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Post by lakers on Feb 4, 2016 13:03:36 GMT -5
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Post by lakers on Feb 4, 2016 2:21:19 GMT -5
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Post by lakers on Feb 3, 2016 13:37:06 GMT -5
The Real Motivation for Efforts to Undermine MNKD There is a continuing —and, to some, inexplicable—drumbeat of negativity concerning the prospects of this (by market cap measures) tiny stock. There is also a relentless campaign of short-selling—notwithstanding the fact only a meager $1 of profit potential remains even if every bearish prognostication is realized. The explanations, to me, are simple. MNKD has dared to threaten a multi-billion dollar franchise . . . and those enterprises which presently have the oligopoly on that franchise want to defend it, at all costs. What are mere millions when billions are at stake? The short selling, from that perspective, is not prosecuted with the traditional profit motive in mind. The objective, rather, is to keep MNKD’s share price depressed . . . for the principal purpose of ensuring that the company cannot use its own stock as currency in any effort to raise additional capital. Regrettably, SNY was not the right marketing partner for MNKD. Indeed, SNY is a member of the very oligopoly that has an interest in ensuring that Afrezza does not gain traction in the market. SNY from the beginning had a greater incentive to realize 100% of the profits on sale of its own diabetes therapies (e.g., Toujeo) than a fraction of the profits on the sale of Afrezza. The fox, in other words, had been contracted to guard the henhouse. The results of SNY’s “marketing efforts” therefore were not surprising . . . nor was SNY’s termination of the contractual arrangement. There have been exchanges on this board regarding the nature of the remedies that MNKD might have against SNY. One or two posters have expressed the opinion that the terms of the contract between MNKD and SNY may (or will?) foreclose MNKD’s rights to damages for breach of that contract. I am not at all certain that I hold the same view. But I believe, in any event, that there exists an independent ground for SNY’s liability. Even if it is concluded that SNY had the right to terminate its relationship with MNKD, that could have been accomplished with a one sentence letter communicating that decision. SNY instead chose to make public statements that it was terminating its relationship with MNKD because (in words and substance) Afrezza would never be a commercially viable product, even if reasonable marketing efforts were made. Those statements (i) were not required for exercise of SNY’s contractual right to terminate, and (ii) had the effect (and were very likely intended to have the effect) of damaging Afrezza’s reputation. Posit, for example, the senior management of a public company that is a potential purchaser of Afrezza, or MNKD partner, who believes in the product’s potential. Any proposal by the management of that company involving Afrezza would certainly elicit shareholder skepticism—if not opposition—based on the stated pronouncement of a major pharmaceutical company that it had concluded, after (purportedly) diligent analysis, that the product would never be commercially viable. Other measures of damage come readily to mind, but will not be elaborated in the interests of space. To put the matter plainly: I believe that SNY’s gratuitous statements concerning MNKD’s prospects amounted to product disparagement, for which SNY is answerable in damages. Indeed, if it were to be determined that SNY purportedly based those statements (which it did not need to make at all) on the results of intentionally inadequate marketing efforts, SNY’s bad faith might well provide a basis for engrossment of MNKD’s compensatory damages with punitive damages. finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1454443357904-880a6f40-a1a6-4e37-8100-269a6ae5f247&tls=la%2Cd%2C8%2C3[the damage may be trebled. I fully expect Sanofi will eventually substantially extend Mnkd's runway.]
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Post by lakers on Feb 2, 2016 21:31:22 GMT -5
Both Sanofi and Mnkd knew in early Aug 2014 that a 6-month Phase 4 Superiority Study enabling label improvement would be the key to place Afrezza higher in PBM formulary w/o PA, ST. Sanofi chose to ignore the obvious - check my posts in other threads re: Hakan interview Oct 2014 and SD early adopter meeting Dec 2015. Mnkd had a slide in a CC w/ Superiority/label improvement study planned. If this is not sandbagging then what is. This is easily proven in court.
