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Post by lakers on Feb 12, 2016 10:37:14 GMT -5
Catalyst's 1) Cash Raised 2) Receptor Life Sciences Partnership Transparency 3) Sanofi Settlement Agreement Announced 4) Mannkind Commercialization Strategy Announced 5) Mannkind Afrezza North America Partnership (s) Distribution Agreements Announced 6) New Chief Commercial Sales & Marketing Executive Hire Announced 7) Mannkind New Commercialization Organization Strategy Announced 8) Afrezza Regulatory Filings Announced Outside The United States 9) Afrezza Partnership (s) & Distribution Agreement Announced Outside The United States 10) Afrezza Licensing Deals With Countries Recognizing FDA Approval Announced 11) New Technosphere External R&D Licensing Deals Announced 12) New Technosphere Internal R&D Partnership Deals Announced 13) Possible Afrezza Asset Sale Announcement 14) 2 Completed REMS Positive Clinical Trial Results Announced @ ADA Meeting June 15) Mannkind Announced New Pricing Strategy For Afrezza 16) Mannkind Pursuing Ultra-Rapid Acting Label Outside The United States 17) Mannkind Pursuing Ultra-Rapid Acting Updated Label In The United States 18) Mannkind Announces Partnership & Regulatory Status In North & Sough America 19) FDA Analysis Of Real World Data Reports No New Safety or Side Effects Associated With Afrezza 20) Wall Street Analysis Begin Upgrading Mannkind Including Goldman Sachs 21) Mannkind Announces Successfully Negotiating Debt Restructuring finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1455289990058-98b52599-dbd6-4d99-800c-fdb444abdbc6&tls=la%2Cd%2C2%2C3Mannkind has joint patents with Technovax & Rose Pharmaceutical who respectively each have licensing deals with Pfizer & Lilly. See below: Mannkind & Technovax & Pfizer: "TechnoVax Licenses Wyeth's Virus-Like Particle Vaccine Technology TechnoVax gained the rights to Wyeth’s patent application in the field of virus-like particle (VLP) technology. This application is based on research conducted by TechnoVax founder, Jose M. Galarza, Ph.D., while serving as principal scientist at Wyeth." "Pub. No.: WO/2014/066856 Publication Date: 01.05.2014 INHALABLE INFLUENZA VACCINE COMPOSITIONS AND METHODS Applicants: MANNKIND CORPORATION [US/US]; 28903 North Avenue Paine Valencia, CA 91355 (US). TECHNOVAX, INC. [US/US]; 765 Old Saw Mill River Road Tarrytown, NY 10591 (US) Inventors: SMUTNEY, Chad, C.; (US). -LEONE-BAY, Andrea; (US) - GALARZA, Jose, M.; (US) -. MUNOZ, Hector; (US). - MARTIN, George, R.; (US). GRANT, Marshall, L.; (US):" ---------------------------------------------------------------------------------------------------------------------- Mannkind + Rose Pharma + Lilly: "Rose Pharma signed an agreement with Eli Lilly and Company (Indianapolis, USA) to in-license a Lilly compound (formerly known as LY307161, now named ROSE-010), an analogue of the naturally occurring intestinal hormone GLP-1. The licensing agreement is a result of an ongoing research collaboration the two companies have participated in since 2004." "Publication Number: 20140187490 Publication Date: 03.07.2014 GLP-1 Composition and Method for Treating Functional Dyspepsia and/or Irritable Bowel Syndrome Applicants: Rose Pharma A/S & MannKind Corporation Inventors: Richardson Peter - Kenny Edna - Hellstrom Per - Grant Marshall L. - Stowell Grayson W. Daniels Scott - Smithson Anthony - Greene Stephani" finance.yahoo.com/mbview/threadview/;_ylt=AkOoYoXKnb0vCOqg_SxpnQjeAohG;_ylu=X3oDMTB2cjZ1YzF1BHBvcwMzNwRzZWMDTWVkaWFNc2dCb2FyZHNYSFJVbHQ-;_ylg=X3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-;_ylv=3?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1455285590788-ead74118-8920-4d28-8ece-46d0639546e3&tls=la%2Cd%2C6%2C3Don't forget Mannkind's joint patent with Technovax for vaccines that could be used for a wide array of vaccine treatments. Technovax licensed the VLP Technology that they are now combining with Mannkind's Technosphere & Drug Deliver Device Platform from Wyeth that is now part of Pfizer. Pfizer has a huge vaccine program that could eventually involve Mannkind. Lots going on behind the scenes for a long time that hopefully will soon be transparent by Mannkind.
