Glucagon-like peptide-1 ( MannKind Corporation)

Bagsværd, Denmark, 4 June 2021 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy™ (the brand name for once-weekly semaglutide 2.4 mg injection in the US) for chronic weight management. Wegovy™ is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity. Wegovy™ is the first and only once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist   therapy approved for weight management for people living with obesity. The approval is based on the results from the STEP phase 3a clinical trial programme. Across the trials in people without type 2 diabetes, an average weight loss of 17-18%1 sustained over 68 weeks was reported for people with obesity treated with Wegovy™. Wegovy™ demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal. “The approval of Wegovy™ in the US brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favour weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy™ available to people living with obesity in the US”. Novo Nordisk expects to launch WegovyTM in the United States later in June 2021. Conference callOn 7 June at 8.30 CEST, corresponding to 2.30 am EDT, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com. About obesityObesity is a chronic disease that requires long-term management. It is associated with many serious health complications and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and certain types of cancer. The current COVID-19 pandemic has highlighted that obesity also increases the risk for severe illness and hospitalisation due to COVID-19. The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. Approximately 650 million adults are estimated to live with obesity worldwide. About Wegovy™ (semaglutide 2.4 mg) and STEPSemaglutide 2.4 mg is a GLP-1 receptor agonist, with 94% similarity to naturally occurring human GLP-1 hormone. It induces weight loss by reducing hunger, increasing feeling of fullness and thereby helping people eat less and reduce their calorie intake. Once-weekly semaglutide 2.4 mg injection is approved for the treatment of adults with obesity or overweight in the US, in addition to diet and exercise. Semaglutide 2.4 mg for weight management is currently under regulatory review in the EU and other countries. The submissions are based on the results from the STEP (Semaglutide Treatment Effect in People with obesity) phase 3 clinical development programme. The global clinical phase 3a programme consists of four trials and enrolled approximately 4,500 adults with overweight or obesity. 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 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube. Further information Company announcement No 38 / 2021 1 Based on the trial product estimand (secondary statistical approach): treatment effect if all people adhered to treatment and did not initiate other anti-obesity therapies. When using a treatment policy estimand, 15-17% weight loss was reported. Attachment

LYON, France, May 26, 2021 (GLOBE NEWSWIRE) -- Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical company specialized in the development of innovative formulations of proteins and peptides announced today that three patent families have been filed for the treatment of metabolic diseases including obesity, NASH (Non-Alcoholic Steato-Hepatitis), type 2 diabetes and neurodegenerative disorders. These patents relate to combinations of short-acting hormones administered via pump. First preclinical results obtained in obese mice population by a combination of glucagon-exenatide (BioChaperone® GluExe) show a weight loss of 25% versus 15% with exenatide alone after 14 days of treatment1. A second combination of pramlintide and exenatide (PramExe), currently in development, also presents promising properties. The pumps used are those already marketed for insulin therapy, and in particular patch-pumps, which are easy to use and suitable for this purpose. The user can adjust the maximal tolerable dose and therefore optimize the benefit/risk balance. "We want to establish a new therapeutic paradigm for chronic diseases such as obesity, allowing patients greater control over their treatment,” explained Gérard Soula, Adocia’s CEO. "Our vision is to empower people by helping them to regain control of their illness, by enabling them to adjust doses in real time with the help of modern pumps and connected devices for better adherence to long-term treatments. This is where the future is heading: personalized medicine and patient empowerment.” Adocia is offering a disruptive therapeutic approach by infusing short-acting hormones via a pump so that patients can easily and quickly adjust the doses administered, in contrast to the current way of thinking which is to extend the duration of action of hormones to offer weekly injections. One of the disadvantages of long-acting hormones is the impossibility to interrupt the side effects - particularly gastrointestinal - which can sometimes last several days after administration. Pharmaco-epidemiological studies on the use of once-weekly GLP-1 hormones in type 2 diabetes reveal that 48,0% of patients stop treatment after one year, while 73,2% stopped after two years2. Pump-infusion opens a number of perspectives: “Our expertise on diabetes hormones and the potential of insulin pumps led us to expand applications to other chronic diseases,” comments Olivier Soula, Deputy CEO and Director of R&D at Adocia. "Our next objective is to establish clinical proof-of-concept with good tolerance and efficacy of PramExe administered via pump, while being well-accepted by people suffering from obesity." PramExe is a fixed-ratio co-formulation of an amylin analog (pramlintide) and a GLP-1 receptor agonist (exenatide). Pramlintide and exenatide are two hormones marketed for the treatment of diabetes and have already demonstrated separately positive effects on weight loss and satiety. Adocia’s innovation lies in combining weight loss effects of these two compounds administered with a wearable pump. Adocia’s PramExe combination is ready to be clinical tested in humans. About obesity and treatments More than 650 million people worldwide, are obese (BMI≥30 kg/m²) according to the official classification of the World Health Organization (WHO), which declares obesity a chronic disease and a major public health problem since 19972. According to the WHO, 2.8 million people die each year worldwide as a result of being overweight or obese. Currently only 2% of patients suffering from obesity are medicated3 and only hormonal treatments appear as a possible alternative to bariatric surgery. About Adocia Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of therapeutic proteins and peptides for the treatment of diabetes and metabolic diseases. In the diabetes field, Adocia’s portfolio of injectable treatments is among the largest and most differentiated of the industry, featuring five clinical-stage products and several pre-clinical products. The proprietary BioChaperone® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone® to each protein for a given application. Adocia’s clinical pipeline includes four novel insulin formulations for prandial treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone® Lispro U100 and U200), a combination of basal insulin glargine and rapid acting insulin lispro (BioChaperone® Combo) and one combination of a prandial insulin with amylin analog pramlintide M1Pram. The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone® Glucagon) for the treatment of hypoglycemia. Adocia preclinical pipeline includes bi-hormonal combinations for diabetes treatment: two combinations of rapid acting insulin analogs and Pramlintide (BioChaperone® Lispro Pram and BioChaperone® Aspart Pram), a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone® Glargine Liraglutide). In addition, there are two bi-hormonal products for the treatment of obesity: a combination of glucagon and exenatide (BioChaperone® GluExe) and a combination of pramlintide and exenatide (PramExe). Adocia recently added a preclinical program to its pipeline with a cell therapy initiative focused on development of a hydrogel scaffold for use in people with type 1 diabetes. The first patent application supporting this program has been filed. Contact Adocia Disclaimer 1 2019 ADA - poster presentation, 7/11/2019 2 3 Novo Nordisk 2020 Annual report