|
Post by lakers on Sept 15, 2018 16:44:19 GMT -5
The STAT Study has been published online in Diabetes Technology & Therapeutics. NEJM, Lancet have huge influence. Any plan to publish STAT on them or any other influencers? Do you plan to advance any of : Tacrolimus, PDE5 Inhibitors, Vancomycin, Linezolid, Amphotericin B ? MC: Yes we will be moving several forward. Stat will be avail for free any day if it’s not already. It’s free at www.liebertpub.com/doi/10.1089/dia.2018.0200
|
|
|
Post by lakers on Sept 15, 2018 14:30:22 GMT -5
The most common types of infections caused by MRSA are skin and soft-tissue infections, bacteremia, infective endocarditis, pneumonia, and osteomyelitis.2 Per current guidelines, oral antimicrobials for the treatment of mild-to-moderate MRSA skin infections include trimethoprim/ sulfamethoxazole, clindamycin, doxycycline, minocycline, and linezolid.
Alternatively, vancomycin tends to be the most common intravenous (IV) agent for empiric coverage of a potentially serious MRSA infection.1 Serious infections caused by MRSA have a high morbidity and mortality, with estimates for mortality as high as 30% to 37% with endocarditis.1 Treatment durations for MRSA infections can vary widely based on the site and source of infection.
|
|
|
Post by lakers on Sept 13, 2018 21:29:54 GMT -5
A short sale pitch, the rep can remember. So can docs.
MannKind Says Afrezza Shows 'Greater Improvement' in Insulin Control vs Insulin Aspart
1:12 PM 9/13/2018 - MT Newswires 01:12 PM EDT, 09/13/2018 (MT Newswires) -- MannKind (MNKD), a developer of inhaled therapeutic products, reported Thursday new clinical data for Afrezza in type 1 diabetes which showed "significant" improvement in postprandial glucose control than insulin aspart.Compared to standard of care for mealtime therapy, the per-protocol use of Afrezza demonstrated significantly increased glucose TIR by approximately two hours per day, significantly reduced time in hyperglycemia, significantly lower PPGE one to four hours post-meal, significant reductions in glucose as early as 60 minutes following dose, and less hypoglycemia.
|
|
|
Post by lakers on Sept 13, 2018 16:24:52 GMT -5
Preliminary positive safety data in MannKind’s Phase 1 clinical study (NCT03464864) showed that treprostinil was safely delivered at varying doses using the Technosphere inhalation device. The trial, which started enrolling patients in March, is still recruiting participants to advance the TreT clinical program. As part of the agreement, MannKind will receive an immediate payment of $45 million from United Therapeutics and potential milestone payments of up to $50 million, depending on the results of specific development goals. During the initial phase, MannKind also will receive royalties from the commercialization of the product. The agreement includes the opportunity for United Therapeutics to expand the license to other active ingredients [Tacrolimus, PDE5 inhibitors likely] for the treatment of pulmonary hypertension, with a price of up to $40 million, as well as royalties, per product added to the license. The companies will seek products outside the scope of the licensing and collaboration agreement. For this purpose, MannKind will receive an upfront payment of $10 million to advance research for new therapies. According to Martine Rothblatt, PhD, chairman and CEO of United Therapeutics, “as we now move into the second generation of United Therapeutics products, we are proud to once again team with Al Mann’s brilliance, this time with his Dreamboat, Bluhale and Cricket devices for inhalation.” Rothblatt is very confident on the success of the TreT clinical program. “These revolutionary new inhalation devices” she said, represent a “further step toward a next generation of treprostinil drug-device systems that enhance options for patients, their families and their prescribers.” pulmonaryhypertensionnews.com/2018/09/06/united-therapeutics-and-mannkind-team-up-to-advance-pulmonary-hypertension-therapy/?ampMeet 2 TS PAHs: Tacrolimus, Treprostinil+PDE5 inhibitor mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor#ixzz5QGQ8Oo4Q
|
|
|
Post by lakers on Sept 9, 2018 14:28:57 GMT -5
