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Post by lakers on Nov 20, 2015 16:41:01 GMT -5
I think it's premature to presume that Hakan was given a choice of resign or be fired. After all, Hakan has been there like 10-15 years already, so firing him now is a bit like calling the fire department after the house has burned down. Plus, as I understood it, he was Al'Mann's personal choice to be CEO back when he was originally hired and also when Al retired. Also, why fire him -- as opposed to finding a new CEO and then just replacing him? Then the news might have been perceived in a more positive light. As it is, with no explanation coming from the company, all investors see is that the ship has lost its captain. Al, while great, is still 90 years old and even though only "interim CEO," investors are bound to wonder if he is up to handling MNKD's current situation. So I think one, at least, should reflect on the possibility that Hakan resigned because he either didn't like getting blamed and taking fire from critics -- perhaps for things over which he had no control over -- and/or, possibly,he didn't like what he saw looming on the horizon. Then it was the correct decision for him to make if he didn't like what was looming on the horizon. I don't want a quitter as our CEO. A Captain (good leader) is the last person off the boat in a crisis. They don't abandon ship when they see rough waters on the horizon. That is when their expertise is most needed. The only reasons I would be ok with Hakan stepping down on his own would be for medical/ethical reasons, or he realized he wasn't giving MNKD what it deserved. Granted, I'm not in the know, but considering the state of the company and no rumors of any health issues and knowing how ethical Al is, I can't help but think he was pushed out. The Web site was immediately updated. Hakan's picture was removed from the all exec mgmt hands. However, accessing the side menu, Hakan's picx is still there. That was quick considering Web site has been slowly updated thus far, but not thorough. This should be fixed. compound26 is needed here although he is overqualified for the job:-) www.mannkindcorp.com/about-us-executive-management.htm |
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Post by lakers on Nov 20, 2015 14:03:33 GMT -5
Thanks Lakers for your contributions! Only cool update I have is a BoD member over at EYES is still a buyer of MNKD. Perhaps he / she has a bit more insight into the ongoings of MNKD then most of us retailers. I've been long for years and was bullish before I got that tidbit of info but it reaffirmed my bullishness. I've got a feeling Al is recruiting a big name to take over so that he can sleep easy. Go get em Al, go get em!!! Do you think Dr. Shannon qualifies as Mnkd's CEO ? Lets vote! James S. Shannon Rejoins MannKind's Board of Directors VALENCIA, Calif., May 21, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that James S. Shannon, MD, MRCP (UK) has been elected to the company's Board of Directors after previously serving as a director from February 2010 until April 2012. The addition of Dr. Shannon brings the total number of MannKind Board members to eight. From May 2012 until his retirement in April 2015, Dr. Shannon was the Chief Medical Officer of GlaxoSmithKline. He formerly held the position of Global Head of Pharma Development at Novartis AG, based in Basel, Switzerland from 2005 until 2008. After joining Sandoz in 1994 as Head of Drug Regulatory Affairs, Dr. Shannon led of the Integration Office for R&D overseeing the creation of the Novartis R&D groups from those of Ciba-Geigy Ltd and Sandoz. Following the merger he was appointed Head of the Cardiovascular Strategic Team and subsequently became Global Head of Project Management before being appointed Global Head of Clinical Development and Medical Affairs in 1999, a position that he held until 2005 when he was appointed to Head Pharma Development. Between 2008 and joining GSK, Dr. Shannon served on the boards of a number of companies, including Biotie, Circassia, Crucell, Endocyte and MannKind. He also sat on the board of Cerimon Pharmaceuticals where he held the position of interim Chief Executive Officer and President from January 2009 until April 2010. He first entered the pharmaceutical industry in 1987 joining Sterling Winthrop Inc., working initially in Europe and subsequently in the USA, where he held positions of increasing responsibility in the management of research and development ultimately serving as Senior Vice-President, Clinical Development. Dr. Shannon is trained in Medicine and Cardiology. He received his undergraduate and postgraduate degrees at Queen's University of Belfast and is a Member of the Royal College of Physicians (UK). "We are very pleased to welcome James back to the board of directors," stated Alfred Mann, Executive Chairman of MannKind Corporation. "His experience as a recognized pharmaceutical industry leader is invaluable to us as we accelerate the commercialization of Afrezza® and build a pipeline of additional product opportunities that utilize our proprietary technologies." |
