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Post by lakers on Nov 10, 2015 12:43:16 GMT -5
Yeah but the big pharmas already know that TS can be used in a number of different possibilities. It just didn't sound very professional coming from our CEO. What is next? Afrezza sign twirling at major intersections. I am just a frustrated long wondering when SNY will put some real money into awareness & DTC..... I disagree it didn't sound professional. I'm 100% sure Al, most likely BoD approved the prepared statement. Don't throw him under the bus and don't underestimate Al. They did that for a reason I mentioned. Some big guys including BPs must have listened in. Think Different! Afrezza takes time. Your best hope would be fast tracked TS pipeline. W/ funding in hand, MNKD will negotiate w/ strength. It's a bootstrap process. Thanks for my promotion to 4-star General w/ this post, BTW.
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Post by lakers on Nov 10, 2015 12:34:49 GMT -5
Remember Hakan said that in a prepared statement. Don't think for a moment that Al didn't review and approve that. Hakan may have directed at GS, JPM, soliciting and possibly entertaining the idea of retaining them as advisors to explore strategic options. He knew who important listeners were.
Teva, GSK, Sny might have listened in too.
As advisors, GS would stop the attack. BoD meeting in Nov 2nd half 2015 will decide on TS partnership. LA Times 11/8/15 cited Hakan on Pain Med which already finished animal trial. Interestingly, Hakan didn't mention that in CC at all thereby showing his hand.
IMHO, MNKD tried to time TS deal w/ fund raising, Notes settlement. Apparently, the potential partners saw that and drug out the negotiations trying to wring out concessions.
With TASE deal done, MNKD will negotiate w/ strength. Even AF said it was a brilliant move.
IMHO, Sny is licking its chop. Nothing can stop them buying in 5%, 22M shares at $2.50/sh OTC. Xmas comes early for them thanks to Al's intransigence.
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Post by lakers on Nov 10, 2015 2:13:41 GMT -5
Robust pipeline .. could be TEVA. Most likely as Teva is the largest generic BP in the world in Al's father land. Hakan seems to solicit GS, JPM, possibly retain them as advisors to explore strategic options. Hakan wouldn't do that w/o Al's blessing. Don't blame him. This is one of the few rare times I defend him. IMHO, MNKD overplayed its weak hands - bluffing. They should have accepted previous overture, I suspect Al's intransigence in price results in this predicament. Let bygone be bygone. I know it's tough to swallow dilution of 50M at $2.5. Most folks thought Sny would buy in 12% at $10. How do we recover? Does Al have some tricks up his sleeve a few days past his 90 BD, 11/7/1925? Now that's the sign of a great Maverick.
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Post by lakers on Nov 10, 2015 1:09:27 GMT -5
Ill have to wait for the transcript. But I heard different. We may hear something by end of year, To that effect. Never heard We will partner by end of year or next quarter. I heard him ask if anyone out there that's interested give him a call, or to those lines. I don't think they would announce something merely about possible partnerships. My take on today's call was that he was talking about an actual partner being announced... built in caveat that if it hasn't happened yet it's not 100%. That surprises me as I thought from previous public remarks they were going to wait until further along in the development process... but perhaps financial realities have changed those plans. You are so perceptive. I too think the same. More from Hakan. In the meantime, we are actively engaged in developing a robust pipeline with additional product candidates that will create shareholder value. As I mentioned last quarter, we were pleased to welcome the new Chief Medical Officer leading the development team. And in the last couple of months, our development group has been very busy moving ahead with the formulation work on the pulmonary hypertension program, as well as lining up a dozen more product candidates with commercial potential. And there is no way we can fund all of this potential activity, so we have also initiated discussions with several firms that could participate in product development as strategic or financial partners. I have made it clear that I'm open to any creative approach that will give us as many of these programs as possibly funded, and get our technology into the hands of healthcare providers and their patients. So to the participants listening to this call, who have an interest in sharing the risk and the rewards of our product development effort or who have a formulation or drug delivery challenge that our technology may address, I would say this, let's talk. My ambition is to have a robust portfolio of product candidates in the pipeline by this time next year.
