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Post by dreamboatcruise on Sept 9, 2014 10:39:32 GMT -5
I think we look at all the really bad reporting regarding MNKD and forget that to a large extent it is just indicative of bad reporting in general related to the constant need for voluminous content to feed the ravenous interweb and its need for clicks.
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Post by EveningOfTheDay on Sept 9, 2014 14:19:23 GMT -5
www.manufacturingchemist.com/technical/article_page/Drug_delivery_innovations_set_to_disrupt_sector/101476Drug delivery innovations set to disrupt sector The global revenue for advanced drug delivery systems was estimated to be US$181.9bn in 2013, according to the report Global Markets and Technologies for Advanced Drug Delivery Systems. And by 2018, revenues are forecast to reach nearly $212.8bn, showing a compound annual growth rate (CAGR) of 3.2%.1 On a more local level, Decision Resources Group2 forecasts the US drug delivery device market alone will exceed $4.5bn by 2022. This market growth is largely being driven by product innovations, such as microneedle patches and subcutaneous implants, the company says. Injection devices continue to represent the major revenues as more diabetic patients adopt pen injectors over traditional drug delivery methods such as insulin pumps or syringes. There is much innovation within this sector with Novo Nordisk, Sanofi and Eli Lilly all developing new versions or more complex pen injectors that are expected to launch within the next 10 years. The global market for pulmonary drug delivery technologies reached $32.4bn in 2013 and is expected to grow to $43.9bn in 2018, a CAGR of 6.2%, according to BCC Research.3 Here too there is considerable innovation – most notably by MannKind, which recently received approval for the Afrezza inhaler, the first inhaler to deliver insulin. Drugs delivered via inhalers are absorbed rapidly by the body, and some see this breakthrough as having the potential to disrupt the traditional insulin delivery device markets. - See more at: If anybody has access or knows anybody that does, please post the whole article. It looks very interesting and I would love to be able to read the whole thing. Thanks and GLTAL
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Post by brentie on Sept 9, 2014 17:01:58 GMT -5
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Post by dreamboatcruise on Sept 9, 2014 18:05:48 GMT -5
I think the transcript said a few pretty positive things. Seem to clearly say going after GPs and endos and expectation of rapid adoption and concern for lack of supply. The part about the three populations seemed to indicate going after Afrezza as first line insulin before basal... would they do that if SNY weren't on board with it? Isn't that significant that they talked about it?
I am curious that they seemed to indicate they believe the bit of info about equivalent royalty was enough to allow analysts to project profit.
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Post by BD on Sept 11, 2014 14:34:10 GMT -5
seekingalpha.com/article/2488805-mannkind-nothing-but-good-news-trading-volume-drops-short-interest-remains-sky-highMannKind: Nothing But Good News, Trading Volume Drops, Short Interest Remains Sky HighSep. 11, 2014 3:30 PM ET | About: MannKind Corporation (MNKD), Includes: SNY Disclosure: The author is long MNKD, SNY. (More...) Summary After a quiet period, more information has emerged about the Sanofi/MannKind deal. More information is available about the coming launch. Short interest remains high but trading volume has dropped dramatically while prices remain historically high. More Details about the Sanofi/MannKind Deal Emerge from the Morgan Stanley Global Healthcare Conference.
MannKind (NASDAQ:MNKD) management presented Tuesday at the Morgan Stanley Global Healthcare Conference. The analysts present asked intelligent questions and received substantial answers. Here are some of the most important points that were covered in the presentation. 1. MNKD believes that the 65/35 profit sharing deal with Sanofi will yield them the equivalent of a 25% royalty, but with several advantages. One is that the deal is for the life of Afrezza as a product, not just the life of the patent. This is important, because the history of other patented insulins like Humalog and Novolog shows that they typically continue to be sold as premium prices long after the patents were due to expire. The other advantage is that the terms of the agreement mean that Sanofi (NYSE:SNY) will be fronting MNKD's development costs going forward into the launch, which means that MNKD will not need to issue more shares. This is good news for shareholders. 2. The tests are done for the 12 unit cartridge and management expects to submit it for approval shortly. The hope is to have these large cartridges available at the time of the product launch. This is very significant, because most people with type 2 diabetes will be using doses that will range from 12-36 units per meal. The larger the cartridges, the fewer needed to fill a prescription. As Matthew Pfeffer, MNKD's CFO points out, the factory measures production in cartridges, not units of insulin, so being able to produce the larger cartridges means that more patients can be served with the same production capacity. 3. There is the possibility that MNKD will also produce cartridges with smaller doses than are currently available. I see this as almost certain. That's because the FDA has asked for a post approval pediatric study involving children as young as age four. Children of that age who have diabetes almost all have type 1 diabetes and they use much smaller doses than adults, often doses in the range of 1/2 to 1 unit. The current smallest Afrezza cartridge is 4 units, which is far too much insulin for very small children. The availability of a smaller dose cartridge would also expand the number of people with Type 1 who could use Afrezza, as many of those who strive for tight control also use doses in the 1-2 unit range. 