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Post by therealisaching on Feb 10, 2016 14:34:08 GMT -5
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Post by symbil on Feb 10, 2016 14:57:27 GMT -5
What are the results of the post‐marketing studies that have already been completed?
The results of both studies were statistically significant, with full data expected to be presented
by MannKind at the American Diabetes Association meeting in June of this year. Because the
ADA meeting is such a prominent platform at which to disclose scientific study results, they
require no pre‐announcement of results by presenting companies, and so we will not go into
more detail regarding those studies here, except to say that outcomes are statistically significant.
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Post by dreamboatcruise on Feb 10, 2016 16:00:57 GMT -5
Still leaves many unanswered questions, but a heck of a lot better than lack of communication.
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Post by Deleted on Feb 10, 2016 16:22:16 GMT -5
Still leaves many unanswered questions, but a heck of a lot better than lack of communication. I agree. After reading this FAQ and comparing it to some contributors posts on this board a lot of people are hearing things. I am not going to pretend that I can remember everything from the call but I am not going to spout things off unless I know I have it correct. While many bitch and moan about me you really need to be careful with some long term members here who really just make things up. |
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Post by lorcan458 on Feb 10, 2016 16:44:57 GMT -5
The question about Al is interesting, because although the "can Al?" portion of the question was left unanswered, we have evidence that he is still actively involved and still enthusiastic about Afrezza. Just a couple of weeks ago, based on the transcript of the interview the the Dexcom CEO, we know that Al is still traveling (Boston), meeting with executives (Dexcom CEO) and still very interested in talking about Afrezza (Dexcom CEO said he spent a long time talking about Afrezza with Al).
Still, I'd really like to hear him address shareholders directly. He is so much more inspirational than Matt or Hakan.
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Post by lakers on Feb 10, 2016 16:50:21 GMT -5
What is going on with deals involving Torrey Pine, Technovax, Colby, Rose Pharma & Tolero? What is happening with the “cricket” inhaler? The so‐called “cricket” is a disposable, single use version of the inhalation device used for other products like Afrezza. There are many potential applications for this device, including MannKind’s recently announced development program in epinephrine for anaphylaxis. Torrey
Pines was an opportunity we could not pursue at this time due to program risk, high costs and
prolonged timelines [Not a commercially known compound]. As far as specific deals involving other companies, MannKind will be
providing updates as significant events unfold. [They are still on-going. Surprised!]Of note, we have discussed in the past prior investigations into migraine and pain management. We still consider these areas attractive and ideally suited to our technology. At this time, we are reevaluating the clinical and commercial aspects of these potential programs. [This is a setback as migraine and pain management has been the front runner. Now I think Treprostenil+PDE5 Inhibitor Tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) PAH w/ United Therapeutics, Epinephrine Anaphylaxis w/ Mylan are leads.]
Patent expiry of major PAH drugs such as Tracleer (Actelion), Letairis (Gilead), Adcirca (Cialis, Lung Bio), and Tyvaso (United Therapeutics) is expected to affect the market revenue during the forecast period, as their generic versions would be sold at prices 70% to 80% lower than that of the branded ones.Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildena fil (a phosphodiesterase-5 inhibitor). Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz3zo0Gpk3wtechnovax.com/inhaled-powder-vaccines/technovax.com/TechnoVaxPresentation-Nov2012-IC-DC.pdfwww.slideshare.net/technovax/technovax-presentation-at“Inhaled Powder” Vaccines “Shelf-Stable, Self-Inhaled, Powderized” VLP Vaccines. TechnoVax and MannKind Corp. have combined their respective technologies to create a Powder Formulation of VLP Influenza Vaccine for Intrapulmonary Self-Delivery by Inhalation.
No refrigeration is required, and because it is potentially self-administered public exposure is limited. In the event of an emerging pandemic the vaccine could be easily distributed to the population, greatly reducing the spread of the virus! Advantages Extended Shelf Life and Elimination of Cold Chain results in improved distribution costs and inventory management.Best Route of Immunization (mucosal surface – respiratory tract) Increased Patient Acceptance (inhaled vs. injection) VLP’s are combined with FPDK Excipient Particles for optimized airflow delivery using the Cricket Inhalation Device. technovax.com/partnering/TechnoVax has partnered with a leading player in the field of pulmonary drug delivery to develop shelf-stable, self- inhaled powder VLP vaccines for flu and RSV. Currently there is no such product on the market for respiratory vaccination, and the need is critical.
Our portfolio of vaccine candidates has a potential addressable market of over $5 billion in annual worldwide sales.investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=792133Colby and MannKind Sign License and Joint Development Agreement to Develop and Commercialize Cancer Immunotherapy Products PDF Add to Briefcase SAN JOSE, Calif. & VALENCIA, Calif.--(BUSINESS WIRE)--Nov. 13, 2012-- Colby Pharmaceutical Company and MannKind Corporation (Nasdaq: MNKD) today announced a license agreement granting Colby exclusive worldwide rights to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind’s novel MKC1106 active immunotherapy programs, which are currently being developed for the treatment of melanoma, prostate, hematological disorders and other human cancers.
