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Post by lakers on Dec 1, 2015 22:14:30 GMT -5
I spoke to Matt on this very subject. Read what I wrote. If SNY is going to start marketing in Isreal and Saudi Arabia and AFREZZA is ONLY approved by the FDA, then the U.S. is the benchmark pricing. If SNY get AFREZZA approved by the EMA then the EMA pricing would be the benchmark for the Middle East and many other Countries. Is SNY looking for volume or profit margins? There is South America as well that can use the FDA approval. It will be interesting to see which Countries will be first as well as the timing. That's why Sny wants to consider EU launch in the context of World launch and keeps Afrezza US price high for negotiation leverage. Mnkd is qualifying Sny's insulin to lower COGS. Sny also wants a better label, hence the slow expansion. All signs point to Sny ready for international expansion.
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Post by lakers on Dec 1, 2015 16:24:53 GMT -5
That's a correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad! Hi Lakers, I'm not familiar with the EU approval process. Once the filing is made, do you know typically how long the approval process is? Is there any fast track for FDA approved drugs? Also, am I correct in assuming that this will be a material event that requires notification to mnkd stockholders? Many thanks. facts There are excellent threads on this board on EMA, CHMP approval process. You can dig it up. The longest step takes 210 days max. It took Toujeo less than 2 months to get approved by EMA. Afrezza is different. EMA MAA filing Is normally considered material by many cos.
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Post by lakers on Dec 1, 2015 13:03:03 GMT -5
I posed the question as either a possibility or not a possibility. Matt is intelligent enough to understand my question. If Sanofi could not seek EU approval based on the 2 completed studies, I would have expected: not possible or no reply. The fact he wrote it is a possibility indicates Sanofi either has or will apply for approval. That's the correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad!
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Post by lakers on Dec 1, 2015 1:38:14 GMT -5
Just as Toujeo failed to claim lower hypo incidents in U.S., but in EU, Sanofi might be able to obtain a better A1c label overseas based on Affinity 2 Study. The TI arm demonstrated a significantly greater reduction in HbA1c at week 24 compared with the TP arm, with a difference of −0.40 percentage points (P < 0.001). A larger percentage of patients in the TI group achieved the desired HbA1c goal of less than 7% compared with the TP group (37.7% versus 19.0%, respectively; P = 0.0005). The mean change in FPG levels was not significantly different between the two groups.24 During the 24-week study period, the patients receiving TI experienced a mean 0.49-kg weight gain, whereas those in the placebo group lost an average of 1.13 kg; the between-group treatment difference was 1.62 kg (P < 0.0001).22 Read more: mnkd.proboards.com/thread/4198/forecast-great-afrezza-article-change#ixzz3t348OdRSIn 2016, $30M for EU Approval. $25M for qualifying Sny's insulin. In 2017, potentially 12 countries of $20.84M annual rev each = $250M qualifying for the first $250M milestone. This also enables Mnkd to recognize deferred rev, and upfront payment. Looking forward, RBC identified three potential catalysts for the stock: 1. European Union filing plans in 2016 in which MannKind will count on Sanofi SA (NYSE: SNY) for an MAA filing where visibility on approval would be a positive. 2. Afrezza post-approval study details as timelines have implications for label expansion. 3. Launch trajectory over the next 12 months.
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Post by lakers on Nov 30, 2015 20:33:37 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? Anecdotal evidence is not admissible for NEJM, Matt has said. You can dig it up. 2 recently completed studies were carried out in Germany for a reason...
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Post by lakers on Nov 30, 2015 20:18:50 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Sanofi wanted a better label before EMA MAA filing. When they do, they will notify Mnkd who in turn most likely will ... They are on track ... Don't be pigeon-holed in the U.S. only. The more countries the merrier. Imagine 12 countries of $20.84M annual rev each = $250M qualifying for the first $250M milestone. $$ bonus for $$ milestone. Bootstrapping process ... Centralised Health Care systems, not fragmented as PBMs in the U.S.