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Post by lakers on Nov 20, 2015 13:20:16 GMT -5
Please do not lock this thread which is created b/c the following thread was locked. 3Q15 ER Mon 11/9/15; BoD to convene Nov 2nd half to decide created Oct 29, 2015 at 1:43pm mnkd.proboards.com/thread/3875/3q15-mon-convene-half-decide?page=5Hakan 3Q15 CC 11/9/15: Negotiating with many for TS partnership- Will have partner by end of year The 50M Mnkd Shares TASE index funds got is such a sweet deal. Al'd rather offer to them than Sny. He really plays hard ball w/ Sny who must be really stingy. ... so is the result of the BOD meeting what you expected or a surprise? Might a TS partnership deal falling through been the proximate cause of a change of leadership? "Pain/Migraine partnership is being discussed as one of topics". Hakan has been on the rock..., not a surprise here. This indeed verifies that there has been a BoD meeting. Any doubter here ? Far from what you surmised, What would be better than letting the ultimate majority shareholder negotiate directly ? Better yet, Ask yourself, would you rather have someone else negotiate the fate of the company, of his own baby ? Al certainly lends gravity to the negotiation. |
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Post by lakers on Nov 19, 2015 15:47:07 GMT -5
Passed animal trials?? Don't ya wonder how they know when a mouse has a headache and when it's gone  ?? Sounds like a post for YMB . Just a guess, but I would imagine that animal trials are used to prove safety rather than efficacy. In other words, prove that it doesn't kill an animal before you give it to a human. Can it be overdosed ? how much ? non-opioid, is it addictive? Built-up resistance... I repeat do not pass judgment until after your thorough DD. |
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Post by lakers on Nov 19, 2015 15:19:17 GMT -5
BoD is still in session as of Thursday today 11/19/15. Pain/Migraine partnership is being discussed as one of topics. Pain med passed animal trial, was ready for human clinical trial. It's furthest along among APIs. Please do your own DD before passing judgement.You can partially verify some. Do not lock this thread just because you can't verify on your own for the benefit of others, out of respect for the long-suffering Old Faithfuls such as rock, kball, dbc, mnholdem, kc, spiro, rob, resident PCPs, ...
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Post by lakers on Nov 19, 2015 11:10:50 GMT -5
It is hard to think as any pharma using the lung to deliver these types of drugs. Il 6 is an important part of the immune system and I think pharma companies would suspect doctors would be extremely cautious with this type of therapy (and the studies needed to put this past the FDA would be huge). Unlikely to happen. Same goes for the unlikely administration of Copaxone via the lung. How big would the phase 3s have to be? Check out New Oncology patent. See the bold API. mnkd.proboards.com/thread/4171/sny-ceo-acquisitions-oncology |
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Post by lakers on Nov 19, 2015 4:04:02 GMT -5
Sanofi and Regeneron Hit Another Bullseye Inhaling helps weak, painful hands which are too weak to inject themselves. Rheumatoid Arthritis Patient. Image source: Wikimedia Commons. It's been nearly half a year since partners Regeneron (NASDAQ:REGN) and Sanofi (NYSE:SNY) gave us a preview of experimental drug sarilumab's ability to treat sufferers of rheumatoid arthritis that don't respond to drugs like Humira. Although the drug reached its goal of reducing signs and symptoms, there really wasn't enough info to gauge its potential in this increasingly crowded space. Luckily, a recent presentation at the American College of Rheumatology's annual meeting just gave us a few hints. Worldwide sales of anti-rheumatics topped $48 billion last year. Success with sarilumab would be a huge boost Regeneron, which recorded $3.8 billion in revenue in the past 12 months. With U.S. sales of Sanofi's leading product Lantus in a freefall, it too could really use a win here. There's a large group of rheumatoid arthritis patients underserved by existing therapies. Let's