Intra-lymph node injections (ILNI, vaccine inoculation directly into the normal lymph node with ultrasound image guided standard syringes) of cancer vaccine antigens have been reproducibly shown to generate much more potent therapeutic T-cell responses, when compared to cancer vaccine antigen immunizations using traditional intra-muscular or sub-cutaneous injections of the same cancer vaccine antigens in animals. In a Phase 1 human melanoma study of MKC1106-MT, the most advanced ILNI regimen from this program, repeat intra-lymph nodal injection for administration of the therapeutic antigens was well-tolerated and generated strong immune responses, clearly meeting the primary endpoints.Under the terms of the agreement, Colby will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, with upfront and potential milestone payments of approximately $140 million total. MannKind will also receive tiered royalties on sales of products.
“We are very keen on this opportunity and in continuing to work with the experienced drug development team at MannKind,” said David Zarling, Ph.D., MBA, Chief Executive Officer of Colby. “MannKind has amassed an extensive and thorough active immunotherapy patent portfolio. We fully appreciate and understand that ILNI generates remarkably superior immune responses that also can be adjuvanted, and our organizations share a passion to advance the current MKC1106 clinical melanoma, prostate and other programs. We will also evaluate ILNI for potential synergy with our lead adjuvant, JVRS-100, a cationic lipid-based immune activator of both innate and adaptive immunity. ILNI and JVRS-100 both represent compelling new therapeutic approaches. We have good reason to believe that our collaboration will uncover other more optimal cancer vaccine modalities and synergies with novel adjuvants not yet realized by others working on cancer vaccines and immune activation. We believe that MannKind’s ILNI and our new immune activators, like JVRS-100 or JVRS-200, or other adjuvants, will prove to be important for rational cancer immunotherapies.” Lead Drugs Colby Pharmaceutical Company has developed a product portfolio containing two small molecule pharma drug candidates, CPC-123 for pain and CPC-551 for age-related macular degeneration and other smoking- or sunlight-related eye or skin conditions. CPC-ILNI™ is a proprietary Intra Lymph Node Injection and Vaccination System for allergy desensitization, cancer and infectious disease immunotherapy. Tolero Pharma - MannKind says it could get $130 million and royalties & licensing fees after licensing drug candidates to Tolero. MannKind said the drug candidates are being studied as treatments for blood cancers and inflammatory diseases. Rose Pharma - 07/03/14 Mannkind & Rose Pharma A/S Joint Patent Application Inhaled GLP-1 Treating IBS &/Or Functional Dyspepsia. No announcement made by Mannkind about this arrangement or financial terms revealed. |
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Post by lakers on Feb 10, 2016 17:42:31 GMT -5
What is the contract termination date with Sanofi, 4/4 or 7/4? Or is it to be negotiated? Will
MannKind disclose the date?
MannKind is targeting April 5 as the transition date of the rights to develop and commercialize
Afrezza, but the transition may occur at a later date. There are many factors that influence
when the transition will occur, including a myriad of regulatory, commercial and development
activities, many of which involve third‐party vendors or regulatory authorities, and all of which
need to be transferred in a smooth and coordinated fashion. As our transition teams work
through these various issues, the top priority is to ensure the continuity of supply of Afrezza for
patients.
The transition team has been named and includes operations, scientific and legal personnel from
both MannKind and Sanofi. The team has met and begun discussions about the complex process
that a transfer like thisinvolves. All members of the transition team are cooperating and working
in good faith.
We will not be commenting publicly on the details of our transfer terms until the transition
agreement is finalized, at which time we will issue a press release and will address questions in
an investor call. [The settlement is being negotiated.] Please know that the Afrezza transition is MannKind’s top priority and getting
the full attention it deserves.
What progress has been made on Diabetes Care Centers? Is there a rollout schedule?
The Care Centers are being started by a separate company so we have no direct information on
their status, but we are informed that they are set to launch their pilot center in New Jersey by
the end of first quarter. These centers will operate as adjunct services to urgent care centers,
focused on the treatment of diabetes. Their business model will support growth in 2016 in
major metro areas, and they will perform several tasks necessary to the success of Afrezza,
including on‐site spirometry testing and hands on and personalized training on the use of Afrezza,
when prescribed. They can also coordinate regional user groups whose members can support
each other as they develop optimal protocols.
Has Sanofi filed for any international approvals? Can MannKind file for international approvals
now or are handstied until Sanofitermination? When do you launch Afrezza in countries which
accept FDA approved drugs? When do you sign with regional partners?