seekingalpha.com/article/4204322-mannkind-corporation-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-20th-annual-globalCompatibility with diverse API. So we do look at small molecules and peptides. I want to say we can go to 150,000 Da or pretty large molecules. We are starting to think about vaccines as well as other local drugs for local effects. So when you think about the company, think about Technosphere as a platform in terms of what that can do to bring additional pipeline molecules forward and our partnerships forward. There is quite a few partners I have talked over the last year. We did some work back with Locust Walk and we have learned a lot through that process. So we will start to see Technosphere lot more. 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. bucket one turns out to be one of the easiest. It really is known compounds already delivered to the lung. We met with FDA. We saw very clear feedback in terms of the pathway to approval. Limited to no clinical work and really a program that looks at Phase 1 dose finding bioequivalency. So a very efficient program to develop and not a lot of concerns when the drugs are delivered to the lung. You don't have to worry about the dosing as much. And in that particular one, we were looking at the higher end dose saying, can we achieve higher therapeutic levels than we have seen with other Treprostinil relay programs and that was the unmet need we were trying to solve for in addition to the convenience factor. One is a reusable Dreamboat family of inhalers. We have worked on these for a long time. Lots of IP around the inhalers and manufacturing of them. And we have a single use Cricket family which are disposable and are single use inhalers. So when we look at these, I think about acute conditions, anxiety, erectile dysfunction, things that you are going to want immediate response like epinephrine where you can use it and throw it out and not worry about it. Our main focus today is on the Dreamboat. That's the one that we got Afrezza approved on and we are also using that in our pivotal trials for as we go forward with Treprostinil and Receptor Life Sciences as well. $10 million upfront research and development collaboration where we will now advance another molecule that's not named into development immediately. So really looking to continue to invest in the Technosphere platform as we go forward as a company. 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.
|
|
|
Post by lakers on Sept 9, 2018 13:55:53 GMT -5
SO answer to hammer: If the company had also announced that it sold off Afreezza for $50-$75 million in exchange for a manufacturing contract and a low double-digit royalty, and was returning to an R&D platform, the stock selloff after the rise to $3 would have been minimal. In fact, the rise could have been much more substantial. The company would be in a position to finish the year with over $100 million in cash, would have massive savings on the $15 million per quarter marketing expense, would have the cash to handle Deerfield, and would be in a position to commit substantial dollars to R&D. Alas that is not where we are. This is why we did not see $5 on the run up, will not see $15 by the end of the year, and will not see $20 by the end of Q2 next year. Those types of numbers are for a different kind of MannKind. The play here still rests with traders, as there are several binary events to consider. 2018 positive binary events are as follows: Announce FTC acceptance of United Therapeutics deal (end of September). Announce a filing for approval in Mexico. Announce a filing for approval in Canada. Approval in Brazil. Announce exercising of warrants. Announce new partner for Afrezza. Negative binary events: Adjust guidance downward. Slow stock price that allows warrants to be played on the short side (perhaps multiple times) any time the equity rises above $2.38. A new authorization for additional shares at the wrong time. Afrezza sales that remain at the current low trajectory. Liquidia announces a deal that is better than MannKind got (unlikely). Investors should still have some caution, and should not get overweight this stock. This is a buy between $1.00 and $1.50. It is a speculative buy in the $1.50 to $2 range. It tends to sell off any time the market cap gets above $300 million. Be aware of that. Improved finances could bring the selloff point to $400 million or even $500 million, but some improvements in the balance sheet or in Afrezza sales are needed to bring that condition closer to reality. seekingalpha.com/article/4205110-mannkind-afrezza-scripts-close-august-600-growth-neededMC: remember, we can always cut costs at the end of the day if we don't think Afrezza is the drug to bet on. But we do know the upside on Afrezza is lot way higher than the downside for the company. So we will continue to invest to grow our lead brand here and make it successful. seekingalpha.com/article/4204322-mannkind-corporation-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-20th-annual-global
|
|
|
Post by lakers on Sept 8, 2018 16:46:59 GMT -5
Next up is Cantor Fitzgerald Global Healthcare Conference on Tuesday, October 2, 2018 at 1:40 pm (ET) at the Intercontinental New York Barclay Hotel in New York City
MC:
Yes we will bring clarity on pipeline soon.
