AZ Symbicort reduces rate of asthma attacks

pharmatimes | May 20, 2019

AstraZeneca’s Novel START trial for its Symbicort Turbuhaler (budesonide/formoterol) demonstrated a reduction in the rate of asthma attacks in patients with mild asthma, compared to common therapies. The trial results, published in the ‘New England Journal of Medicine’, compared Symbicort Turbuhaler with two commonly used treatment regimens in mild asthma and reflected real-world practice. In real-world practice, patients typically use a short-acting beta2-agonist (SABA) reliever in response to symptoms or daily low-dose inhaled corticosteroid (ICS) maintenance therapy with a SABA reliever.  In this trial, patients with mild asthma were randomised to receive either albuterol (a SABA reliever) taken as-needed, or budesonide (an ICS maintenance treatment) plus albuterol as-needed, or Symbicort Turbuhaler used as an anti-inflammatory reliever therapy taken as-needed.

Spotlight

Many birth control pills cause very serious health effect which can sometimes become fatal after prolonged use. Basically, birth control pills increase the estrogen levels in your body and convince the pituitary that you are pregnant. The consequent effect of this misinformation leads to several changes and health risks in your body which many doctors will never tell their patients for fear that they may discontinue the pills altogether.

Spotlight

Many birth control pills cause very serious health effect which can sometimes become fatal after prolonged use. Basically, birth control pills increase the estrogen levels in your body and convince the pituitary that you are pregnant. The consequent effect of this misinformation leads to several changes and health risks in your body which many doctors will never tell their patients for fear that they may discontinue the pills altogether.

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PHARMA TECH

Apollomics Inc., a Late-Stage Clinical Biopharmaceutical Company to be Listed on Nasdaq Through Business Combination

Apollomics, Inc. | September 15, 2022

Apollomics Inc. a late-stage clinical biopharmaceutical company, and Maxpro Capital Acquisition Corp. announced a definitive agreement for a business combination that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market. The business combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol “APLM.” Apollomics’ broad pipeline of drug candidates includes late-stage clinical assets for the treatment of patients with difficult-to-treat cancers. Apollomics’ mission is to develop assets in critically important areas of unmet need. The Company’s leading drug candidates address certain subpopulations within lung cancer and leukemia. Globally, both lung cancer and leukemia affect over 2 million people annually. The Company is dedicated to discovering and developing oncology therapies of different mechanisms of action to inhibit cancer. Its diverse portfolio of innovative drug candidates for treating difficult-to-treat cancers includes precision therapy targeting tumors with specific mutations, as well as assets addressing broader cancer conditions. The Company’s pipeline of nine clinical, preclinical and discovery drug candidates has the potential to improve treatment of a number of tumor types. Upon the closing of the transaction, Apollomics will continue to be led by current Chairman and CEO, Dr. Guo-Liang Yu, Ph.D., a serial entrepreneur, and his team. Dr. Yu is a pharmaceutical researcher with more than 300 patents. “Apollomics’ announcement represents the next major milestone on our journey to provide solutions for patients with difficult-to-treat cancers,” Dr. Yu said. “We anticipate that the funds available to us from this transaction will help us accelerate development of our oncology pipeline.” Apollomics expects results from its global Phase 2 multi-cohort clinical trial of vebreltinib in NSCLC and other solid tumors with cMET dysregulation in 2023, which the Company believes may support its first New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) while generating clinical data for different indications. In addition, the Company expects to complete patient recruitment of its uproleselan Phase 3 study in China in 2023. “Our goal was to find an exciting company with a growing pipeline of innovative product candidates that could positively affect the lives of millions of people. Our team is excited to combine with Apollomics as it has met and exceeded all our key selection criteria. Together with Apollomics, Maxpro will do everything we can to support the Company’s vision of treating patients with difficult-to-treat cancers.” Moses Chen, CEO of Maxpro About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics currently has a pipeline of nine drug candidates across multiple programs, six of which are currently in the clinical stage of development. Apollomics’ lead programs include investigating its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and developing an anti-cancer enhancer drug candidate, uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. About Maxpro Capital Acquisition Corp. Maxpro is a blank check company formed for the purposes of effecting a merger, capital share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in the healthcare and technology industries. In October 2021, Maxpro consummated a $103.5 million initial public offering of 10.35 million units (including the underwriters’ full exercise of their over-allotment option), each unit consists of one share of Class A common stock and one redeemable warrant, each warrant entitles the holder to purchase one share of Class A common stock at a price of $11.50 per share. EF Hutton, division of Benchmark Investments LLC, served as the sole book-running manager of Maxpro’s initial public offering.

