'Envlo' of Daewoong Pharmaceutical, to be launched in the global markets entering the 1.54 billion USD Market in Brazil and Mexico

• A contract signed with 'M8 Pharmaceuticals', a partner in Brazil and Mexico planning to begin sales by 2024
• Entry into the 1.54 billion USD diabetes market in Brazil and Mexico, the largest markets in Latin America

SEOUL, South Korea, Feb. 24, 2023 /PRNewswire/ -- Daewoong Pharmaceutical announced that the launching of their national new drug #36, 'Envlo(ingredient: Enavogliflozin)' in the global market.

On the 24^th February, Daewoong Pharmaceutical (CEO Seng-ho Jeon and Lee Chang-jae) has announced the conclusion of the export contract in Brazil and Mexico of 'Envlo', the SGLT2 enzyme inhibitor type new drug for diabetes on the 24^th. With this export contract with Brazil and Mexico as their stepping-stone, Daewoong Pharmaceutical will actively target the global market in the future. The local partner is 'M8 Pharmaceuticals' (CEO Joel Barlan).

Brazil is a country with the second largest number of diabetic patients after China, India, and the United States, and according to data from global market research firm IQVIA, the diabetes market in both countries is about 1.54 billion USD, accounting for 70% of the entire diabetes market in Central and South America.

The size of the contract will be approx. 84.36 million dollars (approx. KRW 108.2 billion) including royalties and they are aiming to start sales by the late 2024 followed by swift local approval in this year. With this contract, Daewoong Pharmaceutical will provide Envlo to M8 Pharmaceuticals, their local partner, and M8 Pharmaceuticals will be in charge of sales within Brazil and Mexico. Also, both parties will continue to cooperate in an evidence-based market strategy.

M8 Pharmaceuticals is a specialized pharmaceutical company experienced in successful sales of various global pharmaceutical products for digestive systems, cardiovascular systems and central nervous systems, covering all of Brazil and Mexico with not only its hospital and clinic network but also rapid growth as 48% for average in five years. Their past partnership with Daewoong Pharmaceutical consists of local sales of Botulinum toxin 'Nabota' in Brazil which leads 3^rd rank in market share for Brazil within only two years after release and sales of gastro-oesophageal reflux medicine 'Fexuclue Tablet' and hypertension and dyslipidemia medicine 'Olostar' in Mexico and Brazil. The main office of M8 Pharmaceuticals is located in Philadelphia, US, with branches in Brazil and Mexico.

Envlo is a SGLT2(sodium glucose cotransporter 2) inhibitor type diabetes treatment and last November, Daewoong Pharmaceutical has become the first Korean company to achieve its successful development. Phase 3 clinical trials have been performed on type 2 diabetes patients with excellent blood sugar level drop effects. The safety of Envlo has been confirmed and moreover, it has been proven to show equal medicinal effect with only 0.3mg which is 1/30 of the amount of existing SGLT2 inhibitor and is showing promise as a new option of treatment for patients who were unsatisfied with the blood sugar controls. In addition, the proportion of patients with a glycated hemoglobin reduction of more than 0.5% compared to before treatment also recorded up to 82.9%, compared to the 40-60% level of drugs in the same class.

Envlo, which showed effects on weight loss, blood pressure reduction, lipid profile improvement, and insulin resistance improvement, as well as excellent blood sugar lowering and proteinuria improvement effects compared to the same class of drugs in type 2 diabetic patients with reduced renal function, was found in patients with insufficient blood sugar control. It is expected to be a new treatment option for patients. Currently, there are three indications secured: monotherapy, metformin combination therapy, metformin and gemigliptin combination therapy.

In development, Envlo has been dedicated as the first rapid test item by the Ministry of Food and Drug safety in 2020, thus various core items of system such as GIFT (Global Innovative products on Fast Track) could be applied after approval request, enabling swift review and the success of development. With this export contract with Brazil and Mexico as their stepping-stone, Daewoong Pharmaceutical is planning to pick up their advancement to other overseas markets such as Saudi Arabia, Russia and China with Envlo.

CEO Seng-ho Jeon from Daewoong Pharmaceutical stated "This contract with M8 is an example proving that Daewoong Pharmaceutical's synthetic new drugs such as Fexuclue and Envlo, are recognized as global blockbusters" and "With this contract in Central and South America as the starting point, we expect that the 36th domestically produced new drug Envlo will expand its entry into the global market in the future."

Joel Barlan, the CEO of M8, stated that "We are delighted to continue to strengthen our strategic partnership with Daewoong and see a large opportunity to address the unmet needs of millions of Latin Americans suffering from diabetes, by bringing a product like Envlo™® to the SGLT2 market with the potential to be best-in-class".

About M8 PHARMACEUTICALS

M8 is a specialty biopharmaceutical company focused on licensing, marketing and distributing innovative and established therapeutics in Latin America: Brazil and Mexico. We aim to become the preferred pharmaceutical partner for the licensing of high-value innovative and proven therapies across our main therapeutic areas CNS, Respiratory, Cardiometabolic, Immunology, Gastroenterology, Onco-hematology and Rare Diseases. Our mission is to provide the people of Latin America with access to the proven and innovative medicines they need to transform their lives.

SOURCE Daewoong Pharmaceutical Co., Ltd.