|
Post by seanismorris on May 9, 2018 15:06:09 GMT -5
I see why MannKind made the India announcement..
MannKind (NASDAQ:MNKD): Q1 EPS of -$0.25 misses by $0.02.
Revenue of $3.5M (+16.3% Y/Y) misses by $0.74M.
Shares -1.7%.
|
|
|
Post by kc on May 9, 2018 15:07:29 GMT -5
China market is poor too. They biggest issue is getting into a market. China has more high income people, and China has IP protection for drugs. It's easier to command higher selling prices for imported drugs. Sadly both countries are known for copycat products. I would hope that we have adequate protection going forward there iand anywhere else the company might sell products
|
|
|
Post by seanismorris on May 9, 2018 15:13:33 GMT -5
China has more high income people, and China has IP protection for drugs. It's easier to command higher selling prices for imported drugs. Sadly both countries are known for copycat products. I would hope that we have adequate protection going forward there iand anywhere else the company might sell products There is no “adequate protection” in China. They steal IP like kids steal cookies. Unfortunately I know that firsthand with another investment...
|
|
|
Post by digger on May 9, 2018 16:00:12 GMT -5
China's population is approximately the same as India: why would a Chinese company be required to pay more than the India company? What happened to regional partner Mike hoped for? I agree. I almost think it would have been better to walk away from it than accept just 2 million. I have to suspect that any other potential partner is going to demand the same deal.
|
|
|
Post by dreamboatcruise on May 9, 2018 21:04:47 GMT -5
China has more high income people, and China has IP protection for drugs. It's easier to command higher selling prices for imported drugs. Sadly both countries are known for copycat products. I would hope that we have adequate protection going forward there iand anywhere else the company might sell products Actually I hope that they've not patented every important aspect of manufacturing, so that some know how is kept as undisclosed trade secrets. MNKD undoubtedly has tons of experience with FDKP manufacturing that others would not have.
|
|
|
Post by Omega on May 9, 2018 21:28:37 GMT -5
China's population is approximately the same as India: why would a Chinese company be required to pay more than the India company? What happened to regional partner Mike hoped for? I agree. I almost think it would have been better to walk away from it than accept just 2 million. I have to suspect that any other potential partner is going to demand the same deal. While im disappointed with the upfront $, we don't know what $ is waiting in milestone payments for either the India or Brazil deals.
|
|
|
Post by straightly on May 9, 2018 23:42:10 GMT -5
Sadly both countries are known for copycat products. I would hope that we have adequate protection going forward there iand anywhere else the company might sell products There is no “adequate protection” in China. They steal IP like kids steal cookies. Unfortunately I know that firsthand with another investment... That is why I believe MNKD would go for a front loaded deal: Selling the marketing and distributing rights to the Indians and Chineses. If IP can be protected, good for them. If not, shame on them. MNKD can and should be content with Afrezza success in US. We should shoot for money to get us there.
|
|
|
Post by seanismorris on May 10, 2018 0:52:58 GMT -5
There is no “adequate protection” in China. They steal IP like kids steal cookies. Unfortunately I know that firsthand with another investment... That is why I believe MNKD would go for a front loaded deal: Selling the marketing and distributing rights to the Indians and Chineses. If IP can be protected, good for them. If not, shame on them. MNKD can and should be content with Afrezza success in US. We should shoot for money to get us there. Unfortunately in these countries they want the product to be produced locally to have the right to be sold there. That means Afrezza would need to be produced in China to be sold in China (for example). There’s nothing particularly special about Afrezza. With access to the manufacturing data/conditions it could be reverse engineered fairly quickly... Afrezza isn’t like an IPhone where you can keep the secret sauce (OS source code) elsewhere. I’m not as familiar with India... perhaps we’ll have better IP protection there. India is probably more likely to leave the IP protection alone, and mis-report actual sales so MannKinds cut is less. (Just a guess)
|
|
|
Post by akemp3000 on May 10, 2018 1:00:52 GMT -5
Brazil, India, possibly China...all should easily turn out to be better than more upfront money and a global deal with Sanofi...just saying.
|
|
|
Post by mnholdem on May 10, 2018 7:02:56 GMT -5
That is why I believe MNKD would go for a front loaded deal: Selling the marketing and distributing rights to the Indians and Chineses. If IP can be protected, good for them. If not, shame on them. MNKD can and should be content with Afrezza success in US. We should shoot for money to get us there. Unfortunately in these countries they want the product to be produced locally to have the right to be sold there. That means Afrezza would need to be produced in China to be sold in China (for example). There’s nothing particularly special about Afrezza. With access to the manufacturing data/conditions it could be reverse engineered fairly quickly... Afrezza isn’t like an IPhone where you can keep the secret sauce (OS source code) elsewhere.I’m not as familiar with India... perhaps we’ll have better IP protection there. India is probably more likely to leave the IP protection alone, and mis-report actual sales so MannKinds cut is less. (Just a guess) However, manufacturing Technosphere particles requires very specific equipment and an exacting process that is not easily duplicated. Patents provide an overview of the process but not proprietary details. The level of difficulty provides some protection against counterfeits.