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Post by lakers on Feb 2, 2016 16:39:06 GMT -5
Who said Sanofi is free from liability w/ Mnkd. Read Biodel, Genzyme lawsuits. Read more: mnkd.proboards.com/thread/4834/ajmc-sny-mnkd-breakup-insight?page=2#ixzz3z35G6LbqPfizer, Nektar Reach Exubera Settlement November 13, 2007 Pfizer and Nektar Therapeutics have reached an agreement settling their contractual issues regarding Exubera and Nektar's new inhaled insulin product, which is currently in Phase I. Nektar will receive a one-time payment of $135 million from Pfizer to end all obligations under existing agreements relating to Exubera and the new product. Also, if Nektar finds a new partner, Pfizer will transfer its remaining rights and all economic benefits for Exubera and the new product. This would include the transfer of the Exubera NDA and INDs and all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities. Jeffrey B. Kindler, chairman and chief executive officer of Pfizer and Howard W. Robin, president and chief executive officer of Nektar issued a joint statement about the settlement, "This agreement demonstrates the industry leadership of Pfizer and the company's desire to work with world-class biotechnology partners like Nektar. The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and its next generation inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems." - See more at: www.contractpharma.com/contents/view_breaking-news/2007-11-13/pfizer-nektar-reach-exubera-settlement#sthash.pfSObdSy.dpufA fair settlement needs to include $30M EMA MAA, $20M Japan MAA, $25M for qualifying Sanofi's insulin, $200M on-going Pediatric trial, 5-yr/8K PWD lung trial, $30M supply chain transition, $50M breach of min insulin purchase with AMPH, possibly $250M first sale milestone.So, the settlement range is ~ $355M-$605M. This is still pocket change considering that Pfizer sank $2B into Exubera plus $135M settlement. U.S. legal judgement is based on precedence. At min, $355M would extend runway by 2.5 - 3 years.
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Post by lakers on Feb 2, 2016 16:25:50 GMT -5
Matt said through another person that Mnkd IP Counsel deemed slide #9 incl 12 drug candidates may jeopardize IP protection. Ray will talk more about these drug candidates tomorrow. Don't know if Matt will include the missing slide in tomorrow CC. I agree that Internet doesn't forget.
IMHO, this also indicates that new or potential partner(s) besides RLS don't like the fact that their drugs are being shown around. Oops!
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Post by lakers on Feb 1, 2016 19:48:28 GMT -5
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Post by lakers on Jan 31, 2016 23:39:59 GMT -5
The company is currently establishing diabetes centers for patients, powered by Afrezza Diabetes Management. This is going to be a one-window operation, providing the drug, spirometry testing, on-site prescription writing, and healthcare insurance filers. Read more: mnkd.proboards.com/user/1882/recent#ixzz3yt6okfen
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Post by lakers on Jan 31, 2016 17:12:06 GMT -5
The CEO said he was also optimistic about an unrelated venture by a private firm that is looking to create a diabetes care center business model that can provide in-house services to urgent care centers throughout the country. The venture, he said, is bullish on Afrezza and is planning to use the drug as its top treatment for the disorder. The first center is expected to open next month in New Jersey. “They’ve coined the term ‘real time diabetes management, powered by Afrezza,’” Pfeffer said. “This is an excellent opportunity for us and it takes no money at all from MannKind.” In the meantime, Pfeffer noted that discussions are already underway with prospective partners in various regions across the globe who were interested in Afrezza prior to the selection of Sanofi. Any partnerships, he said, could come with some upfront cash that could help the company’s financial situation. Read more: mnkd.proboards.com/thread/4920/danbury-times-mnkd-partner-private#ixzz3yrLpl68uPrivate equity KKR owns 80% of Panasonic Healthcare. For Matt to say it cost nothing, the private firm's investors could own a % of Mannkind. There is no free dinner. BR owns 4.6%, Al owns ~ 37%, if KKR owns 10%, together they could