MannKind Corporation (NASDAQ:MNKD) and BIOMM announced the submission of a registration dossier to ANVISA, seeking the approval of Afrezza® (insulin human) inhalation powder in Brazil.
The registration dossier includes recently updated prescribing information for Afrezza, incorporating new clinical data describing the rapid time-action profile of Afrezza.
“We are excited to file our first international application for approval of Afrezza in Brazil, which is in the top ten countries with the highest diabetes rates in the world according to the World Health Organization,” said Michael Castagna, Chief Executive Officer of MannKind Corporation. “BIOMM’s expertise in the diabetes market allowed the dossier to be updated quickly with the revised prescribing information, thereby providing physicians and patients, if and when Afrezza is approved in Brazil, with accurate information to achieve better glycemic control at mealtime.”
BIOMM, the first Brazilian biopharmaceutical company, is responsible for registering the product with ANVISA. After approval, the drug will be submitted to CMED (the Brazilian drug price control agency) for release, after which MannKind will supply Afrezza to BIOMM, who will be responsible for the promotion, distribution and sales of Afrezza in Brazil.
“We intend to offer Brazilian patients an important technological innovation. Like all chronic diseases, diabetes needs prolonged adherence to treatment. Therefore, more comfortable and effective options may be a differentiating attribute that has the potential to contribute to the quality of life of the patient,” said Heraldo Marchezini, Chief Executive Officer of BIOMM SA.
Corporate Presentation September 2017
Shares of MannKind closed on Friday at $4.11, up $0.15 or 3.79%. MNKD has a 1-year high of $6.96 and a 1-year low of $0.67. The stock’s 50-day moving average is $3.19 and its 200-day moving average is $1.78.
On the ratings front, MNKD stock has been the subject of a number of recent research reports. In a report issued on October 10, H.C. Wainwright analyst Oren Livnat initiated coverage with a Buy rating on MNKD and a price target of $7, which represents a potential upside of 70% from where the stock is currently trading. On October 9, Maxim’s Jason Kolbert maintained a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Oren Livnat and Jason Kolbert have a yearly average loss of -7.6% and -7.1% respectively. Livnat has a success rate of 36% and is ranked #4171 out of 4703 analysts, while Kolbert has a success rate of 35% and is ranked #4629.
MannKind is a biopharmaceutical company. It focuses on the discovery, development and commercialization of therapeutic products for diseases, such as diabetes and cancer.