take a closer look at sarilumab's performance in this group to see just how much of an impact this antibody might have. Room for improvement Anti-TNF biologics dominate the anti-rheumatic market. Last year, Humira, Enbrel, Remicade, and Simponi chalked up a combined $32.5 billion in sales. Despite their monetary success, most rheumatoid arthritis patients aren't too thrilled with their current treatment. In a recent survey by Pfizer, just 30% of patients taking prescription medicines described their disease as under control. You see, not all patients respond well to initial treatment with TNF inhibitors. Among those who do, many develop side effects. It's a bit dated, but a 2006 survey of rheumatologists revealed that more than 94% switched patients from one TNF inhibitor to another because of inadequate response or side effects. Filling unmet need Estimating the number of patients who would gladly switch over to a first-in-class treatment isn't easy. Given the level of dissatisfaction with existing therapies, it seems a viable alternative would do extremely well. Results of the Saril-RA-Target study suggest sarilumab could be that alternative. The trial enrolled hundreds of rheumatoid arthritis patients who were inadequate responders or intolerant of TNF inhibitors. Initially, I didn't expect this difficult-to-treat patient pool would respond well to anything, and I was wrong. When Sanofi and Regeneron announced the trial's results, a surprising 20% of patients receiving sarilumab every other week exhibited a 70% or greater improvement. Years ago, in a similar study, 21% of patients receiving Humira every other week showed an improvement of 70% or greater. Although the percentage of patients achieving a 70% improvement is nearly the same for both drugs, it's important to remember the Saril-RA-Target study only recruited patients for whom Humira isn't an option. Looking ahead Sanofi and Regeneron have already submitted an application for sarilumab to the FDA. Given the combination of safety and efficacy exhibited in the above study, I'll be very surprised if regulators don't give it a green light. Drug launches are exceedingly unpredictable, but those that meet the needs of patients with limited options tend to succeed. If approved, I'd also be taken aback if sarilumab doesn't reach billion-dollar blockbuster status within several years after a possible approval. Something I'm even more certain about is which of the two partners needs a win the most. SNY Revenue (TTM) Chart Regeneron's third-quarter revenue rose 57% this year compared to last, and the company is doing even better on the bottom line. Third-quarter net income more than doubled from $83 million in 2014 to $210 million this year. Next-generation cholesterol-lowering drug Praluent receives the lion's share of attention for Regeneron, but sales from this potential blockbuster have only just started rolling in. After winning FDA approval in late July, Sanofi (who partnered with Regeneron to develop the drug) recorded just $4.3 million in sales of Praluent during the third quarter. With Praluent on the rise, and a possible winner in sarilumab, Regeneron's future could hardly look brighter. The mood at Sanofi HQ is far less jubilant. Sanofi's bottom line has been stagnating for years. Over the summer, the company's new CEO, Olivier Brandicourt, unveiled plans to reorganize business segments. That plan was largely ignored by Wall Street, but long-term guidance given during the November 6 investor day conference got a reaction. SNY Chart The stock is down about 10% after announcing expected top-line growth of between 3% and 4% until 2020. While most companies in this position would try to cut costs, that isn't a part of Sanofi's strategy. In fact, the company insists we'll need to wait until 2018 before margins improve. It's a long way out, but with a bit of luck, sarilumab could go a long way toward helping Sanofi meet those lackluster goals. www.fool.com/investing/general/2015/11/18/sanofi-and-regeneron-hit-another-bullseye.aspx |
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Post by lakers on Nov 19, 2015 2:26:09 GMT -5