LBO Afrezza which would provide sufficient funding for TS. NURTURING POSITIVE PARTNERSHIPS At Ascensia Diabetes Care we appreciate the power of mutually beneficial partnerships. Such collaborations have contributed significantly in the development of groundbreaking products and technologies and also increased our knowledge of diabetes and its management. Our technology and innovation partners help us to explore new ways of delivering cutting-edge diabetes management solutions. We also work closely with healthcare professionals, academic institutions, and patient groups around the world to ensure that the requirements of people with diabetes are central to everything we do. For example, our exclusive international alliance with Medtronic, Inc. is vital to the development of innovative next-generation diabetes management solutions. Through this collaboration the Ascensia Diabetes Care CONTOUR™NEXT LINK and CONTOUR™PLUS LINK meters allow seamless integration to the MiniMed® range of insulin pump systems, transmitting blood glucose results wirelessly to the insulin pump. Click here for further information on the CONTOUR™NEXT LINK and CONTOUR™PLUS LINK meters. ascensia.com/Partners/
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Post by lakers on Jan 31, 2016 15:45:14 GMT -5
Who said Sanofi is free from liability w/ Mnkd. Read Biodel, Genzyme lawsuits. Biodel eliminates half its Danbury staffers By Alexander Soule | January 28, 2016 Biodel headquarters at 100 Saw Mill Road, in Danbury, Conn. Photo: H John Voorhees III / Hearst Connecticut Media / The News-Times Photo: H John Voorhees III / Hearst Connecticut Media Biodel headquarters at 100 Saw Mill Road, in Danbury, Conn. Danbury-based pharmaceutical developer Biodel has laid off 15 people, more than half of its workforce, after a crumbled partnership forced it to suspend a drug trial and evaluate options including a sale or a reverse merger, in which another company would acquire Biodel for its Nasdaq listing and cash reserves. It would amount to an ignominious end for Biodel, created in 2003 by onetime MannKind executive Dr. Solomon Steiner and others who set out initially to develop VIAject, an insulin treatment for diabetics designed to be absorbed into the blood faster than alternatives at the time, with a later version of the technology called Linjeta. In 2007, Biodel held an initial public offering of stock, raising $75 million to support clinical trials, but was unsuccessful in its initial attempts to win Food and Drug Administration approval. Most recently, Biodel has focused on applying its technology as an emergency intervention for diabetics suffering severe hypoglycemia, a condition in which blood sugar levels fall dangerously low. But the company’s stock (Nasdaq: BIOD) has plummeted to about 25 cents after York, Pa.-based Unilife abandoned a co-development agreement with Biodel late last year. A possible settlement over the deal is ongoing as Biodel sued for punitive damages in Connecticut state court while also seeking redress through the American Arbitration Association. Dr. Errol De Souza, who replaced Steiner as CEO in 2010, could not be immediately reached for comment on the layoffs, which were disclosed Wednesday in filing with Securities and Exchange Commission. Biodel is paying out $1.3 million in severance to the 15 people losing their jobs, with the company, which had two dozen employees on staff as of December, listing Danbury locations at 100 Saw Mill Road and 6 Christopher Columbus Avenue. “It’s very difficult for us, under the circumstances, to provide any guidance in terms of the future of (our development) programs,” De Souza said on a conference call with investment analysts in mid-December. “We’ve also been looking at how we could leverage all the investments we’ve made in the program at Biodel — in terms of formulation development, toxicology, the clinical studies that we’ve done — that might be applicable to other auto-reconstitution devices to maintain value in the investments that we’ve made ... That’s something that we continue to make some progress on, but it would be premature to talk about any directions that we would move forward there.” At last report, Biodel had $41 million in cash, but a market valuation of just $16 million based on the value of its stock as of Wednesday. As of Thursday morning, Biodel had yet to release its