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Post by lakers on Sept 28, 2018 2:12:43 GMT -5
MC said Mnkd will be moving several forward. I expect a major pipeline update. My Bucket 1 conjecture follows. Tacrolimus: Lung Transplant, PAH PDE5 Inhibitors: Adcirca (Tadalafil) TrepT+PDE5 Inhibitors Vancomycin: Bacteria Lung infection with MSRA Linezolid: Infection with VRE, MSRA Amphotericin B: Pulminary Aspergillosis Xellia also reported progress on the development of its pipeline of value-added anti-infectives. Its Premixed Vancomycin is a novel liquid dosage form of vancomycin in a ready-to-use infusion bag, and was recently granted QIDP designation from the US Food and Drug Administration (FDA). A new drug application (NDA) submission for this product to the FDA is anticipated during 2018. Xelia is also beginning to expand its US commercial organisation as it prepares for the launch of this and other original anti-infective drug products. QIDP designation is granted under the Generating Antibiotic Incentives Now (GAIN) Act in the US and provides certain incentives for the development of antibiotics that include priority review and eligibility for fast-track designation.
PRV can be sold for $110M-$350M
Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz5SNfczSVo
TobraT 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. Mylan entered into the agreement on July 30, 2018, for approximately $463 million and the company expects to pay approximately $240 million in 2018. Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5SNcuVheECINV: Palonosetron, 2 formulations have been eval'ed Both showed aceptable aero, will require additional work to improve Ambient temp stability Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5SNdVonbuThe patent expiry of leading drugs such as Emend, Aloxi, and others is expected to negatively impact the revenue of CINV. Since the 1950s, amphotericin B (AmB) has been used in the clinical practice to treat systemic fungal infections and leishmaniasis, a neglected parasitic disease that can be fatal if left untreated. Fungizone® (a micellar dispersion) was the “gold standard” for more than three decades but due to the safer profile of novel lipid-based medicines (AmBisome®, Abelcet® and Amphocil®), it is used as second-line in the developed world. These medicines exhibit similar efficacies but more favourable safety profiles (mainly lower nephrotoxicity and infusion-related side effects) allowing the administration of larger doses and therefore higher efficacy. However, all formulations required to be parenterally administered because of its low oral bioavailability (0.2–0.9%) due to the precipitation of drug in aqueous media. In the last decade, strong partnerships between academia and industry has led to the development of innovative drug delivery systems able to deliver and target orally AmB in effective concentration while reducing its nephrotoxicity and infusion-related side effects. Currently, three major platform technologies (cochleates, chitosan nanoparticles and SEDDS) that are undergoing clinical trials. Humira: adalimumab Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=11#ixzz5SPRQ5nrw |
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Post by lakers on Sept 28, 2018 15:22:36 GMT -5
Preventive Migraine market Competetive Landscape - A great opportunity for MC, former VP of Amgen, Novartis Drugmakers are using an unusual tactic to compete in a new class of medication to treat the 38 million Americans who have migraines amp.thisisinsider.com/prices-for-new-migraine-treatments-for-2018-2018-9Lydia Ramsey, Business Insider Sep 28, 2018, 12:09 PM ET Amgen and Novartis, Aimovig: $575 per month list price, two months of free samples, followed by a patient assistance program that provides up to a year of coverage if commercial insurance doesn't cover it. For those with commercial insurance, there's a $5 copay program that's capped at $2,700 a year. Teva, Ajovy: $575 per month list price, and a savings card that lets patients access Ajovy for free until December 2019. Lilly, Emgality: $575 per month list price, as well as starter kits in doctors' offices. Lilly also plans to have a patient access program that provides up to 12 months of Emgality for free. Wei-Li Shao, the vice president of Lilly's neuroscience business told Business Insider that the company is also in conversations with organizations responsible for paying for medications, such as pharmacy benefit managers, to strike up "value-based agreements" in which the drugmaker would get paid for a medication based on how well it reduces migraines in a particular patient. For the drugmakers, providing the drug for free serves as a way to get access to more patients at the upstart. Because the treatments are preventative and migraines are a chronic condition, the expectation is that patients will be on the medication for a long enough time to make up for it, even if the drugmakers aren't making money off of it for months after it comes on the market.
