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Post by lakers on Jun 3, 2016 2:02:50 GMT -5
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Post by lakers on May 31, 2016 16:54:02 GMT -5
The followings increase their Mnkd holdings, Sch 13F, 3/31/16. It's odd that All six BR funds increase their holding in the same qtr, total 4.5735%. If exceeding 5%, they have to file Sch 13G. whalewisdom.com/stock/mnkdVANGUARD GROUP INC owns 19,541,916, 4.6722% BLACKROCK FUND ADVISORS owns 11,641,028, 2.7832% BLACKROCK INSTITUTIONAL TRUST COMPANY, N.A. owns 6,390,165, 1.5278% BLACKROCK INVESTMENT MANAGEMENT, LLC owns 846,194, 0.2023% BLACKROCK ADVISORS LLC owns 119,378, 0.0285% BLACKROCK GROUP LTD owns 114,385, 0.0273% BLACKROCK INC. owns 18,413, 0.0044% GOLDMAN SACHS GROUP INC owns 9,806,548, 2.3446%
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Post by lakers on May 25, 2016 10:20:58 GMT -5
Meanwhile Dance Pharma already has a Chinese Partner. Quite honestly they better get their act together by ADA as they seem to operate as if they are equivalent in size to a giant pharma like Sanofi, and I am NOT impressed at the speed they are moving. They knew since last year that Sanofi was abandoning them. they could have done ALL this work and lined up other suitors by April of this year. Anybody ask him what those sales milestones are that allows Matt to buy a million shares at <$1 ? Is it 1000, 10000, 100000 or 1M scripts ? Dance Biopharm Announces Joint Venture with Harmony Asset for the Development of Inhaled Insulin in Multiple Countries in Asia SAN FRANCISCO, Oct. 15, 2013 /PRNewswire/ -- Dance Biopharm Inc., a privately-held biotechnology company focused on the development of inhaled insulin products to treat diabetes, today announced that it has entered into a joint venture with Harmony Asset for the development of inhaled insulin in China and other Asian countries (excluding Japan). Under the joint venture, Harmony will cover the majority of the development expenses in most of the specified regions and will receive ownership in those territories commensurate with the level of expenses paid. The joint venture will enable Dance Biopharm to significantly expedite its regulatory, manufacturing, and commercial partnering efforts in China. "We are excited to partner with Harmony on this joint venture and believe that Harmony's strong expertise in China and extensive connections among China regulatory, manufacturing, and pharmaceutical business leaders will be invaluable as we move toward product approval of Adagio inhaled insulin. With the help of Harmony, we have already begun a process to select a commercialization partner for mainland China," stated John Patton, Ph.D., chairman and chief executive officer of Dance Biopharm. "We are in active communication with regulatory authorities in Europe and the United States regarding our path to approval for Adagio, and this joint venture represents an important part of our strategy to pursue product approval with multiple regulatory authorities in parallel in order to get this product to millions of diabetic patients in need, worldwide." "We are very excited with this opportunity to partner with Dance. We believe this company holds the key to improving the well-being and lifestyle of millions of diabetic patients everywhere," stated Augustine Chow, Ph.D., chief executive officer of Harmony Asset Limited. "We are thrilled to be bringing these amazing products to Asia Pacific, and we are committed to taking Adagio through regulatory authorities and identifying strategic partners in each country as soon as practical." The joint venture entered into by Dance and Harmony will focus on the development and commercialization of inhaled insulin in multiple countries, of which the major ones are China, Korea, India, Indonesia and Australia. The joint venture, which is majority owned by Harmony, will be governed by a board of directors comprised of an even number of representatives from each company. The objective of the joint venture is to pursue development of the inhaled insulin products and to navigate the products through foreign regulatory processes and then into commercialization in the specified regions. Where desired, the joint venture will seek regional partners for commercialization. About Adagio™, a Second-generation Inhaled Insulin Product Dance Biopharm's Adagio is a novel second-generation inhaled insulin product in development that could resolve issues inherent in the first-generation inhaled insulin products, which were known to be safe and effective yet uneconomical and cumbersome. The liquid formulation of natural human insulin is dispensed through a small, silent, handheld electronic aerosol device, intended to deliver the patient's individualized dose of insulin in one to three breaths at mealtime. Dance has chosen to develop a liquid formulation of insulin instead of a dry powder with the goals of lowering manufacturing costs, eliminating cough, and facilitating ease-of-use. Adagio is currently in clinical trials and is in preparation for pivotal development. The first clinical trial was completed in Germany, and the company has conducted an extensive scientific advice process in Europe, which has resulted in an abbreviated development plan there. The company is actively engaged in discussions with the U.S. Food and Drug Administration (FDA) and is incorporating FDA input into clinical development plans for Adagio. www.prnewswire.com/news-releases/dance-biopharm-announces-joint-venture-with-harmony-asset-for-the-development-of-inhaled-insulin-in-multiple-countries-in-asia-227792911.html
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Post by lakers on May 25, 2016 1:45:30 GMT -5
