- Collaboration combines Teva’s expertise in respiratory
technology development and Launch Therapeutics’ innovative
late-stage drug development model to progress Teva’s Dual-Action
Asthma Rescue Inhaler (TEV-‘248) program
- Development funding agreement to provide up to $150 million
to offset program costs and to accelerate clinical research for
Teva's TEV-‘248 program in line with Teva's Pivot to Growth
strategy to step up innovation and advance its innovative
pipeline
- Teva’s TEV-‘248 has the potential to be the first
Dual-Action Asthma Rescue Inhaler combining an Inhaled
Corticosteroid with a Short-Acting Beta-Agonist (ICS-SABA) for both
adult and pediatric asthma indications
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and
Launch Therapeutics, Inc., today announced a clinical collaboration
agreement to further accelerate the clinical research program of
Teva’s ICS-SABA (TEV-‘248). Teva and Abingworth, a leading
international life sciences investment group, part of global
investment firm Carlyle (NASDAQ: CG), today also announced a
strategic development funding agreement in which Abingworth
provides Teva up to $150 million to offset Teva’s ICS/SABA
(TEV-‘248) program costs.
As part of the clinical collaboration agreement, Launch
Therapeutics, a clinical development company backed by Abingworth
and Carlyle, will have the lead role in the operational execution
and management of the planned clinical trials, focused on
accelerating Teva’s ICS-SABA (TEV-‘248) clinical research program.
Teva will retain primary responsibility for manufacturing,
regulatory interactions in the U.S., and commercialization.
If TEV-‘248 receives U.S. FDA regulatory approval, Abingworth
will be eligible to receive fixed payments as well as success
payments based on ICS/SABA sales. Teva will recognize the funding
as a reduction in research and development expenses and will retain
full rights to the Company’s ICS/SABA program.
Teva’s TEV-‘248 has potential to be the first ICS/SABA for both
adult and pediatric indications, combining fluticasone propionate
and albuterol sulfate delivered via Teva’s breath-activated,
multi-dose dry powder inhaler (MDPI), which is used with other
approved medicines in Teva’s respiratory product portfolio.
“As we execute our Pivot to Growth Strategy, we are focused on
accelerating our late-stage innovative pipeline and delivering
meaningful new therapies to people living with unmet medical need,”
said Eric Hughes, MD, PhD, Executive Vice President, Teva Global
R&D and Chief Medical Officer. “We are especially excited about
the potential to deliver this new asthma therapy to patients
working alongside the team at Launch Therapeutics, who have
valuable experience in expediting clinical development
programs.”
“Launch Therapeutics is excited to partner with Teva to
co-develop its ICS-SABA (TEV-‘248) clinical program and to bring
this vital therapy to asthma patients,” said Anshul Thakral, CEO of
Launch Therapeutics. “Bridging together Teva's deep therapeutic
expertise with Launch Therapeutics' profound clinical and
operational expertise generates value to execute and accelerate
this program. Launch Therapeutics is committed to upholding
uncompromising standards for quality, achieving key milestones, and
delivering this transformative therapy to patients.”
“Abingworth is thrilled to enter this strategic development
funding agreement with Teva around its exciting ICS-SABA (TEV-‘248)
program. It is another great example of where we can put capital to
work, alongside the operational expertise of Launch Therapeutics,
to seek to accelerate the late-stage clinical development of a
highly promising program towards patients in need of new
therapies,” commented Bali Muralidhar, Managing Partner, Chief
Investment Officer & COO at Abingworth.
Notes for Editors
About ICS/SABA – fluticasone/albuterol (TEV-‘248)
Short-Acting Beta-Agonists (SABAs) are used for the treatment of
asthma symptoms providing rapid relief. SABAs do not address the
underlying inflammation, which can lead to SABA overuse and poor
clinical outcomes, including a correlation with increased
mortality. This evidence has led the Global Initiative for Asthma
(GINA) to stop recommending the use of SABA alone for patients with
asthma. Instead, combining SABA with Inhaled Corticosteroids (ICS)
is safer and more effective, addressing both immediate symptoms and
long-term inflammation, leading to improved asthma management,
including a significant reduction in the risk of severe
exacerbations (asthma attacks). Teva’s albuterol/fluticasone
combination (TEV-‘248) is currently in Phase 3 clinical trials to
demonstrate a reduction in severe exacerbations compared to
reliever treatment with SABA alone (Study FpA-AS-30094) and the
airway relaxation effect of albuterol in the combination product
(Study FpA-AS-30093).