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Post by lakers on Nov 30, 2015 19:56:38 GMT -5
PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) clinicaltrials.gov/ct2/show/NCT02485327?term=SAR439065&rank=3This study has been completed.[ way ahead of Jan end 2016, the originally published FDA schedule] Sponsor: Sanofi Information provided by (Responsible Party): Sanofi ClinicalTrials.gov Identifier: NCT02485327 First received: June 25, 2015 Last updated: November 26, 2015Last verified: November 2015 History of Changes Responsible Party: Sanofi ClinicalTrials.gov Identifier: NCT02485327 History of Changes Other Study ID Numbers: PDY14329, 2015-001008-74, U1111-1168-4442 Study First Received: June 25, 2015 Last Updated: November 26, 2015 Health Authority: Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration Locations Germany Investigational Site Number 276001 Mainz, Germany, 55116Sponsors and Collaborators Sanofi Investigators Study Director: Clinical Sciences & Operations Sanofi Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus clinicaltrials.gov/ct2/show/NCT02470637?term=SAR439065&rank=1This study has been completed.[way ahead of Dec end 2015, the originally published FDA schedule]Sponsor: Sanofi Information provided by (Responsible Party): Sanofi ClinicalTrials.gov Identifier: NCT02470637 First received: June 10, 2015 Last updated: September 29, 2015Last verified: September 2015 History of Changes Locations Germany Investigational Site Number 276001 Neuss, Germany, 41460 Sponsors and Collaborators Sanofi Investigators Study Director: Clinical Sciences & Operations Sanofi Responsible Party: Sanofi ClinicalTrials.gov Identifier: NCT02470637 History of Changes Other Study ID Numbers: PDY14324, 2015-000231-33, U1111-1166-5431 Study First Received: June 10, 2015 Last Updated: September 29, 2015 Health Authority: Germany: Ethics Commission United States: Food and Drug Administration
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Post by lakers on Nov 29, 2015 2:22:09 GMT -5
Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence www.ncbi.nlm.nih.gov/pmc/articles/PMC2819898/pdf/ppa-4-001.pdfBarriers to adherence to MS treatment Disease-related factors A patient’s subtype of MS may influence their likelihood of adherence to therapy. One study, which followed 632 patients for a mean period of 47.1 months, found that adherence was poorer in patients with secondary progressive MS than in those with relapsing–remitting MS. The authors also noted that the patients with relapsing–remitting MS who stopped therapy were younger than those who remained on treatment, had higher levels of initial disability and more active disease, and were more likely to be female.11 Cognitive impairment and depression Cognitive impairment often results from MS,12 and may make it difficult for the patient to follow correctly the prescribed treatment regimen. Current MS therapies require regular administration, and impaired memory function may reduce the likelihood of timely administration. Additionally, despite efforts to simplify the injection process through the design of delivery technology, cognitive dysfunction could also impair correct injection technique. However, the impact of cogni- tive impairment on adherence to MS therapy remains to be clarified in studies. Depression is common among patients with MS, and may negatively affect adherence. A study of patients with MS initiating IFN beta-1b therapy found that 41% of patients reported new or increased depression within 6 months of starting treatment. Eighty-six percent of patients who received psychotherapy or antidepressant treatment continued therapy, compared with 38% of patients who received no treatment for depression (P = 0.003).13 Efficacy concerns Perceived lack of efficacy is one of the most commonly cited reasons for treatment discontinuation.8,11,14 The disease course of MS varies between patients, and while therapy is often effective, the individual patient may not fully under- stand the benefits of remaining on treatment. The effects of treatment may not become apparent immediately, which may in part explain the high discontinuation rates observed in the first few months of treatment. Additionally, the unpre- dictability of the disease course means it is impossible to predict how their MS would affect them were they not on treatment, so the true benefit of treatment in the individual patient is unclear. Some patients starting MS therapy tend to be overly optimistic about the benefits of therapy. Unre- alistic expectations have been shown to be highly predictive