annual proxy disclosing its ownership and executive compensation, with Biodel estimating De Souza’s 2014 cash compensation at nearly $700,000, not including the value of stock options that at the time pushed his estimated total compensation to nearly $1.1 million. “From [Wall] Street’s perspective, the strongest asset that we have is our ... cash position relative to our market [capitalization],” De Souza said. “We’re looking to see how we can leverage the strength in the (company’s) cash position to be able to look at ... a reverse merger, synergistic to our assets, (and) other options that might be available ... We want to make sure that we don’t continue to drain the cash position.” m.newstimes.com/business/article/Biodel-eliminates-half-its-Danbury-staffers-6791040.php
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Post by lakers on Jan 31, 2016 14:33:57 GMT -5
Mack-Cali announces new lease with Ascensia Diabetes Care Global Leader in Blood Glucose Monitoring and Diabetes Care Solutions will Open U.S. Headquarters in Parsippany, NJ By Frank Cahill - Jan 29, 2016 parsippanyfocus.com/2016/01/29/mack-cali-announces-new-lease-with-ascensia-diabetes-care/Mayor is proud to announce for the 39th consecutive year, Parsippany has been named a Tree City. ... NJ Patch has put together a list of the "15 Safest Big Towns" in New Jersey and Parsippany-Troy Hills ranks among the top five. KKR, Panasonic form newco Ascensia from Bayer Diabetes buy for $1.1B Panasonic Healthcare has closed its purchase of the Bayer Diabetes Care business for about $1.1 billion. The deal was originally disclosed in June and was funded in part by well-known hedge fund KKR, which holds 80% of Panasonic Healthcare with the remainder owned by the larger Panasonic corporate entity. The acquired business will operate as a stand-alone company known as Ascensia Diabetes Care. Along with Panasonic Healthcare, the newco is expected to continue to develop, manufacture and market blood glucose monitoring meters and strips globally. "Our goal is to ensure high-quality technologies and diabetes care solutions are available to all patients who need them. Bringing together Panasonic Healthcare and Ascensia Diabetes Care will significantly help to achieve this goal," said the President of Panasonic Healthcare Hidehito Kotani in a statement. Sign up for our FREE newsletter for more news like this sent to your inbox! He continued, "Together with KKR, the companies will be able to serve more patients in more places across the globe with world-class products. We greatly look forward to expanding this business and innovating new solutions at this integral point in the diabetes care industry." The Bayer Diabetes Care Business had €909 million ($1 billion) in 2014 sales, with the business primarily driven by sales of the Contour blood glucose monitor products. Ascencia will be headed by Michael Kloss, the head of Bayer Diabetes Care since 2013. The company sells products in 125 countries worldwide; it will have about 1,400 employees in 38 countries after the close of the deal in all the countries. A staggering 9% of the global population has diabetes, according to the latest World Health Organization estimate, and in many poorer nations it is uncommon for diabetic patients to self-monitor blood glucose levels. KKR and Panasonic likely are betting that the relatively inexpensive blood glucose monitors marketed by Bayer could change all that, appealing to the ever-growing diabetic population. An estimated 1.5 million deaths were attributed to diabetes in 2012, with more than 80% of those occurring in low- and middle- income countries. Earlier this year, competitor Abbott ($ABT) offered a slightly different approach to address the same issue. It launched a physician blood glucose monitor in India that works via a quarter-sized sensor attached to the back of a diabetic patient's arm that is reapplied every 2 weeks and records data every 15 minutes. Ascensia is focused on global growth but innovation won't be entirely off the table. "It has a strong pipeline and will continue to invest in research and development of new products that will help to improve patient care," concluded KKR Europe, Africa and Middle East Head Johannes Huth. www.fiercemedicaldevices.com/story/kkr-panasonic-form-newco-ascensia-bayer-diabetes-buy-11b/2016-01-06Indeed.com Ascensia Diabetes Care - Whippany, NJ .... opening a second location in New Jersey Feb 2016. www.indeed.com/m/jobs?sameL=1&q=Ascensia+Diabetes+Care&l=Whippany%2C+NJ&from=searchOnSerpGoogle "ascensia diabetes care feb 2016"
