Jazz Pharmaceuticals plc | March 28, 2022
Jazz Pharmaceuticals plc announced that it has entered into a definitive agreement to divest Sunosi® a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea to Axsome Therapeutics. Under the terms of the agreement, Axsome will receive the rights to Sunosi in all of the existing territories available to Jazz. Jazz will receive attractive financial terms including an upfront payment of $53 million, a high single-digit royalty on Axsome's U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome's U.S. net sales of Sunosi in future indications.
The divestiture of Sunosi to Axsome will enable Jazz to sharpen its focus on its highest strategic priorities designed to deliver sustainable growth and enhanced shareholder value. In assessing the positioning of Sunosi in the overall treatment landscape, Jazz determined Axsome would be well positioned to deliver access to this important medication and to maximize the value of Sunosi to Jazz through future growth. Sunosi's consistent positive feedback from patients, HCPs and providers is underscored by its well-established and clinically meaningful efficacy. Importantly, Jazz and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition.
Wake-promoting agents are most often prescribed by psychiatrists, neurologists and general practitioners. Therefore, Jazz believes Axsome is well placed to leverage its commercial business, which will have highly complementary call points, to drive Sunosi as one of the lead products in their portfolio and ensure Sunosi can continue to reach those patients who may benefit from this important medicine.
"This transaction advances our efforts to deliver sustainable growth, enhanced shareholder value and drive the transformation of Jazz to an innovative, global biopharmaceutical leader. Jazz will continue to be laser-focused on investing in our highest strategic priorities including our ongoing launches, advancing our pipeline, pursuing opportunistic corporate development and achieving margin expansion. Through our development and launch of Sunosi, the Jazz team has laid the foundation for Axsome to continue supporting people who may benefit from this much-needed treatment. As a leader in sleep medicine and rare epilepsies, with a growing oncology franchise, Jazz remains committed to developing new, innovative therapies in neuroscience and oncology for patients and delivering on our recently announced Vision 2025."
Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals
"We are impressed by the clinically meaningful efficacy, unique mechanism of action, positive patient and physician feedback and growth potential of Sunosi, and are excited by the excellent strategic fit with the Axsome portfolio. The addition of Sunosi will augment and accelerate our commercial preparedness ahead of the potential near-term launches of our two existing lead assets and allows us to fully leverage our first-in-class Digital Centric Commercialization™ platform with three complimentary assets," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics.
Sunosi is a dopamine and norepinephrine reuptake inhibitor indicated for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients. Sunosi is the first DNRI approved to treat EDS in adults living with narcolepsy or OSA.
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.
Telix Pharmaceuticals Limited | April 11, 2022
Telix Pharmaceuticals Limited announces that it has entered into a licence agreement with Eli Lilly and Company under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers. Telix's initial development focus will be on a rare type of cancer known as soft tissue sarcoma.
Olaratumab was originally developed by Lilly as a monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha. PDGFRα is expressed in multiple tumour types including STS. STS is generally a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy and olaratumab's ability to target PDGFRα makes it a highly novel and potentially exciting candidate for use as a radionuclide targeting agent. The exclusive worldwide licence will allow Telix to repurpose olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer. Olaratumab has an established safety profile that underpins its potential use as a radionuclide targeting agent.
Material terms of the agreement
Under the terms of the agreement Telix will pay Lilly an upfront payment of US$5M for the grant of an exclusive licence to Lilly's intellectual property related to the development of a radiolabelled olaratumab, as well as access to material for use by Telix in initial pre-clinical and early-phase clinical studies in application to potential uses for the diagnosis and treatment of human cancers.
Lilly may be eligible for up to US$225M in payments based upon the achievement of pre-specified development, regulatory and commercial milestones. Lilly would also be eligible to receive industry standard royalties on net sales. The agreement also includes an option for Lilly to be granted an exclusive licence to a radiolabelled companion diagnostic which would be developed by Telix. If exercised, Lilly will pay Telix US$5M and up to US$30M in potential development milestones, as well as industry standard royalties.
The agreement has typical termination rights for breach and related corporate issues. Telix retains termination rights typical to licence agreements of this nature to enable the Company to exit the agreement based on a development or commercial basis.
"This in-licence transaction with Lilly is a valuable – and rare – opportunity to acquire an asset which has demonstrated clinical safety. In our pre-transaction diligence and research, we have identified that a radiolabelled version of olaratumab could be efficacious in patients with STS, particularly as it is a highly radiation-sensitive cancer. The safety data generated by Lilly in relation to the original development program significantly de-risks the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical information as to whether this asset has potential therapeutic efficacy, demonstrating the advantage of Telix's "theranostic" approach.