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Post by lakers on Feb 12, 2016 10:21:32 GMT -5
Give the guy a break, at 92 he is entitled to some retirement where his main focus is getting a little white ball in the hole. If you are more than a titular director, it can be a lot of work at any company which is why most countries in Europe put hard age limits on initial or re-election to public company boards when the director has attained age 70. That doesn't mean he can't still advise MNKD or EYE, but on a less formal basis. Al is 90 yrs young, DoB 11.7.1925. The later is little known.
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Post by lakers on Feb 12, 2016 1:10:05 GMT -5
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Post by lakers on Feb 11, 2016 14:51:25 GMT -5
Holdings whalewisdom.com/stock/mnkdFiler Shares Held Market Value % of Portfolio Prior % of Portfolio Ranking Change in Shares % Ownership VANGUARD GROUP INC 18,565,467 $ 26,919,000 0.00% 0.00% 2172 381,957 4.3311%BLACKROCK FUND ADVISORS 10,967,147 $ 15,902,000 0.00% 0.01% 2180 1,001,288 2.5585%GROUP ONE TRADING, L.P.(CALL) 7,224,500 $ 10,476,000 0.12% 0.37% 160 1,216,100 N/A BLACKROCK INSTITUTIONAL TRUST COMPANY, N.A. 6,341,795 $ 9,196,000 0.00% 0.00% 2373 119,719 1.4794%GROUP ONE TRADING, L.P.(PUT) 6,356,800 $ 9,217,000 0.11% 0.08% 185 4,628,400 N/A MORGAN STANLEY 2,388,919 $ 3,463,000 0.00% 0.00% 3007 461,326 0.5573%SPOT TRADING L.L.C(CALL) 947,500 $ 1,374,000 0.01% 0.03% 1247 129,600 N/A WELLS FARGO & COMPANY 858,147 $ 1,244,000 0.00% 0.00% 3318 45,960 0.2002% BLACKROCK INVESTMENT MANAGEMENT, LLC 819,191 $ 1,188,000 0.00% 0.00% 2464 2,134 0.1911%SPHERA FUNDS MANAGEMENT LTD.(CALL) 760,000 $ 1,102,000 0.16% 0.00 105 760,000 N/A BANK OF MONTREAL 758,297 $ 1,099,000 0.00% 0.00% 1671 439,320 0.1769% BANK OF MONTREAL(PUT) 775,800 $ 1,125,000 0.00% 0.00% 1658 437,000 N/A SPOT TRADING L.L.C(PUT) 736,200 $ 1,067,000 0.01% 0.00% 1398 598,400 N/A ZEKE CAPITAL ADVISORS, LLC 660,615 $ 958,000 0.82% 0.00 21 660,615 0.1541% CALIFORNIA PUBLIC EMPLOYEES RETIREMENT SYSTEM 633,900 $ 919,000 0.00% 0.00% 2445 0.1479% GROUP ONE TRADING, L.P. 526,553 $ 764,000 0.01% 0.00 1506 526,553 0.1228% CALIFORNIA STATE TEACHERS RETIREMENT SYSTEM 457,260 $ 663,000 0.00% 0.00% 2246 8,120 0.1067%
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Post by lakers on Feb 11, 2016 12:19:23 GMT -5
I can see a scenario in which if well-funded RLS drugs show great trial results they might reverse merge, then sell off Afrezza, state-of-the-art plant, and keep the patents. This way RLS will save 12-14% royalty which is significant for BBs, take advantage of tax write-off, and own TS+patents.
This could happen if Mnkd doesn't obtain funding in time for 2017. The Sanofi settlement should provide sufficient funding for at least 1 year using $135M Pfizer settled with Nektar as baseline.
To realize Afrezza potential, Mnkd needs at least 4-yr funding plus multiple regional partners to share cost.
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Post by lakers on Feb 11, 2016 11:45:37 GMT -5
Reverse merge not at this time doesn't mean never. Got it?