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Post by lakers on Nov 10, 2015 0:09:54 GMT -5
Jay Olson Okay. And then, just on the pipeline, I appreciate the color there on the progress; can you tell us how close you are to moving any of your pipeline assets into the clinic, and when is the soonest that MannKind could sign a partnership or licensing deal to monetize some of those pipeline assets? Hakan Edstrom Well, in regards to -- I would say they are certainly month away from going into a clinic. I mean, they are in the formulation stage right now, particularly on the pulmonary hypertension. In regards to entering into other development partnership or financial partnership, the only thing I can say that, that actioned [ph] over the last week, we've had discussions with potential partners. However, there are still negotiations to be had. So I would say -- I would hope that we could possibly announce something before the end of the year -- oh, sorry, within the next quarter, but that's as specific as I can be at this point in time. www.seekingalpha.com/article/3669586This proves what I've said all along. I feel for mgmt. They really thought they had it. They kept getting bad cards. It made them appear bumbling and incompetent in handling the Notes. Eventually, the law of average will prevail. One of these days, They might get full house when the river is dealt and keep getting good cards early on to raise ante to the Shorts.
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Post by lakers on Nov 9, 2015 20:29:49 GMT -5
11/8/15, 4AM www.latimes.com/business/la-fi-himi-edstrom-20151108-story.htmlBy Stuart Pfeifer The gig: Hakan Edstrom, 65, is chief executive of MannKind Corp., which developed an inhaled insulin drug that could replace injections for people with diabetes. The Valencia biotech company began selling the drug, Afrezza, in February under a partnership with French pharmaceutical company Sanofi. MannKind employs about 300 people. Swedish roots: Edstrom was born in Sweden and graduated from the Stockholm School of Economics in 1973. He worked in marketing for General Foods, designing sales strategies for its Gevalia coffee brand in Scandinavia. "I actually liked it.... You had to be quick on your feet. You had to be sure you produced the right type of advertising and in-store promotions to make sure you retained your market leadership." He later held executive positions for Pharmacia Corp. and Bausch & Lomb, where he ran the surgical equipment division. Getting the call: In February 2001, Edstrom received a telephone call from Alfred Mann, the billionaire medical device entrepreneur and founder of MannKind. "I knew of Al, I did not know him," Edstrom said. But it didn't take long for Mann to woo him. Two months after that call, Edstrom agreed to become president of a company that was later named MannKind. He guided the company through the regulatory process that resulted in the June 2014 approval of Afrezza. He was named chief executive in January, after Mann stepped aside to serve as executive chairman. A slow beginning: Afrezza sales have been far lower than analysts expected, in part because the Food and Drug Administration requires users to pass lung-function tests before they can be prescribed the drug. Also, insurers have required special authorization from doctors before they'll cover the drug. In its first five months, Afrezza generated just $3.3 million in sales, a disappointing result considering some analysts expected it to eventually hit $1 billion a year. Edstrom has had to draw upon years of business leadership experience to keep employees motivated while struggling with financing and attacks from short sellers on Wall Street. MannKind's stock, which closed Friday at $2.86, is down more than 45% so far this year. During the same period, the broad Nasdaq Biotechnology Index is up 9%. Short-sellers frenzy: MannKind has faced intense pressure from short sellers, investors who are betting that the company's stock will fall. "It certainly is very frustrating," Edstrom said. "There's so much being written on the message boards. It's not reflecting the true situation, and you suspect it's being written because it can benefit them. There's not much we can do about that.... We are very much aware that you can have a conversation with the SEC and they can find a reason to look into it. I cannot talk about it because of confidentiality reasons." Will MannKind survive?: "Yes, it will. The basis for that is Afrezza is a unique product, and I absolutely believe we will see a significant uptick over time. I know from the feedback from patients, they absolutely love the product. The second reason is our [inhaler] is a very unique vehicle; it can deliver more than insulin through a pulmonary route. We have already started developing products that eventually will go into clinical testing." One example could be pain medication, he said. Motivating employees: "The word is communication. I think