Janssen Acquires Rights to Novel Gene Therapy for Late-Stage AMD

Janssen Acquires Rights to Novel Gene Therapy, Pioneering Treatment Solutions for Late-Stage Age-Related Macular Degeneration

Acquisition significantly expands Janssen’s eye disease portfolio and strengthens its gene therapy capabilities 

Late-stage AMD affects millions of people with no effective treatments currently available   

View the press release on the Janssen website.

RARITAN, NJ, December 2, 2020 – Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the acquisition of rights to Hemera Biosciences, LLC’s investigational gene therapy HMR59, administered as a one-time, outpatient, intravitreal injection to help preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration (AMD). Financial terms of the transaction with Hemera Biosciences, a privately-owned biotechnology company, are not being disclosed.

Patients with AMD often have low levels of CD59, a protein that protects the retina from damage caused by an essential part of the body’s natural immune response called “complement.” In geographic atrophy, an overactivity of complement destroys cells in the macula, the central part of the retina responsible for central vision and seeing fine details, and results in a relentless progression to blindness. HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision.

Geographic atrophy affects five millioni people globally, and is a leading cause of blindness in people over 50 years of age. The prevalence of geographic atrophy increases as the global population ages with roughly one in 29 people over age 75 affected, and nearly one in four people over age 90. There are currently no available therapies other than vitamins and low vision aids.

“Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James F. List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “Our aim with this novel, single-administration gene therapy is to use our development expertise and deep heritage in vision care to help improve patient outcomes by intervening early, halting the progression to blindness, and preserving more years of sight.”

Gene therapy is an important modality for both therapeutic delivery and protein replacement, and one of the ways Janssen aims to significantly improve health outcomes for patients. Beginning with the eye, Janssen is rapidly developing expertise in the manufacturing, development, and commercialization of gene therapies across a range of mechanisms of action, building the case for future applications to other parts of the body.

“At Janssen, we pursue the best science to uncover transformational treatments that meet patient needs, which often means pioneering the solution. This is especially the case with gene therapy and late-stage eye diseases where the paths are largely uncharted,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “Through this acquisition, we are blazing the trail to bring innovative solutions to patients who are losing their vision.”

The Phase 1 study of HMR59 for patients with geographic atrophy is complete. A second Phase 1 study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate long-term safety.

About Janssen’s Eye Disease Portfolio
Janssen is committed to innovating the eye disease space, translating the biology underlying eye diseases, and pioneering gene therapy solutions to develop treatments that preserve and enhance vision. The Company established its eye disease portfolio in 2018 and is developing expertise and assets across a range of rare and common eye diseases, including achromatopsia and X-linked retinitis pigmentosa, age-related macular degeneration, diabetic retinopathy, and diabetic macular edema.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” regarding the acquisition of rights from Hemera Biosciences, LLC. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: the risk of stockholder litigation relating to the transaction, including resulting expense or delay; the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in new product research and development, especially at an early stage of the development program, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations, including the impact of global public health crises and pandemics, such as the outbreak of the coronavirus (COVID-19) on Johnson & Johnson, including foreign governments in countries in which Johnson & Johnson operates; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and trends toward health care cost containment. In addition, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the clinical work of Hemera Biosciences, LLC. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

i Tufail A, et al. Objective Measurement of Reading Speed and Correlation With Patient-Reported Functional Reading Independence. Presented at the 15th EURETINA Congress, Nice, France, September 17-20, 2015

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