Henry said he was a partner of Shanghai Hequan Mgmt fund majority-owned by China Energy Fund Committee (CEFC), registered in Hong Kong, is a non-profit and non-governmental global think-tank fully funded by CEFC China Energy Company Limited. It is committed to the research into global climate change and environmental economics, international cooperation and sustainable development and holds forums on world civilizations to explore common ethics. As an NGO in Special Consultative Status with the Economic and Social Council of the United Nations, CEFC conducts public diplomacy in the field of energy and culture to promote international cooperation and exchanges and foster philanthropy. It has joined hands with the UN in launching the “Powering the Future We Want” initiative, offering an annual grant to institutions or individuals that have demonstrated leadership and innovation in promoting sustainable energy. www.cefc-ngo.co/en/[The China Energy Company Limited is a huge conglomerate. Check out its org structure below. en.cefc.co/category/zzjg?lang=cnCorporate Profile CEFC China Energy Company Limited (hereinafter referred to as “CEFC China”) is a private collective enterprise with energy and financial services as its core business. As the corporate name implies, CEFC China speaks for credibility of the Chinese. The strategy of the company seeks to serve the national industrial interest by building a modernized “economic community” to compete as a multinational enterprise that expands cooperation in the international energy economy and achieves influence in the energy industry. In 2014, the company was on the Fortune Global 500 List and among the World’s 500 Most Influential Brands with its annual revenues exceeding RMB 220 billion. It has been awarded the “2014 Most Influential Chinese Enterprises”, and has won the title of “Top Ten Chinese Philanthropic Enterprises” for four consecutive years. en.cefc.co/category/wmdzghx?lang=cnstocktraderforgain • 12 hours ago Flag 3users liked this postsusers disliked this posts0Reply exactly what Mr. Orlosky needs to do is approach the company in the normal manner that a person would approach buying a publically traded company. He is not going to buy a Majority interest in a company that has the potential of being worth billions for $500 Million. Not sure what he was smoking but it won't happen . The perfect storm is yet to play out on MannKind. It will be a big one you can count on it. The company has too much inherent value to sell cheap. Perhaps Henry Orlosky was thinking that shareholders would appreciate his overture but everybody saw it for what it was...... A cheap bottom fishing comment.. He wants to buy a piece of the company he can buy shares on the open market to get it cheap today. Heck he can acquire a 5% interest than approach the board to buy more shares. There is a lot wrong with his approach. I agree that if he initiates a 5% stake, he can force the BoD to dialog. Let's see if CEFC starts buying in the next 60 days. After owning 5%, the fund is required to file 13G. I don't think Mnkd had a poison pill yet. I don't mind if CEFC pays a fair price, then influences China drug regulatory to fast track Afrezza as a Chinese owned med. This could open up the huge China diabetes market including Hongkong. In the meantime I expect regional partnership w/ Canada, and/or Israel, and/or Australia this year.
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Post by lakers on May 20, 2016 13:23:13 GMT -5
The man's name is Henry Orlosky. He is a Partner at Heguan Fund. They are a company with ties to China. He said he was Al Mann's friend. He also said he believes in the company. He is a older man and just think he wanted to wow the crowd. The fact is I bought more shares after he spoke. It was a gamble thinking it may spark people into a buy. It did not. To all that I shared dinner and drinks with and then this morning breakfast it was a pleasure meeting all of you. 5/11/2003 The West is littered with cow towns that came and went, but none to rival the one planned by William Buck Johns and Henry Orlosky. Amid the tumbleweeds and dust devils of Harper Dry Lake, a scorched, wind-blasted depression in the high desert just north of Barstow, the two men -- visionaries maybe, or perhaps just energy developers on the make -- see a cow utopia. They want to build the dairy equivalent of a shining city on a hill: the perfect community where farmers and cattle live together in harmony with the environment while turning cow patties into clean, renewable energy for the Los Angeles region. "We're talking cow condos, a complete gated community, sharing all sorts of services. It will be good for dairymen and a good way to dispose of animal waste. We're doing a great service," Orlosky said. Orlosky, 58 [now 71], is his counterpoint. Tall and thoughtful, Orlosky is trained as a pilot and engineer, which taught him to act with careful calculation. He lives in Sacramento, but formed a company in Irvine that makes medical tools. He possesses several patents. Orlosky owns the land for the energy park and is one the biggest holders of water rights in the desert.The dairies would include paved floors and covered stalls, complete with solar panels on the roofs. A plumbing system would continually flush each dairy like a giant toilet. Waste -- a cow can produce 100 pounds of excrement a day -- would be piped to a digester that would use bacteria to extract methane, which would generate enough power to run the cow complex, with some probably left over for sale to the electricity grid serving Southern California, Orlosky said. articles.latimes.com/2003/may/11/local/me-cowtown11Currently, Henry is CEO of U.S. Solar LLC (Sept 2007 - Present). He was Exec VP of Eclipse Aerospace, Inc (Al's company), Nov 2009 - Dec 2012. Member of BoD & VP Asia. Develop, Design/Build, Manage Utility-scale size 300mW solar plant development projects. Acquire site, Design, Permit, Construct, Build, Operate solar plants. Most recent projects: Harper Dry Lake, CA, Harper Lake Solar Plant 300MW Solar Thermal (Renamed Abengoa Solar), size $1.3B (scheduled to be online early 2014). Planned projects: Needles CA & Nevada. www.bio-equip.cn/enshow1manufacture.asp?manuid=biochipFounded in Aug 2000, Shanghai Huaguan Biochip Co., Ltd. is located in Zhang Jiang Hi-Tech Park of Pudong, Shanghai. The Company is backed by a group of renowned institutes including Shanghai Institutes for Biological Sciences (SIBS), Shanghai Institute of Microsystem and Information Technology, both affiliated with Chinese Academy of Sciences (CAS), Chinese National Human Genome Center at Shanghai (CHGC), and Shanghai Biochip Co., Ltd.