4. Production of Afrezza should begin in November. Sanofi is expecting a robust launch in the first quarter of 2015. This is why, as part of the deal, SNY demanded that MNKD contract to buy a lot more insulin so that there will be sufficient insulin on hand to meet these expectations. The ultimate plan is to use SNY's insulin as the raw material, which will reduce costs and increase margin. But because any insulin used to manufacture Afrezza must go through an FDA approval process MNKD ensured it has adequate supplies for the next several years of the one insulin that the FDA has already approved. It has not been decided whether the aging Pfizer insulin (already expensed) will be submitted for approval. With Sanofi being a manufacturer of insulin, that old insulin may well end up a sunk cost. 5. There are plans to apply the Technosphere technology to other drugs, but given the limits on manufacturing capacity the challenge is to determine which drug candidates would be the most profitable and hence worth producing. The most interesting comment made on this topic was the suggestion that the use of the Technosphere technology to administer pain medications has the advantage that, since pain drugs are not administered on a daily basis the way insulin or some GLP-1 drugs are, getting approval for their use with the Technosphere technology may be much easier. This would be because the fear of damaging the lung is much less with only occasional use. This makes a lot of sense, and gives me the impression that the migraine drug is probably the next one to be developed as a Technosphere offering. Though the GLP-1 drug is also discussed as a candidate, and SNY has the right as part of the partnership deal to first refusal for the application of the Technosphere technology to a GLP-1 drug, their drug is not currently approved for use in the U.S.. In addition, given the grave concerns that have been raised about the side effects of this class of drugs, the road to approval for a Technosphere GLP-1 drug could involve long and costly safety studies. Pain drugs are probably a much better choice. Another comment that stood out in this presentation was Pfeffer's comment that there are quite a few important drugs that might be candidates for using the Technosphere delivery system because they have safety problems when delivered into the digestive system, because they are toxic to the liver, but which might be safe if administered in a way that skipped digestion. This makes me suspect that there may be a specific drug under consideration that would fit this description. 6. More details emerge about the marketing strategy. While existing users of fast-acting insulin are an important market, and one that SNY is extremely well positioned to access, given its established relationships with both endocrinologists and general practitioners who prescribe Lantus, the much more enticing market is people with type 2 diabetes who are not currently using any insulin. It sounds like SNY will be aggressively pursuing this market, as we should hope they will, not only for the sake of profits, but because so many of these patients need to lower their blood sugar more aggressively if they are to avoid diabetic complications. Using Afrezza should make this possible and avoid the concerns that are developing around the safety of the incretin drugs. 7. SNY is going to be aggressively pursuing approval in other countries. Most of the testing has already been done that is required for submission to European markets. And the value of the SNY/MNKD deal becomes evident when you realize that Sanofi has already gotten Lantus approved in 120 countries. That means it already has the expertise needed to negotiate the requirements needed to get Afrezza approved in the world market. The whole presentation is worth listening to, especially since the transcript posted here on SA is, as is so often the case, quite garbled. The Other Big News: Shorts Still Hold 29.8% of the Float and Trading Volume has Declined DramaticallyThe latest report on short interest came out after the market closed yesterday, and it revealed that 74,067,605 MNKD shares are held short. This number has only dropped 4.2% since the middle of August, which was right after the announcement of the partnership with SNY. More importantly, the volume of MNKD shares traded daily has dropped dramatically since the announcement of the deal. And it has dropped more than the statistics you may have seen would indicate. That is because a whopping 73.8 million shares traded in the two days surrounding the announcement of the Sanofi partnership, boosting the average volume for the month. However, since Sept. 2, the average daily volume of MNKD shares traded has only been 4.854 million. So the actual days to cover for the stock, trading at the rate it has been trading recently, is a robust 15.25--more than three weeks of trading. You can examine the volume numbers here: www.nasdaq.com/symbol/mnkd/historicalAll this tells you there are a lot of people and hedge funds holding short positions in MNKD. With no bad news on the horizon and low trading volume, the best way for these shorts to get out of their positions is to spread doubt in the media. This strategy has certainly been evident on CNBC. For example, Jim Cramer, who has always been unceasingly negative on MNKD stock, was asked about MNKD by a caller on last Monday's Mad Money. In response, he resorted to muttering that he'd heard negative things about the stock from people who knew, though not a word was said illuminating what these negative things might have been. But the shorts can't hold on forever, and the critical thing to keep in mind is that 63,995,678 MNKD shares were held short on March 29, 2014, just before the ADCOM meeting where Afrezza received the near unanimous expert recommendations that led to its approval. That tells us a lot about the prices at which most of these shares were shorted. That's because, at the time of the ADCOM when those roughly 64 million share were held short, MNKD stock had not traded over $6/share since 2010 except for three months in the summer of 2013. During much of this time it traded under $3. Over the months right before the ADCOM, the price mostly traded in the $5 range. So while shorts who bought in during the brief periods in the past when the stock surged over $7/share may have closed out their positions with a profit, it's likely there are a lot of shorts left who will need the price to drop considerably lower than its current level to be able to close their positions without taking a loss. The last hope of these shorts is that Afrezza will fail to sell when it finally hits the market this winter. If it doesn't, there are going to be a lot of shorts all heading for the exits at once and, once again, this drama queen of a stock could get very interesting indeed.
