Roche to develop companion diagnostic test for acute coronary syndrome

Agreement with DalCor includes use of the assay for a phase III clinical trial of dalcetrapib.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has entered into an agreement to develop a companion diagnostic (CDx) test for dalcetrapib, a therapeutic from DalCor Pharmaceuticals (DalCor), which will target patients with a specific genotype who have experienced a recent Acute Coronary Syndrome (ACS) event. The CDx test from Roche will be used in a phase III clinical trial that will seek to validate the clinical efficacy of dalcetrapib, an investigational medicine that according to a recently published analysis by the Montreal Heart Institute, could potentially reduce cardiovascular morbidity and mortality by as much as 39 percent in patients with a specific genetic profile.

“At Roche, we understand the importance of forging partnerships that make significant impacts on patient lives,” said Paul Brown, Head of Roche Molecular Diagnostics. “Our first companion diagnostic test in cardiovascular disease represents a significant innovation, and leverages our expertise in developing FDA approved CDx tests. Working with DalCor is a good opportunity for us to enter this market and deliver on our mission of personalized healthcare.”

“The possibility of reducing morbidity and mortality for patients who have experienced ACS by identifying genetic markers that can respond to therapy, is an exciting prospect and one that we are eager to be a part of,” said Robert McNeil, CEO, DalCor Pharmaceuticals. “The DalCor and Roche collaboration for the genetic testing is the right combination for successful execution of the phase III trial.”

ACS is a disease that affects patients globally. It occurs when the blood supply to the heart muscle is suddenly blocked. The disease accounts for more than one million hospital admissions annually in the United States alone. According to the American Heart Association, approximately every 40 seconds, an American will experience a coronary event, and approximately every one minute, an American will die from one. Patients who survive an ACS event carry a significant risk for a recurrent episode. The test from Roche, which is still in development, will identify a specific genetic variation from patients with recent ACS and aid in determining if a patient is eligible to receive the therapeutic.

About DalCor Pharmaceuticals
DalCor is initially focused on providing precision medicine to patients through identification of patient populations that derive clinical benefits. By integrating clinical and genetic insights, DalCor and its partners intend to deliver superior outcomes in clinical medicine.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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Roche Molecular Diagnostics Media Enquires
Bob Purcell
+1 925 730 8114 (US)

DalCor Media Enquires
Louise Proulx
+1514 564 6474 (CANADA)