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Post by mannmade on Sept 5, 2018 18:05:17 GMT -5
True, but I would rather have us put more effort in getting epinephrine out sooner. not sure Epi is best. Liane as a doctor would know more, however as much as I hate needles I am not sure how well inhaling would work when your throat is closing up on you. Just my opinion.
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Post by mannmade on Sept 5, 2018 18:09:52 GMT -5
I once mentioned to Matt P mnkd should try seeing if 5hr Energy would work. Not only would it be faster there would not be the awful taste.
I also mentioned aspirin in a cricket for key chains as a faster way to prevent heart damage when having a heart attack. Am not a doctor but both seems practical and commercially marketable on a mass scale at decent price points.
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Post by liane on Sept 5, 2018 18:18:07 GMT -5
True, but I would rather have us put more effort in getting epinephrine out sooner. not sure Epi is best. Liane as a doctor would know more, however as much as I hate needles I am not sure how well inhaling would work when your throat is closing up on you. Just my opinion. If someone still had a patent airway, this would be a great application. And a person might be inclined to self administer it sooner if it doesn't require an injection. But I would think you would still want an auto-injector just in case.
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Post by wgreystone on Sept 5, 2018 18:39:04 GMT -5
A good candidate would ideally meet the following two criteria: 1) frequent use, 2) fast-in fast-out. Viagra seems like a good candidate. With fast absorption, lower dosage may work as well.
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Post by wgreystone on Sept 5, 2018 18:45:29 GMT -5
True, but I would rather have us put more effort in getting epinephrine out sooner. The clinical trial for Epi-hale is difficult to design, how to design a trial that can prove patients with life-threatening allergy reaction can inhale enough powder to stop it?
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Post by brotherm1 on Sept 5, 2018 20:27:03 GMT -5
Simple, feed them peanuts, shell fish,... pay extra to those allergic to and willing to be stung by bees, etc. 🤓
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Post by peppy on Sept 5, 2018 20:45:26 GMT -5
A good candidate would ideally meet the following two criteria: 1) frequent use, 2) fast-in fast-out. Viagra seems like a good candidate. With fast absorption, lower dosage may work as well. UTHR has Tadalafil Brand name: Cialis Lasts longer. The "nil" the vaso dilators. The "fil" the viagra, cialis stuff. good love it. www.unither.com/products.html
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Post by mytakeonit on Sept 5, 2018 21:22:17 GMT -5
Okay ... tell UTHR to throw in another 50M and we'll do it.
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Post by bundy on Sept 5, 2018 21:30:39 GMT -5
Yup I think Mike set a great rate and did some great negotiating 40m +royalties for everything else to follow sounds great!
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Post by mytakeonit on Sept 5, 2018 21:40:00 GMT -5
Easier, but not faster onset. Something doesn't seem right if this is a woman's point of view. "Wait darling, let me get my inhaler." And, because faster onset also has a faster exit the body finish. Most women I know like ... www.youtube.com/watch?v=dbk29JZdl5A
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Post by mango on Sept 6, 2018 0:32:22 GMT -5
True, but I would rather have us put more effort in getting epinephrine out sooner. The clinical trial for Epi-hale is difficult to design, how to design a trial that can prove patients with life-threatening allergy reaction can inhale enough powder to stop it? MannKind will not be required to do a clinical trial like that because MannKind is basically developing a generic version of inhaled epinephrine, and essentially only needs to meet the FDA requirements for generic drug approval—stuff like pharmaceutical equivalency, bioavailability and bioequivalence, manufacturing capabilities, excipients/inactive ingredient safety data, stability studies, safety data etc. Inhaled epi is already FDA approved so it is gonna be pretty straight forward process for MannKind. As far as outcomes with inhalation via EpiHale vs intramuscular via EpiPen...I have no doubt at all that MannKind’s formulation reaches plasma concentrations needed for hemodynamic stabilization much quicker than Epipen. Probably in just one or two painless inhalations. Intramuscular administration is certainly faster than subcutaneous, but still much slower than intra-arterial administration. There is MannKind patent with some epinephrine performance studies, looks very promising and would probably be a life saver for decades to come. Something to keep in mind is that MannKind inhalers are every bit as revolutionary as Technosphere technology. MannKind inhalation devices function with a diverse range of dry powder formulations, and their performance is the same in navigating the anatomical airway. It is this synergy produced by MannKind's inhalation devices and Techosphere dry powder formulations that is so revolutionary. Watch this video of Chad Smutney in the MannKind Device Laboratory, it will blow your mind.