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Post by lakers on Feb 10, 2016 17:42:31 GMT -5
What is the contract termination date with Sanofi, 4/4 or 7/4? Or is it to be negotiated? Will
MannKind disclose the date?
MannKind is targeting April 5 as the transition date of the rights to develop and commercialize
Afrezza, but the transition may occur at a later date. There are many factors that influence
when the transition will occur, including a myriad of regulatory, commercial and development
activities, many of which involve third‐party vendors or regulatory authorities, and all of which
need to be transferred in a smooth and coordinated fashion. As our transition teams work
through these various issues, the top priority is to ensure the continuity of supply of Afrezza for
patients.
The transition team has been named and includes operations, scientific and legal personnel from
both MannKind and Sanofi. The team has met and begun discussions about the complex process
that a transfer like thisinvolves. All members of the transition team are cooperating and working
in good faith.
We will not be commenting publicly on the details of our transfer terms until the transition
agreement is finalized, at which time we will issue a press release and will address questions in
an investor call. [The settlement is being negotiated.] Please know that the Afrezza transition is MannKind’s top priority and getting
the full attention it deserves.
What progress has been made on Diabetes Care Centers? Is there a rollout schedule?
The Care Centers are being started by a separate company so we have no direct information on
their status, but we are informed that they are set to launch their pilot center in New Jersey by
the end of first quarter. These centers will operate as adjunct services to urgent care centers,
focused on the treatment of diabetes. Their business model will support growth in 2016 in
major metro areas, and they will perform several tasks necessary to the success of Afrezza,
including on‐site spirometry testing and hands on and personalized training on the use of Afrezza,
when prescribed. They can also coordinate regional user groups whose members can support
each other as they develop optimal protocols.
Has Sanofi filed for any international approvals? Can MannKind file for international approvals
now or are handstied until Sanofitermination? When do you launch Afrezza in countries which
accept FDA approved drugs? When do you sign with regional partners?
Sanofi had not filed for any international approvals. Until the transition officially occurs, Sanofi
retains all rights associated with the distribution and commercialization of Afrezza, including
marketing and sales responsibilities, study management, and regulatory filings in the US and
foreign jurisdictions. MannKind is also unable to make any regulatory filings, including filing for
approval in other jurisdictions, until the NDA is transferred back to us. Prior to signing the
agreement with Sanofi, MannKind was in discussions with multiple international groups
representing substantial regional markets. Those discussions have been restarted in recent
weeks, with our priority being those regions in which we can use our US NDA as the basis for a
regulatory submission without additional trials. Other regions will require additional studies of
varying sizes and complexity. We are currently finalizing our ex‐US strategy. As these plans firm
up, we will be sharing them with you.
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Post by lakers on Feb 10, 2016 17:35:19 GMT -5
www.fiercepharma.com/story/sanofi-tried-and-failed-afrezza-why-does-mannkind-still-think-it-can-win/2016-02-10 Excerpts follow. Those obstacles are indeed daunting: To get access to the drug, patients have to undergo lung testing with a spirometer, which isn't a common piece of physician-office equipment. The testing was "a major hurdle," JPMorgan analyst Cory Kasimov said last year, and that requirement, along with the FDA's cautionary language about breathing difficulties, made already wary doctors even more so. The truth is, Sanofi may have overestimated the appeal of an inhaled product over an injected one. It may have over-attributed the failure of Pfizer's ($PFE) inhaled insulin, Exubera, to the unwieldy design of its Pringles-size delivery device. But even among the 6,000 patients who wanted the inhaled product, only 35% stayed on the drug, a Sanofi spokeswoman told the WSJ. MannKind appears set to ignore those statistics. Pfeffer maintains that patients want a needle-free option and sees Afrezza's whistle-shaped device as the answer. To him, Afrezza would have been fine if it had been priced lower and earned better coverage with payers. After Sanofi ended the partnership, Pfeffer said he'd look for a new partner and cut the price of the drug. Priced at a premium to injectables, Afrezza sits on most payers' third tier for reimbursement, the WSJ says, and Pfeffer says pricing and reimbursement "dramatically outweigh other factors" that hampered the new launch.
Future Afrezza plans have to involve educating patients and doctors, as well as improving patient access, Pfeffer said on a call with analysts last month. He believes patients really are clamoring for a drug like Afrezza, even with all the evidence to the contrary. Why? " The real world experience of Afrezza users ... is everything we hoped it would be," Pfeffer said during the call, vowing, "this is not the end of the line for Afrezza or MannKind by any means."