www.fool.com/investing/general/2015/04/29/mannkinds-future-more-than-just-afrezza.aspxMannKind has also hinted in the past that another opportunity may exist in the diabetes space: GLP-1 agonists. This drug class, which is designed to stimulate the pancreas to produce more insulin when blood sugar levels are high, is already on the market and is used to treat patients with type 2 diabetes. When asked about the opportunity here, CEO Edstrom confirmed that they are discussing the opportunity with their partner Sanofi, and hinted that there many be a development project in the works. We do not have a lot to go on about the clinical status of the GLP-1 opportunity, as the company hasn't put out a follow up press release since posting positive phase 1a results way back in November 2007. However, with CEO Edstrom calling it out as a potential development project with Sanofi, it could be an interesting opportunity for the company. www.mannkindcorp.com/Collateral/Documents/English-US/MKC-253-001%20PKPD_ADA_June8v6.pdfPulmonary Administration of GLP-1 Technosphere® Powder Elicits Dose-dependent Insulin Response Robert Baughman, PhD, PharmD Vice President, Experimental Pharmacology MannKind Corporation MannKind Corporation screencast.com/t/lfvJnQwPlF5HLyxumia® (lixisenatide), a once-daily prandial GLP-1 receptor agonist was approved for treatment of T2 in Europe in Feb 2013. U.S. regulatory decision expected in 3Q16. www.mannkindcorp.com/Collateral/Documents/English-US/marino%202010%20pk%20pd%20inhaled%20GLP-1%20MKC%20253%20POC%20T2.pdfPharmacokinetics and Pharmacodynamics of Inhaled GLP-1 (MKC253): Proof-of-Concept Studies in Healthy Normal Volunteers and in Patients With Type 2 Diabetes MT Marino1, D Costello1, R Baughman1, A Boss1, J Cassidy1, C Damico1, S van Marle2, A van Vliet2 and PC Richardson1 MKC253 is glucagon-like peptide 1 (GLP-1, 7–36 amide) adsorbed onto Technosphere microparticles for oral inhalation. The pharmacokinetics of inhaled GLP-1 and the pharmacokinetic–pharmacodynamic (PK–PD) relationship between inhaled GLP-1 and insulin were analyzed in two trials, one in healthy normal volunteers and the other in patients with type 2 diabetes. Inhaled GLP-1 was absorbed quickly, with peak concentrations occurring within 5min, and levels returned to baseline within 30min. Inhaled GLP-1 appeared to produce plasma levels of GLP-1 comparable to those of parenteral administration and sufficient to induce insulin secretion resulting in attenuation of postmeal glucose excursions in subjects with type 2 diabetes. An Emax (maximum effect) model described the relationship between GLP-1 concentration and insulin release. The variability in the Emax may be due to differences in baseline glucose levels, differences resulting from genetic polymorphisms in GLP-1 receptors (GLP-1Rs), or the stage of diabetes of the patient. www.mannkindcorp.com/Collateral/Documents/English-US/DOM%20GLP-1%20CMC%20PK%20PD%20paper.pdfEvaluation of novel particles as an inhalation system for GLP-1 A. Leone-Bay, M. Grant, S. Greene, G. Stowell, S. Daniels, A. Smithson, S. Villanueva, S. Cope, K. Carrera, S. Reyes and P. Richardson MannKind Corporation, Valencia, CA, USA professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=74463 Inhaled GLP-1 and Exenatide: Different Effects on Pancreatic and Gastric Activity Year: 2009 Abstract Number: 160-OR Authors: ROBERT A. BAUGHMAN, DONALD J. COSTELLO, MARK T. MARINO, JAMES P. CASSIDY, ANDERS H. BOSS, CHRISTINE A. DAMICO, PAMELA C. HAWORTH, PETER C. RICHARDSON, JEROEN VAN DE WETERING DE ROOIJ, ANDRE A. VAN VLIET Institutions: Valencia, CA, Zuidlaren, The Netherlands Results: MKC253 is GLP-1 adsorbed onto Technosphere® microparticles for oral inhalation. This double-blind, double-dummy, placebo and active control crossover trial compared the effects of MKC253 (1.5 mg) and subcutaneous injection of exenatide (EXE; 10 µg) on postprandial glucose (PPG) excursions, postprandial insulin, gastric emptying, and GLP-1 pharmacokinetics. Included were 20 nonsmoking subjects with type 2 diabetes (A1C 6.2%-8.5%) on a stable oral antidiabetic regimen. Subjects received 5 treatments 2 days apart. All received MKC253 or inhaled placebo (InhP) while fasting. EXE or placebo sc (SCP) was given 15 min premeal, and MKC253 or InhP was given premeal (Pre) or 30 min postmeal (Post). Subjects received in randomized order: SCP + MKC253 Pre + InhP Post; SCP + MKC253 Pre + MKC253 Post; EXE + InhP Pre+InhP Post; or SCP + InhP Pre + InhP Post. Gastric emptying was measured by absorption of 13C-octanoate from a 575 Kcal standardized meal. MKC253 produced a rapid spike in insulin. Mean insulin Cmax occurred <10 min after dosing and fell sharply thereafter. Mean peak insulin was 60 µU/mL. Mean PK of insulin release closely tracked mean GLP-1 kinetics. The insulin response following EXE was slower and less pronounced. In fasting subjects with baseline glucose <9 mmol/L, MKC253 produced a mean maximal decrease in glucose of 0.75 mmol/L about 30 min after inhalation. Subjects with baseline glucose >9 mmol/L had a 1.2 mmol/L decrease in glucose approx. 