This is one of the reasons I have concerns about the possibility of Amphastar manufacturing Afrezza at their facility in China, should they win distribution rights.
|
|
|
Post by mnholdem on May 10, 2018 7:14:12 GMT -5
Will trials be required in India before approval is granted? Here is a link to a Slideshare that compares U.S., Europe and India drug approval processes (India starts on page 36). Slide page 44 has an interesting factoid: But a provision is there in the Rule - 122A of the Drug and Cosmetics Act 1940 and Rules 1945 that the licensing authority can give waiver to the trial.
- If the authority believes that it is in the interest of public health based upon the data of trials conducted in other countries.
- If the drug is approved and is being used for several years in other countries.
---
Without the waiver, the approval process for India is 12-18 months (Slideshare Page 55).
Source: www.slideshare.net/DrPankajBablani/seminar-presentations-14th-may-2015-autosaved-48137557
Mike confirmed what I posted (above) when he stated this at the 1Q18 earnings call:
"The second one we just announced is India, this morning, with Cipla. So with this announcement, one in four people living with diabetes will have the option for Afrezza as we continue to expand.
"And we expect this to potentially get approved as soon as six months, but more realistically 12 to 24 months. We anticipate a small Phase 3 trial will be required, but here is a chance under new Indian SCFDA guidelines that we could get approval sooner. "
|
|
|
Post by mnholdem on May 10, 2018 7:35:39 GMT -5
Mike Castagna excerpt from 1Q18 earnings call:
The reason we selected Cipla is because we believe they are one of the top leaders in healthcare within India. They understand the market. They have infrastructure in diabetes, and they have 70% market share in respiratory products. So when you think about a partner being able to understand the inhalation aspects of the drug and having diabetes experience is really incredible. You may or may not know, they also had inhaled insulin in their pipeline that they were struggling with, and this really allows us to bring a partner in who is already striving to achieve what we've already accomplished. We believe they'll be a great partner, and it's already been an extremely collaborative relationship.
And we look forward to helping people in India get access to meal time insulin. It's something that's very difficult when you don't have enough endocrinologists to teach and educators to help people learn. And being able to approach them and say take one yellow cartridge three times a day or make it very easy to have meal time control is something that we find very important as we go into some of these developing markets. The meal time penetration has been severely underutilized.
---
Considering that Cipla is one of the top healthcare leaders in India AND they have been trying, unsuccessfully, to develop an inhaled insulin on their own tells me that they see a big market for it in their country. I suspect that the same holds true globally in many other regions and Mike Castagna seems to think so, as well:
We're also working on additional filings in other markets, and I hope to be able to share some of that information with you soon. Additionally, we have started negotiating term sheets for some other key markets which we will try to get done in second quarter but it could go into third quarter.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on May 10, 2018 7:52:25 GMT -5
Mike Castagna excerpt from 1Q18 earnings call:
The reason we selected Cipla is because we believe they are one of the top leaders in healthcare within India. They understand the market. They have infrastructure in diabetes, and they have 70% market share in respiratory products. So when you think about a partner being able to understand the inhalation aspects of the drug and having diabetes experience is really incredible. You may or may not know, they also had inhaled insulin in their pipeline that they were struggling with, and this really allows us to bring a partner in who is already striving to achieve what we've already accomplished. We believe they'll be a great partner, and it's already been an extremely collaborative relationship.
And we look forward to helping people in India get access to meal time insulin. It's something that's very difficult when you don't have enough endocrinologists to teach and educators to help people learn. And being able to approach them and say take one yellow cartridge three times a day or make it very easy to have meal time control is something that we find very important as we go into some of these developing markets. The meal time penetration has been severely underutilized.
---
Considering that Cipla is one of the top healthcare leaders in India AND they have been trying, unsuccessfully, to develop an inhaled insulin on their own tells me that they see a big market for it in their country. I suspect that the same holds true globally in many other regions and Mike Castagna seems to think so, as well:
We're also working on additional filings in other markets, and I hope to be able to share some of that information with you soon. Additionally, we have started negotiating term sheets for some other key markets which we will try to get done in second quarter but it could go into third quarter.
Anyone have insight as to how influential Cipia is on their own turf, ie odds they can get approval is 6 mos? Is there any existing data from all of Mannkinds studies that Cipia could use to help expedite approval? I still think Mannkind succeeds or fails based on the company making Afrezza commercially viable in the US. Side note - trying to get medicare to reimburse for CGM supplies when data is sent to a smartphone. Dexcom's earlier sensors sent data to a receiver while their latest product can send data to. smartphone. Abbott Libre also sends data to a receiver that is waived over the sensor the patient is wearing. No idea if Libre has or is developing an app that allows a smartphone to scan the sensor but this legislation for a variety of reasons you all know is important. A lot easier to upload data to the cloud from a smartphone and one less thing for the person with diabetes to carry on their person. diatribe.org/foundation/about-us/dialogue/senate-and-house-leaders-ask-medicare-cover-smartphone-cgm-use?utm_source=diaTribe&utm_campaign=0d4a7f0c2d-EMAIL_CAMPAIGN_2018_05_09_m162&utm_medium=email&utm_term=0_22467a8528-0d4a7f0c2d-150106909
|
|
|
Post by brentie on May 10, 2018 8:30:32 GMT -5
|
|
|
Post by kite on May 10, 2018 8:33:41 GMT -5
That's a chubby one! I wonder if the dreamboat will be different for Brazil, too?
|
|