of premature discontinuation. Therefore, it is important that patients’ expectations are managed prior to treatment initiation.9,15 Importantly, if a patient does not adhere to the prescribed treatment regimen, they may experience poorer outcomes, lose faith in their treatment, and become even more likely to be poorly adherent. Adverse events AEs associated with MS therapy may also contribute to non- adherence to treatment regimens. The incidence of AEs asso- ciated with MS therapy tends to decrease the longer a patient is on therapy. Therefore, long-term adherence to treatment is more likely to be achieved if patients remain on treatment through the initial period when AEs can be particularly prob- lematic. Management strategies to minimize the impact of AEs are therefore imperative to preserve adherence. One of the most common AEs associated with IFN beta therapy is flu-like symptoms.16 These symptoms tend to appear early in the treatment course, then diminish in frequency and severity with increased time on treatment. For example, in the pivotal trial of sc IFN beta-1a, flu-like symptoms were reported by 69% of patients receiving IFN beta-1a over years 1 to 4, but by only 12% after up to 8 years of follow up.17,18 Injection-site reactions (ISRs) are another commonly reported AE associated with MS therapies. The incidence and severity of such reactions may vary between treatments.8 Injection-site necrosis can occur with IFN beta treatment, and is very rarely seen with glatiramer acetate.19–21 However, glatiramer acetate injection can sometimes cause lipoatrophy at the application site, leading to, sometimes permanent, disfigurement.22,23 Correct injection technique and rotation of injection sites can help to avoid ISRs.24 inconvenience and needle phobia Aside from the AEs associated with MS therapies, some patients also find the process of regular self-injection bur- densome, and adherence can be compromised as a result. Furthermore, physical disability and cognitive impairment resulting from MS can make self-injection and ability to comply with treatment regimens difficult.25 Needle phobia, which is experienced by up to 22% of the general population, can also be a significant barrier to self-administration of parenteral therapies among patients with MS.26 Studies in other therapy areas have shown that a complex regimen and frequent dosing schedule can be barriers to adherence.27 Currently, all first-line therapies for MS require parenteral administration weekly (in the case of im IFN beta-1a) or more frequently. In the case of glatiramer acetate,patients are required to inject daily. It may be speculated that patients with MS would be more adherent to drugs requiring less-frequent administration. Natalizumab is delivered via a monthly intravenous infusion. It could be argued that the dosing fre- quency and the fact that natalizumab is administered during a clinic visit could encourage adherence. Conversely, this route of administration may be considered inconvenient by some patients.
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Post by lakers on Nov 29, 2015 1:47:46 GMT -5
Pill or Inhaler soon to be out! www.friendswithms.com/pillinhaler.htmEarly Trial Results of Teva's Oral MS Drug Disappointing NEW YORK (Reuters Health) Sept 17 - Israeli drugmaker Teva Pharmaceutical Industries Ltd. on Monday announced that interim clinical trial results on an oral formulation of the company's approved injectable multiple sclerosis (MS) drug Copaxone (glatiramer acetate) has failed to achieve statistical endpoints. In early morning trading on the NASDAQ, shares of Teva dropped 5.98 to 61.07, a decline of almost 9%. According to Teva, an independent Data Safety Monitoring Committee (DSMC) has recommended that the trial still continue to completion, expected by October, due to the favorable safety profile of the drug. Henry McFarland, chairman of the DSMC, noted, however, that there was little chance that the final results of the study would differ from the interim results. Although disappointed, Teva executives said during a Monday morning conference call that they intend to continue pursuing an oral MS treatment. They added that since the early results of the oral Copaxone trial showed a trend for a treatment effect in favor of the higher dose, future studies of the oral formulation are expected to use much higher doses. Pill or Inhaler soon to be out! By Beth M. Mantz Of DOW JONES NEWSWIRES NEW YORK (Dow Jones)--Swallowing a pill or breathing through an inhaler is much easier and less painful than getting an injection. With