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Post by akemp3000 on Aug 1, 2017 15:46:22 GMT -5
Someone once ridiculously suggested that Andrea Leone Bay and Diane Palumbo may have known more than the higher C-level executives at Mannkind and wisely got out. With regard to that rumor...let's just say, another one bites the dust! Regardless of who signs her paycheck and whatever structure she's working under, this is good news. Not huge, but good.
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Post by peppy on Aug 1, 2017 16:04:38 GMT -5
New MannKind Granted Patent Published August 1, 2017 Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agentsType: Grant Filed: February 5, 2016 Date of Patent: August 1, 2017 Assignee: MannKind Corporation Inventors: Keith A. Oberg, Joseph Sulner, Marshall L. Grant Abstract:Methods are provided for coating crystalline microparticles with an active agent by altering the surface properties of the microparticles in order to facilitate favorable association on the microparticle by the active agent. Types of surface properties that are altered by the disclosed methods include electrostatic properties, hydrophobic properties, and hydrogen bonding properties. patents.justia.com/patent/9717689More particularly, active agents may include, in a non-limiting manner, insulin and analogs thereof, growth hormone, parathyroid hormone (PTH), ghrelin, granulocyte macrophage colony stimulating factor (GM-CSF), glucagon-like peptide 1 (GLP-1), Texas Red, alkynes, cyclosporins, clopiogrel and PPACK (D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone), antibodies and fragments thereof, including, but not limited to , humanized or chimeric antibodies; F(ab), F(ab)2, or single-chain antibody alone or fused to other polypeptides; therapeutic or diagnostic monoclonal antibodies to cancer antigens, cytokines, infectious agents, inflammatory mediators, hormones, and cell surface antigens. Non-limiting examples of antibodies to tumor antigens include anti-SSX-241-49 (synovial sarcoma, X breakpoint 2), anti-NY-ESO-1 (esophageal tumor associated antigen), anti-PRAME (preferentially expressed antigen of melanoma), anti-PSMA (prostate-specific membrane antigen), anti-Melan-A (melanoma tumor associated antigen), anti-tyrosinase (melanoma tumor associated antigen), and anti-MOPC-21 (myeloma plasma-cell protein).
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Post by dreamboatcruise on Aug 1, 2017 16:12:09 GMT -5
Even with her name on the patent? Absolutely. I've been the one responsible for chasing down ex-employees to get ongoing signatures necessary to finalize patents. If a person was involved in the invention, they MUST by law be included on the patent. When employees are hired they sign assignment documents where they obligate themselves to give their patents rights over to the company and to execute the necessary documents even if they are no longer an employee. It's amazing how quickly people jump to conclusions (ones they are hoping to jump to) without having relevant knowledge. This in no way means she is still employed or working with MNKD.
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Post by n8 on Aug 1, 2017 16:24:29 GMT -5
Even with her name on the patent? Absolutely. I've been the one responsible for chasing down ex-employees to get ongoing signatures necessary to finalize patents. If a person was involved in the invention, they MUST by law be included on the patent. When employees are hired they sign assignment documents where they obligate themselves to give their patents rights over to the company and to execute the necessary documents even if they are no longer an employee. It's amazing how quickly people jump to conclusions (ones they are hoping to jump to) without having relevant knowledge. This in no way means she is still employed or working with MNKD. So mothball the patents until employees leave the company then file? OR work with employees and file as soon as you can? Which is more likely?