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Post by mytakeonit on Sept 6, 2018 1:47:09 GMT -5
Thinking about it further ... UTHR also didn't do an inhaled cialis because it didn't make sense to them also. Of course they are established and have the plant cranking it out ... but, to take a pill ahead of time and not doing an inhaler ... yeah, I think we shouldn't do an ED inhaler. But, that's mytakeonit ...
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Post by lakers on Sept 6, 2018 2:42:53 GMT -5
But overall, out of the 45 molecules we have developed, our 43 have been successfully developed. So we feel very good. We have everything from migraine to depression to nausea and vomiting. So we have quite a few these already formulated that we will now go through and figure out what's in the filter, which ones do we want to move forward now that we have gotten Technosphere with treprostinil behind us, we will be moving a couple of additional ones forward.
So bridging to the pipeline. We talked about pulmonary hypertension, a large market. Our deal with United Therapeutics gives them exclusivity on pulmonary hypertension. We have excluded a couple of categories within that. But we are moving another drug within that category down into powder formulations.
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Post by lakers on Sept 6, 2018 3:08:42 GMT -5
The followings shed some light on potentially additional R&D work with UTHR. Let’s now transition to our product pipeline, which currently consists of numerous investigational programs including therapies for PAH and other forms of pulmonary hypertension, innovative drug delivery devices, gene therapy and oncology. We will also continue to work on technologies to ultimately create an unlimited supply of tolerable, transplantable manufactured organs for those who suffer from end-stage organ disease. In addition to these drug delivery devices, let me update you on our seven ongoing Phase III clinical trials. We have two Phase III clinical trials in PAH, Freedom-EV and Beat, and are still expected to unblind in the near term time frame. Freedom-EV is the study of Orenitram in combination with other therapies in treating PAH. Beat is the study of two drugs in combination, Tyvaso, an inhaled prostacyclin analog, and Esuberaprost, an oral prostacyclin analog. This study represents a novel approach to treating PAH with the delivery of prostacyclin therapy from both the airway side using Tyvaso and systemically using Esuberaprost. If both of these clinical trials are successful, we will have two therapies to address morbidity and mortality in PAH and potentially extend survival for PAH patients. We expect this to result in a greater number of patients living longer and receiving our therapies, further supporting our long term revenue growth. We have three clinical trials in just pulmonary hypertension, which includes Increase, Perfect, and Southpaw, and all three of these are currently enrolling patients; in fact, the Increase clinical trial is now over 50% enrolled. These three clinical trials are for pulmonary hypertension indications that do not have any FDA approved therapies with patient populations significantly larger than the current estimated treated PAH population of only 40,000 patients in the U.S. Lastly, our Sapphire gene therapy clinical trial for pulmonary arterial hypertension and our Distinct clinical trial with dinutuximab for small cell lung cancer continues to progress and enroll patients; in fact, the Distinct clinical trial in lung cancer is now over 50% enrolled. These seven ongoing Phase III clinical trials as well as our other R&D programs are expected to sustain our revenue growth in the near and medium term. Longer term, we are working very diligently to drive further revenue growth through R&D programs that are currently underway to develop technologies in the nascent field of organ manufacturing. we have a future growth strategy that fully contemplates our expectation for the generic entry of Adcirca as well as generic versions of Remodulin later this year. [That’s why they need Trep-T] seekingalpha.com/article/4193068-united-therapeutics-uthr-ceo-martine-rothblatt-q2-2018-results-earnings-call-transcript
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Post by lakers on Sept 6, 2018 3:38:32 GMT -5
Teva or Helsinn could partner with Mnkd for Inhaled palonosetron.