(SBC) & Shanghai Engineering Center for Biochip. In 2000, the Company received subsidized funding from the State High Tech Research and Development (863) Program granted by Chinese Ministry of Science and Technology to develop its biochip program. We have been engaging in research, development and commercialization of a variety of biochip and diagnostic products, including one-step rapid test and ELISA test products. Our complete line of diagnostic tests are customerized in various formats to meet the specific needs of our global clients. We produce and ship millions of quality diagnostic test kits every year to supply our international distribution network supplying hospitals, clinical laboratories and all other users. We offer a short turn-around time and shipping of our product to overseas markets. Our products are backed with timely and friendly after-sale support to address issues in using our products . In addition, with the support of an in-house well-equipped production facility and a creative technical team, we are looking forward to forging close relationships with our clients around the globe to meet their specific product need. We are always interested in cultivating long-term cooperations with interested parties on the basis of quality and mutual benefits. Welcome to Shanghai Huaguan Biochip Co., Ltd. It is a great honor and pleasure to have us fulfill your need. www.china-briefing.com/news/2016/03/16/investing-in-chinas-biotech-industry.htmlMar 16, 2016 - Biotech investment is central to China's 13th Five Year Plan. ... Bio-Engineering, Shanghai Huaguan Biochipwww.wallstreet-online.de/nachricht/6353917-in-depth-understanding-of-the-chinese-pharmaceutical-industryThe Chinese biopharmaceutical market is presented as follows: By Company (e.g., AMOYTOP BIOTECH, BEIJING CONTINENT PHARMACEUTICALS, FUSOGEN, SHANGHAI HUAGUAN BIOCHIP, SIBIONO GENETECH, ABBOTT, ROCHE, PFIZER, GSK, NOVARTIS) By Therapeutic Area (e.g., Anti-infective, Cancer, Diabetes, Dementia, Depression) Key concerns to the Chinese biopharmaceutical market such as: Lack of regulatory policy and legislation Reimbursement schemes and payers concerns Funding and government sponsorship issues International scepticism of Chinese safety and efficacy therapeutic profiles
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Post by lakers on May 20, 2016 1:09:22 GMT -5
Kevinmik added.
- during Q&A a women read a statement about SEC investment including insider trading violation and Matt answered stating company is aware of short sales investigation, but never heard anything about insider trading violations. - Mat asked if company has a final termination agreement including compensation for Sanofi sabotaged launch and he said they have a termination agreement getting Afrezza back, but could not discuss any monetary arrangements/discussion/strategies and said say tune. - Michael Castaglia presented a very thorough commercial strategy that will build on what Sanofi did not do, did wrong and would target healthcare provider education, Endo's and an easier/faster patient 1st time user experience for Afrezza. He is introducing the low cost Spirometry to healthcare providers and a 24/7 Afrezza Service Line, whereby, doctors and patients can get prior authorization done and patients filing their 1st prescriptions a quickly as 72 hours. - Q&A someone brought up an interesting suggestion Mannkind should use Pfizer Insulin to make Afrezza available outside the U.S. in 3rd world countries with the help of the Gates Foundation, not so much to make money, but to get Afrezza used globally to demonstrate its paradigm changing benefits. - tour of the manufacturing plant was truly impressive and its a state of the art facility.What Mannkind is doing in Danbury is unmatched in the industry and likely cannot be matched exactly by big pharma. Generic competition will be very difficult and it will keep Mannkind protected long after patent expiration. - shareholders at the meeting blaming Sanofi for Afrezza failed launch.
I would say the Michael Castagna (sorry for misspelling his name earlier) was very sincere and open with his presentation. The meeting focused on Afrezza Commercial Strategy & state of the manufacturing facility and not much of anything else. Matt was on a short leash with Mannkind legal counsel sitting there as to what could be discussed and it was limited. The commercial effort Mannkind is putting forth tells me the company is on the right track and we will soon get more transparency.
Matt acknowledge that cash raising initiatives were being worked on, but he wasn't saying what exactly is being worked on. I believe Mannkins is waiting to relaunch Afrezza starting in early July and once they demonstrate strong script sales out of the gate they will have many big pharma partners & outside investors knocking on their door to do a deal with Mannkind that could and should include $1 billion upfront payment.
They were all very passionate about the manufacturing facility and the work they are doing. Seeing first hand the manufacturing plant and how Technosphere is created is truly amazing. One employee stated that the process is unlike anything being done in the industry and it not something that can easily be replicated. If Mannkind's commercial organization turns out as good as the company's manufacturing organization Afrezza is in excellent hands on both fronts.
