CiVi Biopharma Receives Worldwide Exclusive License to Develop a Novel, RNA Targeted Drug Against PCSK-9

HORSHOLM, Denmark, Jan. 5, 2017 /PRNewswire/ -- CiVi Biopharma, Inc. (CiVi Biopharma) a privately held biopharmaceutical company, announced today that it has signed an agreement with F. Hoffmann-La Roche Ltd (Roche), which provides CiVi Biopharma worldwide, exclusive rights to research, develop and commercialize Roche's single stranded,  anti-PCSK-9 anti-sense drug candidate. Drug mediated inhibition of PCSK-9 causes an upregulation of surface expressed LDL-receptors on liver cells, which in turn increases systemic clearance of LDL-cholesterol, commonly referred to as bad-cholesterol because of its involvement in atherosclerosis. The investigational drug candidate is based on Roche's proprietary Locked Nucleic Acid (LNA) technology and will enter phase I clinical development in 2017.

Under the terms of the agreement, CiVi Biopharma will pay to Roche an upfront fee and Roche is eligible to receive clinical, regulatory and sales milestones as well as royalties.

Announcing the license agreement, Founder of CiVi Biopharma, Henrik Ørum, said, "We are delighted that Roche has selected CiVi Biopharma as their license partner for this exciting new drug candidate that will be developed for patients with elevated cholesterol despite treatment with maximally tolerated statins. We are convinced that the characteristics of the drug candidate with regards to dosing, safety and efficacy, have the potential to translate into an important new medicine in the emerging anti-PCSK-9 class of drugs."

About the LNA PCSK-9 drug candidate

The LNA PCSK-9 drug is based on Roche's proprietary LNA drug technology, which enables scientists to rapidly develop safe and effective drug-candidates against RNA targets, involved in a number of human diseases. The LNA PCSK-9 drug candidate further incorporates Roche's proprietary GalNac targeting technology that directs the payload to the liver.  By using the GalNac technology, the number of injections per year and the cost of the drug may be significantly lower compared to the commercially available antibodies against PCSK-9.

About Civi Biopharma Inc.

Civi Biopharma Inc. is a US-based, privately held biopharmaceutical company, founded in 2016. The company's research and development activities are focused on creating novel therapies against cardiovascular and metabolic diseases. The company is incorporated in Delaware and has a wholly owned Danish subsidiary, Civi Biopharma A/S, which is located in Hørsholm Science Park, Denmark. Civi Biopharma Inc. recently concluded a $40M series A financing with Boxer Capital of the Tavistock Group.

Civi Biopharma Forward-Looking Statements

This announcement contains forward-looking statements, identified by the use of words such as "believes," "expects," "may," "will," "should", "potential," "anticipates," "plans" or "intends" and similar expressions. Such forward-looking statements involve risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in this announcement. Readers are cautioned not to place undue reliance on such forward-looking statements. 

For further information, please contact

Henrik Ørum, Founder
Cell.: (+45) 2834 6474
e-mail: [email protected]

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SOURCE CiVi Biopharma, Inc.