Buffett surprised the market with a big bet on flailing pharma giant Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) back in Q417. He gobbled up 19 million shares in TEVA, worth about $358 million. Since then, Buffett hasn’t stopped buying.
He picked up a further 21.6 million shares in Q1. And now for Q2 we see another 6% boost to his position (with 61 million shares). This takes his total bet on TEVA to a staggering $1.05 billion.
Under its new management team, a $1.03-per-share profit was turned in the first quarter of 2018, and projections for full-year profitability were also given. Teva also said it is on track to save $1.5 billion in expenses this year and $3.0 billion by the end of 2019. That's a big number considering trailing-one-year revenues are just shy of $22 billion.
Thus, it would appear that the scandal-ridden drugmaker is on a clear path to recovery, at least when it comes to shoring up the bottom line. But what about those declining generic prices? Revenues were down 10% in the first quarter compared to a year ago, but the expectation is that pricing pressure will begin to ease later in 2018. Plus, Buffett's bet on Teva seems to jive with Berkshire's team-up with Amazon and JPMorgan Chase to create a company to help lower the cost of healthcare in America. With those powerful names looking to disrupt the status quo, Teva could be a big beneficiary in the years ahead.
Teva Announces the Launch of a Generic Version of ALOXI® in the United States. JERUSALEM --(BUSINESS WIRE)--Mar. 23, 2018-- Teva Pharmaceutical Industries Ltd. , (NYSE: TEVA) today announced the launch of a generic version of ALOXI®1 (palonosetron HCI) injection, 0.25 mg/5 mL, in the United States .Mar 23, 2018
About Chemotherapy-Induced Nausea and Vomiting (CINV)
Research has shown that patients with cancer consider CINV among the most dreaded side effects following therapy. Despite prophylactic antiemetics, on the day of chemotherapy, about 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of moderately emetogenic chemotherapy. Failure to control acute nausea and vomiting on the first day of chemotherapy will increase the risk of nausea and vomiting on subsequent days and in subsequent cycles of chemotherapy.
Eisai licensed the North American distribution and marketing rights for ALOXI from Helsinn Healthcare SA. About HELSINN HEALTHCARE SA
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of palonosetron. HELSINN's core business is the licensing of pharmaceuticals in therapeutic niche areas. The company's business strategy is to in-license early stage new chemical entities and complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). HELSINN's products are eventually out-licensed to its marketing partners for distribution. The active pharmaceutical ingredients and the finished dosage forms are manufactured at HELSINN's cGMP facilities and supplied worldwide to its customers.
HELSINN‘S and Mnkd’s biz model are similar.
Mundipharma brings its cancer supportive care expertise to Vietnam after signing agreement with Helsinn Group for ALOXI® (palonosetron HCl) 15th August 2018
Mundipharma and Helsinn Group expand exclusive licensing and distribution agreement for anti-emetic medicine ALOXI® This agreement builds on similar existing arrangements in a range of territories. SINGAPORE and LUGANO, August 15, 2018: Mundipharma and Helsinn Group signed a licensing and distribution agreement for the anti-emetic agent ALOXI® in Vietnam, extending an international collaboration.
ALOXI®(palonosetron hydrochloride), a 5-HT3 receptor antagonist was approved in Vietnam. For additional information please see the Product Information.
Chemotherapy-Induced Nausea and Vomiting (CINV) is one of the most common and distressing side effects of cancer chemotherapy. Mundipharma and Helsinn are experts in the CINV field with decades of shared experience and are currently providing medicine to CINV sufferers.
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