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Post by dreamboatcruise on Aug 1, 2017 16:35:41 GMT -5
Absolutely. I've been the one responsible for chasing down ex-employees to get ongoing signatures necessary to finalize patents. If a person was involved in the invention, they MUST by law be included on the patent. When employees are hired they sign assignment documents where they obligate themselves to give their patents rights over to the company and to execute the necessary documents even if they are no longer an employee. It's amazing how quickly people jump to conclusions (ones they are hoping to jump to) without having relevant knowledge. This in no way means she is still employed or working with MNKD. So mothball the patents until employees leave the company then file? OR work with employees and file as soon as you can? Which is more likely? Neither... There is no benefit to "mothballing", whatever that means (there are strict deadlines in the application process). The company has the same ownership regardless of whether an inventor is still an employee. However, you generally work on a pretty similar time frame for all patents. No one rushes patents, generally you try to delay having it published where your competitors can see it... and while it is in process you may develop new claims that strengthen it. So in general you're submitting things just a little ahead of the deadline for each step. It is always helpful to have all involved inventors still around, but it is very routine to not have that be the case. I simply don't get why people are trying desperately to believe that one given employee might have decided to leave the company... geez that happens all the time. No big deal. No reason to jump through hoops to pretend it didn't happen. Who knows, if my speculation about RLS is correct, she might come back. Apparently even here thinks she is really important.
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Post by mango on Aug 3, 2017 23:02:31 GMT -5
LADIES AND GENTLEMEN OF MANNKIND PROBOARDS— IT IS OFFICIAL. IT IS FINALLY HERE. THE WAIT IS OVER. THE… MannKind... Cannabis DREAM has manifested into reality! MannKind has officially published an international patent application tailored for inhaled cannabinoids!***This patent is ALSO specifically tailored for inhaled epinephrine, palonosetron, treprostinil, AND New Inhaler Designs*** (Sorry, mango is just Cannabis biased and did not intend to undermind these other 3 wonderful inhaled therapeutics of MannKind’s nor does mango not intend to acknowledge that this patent also contains a plethora of other agents and compounds in this wonderful patent, however, these 4 are the highlights of this patent). Without further delay!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! (Sorry folks. Mango is excited) The New MannKind International Patent Application Published on August 3, 2017. DRY POWDER INHALERInternational Filing Date: 27.01.2017 Publication Date: 03.08.2017 Applicants: MANNKIND CORPORATION Inventors: KINSEY, P. Spencer; (US) LAURENZI, Brendan; (US). SMUTNEY, Chad, C.; (US). ADAMO, Benoit; (US). GUARNERI, Joseph; (US) Title (EN) DRY POWDER INHALER (FR) INHALATEUR À POUDRE SÈCHE Abstract: (EN) A dry powder inhaler including replaceable cartridges containing a dry powder for local or systemic delivery through the pulmonary tract and lungs is disclosed. The inhalers are used with inhalable dry powders, including medicament formulations comprising active agents for local or systemic delivery and for the treatment of diseases such as, pulmonary hypertension, cardiovascular disease, anaphylaxis, diabetes, obesity, cancer, and other diseases, or symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation. [00116] The following examples illustrate some of the processes for making dry powders suitable for using with the inhalers described herein and data obtained from experiments using the dry powders. Example 2[00120] Preparation of dry powder comprising microcrystalline FDKP particles containing epinephrine. An approximately 5 wt% solution of epinephrine in about 5% aqueous acetic acid was added to a suspension of FDKP microcrystallites obtained as described in Example 1. Optionally, leucine was also added to the FDKP microcrystallite suspension. The mixture was spray dried using a Buchi B290 spray-dryer equipped with a high efficiency cyclone. Nitrogen was used as the process gas (60 mm). Mixtures were dried using 10 - 20% pump capacity, 90 - 100% aspiration rate and an inlet temperature of 170 - 190 °C. The weight % concentrations of epinephrine and leucine in the resultant powders were 2 - 30% and 0 -20%, respectively. Delivery efficiencies of these powders after discharge from a dry powder inhaler ranged between