our employees know what to expect. Hopefully, we've communicated with them in a forthright and upfront manner, so they have an understanding of the product and an idea of what it will take [to succeed]. As a management team, we are transparent. I have very much an open-door policy so people can come up to me and ask questions. We try to get people together and tell them what's happening so nothing will be a complete surprise." Managing in Europe versus U.S.: "In San Francisco and L.A., you have so many opportunities in terms of finding new jobs if you don't like what you're doing. In places like Sweden, when you're employed with a company you tend to stay very loyal to the company, almost to a fault, because the options where you're living may not be many. In the U.S., I have to inspire, build loyalty with my employees because they always have options here to go somewhere else. Here, I'm buying their time, I'm buying their loyalty. As long as what I'm offering is good, they'll stay. If someone else comes along and offers something better, then I'm at a much bigger risk. It doesn't mean U.S. employees are less loyal, it just means they have more opportunities." Leadership advice: "You can never be successful alone. A team can always beat you, no matter how smart you are. Choose your team with much care. Make sure you have a business culture, business philosophy and way of working that is a foundation for a strong team.... Together with your team, plan your business: What are the objectives, the strategies? You need to be a preacher and communicate with your staff; they need to understand what you're trying to accomplish." Family man: Edstrom and his wife, Marie, have been married 40 years and have two adult sons and two grandchildren. They live in Santa Clarita. stuart.pfeifer@latimes.com
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Post by lakers on Nov 9, 2015 20:17:56 GMT -5
That was a real eye-opener for me as well. Same here, I didn't get that. Hopefully part of me being paranoid but shows me they have nothing going as far as a TS partnership, we'll see. "GS' Jay Olson: Pipeline - how close to moving into the clinic stage and partnership deal - when? Hakan: months away from going into clinic stage (pulminary hypertension). As far as partnerships, discussions are ongoing. Hope for announcement within the next quarter or so." mnkd.proboards.com/thread/4034/notes-on-cc-11-2015The BoD meeting date was set before Oct 29, 2015 at 1:43pm, and before the ER CC 11/9. Secondly, IMHO, mgmt can't risk misleading a material event like that. mnkd.proboards.com/thread/3875/3q15-mon-convene-half-decideWill MannKind survive?: "Yes, it will. The basis for that is Afrezza is a unique product, and I absolutely believe we will see a significant uptick over time. I know from the feedback from patients, they absolutely love the product. The second reason is our [inhaler] is a very unique vehicle; it can deliver more than insulin through a pulmonary route. We have already started developing products that eventually will go into clinical testing." One example could be pain medication, he said. www.latimes.com/business/la-fi-himi-edstrom-20151108-story.htmlMannKind Corporation’s Pain Management Plans: Looking Back mnkd.proboards.com/thread/4017/pain-management-plans
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Post by lakers on Nov 9, 2015 20:03:30 GMT -5
"1. jay olsen GS - 25 mil milestone that should be coming due to manufactuering when is it coming - hakan, no, no payment coming due now. only additional payment coming due to R&D. Any time soon? eh, ah, eh, no timing on that one." I have said all along, it was not mfgr but dev milestone bonus. "I forgot to mention $25M milestone bonus for qualifying Sanofi's insulin for Afrezza, which could be due 1Q16. It's categorized as dev" Read more: mnkd.proboards.com/thread/3875/3q15-mon-convene-half-decide#ixzz3r2ty8YTz
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Post by lakers on Nov 9, 2015 19:27:18 GMT -5
I mentioned in my first post here that I know someone who is familiar with the pharma world and doing deals. I listened to the call and Hakan, to my recollection, did not say a new TS deal was in the works. What he said is that they are in negotiations. Negotiations in pharma speak doesn't mean a deal is imminent. On the contrary, pharmaceutical companies are always in "negotiations" with numerous companies. They will look at hundreds if not thousands of deals a year and if lucky, might do one. All of those are "negotiations." So I would tell everyone to temper their expectations about a new technosphere deal because we have heard Hakan and, I think, Matt discuss this over the last 2 calls and yet we have heard nothing new. Why? Because those "negotiations" are just informal talk but not serious discussions about forming a partnership. It could also be that the company had a pending deal and the other side backed out. That happens often especially if the other