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Post by lakers on Jan 31, 2016 12:44:04 GMT -5
Receptor Life Sciences Comes To MannKind Corporation Rescued After Failed Deal MannKind Corporation (NASDAQ:MNKD) stock sky-rocketed yesterday, following an insight into the company’s selling block. A Reuters report cited unnamed sources, asserting that the drug maker is looking for a buyer. The very likely reason is the termination of the deal between itself and Sanofi SA (ADR), a marketing partner for the former's Afrezza drug. It suggested Mannkind will get the selling rights back over the next three to six months, with a finalized deal no later than July 4. CEO Matt Pfeffer was not available to comment. In addition to the setback in the sales of Afrezza (human insulin), the company has faced other problems. Its chief executive resigned in November 2015, compelling former CFO Matt Pfeffer to take over. In an interview with The Times, he said the company is looking for new distribution partners, as well as changing the sales policy for Afrezza, adding that the company is looking at markets outside the US. He did not provide any insight into the sale of the company. It is time the drug maker stops relying overwhelmingly on Afrezza. It has other assets, including inhalable drug technology, that could rescue sales and revenue. Besides this, the company is also in the process of developing inhalable epinephrine, for the treatment of allergic reactions. In 2006, Pfizer Inc Exubera was approved in the formulation of inhalable insulin, but upon entering the market, failed, owing to poor safety, dosage, and price factors, costing the company $2.8 billion. Pharma giants were not able to develop insulin inhalers. This was all while the chairman of Mannkind spent a decade, plus $1 billion, on the approval of Afrezza. The drug was rejected twice, due to safety risks. SANOFI AND MANNKIND DEAL The drug maker had an accord with French drug company Sanofi, in August 2014, for the marketing of Afrezza. In 2014, Sanofi agreed to pay $925 million for the rights and distribution of Afrezza. The sale of the drug came in at a paltry $5 million in the first nine months of last year, falling terribly short of its target. On January 5, 2015, the stock tumbled 50%, with an average downtrend of 67% over the last three months, inclusive of Tuesday’s decline, due to the termination of the deal. In a conference call, CEO Matthew Pfeffer said: “This is not the end of the line for Afrezza or MNKD by any means.” Now that Sanofi is out of the picture, and MNKD has resumed full control of the drug, it needs to address its price, since Sanofi was marketing it at a premium level. In addition, the company has to educate both, doctors, and patients, of Afrezza's mode of action, since it belongs to a different class of drugs, with enhanced benefits. The drug maker must also engage in spreading awareness regarding the inhaled insulin method within the diabetic population. The intake process is revolutionary, since most diabetics take insulin via needles. Sanofi did not adopt this intake process, and therefore failed to rake in sales as excepted. The company is currently establishing diabetes centers for patients, powered by Afrezza Diabetes Management. This is going to be a one-window operation, providing the drug, spirometry testing, on-site prescription writing, and healthcare insurance filers. COLLABORATION WITH RECEPTOR LIFE SCIENCES The company is being reported to have reached a deal with Receptor Life Sciences on January 21, 2016. Under the agreement, the companies would be responsible for the development of multiple inhaled therapies for the treatment of chronic pain, neurological diseases, and inflammatory disorders. Receptor Life Sciences will bear all the development costs. Mannkind will share technology with Receptor, which will manufacture and commercialize the inhaled drugs. MNKD will be entitled to garner development and commercialization milestones of up to $102.25 million. Furthermore, the drug maker will also receive mid-single to low double-digit royalties, on net sales. ANALYST’S VIEW Griffin Securities analyst Keith Markey said: “I don’t know where