45 min after inhalation. MKC253 reduced PPG excursions. Compared with InhP, MKC253 Pre decreased PPG by ≥1 mM/L for >1 hr and MKC253 Pre + Post decreased PPG for >3 hr. Reductions were longer than that predicted by a GLP-1 t1/2 of <2 min. MKC253 had little or no effect on gastric emptying. In contrast, EXE also reduced PPG but acted by delaying gastric emptying. More than 90% of 13C ingested was unabsorbed 4 hr after the meal compared with <60% with MKC253. After EXE injection, insulin response to meal challenge was much smaller than with MKC253. Only 1 of 20 subjects reported nausea with MKC253 vs rates >66% from literature with injected GLP-1. Both MKC253 and EXE reduce PPG excursions, but appear to do so by different mechanisms. books.google.com/books?id=nN9sBgAAQBAJ&pg=PA35&lpg=PA35&dq=inhaled+glp-1&source=bl&ots=TPNLjCxtDB&sig=0qXUe4f2dry_IcmWsKD9YnKunSo&hl=en&sa=X&ved=0CE0Q6AEwBWoVChMItuGomfybyQIVRjeICh2MAw06#v=onepage&q=inhaled%20glp-1&f=falseEnvironmental Biomedicine - Page 35 - Google Books Result books.google.com/books?isbn=3319146904Mieczyslaw Pokorski - 2015 - Science In the treatment period, patients received five different treatments (I: 1.5 mg GLP-1 as MKC253 inhalation powder or Technosphere® inhalation powder with.. www.biotechduediligence.com/mnkd.htmlIn consideration for the rights granted to Sanofi by us under the Sanofi License Agreement, upon effectiveness of the Sanofi License Agreement, we will receive an upfront payment of $150.0 million. If certain manufacturing, regulatory and sales milestones are achieved, we will also eligible to receive up to $775.0 million in milestone payments, of which $75.0 million in milestone payments relate to certain development and manufacturing milestone events, $50.0 million in milestone payments relate to the filing and completion of regulatory approvals and $650.0 million in milestone payments relate to the achievement of certain product sales milestones. In addition, worldwide profits and losses be shared 65% by Sanofi and 35% by us. [$25M remained for Qualifying Sny's insulin for Afrezza. $30M for EU, $20M for Japan approval. $250M for annual Afrezza sale of first $250M probably, dollar bonus for dollar rev.] Under the terms of the Sanofi License Agreement, we granted to Sanofi a right of first negotiation in the event we propose to grant to any third party a license to develop or exploit an inhaled glucagon-like peptide-1 agonist. In addition, if our board of directors determines to pursue a change of control of MannKind, we will be required notify Sanofi of such determination within a certain period of time so that Sanofi may, at is discretion, negotiate with us for a potential acquisition of MannKind by Sanofi. In addition, we received a commitment letter from an affiliate of Sanofi to provide the Sanofi Loan Facility. The commitment letter provides for a $175.0 million secured revolving loan facility to fund our share of net losses under the Sanofi License Agreement. Pursuant to the commitment letter, loans under the Sanofi Loan Facility would bear interest at a rate of 8.5% per annum, paid-in-kind on a quarterly basis (2.06% per quarter compounded) and would become due and payable in full on the tenth anniversary of the effective date of the Sanofi License Agreement. We would be required to prepay any loans with net profits received under the Sanofi License Agreement. The commitment letter provides that our obligations under the Sanofi Loan Facility would be secured by a first priority mortgage on our facility in Valencia, California, a first priority security interest in certain insulin inventory located at our facility in Danbury, Connecticut and any contractual rights and obligations pursuant to which we purchase or have purchased such insulin, and a second priority security interest in our assets that secure our obligations under the Facility Agreement. The commitment is subject to customary conditions, including the effectiveness of the Sanofi License Agreement, the finalization of loan documentation and the entry into satisfactory intercreditor agreement with Deerfield. The effectiveness of the Sanofi License Agreement and the Supply Agreement is contingent upon satisfaction of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the entry into the definitive loan documents relating to the Sanofi Loan Facility (unless we terminate the commitment letter for the Sanofi Loan Facility). The Sanofi License Agreement will remain in effect unless either party terminates the Sanofi License Agreement in accordance with its terms. Either party may terminate the Sanofi License Agreement for a material breach the other party if such breach remains uncured for 90 days, or 45 days in the case of a non-payment breach; provided