that in mind, a number of drug companies - Teva Pharmaceutical ndustries Ltd. (TEVA), Schering AG (SHR), Biogen Inc. (BGEN) and Genzyme Corp-General Division (GENZ) - are racing to develop multiple-sclerosis treatments in these forms in the hope that the added convenience will win a big share of the potential $2.1 billion world-wide market. Currently, the only treatments available are injections like the weekly shot of Biogen's Avonex Valerie Millerick receives for her MS. Millerick, a 56-year-old nurse from Valley Cottage, N.Y., who founded and runs a $2-million-a-year dialysis services business, is eager for a pill or inhaler. "Oral medication wins out over injection every time," says Millerick. "Once there is an oral drug, the rest of the industry should just pack up their bags and go home." In MS, the body's immune system turns on itself. The disease attacks the nerves and brain and slowly strips away the protective sheath coating the nerves called myelin. Symptoms range from numbness and tingling to paralysis and blindness. Of the 350,000 Americans that live with this potentially crippling and nonfatal disease, 70% share Millerick's diagnosis: relapsing-remitting MS where the disease worsens in acute episodes and then recovers. While sufferers don't number in the millions, treating MS can be a lucrative venture. To date, Avonex leads the market reaping first-quarter world-wide sales of $220 million with more than half coming from the U.S. Another treatment, Betaseron, generated sales of $145 million for Schering and sales of $20 million for Chiron Corp. (CHIR) during the first quarter. Barred from sale in the U.S., Serono SA's (SRA) Rebif commanded $83 million in sales while Teva's Copaxone logged $74 million in sales during the first quarter. These medicines can stave off the frequency and severity of the neurological attacks in many relapsing-remitting MS sufferers. Some studies have demonstrated these drugs can trim the number of exacerbations by one-third. They may slow the disease, but they can't stop it, let alone repair the damage. "The ideal drug for relapsing-remitting MS is one that stops all relapses, prevents exacerbations and recovers disabilities," says Stephen Reingold, vice president of research at National Multiple Sclerosis Society. "We have nothing close to that." Injections Underused Neither are these injections ideal treatments. Various drawbacks limit their use to as few as 70,000 patients of the estimated 350,000 who could benefit from them. Some sufferers claim their illness does not warrant treatment. Many refuse therapy because they fear needles or they don't want to disrupt their lives with routine injections. Some patients begin treatment and then stop because of adverse side effects like rashes. Others want the medicine but their insurance either doesn't cover the injections or charges a higher copayment. However, an oral MS drug - even if it just matched an injectable's efficacy and safety - could improve the standard of care in treating MS and surmount these obstacles. Teva, Schering, Biogen, and Genzyme are hoping their oral or inhalable MS medications can capitalize upon the injections' shortcomings. Each anticipates its version will be the one to convert patients who refuse current medicines, says Salomon Smith Barney analyst Elise Wang. A pill or inhalant could be priced lower or might prompt managed-care companies to add these new MS medicines to the list of drugs they cover, adds Wang. Teva has made the most progress with a pill, a version of its current MS treatment Copaxone, or glatiramer acetate. The compound releases cells that block proteins called cytokines in order to suppress inflammation. The Israeli drug maker is halfway through tests comparing two dosage forms of the daily pill against a dummy pill in 1,650 relapsing-remitting MS patients around the world. Set to last 14 months, the "Copaxone Oral," or CORAL, study should enroll its last patient by this fall. Biogen does not intend to let its competitors eat into its Avonex market share and in fact hopes to leapfrog oral MS treatments. "A non-injectable form would provide a great advantage to our product, even if it already the market leader, and would help increase our market share even more," says Nancy Sinomian, senior director of medical research. The Cambridge, Mass., biotechnology company partnered with Inhale Therapeutic Systems Inc. (INHL), of San Carlos, Calif., to develop an inhalable version of Avonex, whose safety and tolerability in healthy volunteers are under examination in early-stage studies, slated to