TITUSVILLE, NJ, May 19, 2015 / PRNewswire / – Janssen Pharmaceuticals, Inc. (Janssen), one of Johnson & Johnson’s Janssen pharmaceutical companies, today announced that it has entered into an exclusive worldwide license and collaboration agreement with Achillion Pharmaceuticals, Inc (Achillion) to develop and commercialize one or more of the main assets of Achillion hepatitis C virus (HCV), including ACH-3102, ACH-3422 and sovaprevir.
A key goal of the collaboration will be to develop a short-acting, highly effective pan-genotypic oral regimen for the treatment of HCV. An initial treatment regimen that should be explored will include Achillion ACH-3102, an NS5A inhibitor currently in Phase 2 clinical studies that has received Fast Track designation by the US Food and Drug Administration, in combination with an NS3 / 4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.
âDespite recent advances in treatment, there remain significant unmet needs to effectively address the burden that hepatitis C imposes on both patients and society. Janssen is committed to optimizing outcomes and the new collaboration with Achillion offers the opportunity to develop a new, streamlined treatment option for those affected by hepatitis C, âsaid Laurent M. Blatt, Ph.D., Head of Global Therapeutics, Janssen Infectious Diseases and Vaccines, and President and CEO of Alios BioPharma, Inc.
Under the terms of the agreement, Achillion will grant Janssen an exclusive worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of the licensed HCV assets. Achillion will be eligible to receive milestone payments based on the achievement of specified development, regulatory and sales milestones and tiered royalties on future global sales.
In addition, and independent of the exclusive licensing and collaboration agreement, Johnson & Johnson Innovation – JJDC, Inc. will make an equity investment in Achillion.
Transactions are subject to customary closing conditions, including the termination or expiration of any applicable waiting period under Hart-Scott-Rodino law.
About the Janssen Hepatitis C Development Program
The goal of Janssen’s Hepatitis C Virus (HCV) Clinical Development Program is to provide physicians with multiple treatment options to provide patients with the best possible chance of therapeutic success. Ongoing studies focus on investigating the NS3 / 4A protease inhibitor simeprevir in a number of different treatment combinations and HCV patient populations, including those who are difficult to cure. Following the acquisition of Alios BioPharma by Johnson & Johnson in november 2014 The Janssen HCV pipeline also includes AL-335, a uridine-based nucleotide analogue in phase 1 development, and AL-516, a guanosine nucleotide analogue in preclinical development NS5B polymerase inhibitor. These compounds are developed with the express intention of targeting critical steps in the HCV virus replication cycle.
About the hepatitis C virus
Hepatitis C virus (HCV), an infectious disease of the liver transmitted by blood and one of the leading causes of chronic liver disease, is a major global public health problem. Eleven HCV genotypes with several distinct subtypes have been identified worldwide. These diversities have distinct consequences: although it has not been shown that different strains differ significantly in their virulence or pathogenicity, different genotypes vary in their responsiveness to treatment.
Around 150 million people are infected with hepatitis C worldwide and 350,000 people die from the disease each year worldwide. When left untreated, hepatitis C can cause significant damage to the liver, including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.
About Johnson & Johnson Janssen Pharmaceutical Companies
At Janssen, we are committed to meeting and resolving some of the most significant unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Based on our commitment to patients, we develop innovative healthcare products, services and solutions to help people around the world. Janssen Pharmaceuticals Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. For more information, please visit www.janssen.com.
About Johnson & Johnson Innovation – JJDC
Johnson & Johnson Innovation – JJDC, Inc. (JJDC) is the venture capital arm of Johnson & Johnson which has been investing since 1973 in the fields of medical devices, diagnostics, pharmaceuticals and consumer health. Our goal is to create opportunities that meet the strategic needs of our operating subsidiaries while providing visibility into innovative technologies, companies and emerging business models. JJDC measures the success of an investment’s performance not only in terms of financial return, but also in terms of viability in providing strategic growth opportunities for the Johnson & Johnson family of companies. JJDC is interested in opportunities that meet significant unmet medical needs, have clear competitive advantages, intellectual property protection, an enforceable clinical and commercialization plan, and are led by experienced management. JJDC invests in businesses across the continuum, from seed investments to the advanced stages of running serial businesses. Our investment teams are based in the four regional centers of Johnson & Johnson Innovation in Boston, California, London, and Asia Pacific, as good as New Brunswick. For more information, please visit: www.jjdevcorp.com
Note on forward-looking statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding further collaboration and product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If the underlying assumptions prove to be incorrect or if known or unknown risks or uncertainties materialize, actual results could differ materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and / or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the satisfaction of the closing conditions of the transaction, including the authorization under the Hart-Scott-Rodino Act on antitrust improvements; the possibility that the expected benefits and opportunities of collaboration may not materialize or take longer than expected to materialize; the challenges and uncertainties inherent in the development of new products, including the uncertainty of clinical success and obtaining regulatory approvals; competition, including technological advances, new products and patents obtained by competitors; patent challenges; changes in the behavior and spending habits or financial difficulties of buyers of health care products and services; and global health care reforms and trends in health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s annual report on Form 10-K for the year ended. December 28, 2014, including in Attachment 99, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The pharmaceutical companies Janssen and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.
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SOURCE Janssen Pharmaceuticals, Inc.