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Post by lakers on Feb 10, 2016 16:50:21 GMT -5
What is going on with deals involving Torrey Pine, Technovax, Colby, Rose Pharma & Tolero? What is happening with the “cricket” inhaler? The so‐called “cricket” is a disposable, single use version of the inhalation device used for other products like Afrezza. There are many potential applications for this device, including MannKind’s recently announced development program in epinephrine for anaphylaxis. Torrey
Pines was an opportunity we could not pursue at this time due to program risk, high costs and
prolonged timelines [Not a commercially known compound]. As far as specific deals involving other companies, MannKind will be
providing updates as significant events unfold. [They are still on-going. Surprised!]Of note, we have discussed in the past prior investigations into migraine and pain management. We still consider these areas attractive and ideally suited to our technology. At this time, we are reevaluating the clinical and commercial aspects of these potential programs. [This is a setback as migraine and pain management has been the front runner. Now I think Treprostenil+PDE5 Inhibitor Tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) PAH w/ United Therapeutics, Epinephrine Anaphylaxis w/ Mylan are leads.] Patent expiry of major PAH drugs such as Tracleer (Actelion), Letairis (Gilead), Adcirca (Cialis, Lung Bio), and Tyvaso (United Therapeutics) is expected to affect the market revenue during the forecast period, as their generic versions would be sold at prices 70% to 80% lower than that of the branded ones.Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz3zo0Gpk3wtechnovax.com/inhaled-powder-vaccines/technovax.com/TechnoVaxPresentation-Nov2012-IC-DC.pdfwww.slideshare.net/technovax/technovax-presentation-at“Inhaled Powder” Vaccines “Shelf-Stable, Self-Inhaled, Powderized” VLP Vaccines. TechnoVax and MannKind Corp. have combined their respective technologies to create a Powder Formulation of VLP Influenza Vaccine for Intrapulmonary Self-Delivery by Inhalation.
No refrigeration is required, and because it is potentially self-administered public exposure is limited. In the event of an emerging pandemic the vaccine could be easily distributed to the population, greatly reducing the spread of the virus! Advantages Extended Shelf Life and Elimination of Cold Chain results in improved distribution costs and inventory management.Best Route of Immunization (mucosal surface – respiratory tract) Increased Patient Acceptance (inhaled vs. injection) VLP’s are combined with FPDK Excipient Particles for optimized airflow delivery using the Cricket Inhalation Device. technovax.com/partnering/TechnoVax has partnered with a leading player in the field of pulmonary drug delivery to develop shelf-stable, self- inhaled powder VLP vaccines for flu and RSV. Currently there is no such product on the market for respiratory vaccination, and the need is critical. Our portfolio of vaccine candidates has a potential addressable market of over $5 billion in annual worldwide sales.investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=792133Colby and MannKind Sign License and Joint Development Agreement to Develop and Commercialize Cancer Immunotherapy Products PDF Add to Briefcase SAN JOSE, Calif. & VALENCIA, Calif.--(BUSINESS WIRE)--Nov. 13, 2012-- Colby Pharmaceutical Company and MannKind Corporation (Nasdaq: MNKD) today announced a license agreement granting Colby exclusive worldwide rights to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind’s novel MKC1106 active immunotherapy programs, which are currently being developed for the treatment of melanoma, prostate, hematological disorders and other human cancers.
Intra-lymph node injections (ILNI, vaccine inoculation directly into the normal lymph node with ultrasound image guided standard syringes) of cancer vaccine antigens have been reproducibly shown to generate much more potent therapeutic T-cell responses, when compared to cancer vaccine antigen immunizations using traditional intra-muscular or sub-cutaneous injections of the same cancer vaccine antigens in animals. In a Phase 1 human melanoma study of MKC1106-MT, the most advanced ILNI regimen from this program, repeat intra-lymph nodal injection for administration of the therapeutic antigens was well-tolerated and generated strong immune responses, clearly meeting the primary endpoints.Under the terms of the agreement, Colby will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, with upfront and potential milestone payments of approximately $140 million total. MannKind will also receive tiered royalties on sales of products.
