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Post by jbe on May 31, 2017 18:03:17 GMT -5
I think United Arab Emirates is still in play, so this Brazil news is just a bonus...
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Post by boca1girl on May 31, 2017 18:10:28 GMT -5
This link also says the approval process takes about 9 months. I wonder if the approval process is already underway? The one thing that someone else already mentioned is that the distributor will be responsible for pricing. I hope they price it competitively, unlike SNY. Will MNKD just be the manufacturer/wholesaler and sell at a fixed (volume based) price? Very encouraging announcement and hope there are many more to come shortly.
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Post by otherottawaguy on May 31, 2017 18:22:08 GMT -5
Wondering about the dollars of the deal. No mention of funding as of yet. Assuming 9 months till approval this will have no effect on MNKD bottom line unless there is some money up front.
Does the company do another round of dilution to raise funds when this news raises the price up over 2.00?
Be interested to know what MNKD revenue will be in this jurisdiction. Once in will the product migrate across borders increasing the potential market. What percent of the population can afford the drug?
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Post by n8 on May 31, 2017 18:25:50 GMT -5
Great storms are announced by a simple breeze....
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Post by mytakeonit on May 31, 2017 18:25:51 GMT -5
Wondering about the dollars of the deal. No mention of funding as of yet. Assuming 9 months till approval this will have no effect on MNKD bottom line unless there is some money up front. Does the company do another round of dilution to raise funds when this news raises the price up over 2.00? Be interested to know what MNKD revenue will be in this jurisdiction. Once in will the product migrate across borders increasing the potential market. What percent of the population can afford the drug? I hope the percentage isn't that great ... well definitely under 15M ... because we need to start building another production plant ... SOON! Canada next? Or China? Or Mexico? Or the Moon? ?? Better build 2 more plants to be safe. And to N8 ... "pfffft"
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Post by kc on May 31, 2017 18:41:37 GMT -5
Job well done by MannKind Management team. They made a real deal with a big player in the Brazil marketplace.
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Post by anderson on May 31, 2017 18:49:52 GMT -5
This link also says the approval process takes about 9 months. I wonder if the approval process is already underway? The one thing that someone else already mentioned is that the distributor will be responsible for pricing. I hope they price it competitively, unlike SNY. Will MNKD just be the manufacturer/wholesaler and sell at a fixed (volume based) price? Very encouraging announcement and hope there are many more to come shortly. 9 months? Is that with or without fast-track? www.jmcinc.net/brazil-oks-fast-track-assessment-for-device-and-pharma-trial-applications/Brazil OKs fast-track assessment for device and pharma trial applications by JMC on July 6, 2012 Brazil’s regulatory agency, Anvisa, has announced that proposals to fast-track the licensing-assessment of a large proportion of applications for clinical trials of drugs and medical devices have received approved1. Pending the formal publication of the enacted resolution by Anvisa and the precise detail of the policy, the government has issued a statement confirming that applications involving trials already approved in the EU, US, Japan, Australia or Canada will be fast-tracked, said Anvisa…
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Post by akemp3000 on May 31, 2017 19:01:11 GMT -5
This is of course excellent news. If they can follow up quickly with something being done in the Middle East I think there will be a lot of sweat mopped off the brow of us long shareholders. I left out "suffering" but that goes without saying. I have no knowledge of how Kingdoms/Royalties work when it comes to doing pharma deals but the Gulf countries, Kingdom of Saudi Arabia, have state-run Healthcare systems. I thought they might be able to make bulk purchases of insulin and maybe help with the cash Runway. Dreaming. You mean like a 10.5 ton shipment to Abu Dhabi. Sounds like there's quite a bit of dreaming going on. Not a bad thing
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Post by promann on May 31, 2017 19:03:38 GMT -5
You gotta think part of making a deal like this where a company is going to invest a lot of time and money to set up distribution of Afrezza in another country that they were assured Afrezza will be available when it's required . Weather it's 9 months or not there is a plan in place where we will be able to sell Afrezza at the date and time needed. Rest assured big companies don't make deals like this if they think the company they are dealing with will be bankrupt. So. I don't care what any naysayers say Afrezza and MannKind is here to stay and will be a huge success. Congrats to all the hard working people at MNKD. Well done..