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Post by BD on Sept 12, 2014 10:26:38 GMT -5
seekingalpha.com/article/2490315-mannkind-in-turmoil-is-it-time-to-buy-or-sellMannKind In Turmoil: Is It Time To Buy Or Sell?Sep. 12, 2014 7:52 AM ET | 24 comments | About: MannKind Corporation (MNKD), Includes: SNY Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...) Summary MannKind and Sanofi anticipate US launch for Afrezza in Q1 2015, which would mark a landmark achievement for a company that has long awaited commercialization of its insulin inhaler. Significant short interest in conjunction with bearish options sentiment suggests that many are positioning for a drop in MannKind shares. I believe this reflects numerous near-term challenges that could impede the success of the MannKind-Sanofi partnership. Thus, I propose two conservative investment strategies that mitigate risk at the expense of sacrificing significant upside. MannKind (NASDAQ:MNKD) is a commercial stage biopharmacetuical company focusing on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MNKD Chart Background Overview Undoubtedly, my initial article on MannKind (NASDAQ:) didn't sit well with shareholders, and understandably so. I theorized that FDA approval of Afrezza was already priced into the stock, and thus, a "conservative" options strategy that accounted for this risk would prove superior to the standard buy-and-hold strategy. In spite of devising a strategy that captured 50% potential upside -- in the event that regulatory approval for Afrezza would've triggered 50% upward movement, which it clearly didn't -- some commentators criticized this ceiling for being too low. Others capitalized on a golden opporunity to overwhelm an outspoken author, resorting to ad hominem attacks and fallacious assertions about my motives for covering MannKind. While I don't intend to pour salt on fresh wounds in providing this background information, since, after all, MannKind has taken a beating ever since my initial article was released, I think it's important, nonetheless, for readers to understand where I'm coming from in order to avoid any further misconceptions. As such, I will state that while I remain bullish on MannKind, I possess realistic concerns and expectations that warrant both candid and civilized debate. The MannKind-Sanofi partnership As a recap, MannKind managed to license Afrezza to Sanofi (NYSE:SNY) last month, preceeding a massive drop in share price prior to commercial launch early next year. Details of MannKind's arrangement with Sanofi are as follows: US launch of Afrezza scheduled for Q1 2015. MannKind receives $150 million upfront and up to $775 million in potential milestone payments upon achieving unspecified marketing and sales criteria. Both firms will share profits and losses worldwide, with Sanofi retaining 65 percent and MannKind retaining 35 percent. Sanofi will advance collaboration expenses of up to a limit of $175 million to MannKind. At the Morgan Stanley Global Healthcare Conference on September 9th, we learned more details about the arrangement, including, but not limited to: MannKind expects to garner 25% in royalty payments from Sanofi based on the 65/35 percent arrangement. Production of Afrezza is expected to commence in November. Sanofi should likely focus efforts to achieve approval of Afrezza outside the US, possibly increasing its market penetration in the years to come. MannKind also expects to submit the 12 unit cartridge for regulatory approval. For more insight, I encourage readers to visit Psycho Analyst's latest article which further analyzes the partnership. Financial strength As expenses increased largely due to cash stock compensation of $36.2 million in Q2 2014, clinical expenses decreased following the completion of the Affinity studies in 2013. MannKind also experienced a $15.5 million increase in non-cash stock compensation and spent $2.7 million on commercial readiness for Afrezza. The company maintains a strong cash position at $41.2 million, and is optimally situated with $100 million in convertible debt ($70 million in sales of Tranche B notes from Deerfield and roughly $30 million of available debt from The Mann Group). From a financial standpoint, MannKind is strong. Trading factors highlight risk In assessing risk, I believe there are several trading factors that shouldn't be overlooked. On the one hand, there is a short position in MannKind at around 74 million shares out of roughly 394 million outstanding, or 29.8 percent of the float. This indicates that there are many who are betting on a decline going into the US launch of Afrezza in Q1 2015. As a reminder, the short position in MannKind stood around 68 million shares out of roughly 389 million outstanding one month prior to the PDUFA date for Afrezza, so it's clear that regulatory approval doesn't cripple the bear thesis. On the other hand, my analysis of the option market has led me to conclude that many professionals are positioning for a drop in MannKind shares. This is derived from the clear disparity between the high protection costs and the low costs of garnering upside. Nevertheless, trading factors can only provide so much insight into the bear thesis, for one cannot determine the motive of shorting a stock or buying protection simply by analyzing a series of numbers. In an attempt to infer this motive, I provide an overview of MannKind's risk profile, exhibited as follows: Commercial risk: Indeed, MannKind successfully inked a deal with Sanofi to commercialize Afrezza worldwide, in which it now has the opportunity to receive $775 million in milestone payments in addition to the $150 million MannKind received upfront. However, the company is not only exposed to losses on a global basis, but also to the risk of any possible disruption to commercial activities. Is it ludicrous to suggest that something could impede commercial success? Unfortunately, I think not, and it wouldn't be surprising if commercial risk is one of the pillars of the bear thesis. Regulatory risk: Afrezza's FDA label is accompanied with a Boxed Warning for risk of acute bronchospasm in patients with chronic lung disease. Approval also came with the contingency that physicians must monitor lung function over time with spirometry. Even if such restrictions are minor, is it possible that they could impact the adoption of Afrezza among physicians and patients? If