company gets the sense that Mannkind is in desperate straits, which from today's call sounds like they are. Any company that senses this will use that to get a better deal for them. What ever the issues are, today's conference call was not a confidence booster and showed that Mannkind has some serious problems. And you can bet that the analysts are going to reiterate their sell recs and even point out that Mannkind might not make it through 2016 if Afrezza doesn't start to sell. I would not be surprised to see MNKD hit the lows we saw back in 2012. I know some of you are very loyal to Al and the company and you'll see what you want to see but any student of business knows that Mannkind has put itself in a very precarious situation at this point in time. We all better hope that Hakan's hope of better Afrezza sales happens sooner rather than later. -She believes that Afrezza will ultimately have more success outside the United States because of how medicine is dispensed in socialized health. But that will impact how successful Afrezza is revenue wise. If Sanofi believes Afrezza can become a monopoly in the fast acting parandial insulin market by displacing needle based insulin, better to be a monopoly with lower margins than having nothing at all. She believes that Health ministries could make Afrezza the insulin of choice assuming they see the benefits of Afrezza with increased compliance that lowers over all cost of care for diabetics. If the data supports what we are initially seeing, Sanofi has the ability politically to get health ministries to make the move to Afrezza as the first line of care. In regards to the US, she isn't so sure Afrezza will become a leader due to how drugs are marketed and sold here. She said it will ultimately come down to whether or not Doctors become comfortable prescribing an insulin that is absorbed in the lungs after decades of being comfortable with needle based delivery. Read more: mnkd.proboards.com/user/1958/recent#ixzz3r2k5RVL7I agree w/ what you and your lady friend said. That's why 1Q16 will be the watershed moment for international expansion. The PBM in US is so fragmented. Afrezza will have an easier time in a National Health Care system in my previous threads. 10-Q: U.S. 3rd Party Payor vs EU Pricing System Read more: mnkd.proboards.com/thread/3768/3rd-party-payor-pricing-system#ixzz3r2mG9pnPInternational Pharmaceutical Law and Practice mnkd.proboards.com/thread/3844/drug-approval-process-countries
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Post by lakers on Nov 9, 2015 18:07:10 GMT -5
Too bad they couldn't have delayed the listing on TASE until they could time the required index purchase with the announcement of a partnership... under the assumption the latter will positively affect share price. Matt said months ago, Mnkd may have enough cash to pay off the Notes. At that time, he must have thought the TS partner(s) would be found before 8/15/15. Well Mnkd didn't get the first two desirable cards while the shorts were stepping up the attack. Mnkd then extended the Notes conversion for more time hoping the TS partnering would be inked before the second deadline. The floor price in the first deal was $4.64. The negotiation was drug out apparently. Mnkd tried to time the partnering but it got the wrong cards dealt. Mnkd ended up having to play the cards they were dealt. Al could have allowed Sny to Buy-In 10% at much higher price than $2.50/sh. Mnkd kept getting the wrong cards dealt. Ostensibly, Mnkd was willing to wait till the TS partner pays the right Licensing upfront fee plus royalty even at the expense of 12-14% dilution at fire sale price of $2.50/sh. Time will tell if this is the right call in the long run as the first deal'd set precedence for subsequent ones. You would want to get the best deal possible for the first one.
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Post by lakers on Nov 9, 2015 17:47:07 GMT -5
Please do not lock this thread which is created b/c the following thread was locked. 3Q15 ER Mon 11/9/15; BoD to convene Nov 2nd half to decide created Oct 29, 2015 at 1:43pm mnkd.proboards.com/thread/3875/3q15-mon-convene-half-decide?page=5Hakan 3Q15 CC 11/9/15: Negotiating with many for TS partnership- Will have partner by end of year The 50M Mnkd Shares TASE index funds got is such a sweet deal. Al'd rather offer to them than Sny. He really plays hard ball w/ Sny who must be really stingy.
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Post by lakers on Nov 9, 2015 0:28:20 GMT -5
MannKind Corporation Files Chinese Patent Application for Dry Powder Inhalation System PHARMACEUTICAL | Sat 07 Nov 2015 Beijing, Nov. 7 -- MannKind Corporation has filed a patent application for dry powder inhalation system. This invention was developed by Chad C Smutney, P Spencer Kinsey, John M Polidoro, Carl R Sahi, Benoit Adamo, Scott Mclean, Dennis Overfield and Anthony Bryant. The patent application number is CN2014175084 20090327. The p..