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Post by mnholdem on May 31, 2017 19:04:29 GMT -5
The proposed fast-tracking is encouraging, especially because insulin(human) has been around a long time.
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Post by akemp3000 on May 31, 2017 19:05:33 GMT -5
Would like to hear a Middle East deal next...then be a fly on the wall in the Sanofi board room!
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Post by porkini on May 31, 2017 19:19:30 GMT -5
I wonder who negotiated the deal? MC or MP? Mannkind hired someone a couple of months ago who's qualifications were for international expansion. Perhaps from Amgen.... I would have to dig it up.
How about Stuart Tross? Quote: The addition of his wide-ranging experience will be transformational at MannKind," said Mr. Pfeffer. "Stuart's experience will not only facilitate a quick and efficient expansion of our Afrezza launch capability, but he will be instrumental in building an organization to accommodate other strategic initiatives, such as product development and global expansion." Source: investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1006312
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Post by sayhey24 on May 31, 2017 19:27:40 GMT -5
Very exciting times ahead for MNKD. During one of the tours I have taken through the factory some very nice QA people where answering questions. I had a number of questions on refrigeration and stability. Based on what I was told I suspect similar tests have already been done and this requirement is not an issue. Whether these tests will apply to afrezza since it is currently spec'ed to require refrigeration, I doubt. However, it would be nice to seem them remove the refrigeration from it especially since it actually works better for the inhaler when not cold. It doesn't clump and you get more insulin into the lungs.
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Post by kc on May 31, 2017 19:28:14 GMT -5
This link also says the approval process takes about 9 months. I wonder if the approval process is already underway? The one thing that someone else already mentioned is that the distributor will be responsible for pricing. I hope they price it competitively, unlike SNY. Will MNKD just be the manufacturer/wholesaler and sell at a fixed (volume based) price? Very encouraging announcement and hope there are many more to come shortly. 9 months? Is that with or without fast-track? www.jmcinc.net/brazil-oks-fast-track-assessment-for-device-and-pharma-trial-applications/Brazil OKs fast-track assessment for device and pharma trial applications by JMC on July 6, 2012 Brazil’s regulatory agency, Anvisa, has announced that proposals to fast-track the licensing-assessment of a large proportion of applications for clinical trials of drugs and medical devices have received approved1. Pending the formal publication of the enacted resolution by Anvisa and the precise detail of the policy, the government has issued a statement confirming that applications involving trials already approved in the EU, US, Japan, Australia or Canada will be fast-tracked, said Anvisa… The partner may already have it approved since diabetes is it epidemic proportions in Brazil. BIOMM is a known insulin producer in the country. It's their business. I bet you they get this fast tracked if not handled already.
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Post by mnkdfann on May 31, 2017 19:28:50 GMT -5
The one thing that someone else already mentioned is that the distributor will be responsible for pricing. I hope they price it competitively, unlike SNY. [Quotes below are from various online sources.] Lots of issues to deal with in Brazil, when it comes to drugs. "Despite the financial troubles facing the country, Brazil's federal government announced that as of January 1, 2017 the minimum wage will increase to R$937.00 per month (US$287.89), which corresponds to R$4.26 per hour or R$31.23 per day." So safe to say Mannkind won't be charging an arm and a leg. At least not to people who have to pay out of pocket. "Brazil is among the greatest consumers markets for drugs, accounting for 3.5% share of the world market." But the push in Brazil is for inexpensive generic drugs. "To expand the access of the population to drugs, incentives have been offered for marketing generic products, which cost an average of 40% less than brand-name products. In 2000, there were 14 industries authorized to produce generic drugs and about 200 registered generic drugs were being produced in 601 different forms." This link mentions the high cost of non-generic drugs and devices, and the difficulty Brazilians have gaining access to them: plus55.com/brazil-business/2017/02/healthcare-in-brazil-legal-matterBut when they do get access, the state often has to pay. "As most patients are expected to win their cases, pharmaceutical companies have boosted their prices. They follow a simple but perverse logic: if the state is going to pay, then the sky is the limit for pricing. Take insulin pumps, for example. A few decades ago, they would have cost almost as much as a small car. Pharmaceutical companies would encourage patients to file lawsuits against the government."
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