so, to what degree would this impact future revenue, and what would this translate to in milestone and royalty payments? Marketing risk: As it stands, it's estimated that the global insulin market is $32 billion, leading me to believe that MannKind and Sanofi have a significant market opportunity. Nevertheless, the sales performance of Afrezza will likely be directly correlated to the effectiveness of Sanofi's marketing strategy. Moreover, major analyst firms have already constructed high sales estimates for Afrezza. This applies additional pressure on the partnership to execute properly, since MannKind will likely be met with downgrades and a lower market valuation should sales of Afrezza disappoint. External risk: As with any biopharmaceutical company, MannKind is susceptible to general market trends. It is widely accepted that general market trends are affected by global uncertainty. Accordingly, I believe the general market has under-priced the ongoing conflict in Ukraine, as Putin's actions appear to be poorly predicted by the West. There's also the fragile peace agreement between Israel and Hamas which could dissolve at any point. Finally, there's the uncertainty surrounding the emerging ISIS threat in Iraq and Syria, as well as the United States' newly announced three-year military campaign to target and destroy ISIS in both countries. Going forward, I strongly believe that MannKind will perform with the general market in reaction to such affairs, for the better or the worse. Takeaway alternatives Provided this understanding of the US launch for Afrezza in Q1 2015, as well as the overall market sentiment with respect to MannKind, I feel that the risk to the standard buy-and-hold strategy is only suitable for speculative investors. For the most conservative investors, it would be prudent to consider selling January/February 2015 in-the-money calls as a means to garner decent premium and modest upside, while achieving significant downside protection. A more speculative alternative could consist of a structured options strategy in which one locks up one-half to two-thirds of their total shares in MannKind through the selling of in-the-money calls at varying strike prices and expirations. This strategy would achieve similar goals to the former, but leave one-third or one-half of one's position unrestricted in order to capture unlimited upside in the event that MannKind stock soars due to a successful launch and/or buyout. Given my view of MannKind, I support both options strategies outlined above. For the most conservative of investors, restricting their entire position through options could be a viable alternative to the standard buy-and-hold strategy. This includes significant downside protection and a modest premium at the (likely) expense of forfeiting shares under each option contract. For more aggressive investors, restricting a certain amount of shares through options while preserving unlimited upside on the remaining shares could prove lucrative as well. Ultimately, both strategies are viable, since they provide various levels of protection around which each investor individually must assess his/her risk tolerance.
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Post by babaoriley on Sept 12, 2014 12:34:25 GMT -5
Sorry, originally posted an article that mannmade was already all over.
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Post by jpg on Sept 12, 2014 14:04:26 GMT -5
Not related to Mannkind but in the spirit of the falling share price I thought I would bring an update from 2 Mannkind foes (one a rich smart professional and the other a less rich blogger): Shekreli and Derek Lowe. I will let you guess which one is the rich pro... The Most Unconscionable Drug Price Hike I Have Yet Seen by Derek Lowe There's a drug called Thiola (tiopronin) that most people have never heard of. It's on my list of "smaller than aspirin" drugs, and I'd never heard of it until I put that one together. But thanks to a little company called Retrophin, we all get to hear about it now. It's used to treat cystinuria, a rare disease that causes painful kidney complications, namely unusual kidney stones of pure cystine. And until recently, tiopronin (as a small, nearly forgotten drug for an orphan indication) was rather cheap. It was sold by a small company in Texas, Mission Pharmacal, until Retrophin bought the marketing rights earlier this year (a move complicated by the company's CEO, investor Martin Shkreli, who may have let the news of the deal leak on his Twitter account). seekingalpha.com/article/2487595-the-most-unconscionable-drug-price-hike-i-have-yet-seen?ifp=0
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Post by Chris-C on Sept 12, 2014 23:30:10 GMT -5
Not related to Mannkind but in the spirit of the falling share price I thought I would bring an update from 2 Mannkind foes (one a rich smart professional and the other a less rich blogger): Shekreli and Derek Lowe. I will let you guess which one is the rich pro... The Most Unconscionable Drug Price Hike I Have Yet Seen by Derek Lowe There's a drug called Thiola (tiopronin) that most people have never heard of. It's on my list of "smaller than aspirin" drugs, and I'd never heard of it until I put that one together. But thanks to a little company called Retrophin, we all get to hear about it now. It's used to treat cystinuria, a rare disease that causes painful kidney complications, namely unusual kidney stones of pure cystine. And until recently, tiopronin (as a small, nearly forgotten drug for an orphan indication) was rather cheap. It was sold by a small company in Texas, Mission Pharmacal, until Retrophin bought the marketing rights earlier this year (a move complicated by the company's CEO, investor Martin Shkreli, who may have let the news of the deal leak on his Twitter account). seekingalpha.com/article/2487595-the-most-unconscionable-drug-price-hike-i-have-yet-seen?ifp=0Actually, it turns out there is a MNKD connection here. Shkreli, a short seller, is alleged to have been instrumental in finding a way to influence the FDA to issue a second CRL for MNKD, thus tanking the stock. When subsequent inquiries into insider trading at the FDA revealed an employee who had taken out a significant long position expecting approval of the drug, it appeared that something had happened within the FDA at the last minute to change some minds, and