"We view this strategy as testament to the recognized long-term size/value of this largely prevalent pool of patients where we expect a significant degree of 'stickiness' once patients are on treatment with a specific agent as opposed to competing on price," RBC Capital Markets analyst Kennen MacKay said in a note Friday.
Analysts expect Aimovig alone to reach $1 billion in annual sales by 2022, while Wells Fargo projected Ajovy to have $818 million in sales by 2022. |
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Post by brotherm1 on Sept 28, 2018 21:19:53 GMT -5
I think anti-fungal and antibiotic orals are hard on the liver? Would inhalables be any less damaging to the liver, kidneys, or perhaps other organs?
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Post by prcgorman2 on Sept 28, 2018 21:33:00 GMT -5
One of the more common causes of death in the elderly is pneumonia and flu. I've wondered how many times could people have been saved if they had been able to inhale their antibiotics instead of taking them orally and waiting for systemic uptake. (I realize flu is a virus and not directly treatable with antibiotics, but secondary infections can accompany an immune system weakened by a virus.)
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Post by mnkdfann on Sept 28, 2018 23:25:23 GMT -5
One of the more common causes of death in the elderly is pneumonia and flu. I've wondered how many times could people have been saved if they had been able to inhale their antibiotics instead of taking them orally and waiting for systemic uptake. Inhaled antibiotics already exist. I've no idea whether inhaled ones work faster than those taken, say, orally. Do they? How much faster? |
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Post by mango on Sept 30, 2018 0:44:40 GMT -5
One of the more common causes of death in the elderly is pneumonia and flu. I've wondered how many times could people have been saved if they had been able to inhale their antibiotics instead of taking them orally and waiting for systemic uptake. Inhaled antibiotics already exist. I've no idea whether inhaled ones work faster than those taken, say, orally. Do they? How much faster? For pulmonary infections, oral inhalation will allow for a higher concentration to be deposited directly in the lungs so that pathogens are exposed to supralethal concentrations. It has been proven difficult to achieve adequate lung penetration that is effective following systemic administration, making inhalation ideal. A dry powder Technosphere antibiotic administered by oral inhalation via an MannKind inhaler would result in a more rapid onset, greater therapeutic index, improved efficacy, and less undesirable side-effects than comparators. |
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Post by mango on Sept 30, 2018 1:08:50 GMT -5
MC said Mnkd will be moving several forward. I expect a major pipeline update. My Bucket 1 conjecture follows. Tacrolimus: Lung Transplant, PAH PDE5 Inhibitors: Adcirca (Tadalafil) TrepT+PDE5 Inhibitors Vancomycin: Bacteria Lung infection with MSRA Linezolid: Infection with VRE, MSRA Amphotericin B: Pulminary Aspergillosis Xellia also reported progress on the development of its pipeline of value-added anti-infectives. Its Premixed Vancomycin is a novel liquid dosage form of vancomycin in a ready-to-use infusion bag, and was recently granted QIDP designation from the US Food and Drug Administration (FDA). A new drug application (NDA) submission for this product to the FDA is anticipated during 2018. Xelia is also beginning to expand its US commercial organisation as it prepares for the launch of this and other original anti-infective drug products. QIDP designation is granted under the Generating Antibiotic Incentives Now (GAIN) Act in the US and provides certain incentives for the development of antibiotics that include priority review and eligibility for fast-track designation.
PRV can be sold for $110M-$350M
Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz5SNfczSVo
TobraT
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.