|
|
|
Post by lakers on Sept 8, 2018 14:02:49 GMT -5
|
|
|
Post by lakers on Sept 7, 2018 2:21:46 GMT -5
Deerfield can convert some of their debt to shares above $1.80 a share.
|
|
|
Post by lakers on Sept 6, 2018 23:52:05 GMT -5
www.google.com/amp/s/www.newstimes.com/business/amp/MannKind-enters-into-45M-agreement-to-treat-PAH-13202961.php“Danbury is stable and that’s important,” he said. “We’ll continue to be an employer in Danbury and we’ll add jobs.” Castagna said the agreement is a “validation of our platform,” He said the agreement gives MannKind enough cash flow to pay off debt and reach the break-even point. “This doesn’t solve all of the company’s problems, but it helps with the debt problem,” he said. “Now we have money and we’ll continue to raise more.” MannKind granted United Therapeutics an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension. Each optioned product would be subject to the payment to MannKind of up to $40 million. MannKind will also receive $10 million in a research agreement for products outside the scope of the PAH agreement.
|
|
|
Post by lakers on Sept 6, 2018 15:38:12 GMT -5
The folowing shows Tobra-T potential in Bucket-1. Chiesi USA or Dr. Reddy could partner w/ Mnkd. Tobramycin is a type of inhaled antibiotic prescribed for people with cystic fibrosis who develop a Pseudomonas aeruginosa infection. P. aeruginosa is a bacteria that can cause infections in the lungs of people with weakened immune systems, as is the case with CF patients. Tobramycin is commercialized as an inhalation solution under the brand names TOBI and Bethkis, or as inhalation dry powder under the brand name TOBI Podhaler.The antibiotic is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted for administration by a compressed air, reusable nebulizer. According to the Cystic Fibrosis Foundation (CFF), antibiotics are an important part of the treatment plan for CF patients, due to the high prevalence of respiratory infections from agents like P. aeruginosa. Trobramycin was first approved to treat these infection in 1997 under the brand name TOBI by Novartis, and in 2002 as Bethkis by Chiesi USA. Dr. Reddy acquired Tobramycin Inhalation Solution (generic equivalent to Tobi™) from Teva. in 2016.newsroom.mylan.com/press-releases?item=123592Mylan Statement: Novartis TOBI Podhaler® and TOBI® Solution Agreement: We are pleased to confirm that on Aug. 31, 2018, Mylan closed an agreement with Novartis to purchase the worldwide rights to commercialize their global cystic fibrosis products consisting of TOBI Podhaler® and TOBI® solution, which will further enhance Mylan’s respiratory portfolio in the U.S., Europe and certain Rest of World markets. The transaction was subject to customary closing conditions, including antitrust clearances, and certain pre-closing confidentiality restrictions. Our financial disclosure related to this transaction was included in our second quarter 2018 Form 10-Q, in which we stated that Mylan entered into the agreement on July 30, 2018, for approximately $463 million and the company expects to pay approximately $240 million in 2018.Triangle Business Journal names Chiesi as one of 50 winners of 2018 Best Places to Work awards. globenewswire.com/news-release/2018/08/22/1555047/0/en/Chiesi-USA-Inc-Named-a-Best-Place-to-Work.htmlCINV Existing and Pipeline Drugs Market is Expected to Post a CAGR of 5.7% Between 2014 and 2020 Nirav Gokani September 5, 2018 dailyindustryreports.com/cinv-existing-and-pipeline-drugs-market-is-expected-to-post-a-cagr-of-5-7-between-2014-and-2020/36873/This market is anticipated to reach an evaluation of US$1.88 bn by 2020. CINV Drug: Aloxi (palonosetron), Zofran generic (ondansetron), Kytril generic (granisetron), Emend (aprepitant) and Akynzeo (netupitant-palonosetron FDC). It is expected that in the years to come two new drugs will be introduced. They are: rolapitant and SUSTOL (APF-530). The patent expiry of leading drugs such as Emend, Aloxi, and others is expected to negatively impact the revenue of CINV. Generic manufacturers are: Barr Laboratories, Inc., Baxter Healthcare, Sun Pharma, Teva Pharmaceuticals, Mylan Pharmaceuticals, Inc., Sandoz (Novartis AG), and Orchid Healthcare. Some of the other important companies within the global chemotherapy induced nausea and vomiting drugs market are: Heron Therapeutics, Inc., Helsinn Holding S.A., Merck & Co., Inc., GlaxoSmithKline plc, and Tesaro, Inc.