Mr. Shkreli's contacts with FDA officials, which seem to have occurred at that time, were identified and revealed later, raising questions about his motives (given that he had acknowledged a short position and therefore, ipso facto, he had a conflict of interest and his submission as a concerned citizen should have been disqualified, in the same way that Advisory Committee meetings are carefully orchestrated to create transparent and balanced hearings. Suspicions about the works of Mr. Shkreli are highlighted in a press release by the Washington DC-based watchdog group, Citizens for Responsibility and Ethics in Washington (CREW), See announcement here which accompanied their submission to the Dept of Justice requesting an investigation. It appears that when it comes to making money in the pharmaceutical industry, certain individuals exploit the gray areas of regulations, laws and government policies without even a moment's consideration to the potential harm that may accrue from their actions to thousands of innocent people needing medicines. At the bottom of the ocean, there is whale excrement and slime. Some players on Wall Street seem to be descendants of creatures that somehow emerged from this deep sea cesspool. They don't eat plankton, they thrive on creating ill begotten investment gains to nourish their greed. Of course, no intentional inferences are made here about particular individuals, as these are just observations. Readers are encouraged to draw their own conclusions. GLTAL Chris-C
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Post by jpg on Sept 13, 2014 11:21:19 GMT -5
[/quote]Actually, it turns out there is a MNKD connection here. Shkreli, a short seller, is alleged to have been instrumental in finding a way to influence the FDA to issue a second CRL for MNKD, thus tanking the stock. When subsequent inquiries into insider trading at the FDA revealed an employee who had taken out a significant long position expecting approval of the drug, it appeared that something had happened within the FDA at the last minute to change some minds, and Mr. Shkreli's contacts with FDA officials, which seem to have occurred at that time, were identified and revealed later, raising questions about his motives (given that he had acknowledged a short position and therefore, ipso facto, he had a conflict of interest and his submission as a concerned citizen should have been disqualified, in the same way that Advisory Committee meetings are carefully orchestrated to create transparent and balanced hearings. Suspicions about the works of Mr. Shkreli are highlighted in a press release by the Washington DC-based watchdog group, Citizens for Responsibility and Ethics in Washington (CREW), See announcement here which accompanied their submission to the Dept of Justice requesting an investigation. It appears that when it comes to making money in the pharmaceutical industry, certain individuals exploit the gray areas of regulations, laws and government policies without even a moment's consideration to the potential harm that may accrue from their actions to thousands of innocent people needing medicines. At the bottom of the ocean, there is whale excrement and slime. Some players on Wall Street seem to be descendants of creatures that somehow emerged from this deep sea cesspool. They don't eat plankton, they thrive on creating ill begotten investment gains to nourish their greed. Of course, no intentional inferences are made here about particular individuals, as these are just observations. Readers are encouraged to draw their own conclusions. GLTAL Chris-C[/quote] Hi Chris, This connection is why I bring it up. Derek Lowe has been a less then kind (and ill informed as far as I am concerned) Mannkimd basher. Shkreli is certainly much better informed and as you point out an amazing chronic bottom feeder. It sadly seems being a bottom feeder is what pays. Innovation is so yesterday...
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Post by mannmade on Sept 13, 2014 12:02:42 GMT -5
Only if your view is short term...
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Post by kc on Sept 14, 2014 0:15:06 GMT -5
Can anybody translate Italian? www.pharmastar.it/?cat=6&id=15913Accordo MannKind-Sanofi sulla nuova insulina spray, lancio all'inizio del 2015 11 settembre 2014 La nuova insulina per via inalatoria (Afrezza, sviluppata da MannKind) approvata nel giugno scorso negli Stati Uniti per la terapia del diabete di tipo 1 e di tipo 2, sarà lanciata all'inizio del prossimo anno a seguito di un accordo commerciale siglato tra MannKind e Sanofi. I termini dell’accordo prevedono la concessione a Sanofi di una licenza esclusiva per sviluppare e commercializzare in tutto il mondo la nuova formulazione, una polvere di insulina umana ad azione rapida per inalazione. L'accordo è visto come la chiave per garantire un futuro immediato all’insulina spray. Alcuni analisti, infatti, avevano espresso preoccupazione circa il fatto che MannKind, in quanto piccola azienda, avesse le risorse necessarie per promuovere il prodotto, anche alla luce del fatto che la Food and Drug Administration (Fda) gli ha dato l’ok, ma a una condizione: mettere in campo una strategia di valutazione e attenuazione del rischio (REMS). La scheda del prodotto conterrà anche un ‘boxed warning’, cioè un’avvertenza speciale per segnalare che nei pazienti con asma e broncopneumopatia cronica ostruttiva si sono verificati casi di broncospasmo. La REMS è tenuta a garantire che i benefici dell’insulina spray superino il potenziale rischio di broncospasmo acuto nei pazienti con pneumopatia cronica. Inoltre, l’Fda ha richiesto quattro studi postmarketing come condizione per dare il suo ok: uno per valutare la farmacocinetica, la sicurezza e l'efficacia del prodotto nei pazienti pediatrici; un altro per valutare il possibile rischio di neoplasia polmonare, nonché il rischio cardiovascolare e di effetti avversi a lungo termine sulla funzionalità polmonare, e, infine, due studi clinici di farmacocinetica-farmacodinamica sul clamp euglicemico, di cui uno per caratterizzare la relazione dose-risposta e l'altro la variabilità intra-soggetto. Secondo i termini dell'accordo, Sanofi sarà responsabile a livello globale delle attività commerciali, regolatorie e di sviluppo. Nell'ambito di un accordo a parte che riguarda le forniture del prodotto, MannKind produrrà l’insulina presso lo