end in the third quarter. If those results are encouraging, Biogen aims to begin dosing and further safety tests early next year, and aggressively developing this version for currently approved for Avonex users, the relapsing-remitting MS sufferers. Betting On New Drugs Unlike some rivals, Schering is not betting on an oral form of its current treatment Betaseron because it does not believe an oral form of the beta interferon product would survive the stomach and intestines. Instead, the German drug maker is working on three different pills that would be at least as effective, if not more, than current therapies. It wants these pills to cut the frequency and severity of MS attacks by at least 30%, says Steffen Stuerzebecher, vice president of clinical development for central nervous system therapeutics. Its two most advanced projects are in phase II tolerance trials: Mesopram and an unnamed compound that block proteins spurring inflammation in the central nervous system. The third drug, a CCR1 antagonist that targets certain immune cell responses, is undergoing early-stage safety tests and should begin phase II studies by the middle of next year. Schering plans to wait for data from all three programs before proceeding to massive testing in relapsing-remitting patients. Genzyme, a relatively new player, is intent on creating an oral MS medicine that is significantly more effective than the treatments currently available. "I don't think Genzyme or (Chairman and Chief Executive) Henri (Termeer) are looking for incremental effect," says Frederic Vinick, senior vice president of drug discovery at the Cambridge, Mass. biotechnology company. "We want to see a definitive clinical event - a profound effect like 60% to 70% reduction in attacks or remissions within 12 to 18 months." With nearly six early-discovery and development projects in the queue, Genzyme is studying how these compounds may work alone or in combination to affect the various molecular pathways of the disease. Even if oral and inhalable MS drugs become blockbusters, many experts believe, injectable MS treatments will survive. They expect the most severely debilitated patients will receive the injections or MS sufferers, as a whole, will use a panoply of medicines including both orals and injections to fight the neurological disease on a variety of fronts. -By Beth M. Mantz, Dow Jones Newswires; 201-938-5287; brand.excellusbcbs.com/broker/downloads/Pharmacy_Forecast_January_EBCBS.pdfCopaxone® is number three on the health plan’s list of the most commonly prescribed specialty drugs. The generic version of once daily Copaxone, for patients with relapsing- remitting multiple sclerosis, is expected to enter the market in May 2014. Copaxone costs more than $35,000 per year per member. The health plan spends $34 million annually on Copaxone. The cost of Copaxone went up 9.9 percent in 2014, and the trend shows that it will continue to rise. Gleevec is number six on our list of most commonly prescribed specialty drugs. The generic version, which treats certain types of cancer, is expected to enter the market in January 2015. Gleevec costs more than $57,000 per year per member. The health plan spends more than $10 million annually on Gleevec.
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Post by lakers on Nov 26, 2015 18:37:53 GMT -5
www.google.com/patents/US20060099269Credit: peppy Pulmonary delivery of inhibitors of phosphodiesterase type 5 US 20060099269 A1 ABSTRACT Provided herein are compositions of 1) diketopiperazine salts of PDE5 inhibitors, and 2) DKP microparticles having a PDE5 inhibitors thereon, as well as methods for the pulmonary delivery of these compositions for the treatment of pulmonary hypertension and sexual dysfunction(s). Publication number US20060099269 A1 Publication type Application Application number US 11/210,709 Publication date May 11, 2006 Filing date Aug 23, 2005 Priority date Aug 23, 2004 Also published as CA2575684A1, 4 More » Inventors Wayman Cheatham, Andrea Leone-Bay, Marshall Grant, Per Fog, David Diamond Original Assignee Mannkind Corporation Export Citation BiBTeX, EndNote, RefMan [0049] In another embodiment of the present invention a method is provided for treating sexual dysfunction comprising delivering to the pulmonary system of a patient in need of treatment for sexual dysfunction, a DKP salt of a PDE5 inhibitor or DKP microparticles comprising a PDE5 inhibitor or a salt thereof. [0050] To treat a patient for sexual dysfunction, the patient simply inhales the composition of the present invention before erectile function