Mylan entered into the agreement on July 30, 2018, for approximately $463 million and the company expects to pay approximately $240 million in 2018.Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5SNcuVheECINV: Palonosetron, 2 formulations have been eval'ed Both showed aceptable aero, will require additional work to improve Ambient temp stability Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5SNdVonbuThe patent expiry of leading drugs such as Emend, Aloxi, and others is expected to negatively impact the revenue of CINV. Since the 1950s, amphotericin B (AmB) has been used in the clinical practice to treat systemic fungal infections and leishmaniasis, a neglected parasitic disease that can be fatal if left untreated. Fungizone® (a micellar dispersion) was the “gold standard” for more than three decades but due to the safer profile of novel lipid-based medicines (AmBisome®, Abelcet® and Amphocil®), it is used as second-line in the developed world. These medicines exhibit similar efficacies but more favourable safety profiles (mainly lower nephrotoxicity and infusion-related side effects) allowing the administration of larger doses and therefore higher efficacy. However, all formulations required to be parenterally administered because of its low oral bioavailability (0.2–0.9%) due to the precipitation of drug in aqueous media. In the last decade, strong partnerships between academia and industry has led to the development of innovative drug delivery systems able to deliver and target orally AmB in effective concentration while reducing its nephrotoxicity and infusion-related side effects. Currently, three major platform technologies (cochleates, chitosan nanoparticles and SEDDS) that are undergoing clinical trials. Humira: adalimumab Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=11#ixzz5SPRQ5nrw• Is not a high resistant inhaler • The inhaler is not user-friendly • The inhaler requires numerous steps to use: treatment burden • It is common for pieces of the capsule to become inhaled (via the capsule puncture) • Piercing the capsule requires pushing a button. This is done only after you have: 1. Unscrewed the lid of the storage case 2. Unscrewed the mouthpiece of the inhaler 3. Placed a capsule in the chamber 4. Screwed the mouthpiece back on the inhaler • Each dose consists of 4 individual capsules and requires for 2 inhalations per capsule • Utilizes an inferior excipient • Contains sulfuric acid • People with CF need an inhaler that can be throw away immediately after using and/or an inhaler that requires minimal cleaning and maintance and is low risk for contamination. The Podhaler is used for 7 days and has many components, posing a risk for contamination and inducing bacterial infection in the person with CF • Requiring a button-push to pierce the capsule poses high risk of breaking the capsule into tiny pieces and potentially inhaling them during treatment • Much the powder is impacted in the mouth and the back of the throat • Two inhalations per capsule is required because an inhaled volume of ≥ 1.2 L is required to empty the powder from the capsule. • This drug/device combo is far too complex and burdensome, especially for a child to use without supervision. All these indicate that the currently available inhaled TOBI DPI is no where good enough • There is an unmet need for a once daily, single use dry powder Tobramycin inhaler that is also safe, effective and user-friendly with no treatment burdens, This would allow for bacterial suppression during dosing intervals and would also help reduce the development of adaptive resistance. An inhalers resistance is a critical factor in the outcome of severity of cough in CF patients. A high resistance MannKind inhaler would decrease cough severity by requiring lower inspiratory flow rates and volumes. Tobramycin—Currently available inhaled options: nebulization via TOBI & TOBI Podhaler via DPI. —Potential for OTC? In some countries Tobramycin is sold OTC. United States and Canada is prescription only. • Systemic Indications Aerobic Gram-positive1. Staphylococcus aureus Aerobic Gram-negative1. Citrobacter 2. Enterobacter 3. Escherichia coli 4. Klebsiella 5. Morganella morganii 6. Pseudomonas aeruginosa 7. Proteus mirabilis 8. Proteus vulgaris 9. Providencia 10. Serratia • Inhaled Indications: 1. P. aeruginosa in CF patients • Potential Indications/Off Label Use: 1. CF patients with gram-negatives other than P. aeruginosa 2. Non-CF patients with bronchiectasis? 3. Non-CF patients with Pseudomonas? 4. Ages < 6 years old? • Safety and Efficacy that has Not Been Established With Inhaled Tobramycin: 1. < 6 years old 2. FEV1 < 25% or > 80% predicted 3. Patients with Burkholderia cepacia • Concerns 1. Tobramycin is ototoxic (primarily vestibulotoxic) 2. Tobramycin is nephrotoxic —Solution: Inhaled antibiotics are associated with minimal systemic toxicity and adverse events compared with oral and IV. • Question Can MannKind's TobraT potentially be sold OTC? |