that if Sanofi breaches the Sanofi License Agreement for failure to comply with its obligation to use commercially reasonable efforts to file for, obtain and maintain regulatory approval for AFREZZA in certain major markets and countries and to market, promote and commercialize AFREZZA in countries where regulatory approval has been received, as set forth in the Sanofi License Agreement, with respect to (i) the United States, we may terminate the Sanofi License Agreement in its entirety, and (ii) certain major markets or countries, we may terminate the Sanofi License Agreement only with respect to such markets or countries and not in its entirety. Either party may also terminate the Sanofi License Agreement upon written notice to the other party in the event of the other party’s insolvency. Sanofi may terminate the Sanofi License Agreement at any time on or after January 1, 2016 (a) upon 90 days’ written notice if Sanofi determines in good faith that the commercialization of AFREZZA is no longer economically viable in the United States, and (b) without cause upon six months’ written notice in its entirety or on a country-by-country basis other than with respect to the United States, subject to certain exceptions. In addition, Sanofi may terminate the Sanofi License Agreement on a country-by-country basis upon 30 days’ written notice for certain safety or regulatory reasons.
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Post by lakers on Nov 18, 2015 23:16:15 GMT -5
The one thing that leaves me unsure about this Teva-Capaxone "connection" or theory is the fact that Teva would have to believe there is some pharmacological advantage to administering Capaxone through Technosphere. It is reasonable to think not every drug under the sun will have increased efficacy through a Technospehere application as compared to Afrezza where the quicker onset results in increased efficacy. I wonder if the patent extension potential alone would be enough to convince them they need Technosphere in their pipeline. New Oncology patent. See the bold API. mnkd.proboards.com/thread/4171/sny-ceo-acquisitions-oncology |
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Post by lakers on Nov 18, 2015 20:38:27 GMT -5
Oversea-version, German-insulin Afrezza is bio similar to U.S. Version, French-insulin Afrezza. One stone kills Two birds.
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Post by lakers on Nov 18, 2015 19:43:45 GMT -5
Generic Copaxone Isn't Derailing Teva Pharmaceuticals...Yet Revenue from Copaxone has yet to fall dramatically following this year's approval of a generic version of the widely used MS therapy. The FDA approval of Novartis (NYSE:NVS) and Momenta Pharmaceuticals (NASDAQ:MNTA) Glatopa in April led many to believe that Teva Pharmaceuticals (NYSE:TEVA) revenue may suffer significantly; however, despite facing off against a lower-cost generic for the first time, sales of Teva's Copaxone barely flinched year over year in the third quarter. Targeting a top seller Teva's Copaxone is a daily injection therapy for the treatment of multiple sclerosis, and since winning FDA approval in 1996, Copaxone has become the most widely prescribed therapy for this indication, with a total market share of roughly 30% last year. As a result, despite Teva Pharmaceuticals racking up billions of dollars in sales from its generic drugs, Copaxone's market share and roughly $6,000 per month price tag led to it accounting for more than 20% of Teva Pharmaceuticals' $20.3 billion in sales last year. With more than $4 billion in annual sales at stake, and more people being diagnosed with MS every year, it's little wonder that Novartis, via its Sandoz unit, and Momenta Pharmaceuticals developed Glatopa so they could steal revenue from Teva Pharmaceuticals when Copaxone's patent expired this year.Maintaining market share The threat of losing so much of its total revenue to a generic version of Copaxone led to a series of legal challenges by Teva Pharmaceuticals designed to delay Glatopa's launch, and although those legal challenges ultimately failed to prevent Glatopa's approval, they did buy Teva Pharmaceuticals valuable time that it used to develop and commercialize a higher-dosage and longer-lasting variation of Copaxone that it's been aggressively marketing to patients. That 40 mg variation of the drug can be taken three times weekly, rather than daily, an advantage that has been resonating with patients given that, despite only launching last year, the 40 mg variation has grown to represent 76% of Copaxone's total sales exiting Q3, up from 67% in Q2. Thanks to that conversion strategy, combined sales of Teva