Novo Nordisk | September 02, 2022
Novo Nordisk and Forma Therapeutics, Holdings Inc. announced that they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for $20 per share in cash, which represents a total equity value of $1.1 billion. Forma Therapeutics is a clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders.
The acquisition of Forma Therapeutics, including its lead development candidate, etavopivat, is aligned with Novo Nordisk’s strategy to complement and accelerate its scientific presence and pipeline in hemoglobinopathies, a group of disorders in which there is abnormal production or structure of the hemoglobin protein in the red blood cells.
“Novo Nordisk has worked for more than 40 years to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. By adding Forma’s differentiated approach to address unmet needs for patients, we are taking a step forward in enhancing our sickle cell disease pipeline,” said Ludovic Helfgott, executive vice president and head of Rare Disease at Novo Nordisk. “We have an ambition to build a leading portfolio with standalone and combination treatments to tackle the complications and underlying causes of sickle cell disease.”
Etavopivat, an investigational oral, once-daily, selective pyruvate kinase-R (PKR) activator, is being developed to improve anemia and red blood cell health in people with SCD, a seriously debilitating, life-threatening and life shortening disease. Etavopivat is currently being evaluated in a global phase 2/3 clinical trial (Hibiscus) in patients with SCD, and in a phase 2 trial (Gladiolus) in patients with transfusion-dependent SCD and another inherited hemoglobinopathy called thalassemia.
“Today’s announcement is an exciting milestone that accelerates Forma’s purpose to transform the lives of patients with sickle cell disease and other serious hematological diseases,” said Frank D. Lee, president and chief executive officer of Forma. “Novo Nordisk will partner closely with the sickle cell community to amplify our impact for patients around the world who urgently need new treatment options. We look forward to working together with Novo Nordisk to serve as a trusted partner to our communities and to advance innovation, access and health equity for patients.”
The transaction will not impact Novo Nordisk’s previously communicated operating profit outlook for 2022 or the ongoing share buy-back program. Novo Nordisk will fund the acquisition from financial reserves.
About the transaction
Under the terms of the agreement, Novo Nordisk will initiate a tender offer to acquire all outstanding shares of Forma Therapeutics’ common stock at a price of $20 per share in cash (or aggregated value of $1.1 billion) and a premium of 92% to Forma Therapeutics’ volume-weighted average price per share over the past 30 days ended August 31, 2022.
The transaction has been unanimously approved by the Forma Therapeutics Board of Directors. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing a majority of Forma Therapeutics’ outstanding shares, receipt of applicable regulatory approvals and other customary conditions. Upon the successful completion of the tender offer, Novo Nordisk’s acquisition subsidiary will merge into Forma Therapeutics, and any shares of common stock of Forma Therapeutics not tendered into the offer will receive the same USD per share price payable in the tender offer. The transaction is expected to close in the fourth quarter of 2022.
In addition, certain affiliates of RA Capital Management, L.P., which collectively own approximately 19% of Forma Therapeutics’ outstanding shares, have entered into a support agreement pursuant to which they committed to tender their shares in the tender offer.
Novo Nordisk is represented by Moelis & Company UK LLP as financial advisor and Davis Polk & Wardwell LLP as legal advisor. Forma Therapeutics is represented by Centerview Partners LLC as financial advisor and Goodwin Procter LLP as legal advisor.
About sickle cell disease
Sickle cell disease (SCD) is a chronic and progressive inherited disorder associated with a decrease in the health and lifespan of red blood cells. People living with SCD have red blood cells that are crescent shaped, rendering them inflexible, fragile, and unable to effectively deliver oxygen. The health of these sickle red blood cells is impaired and characterized by reduced cellular energy, poor deformability, decreased membrane repair, and increased adhesion.
Around 17 million people worldwide live with SCD, including approximately 100,000 people in the United States, as well as approximately 30,000 in France, Germany, Italy, Spain, and the United Kingdom. SCD can cause serious health problems, including anemia, fatigue, episodes of pain known as vaso-occlusive crises (VOCs), and chronic, progressive end-organ damage. Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, reduced quality of life, and shortened life expectancy.
Etavopivat is an investigational, once-daily, selective pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy with the potential to improve red blood cell health and transform the lives of people living with SCD. Employing a multimodal approach, etavopivat works by activating the red blood cell’s natural PKR activity to decrease levels of the metabolite 2,3-DPG, allowing sickle hemoglobin to hold on to oxygen longer, resulting in decreased polymerization, hemolysis, and sickling. Etavopivat-mediated PKR activation also increases adenosine triphosphate (ATP) levels, to improve red blood cell function, which can lead to improved deformability, capacity for membrane repair, red blood cell health, and lifespan. Together, these effects are anticipated to improve the health of sickle red blood cell and lead to a reduction in anemia, hemolysis, vaso-occlusive crises, and end organ damage.
In a phase 1 trial, etavopivat improved anemia and red blood cell health and appeared to have a safe and well-tolerated profile, demonstrating a potential to improve the lives of patients with SCD, including increases in hemoglobin, improvements in red blood cell health, and decreases in vaso-occlusive crises (VOCs).
The U.S. Food and Drug Administration (FDA) has granted etavopivat Fast Track, Rare Pediatric Disease and Orphan Drug designations. Additionally, etavopivat was granted Orphan Drug designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Forma Therapeutics R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries.
Salarius Pharmaceuticals, Inc. | August 03, 2022
Salarius Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, and VolitionRx Limited a multinational epigenetics company, today announced the signing of a research and development collaboration to advance rapid epigenetic profiling using Volition’s Nu.Q® technology to support further development of Salarius’ clinical stage drug, seclidemstat.