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Post by lakers on Nov 8, 2015 23:37:20 GMT -5
MannKind Corporation’s Pain Management Plans: Looking Back MannKind’s inhaled insulin treatment Afrezza has been in the market for over four months. But its sales have been below expectations. The biopharmaceutical firm sold only $1.1 million worth of Afrezza in the first two months of launch. Jefferies analysts expect Afrezza sales to pick up in the third-quarter as MannKind and its marketing partner Sanofi gear up to launch an extensive advertising campaign. MannKind Pain Management MannKind plans to expand its Technosphere to pain management Meanwhile, the Valencia-based company has said on various occasions that it would expand the use of its Technosphere technology in the pain management market. At the company’s Q1, 2015 conference call, MannKind CEO Hakan Edstrom said that the company would make a material progress in this direction within 12-18 months. He specifically mentioned migraines, a lucrative market considering over 37 million U.S. citizens suffer from migraines. However, MannKind is not the first or only company looking to explore this market, notes Seeking Alpha contributor Looking For Diogenes. Today, the most commonly used treatment for migraines is triptan under different brand names, which was first introduced in 1990s. Triptan is already available in the forms of pills, injections, needleless injections, nasal sprays, and rectal suppositories. Besides impacting blood vessels in the brain, triptan also causes constrictions in the arteries in the heart. That’s why MannKind might be concerned with the expansion of triptan or any other inhaled drug for migraine in a user’s lungs. In the past, MAP Pharmaceuticals, NuPathe, Teva Pharma, Alder Biopharmaceuticals and others have experimented with various migraine molecules, but without much success. MannKind’s former partner still struggling While MannKind continues to reiterate that it would expand its Technosphere into pain management category, it has already tried doing that via a partnership. In February 2012, MannKind partnered with Torrey Pines Institute for Molecular Studies to develop what was described as a breakthrough in pain medication. The drug was supposed to use MannKind’s proprietary technology for dosing. Three years later, the Torrey Pines Institute is still struggling to recover from the recession. The clinical trials of the “pretty marvelous” medication were supposed to begin in 2013. MannKind has avoided mentioning that project while telling investors about its ambitious plans to get into the pain medication category. www.valuewalk.com/2015/06/mannkind-pain-management/Matt in early Aug 2015 the other program in pain has actually been in animals already, so it’s a bit ahead in that regard. But that one is a little different because we have multiple APIs we’re evaluating. We haven’t selected one yet and all of us coming from that animal model preclinical, pre-human work, but that’s already underway. Torrey Pines employee also said the API has finished animal clinical trial in 2013 awaiting human trial. She said it worked wonderfully in animal and could not wait for human trial in 2014. The pain management program is focused on the product that is intended to manage moderate-to-severe acute pain and is also in the technical feasibility phase. We have already prepared several prototype powders to formulate around a small number of active pharmaceutical ingredients or API, and we have evaluated some in preclinical models. The results have been actually very encouraging so far. The focus now is to select the optimal API and move to Investigational New Drug or IND-enabling studies. abstracts.aaps.org/Verify/aaps2013/postersubmissions/T3083.pdfStability of Novel Pain Therapy Tetrapeptide TPI-23 in Technosphere® Inhalation Powder and Identification of Related-Compounds by Liquid Chromatography/Mass Spectrometry Y. Livson, E. Harris, K. Fabio, J. Guarneri MannKind Corporation Purpose To evaluate the stability of TPI23 tetrapeptide WsSF-NH2 under room temperature and accelerated conditions in a Technosphere inhalation powder using HPLC, and to identify the major related-compounds present using LC/MS. Methods TPI23/Na2FDKP Technosphere inhalation powder was prepared at 50% weight API and placed on stability under room temperature and accelerated stability conditions in open container and inhalation cartridges. LC/UV separation was carried out on a Phenomenex Kinetex 2.6 C18 column (150x3.0mm) column at a flow rate of 0.5mL/min with an analysis time of 50 minutes. Compounds were eluted using a linear gradient consisting of mobile phase A of water/tetrahydrofuran/trifluoroacetic acid/ammonium hydroxide (970/30/1/1 (v/v/v/v)) and mobile phase B of acetonitrile/methanol/isopropanol/trifluoroacetic acid (850/150/30/1 (v/v/v/v)). Initial assay and stability analyses were conducted on a Waters 2695 Separations Module equipped with a Waters 2487 Dual Absorbance Detector. Related- compounds were identified using HPLC coupled with an Agilent 1100 Trap XCT mass spectrometer and an Agilent 6210 