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Post by porkini on May 31, 2017 17:03:35 GMT -5
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Post by harryx1 on May 31, 2017 17:04:52 GMT -5
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Post by sla55 on May 31, 2017 17:07:11 GMT -5
investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1028526VALENCIA, Calif. and BELO HORIZONTE, Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos. Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil. "We are pleased to partner with Biomm to bring Afrezza to the Brazilian diabetes market," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "Our founder, Alfred Mann, had a vision to reduce the global burden of diabetes through novel technologies. In 2015, more than 14 million people were estimated to have diabetes in Brazil. Given Biomm's presence and knowledge of the diabetes market in Brazil, we believe that Biomm is the ideal partner to reach healthcare providers and patients with the message that there is another potential option in their fight against diabetes." "As a pioneering biotechnology company in Brazil, we believe that we can leverage our current portfolio of diabetes products to offer another option to the significant and growing numbers of patients with diabetes," said Heraldo Marchezini, Diretor Presidente/CEO of Biomm SA. "We are proud to be the first company to bring inhaled mealtime insulin to the Brazilian market." ABOUT MANNKIND CORPORATION MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website. ABOUT BIOMM SA Biomm SA company (BOVESPA:BIOM3) is the First Brazilian Biopharmaceutical Company and the only human biotech company listed on the Brazilian BOVESPA Stock Exchange. The company is committed to making difficult to treat chronic diseases more cost effective, thereby improving the quality of life for patients. With innovation in its DNA, Biomm is pioneer in biotechnology and in the production of insulin in Brazil. Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind's ability to directly commercialize pharmaceutical products. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to obtain regulatory approvals, the ability to get satisfactory pricing terms from regulators and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
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Post by therealisaching on May 31, 2017 17:07:34 GMT -5
Huzzah!
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Post by comny on May 31, 2017 17:12:01 GMT -5
Because of the local climate, Brazil wants to see additional drug stability data (which is used to determine the drug shelf-life) at 30C and 75% relative humidity.
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Post by mnholdem on May 31, 2017 17:14:04 GMT -5
MNKD after hours trading is soaring at 11% with 300k shares in just less than an hour.
From the BIOMM website - History
1983 - PRODUCTION AND FORMULATION OF HIGHLY PURIFIED INSULINS
Development of highly purified insulins and formulation of injectable insulin, i.e. ready to be used. 4A. LARGEST INTEGRATED INSULIN PRODUCER IN THE WORLD Biobrás conquers new markets, diversifying its product line. Herewith, it became the 4th largest insulin producer in the world and the largest in Latin America, selling to over 25 countries a complete line of drugs in cardiology and endocrinology.
2001 - BIOMM FOUNDATION
Biobrás is split and part of it is named Biomm, into which is transferred all the intellectual property, know-how, researchers and executives who made Biobrás the fourth largest producer of insulin in the world.
2002 - SALES OF CORPORATE CONTROL OF BIOBRÁS
The shareholder control of Biobrás was sold to Novo Nordisk, having Biomm remained under control of the same entrepreneurs who in 1975 had the vision of mastering biotechnology. This group led the development of biotechnology applied to health in Brazil.
TODAY - NEW BUSINESSES
All Biomm technology produced on national soil is available for patent licensing to companies interested in insulin production.
Today, Biomm is a pioneer in processes and production of biotechnological products for industrial applications, with more than 30 years of experience in biotechnology and high investments in new markets and technological development.
Thus, the company integrates a network of innovation with the vast experience of institutions in Brazil and worldwide.
In addition, the company seeks partnerships to include more innovative products.
Source: www.biomm.com/About/History
---
In 1983, under a different company name, they were selling " a complete line of drugs in cardiology and endocrinology". Unless I'm reading this incorrectly, in 2001 Biobras was split into two entities. IN 2002 Novo Nordisk apparently got control of the manufacturing arm (Biobras) while all the intellectual property, researchers and executives went to Biomm.