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Post by lakers on May 19, 2016 18:02:45 GMT -5
"a gentleman stood up identifying himself as a friend & former business partner of Alfred Mann having served on a Board of Directors with Al for an Aerospace Company and he also identified himself as a current member of Chinese Investment Group and he went on to make a very public offer to Mannkind at the meeting that his investment firm wants to make a sizable investment in Mannkind and would like to speak to Mannkind. " He [ Al Mann] served as a Director of Advanced Bionics Corporation and Eclipse Aerospace, Incwww.bloomberg.com/research/stocks/people/person.asp?personId=206793&privcapId=9282918en.wikipedia.org/wiki/History_of_Eclipse_Aviation1998–2002 Eclipse Aviation Corporation was founded in 1998 by former Microsoft employee Vern Raburn. Due to Raburn's relationship with Microsoft, Bill Gates became a major stakeholder early in the Eclipse project. The founders initially based the company in Scottsdale, Arizona, formed a Board of Directors in 1999 and started design work on the first aircraft. Due to investments made by the State of New Mexico and incentives and concessions from the City of Albuquerque, the company decided to set up its production facilities in Albuquerque, and also moved its headquarters there in 2000.[6][7][8] The Eclipse service center at Gainesville Regional Airport In addition to its factory in Albuquerque, Eclipse established three service centers, at Albuquerque, at Gainesville Regional Airport in Florida, and at Albany International Airport in New York.[9] Preliminary design work on the Eclipse 500 was completed in 2000. The design was finalized in 2001 and construction of the first prototype commenced that year. The prototype first flew on 26 August 2002, powered by two Williams International EJ22 turbofans. July 2008 Founding President and CEO Vern Raburn resigned as a condition of a financing package by European Technology and Investment Research Center (ETIRC) Aviation, the company that had invested more than US$100 million in Eclipse in 2008. Raburn announced his resignation in an unexpected public event at AirVenture on Monday 28 July 2008. In departing Raburn stated that he believed Eclipse fundamentally changed aviation but he did acknowledge that events did not occur as quickly or as smoothly as he had planned.[28] Raburn was replaced as CEO by Roel Pieper, the chairman of the board of directors and president of ETIRC. Raburn was initially offered an executive position at ETIRC; he turned it down, thus ending his relationship with Eclipse. www.ainonline.com/aviation-news/aviation-international-news/2009-11-23/former-eclipse-execs-embroiled-lawsuitsFormer Eclipse execs embroiled in lawsuits by Matt Thurber - November 23, 2009, 5:49 AM Although Eclipse Aviation no longer exists, having been liquidated following a Chapter 7 bankruptcy filing earlier this year, legal actions surrounding the company continue to multiply. Four lawsuits were filed on October 14 in New Mexico district courts by former deposit-holders for Eclipse 500 very light jets, alleging various wrongdoings–including fraud–by Eclipse Aviation executives before the company’s bankruptcy. Named in the suits are former Eclipse Aviation CEO Vern Raburn, chairman Roel Pieper, COO Peg Billson, president and general manager Michael McConnell, CFO Mark Borseth and other former executives and employees. One of the suits also lists defendants who were on the Eclipse Aviation board of directors, including Harold Poling (former Ford chairman and CEO), Kent Kresa (former chairman and CEO of Northrop Grumman) and Alfred Mann (chairman and CEO of MannKind and reportedly the largest investor in Eclipse Aviation as well as an investor in the new Eclipse Aerospace).
The lawsuits appear to be an attempt to wrest some money out of the insurance companies that provided directors and officers insurance for Eclipse Aviation, according to Raburn. “The insurance policy expired on Sunday the 18th [of October]. That’s what triggered most of this stuff,” he told AIN. The lawsuits have no bearing on Eclipse Aerospace, which purchased the assets of bankrupt Eclipse Aviation on September 30. Some of those named in the lawsuits are salespeople, customer support personnel and contracts administrators. According to Raburn, these lawsuits will succeed only in generating “a lot of anguish.” People will have to testify during depositions and spend money on their own lawyers to defend themselves, he said, “which most of them can’t afford, just because some plaintiff put their name down because they talked to them once.” That angry depositors, who each lost from tens to hundreds of thousands of dollars, filed the lawsuits doesn’t surprise Raburn. “It wasn’t unexpected,” he said. “To say it’s a massive disappointment is an understatement. It seems to be the American way. This is going to take years and years, and in the end, the only people who make money are the lawyers. There will be millions and millions in legal fees, and that all comes out of the insurance money, if the insurance pays for it.” Raburn himself lost plenty of money in the bankruptcy of the company he founded. “I lost far more money in the whole Eclipse thing than anybody who sued,” he said, “from money I invested as a straight shareholder and money as stock.” In any case, he added, he already left the company months before its first Chapter 11 bankruptcy filing late last year. “I had no plans to do what happened when I was kicked out,” he said. “The investors who haven’t gotten sued, they are the ones who should have been. I lost a whole lot of money, but I’m not suing anybody.” The new owners at Eclipse Aerospace have hired some former Eclipse Aviation employees and are working on supporting the 260 Eclipses that were built. “I’m glad that people who truly understand what a great airplane the Eclipse is ended up buying the company, and it wasn’t just a conglomerate.” Raburn is also happy that Eclipse Aerospace is supporting