TOF mass spectrometer. ESI mass spectra were acquired in positive ion mode with full scan monitoring. TPI23 was subjected to forced degradation conditions to confirm the identity of the impurities formed in the inhalation powder during the stability study. Results Samples stored at room temperature lost 3.3% TPI23 assay after 16 weeks in an open container and 0.7% assay after 4 weeks in cartridges. Samples stored under accelerated conditions were most susceptible to degradation, with TPI23 assay losses after 4 weeks of 7.6% (open dish) and 8% (cartridges). Five major impurities (A-E) were present at more than 0.15 area% (ADE increased, BC remained constant). Conclusion TPI23 in a 50% weight Technosphere inhalation powder was stable (>96%) for up to 16 weeks when stored at room temperature, whereas samples stored for 4 weeks under accelerated stability conditions lost about 8% API. Using LC/MS and forced degradation experiments, five related-compounds were identified. Acknowledgement: TPI-23 was discovered by the Torrey Pines Institute for Molecular Studies, Port St. Lucie, FL. "It's actually pretty marvelous," Houghten said. "You can't (overdose) on this drug." The drug is being developed in partnership with Mannkind Corp., which has created a small device that allows people to inhale medicine. By inhaling, the medicine can relieve pain quicker than through pill form, Houghten said. "Our pain compound, if it all works out, ... if you can take that pain compound and just inhale within just 30 seconds to a minute, your pain will be alleviated," Houghten said. "So you can see that that can be a real important step." The drug has been tested on two separate animal groups and Houghten said the drug will be tested on a third before going before the U.S. Food and Drug Administration, which must give approval for human trials. Houghten said the unique nature of the drug could make it easier to get approval. "You never really quite know," he said. "Right now, everything's looking really good. ... We can't get a high enough dose that causes a problem." Patients also do not build up a tolerance to the medicine, whereas other pain relievers require patients to take more and more to get the same effect. Houghten said he is thrilled with the drug's progress. "In reality is if it's 2014 (before human testing), I'm still going to be happy," Houghten said. "I don't think it's going to be a problem with the FDA. It's very simple what we want to do, so we can show them clearly here's the effective dose, here's the toxic dose. That's 90 percent of it right there. It's effective and it's not toxic." www.tcpalm.com/business/torrey-pines-could-begin-human-testing-of-new-pain-medication-in-2013-ep-383096049-331604552.html?d=mobile
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Post by lakers on Nov 8, 2015 15:57:10 GMT -5
Short-sellers frenzy: MannKind has faced intense pressure from short sellers, investors who are betting that the company's stock will fall. "It certainly is very frustrating," Edstrom said. "There's so much being written on the message boards. It's not reflecting the true situation, and you suspect it's being written because it can benefit them. There's not much we can do about that.... We are very much aware that you can have a conversation with the SEC and they can find a reason to look into it. I cannot talk about it because of confidentiality reasons." Will MannKind survive?: "Yes, it will. The basis for that is Afrezza is a unique product, and I absolutely believe we will see a significant uptick over time. I know from the feedback from patients, they absolutely love the product. The second reason is our [inhaler] is a very unique vehicle; it can deliver more than insulin through a pulmonary route. We have already started developing products that eventually will go into clinical testing." One example could be pain medication, he said. [We will hear about progress on Pain Med tomorrow, which already finished animal trial. PAH must be bound by NDA.] www.latimes.com/business/la-fi-himi-edstrom-20151108-story.html
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Post by lakers on Nov 7, 2015 19:19:27 GMT -5
Netherland is a good bet for first launch.
This LICENSE AND COLLABORATION AGREEMENT (the “Agreement”) is entered into as of August 11, 2014 (the “Execution Date”) between MANNKIND CORPORATION, a Delaware corporation, having a principal place of business at 28903 North Avenue Paine, Valencia, California 91355, USA (“MannKind”), TECHNOSPHERE INTERNATIONAL C.V., a Dutch limited partnership, having a principal place of business at 1097 JB Amsterdam, Prins Bernhardplein 200, Netherlands (“TICV”), MANNKIND NETHERLANDS B.V., a Dutch limited liability company, having a principal place of business at 1097 JB Amsterdam, Prins Bernhardplein 200, Netherlands (“BV” and together with MannKind and TICV, jointly and severally, the “Licensors”), and SANOFI-AVENTIS DEUTSCHLAND GMBH, a company organized and existing under the laws of Germany with a place of business at 65926 Frankfurt am Main, Germany (“Sanofi”).
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