|
|
|
Post by lakers on Sept 6, 2018 14:02:10 GMT -5
|
|
|
Post by lakers on Sept 6, 2018 13:35:55 GMT -5
1/12/2017, I wrote: Progressing pipeline forward with a focus on strategic partnerships [upfront money plus royalty]. As I often said Mnkd wouldn't go alone. Is it clear enough now? Initial clinical eval criteria
Aero performanceAmbient temp stabilityEpiHale: 2 formulations have been eval'ed Both met performance. PK profiling underway Successful meeting w/ FDA in Dec 2016 PAHale: Tresprostinil, 6 formulations have been eval'ed 4 met performance, moving to PK profiling Additional formulation dev on all 4 continuing in 2Q17 CINV: Palonosetron, 2 formulations have been eval'edBoth showed aceptable aero, will require additional work to improve Ambient temp stabilitymnkd.proboards.com/thread/6408/mnkd-state-union?q=palonosetron9/11/2017, Sports wrote: "MannKind Corporation's (MNKD) CEO Michael Castagna Presents at Rodman & Renshaw 19th Annual Global Investment Conference (Transcript) $MNKD www.seekingalpha.com/article/4105856Bucket-3 and 4, we’re just not in a position to fund these and we’re not going to be targeting these, but these will be available for partnering and moving them forward; known compounds non-drug delivery chronic use and Bucket-4 new NCEs [New Chemical Entity]. So when you take all the programs we’ve worked on, we put them in the buckets. You see Trepostinil, Epinephrine, Tobramycin here in Bucket-1 and then Bucket-2 a lot of short-acting products, oxytocin and glucagon are two that look -- importantly, we’ve worked with on oxytocin and glucagon as one that we get a lot of feedback from our doctors that say, if you can get me inhale Palonosetron or glucagon, especially with AP system, this is important. So we’ve redefined what we’re focused on from an R&D perspective. And then what’s most important obviously in any pharmaceutical company as IP. We have over 780 patents in this product protecting after the 2030s. So this isn’t something that worries us in the near-term. And personally I can tell you I haven’t worked in biosimilars on and off over 10 years in order to make a copycat of this, it’s extremely hard to us, there has no generic today and you got to get this solution right, you got to get the particle size right, you got to get the inhaler and then you got to match the insulin. So there is a lot of work for someone to make copycats of this type of thing. So we feel pretty confident in there." Like all aminoglycosides, tobramycin does not pass the gastro-intestinal tract, so for systemic use it can only be given intravenously or intramuscularly. Ophthalmic (tobramycin only, Tobrex, or combined with dexamethasone, sold as TobraDex) and nebulised formulations both have low systemic absorption. The formulation for injection is branded Nebcin. The nebulised formulation (brand name Tobi) is indicated in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in patients diagnosed with cystic fibrosis. A proprietary formulation of micronized, nebulized tobramycin has been tested as a treatment for bacterial sinusitis.
Tobrex is a 0.3% tobramycin sterile ophthalmic solution is produced by Bausch & Lomb Pharmaceuticals. Benzalkonium chloride 0.01% is added as a preservative. It is available by prescription only in the United States and Canada. In certain countries, it is available over the counter. Tobrex and TobraDex are indicated in the treatment of superficial infections of the eye, such as bacterial conjunctivitis. Tobramycin (injection) is also indicated for various severe or life-threatening gram-negative infections: meningitis in neonates, brucellosis, pelvic inflammatory disease, Yersinia pestis infection (plague). Tobramycin is preferred over gentamicin for Pseudomonas aeruginosa pneumonia due to better lung penetration.
|
|
|
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.
|
|
|
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
|
|