the fleet. “It really is a staggeringly wonderful airplane,” he said. “We were awfully close to succeeding.” More Legal Disputes Meanwhile, legal disputes are erupting on another Eclipse front, between Alfred Mann and former Eclipse board chairman Roel Pieper. The Alfred E. Mann Living Trust is a plaintiff in a March 19 motion for summary judgment, seeking repayment of $10 million by Etirc Aviation and Etirc founder, chairman and managing director Pieper. The money was part of an agreement by Alfred Mann and Pieper each to provide $10 million in debtor-in-possession financing to keep Eclipse alive until Pieper could buy the company. But Pieper wasn’t able to complete the deal and defaulted on his $10 million promissory note to Mann, according to the Mann Living Trust motion. “Pieper has never denied that Etirc is in default of the promissory note,” the motion states, “or that he is in default of the Guaranty. To the contrary, Pieper has informed Plaintiff that he allegedly does not have adequate funds to fully meet his payment obligations, taking the cavalier position that ‘it is what it is.’” The court eventually granted the Mann Living Trust’s motion for summary judgment and on June 19 ordered Pieper to pay $10,206,027.39 plus per diem interest of $2,796.17 starting from February 28 until the full amount was paid. Pieper never paid, and on September 18 the Mann Living Trust subpoenaed Pieper, “directing that he produce certain documents and appear for a deposition under oath concerning the nature and whereabouts of his income, property and other assets.” Pieper has applied to the court to quash the subpoena and for a protective order, but on November 4 the Mann Living Trust filed a motion, asking the court to force Pieper to produce documents and pay legal fees and “other such relief as the Court deems necessary,” and “deny Pieper’s application to quash subpoena or for a protective order.” According to the motion, “The court should be reminded that the document requests served on Pieper have been rendered necessary only because Pieper has refused to comply with the Court’s judgment and has continued to incredulously [sic] tell Plaintiff–while maintaining his lavish lifestyle in the South of France–that he lacks sufficient assets to satisfy the judgment. Thus, regardless of how ‘burdensome’ Pieper may claim the document request to be, it is the end result of his own stonewalling.” Mann’s lawyers haven’t given up on getting money from Pieper and have filed a “Writ of declaration of concerted concealment before the District Court of Grasse, France,” seeking to prove that Pieper intentionally concealed the true ownership of a Swan 80 sailboat and a villa in Antibes. The boat is worth about U3 million and the villa was purchased by property investment company l’Hermitage for U2.65 million in January 2008. According to the declaration, l’Hermitage is owned by four shareholders, Pieper’s children, two of whom are minors. Mann is claiming a “de facto” lien on these assets, the value of which is a substantial portion of what he is owed by Pieper. en.wikipedia.org/wiki/One_AviationThe One Aviation Corporation, stylized as ONE Aviation, is a company formed in 2015 to merge[2] the aircraft manufacturers Eclipse Aerospace and Kestrel Aircraft. It was announced on 15 April 2015 at the AERO Friedrichshafen aviation trade show.[1][3] Alan Klapmeier, the former CEO of Kestrel, and before that, Cirrus Aircraft, was named as the first CEO of One Aviation.[2][4] The new company will produce the Eclipse 550, which is already in production, and will complete certification of the Kestrel K-350.[3] The company will have a unified management and business operation along with one supply system and marketing & sales team, but the two previous manufacturing lines will continue at their current locations—in Albuquerque, New Mexico and Chicago, Illinois for the Eclipse 550; and Superior, Wisconsin and Brunswick, Maine for the Kestrel K-350.[3] Aircraft Summary of aircraft built by One Aviation Model name First flight Number built Type Eclipse 550 March 2013 6 (April 2014) Six seat, twin-engine jet Kestrel K-350 29 July 2006 1 proof-of-concept (April 2015) Six seat, single-engine turboprop One Aviation One Aviation logo.png Type Private Industry Aerospace Founded 2015 Headquarters Albuquerque, New Mexico, United States Key people Alan Klapmeier (CEO) Mason Holland (Chairman) Ken Ross (President)[1] Products Eclipse 550, Kestrel K-350 Divisions Eclipse Aerospace and Kestrel Aircraft Website www.oneaviation.aero
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Post by lakers on May 18, 2016 0:54:43 GMT -5
American Diabetes Association - 76th Scientific Sessions Home Print Page Share Page 931-P / 931 - Technosphere® Inhaled Human Insulin Has a More Rapid Onset of Action Than Subcutaneous Insulins: Meta-analysis of Clamp Data from Three Clinical Studies Itinerary June 11, 2016, 11:30 - 1:30 PM Authors YOUSSEF HIJAZI, ANDERS BOSS, THOMAS KLABUNDE, RAPHAEL DAHMEN, DIETHER RUEPPEL, ROBERT A. BAUGHMAN, Frankfurt, Germany, Bridgewater, NJ, Danbury, CT Disclosures Y. Hijazi: Employee; Author; Sanofi. A. Boss: Employee; Author; Sanofi. T. Klabunde: Employee; Author; Sanofi. R. Dahmen: Employee; Author; Sanofi. D. Rueppel: Employee; Author; Sanofi. R.A. Baughman: Employee; Author; MannKind Corporation.
937-P / 937 - Effects of Inhaled Technosphere Insulin (TI) on the Pulmonary Function of Patients with T1D and T2D Itinerary June 11, 2016, 11:30 - 1:30 PM Authors JOSEPH BRAIN, NIKHIL AMIN, JOHN STEWART, ELENA NIKONOVA, ROBERT WISE, Boston, MA, Danbury, CT, Laval, QC, Canada, Morristown, NJ, Baltimore, MD Disclosures J. Brain: Consultant; Author; Sanofi U.S., MannKind Corporation. N. Amin: Employee; Author; MannKind Corporation. J. Stewart: Employee; Author; Sanofi Canada. Stock/Shareholder; Author; Sanofi Canada. E. Nikonova: Other Relationship; Author; Artech Information Systems, LLC, under contract with Sanofi US, Inc. R. Wise: Consultant; Author; Sanofi U.S., MannKind Corporation.