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BUSINESS INSIGHTS

Novo Nordisk to acquire Forma Therapeutics and expand presence in sickle cell disease and rare blood disorders

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. About etavopivat 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.

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BUSINESS INSIGHTS

IntegriChain Partners with PurpleLab to Enhance Pharmaceutical Channel Data for More Accurate GTN Forecasting and Accruals

IntegriChain | November 18, 2022

IntegriChain, delivering pharma's only comprehensive technology, data, consulting, and outsourcing platform for data-driven commercialization, announced a strategic data partnership with PurpleLab, a healthcare technology company delivering analytics to drive real-world evidence decision-making. As a first step to this partnership, IntegriChain will incorporate PurpleLab prescription drug claims data to address challenges in visibility to demand and inventory that has resulted from evolving pharmaceutical channels for new specialty pharmaceutical products. "As the Pharma industry has shifted to more fragmented non-retail therapies such as specialty lite and specialty self- and HCP-administered products, distribution channels are more diverse and complicated. These new channels have visibility gaps that create unreasonable risk of errors in gross-to-net forecasting and accrual management. PurpleLab data – covering more than 350 million patient lives, 4 billion annual claims, and 98% of payers – enhances our ability to deliver true demand and inventory visibility, more accurate gross-to-net forecasting and accruals, and most importantly data-driven commercialization for specialty products to Pharma commercial and financial teams." Gary Palgon, IntegriChain's General Manager and Senior Vice President, Data Solutions With this partnership, IntegriChain will seamlessly integrate PurpleLab pharmacy and medical claims data into the ICyte platform and the Inventory Analytics product, improving demand and inventory visibility to actual dispensing volumes at the site of dispense or administration. This data integration will deliver a more accurate depiction of demand attributed to individual outlets, ensuring a closer alignment between net sales and demand at a channel and more accurate pipeline inventory calculations. In addition, IntegriChain will deliver increased fidelity of national and subnational datasets for targeting by incorporating PurpleLab data into ICyte's unblinding process. The seamless addition of PurpleLab data into the ICyte Platform will be generally available in ICyte Inventory Analytics in January 2023. Additional future data enhancements will be announced in due course. About ICyte Data Solutions IntegriChain offers a full suite of channel data products, including: Channel Data Aggregation: Aggregation of all channel and distribution datasets including ExFactory Sales, Distributor Inventories, Demand, and Returns to deliver the highest quality master data, including industry-leading data science and enrichment algorithms to deliver end-to-end views of product distribution. Inventory Analytics: Manufacturers have few existing measures of the inventory held in retail stores, distribution centers, and third-party returns processors. IntegriChain Inventory Analytics reports 100% of inventory in the retail channel, even in pharmacy stores and distribution centers that do not report their inventories. Distribution Contract Management: Distribution Contract Management is a single, auditable application for managing all aspects of trade partner agreements. Configurable trade partner scorecard functionality features payment adjudication, custom pay-for-performance metrics, payment roll forward, and top- and bottom-line functionality adjustments. Channel Data Consulting Services: Based on IntegriChain pioneering the field of channel data aggregation, stewardship, and advanced analytics, the Channel Insights and Optimization practice delivers Market Demand Analysis, Class of Trade, Downstream Inventory Analytics, Returns Forecasting, and Revenue Analytics consulting services to Pharma manufacturers of all types and sizes. About PurpleLab PurpleLab is a healthtech company with a mission to spur value-driven innovation in healthcare to improve outcomes for patients. HealthNexus™, the company's no-code analytics platform empowers life sciences, payers, providers and other stakeholders with real-world evidence to solve conventional and emerging challenges faster and more cost effectively. About IntegriChain IntegriChain delivers pharma's only comprehensive technology, data, consulting, and outsourcing platform for market access departments. We provide the strategy and operational execution for data-driven product commercialization and market access. More than 400 manufacturers rely on our consulting expertise and ICyte Platform to orchestrate their prescription management, patient data management, inventory and demand visibility, enterprise GTN technology, and platform insights. ICyte is the first and only platform that unites the financial, operational, and commercial data sets required to support commercialization and access in the era of specialty and precision medicine.

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