is desired at the time of a sexual encounter in a pharmacologically active amount sufficient to achieve vasodilation. Physicians and pharmacologists of ordinary skill in the art are knowledgeable in titrating doses to obtain the amount sufficient to achieve the desired clinical endpoint. A pharmacologically sufficient amount of drug is a dose that achieves the desirable clinical endpoint but does not have a undesirable side effects at a level which would result in the cessation of treatment. Typical doses for the pulmonary drug delivery of the present invention can be from about 0.1 to about 100 mg, depending on the particular drug being used. Preferably the dose delivered to the alveolar surface is in the range of from about 0.5 to about 50 mg. Although conventional oral PDE5 inhibitor formulations do not produce efficacious, systemic concentrations of the drug until several hours after administration, an oral formulation that provides a rapid onset of action is nonetheless desirable as an alternative to pulmonary delivery. A rapid-acting formulation can be prepared by use of an agent, such as a DKP, that facilitates rapid drug absorption following oral administration. Thus, an oral dosage form containing, for example, a combination of FDKP and sildenafil, either as a salt or a physical mixture, can provide a rapid onset of drug action. [0051] Sexual dysfunction exists in many forms and can be classified into two classes, male sexual dysfunction and female sexual dysfunction. The most common form of male sexual dysfunction is erectile dysfunction. Female sexual dysfunction can be due to a variety of causes including, but not limited to, antidepressant-induced sexual dysfunction, sexual dysfunction secondary to multiple sclerosis, anorgasmia, low arousal, delayed orgasm, decreased vaginal engorgement, dyspareunia or infertility-induced sexual dysfunction. [0052] In one embodiment of the present invention, a method is provided for treating pulmonary hypertension comprising delivering to the pulmonary system of a patient in need of treatment for pulmonary hypertension, a DKP salt of a PDE5 inhibitor or DKP microparticles comprising a PDE5 inhibitor or a salt thereof. For treatment of pulmonary hypertension the patient would take a dose of 0.5 to 50 mg one to six times daily. The ability to administer a therapeutically active drug directly to the internal surfaces of the lung is particularly important to the pathology of pulmonary hypertension. As compared to systemic administration, pulmonary administration can provide a significant improvement and efficiency in the treatment of this life threatening disorder. [0053] Pulmonary hypertension is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life threatening. Symptoms of pulmonary hypertension include shortness of breath with minimal exertion, fatigue, chest pain, dizzy spells and fainting. When pulmonary hypertension occurs in the absence of a known cause, it is referred to as primary pulmonary hypertension (PPH). This term should not be construed to mean that because it has a single name it is a single disease. There are likely many unknown causes of PPH. PPH is extremely rare, occurring in about two persons per million population per year. [0054] Secondary pulmonary hypertension (SPH) means the cause is known. Common causes of SPH include the breathing disorders emphysema and bronchitis. Other less frequent causes are the inflammatory or collagen vascular diseases such as scleroderma, CREST syndrome or systemic lupus erythematosus (SLE). Congenital heart diseases that cause shunting of extra blood through the lungs like ventricular and atrial septal defects, chronic pulmonary thromboembolism (old blood clots in the pulmonary artery), HIV infection, liver disease and diet drugs like fenfluramine and dexfenfluramine are also causes of pulmonary hypertension. [0055] Many forms of pulmonary hypertension are suitable for treatment with the compositions of the present invention including, but not limited to, primary pulmonary hypertension (PPH), acute pulmonary hypertension, pulmonary arterial hypertension (PAH), pregnancy-associated hypertension such as preeclampsia, and persistent pulmonary hypertension of the newborn (PPHN).
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Post by lakers on Nov 26, 2015 17:11:03 GMT -5
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Post by lakers on Nov 26, 2015 15:57:41 GMT -5
There were execs who leaked Trade secret after leaving the company and signing NDA, non-competing agreement. They much less likely leak if still employed.