“We are very keen on this opportunity and in continuing to work with the experienced drug development team at MannKind,” said David Zarling, Ph.D., MBA, Chief Executive Officer of Colby. “MannKind has amassed an extensive and thorough active immunotherapy patent portfolio. We fully appreciate and understand that ILNI generates remarkably superior immune responses that also can be adjuvanted, and our organizations share a passion to advance the current MKC1106 clinical melanoma, prostate and other programs. We will also evaluate ILNI for potential synergy with our lead adjuvant, JVRS-100, a cationic lipid-based immune activator of both innate and adaptive immunity. ILNI and JVRS-100 both represent compelling new therapeutic approaches. We have good reason to believe that our collaboration will uncover other more optimal cancer vaccine modalities and synergies with novel adjuvants not yet realized by others working on cancer vaccines and immune activation. We believe that MannKind’s ILNI and our new immune activators, like JVRS-100 or JVRS-200, or other adjuvants, will prove to be important for rational cancer immunotherapies.” Lead Drugs Colby Pharmaceutical Company has developed a product portfolio containing two small molecule pharma drug candidates, CPC-123 for pain and CPC-551 for age-related macular degeneration and other smoking- or sunlight-related eye or skin conditions. CPC-ILNI™ is a proprietary Intra Lymph Node Injection and Vaccination System for allergy desensitization, cancer and infectious disease immunotherapy. Tolero Pharma - MannKind says it could get $130 million and royalties & licensing fees after licensing drug candidates to Tolero. MannKind said the drug candidates are being studied as treatments for blood cancers and inflammatory diseases. Rose Pharma - 07/03/14 Mannkind & Rose Pharma A/S Joint Patent Application Inhaled GLP-1 Treating IBS &/Or Functional Dyspepsia. No announcement made by Mannkind about this arrangement or financial terms revealed.
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Post by lakers on Feb 10, 2016 3:08:37 GMT -5
MannKind Corporation (NASDAQ:MNKD) were up more than 10% as of 11:30 a.m. ET today after the company's soon-to-be former marketing partner Sanofi (NYSE:SNY) released its fourth-quarter and full-year results. So what: The French pharma giant said that they sold roughly $2.2 million worth of Afrezza in the fourth quarter, which was flat with their results in each of the previous two quarters. That puts total Afrezza sales for full-year 2015 right around $7.9 million. It's doubtful that investors are bidding up shares today based on another quarter of flat results. The more likely reason behind today's price action is the news that Sanofi has set a date of April 4 for when it will officially hand Afrezza back to MannKind. Investors already knew that MannKind was targeting early April as a likely transition date but the original press released stated that it could be up to 180 days. Hearing that Sanofi is looking to hand back Afrezza as soon as possible is good news for MannKind's shareholders as the terms of its collaboration agreement prevent the company from promoting the drug or making any changes to the sales strategy until it is back in MannKind's control. The deal is also currently preventing MannKind from filing Afrezza for regulatory approval in new jurisdictions, so you can bet the company is now chomping at the bit to take back control as quickly as possible. Another potential reason that shares could be popping today is that short interest for MannKind's stock is once again near an all-time high, so traders could be looking to cover their huge position now that quarterly sales results have been released. Now what: January was a very turbulent month for MannKind's stock, and with shares currently trading hands for right around a dollar each, it's likely that they will continue to be extremely volatile in the foreseeable future. MannKind's stock isn't for the faint of heart, so investors with a low tolerance for risk should probably keep away. www.fool.com/investing/general/2016/02/09/why-mannkind-corporation-is-up-today.aspx
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Post by lakers on Feb 9, 2016 21:02:23 GMT -5
But this all is old news, right? Where is the 'new light'? Why bother to start another thread? Agreed Intrinsic! Lakers, the tidbits and quotes above were all spoken about at the JPM conference. Are we missing something here.... RLS can do a reverse merger in the future with Mnkd although Matt said "Our reverse merger with Receptor is not under consideration at this time." There are many companies that perform reverse mergers, also known as reverse takeovers, as opposed to other, more traditional forms of raising capital. A reverse merger is when a private company becomes a public company by purchasing control of the public company. The shareholders of the private company usually receive large amounts of ownership in the public company and control of its board of directors (B of D). Once this is complete, the private and public companies merge into one publicly traded company. Advantages of Reverse Mergers The following are the many advantages to performing reverse mergers. The ability for a private company to become public for a lower cost and in less time than with an initial public offering (IPO). When a company plans to go public through an