[Ad hoc announcement pursuant to Art. 53 LR] Roche enters into a
definitive agreement to acquire Telavant including rights to novel
TL1A directed antibody (RVT-3101) for the treatment of inflammatory
bowel disease from Roivant
- Roche will gain the rights
to develop, manufacture and commercialise RVT-3101 in the US and
Japan for the treatment of inflammatory bowel disease and
potentially multiple other diseases
- RVT-3101 is a Phase 3-ready
antibody with first-in-class and best-in-disease potential, a novel
mode of action and strong Phase 2b data in ulcerative
colitis
- Roche will also obtain an
option to enter into a global collaboration with Pfizer on a
next-generation p40/TL1A directed bispecific antibody, currently in
Phase 1
- Under the terms of the
agreement, Roche will pay a purchase price of US$ 7.1 billion
upfront and a near-term milestone payment of US$ 150
million
Basel, 23 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the entry into a definitive agreement to acquire
Telavant Holdings, Inc. (Telavant), a Roivant company, owned by
Roivant Sciences Ltd. and Pfizer Inc.. The agreement includes the
development, manufacturing and commercialisation rights in the US
and Japan for Televant’s RVT-3101, a novel TL1A directed antibody.
RVT-3101 is a promising new therapy in development for people
suffering from inflammatory bowel disease, including ulcerative
colitis and Crohn’s disease. Inflammatory bowel disease is a group
of chronic gastrointestinal disorders with almost 8 million people
diagnosed worldwide and 80% of all individuals not experiencing
lasting remission.1 Given the antibody’s novel mode of action
targeting both inflammation and fibrosis, it has potential to be
applied in multiple other diseases.
RVT-3101 has been investigated in the TUSCANY-2 phase 2b study
in patients with moderate to severe ulcerative colitis. The global,
randomised, double-blinded, placebo controlled trial delivered the
first long-term, dose finding data in a large number of patients
(n=245). The maintenance treatment phase following induction
resulted in improved clinical remission (36% at week 56) and
endoscopic improvement (50% at week 56) at the proposed Phase 3
dose administered subcutaneously every month. Beyond the efficacy
results, the maintenance dosing period of RVT-3101 also showed a
favourable safety profile across all patients.
“We strongly believe this novel TL1A directed antibody has the
transformational potential to make a significant difference for
patients living with inflammatory bowel disease and potentially
other diseases,” said Thomas Schinecker, CEO Roche Group. “We are
excited to add this promising new therapy in development to our
portfolio and to make it available to patients as quickly as
possible.”
“The recent Phase 2b for RVT-3101 delivered the first long-term,
robust dataset demonstrating improved clinical remission in the
maintenance treatment phase,” says Levi Garraway, Roche’s Chief
Medical Officer and Head of Global Product Development. “Given this
promising data, we believe that RVT-3101 has the potential to be
the first therapy that offers both high efficacy and safety for
people with inflammatory bowel disease and the convenience of an
at-home, subcutaneous administration."
Terms of the acquisitionUnder the terms of the
agreement, Roche will pay a purchase price of US$ 7.1 billion
upfront and a near-term milestone payment of US$ 150 million. Upon
closing of the transaction, Roche will have full rights to further
develop and manufacture RVT-3101 and commercialise it in the US and
in Japan pending clinical and regulatory success. Roche is
committed to starting a global Phase 3 trial for RVT-3101 as soon
as possible to bring this promising therapy to the patients
suffering from inflammatory bowel disease. Outside of the US and
Japan, Pfizer holds commercialisation rights.
In addition, following the closing of the transaction, Roche
will also have an option to enter into a global collaboration with
Pfizer on a next-generation p40/ TL1A directed bispecific antibody,
currently in Phase 1. Telavant was jointly formed by Roivant and
Pfizer in 2022 to develop and commercialise RVT-3101 in the US and
Japan. Roivant owns 75% of the issued and outstanding shares of
common stock and preferred stock of Telavant and Pfizer owns the
remaining 25%.
The transaction is subject to the expiration or termination of
the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 and other customary closing conditions.
The closing of the transaction is currently expected to take place
in Q4 2023 or in Q1 2024.
Citi is acting as the exclusive financial advisor to Roche and
Davis Polk & Wardwell LLP is acting as legal counsel to Roche.
Freshfields Bruckhaus Deringer LLP is acting as legal counsel for
Roivant.
