Mannkind & Rose Pharma has a joint patent pending. This could be one of the first next drug candidate to benefit from Technosphere. It may be revealed at the Piper Jaffray Confernce next week. Here is abstract about the potential drug candidate.
INTRODUCTION: Subcutaneous administration of ROSE-010, a GLP-1 analogue, reduces bowel spasm and relieves
acute pain in patients with irritable bowel syndrome (IBS). The feasibility of non-invasive, pulmonary therapy
for IBS was studied in the rat migrating myoelectric/motor complex (MMC) model. The test article was a dry
powder formulation of ROSE-010 prepared using Technosphere® technology. Technosphere® technology
provides rapid systemic drug delivery by inhalation of a powder containing the drug and a novel excipient.
Al is almost 90 years old and have many other things going on with other companies and isn't actively involved with Mannkind. Senior Management at Mannkind other than overseeing Afrezza's manufacturing out of Danbury, doesn't have anything else going on surrounding R&D, Clinical Trials or Regulatory. I wonder who is actually calling the shot at Mannkind and I wouldn't be surprised if Alfred Mann's Private Bankers at Bank of America are involved in a big way recommending the strategic actions being under taken by Mannkind. Could explain why everything is on hold publicly and why the stock price isn't doing anything until Bank of America's buyout strategy for Mannkind is fully executed.
Pricing & Manufacturing is done and it's now up to Sanofi to start marketing and selling it.
Mannkind is commercially producing Afrezza supply and if Sanofi wanted, they could begin selling the drug tomorrow. They will not launch it during the holiday season and will begin selling it sometime in January 2015, likely announcing the launch date during their JP Morgan Healthcare Presentation on January 12, 2015 an launch it before the Lantus patent expires in February 2015. Here is info for Sanofi JP Morgan Healthcare Conference:
Sanofi - A diversified healthcare company, focused on patients’ needs. ... January 12, 2015. 33rd Annual JP Morgan Healthcare Conference, San Francisco, ...
I expect an early launch and the good doctors mention of January 19th, sounds about right. If Mannkind was expecting Sanofi to launch towards the end of the 1Q 2015, I don't believed they would have rushed to get commercial production up and running in October 2014.
They are delaying it for some reason ? It's likely a major marketing/branding of Afrezza will happen that will include website updates, an Afrezza website, marekting. promotional ads and it could also coincide with a deal being announced between Mannkind & Medtron that will impact Sanofi's Afrezza strategy.
Doctor Bandaidman44...thank you for update and it seems very doable given the fact Mannkind started commercial production in late October 2014 and will have 3 full months of Afrezza supplies in inventory and ready to be sold by late January 2015.. Thanks again and have a nice Thanksgiving. Kevinmik
I expect Sanofi & Medtronic will combine their expertise & marketing clout to create a major paradigm shift in the way diabetes is treated gloabally, including pre-diabetes, early Type II, mid-stage Type II, late state Type II & Type I. The change will include a number of revolutionary diabetes drugs, technologies & healthcare services that will be blended to create the best diabetes franchise in the industry. At the center of Sanofi's & Medtronic paradigm shift will be Afrezza & Inhaled Technosphere GLP-1 , to be jointly marketed by both company's. I looks like another deal is about to happen between Medtronic & Mannkind, that will feed Afrezza & Inhaled Technosphere GLP-1 into a master plan diabetes agreement between Sanofi & Medtronic The questions remains what will the relationships between Sanofi & Medtronic & Mannkind look like when the dust settles and will Mannkind be sold as a company to one or both Sanofi & Medtronic or will they just negotiate a new partnership deal with Medtronic ?
I don't get hit ? How can Morningstar write an article about Sanofi's pipeline coming off the Sanofi's November 20th Conference Call and not include anything about Afrezza ? Here is the article and I am still completely amazed nothing was said about Afrezza or Mannkind.
"Sanofi Shakes Off Patent Losses
The drugmaker faces less long-term volatility as the focus shifts to steady businesses.
By Damien Conover, CFA | 11-24-14 | 06:00 AM "
Closing in on 90 Years, Alfred Mann Financial Planners seems to be working on Estate Planning for Al that includes selling his holdings and converting them into cash to support his foundation & new companies after his death. The strategy could also be designed to avoid upcoming increases to the capital gains tax that is expected to go up in a few years. Al just recently sold commercial properties in California and he may have plans in place to sell his biggest and most valuable asset Mannkind Inc. in 2015. The sale of Mannkind will add $ billions to Alfred Mann' s fortune and it would over night put his net worth at well over $4 billion provided Mannkind is sold for $30 - $40 dollars a share. Alfred Mann's Minimed legacy is doing great under Medtronic 10 years after selling them the company for $3 billion and I believe he will now hand off Mannkind' to Medtronic for a lot more money secured in knowing Medtronic be successful with the Mannkind Technologies as they were with Minimed.Technologies. Medtronic will be in a unique position to own two of Alfred Mann;s Companies and combine their technologies to create a huge paradigm change in diabetes and advance Mannkind Technologies into other areas as well.