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8-K
Nov 26, 2015 12:57:18 GMT -5
via mobile
ricguy likes this
Post by lakers on Nov 26, 2015 12:57:18 GMT -5
As President, Chief Operating Officer and Director at MANNKIND CORP, Hakan S. Edstrom made $2,687,254 in total compensation. Of this total $748,846 was received as a salary, $647,003 was received as a bonus, $941,556 was received in stock options, $319,050 was awarded as stock and $30,799 came from other types of compensation. This information is according to proxy statements filed for the 2014 fiscal year. Hakan had a raise and more stock option, RSU when he was promoted to CEO. He has been quite expensive. BoD doesn't spend as a company on the verge of BK. www1.salary.com/Hakan-S-Edstrom-Salary-Bonus-Stock-Options-for-MANNKIND-CORP.htmlAs soon as a new, permanent CEO is announced, let's see if Hakan will be terminated immediately as Mnkd can't afford to pay at least another $3M total comp while still paying Hakan till 7/1/17. The 1 year 7 mos pay plus 2015 salary and avg of last 3 yrs bonus for 2015 is extraordinarily generous for a cash trapped company. If Hakan is still employed then he is kept for CTO reason. Some thought why not keeping him around b/c we'd pay him severance anyway. I think not. In most case the resigning CEO would have been shown the door for the sake of employee morale. Especially, he resigned when the boat was in a storm negotiating a passage to safety. No credible captain would voluntarily bails out at this time. He didn't resign for health reason. Investors forced BoD to disclose Steve Jobs' poor health since as a CEO his health would impact his company's performance. If Hakan had poor health, he wouldn't work until 7/1/17. Apparently, he was forced to resign. Some thought Hakan was kept to serve as a COO for Al. I think not. Juergen A. Martens, Ph.D. has been our Chief Operating Officer since January 2015 and, before that, was our Corporate Vice President of Operations and Chief Technology Officer since September 2005. From 2000 to August 2005, he was employed by Nektar Therapeutics, most recently as Vice President of Pharmaceutical Technology Development. Previously, he held technical management positions at Aerojet Fine Chemicals from 1998 to 2000 and at FMC Corporation from 1996 to 1998. From 1987 to 1996, Dr. Martens held a variety of management positions with increased responsibility in R&D, plant management, and business process development at Lonza, in Switzerland and in the United States. Dr. Martens holds a bachelor’s degree in chemical engineering from the Technical College Mannheim/Germany, a bachelor’s and master’s degree in Chemistry and a doctorate in Physical Chemistry from the University of Marburg/Germany. Joseph Kocinsky is our Senior Vice President of Technical Operations and Chief Technology Officer. Mr. Kocinsky has over 28 years experience in the pharmaceutical industry in technical operations and product development. Prior to joining MannKind in 2003, he held a variety of technical and management positions with increased responsibility at Schering-Plough. Mr. Kocinsky holds a bachelor’s degree in Chemical Engineering and a master’s degree in Biomedical Engineering from New Jersey Institute of Technology and a master's degree in Business Administration from Seton Hall University. There would be a SH revolt in an annual SH meeting if Hakan being kept around that long and weren't for CTO reason. I empathize with SH when we are so called "on the verge of ...". How does Matt claim the burn rate will be kept $8-$10M per month if Hakan is around till 7/1/17 and another $3M annually at least for the new CEO? CTO: Afrezza Confidential Treament Order filed with SEC in 2014 to keep 3 Exhibits redacted and secret until after 11/10/17.
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Post by lakers on Nov 25, 2015 23:59:29 GMT -5
At this juncture, Mnkd needs a CEO with different skill sets, especially negotiation skill, and authority. Al has that. It may be early to judge whether Afrezza deal is a raw deal or not as CTO obfuscated many details. One mysterious milestone has no title, type, $$$. The Buy In/Out detail was redacted. Interestingly, CTO expires 11/10/2017, 4.5 mos after Hakan's service ending 7/1/17 indicating an air tight gag order for something extraordinarily important such as a mysterious joint dev, or Buy In/Out based on certain milestones, CRVs.