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Post by mango on Sept 30, 2018 2:54:55 GMT -5
One of the more common causes of death in the elderly is pneumonia and flu. I've wondered how many times could people have been saved if they had been able to inhale their antibiotics instead of taking them orally and waiting for systemic uptake. (I realize flu is a virus and not directly treatable with antibiotics, but secondary infections can accompany an immune system weakened by a virus.) The current inhaled antibiotics have minimal systemic absorption, not sure how MannKind's will operate but if it's for lung infections it needs to have high affinity & slow dissolution so there's high lung retention where the local infection is. But the solution to the flu could be TechnoVax/MannKind inhaled flu vaccine. Think they said aiming for ~5 years of coverage. Would be two-fold, preventing viral pneumonia caused by flu. |
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Post by mnholdem on Sept 30, 2018 8:22:01 GMT -5
NanoFlu (Novavax) is the most promising flu vaccine platform I've seen in years. It's too bad that it's injected but most flu vaccines are. A disposable Cricket inhaler would be the ideal choice for delivering the vaccine into the bloodstream, IMO. Although, after NanFlu becomes #1 (which I think will happen) Novavax will have the cash to explore an inhalable version...if they aren't bought out first.  |
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Post by lennymnkd on Sept 30, 2018 10:55:53 GMT -5
Just saw a bayer aspirin advertisement: if your prone to a heart attack ; call 911 and take a bayer aspirin / would not a cricket on your key chain work a hell of a lot faster and more effective..
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Post by Deleted on Sept 30, 2018 11:54:47 GMT -5
Just saw a bayer aspirin advertisement: if your prone to a heart attack ; call 911 and take a bayer aspirin / would not a cricket on your key chain work a hell of a lot faster and more effective.. I believe a report/study came out last week that the "Aspirin Theory" does not prevent a heart attack. |
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Post by mango on Sept 30, 2018 12:00:09 GMT -5
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Post by lennymnkd on Sept 30, 2018 12:05:01 GMT -5
Did anybody tell bayer 😀. In all fairness probably not enough time to pull the ads
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Post by Deleted on Sept 30, 2018 12:59:23 GMT -5
Are antibiotics for MSRA and other hospital caused infections administered exclusively via IV? If they are currently IV, are these pre-mixed or reconstituted in the hospital pharmacy. Assuming > or = efficacy, labor savings of inhaled over IV are significant (hospital pharmacy time and floor nurses).
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Post by mango on Sept 30, 2018 16:01:43 GMT -5
Another that MannKind could do HIV related PAH —Didanosine (DDI) and/or azidothymidine (AZT) • HIV-related pulmonary arterial hypertension (HRPAH) affects more individuals who are infected with HIV than individuals who are uninfected. • Patients who are infected with HIV and have HIV-related PAH (HRPAH) exhibit increased mortality compared with counterparts who are HIV-positive and normotensive; half of the deaths reported in patients with HIV infection as the only risk factor for PAH are due to cardiopulmonary complications (eg, right ventricular failure or sudden cardiac death) and not to HIV/AIDS itself. • Approximately 90% of the patients with HRPAH survive 1 year, while 70% have a 3-year survival rate. • PAH is diagnosed more frequently in the patient population infected with HIV than in the general population. www.ncbi.nlm.nih.gov/pmc/articles/PMC2882114/ |
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