Excerpt comments made by Sanofi & Medtronic.
"Medtronic and Sanofi embark on a global alliance to combine human and financial resources in the interest of new products and services for patients with diabetes."
"The 2nd 1, the non-intensive diabetes therapy business, is really our step into Type II in a broad way. And this starts with the Sanofi (NYSE:SNY) partnership, but I think you'll see from us that it's going to extend."
"And with Sanofi, I think, we've got some really innovative thing on the horizon that we're both excited about."
"Medtronic may also look to acquisitions to build out the non-intensive and service & solutions portions of its diabetes business, Warren said."
Yep I agree and I would add the second Mannkind deal was likely suppose to happen in 4Q 2014, to coincide with the closing of the Medtronic & Covidien deal, but the U.S. Government threw a temporary wrench in the Medtronic & Covidien deal when they changed the rules for tax inversion thus extending the Medtronic/Covidien deal into the 1Q 2015. That's likely why Mannkind guided the street from November to February to have an update about Mannkind's Technology Platform. I am now convinced more then ever that Sanofi, Medtronic & Mannkind will all be working together in 2015.
Neither Sanofi or Medtronic are currently big players in Type II diabetes, yet it seems both are planning to work together to make a big move into this huge market. Sanofi said during their conference last week that they are planning to initially introduce Afrezza targeting insulin naive Type II Patients and Medtronic said the following during their conference call last week. You be the judge whether or not the common denominator to help both companies achieve their goals is going to be Afrezza.
"The second one, the non-intensive diabetes therapy business is really our step into type 2 in a broad way. And this starts with the Sanofi partnership but I think you'll see from us that it's going to extend. And with Sanofi, I think, we've got some really innovative thing on the horizon that we're both excited about."
They are not hiring for anything other than manufacturing jobs in Danbury and are just in a holding pattern until a buyout announcement is made. The billion dollar question is how will Mannkind and its assets be sold and who will be the acquirer or acquirers ?
Another excerpt from the Medtronic Conference Call.
"It is also worth noting that in Q2, we realigned our Diabetes Group into three specific business units focused on transforming diabetes care. The first business, intensive insulin management, will concentrate in type 1 and intensive type 2 diabetes management. The second business, non-intensive diabetes therapies will focus on type 2 solutions across the diabetes care continuum.
The third business, diabetes service and solutions will focus on improving their customer experience by bringing together data management and customer support solutions, including consumables, supplies and financial services. We believe that collectively these businesses can leverage Medtronic Technology and services to expand, access, integrate care and improve outcomes, collaborating with patients, providers and peers to change the management of diabetes."
The following statement was made by a Medtronic Executive during the company's 3Q Conference Call seems to fit in with an upcoming deal to be announced surrounding Mannkind & Sanofi. In the 2Q 2014, Medtronic restructured it's diabetes group into 3 strategic groups that is explained further in the following excerpt from the conference call Q&A session.
"If you take a look at the three business units that we've created, the first one the intensive insulin management, this is really our core business where we're going after the type 1 patient and the intensive type 2 with product and solutions.
The second one, the non-intensive diabetes therapy business is really our step into type 2 in a broad way. And this starts with the Sanofi partnership but I think you'll see from us that it's going to extend.
And with Sanofi, I think, we've got some really innovative thing on the horizon that we're both excited about. And then service and solution, this I think, absolutely can leverage Cardiocom. There is asset both within diabetes, with CareLink and across Medtronic with Cardiocom that can be leveraged as we think about patient management and data management. And you'll see some additional activity from us along these lines later this year.
But I think you can even extend beyond those types of things. So I think its going to be a mixture of both organic and inorganic activity as we look to build out particularly non-intensive and also service and solution."
I just listened to the conference call again and the portion of the call that compared the 2 devices head to head was one of the most impact-full moments during the call. When displayed the Exubera Bong Delivery Device was found to be ridiculously funny by the audience who actually laughed at device when saw it and then you had Afrezza's much smaller and cooler looking device Dreamboat being displayed next to the Bong and the audience actually applauded for the Afrezza device. I honestly believe the positive audience reaction that was seen during the call for the novel Afrezza delivery device is going to replayed over and over again by millions of diabetes patients and medical professionals when they get their first look at this cool device.
The following is posted on Sanofi's calendar of events on their website and Mannkind will likely get around at the last minute to announce the date of their presentation at the conference.
January 12, 2015 33rd Annual JP Morgan Healthcare Conference, San Francisco, U.S.
It's called creating market awareness for Afrezza ahead of the launch. The more diabetes patients and medical professionals that are familiar with Afrezza ahead of time will only enhance the chances for seeing a great launch take off.