Mnkd BoD must have consulted Sanofi before deciding to retain Hanka's service that extraordinarily long. This indicated Sanofi and Mnkd can't afford to leak CTO.
IMHO, Hakan made a poor judgment by committing to a deal before EOY. He might have been scorned by Matt. Hakan then quickly added "or 1Q16". In negotiations, when you need it more than the potential partners, do not announce a deadline to the public b/c it undermines your leverage as they know mgmt would be subject to SH law suit if that won't materialize. Al had no choice but took over.
Back in May, Matt seemed so cavalier saying that Mnkd might have enough cast to pay off $100M Notes. Moreover, mgmt didn't have a sense of urgency about the cash balance or how to fund TS pipeline. Mgmt must have thought deals were imminent.
Ironically, to avoid another SH law suit, Al has to close deals in the timeline dictated by his subordinate. As a deal making veteran, Al felt boxed in. He had to take over to prevent future mishaps.
Al is not entirely irreprehensible as he knows Hakan and Matt better than anyone else. Hakan is a decent COO but the CEO job was beyond his league. I didn't feel Hakan qualified. Al rewarded loyalty for the CEO job. He must have been overconfident that Afrezza would be launched smoothly out of the gate. Afrezza is Al's first drug gig. He underestimated what it took and BP's, shorts' resolve to kill Afrezza.
Al put all eggs in one basket. He should have pumped more money into Mnkd to dev TS pipeline concurrently instead of suspending them and laying off developers. He should know drug dev is very time consuming.
Afrezza superior study should have been started last year right after the Sny deal.
Many asked why mgmt didn't raise fund when pps was in double digits. The simple answer was everyone thought Afrezza would be a BB out of the gate. Apparently, they repeat the same mistake as another drug. The pre-launch mkt research mgmt conducted about Afrezza was faulty. You can't say you didn't anticipate the spirometer, mkt access, pricing, conservative MDs considering that Sny has launched many drugs and knew about the other drug debacle.
To be fair it's 90% Al's, 10% Hakan's culpability. Al was the one who recruited, groomed, and promoted Hakan. He must know Hakan's limitation. I chalk it up as Al's lesson learned as he was an amateur in drug biz.
Al has had more experience in device than drug biz. Ditto his deal making expertise.
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Post by lakers on Nov 25, 2015 20:01:09 GMT -5
It just seems bizarre to think he gets promoted for a year, then gets 2 years additional pay at that job level. So 3 years of pay for 1 year of service. That's not a very good plan ha. The arrangement aims at hard-blocking him from joining a competitor as he knew so much about TS pipeline dev and negotiation, and Afrezza CTO which expires after 7/1/17. BoD likely conferred w/ Sanofi who requested that strange arrangement. "Mr. Edstrom would provide the Company with a general release of claims and remain employed with the Company to provide transition and other services through July 1, 2017, subject to his earlier resignation or termination by the Company" UNITED STATES SECURITIES AND EXCHANGE COMMISSION December 15, 2014 ORDER GRANTING CONFIDENTIAL TREATMENT UNDER THE SECURITIES EXCHANGE ACT OF 1934 MannKind Corporation File No. 000-50865 - CF#31824 _____________________ MannKind Corporation submitted an application under Rule 24b-2 requesting confidential treatment for information it excluded from the exhibits to a Form 10-Q filed on November 10, 2014. Based on representations by MannKind Corporation that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibits will not be released to the public for the time periods specified: Exhibit 10.1 Exhibit 10.2 Exhibit 10.3 through November 10, 2017 through November 10, 2017 through November 10, 2017 For the Commission, by the Division of Corporation Finance, pursuant to delegated authority: Brent J. Fields Secretary
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