Seclidemstat, a novel oral, reversible, targeted LSD1 inhibitor that affects gene expression, is currently in Phase 1/2 clinical studies for solid and hematologic cancers where LSD1 is implicated in disease progression. Nu.Q® has been developed as simple, easy-to-use, cost-effective blood tests to diagnose and monitor a range of life-altering diseases including cancer in humans and animals.
“We are delighted to collaborate with Volition and believe its Nu.Q® technology may provide valuable biomarker information as we seek to advance the development of seclidemstat in multiple clinical indications. Biomarkers allow for a noninvasive method for determining target engagement and potential drug activity in patients. So, this exciting research collaboration with Volition Rx Limited provides another tool to aid in the development of seclidemstat in clinic.”
David Arthur, Chief Executive Officer of Salarius
Gael Forterre, Chief Commercial Officer of Volition, added, “We are excited to be collaborating with Salarius as part of our Nu.Q® Discover program which offers biopharma companies and academia access to our state-of-the-art assays for rapid epigenetic profiling. We are looking forward to supporting Salarius in the development and release of their groundbreaking seclidemstat therapy, to directly benefit patients with cancer.”
VolitionRx Limited is a multinational epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19. Early diagnosis and monitoring have the potential not only to prolong the life of patients but also to improve their quality of life. The tests are based on the science of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid to indicate that disease is present. Volition is primarily focused on human diagnostics and monitoring but also has a subsidiary focused on animal diagnostics and monitoring.
Volition's research and development activities are centered in Belgium, with an innovation laboratory and office in the U.S. and additional offices in London and Singapore. For more information, please visit the Volition Rx Limited website.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, Salarius’ lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing’s sarcoma and certain additional sarcomas that share a similar biology, also referred to as Ewing’s-related or FET-rearranged sarcomas. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations for Ewing’s sarcoma from the U.S. Food and Drug Administration. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing’s sarcoma clinical program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas.
Septerna | July 29, 2022
Septerna, a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors announced the addition of Liz Bhatt, MS, MBA, as Chief Operating Officer, and Ran Xiao as Vice President of Finance and Business Operations to its leadership team. Septerna launched in January 2022 and is growing a pipeline of differentiated products using its GPCR Native Complex™ platform to unlock the vast untapped potential of GPCR drug targets for a wide range of diseases.
We are thrilled to welcome Liz and Ran as we continue to build our exceptional team. Together, they bring deep experience in corporate, commercial, and business strategy. They also have significant operational expertise building and supporting both private and public companies,” said Jeffrey Finer, MD, PhD, Chief Executive Officer and Co-founder of Septerna and Venture Partner at Third Rock Ventures. “Since our launch in January, we’ve made rapid progress advancing our platform and early discovery programs, and now expanding our focus to strategic growth and operational excellence is absolutely critical so that we can fully realize the untapped opportunity space for new GPCR medicines.”
“Septerna launched with the ambitious plan to expand the GPCR target landscape by developing and industrializing new drug discovery technologies and processes that can convert this target-rich superfamily of proteins into impactful new therapies for patients across a range of therapeutic areas. I’m excited to be working with a team of talented GPCR scientists and drug hunters and look forward to using my experience leading teams and developing corporate and product strategies to build Septerna into a robust company poised for long-term growth.”
Liz Bhatt brings more than 25 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies. Liz was previously Chief Business & Strategy Officer at Applied Molecular Transport where she oversaw corporate development, portfolio and project management, and commercial strategy. Prior to AMT, Liz was Chief Operating Officer at Achaogen where she held various strategic and operational roles. Liz spent over a decade at Gilead Sciences as VP, Corporate Development leading deals across all therapeutic areas and as Senior Director, Commercial Strategy leading long-term global commercial and strategic planning, and supporting the launch of several products. Liz also held management roles at Eli Lilly and Maxygen and started her career in research at Affymax. She currently serves as an independent director on the board of eFFECTOR Therapeutics. Liz earned a BA in chemistry from Pomona College, an MS in biomedical sciences from the University of California San Diego, and an MBA from the Kellogg School of Management at Northwestern University.
Ran Xiao has more than 20 years of experience in corporate accounting, finance, and business operations in the biotech industry. Prior to Septerna, Ran was the VP of Finance and Corporate Controller at Ambys Medicines, Inc, where she supported the company launch and managed various general and administrative functions through a rapid growth period. Before joining Ambys, Ran was the Corporate Controller at Corvus Pharmaceuticals, where she played a key role in the company’s initial public offering. Prior to Corvus, Ran held various managerial positions at Intermune, Natus Medical, Celera Genomics and CV Therapeutics. Ran has a BS in accounting from Shanghai University of Finance and Economics and an MBA from the Illinois Institute of Technology. Ran is a Chartered Financial Analyst.
G protein-coupled receptors are the largest and most diverse family of cell membrane receptors, and humans have hundreds of different GPCRs, each involved in controlling specific biological functions. GPCRs on the surface of each cell bind a wide range of external signaling molecules from throughout the body, and the GPCR transmits the signal across the cell membrane to drive internal cellular mechanisms. GPCRs have been widely studied as drug targets and are the largest family of proteins targeted by approved drug products. An estimated 700 approved drugs target GPCRs, representing approximately one-third of all currently approved drugs. Despite the pharmacological success of GPCRs as a drug class to date, the large majority of potential therapeutic GPCR targets remain undrugged.
Septerna, Inc., is a biotechnology company creating broad new drug discovery opportunities across many disease areas for the abundant drug target class of G protein-coupled receptors. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched in 2022 by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.