approximately 50% and 80%. Example 3[00121] Preparation of dry powder comprising microcrystalline FDKP particles containing palonosetron. An approximately 5 wt% solution of palonosetron hydrochloride in DI water was added to a suspension of FDKP microcrystallites obtained as described in Example 1. Optionally, solutions of leucine and methionine in deionized (DI) water were also added. The mixture was titrated with ammonium hydroxide to pH 6.5 ± 0.5. The mixture was spray dried using a Buchi B290 spray-dryer equipped with a high efficiency cyclone. Nitrogen was used as the process gas (60 mm). Mixtures were dried using 10-12% pump capacity, 90-100% aspiration rate, and an inlet temperature of 170 - 190°C. The weight % concentrations of palonosetron, leucine, and methionine in the resultant powders were 5%, 0-20%, and 0-10%, respectively. Delivery efficiencies of these powders after discharge from a dry powder inhaler ranged between approximately 50% and 70%. Example 4[00122] Preparation of dry powder comprising microcrystalline FDKP particles containing treprostinil. A solution containing 0.2 - 1.0 wt% treprostinil in ethyl alcohol was added to a suspension of FDKP microcrystallites obtained as described in Example 1. The mixture was spray dried using a Buchi B290 spray-dryer equipped with a high efficiency cyclone. Nitrogen was used as the process gas (60 mm). Mixture were dried using 10-12% pump capacity, 90-100% aspiration rate, and an inlet temperature of 170 - 190°C. The weight % concentration of treprostinil in the resultant powder was 0.5 - 10%. Delivery efficiencies of these powders after discharge from a dry powder inhaler ranged between approximately 50% and 70%. Example 5[00123] Preparation of dry powder comprising microcrystalline FDKP particles containing A9-THC or CBD. Isolated FDKP microcrystalline particles prepared as in Example 1 were suspended in ethyl alcohol. An approximately 1-4 wt% solution of cannabis extract, primarily comprising either A9-THC or CBD, in ethanol and the ethanolic suspension of FDKP microcrystallites was added. Optionally, solutions of additives dissolved in ethanol were also added. The mixture was spray dried using a Buchi B290 spray-dryer equipped with a high efficiency cyclone. Nitrogen was used as the process gas (60 mm). Mixture were dried using 12 - 15% pump capacity, 70 - 100% aspiration rate, and an inlet temperature of 110 -140 °C. The weight % concentrations of A9-THC and additional additives are provided in Table 3. Delivery efficiencies of these powders after discharge from a dry powder inhaler ranged between approximately 50% and 70%. [00124] Table 3. Composition of microcrystalline FDKP particles containing A9-THC or CBD Component Component Range (wt. %) A9-THC and /or 10 - 40 CBD DPPC 5 - 15 DSPC 5 - 15 PVP 0.5 - 5 PEG 2 PS-80 2 [00125] Dry powders made by the method described above were tested using a substantially anatomically correct airway (ACA) system as described in U.S. Patent No. 9,016,147. The dry powders exhibited significant degree of stability at room temperature, for example, at one-month storage, greater than 90% of the THC or CBD remained active with delivery efficiencies ranging from about 35% to about 75% using this method.Text in the Description: Cannabinoids[00106] In an embodiment, the compositions for delivering with the inhalers herein can comprise fumaryl diketopiperazine crystalline particles and an active agent such as cannabinoids, including tetrahydrocannabinol (THC) and/or cannabidiol, treprostinil, palonosetron, parathyroid hormone, sildenafil, or epinephrine. In composition wherein a cannabinoid is used as an active agent, the cannabinoid, including, derivatives and/or analog thereof content can be up to 40% (w/w) with powder delivery greater than 40% of the inhaler content. In some embodiments, the cannabinoid content in the composition can range from about 1% to about 30%, from about 5% to about 25% (w/w) of the powder content. The compositions herein can also comprise one or more excipients including amino acids such as leucine, isoleucine, methionine and the like and one or more phospholipids, for example, 1 ,2- dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) or l,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) prior to spray drying in amounts up to about 25% (w/w), ranging from about 1% (w/w) to about 25%, or 2.5% to 20% (w/w), or 5% to 15 % (w/w) . In this embodiment, the inhalers can discharge from about 50% to 100% of the composition in a single inhalation. In this embodiment, the compositions can be administered to a subject in need of treatment as needed. Epinephrine[00107] In an embodiment wherein epinephrine is used as an active agent, the content of the epinephrine composition comprises