Pharmaceuticals 20 mg and 40 mg Copaxone fell by just 2% year over year to $1.08 billion in the third quarter, and importantly, the company's total MS market share only declined by 2.2% in the past year. Remaining threats Although Teva Pharmaceuticals investors are cheering management's ability to convert so many Copaxone patients to the new formulation, Teva Pharmaceuticals isn't out of the woods -- at least not yet. While the majority of patients are on the longer-lasting 40 mg version, the 20 mg variation still accounts for roughly $250 million in quarterly sales, some of which are bound to defect to Glatopa, which is priced at a 15% to 18% discount to Copaxone. Additionally, generic manufacturers are challenging the validity of key patents protecting the 40 mg variation, and if those challenges succeed, a generic alternative to 40 mg Copaxone could hit the market in the next couple of years. According to Teva Pharmaceuticals, if generic alternatives to the 40 mg formulation are approved, it could end up reducing its sales and earnings per share by $1.2 billion and $0.65 in 2017, respectively. Looking forward Teva Pharmaceuticals isn't about to sit back and give up its 40 mg sales easily, and that means we're likely to hear more on the legal front in the coming year, but Teva isn't relying solely on its lawyers to hold off the inevitable shift to generics. Earlier this year, the company acquired Allergan's generic business in a deal valued at $40.5 billion, and with billions of dollars in annual cash flow, there's still plenty of money to fund the company's generic drug and specialty drug pipelines. That's good news, especially since it's unlikely that Novartis, Momenta, and other lower-cost generic drugmakers will fail to capture a larger share of Copaxone sales next year than they do today, or that they'll give up on rolling out a generic 40 mg Copaxone anytime soon. www.fool.com/investing/general/2015/10/31/generic-copaxone-isnt-derailing-teva-pharmaceutica.aspx |
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Post by lakers on Nov 18, 2015 16:38:18 GMT -5
New Oncology patent. See the bold API. Title: Formation of N-protected 3,6-bis-(4-aminobutyl) -2, 5-diketopiperazine through a cyclic α-N-protected active amino ester intermediate Document Type and Number: United States Patent 9187433 mnkd.proboards.com/thread/4201/patent-biologically-active-agentswww.freepatentsonline.com/9187433.htmlApplication Number: 14/629046 Publication Date: 11/17/2015
Filing Date: 02/23/2015BACKGROUND Drug delivery is a persistent problem in the administration of active agents to patients. Conventional means for delivering active agents are often severely limited by biological, chemical, and physical barriers. Typically, these barriers are imposed by the environment through which delivery occurs, the environment of the target for delivery, or the target itself. Biologically active agents are particularly vulnerable to such barriers. For example in the delivery to humans of pharmacological and therapeutic agents, barriers are imposed by the body. Examples of physical barriers are the skin and various organ membranes that must be traversed before reaching a target. Chemical barriers include, but are not limited to, pH variations, lipid bi-layers, and degrading enzymes. These barriers are of particular significance in the design of oral delivery systems. Oral delivery of many biologically active agents would be the route of choice for administration to animals if not for biological, chemical, and physical barriers such as varying pH in the gastrointestinal (GI) tract, powerful digestive enzymes, and active agent impermeable gastrointestinal membranes. Among the numerous agents which are not typically amenable to oral administration are biologically active peptides, such as calcitonin and insulin; polysaccharides, and in particular mucopolysaccharides including, but not limited to, heparin; heparinoids; antibiotics; and other organic substances. These agents are rapidly rendered ineffective or are destroyed in the gastrointestinal tract by acid hydrolysis, enzymes, or the like. Earlier methods for orally administering vulnerable pharmacological agents have relied on the co-administration of adjuvants (e.g., resorcinols and non-ionic surfactants such as polyoxyethylene oleyl ether and n-hexadecylpolyethylene ether) to increase artificially the permeability of the intestinal walls, as well as the co-administration of enzymatic inhibitors (e.g., pancreatic trypsin inhibitors, diisopropylfluorophosphate (DFF) and trasylol) to inhibit enzymatic degradation. Liposomes have also been described as drug delivery systems