stabilimento di Danbury nel Connecticut, mentre le due aziende collaboreranno per ampliare la capacità di produzione in modo da soddisfare la domanda globale, "se necessario". MannKind riceverà da subito 150 milioni di dollari e potrà averne fino a 775 in base al raggiungimento di determinati traguardi regolatori e di sviluppo, nonché di vendita. Sanofi e MannKind si divideranno gli utili e le perdite a livello globale in modo che al colosso francese spetterà il 65% e a MannKind il restante 35%. "Afrezza rappresenta un'ulteriore aggiunta al nostro portafoglio di soluzioni integrate per il diabete. È in una posizione unica per fornire ai pazienti un’ulteriore opzione per l’insulino-terapia…, ma non richiede iniezioni multiple giornaliere" afferma Pierre Chancel, vice presidente senior di Sanofi, nel comunicato aziendale. "Sanofi è il partner ideale dato il suo portafoglio prodotti complementare, la sua vasta presenza sul mercato delle insulina e la sua infrastruttura commerciale leader mondiale. Il nostro accordo di partecipazione agli utili permette di allineare gli interessi di MannKind e Sanofi in modo da ottimizzare lo sviluppo, la commercializzazione e i costi di produzione" dichiara, invece, Alfred Mann, presidente e amministratore delegato di MannKind. Progettata in modo da essere assunta all’inizio di un pasto, l’insulina spray si scioglie rapidamente dopo essere stata inalata nella parte profonda del polmone e rilascia rapidamente il farmaco in circolo. Il picco di insulina si raggiunge entro 12-15 minuti dalla somministrazione e la concentrazione plasmatica torna ai livelli basali in circa 180 minuti. Nei pazienti con diabete di tipo 1, l’insulina inalatoria deve essere utilizzata in combinazione con un'insulina ad azione prolungata e non è raccomandata per il trattamento della chetoacidosi diabetica o per i pazienti che fumano. Se l’insulina spary si rivelerà un successo oppure no sarà il tempo a dirlo. Il primo tentativo di insulina spray , Exubera, sviluppata da Pfizer e approvata nel 2006, si è rivelato un flop clamoroso. Il prodotto non ha fatto presa: è stato ritirato dal mercato nel 2007 e Pfizer ci ha rimesso quasi 4 miliardi di dollari. Allora, anche le altre aziende del settore che stavano cercando di sviluppare un’insulina spray si erano ritirate con la coda tra le gambe, spaventate dalle difficoltà dell’impresa e dai ritorni incerti. Tuttavia, ci sono alcune ragioni per essere ottimisti sul fatto che la nuova insulina spray avrà maggior fortuna. Il farmaco di Pfizer era contenuto in un device enorme, della forma di un contenitore per palline da tennis, oggetto di molta ironia sul web e non gradito dai pazienti che, all’epoca, preferirono continuare a usare le classiche penne. Afrezza, invece, viene erogata con un device della forma di un fischietto, di dimensioni di gran lunga inferiori rispetto all’inalatore Exubera, e la somministrazione è più semplice; inoltre, il nuovo prodotto sembra gravato da un minor rischio di aumento di peso e di ipoglicemia grave rispetto all'insulina standard. Tuttavia, non si sa ancora quanto costerà e come sarà il prezzo rispetto a quello degli altri prodotti a base di insulina, già in commercio. Infine, non manca qualche preoccupazione sul fatto che i medici siano disponibili a cambiare terapia ai loro pazienti, facendoli passare all’insulina spray. Secondo gli analisti, il prodotto potrebbe generare un fatturato di 600 milioni di dollari l’anno. Ma l’ultima parola spetterà ai pazienti. © Riproduzione riservata
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Post by liane on Sept 14, 2014 5:23:53 GMT -5
From Google translate:
MannKind Sanofi-agreement on the new insulin spray, launch in early 2015 September 11, 2014
The new inhaled insulin (Afrezza, developed by MannKind) approved in June last year in the United States for the treatment of type 1 diabetes and type 2, will be launched early next year as a result of a trade agreement signed between MannKind and Sanofi.
Terms of the agreement provide for the granting of an exclusive license to Sanofi to develop and market worldwide the new formulation, a powder of rapid-acting human insulin by inhalation.
The agreement is seen as the key to ensuring the immediate future insulin spray. Some analysts, in fact, had expressed concern about the fact that MannKind, as a small company, had the necessary resources to promote the product, especially in light of the fact that the Food and Drug Administration (FDA) gave the go ahead, but on one condition: to field an evaluation strategy and risk mitigation (REMS).
The details of the product will also contain a 'boxed warning', ie a special warning to indicate that in patients with asthma and chronic obstructive pulmonary disease there have been cases of bronchospasm. The REMS is required to ensure that the benefits outweigh the potential risk of insulin spray of acute bronchospasm in patients with chronic lung disease.
In addition, the FDA required four postmarketing studies as a condition of giving its ok: one to evaluate the pharmacokinetics, safety and efficacy of the product in pediatric patients; another to assess the possible risk of lung cancer as well as cardiovascular risk and long-term adverse effects on lung function, and, finally, two clinical studies of pharmacokinetics-pharmacodynamics in the euglycemic clamp, one of which is to characterize the dose-relationship response and the other intra-subject variability.
Under the terms of the agreement, Sanofi will be responsible for global business activities, regulatory and development. Under a separate agreement, which relates to the supply of the product, MannKind produce insulin at the plant in Danbury, Connecticut, and the two companies will collaborate to expand production capacity to meet global demand, "if necessary ".
MannKind immediately receive $ 150 million and will have up to 775 based on the achievement of certain regulatory milestones and development as well as sales.
Sanofi and MannKind will share the profits and losses on a global level so that the French giant MannKind will be up 65% and the remaining 35%.
"Afrezza is a further addition to our portfolio of integrated solutions for diabetes.'s In a unique position to provide patients an additional option for insulin therapy ... but does not require multiple daily injections," said Pierre Chancel, vice senior president of Sanofi, in the company statement.