973-P / 973 - The Impact of Baseline Lung Function on Outcomes with Inhaled Technosphere Insulin (TI) Itinerary June 11, 2016, 11:30 - 1:30 PM Authors JOSEPH BRAIN, NIKHIL AMIN, JOHN STEWART, ELENA NIKONOVA, ROBERT WISE, Boston, MA, Danbury, CT, Laval, QC, Canada, Morristown, NJ, Baltimore, MD Disclosures J. Brain: Consultant; Author; Sanofi U.S., MannKind Corporation. N. Amin: Employee; Author; MannKind Corporation. J. Stewart: Employee; Author; Sanofi Canada. Stock/Shareholder; Author; Sanofi Canada. E. Nikonova: Other Relationship; Author; Artech Information Systems, LLC, under contract with Sanofi US, Inc. R. Wise: Consultant; Author; Sanofi U.S., MannKind Corporation.
975-P / 975 - A Population PK/PD Model of Technosphere® Insulin Administered to Healthy Subjects Itinerary June 11, 2016, 11:30 - 1:30 PM Authors DIETHER RUEPPEL, RAPHAEL DAHMEN, ANDERS BOSS, MARSHALL GRANT, ROBERT BAUGHMAN, THOMAS KLABUNDE, Frankfurt, Germany, Bridgewater, NJ, Danbury, CT Disclosures D. Rueppel: Employee; Author; Sanofi. R. Dahmen: Employee; Author; Sanofi. A. Boss: Employee; Author; Sanofi. M. Grant: Employee; Author; Mannkind Corporation. R. Baughman: Employee; Author; MannKind Corporation. T. Klabunde: Employee; Author; Sanofi.
100-LB / 100 - Technosphere Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration than Insulin Lispro (Lispro) Itinerary June 12, 2016, 12:00 - 2:00 PM Authors ROBERT A. BAUGHMAN, TIM HEISE, MARSHALL L. GRANT, PHILIPPE GROSJEAN, LAURENT PERRIN, YOUSSEF HIJAZI, BRITTA GOEBEL, RAPHAEL DAHMEN, Danbury, CT, Neuss, Germany, Paris, France, Frankfurt, Germany Disclosures R.A. Baughman: Employee; Author; MannKind Corporation. T. Heise: Consultant; Author; Profil Institute for Clinical Research, Inc. M.L. Grant: Employee; Author; MannKind Corporation. P. Grosjean: Employee; Author; Sanofi-Aventis Deutschland GmbH. L. Perrin: Employee; Author; Sanofi-Aventis Deutschland GmbH. Y. Hijazi: Employee; Author; Sanofi-Aventis Deutschland GmbH. B. Goebel: Employee; Author; Sanofi-Aventis Deutschland GmbH. R. Dahmen: Employee; Author; Sanofi-Aventis Deutschland GmbH.
102-LB / 102 - Within-Subject Variability of Insulin Exposure and Metabolic Activity following Replicate Doses of Technosphere® Insulin Inhalation Powder (TI) in Patients with T1DM Itinerary June 12, 2016, 12:00 - 2:00 PM Authors ROBERT A. BAUGHMAN, MARSHALL GRANT, LEONA PLUM-MORSCHEL, VIRGINIE ESPOSITO, ASTRID DELFOLIE, YOUSSEF HIJAZI, RAPHAEL DAHMEN, Danbury, CT, Mainz, Germany, Paris, France, Frankfurt, Germany Disclosures R.A. Baughman: Employee; Author; MannKind Corporation. M. Grant: Employee; Author; MannKind Corporation. L. Plum-Morschel: Employee; Author; Profil Institute for Clinical Research, Inc. V. Esposito: Employee; Author; Sanofi-Aventis Deutschland GmbH. A. Delfolie: Employee; Author; Sanofi-Aventis Deutschland GmbH. Y. Hijazi: Employee; Author; Sanofi-Aventis Deutschland GmbH. R. Dahmen: Employee; Author; Sanofi-Aventis Deutschland GmbH.
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Post by lakers on May 17, 2016 18:30:56 GMT -5
Mike Castagna @castagna2011 · 1h1 hour ago Thank you AstraZeneca for letting go of some great people with diabetes experience this week! ------------------------------------ www.fiercepharma.com/pharma/astrazeneca-cuts-1-600-contract-reps-house-force-drive-to-save-1-1b-sourcesLast month, AstraZeneca said it would cut $1.1 billion in annual costs, zeroing in on sales and administrative expenses for a big part of those savings. Now, the U.K.-based company’s sales operation in the U.S. is feeling the effects. AstraZeneca cut its contract salesforce from Publicis Touchpoint Solutions, the company confirmed in an emailed statement Tuesday, and is reviewing its AstraZeneca sales staffing as well. Publicis handles AstraZeneca brands in a variety of therapeutic areas, AstraZeneca spokeswoman Abby Bozarth said. The clinical educator team will also see some cutbacks.