About RVT-3101RVT-3101 is a potential
first-in-class agent that targets both inflammatory and fibrotic
pathways by inhibiting TL1A. It has been shown to modulate the
severity of inflammation and fibrosis by stimulating the TH1 and
TH17 pathways, in addition to activating fibroblasts. As such,
RVT-3101 has the potential to provide greater efficacy by hitting
multiple inflammatory and fibrotic pathways.
RVT-3101 has been evaluated in a Phase 2 study (TUSCANY) in 50
patients, and in a large global Phase 2b study (TUSCANY-2) in 245
adult participants with moderate to severe ulcerative colitis.
TUSCANY-2, a large, global, randomised, double-blinded,
placebo-controlled dose-ranging Phase 2b study was set up to
investigate the efficacy, safety and pharmacokinetics of RVT-3101
administered monthly subcutaneously in adult patients.
Key efficacy analyses from the induction period were measured at
week 14 and the maintenance (chronic) phase at week 56. Patients
who received RVT-3101 in the induction period were preassigned to
receive either the same or a lower dose in the maintenance
(chronic) period. Roivant reported positive data for the induction
period of the study in January 2023 and the chronic phase in June
2023. A Phase 2 study in Crohn’s disease is ongoing.
About inflammatory bowel diseases and ulcerative
colitisInflammatory bowel diseases (IBD) are a group of
chronic gastrointestinal disorders affecting almost 8 million
people worldwide.1 The two main types of IBD are ulcerative colitis
(mainly affecting the colon and rectum) and Crohn’s disease
(affecting the entire gastrointestinal tract).2,3 Patients can
experience unpredictable symptoms that include abdominal pain and
cramping, frequent and urgent bowel movements, diarrhoea, leakage,
rectal bleeding, weight loss, energy loss and fatigue.2,3 About 80%
of all individuals with IBD do not experience lasting remission,
which can have a long-term impact on quality of life and leave many
feeling like they have little control over their daily lives.4
Ulcerative colitis is most commonly diagnosed in young people
aged 15 to 30 years, affecting them over the course of their entire
future lives.5 Up to a quarter of people with ulcerative colitis
will require a colectomy within 10 years of diagnosis, in which all
or part of the colon is removed.6About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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.
All trademarks used or mentioned in this release are protected
by law.References[1]
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4314302/pdf/10.1177_1756283X14558193.pdf[2]
Ungaro R, et al. Ulcerative colitis. Lancet. 2017;
389(10080):1756-70.[3] Torres J, et al. Crohn's disease. Lancet.
2017; 389:1741-55.[4] Sandborn WJ. The Present and Future of
inflammatory bowel disease Treatment. Gastroenterol Hepatol. 2016;
12:438–41.[5] Johnston RD and Logan RFA. What is the peak age for
onset of IBD? Inflamm Bowel Dis. 2008; 14(supp 2):S4–S5.[6]
Langholz E, et al. Course of ulcerative colitis: analysis of
changes in disease activity over years. Gastroenterology 1994;
107(1):3-11.
Roche Global Media RelationsPhone: +41 61 688
8888 / e-mail: media.relations@roche.com
Hans Trees, PhDPhone: +41 79 407
72 58 |
Nathalie
AltermattPhone: +41 79 771 05 25 |
Simon
GoldsboroughPhone: +44 797 32 72 915 |
Karsten
KleinePhone: +41 79 461 86 83 |
Nina
MählitzPhone: +41 79 327 54 74 |
Kirti
PandeyPhone: +49 172 6367262 |
Rebekka
SchnellPhone: +41 79 205 27 03 |
Sileia
UrechPhone: +41 79 935 81 48 |
Roche Investor Relations
Dr. Bruno
EschliPhone: +41 61 68-75284e-mail:
bruno.eschli@roche.com |
Dr.
Sabine BorngräberPhone: +41 61 68-88027 e-mail:
sabine.borngraeber@roche.com |
Dr.
Birgit MasjostPhone: +41 61 68-84814e-mail:
birgit.masjost@roche.com |
Dr.
Gerard Tobin Phone: +41 61 68-72942 e-mail:
gerard.tobin@roche.com |
Investor Relations North America
Loren
Kalm Phone: +1 650 225 3217 e-mail:
kalm.loren@gene.com |
|
- 23102023_MR_TelevantRoivant_en
Grafico Azioni Roche (LSE:0QQ6)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Roche (LSE:0QQ6)
Storico
Da Mag 2023 a Mag 2024