IPO, the process can take a year or more to complete. This can cost the company money and time. With a reverse merger, a private company can go public in as little as 30 days. Public companies have higher valuations compared with private companies. Some of the reasons for this include: greater liquidity, increased transparency and publicity, and they have a faster growth rates compared to private companies. Reverse mergers are less likely to be canceled or put on hold because of the adverse effects of current market conditions. This means that if the equity markets are performing poorly or there is unfavorable publicity surrounding the IPO, underwriters can pull the offering off the table. The public company can offer a tax shelter to the private company. In many cases, the public company has taken a series of losses. A percentage of the losses can be carried forward and applied to future income. By merging the private and public company, it is possible to protect a percentage of the merged company's profits from future taxes. www.investopedia.com/articles/stocks/08/reverse-merger.asp
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Post by lakers on Feb 9, 2016 20:08:22 GMT -5
On the other hand, the patent expiry of major PAH drugs such as Tracleer (Actelion), Letairis (Gilead), Adcirca (Cialis, Lung Bio), and Tyvaso (United Therapeutics) is expected to affect the market revenue during the forecast period, as their generic versions would be sold at prices 70% to 80% lower than that of the branded ones. Development of breakthrough therapy for the treatment of PAH is expected to be a growth opportunity for drug manufacturers, as the currently available drugs are not enough to meet the medical needs of people suffering from PAH . Page 8, 11, 12 shows a huge Tyvaso bong larger than Exubera's.www.tyvaso.com/Content/dtc/pdf/Tyvaso_Patient_Brochure.pdfIndication Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve
exercise ability in people who also take bosentan
(an endothelin receptor antagonist) or sildena l (a
phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities. [Mnkd could partner with United Therapeutics for inhaled Treprostinil + PDE5 Inhibitor PAH]
Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). Important Safety Information for Tyvaso ■ Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System ■ The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age ■ If you have low blood pressure, Tyvaso may cause symptomatic hypotension (low blood pressure) ■ Because Tyvaso reduces the ability of your blood to clot (coagulate), it may increase your risk for bleeding if you are taking blood thinners (anticoagulants), such as warfarin or heparin ■ The use of Tyvaso with diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase your risk for hypotension (low blood pressure) Other medical conditions and medicines may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking, including: ■ If you are taking gem brozil (for high cholesterol) or rifampin (for infection), your Tyvaso dosage may need adjustment ■ If you have liver or kidney problems, your ability to tolerate Tyvaso may be a ected ■ If you are pregnant, breast-feeding, or planning to become pregnant, talk with your healthcare provider about whether you should take Tyvaso The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck ( ushing), and fainting or loss of consciousness. These are not all the possible side e ects of Tyvaso. Tell your doctor about any side e ects that bother you or do not go away. Your doctor may be able to help you manage the side effects. The above is a rebuttal to the followings. seekingalpha.com/article/3877806-mannkind-naso-oblongo-syndromeLet's merely look at two medical drugs United Therapeutics has approved by the FDA. Actual having approved drugs this allows United being able to generate a stock price that is valued $123.00 dollars more per share than MannKind's share price. These same drugs that Dr. Urbanski cites, has given United Therapeutics the ability for generating through the first three quarters of 2015, revenues totaling more than $748 million. Based on historical sales they will once again exceed one billion dollars in revenue for 2015. The first product to look at is Remodulin, where 7 out of 10 patients on continuous PAH therapy are prescribed this drug. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion. . So is this the market that MannKind will take away from United Therapeutics? If that is the case maybe investors need to become acquainted with another product that is approved by the FDA, and marketed by United Therapeutics. A drug they market under the name Tyvaso. And guess how Tyvaso is dosed? If you guessed that it is dosed with a United Therapeutics inhaler---BINGO! If you guessed it's treprostinil for PAH, then you get to move to the head of the class. I'm sure that United Therapeutics' executives are trembling in their executive suites and laboratories knowing that MannKind, with no funding to explore anything, is nipping at their heels with a "me-too" drug. Once again, MannKind executive keep their rolling and constantly evolving promises where their technology is going too control the delivery of drugs. However, in 25 years they haven't been able to convince anyone with any money or public presences to partner with their inhaler technology. That is other than their former partner Sanofi (NYSE:SNY).
