

The principal researcher for the study, Dr. Jeffrey Carson of Rutgers University, said in a written statement that he stands behind the science and the ethics of the study, called the Myocardial Ischemia and Transfusion (MINT) trial. The study is being funded through a $16.1 million grant from the National Institutes of Health.