pre-IPO PHARMA

ViiV Healthcare announces exclusive license agreement with Shionogi to develop third-generation HIV integrase inhibitor with potential for ultra long-acting dosing intervals

Tags:   License   HIV  

S-365598 aims to build on the success of dolutegravir and cabotegravir with potential to anchor the next generation of VHC’s future pipeline of innovative long-acting therapies for HIV


LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (GSK), with Pfizer and Shionogi as shareholders, today announced an exclusive collaboration and license agreement with Shionogi and Co. Ltd. (Shionogi) for S-365598, a third-generation investigational integrase strand transfer inhibitor (INSTI) with potential for use in ultra long-acting HIV regimens (regimens with dosing intervals of three months or longer).


Under the terms of the agreement, ViiV Healthcare will make an upfront payment of £20 million to Shionogi, a £15 million payment for the achievement of a clinical development milestone and royalties on net sales. The royalty levels are aligned with those in Shionogi’s existing integrase inhibitor agreements with ViiV Healthcare. Shionogi will contribute to development costs up to an annual maximum.



Kimberly Smith, M.D., MPH, Head of Research and Development at ViiV Healthcare said: “Our 20-year relationship with Shionogi has been incredibly successful, producing what are arguably two of the most important HIV medicines of the last decade. Dolutegravir is now taken by 17 million people globally, and cabotegravir has allowed us to develop the first long-acting regimen for treatment. With today’s announcement about the in-licensing of a third integrase inhibitor from Shionogi, we will continue this collaboration and explore the potential of S-365598 to anchor ViiV Healthcare’s pipeline beyond 2030.”


John Keller, Ph.D., Senior Executive Officer, Senior Vice President, Corporate Strategy Division at Shionogi said: “Many people living with HIV and those vulnerable to acquiring HIV have concerns about daily oral medication, such as the daily reminder of living with HIV, HIV status disclosure and consistency of adherence. Long-acting HIV medications have the potential to bring considerable benefit to these individuals. We are looking forward to continuing to work with ViiV to further advance this innovative approach to HIV therapies.”


Preliminary data has shown that S-365598 has a high genetic barrier and a resistance profile that is distinct from that of dolutegravir and cabotegravir. Its long half-life may support its development as an ultra-long medicine that could be delivered with infrequent dosing of every three months or longer.


Preclinical studies are underway. ViiV Healthcare and Shionogi intend to initiate first time in human studies with S-365598 by 2023.


Important Safety Information for Cabenuva (cabotegravir 200 mg/mL; rilpivirine 300 mg/mL) extended release injectable suspensions



Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.


CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions:

Post-Injection Reactions:

Hepatotoxicity:

Depressive Disorders:

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:


Long-Acting Properties and Potential Associated Risks with Cabenuva:


ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information for Cabenuva.


About Shionogi

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. Leveraging the key strengths in our integrated value chain from RandD to manufacturing and marketing, we continue to engage in RandD into therapeutic agents for a wide range of infectious diseases, such as "world’s three major infectious diseases" including HIV, "viral infections" including the novel coronavirus (SARS-CoV-2) and influenza, and "severe infectious diseases" including AMR. We are not only pursuing the research and development of therapeutics, but are also working towards total care for infectious diseases, through awareness building, epidemic monitoring, prevention, diagnosis, and addressing exacerbations, as well as the treating the infection itself. We also aim to both solve social issues related to infectious disease and establish a sustainable business model to fight infectious disease as a leading company.



For more information on Shionogi and Co., Ltd., visit https://www.shionogi.com/global/en/.


About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.


About GSK

GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.


Cautionary statement regarding forward-looking statements


GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020, GSK’s Q2 Results and any impacts of the COVID-19 pandemic.


Registered in England and Wales:

GSK PLC

ViiV Healthcare Limited

No. 3888792

No. 06876960

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

Contacts

ViiV Healthcare Media enquiries: Melinda Stubbee +1 919 491 0831 (North Carolina) Catherine Hartley +44 (0) 7909 2403 (London)


GSK enquiries: Media enquiries: Tim Foley +44 (0) 20 8047 5502 (London) Kristen Neese +1 804 217 8147 (Philadelphia) Kathleen Quinn +1 202 603 5003 (Washington DC)


Analyst/Investor enquiries: James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia)


Shionogi enquiries: Media/Analyst/Investor enquiries: Corporate Communications: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html (Japan)


ViiV Healthcare Media enquiries: Melinda Stubbee +1 919 491 0831 (North Carolina) Catherine Hartley +44 (0) 7909 2403 (London)


GSK enquiries: Media enquiries: Tim Foley +44 (0) 20 8047 5502 (London) Kristen Neese +1 804 217 8147 (Philadelphia) Kathleen Quinn +1 202 603 5003 (Washington DC)


Analyst/Investor enquiries: James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia)


Shionogi enquiries: Media/Analyst/Investor enquiries: Corporate Communications: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html (Japan)