“We flexibly shape our selling teams to fit the realities of the marketplace and maximize opportunities for both our growth and future brands,” Bozarth said. Publicis sales reps on the AstraZeneca force said the cutbacks would hit 1,600 contract employees, largely in diabetes, although the respiratory team and the Movantik force would also see some reductions. The sources spoke on condition that they remain anonymous. The Publicis cuts take effect June 30. They were announced via conference call Monday. AstraZeneca would not confirm hard numbers on the staffing changes. But the company said it’s revisiting its “field force deployment” as part of its “ongoing strategy to operate its business more efficiently.” Bozarth said the company is working through the details of the cutbacks now. “We are reviewing all staffing as we make decisions on how best to align our sales organization for success,” she told FiercePharma via email, and “this includes both AstraZeneca and contracted sales force roles.” As Bozarth pointed out, pharma companies commonly use contract sales groups to augment in-house sales forces as a way to manage staffing levels. Drugmakers often grow and shrink their sales teams by adding or subtracting contract reps. The approach “gives us the flexibility to change our sales force size to react to market changes and to meet customer needs,” Bozarth said. “[T]hese changes will not impact our ability to bring innovative medicines to people who need them.” AstraZeneca is hardly alone in cutting sales jobs. Japan-based Daiichi Sankyo recently announced up to 1,200 layoffs in its U.S. unit, many of them in its commercial headquarters, and Sanofi told French unions earlier this year that it would cut 155 jobs in its sales and marketing force there. In late 2014, GlaxoSmithKline said it would cut hundreds of commercial jobs; the layoffs were part of a $1.6 billion restructuring designed to cope with fast-declining sales of respiratory giant Advair. More recently, the embattled drugmaker Valeant Pharmaceuticals, facing a sales hit after promising to abandon its growth-through-price-hikes strategy, said it would cut loose 140 contract reps handling the new female libido pill Addyi, as well as 140 salespeople repping its dermatology, GI and women’s health brands. Like Daiichi, which cut jobs as its big-selling blood pressure drug Benicar neared the end of its patent life, AstraZeneca is anticipating sales slippage for a blockbuster med now facing generics. The cholesterol fighter Crestor, the company’s top seller with $5 billion in 2015 sales, lost its exclusivity May 1.
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Post by lakers on May 17, 2016 18:22:22 GMT -5
investors.mannkindcorp.com/secfiling.cfm?filingID=1193125-16-583791&CIK=899460There may be disputes between us and Sanofi that may result in the delay of the achievement of regulatory and commercial objectives, or costly litigation or arbitration that diverts our management’s attention and resources; We have sought to develop our other product candidates through our internal research programs. All of our product candidates will require additional research and development and, in some cases, significant preclinical, clinical and other testing prior to seeking regulatory approval to market them. Accordingly, these product candidates will not be commercially available for a number of years, if at all. Further research and development on these programs will require significant financial resources. Given our limited financial resources and our focus on development and commercialization of AFREZZA, we will not be able to advance these programs unless we are able to enter into collaborations with third parties to fund of these programs or to obtain funding to enable us to continue these programs.
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Post by lakers on May 16, 2016 19:33:54 GMT -5
Omeros' (OMER) CEO Greg Demopulos on Q1 2016 Results - Earnings Call Transcript May 11, 2016 7:00 PM ET seekingalpha.com/article/3974285-omeros-omer-ceo-greg-demopulos-q1-2016-results-earnings-call-transcript?part=singleFinally, our GPCR program is making substantial strides. We’re advancing preclinical programs targeting appetite and eating disorders, triple negative breast cancer, demyelinating diseases such as multiple sclerosis, neuropathic pain and osteoporosis as well as the receptor that appears to modulate T-cell regulation important in immunologic disorders and cancer. Compounds across these programs have been optimized sufficiently to conduct animal studies and data have been generated. That concludes our update on Omeros’ products and programs. Greg Demopulos Yes. I mean I think that we’ll be putting out 721 data as you said from our Phase II program or programs. There will be publications on both 721 and 527. I think there will be more data coming out of the GPCR program. So I think that there’s going to be a long line of data and journal articles publications throughout the year. www.veracast.com/webcasts/baml/healthcare2016/events/3012_mannki/pdf/MannKind_Corp.pdfDemonstrate License Model for Technosphere – First Technosphere® licensing deal complete with Receptor Life Sciences (Jan) • Highly credible backers
• Under NDA • $250k signing • 1 st milestone later in year
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Post by lakers on May 15, 2016 16:04:42 GMT -5
MNKD 2.0: Financial Keys to Success • Aggressive financial control, with vigorous attention to costs and efficiency throughout organization • Successfully negotiate favorable termination terms with SNY Pg 14
$68M of $150M LOC used so far. The remain will be avail till Q3.
IMHO, a successful settlement entails $180 - $200M cash, plus used $80M 8.5% interest LOC forgiven so that Mnkd can get the proceed from selling the Valencia building ~ $30 M as SoCal real estate mkt is red hot.
To increase leverage Mnkd had to obtain bridge finance and ramps up Afrezza sale in 4Q16.
Signing up regional partners is given, TBA this May hopefully. It'd be nice if announced at ASH.