for insulin and heparin. See, for example, U.S. Pat. No. 4,239,754; Patel et al. (1976), FEBS Letters, Vol. 62, pg. 60; and Hashimoto et al. (1979), Endocrinology Japan, Vol. 26, pg. 337. However, broad spectrum use of drug delivery systems is precluded due to a variety of reasons including: (1) the systems require toxic amounts of adjuvants or inhibitors; (2) suitable low molecular weight cargos, i.e. active agents, are not available; (3) the systems exhibit poor stability and inadequate shelf life; (4) the systems are difficult to manufacture; (5) the systems fail to protect the active agent (cargo); (6) the systems adversely alter the active agent; or (7) the systems fail to allow or promote absorption of the active agent. More recently, microspheres of artificial polymers of mixed amino acids (proteinoids) have been used to deliver pharmaceuticals. For example, U.S. Pat. No. 4,925,673 describes drug-containing proteinoid microsphere carriers as well as methods for their preparation and use. These proteinoid microspheres are useful for the delivery of a number of active agents. There is still a need in the art for simple, inexpensive delivery systems which are easily prepared and which can deliver a broad range of active agents. One class of delivery system that has shown promise is diketopiperazines. In particular, 3,6-bis-substituted diketopiperazines have been shown to effectively deliver biologically active agents across the lining of the lung. www.americantradejournal.com/company-shares-of-momenta-pharmaceuticals-inc-nasdaqmnta-rally-1-97/6146657/Momenta Pharmaceuticals, Inc. (Momenta) is a biotechnology company specializing in the characterization and process engineering of complex molecules. These complex molecules include proteins, polypeptides, and cell surface polysaccharides, such as heparan-sulfate proteoglycans (HSPGs). This results in a diversified product pipeline of complex generic, follow-on biologic (FOB) and novel drugs. The Companys complex generic programs target marketed products, which were originally approved by the United States Food and Drug Administration (FDA) as New Drug Applications (NDAs). Its M356, is designed to be a generic version of Copaxone (glatiramer acetate injection), a drug that is indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). During the year ended December 31, 2011, it acquired the assets of Virdante. On February 13, 2012 it entered into a global collaboration (Baxter Agreement) with Baxter International Inc. Could Teva partner w/Mnkd for expiring Copaxone MS BlockBuster ?mnkd.proboards.com/thread/3827/teva-partner-expiring-copaxone-blockbust#ixzz3rsphmgkZ |
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Post by lakers on Nov 18, 2015 15:20:53 GMT -5
The article is based on FDA trial results. You can submit for peer review and go through vetting process. It can be done. What can you do to help Mnkd ? Paraphrasing JFK. Affinity 2 result needs to be better publicized, or infomercialized. Anyone can submit an original research manuscript to the NEJM but review articles like this are usually (more like always) by invitation. You don't think Al, BoD, Sny, Dr Bode, Dr Edelman can pull the string to get invited. Think Different ! |
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Post by lakers on Nov 18, 2015 15:17:28 GMT -5
Matt, Roberta are OOO today 11/18. A good request would be asking Hakan to work with authors to submit the following great article for peer review and go through the vetting process to get it printed by trade journals such as NEJM, ADA, ... It contains superior FDA trial results especially Affinity 2.This route is very cheap and reach the largest worldwide mindshare of MDs, nurses, PAs, investors, PWDs. Afrezza (Insulin Human) Inhalation Powder A New Inhaled Insulin for the Management Of Type-1 or Type-2 Diabetes Mellitus Tamara Goldberg, PharmD, BCPS; and Elaine Wong, PharmD, BCPS www.ptcommunity.com/system/files/pdf/ptj4011735.pdfVol. 40 No. 11 • November 2015 • P&T |
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Post by lakers on Nov 18, 2015 15:11:40 GMT -5
Could you email that article to Hakan asking him to work w/authors to publish on NEJM which reaches most MDs. Worldwide? This is more effective and cheaper than any infomercial. To state the obvious: NEJM doesn't work that way... The article is based on FDA trial results. You can submit for peer review and go through vetting process. It can be done. What can you do to help Mnkd ? Paraphrasing JFK. Affinity 2 result needs to be better publicized, or infomercialized. |
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?? Sounds like a post for YMB . 
