Clinical Collaboration Agreement between Teva and Launch Therapeutics to Accelerate Development of Dual-Action Asthma Rescue Inhaler (ICS-SABA/TEV-’248) Respiratory Program; Teva and Abingworth Enter Strategic Development Funding Agreement

Rhea-AI Summary

Teva Pharmaceutical Industries and Launch Therapeutics collaborate to advance Teva's Dual-Action Asthma Rescue Inhaler program TEV-‘248, with a strategic funding agreement of up to $150 million. The program aims to be the first ICS-SABA for both adult and pediatric asthma indications, combining fluticasone propionate and albuterol sulfate.

Insights

Financial Analyst

The strategic collaboration between Teva Pharmaceutical Industries and Launch Therapeutics, backed by Abingworth and Carlyle, is indicative of the current trend in the pharmaceutical industry where companies are seeking to expedite the development and commercialization of innovative products. The development funding agreement to provide up to $150 million not only serves to offset program costs but also aligns with Teva's 'Pivot to Growth' strategy, which focuses on innovation and advancing the pipeline of new treatments.

The potential market impact of Teva's TEV-‘248, if approved, could be substantial, as it would be the first Dual-Action Asthma Rescue Inhaler for both adult and pediatric indications. This would likely contribute positively to Teva's revenue stream and could be a factor in stock price movements. The financial arrangements, including the recognition of funding as a reduction in R&D expenses and the retention of full rights to the ICS/SABA program, are critical elements that investors should monitor, as they can influence the company's financial health and R&D efficiency.

Medical Research Analyst

The clinical collaboration to advance Teva's Dual-Action Asthma Rescue Inhaler, TEV-‘248, represents a significant step in addressing unmet medical needs within the respiratory care space. TEV-‘248's combination of an Inhaled Corticosteroid and a Short-Acting Beta-Agonist in one device could simplify treatment regimens and improve patient compliance. This innovation could potentially disrupt the market by setting a new standard for asthma rescue medications.

From a medical research perspective, the partnership's focus on accelerating clinical trials is key to bringing this treatment to market more rapidly. The involvement of Launch Therapeutics in operational execution and trial management could streamline the process and leverage their expertise in late-stage drug development. The terms of the agreement, which include fixed and success-based payments contingent on FDA approval and sales, reflect a performance-oriented approach that aligns the interests of all parties involved.

Healthcare Market Analyst

Within the context of the broader healthcare market, Teva's collaboration with Launch Therapeutics and the associated funding agreement represent strategic moves to secure a competitive edge in the respiratory therapy market. The potential introduction of TEV-‘248 as the first ICS-SABA of its kind could capture a significant share of the asthma treatment market, which is currently experiencing a demand for more integrated and convenient treatment options.

Analyzing the market dynamics, the success of TEV-‘248 hinges not only on clinical efficacy and safety but also on its ability to gain market acceptance. Factors such as pricing, insurance coverage and the competitive landscape will play important roles in its commercial success. The financial support from Abingworth and the operational expertise from Launch Therapeutics could mitigate some of the risks associated with clinical development and market entry, making it a noteworthy event for stakeholders and investors.

• 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

LONDON & BOSTON & TEL AVIV, Israel--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240401099571/en/

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

Source: Teva Pharmaceutical Industries Limited

FAQ

What is the collaboration about between Teva Pharmaceutical Industries and Launch Therapeutics?

The collaboration aims to advance Teva's Dual-Action Asthma Rescue Inhaler program TEV-‘248.

What is the funding agreement amount provided by Abingworth to Teva?

Abingworth provides Teva up to $150 million to offset program costs for TEV-‘248.

What is TEV-‘248 and what is its potential in the market?

TEV-‘248 is a potential first Dual-Action Asthma Rescue Inhaler combining fluticasone propionate and albuterol sulfate for both adult and pediatric asthma indications.

Who will have the lead role in the operational execution of the planned clinical trials for TEV-‘248?

Launch Therapeutics, backed by Abingworth and Carlyle, will have the lead role in the clinical trials.

What will happen if TEV-‘248 receives U.S. FDA regulatory approval?

Abingworth will be eligible to receive fixed payments and success payments based on ICS/SABA sales.