Sanofi had not filed for any international approvals. Until the transition officially occurs, Sanofi
retains all rights associated with the distribution and commercialization of Afrezza, including
marketing and sales responsibilities, study management, and regulatory filings in the US and
foreign jurisdictions. MannKind is also unable to make any regulatory filings, including filing for
approval in other jurisdictions, until the NDA is transferred back to us. Prior to signing the
agreement with Sanofi, MannKind was in discussions with multiple international groups
representing substantial regional markets. Those discussions have been restarted in recent
weeks, with our priority being those regions in which we can use our US NDA as the basis for a
regulatory submission without additional trials. Other regions will require additional studies of
varying sizes and complexity. We are currently finalizing our ex‐US strategy. As these plans firm
up, we will be sharing them with you.
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Post by benh on Feb 10, 2016 18:55:26 GMT -5
Interesting part on the AMPH supply. Was not aware they had neg'd this already. (I don't know if this is new info or not?). Need to look back at the 10q's to get a better handle on it, but savings in this area will certainly help.
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Post by patten1962 on Feb 10, 2016 19:02:37 GMT -5
Bottom line. This is not a company that is going under! They are doing a lot of work. I like it! Read between the lines on insider buying! They have news ! Just my opinion!
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Post by BlueCat on Feb 10, 2016 19:13:45 GMT -5
Hey Lakers - why do you copy and paste verbatim the docs that are linked to? Do you have a comment to make on what you posted? Finding it hard to follow a thread with all the info strung together without context ..... perhaps i saw one inserted [settlement] comment at most, and a lot of bold.
Interested to hear what you have to say, but help us out that are trying to listen in ....
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Post by dreamboatcruise on Feb 10, 2016 19:22:51 GMT -5
Bottom line. This is not a company that is going under! They are doing a lot of work. I like it! Read between the lines on insider buying! They have news ! Just my opinion! I didn't see anything about sources of funding so not sure where you see anything regarding future solvency or lack thereof. Also... hate to say I think you can read between the regarding insider buying a "whew, glad we can hide behind SEC as an excuse" just as easily as putting a positive spin on it. They had planned sales that occurred automatically, and those can be used to avoid insider info buying restrictions as well. So in reality if they had conviction, purchases would be possible. I don't blame them for not, however. They have plenty of upside exposure with options they are given and they already have downside exposure in that they'll be out of jobs in the worst case scenario. |
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Post by dreamboatcruise on Feb 10, 2016 19:24:46 GMT -5
Interesting part on the AMPH supply. Was not aware they had neg'd this already. (I don't know if this is new info or not?). Need to look back at the 10q's to get a better handle on it, but savings in this area will certainly help. That came as new info to me as well. |
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Post by mindovermatter on Feb 10, 2016 19:27:39 GMT -5
Bottom line. This is not a company that is going under! They are doing a lot of work. I like it! Read between the lines on insider buying! They have news ! Just my opinion! I didn't see anything about sources of funding so not sure where you see anything regarding future solvency or lack thereof. Also... hate to say I think you can read between the regarding insider buying a "whew, glad we can hide behind SEC as an excuse" just as easily as putting a positive spin on it. They had planned sales that occurred automatically, and those can be used to avoid insider info buying restrictions as well. So in reality if they had conviction, purchases would be possible. I don't blame them for not, however. They have plenty of upside exposure with options they are given and they already have downside exposure in that they'll be out of jobs in the worst case scenario. Some on here believe that Mannkind is like HeLa cells and can survive anything. The company needs cash to survive and so far we haven't seen anything to suggest they will be able survive past this year let alone this year. Hence why the stock is under $1. |
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Post by patten1962 on Feb 10, 2016 19:48:16 GMT -5
I didn't see anything about sources of funding so not sure where you see anything regarding future solvency or lack thereof. Also... hate to say I think you can read between the regarding insider buying a "whew, glad we can hide behind SEC as an excuse" just as easily as putting a positive spin on it. They had planned sales that occurred automatically, and those can be used to avoid insider info buying restrictions as well. So in reality if they had conviction, purchases would be possible. I don't blame them for not, however. They have plenty of upside exposure with options they are given and they already have downside exposure in that they'll be out of jobs in the worst case scenario. Some on here believe that Mannkind is like HeLa cells and can survive anything. The company needs cash to survive and so far we haven't seen anything to suggest they will be able survive past this year let alone this year. Hence why the stock is under $1. Some call it investing! Some call it Gambling! Either way a stock this low is not going to have solid numbers! I believe Afrezza is a solid drug with tons of upside! But honestly if this company had better numbers stock price would be much higher. I will continue to put money in! Let the chips fall where they may! Good luck longs! |
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Post by liane on Feb 10, 2016 20:03:25 GMT -5
Hey Lakers - why do you copy and paste verbatim the docs that are linked to? Do you have a comment to make on what you posted? Finding it hard to follow a thread with all the info strung together without context ..... perhaps i saw one inserted [settlement] comment at most, and a lot of bold. Interested to hear what you have to say, but help us out that are trying to listen in .... I have to agree. People on this board are quite capable of following the link. There is no need to c/p reams of text; it just makes this board hard to follow. So - lakers (and everyone) - I will start deleting or editing excessive copy / paste posts. |
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