"Sanofi is the ideal partner because of its complementary product portfolio, its large market presence of insulin and its commercial infrastructure world leader. Our profit-sharing agreement allows you to align the interests of MannKind and Sanofi in order to optimize the development, marketing and production costs, "said the other hand, Alfred Mann, Chairman and CEO of MannKind.
Designed to be taken at the beginning of a meal, insulin spray dissolves quickly after being inhaled into the deepest part of the lung and rapidly releases the drug into the circulation. The peak of insulin is reached within 12-15 minutes of administration and the plasma concentration returns to baseline levels in approximately 180 minutes.
In patients with type 1 diabetes, inhaled insulin should be used in combination with longer-acting insulin and is not recommended for the treatment of diabetic ketoacidosis or for patients who smoke.
If insulin spary will be a success or not only time will tell. The first attempt to spray insulin, Exubera, developed by Pfizer and approved in 2006, has proved a resounding flop. The product has taken hold: it has been withdrawn from the market in 2007, Pfizer has put nearly $ 4 billion. Then, the other companies that were trying to develop an insulin spray had retreated with his tail between his legs, frightened by the difficulty of the task and returns uncertain.
However, there are some reasons to be optimistic that the new insulin spray will have better luck. The Pfizer drug was contained in a huge device, shaped like a container for tennis balls, the subject of much irony on the web and not appreciated by the patients, at the time, preferred to continue to use the classic pens. Afrezza, instead, is provided with a device in the form of a whistle, of dimensions of far lower than all'inalatore Exubera, and the administration is more simple; In addition, the new product seems burdened with a lower risk of weight gain and severe hypoglycemia compared to insulin standard.
However, we do not know yet what it will cost and how will the price compared to other products of insulin, already on the market. Finally, do not miss some concern about the fact that doctors are willing to change therapy to their patients, making them switch to insulin spray.
According to analysts, the product could generate a turnover of 600 million dollars a year. But the last word is up to the patients.
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Post by kc on Sept 14, 2014 8:00:01 GMT -5
LA Times article
Billionaire inventor Alfred Mann is on a mission
Inventor Alfred Mann's companies have created such devices as a rechargeable pacemaker, an implant for deaf people, an insulin pump and a prosthetic retina.
BY STUART PFEIFER September 14, 2014, 7:00 a.m.
Many executives would have given up after sinking a decade and $1 billion into an unsalable product.
Wall Street had hammered the company's stock after regulators issued yet another round of safety concerns. Analysts piled on, some declaring the product would never reach the market. Shareholders sued.
But Alfred Mann's motivations went far deeper than money.
The Los Angeles billionaire already could claim a stunning array of medical advances: His companies had created a rechargeable pacemaker; an implant that enables deaf people to hear; a prosthetic retina that helps blind people see; an insulin pump that transformed the treatment of diabetes; a device that enables amputees to control prosthetic fingers with their brains.
It was 2011, and Mann had his sights on inhaled insulin — a breakthrough that could spare millions of diabetics the pain of billions of daily pinpricks.
Mann ordered his executives to cancel all the company's other projects, make painful job cuts and focus on the future of the drug, Afrezza.
The effort paid off. In June, the FDA blessed the drug, which led French pharmaceutical company Sanofi to pay MannKind Corp. $925 million for marketing rights, plus 35% of profits.
The deal could generate billions of dollars for MannKind. But for its chief executive — an 88-year-old physicist, inventor and entrepreneur who has launched 17 companies in five decades — it marks the capstone of a singular crusade.
"I know what motivates him," said Keith Markey, a Griffin Securities analyst who covers MannKind. "He'd like to do as much as he can for humanity."
Today, Mann walks a little slower than he once did. He's recovering from two recent surgeries. But during an interview at his 17,000-square-foot estate in Beverly Hills, Mann said he still routinely works 70 hours a week, managing a portfolio of companies and a charitable foundation that he hopes will continue his efforts to find solutions for unmet medical needs long after he is gone.
"I'm trying to help people," he said. "How else would I have been able to work until I'm almost 90, if I didn't have something to motivate me?"
Business associates say it's Mann's tenacity — some call it stubbornness — that has fueled his companies' success.
"He's unwilling to give up," said Robert Greenberg, chief executive of Second Sight Medical Products Inc., the company Mann co-founded to search for a cure for blindness.
During two years of testing for Second Sight's "bionic eye" device, engineers had been unable to solve a significant problem: It kept tearing the eye tissue of animals on which it was tested.
A board member told Mann: Maybe this is just too hard. Maybe it's impossible. Maybe we should quit.
Mann wouldn't hear it.
"No way. This is just an engineering problem," Greenberg recalled Mann saying. "And it's solvable."
In 2013, the Food and Drug Administration approved Second Sight's Argus II System, a prosthetic retina that has helped some blind people see. Last month, the company filed for an initial public stock offering, touting Argus II as its most promising source of revenue.
"It was that recognition of when to quit — and when not to quit — that separates Al from others," Greenberg said.
Mann was born and raised in Portland, Ore., the middle son of immigrants: his father from England, his mother from Poland. He graduated from high school at age 16, spent a couple of years in college and then joined the Army Air Corps during World War II, but didn't see combat duty.
After the war ended, Mann settled in Southern California and helped his father tend to a lemon orchard before enrolling at UCLA, where he earned a degree in physics.
His first business breakthrough came in 1956, when the U.S. military hired him to improve guidance system technology for missiles, leading him to launch his first company, Spectrolab Inc. A few years later, he won a contract with Aerospace Corp. designing solar cells for spacecraft, leading to a second company, Heliotek Corp.