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Post by lakers on May 12, 2016 15:44:41 GMT -5
Here is the exact quote from Matt regarding the offering. .. "were very careful in placing the new shares with a few select investors, which is important to existing shareholders" Ok, so I don't really like reading into things that Matt says (well anyone from MNKD really), but I'm going to take a shot on this one anyways... Any chance Matt said this because he was talking about only selling these new shares to investors who won't lend them out to be shorted? That's the only thing I can think of as to why WHO he is selling to would be important to existing shareholders. Thoughts? IMHO, Mnkd likely sold shares to RLS' investors as they have a vested interest to see Mnkd survives. Once their identity is revealed, we can figure out who RLS is. If RLS' Technosphere drugs show great result, a reverse merge may happen to save tax for both cos.
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Post by lakers on May 10, 2016 16:19:37 GMT -5
MatthewPfeffer Okay, so let me try to answer the first part of that query real quickly. It's going to be a little bit difficult, I mean we've been pretty open that a large portion of our strategy is revolved around opening some international markets and doing deals as our first preference for raising money. That said we can't wait forever and if we need to do a small equity financing there device full time we will do that. I hope will be in a position to answer that question with more details and specifics very. Frankly I have to go to do it by now, that didn't work out quite the way I thought it would but it should be imminent I believe and all I can do is ask for your patience and hope you'll stay tuned.
We continue to have a high interest from a number of potential international partners interested in adding Afrezza to their portfolios. These partnerships are strategically attractive and will continue to progress in tandem with our marketing plans in the U.S. but these deals will not be completed in our target timeframe for financing. Therefore, we still have yet to address that but we expect to very shortly. So I will appreciate your patience as we're quite close.
IMHO, I expect near-term international partners: Canada, Israell, Australia.
Our commercial organization will cost in the range of 20 million to 22 million through the remainder of the year. As you'll hear in Rose's presentation of our first quarter financials in just a moment, we've continued to realize cost savings in other areas and anticipate offsetting some of these increased expenses with the reductions in these areas. In addition, with the full value of product sales of our own branded product coming to mankind during the fourth quarter we're in a better position to benefit from a ramp up of sales. As a result of all of the above we expect our cash burn rate to remain approximately 10 million to 12 million per month for the remainder of the year more or less the same ratio of burn as we've been reporting for about as long as I can remember.
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Post by lakers on May 9, 2016 19:50:45 GMT -5
$MNKD R&D: 2 EpiT & 4 TreT compounds progressing to PK profiling during 2Q16. $MNKD R&D: To date, tested 2 EpiT, 6 TreT & 2 PalT compounds for aerodynamic performance and ambient temperature stability. $MNKD R&D: In 2Q16, testing in process on Technosphere compounds for Epinephrine (EpiT), Treprostinil (TreT), and Palonosetron (PalT). www.mannkindcorp.com/Collateral/Documents/English-US/MNKD%20Investor%20Call%202%203%2016%20v9.pdfSlide 11-16 12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind 13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential 14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency Trials Former Mylan CMO Ray said, "The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around. They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection. Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017. For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option. Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need." 26users liked this postsusers disliked this posts2Reply Take Away's From The Conference Call by kevinmik • 3 hours ago Flag 1) Sounds like a partnership deal (s) is being negotiated that's close to being announced raising cash 2) Afrezza will be relaunched in July 3) Afrezza packaging is now being produced under Mannkind's name 4) Both Sanofi & Mannkind Afrezza inventory will be sold in the 3Q 5) Mannkind Afrezza inventory only will be sold starting in the 4Q 7) 3Q Affrezza sales will be 35% from Sanofi inventory &100% from Mannkind inventory sold 8) Sales force will target 7,000 Endo's & Specialty doctors accounting for 70% of insulin sold in U.S. 9) Commercial Organization will cost approximately $22 million to be paid by cost saving cuts 10) 2 internal drug candidates advancing led by Epinephrine with IND filing in Jan 2017 11) Mannkind will have 6 abstracts and a commercial booth a the ADA Meeting in June 12) 7 out of 10 patients are getting pre-authorized approval for Afrezza 13) 1st Sanofi debt payment not due until 2024 14) Sales force will hit the market beginning in July 15) Sounds like Mannkind expects Afrezza sales to fund & support operations quickly 16) Sound like today's conference call was scaled back due to partnership deal (s) that were likely expected to close by now but still being worked on. Coming reals soon. 17) Today's call did not mirror in any way, shape or form all the activities going on at Mannkind. Looks like delayed partnership deal (s) are keeping a lid on what can be said and I believe it's also affected VDEX roll out. 18) There is clearly something going on behind the scene likely having to do with partnership, restructuring the company or selling the company. Who knows maybe investment banks hired by Mannkind are working on a buyout deal. 19) Only 2 analyst on the conference call today is very telling 20) $250,000 Receptor milestone payment received in 1Q and another one is due in the 4Q 21) missed 2016 cutoff for Medicare but will happen in 2017 Excerpt from today 10-Q Filing: "Under the terms of the Sanofi Supply Agreement, in the event that Sanofi terminates the Sanofi License Agreement for various reasons (including the reasons cited in its notice of termination to the Company), then upon written notice from the Company within 30 days following the termination date, Sanofi is obligated to purchase up to $50 million of the Company’s insulin inventory as a percentage of each lot received or receivable by the Company (the “Insulin Put”). On April 14, 2016, the Company provided Sanofi with written notice that it was exercising the Insulin Put. The Company and Sanofi are currently discussing the schedule of purchases and deliveries pursuant to the Insulin Put."
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