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Post by liane on May 31, 2017 17:15:59 GMT -5
Because of the local climate, Brazil wants to see additional drug stability data (which is used to determine the drug shelf-life) at 30C and 75% relative humidity. Where do you see that? |
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Post by tw12 on May 31, 2017 17:16:30 GMT -5
From the report of The Diabetes Summit on Latin America, held in Bahia, Brazil, in 2010:
"Brazil is experiencing a series of transitions, cutting across the whole of Brazilian society and having a huge impact in the health sector. The first of these transitions is a demographic one. Brazil is doing in 50 years what Europe took 100 years to do. The differences and inequalities that persist in Brazilian society mean that the chronic diseases associated with affluence exist side by side with the problems of underdeveloped countries. As the structure of the Brazilian family evolves, the average family’s pattern of consumption is changing, with a tendency to eat more foods with a high concentration of sodium, sugar and fat.
This is reflected in the illnesses suffered and causes of death of Brazilian citizens. The most recent research shows that 40% of the Brazilian population are overweight and 15% are obese. It is estimated that 11 million people have diabetes, of whom 7.5 million are aware of their diagnosis."
Estimates of T2 in Brazil are now about 15 million people.
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Post by avi8torslc on May 31, 2017 17:19:51 GMT -5
VALENCIA, Calif. and BELO HORIZONTE, Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) (MNKD) and BIOMM SA (BIOM3.SA) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos. Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil.
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Post by cannon5974 on May 31, 2017 17:20:13 GMT -5
Anyone have any idea of how the income/revenue from the sale of Afrezza will be split between the 2 companies?
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Post by ilovekauai on May 31, 2017 17:22:00 GMT -5
Fantastico!!! Now that's what I'm talking about! And, more to come soon IMO! The rock is raised, no need to hide from the other side anymore now, and at last they find themselves on the run! Awesome. Love it! Aloha!!!!!!!
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Post by babaoriley on May 31, 2017 17:26:06 GMT -5
Do get too excited, people, tomorrow's headline may read:
"Sanofi to acquire BIOMM SA"
On a bit more serious note, anyone know how long the process is way down south?
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Post by avi8torslc on May 31, 2017 17:28:47 GMT -5
Correction....going to be in Brazil
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Post by mango on May 31, 2017 17:28:55 GMT -5
Who is Biomm? Let's meet them shall we? The Biomm Timeline• 1975 PRODUCTION PIONEERS IN BRAZIL INSULINBiobrás and Eli Lilly & Co (USA) form a joint venture, which is a pioneer in insulin production in Brazil. Insulin crystals are produced in Montes Claros and marketed worldwide. The Biobrás is inspected and approved by the US FDA •1979 PRODUCTION PIONEERS IN BRAZIL INSULINBiobrás and Eli Lilly & Co (USA) form a joint venture, which is a pioneer in insulin production in Brazil. Insulin crystals are produced in Montes Claros and marketed worldwide. The Biobrás is inspected and approved by the US FDA • 1983 PRODUCTION AND FORMULATION OF HIGHLY PURIFIED INSULINSDevelopment of highly purified insulins and formulation of injectable insulin, i.e. ready to be used. 4A. LARGEST INTEGRATED INSULIN PRODUCER IN THE WORLD Biobrás conquers new markets, diversifying its product line. Herewith, it became the 4th largest insulin producer in the world and the largest in Latin America, selling to over 25 countries a complete line of drugs in cardiology and endocrinology. • LATE 90’S HUMAN RECOMBINANT INSULINBiobrás concludes its technological development in recombinant human insulin production. After taking all manufacturing processes to an industrial scale, the first patent was obtained in 2000. • 2001 BIOMM FOUNDATIONBiobrás is split and part of it is named Biomm, into which is transferred all the intellectual property, know-how, researchers and executives who made Biobrás the fourth largest producer of insulin in the world. • 2002 SALES OF CORPORATE CONTROL OF BIOBRÁS The shareholder control of Biobrás was sold to Novo Nordisk, having Biomm remained under control of the same entrepreneurs who in 1975 had the vision of mastering biotechnology. This group led the development of biotechnology applied to health in Brazil. • Today NEW BUSINESSES All Biomm technology produced on national soil is available for patent licensing to companies interested in insulin production. Today, Biomm is a pioneer in processes and production of biotechnological products for industrial applications, with more than 30 years of experience in biotechnology and high investments in new markets and technological development. Thus, the company integrates a network of innovation with the vast experience of institutions in Brazil and worldwide. In addition, the company seeks partnerships to include more innovative products. www.biomm.com/About/History#timeline |
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Post by mango on May 31, 2017 17:29:48 GMT -5
Sorry just saw Holdem beat me to it
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