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Post by lakers on Feb 9, 2016 17:36:57 GMT -5
The Nasdaq link worked for me. Not a bad article, they even have a quote from mikep! Very fair article. Plain english - change the label and Dr's wont be afraid of being sued. This is where smart money got it right while retail has posters of Sam Finta on their walls. The trial design was before my time as a share holder and also is out of my understanding. Whose fault are the trial results? I posted this many times here and on YMB. How Mnkd'd Change How They Conduct Clinical Trials in Future October 27, 2014 12:00 p.m Read more: mnkd.proboards.com/thread/4532/change-conduct-clinical-trials-future#ixzz3ziFCvymXSCVBJ: What lessons were learned along the way about how to bring a new drug to market? Hakan: In hindsight it’s always a learning process as to how to benefit going forward. Going forward, we would conduct some of the clinical studies in a different manner if we did it again. We would probably do comparative clinical studies with other therapies for patients and show the superiority or benefit of Afrezza over competitive products. We probably did not give ourselves the optimum ‘label’ (product description) that the product deserves where you can show and differentiate your product from other therapies – showing the incidence of hyperglycemia, high blood sugar, or the recipe of how you can use the product and what you can expect from it, like a prescription advisory to doctors and patients. The benefit would been an even stronger differentiation of benefits for Afrezza as compared to parallel therapies for Type I and type II therapies. It makes it easier to sell the product and presents stronger arguments to present to doctors and patients; why they should use our product as opposed to alternative. It eventually gives you a stronger franchise and better opportunity for higher sales. When you do clinical studies for the FDA you’re trying to prove you have a worthy product and show overall safety and efficacy. We were more focused on the clinical side of our studies given history with Pfizer’s (diabetes) medication and other studies than comparing our treatment to others on the market; we wanted a really clean study. The studies are very expensive and we were being careful about how we managed shareholder investments. Now with an approved product we can do all of the studies and we’ll certainly turn our focus to showing the superiority of the product in therapy.
[ This article and JAC meeting minutes would shine in deposition. Mnkd urged Sanofi to start the Phase 4 Superiority Trial ASAP to no avail. Mnkd's fault was giving Sanofi full Sales and Marketing control. Matt said next time Mnkd would control that. The new partners would be co-marketers. Sanofi started the 2 clamp studies and Pediatric very late, let alone the 5yr/8K lung study. NRx hardly budged since June 2015. This showed Olivier planned to drop Afrezza soon after he became CEO while masquerading it as a Controlled, Slow Launch. Investors ate that up like hungry fools.] Read more: mnkd.proboards.com/thread/4532/change-conduct-clinical-trials-future#ixzz3ziFOc7QG
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Post by lakers on Feb 9, 2016 17:08:00 GMT -5
Excerpts follow. But others saw more fundamental reasons to scrap the idea: Novo Nordisk said at the time that it couldn't overcome the fact that inhaled insulin wouldn't eliminate the need for injections. That is because only short-acting insulin, which is taken as a boost at mealtimes, could be administered via an inhaler. Most diabetes patients on insulin--those with Type 1 or advanced Type 2-- also take a long-acting version to provide a constant minimum level, which would need to be injected. By ending the agreement when it did, Sanofi capped its 2015 losses at roughly EUR200 million. [ This wouldn't stand as CRE. Pfizer spent $2B+$135M settlement. This is great news for the expected Sanofi's large settlement extending Mnkd runway by a few years.] But Sanofi badly underestimated the toll that safety concerns would have on Afrezza's sales. Existing worries among doctors over links with lung cancer were compounded by the U.S. Food and Drug Administration's warning that inhaled insulin could cause breathing difficulties in people with respiratory problems. The agency also required MannKind to run a follow-on trial to determine whether Afrezza did increase patients' cancer risk. The agency also stipulated that doctors test patients' lung health with a device known as a spirometer before prescribing the drug. As most diabetes doctors don't have a spirometer, they would need to send patients to another physician for the test. Doctors might have been more willing to take on the risk and effort of prescribing Afrezza if MannKind had demonstrated that it is more effective than injected insulin, said Jane Chiang, senior vice president for medical affairs at the American Diabetes Association. But the company's clinical trials for Afrezza proved only that it is as effective