Mann sold both companies for $10 million in 1960, the equivalent of about $80 million in today's dollars, plus a piece of future sales. In 1969, Johns Hopkins University researchers asked Mann if he could use space technology to help create a longer-lasting pacemaker.
Mann, whose father had died of a heart attack, responded with Pacesetter Systems Inc. It would become the nation's second-leading supplier of pacemakers.
It also, unexpectedly, led Mann to take an interest in diabetes.
While running Pacesetter, Mann visited the cardiac intensive care unit at the University of Alabama in Birmingham. His host on the trip was heart surgeon Dr. Richard B. Shepard, who told him that every patient there recovering from heart surgery also had diabetes, including a man and woman who each had both legs amputated.
Shepard told him, in strong terms, that he should put his talents to work on diabetes.
"He must have taken this to heart," Shepard said.
After selling Pacesetter to Siemens in 1985 for about $150 million, Mann began to focus on treatments for diabetes. His company MiniMed Inc. developed a small insulin pump that automatically delivers insulin throughout the day.
In 2001, Mann sold MiniMed to Medtronic Inc., a medical device giant, for more than $3 billion. The sale enabled Mann to focus on MannKind's inhaled insulin — and on his own nonprofit charitable foundation, which researches and licenses medical products.
Mann also founded a company, Advanced Bionics, that manufactured cochlear implants to help deaf people hear. In 2004, he sold the company to Boston Scientific Corp. for $740 million, plus unspecified future payments.
"His passion, as he's gotten older, is to try to eradicate as many terrible medical conditions as he can within his lifetime," said David Hankin, chief executive of the Alfred Mann Foundation. "At the age of 88, the guy is prolific. He's still inventing. We had a meeting a few weeks ago at his house to talk about some different forms of a device he's thinking about. He had this amazing passion and gleam in his eye.
"His mind is as sharp as it's ever been," Hankin said. "I think he wakes up thinking about new devices every day."
Last year, Mann teared up as he embraced retired Marine Corps Staff Sgt. James Sides at the Mann Foundation's annual dinner.
Sides lost his right hand when a roadside bomb exploded on a dusty Afghanistan road in July 2012. Several months later, doctors at Walter Reed National Military Medical Center told him about a prosthetic hand that had been developed by the Alfred Mann Foundation. The device includes electrodes, implanted into arm muscles, that would enable him to intuitively move his prosthetic fingers. It was the most advanced prosthetic hand ever developed.
Surgeons implanted the new device in June 2013. Sides, now a student at Santa Monica College, said it has dramatically improved his life.
"It's a whole new world," he said. "I'm much more fluid with my daily tasks. I can pull money out of the ATM. Essentially, I'm acting as though I have a hand."
Mann said meeting Sides was memorable.
"I get so much satisfaction out of helping people," Mann said. "It's not for money. My kids are well taken care of."
Mann's personal life has sometimes suffered while his businesses thrived. He has been divorced three times. He has spoken openly about his disappointment with some of his six children, whom he identified by birth order, rather than name, in an interview with The Times.
"My No. 5 kid has never worked. No. 6 has never worked," he said. "No. 3 ran a restaurant and retired."
Mann has said he intends to leave most of his fortune to his foundation and other charities.
"I've already given them too much," he said, "so they're not really motivated."
Mann and his fourth wife, Claude Mann, have been married 10 years. They spend most of their time at their home in Las Vegas, where Mann works out of a home office. The couple spend quiet nights eating Claude's home-cooked dinners — his favorite dish is chicken a l'Orange — and playing French rummy.
"He beats me most of the time," she said. "That's just the way his brain works."
Claude forces her husband to take two weeks of vacations a year, one to Cabo San Lucas, Mexico. She'll catch him reading business documents, checking emails, or quietly taking business calls when they're supposed to be relaxing.
"I love him so much, so I don't complain," Claude said. "I know I will be first in his heart, but not his first priority. His first priority will always be work and doing what he does best."
Recently, Alfred Mann has been focused on inhaled insulin. It's been a long, expensive journey to get Afrezza to this stage. MannKind has spent about $1.8 billion developing Afrezza, with nearly $1 billion of that coming from Mann's personal wealth, the entrepreneur said.
Investors have rewarded Mann's persistence. MannKind shares, which sank as low as $2.25 in 2011, closed Friday at $6.68.
MannKind was a bystander in 2006 when Pfizer Inc. introduced the world's first inhaled insulin product, Exubera, which it later yanked from the market because of poor sales, absorbing a loss of more than $2 billion.
Mann says Afrezza will succeed where Exubera failed because Afrezza has another benefit: It's much faster-acting than insulin injections, in addition to being more convenient.
The drug is a powder that is inhaled with a device about the size of a whistle. It would be most often used to help control blood-sugar levels at meal time, a quick puff replacing an injection before a meal.
Those who know Mann are not surprised that he pushed Afrezza through.
"The guy is unrelenting," said John Mastrototaro, who spent eight years working for Mann at MiniMed. "He recognizes that along the way you're going to have certain setbacks."
Still, Mastrototaro said he was concerned when he first heard of Mann's plans for inhaled insulin.
"I actually thought it was a bad idea for him to get into the pharmaceutical space after all his success with devices," he said. "Pharmaceuticals are just a different beast in terms of the time and money involved. But if anyone could get it done, it's Al."
stuart.pfeifer@latimes.com
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Post by liane on Sept 14, 2014 13:38:56 GMT -5
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