up to about 30% (w/w); and ranging from about 1 % to about 35% of the powder content. In certain embodiments, compositions comprising microcrystalline particles can contain from about 2% to about 30% or from about 0.1 % to about 20% (w/w) epinephrine. In this embodiment, epinephrine powders can be delivered with an inhaler described herein with a delivery efficiency of the powder greater than 50% of the dose content. In this embodiment, the compositions are used for a method of treating symptoms of an allergic response, prior to onset of anaphylaxis cause by an allergen, such as a nut, including peanut allergens, antibiotics such as penicillin, and other substances. The method comprises, providing to a subject in need of treatment for symptoms of an allergic response and who exhibits early symptoms of anaphylaxis an inhaler comprising a dose of about 1 mg to about 15 mg of a composition effective to prevent the onset of anaphylaxis, and having the subject inhale a dose of a composition comprising epinephrine in amounts sufficient to prevent onset of anaphylaxis in the subject. Treprostinil[00108] In an embodiment wherein treprostinil is used as an active agent, the dry powder compositions comprise microcrystalline particles of fumaryl diketopiperazine, wherein the treprostinil is adsorbed to the particles and wherein the content of the treprostinil in the composition comprises up to about 20% (w/w) and ranges from about 0.5% to about 10% (w/w), or from about 1 % to about 5% (w/w) of the dry powder. In one embodiment, the composition herein can comprise other excipients suitable for inhalation such as amino acids including methionine, isoleucine and leucine. In this embodiment, the treprostinil composition can be used in the prevention and treatment of pulmonary hypertension by self-administering an effective dose comprising about 1 mg to 15 mg of a dry powder composition comprising microcrystalline particles of fumaryl diketopiperazine and treprostinil in a single inhalation.Palonosetron[00109] In an embodiment wherein palonosetron is used as an active agent for inhalation powders, the dry powder content of the palonosetron in the composition comprises up to about 20% (w/w) and ranges from about 0.1 % to about 20% , or 0.1 % to about 10% of the dry powder content. In one embodiment, palonosetron compositions can be made comprising fumaryl diketopiperazine disodium salt or crystalline composite particles of fumaryl diketopiperazine and an excipient including an amino acid such as leucine, isoleucine or methionine to improve storage stability to the composition. In this embodiment, the palonosetron inhalable composition can be used in the prevention and treatment of chemotherapy-induced nausea and vomiting by self-administering in a single inhalation using an inhaler herein a dose of the composition from about 5 to 30 minutes and preferably from about 5 to 15 minutes prior to or concurrently with the patient receiving the dose of the chemotherapy.Some of the Claims: 15. The dry powder inhaler of claim 14, wherein the dry powder comprises a cannabinoid in an amount from 1% to 40% (w/w). 16. The dry powder inhaler of claim 15, wherein the cannabinoid is tetrahydrocannabinol or cannabidiol. 19. The dry powder inhaler of claim 18, wherein the drug is tetrahydrocannabinol or cannabidiol. The New InhalersThe Wonderful Patentforever flying in the wings-- of synchronicity
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Post by reality on Aug 3, 2017 23:42:36 GMT -5
Nice find! Could it be that RLS and MNKD are about to become one? I think Mike should have some exciting news for us soon.
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Post by kimi on Aug 4, 2017 4:11:22 GMT -5
liane - this patent seems to be too important. Please make it an isolated thread?
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Post by promann on Aug 4, 2017 5:00:24 GMT -5
Nice find! Could it be that RLS and MNKD are about to become one? I think Mike should have some exciting news for us soon. MNKD to patent the work of RLS? Or is this MNKDs work with the help of RLS ? Maybe this is just part of thier agreement who knows but if they are working together and sharing expenses is that already a merger without technically saying so. The big huge question is does RLS have money to bring to the table if they do officially announce a merger? I hope RLS has huge financial backing to share with MNKD.
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Post by sayhey24 on Aug 4, 2017 5:31:40 GMT -5
Mango - awesome news! Finally what we have been talking about for what seems like forever in a published patent. GWPH closed down yesterday at $110 and change. As we have been saying for a long time MNKD/RLS have a better solution.