as, not better than, the injected alternative, a status that is reflected in Afrezza's FDA label. Further, most payers in the U.S. have Afrezza in a "tier three" reimbursement category. That generally comes with higher copays and requires physicians to explain why they prescribed Afrezza over standard injected insulin. Sanofi also priced Afrezza at a premium to its injectable counterparts. MannKind's Mr. Pfeffer said pricing and reimbursement issues "dramatically outweigh the other factors" related to Afrezza's slow uptake. Without a clinical trial showing that Afrezza worked better than injected insulin [Ground for breach of Commercially Reasonable Effort (CRE). Sanofi should have started Phase 4 Superiority trial in Sept 2014 before PBMs place Afrezza as Tier2 w/o PA, ST.], Sanofi's advertising campaign centered on the novelty of inhaling versus injecting. But the company overestimated the extent to which patients would switch to Afrezza due to a needle aversion, said Eamonn O'Connor, an analyst at the health-care consulting firm Decision Resources Group. Despite these setbacks, Afrezza has gained a small but avid following among patients who say it works significantly better for them than injected insulin. Forty-year-old Mike Parise said his blood sugar starts falling within five to 10 minutes after he takes Afrezza, much quicker than with injected insulin. "For someone who's had Type 1 for 20 years, that's a beautiful thing," he said. Jackie Klass, 52, said using Afrezza had helped her gain control over her blood-sugar levels for the first time since she was diagnosed 17 years ago and had "changed my life." She owns shares in MannKind. But many others didn't stick with it: A Sanofi spokeswoman said that of the 6,000 patients prescribed Afrezza since its launch, only 35% stayed on the treatment. Read more: www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284#ixzz3zi8y5U3O
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Post by lakers on Feb 9, 2016 13:09:27 GMT -5
What A Joke Sanofi Is Claiming They Made A Substantial Effort To Sell Afrezza In Today's Press Release Sanofi did virtually little to promote Afrezza in the United States alone, narrowly targeting only a handful of markets to promote the drug using very limited marketing means like a couple of print ads and a very small sales force. Sanofi did not even make an effort to talk about Afrezza during their own healthcare/investor presentations, keeping it completely off their radar screen. Now in comparison Sanofi did do a substantial effort to promote Toujeo across the globe spending a lot of money on print ads, television ads and using their entire diabetes sales force to promote and sell the drug globally. Despite the huge disparity in resources and support Sanofi allocated in favor of Toujeo vs. Afrezza, Afrezza managed to still generate some sales in the U.S. thanks to the amazing effort early adopters using the drug initiated on their own to promote the great benefits they were experiencing using Afrezza across social media. Had Sanofi reversed its strategy placing all its emphasis and resources on Afrezza instead of Toujeo I believe the two drugs sales results in 2015, would be reversed with Afrezza nearing blockbuster results. Here is Sanofi comments about Afrezza from today's press release. "Afrezza® sales were €2 million and €7 million in the fourth quarter and 2015, respectively. On January 4, 2016, Sanofi informed MannKind Corporation, that it has exercised its option to terminate its agreement. This termination will become effective on April 4, 2016. This action is in line with the terms of the contract, and the decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza® despite Sanofi's substantial efforts. Sanofi intends to work with MannKind to support a smooth transition and will continue to make Afrezza® available in the United States for a period of up to approximately 180 days after the date of Termination, as set forth in the License and Collaboration Agreement" finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1455021382894-ac3a8458-dded-415f-a8cc-9f290234cf68&tls=la%2Cd%2C3%2C3As for Toujeo, I'm pleased to see the encouraging launch uptake. As you can see from the chart, the sales performance of the brand has accelerated over the recent quarters, primarily driven by rapid market access in the US and fast adoption by prescribers. This uptake compares favorably with other brands in the same therapeutic category. Outside the US, Toujeo is also gaining momentum following its rollout in over 20 markets, including Germany, the UK, Japan, and Canada. Overall, diabetes performed in line with our revised guidance, and we continue to expect global sales to be down minus 4% to minus 8% annually over the period of 2015 to 2018. As we enter 2016 we expect benefit from the initiatives we launched last year to further improve our operational effectiveness. www.thestreet.com/story/13453308/3/sanofi-sny-earnings-report-q4-2015-conference-call-transcript.html
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