a story like this comes from, but I really don’t give it much credence.” Markey added that at a J.P. Morgan health-care conference about its future plans and actions, the company had made it very clear, that these included the marketing of Afrezza on its own, and the developing other uses for its proprietary inhaler. After the termination of the contract, Griffin raised its opinion to a "Buy," but Piper Jaffray and RBC downgraded their respective price targets to $0.05 and $0.15 respectively. STOCK POSITION The company’s stock is trending upwards at 17.28% at 12:54 AM EST. www.businessfinancenews.com/27472-receptor-life-sciences-comes-to-mannkind-mnkds-rescued-after-failed-deal/
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Post by lakers on Jan 31, 2016 12:12:55 GMT -5
Sanofi Should Pay Mannkind For Doing Little To Nothing For Afrezza & Walking Away There is clearly no doubt Sanofi did not meet their good faith effort obligation under the 2014 Global Licensing Deal and should be forced to compensate Mannkind paying cash to Mannkind and forgiving debt owed by Mannkind to Sanofi. Here is Sanofi is guilty of not doing.... 1) Sanofi did little to create market awareness across the entire United States for Afrezza 2) Sanofi's spending was anemic promoting & educating Afrezza to patients and healthcare professionals 3) Sanofi commercialization budget & support was inferior in proportion to what was done for Toujeo 3) Sanofi did nothing in the clinic to pursue an improved label for Afrezza 4) Sanofi REMS efforts were minimal choosing a limited pediatric study & delaying lung safety study 5) Sanofi did nothing outside get Afrezza approved & selling outside the United States 6) Sanofi's DTC Campaign rolled out in September was a joke with only a few print ads placed 7) Sanofi did little to promote Afrezza during public forums like investor & healthcare conferences 8) Sanofi completely ignored the great benefits early adopters were seeing and talking about in the real world 9) Sanofi's sales organization did little face to face place of business calls to healthcare providers 10) Sanofi's sales organization did little face to fact place of business calls to pharmacists 11) Sanofi consistently downplayed or ignored Afrezza during all conference calls and presentations 12) Sanofi's marketing budget for Afrezza vs. Toujeo was disproportional favoring Toujeo 13) Sanlofi's intentionally priced Afrezza at a premium opposite Mannkind's recommendation 14) Sanofi's development/clinical effort for Afrezza vs. Toujeo was disproportional favoring Toueo 15) Sanofi's promised to have Afrezza available in Israel quickly and it never happened 16) Sanofi did not allocate the time, money and resources to promote Afrezza game changing benefits 17) Sanofi's spending & people support for Afrezza was less compared to other drugs finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1454253323072-45cb1bd9-d71e-43bd-a6b2-1291bec7b01d&tls=la%2Cd%2C3%2C3By Kevinmik IMHO the biggest disservice SNY did to MNKD shareholders, a slight that should be pursued in court, is 1) poorly supporting afrezza commercialization, while 2) assuring us in a very misleading fashion that this was all ok because it was a controlled launch. IMO this is nothing short of willfully misrepresenting marketing efforts at the expense of MNKD shareholders. By dtrouble1003
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Post by lakers on Jan 30, 2016 15:39:33 GMT -5
Lakers, You mentioned a BOD meeting was just scheduled to happen in a few weeks. Any other thoughts on it? Note that Ray will present at 2/3 meeting. So, there must be an update related to TS, a mere 2.5 weeks after 1/13 CC, in addition to slide 9 removal. It's unusual that we have 3 important events in a single month: 2/3 SH CC, 2/18 BoD, 2/29 ER. This is the first time in Mnkd history that happens for a tight lipped co.
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Post by lakers on Jan 30, 2016 13:50:15 GMT -5
Third possible answer: Maybe TECHNOSPHERE has been sold and the pipeline with it! No way TS is sold before Afrezza as Mnkd at its core is a drug dev co. or reduced to a licensing co. earning royalty. Afrezza is likely sold before TS or they are sold together. If RLS's RA, MS, Alzheimer's become BB, Mnkd could have multi-billion mkt cap again.
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