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Post by mango on Aug 4, 2017 6:32:59 GMT -5
Nice find! Could it be that RLS and MNKD are about to become one? I think Mike should have some exciting news for us soon. MNKD to patent the work of RLS? Or is this MNKDs work with the help of RLS ? Maybe this is just part of thier agreement who knows but if they are working together and sharing expenses is that already a merger without technically saying so. The big huge question is does RLS have money to bring to the table if they do officially announce a merger? I hope RLS has huge financial backing to share with MNKD. • RLS and MannKind are developing Receptor's inhaled proprietary compounds here: • I have realized the wording by MannKind in regards to this license deal was meant to be as confusing as possible. Al probably spent 5 years perfecting each answer to each question so the confusion seemed clarified, yet, remained confusing
• The inhaled proprietary compounds that Receptor will ultimately manufacture and market relies on utilizing Technosphere, which essentially IS the foundation of MannKind. Whatever compounds comes out of these two entities will be of great importance because Al would never do this confusing internal development collaboration like this unless it were with trusted individuals. • Torrey Pines supposedly has over a trillion compounds to test. I feel they could be involved in some way, but just speculating. CB1 and CB2 are G protein-coupled receptors and Torrey Pines specializes in that protein family. • Could the two items (epinephrine and cannabinoids) that are not listed on MannKind's Pipeline be what Receptor is developing? Thinking out loud here that's not a real question. • Here's some of the info MannKind gave us: I want to see a Raphael Mechoulam cannabinoid compound combined with Technosphere, personally. Yeehaw the closer we get the more confused we become.
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Post by peppy on Aug 4, 2017 7:00:09 GMT -5
Mango, I love you. Abstract: (EN) A dry powder inhaler including replaceable cartridges containing a dry powder for local or systemic delivery through the pulmonary tract and lungs is disclosed. The inhalers are used with inhalable dry powders, including medicament formulations comprising active agents for local or systemic delivery and for the treatment of diseases such as, pulmonary hypertension, cardiovascular disease, anaphylaxis, diabetes, obesity, cancer, and other diseases, or symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation.
Reply: symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation.
pain and inflammation. arthritis. Nausea and vomiting - chemo and.... This country gives a lot of chemo. can we say, preventative care? Come in and get your screening. Catch your cancer early, so we have a longer chemo window.
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Post by mnholdem on Aug 4, 2017 7:24:12 GMT -5
I noticed that even though this patent includes discussion of embodiments involving Cannabinoids [00106] the name Andrea Leone-Bay is not included among the inventors list. At first blush, that seems to shoot a big hole through the RLS-cannabis connection theory?
"MannKind retains all rights for Technosphere technology, except for the use of our technology for the specific proprietary compounds of Receptor that are the subject of their license."
Perhaps the discussion of cannabinoids is simply too generic to be considered an infringement of Receptor Life Sciences' proprietary compounds, which so many have deduced will involve cannabinoids.
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Post by peppy on Aug 4, 2017 7:30:10 GMT -5
I noticed that even though this patent includes discussion of embodiments involving Cannabinoids [00106] the name Andrea Leone-Bay is not included among the inventors list. At first blush, that seems to shoot a big hole through the RLS-cannabis connection theory?
"MannKind retains all rights for Technosphere technology, except for the use of our technology for the specific proprietary compounds of Receptor that are the subject of their license."
Perhaps the discussion of cannabinoids is simply too generic to be considered an infringement of Receptor Life Sciences' proprietary compounds, which so many have deduced will involve cannabinoids.
specifically: containing A9-THC or CBD.
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Post by promann on Aug 4, 2017 8:27:37 GMT -5
I noticed that even though this patent includes discussion of embodiments involving Cannabinoids [00106] the name Andrea Leone-Bay is not included among the inventors list. At first blush, that seems to shoot a big hole through the RLS-cannabis connection theory?
"MannKind retains all rights for Technosphere technology, except for the use of our technology for the specific proprietary compounds of Receptor that are the subject of their license."
Perhaps the discussion of cannabinoids is simply too generic to be considered an infringement of Receptor Life Sciences' proprietary compounds, which so many have deduced will involve cannabinoids.
Them names are for the patent on the new type of inhaler. They did not include names of inventers for its uses.
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