Telix Group CEO and Managing Director, Dr. Christian Behrenbruch
"This acquisition mirrors the approach that Telix has taken in building its existing pipeline by in-licencing or acquiring assets that have already been proven to be safe for use in humans that can be harnessed as novel radiolabelled targeting agents. This partnership also demonstrates the value that Telix can bring as a capable partner with the expertise in radiopharmaceutical development and manufacturing, to help repurpose or expand the use of promising candidates to better target, find and treat cancer."
About Soft Tissue Sarcoma
Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In the United States, it is estimated that 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% of overall cancer mortality.1 In Europe, nearly 23,600 new STS cases rose annually, and the crude incidence rate was 4.7 per 100,000.2 Approximately 39,900 new STS cases occurred nationwide in China in 2019, accounting for 1.05% of overall cancer incidence.3 The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12–18 months.
Olaratumab was originally developed as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the US and "Conditional Approval" in the EU based on Phase 2 trial data which showed a 1-year survival benefit in patients with STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab did not improve survival for patients.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
Direct Biologics | April 13, 2022
Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle platform drug technology, announced that the U.S. Food and Drug Administration has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clinical evidence indicating the ability to address an unmet medical need for a serious life-threatening disease or condition. Under the RMAT designation, the FDA provides intensive guidance on drug development and post-market requirements through early and frequent interactions. Additionally, an RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications.
"After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicenter, double blinded, placebo controlled randomized clinical trial, the FDA has recognized ExoFlo as a lifesaving treatment for patients suffering from Acute Respiratory Distress Syndrome (ARDS) due to severe or critical COVID-19. The additional attention, resources, and regulatory benefits provided by an RMAT designation demonstrate that the FDA views ExoFlo as a product that can significantly enhance the standard of care for the thousands still dying from ARDS every week in the US," he said.
Mark Adams, Chief Executive Officer
"We are very pleased that the FDA has recognized the lifesaving potential of our platform drug technology ExoFlo. The RMAT has provided a pathway to expedite our drug development to achieve a BLA in the shortest possible time," said Joe Schmidt, President. "I am very proud of our team. Everyone has been working around the clock for years in our mission to save human lives taken by a disease that lacks treatment options, both in the US and abroad. We are grateful for the opportunity to accelerate development of ExoFlo under the RMAT designation as it leads us closer to our goal of bringing our life saving drug to patients who desperately need it."
ExoFlo is an acellular human bone marrow mesenchymal stem cell derived extracellular vesicle product. These nanosized EVs deliver thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA to cells in the body, harnessing the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity and limitations of scalability associated with MSC transplantation. ExoFlo is produced using a proprietary EV platform technology by Direct Biologics, LLC.
Physicians can learn more and may request information on becoming a study site at clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit: https://directbiologics.com.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in San Antonio, Texas. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust EV platform technology. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving segment of next generation regenerative biotherapeutics. Direct Biologics has obtained and is pursuing multiple additional clinical indications for ExoFlo through the FDA's investigational new drug (IND) process.
Novartis Pharma AG | March 14, 2022
Sandoz, a Novartis division, announced that it has successfully acquired the UK-based medical and drug delivery device development company, Coalesce Product Development Limited.
Through this deal, Sandoz has acquired the significant capabilities and assets of Coalesce, which will help it build on its existing portfolio of respiratory medicines and further improve patient access to these high-quality, complex therapies.
“Respiratory and complex generics are areas of relatively high unmet medical need, due largely to their comparatively high technical complexity,”
Sandoz CEO, Richard Saynor
“At Sandoz, we have the experience and expertise to succeed in these fields and this acquisition offers us a significant new growth platform, particularly in the US and Europe, reinforcing our commitment to pioneer access for patients.”
Respiratory diseases are leading causes of death and disability worldwide.1 Asthma is a major non-communicable disease affecting both children and adults, and in 2019 it affected an estimated 262 million people.2 In the same year, about 3.23 million deaths were attributed to chronic obstructive pulmonary disease (COPD).3 The resulting burden of respiratory diseases on healthcare systems and productivity amounted to more than USD 380 billion per year across 28 EU member states.4
With an existing portfolio of six in market-products and nearly twice as many more in the pipeline, Sandoz sees respiratory as a key pillar of its ambitious long-term growth strategy and intends to actively explore further opportunities both in-house and externally. More generally, Sandoz is determined to grow its portfolio in the complex generics space, including complex injectables.
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.