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global pharmaceutical leader with a category-defying portfolio,
harnessing our generics expertise and stepping up innovation to
continue the momentum behind the discovery, delivery, and expanded
development of modern medicine. For over 120 years, Teva's
commitment to bettering health has never wavered. Today, the
company’s global network of capabilities enables its 37,000
employees across 58 markets to push the boundaries of scientific
innovation and deliver quality medicines to help improve health
outcomes of millions of patients every day. To learn more about how
Teva is all in for better health, visit www.tevapharm.com.
About Abingworth
Abingworth is a leading transatlantic life sciences investment
firm. Abingworth helps transform cutting-edge science into novel
medicines by providing capital and expertise to top caliber
management teams building world-class companies. Since 1973,
Abingworth has invested in 185 life science companies, leading to
50+ M&A transactions and more than 75 IPOs. Our therapeutic
focused investments fall into three categories: seed and
early-stage, development stage, and clinical co-development.
Abingworth supports its portfolio companies with a team of
experienced professionals at offices in London, Menlo Park
(California), and Boston.
About Carlyle
Carlyle (NASDAQ: CG) is a global investment firm with deep
industry expertise that deploys private capital across its business
and conducts its operations through three business segments: Global
Private Equity, Global Credit and Global Investment Solutions. With
$426 billion of assets under management as of December 31, 2023,
Carlyle’s purpose is to invest wisely and create value on behalf of
its investors, portfolio companies and the communities in which we
live and invest. Carlyle employs more than 2,200 people in 28
offices across four continents. Further information is available at
www.carlyle.com. For more, follow Carlyle on LinkedIn and X.
About Launch Therapeutics
Launch Therapeutics is a clinical development company with a
mission to disrupt the late-stage development paradigm, accelerate
timelines to regulatory success, and bring new medicines to
patients faster. Launch Therapeutics offers pharmaceutical and
biotech companies a variety of innovative models that combine
access to capital with deep drug development, medical, clinical
operations, regulatory, and commercialization expertise. Founded in
2022, Launch Therapeutics is backed by leading investors, Carlyle
and its life sciences franchise, Abingworth, and is led by a
committed, experienced team with an enthusiastic passion to fulfil
its mission.
Teva Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to: our ability to effectively
execute our clinical collaboration agreement with Launch
Therapeutics; our ability to effectively execute the development
funding agreement with Abingworth; our ability to develop and
commercialize ICS-SABA (TEV-‘248) for both adult and pediatric
indications; our ability to pay milestone payments under the
development funding agreement with Abingworth; the risk that we
will incur significant costs in connection with the development of
the ICS-SABA (TEV-‘248) program, which may exceed any revenue
generated by the product; risks that regulatory approvals and other
requirements may delay the development and commercialization of the
product; our ability to successfully launch and execute our Pivot
to Growth strategy including to expand our innovative and
biosimilar medicines pipeline and profitably commercialize the
innovative medicines and biosimilar portfolio, whether organically
or through business development; our substantial indebtedness; our
business and operations in general; compliance, regulatory and
litigation matters; the impact of the state of war declared in
Israel and the military activity in the region; other financial and
economic risks; and other factors discussed in this press release,
and in our Annual Report on Form 10-K for the year ended December
31, 2023, including in the sections captioned “Risk Factors.”
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
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For Teva
Media Contacts
Kelley Dougherty +1 (973) 832-2810
Eden Klein +972 (3) 906-2645
IR Contacts
Ran Meir +1 (267) 468-4475
Yael Ashman +972 (3) 914-8262
Sanjeev Sharma +1 (973) 658 2700
For Abingworth
Kurt von Emster
Managing Partner & Head of Abingworth Life Sciences
Tel: +1 (650) 926 0600
Bali Muralidhar
Managing Partner, Chief Investment Officer & COO
Tel: +44 (207) 534 1500
www.abingworth.com
For media inquiries:
Mark Swallow or Frazer Hall, MEDiSTRAVA Consulting
Tel: +44 (203) 928 9600
Email: abingworth@medistrava.com
For Launch Therapeutics
Elizabeth Kuronen
Email: elizabeth.kuronen@launchtx.com
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