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Post by lakers on Dec 9, 2016 12:52:41 GMT -5
I agree with Hillsave. That's called conflict of interest. That's why Sny never bothered trying to improve label and start pediatric trials ASAP. More than Two years have been wasted.
IMHO, Novo could pick up the baton dropped by Sny. The relay will continue.
Afrezza is promotionally sensitive. Afrezza needs sufficient budget from a deep pocket parent for DTC, TV Ads.
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Post by lakers on Dec 9, 2016 1:11:33 GMT -5
Afrezza + Tresiba Insulin Options (For a Guy Who Misses Doses and Miscalculates Carbs) Written by Mike Hoskins Published on November 25, 2016 www.healthline.com/diabetesmine/afrezza-and-tresiba-comboNovo execs must be reading the glowing review by Mike Hoskins. It begins to sink in me that Novo may acquire Mnkd after all for Afrezza, 12 TS pipeline, EpiHale, PAHale, CINV, Pain, RLS' CBD pipeline royalty, thousands of patents, and NOL. It's just a matter of when, not if. Novo would make Afrezza a long overdue blockbuster if they own it outright. No one can deny such a potent Afrezza+CGM+Tresiba (ACT) combo, not even AF, LDG.
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Post by lakers on Dec 8, 2016 18:39:19 GMT -5
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Post by lakers on Dec 8, 2016 15:37:58 GMT -5
seekingalpha.com/article/4021887-mannkinds-mnkd-ceo-matthew-pfeffer-q3-2016-results-earnings-call-transcript?part=singleStephen Weil from Oppenheimer Yes. Hi. This is Steven Weil. MannKind Corporation has many patents for various products [inaudible]. Can you give us any information on things other than Afrezza and the epinephrine. Raymond Urbanski Yes. Certainly, so we have a range of compounds in development, slightly more than 10 on the list, some include NCEs related to sort of pain management, others are B2 type of drugs, which we’ll be looking at, some are related to diabetes such as Symlin, for example, others are related to other disorders like parathyroid hormone, for example. So we have -- we do have a fairly extensive portfolio that we are still looking at to leverage, our innovative oral inhalation technology and the pharmacokinetic profile that will provide. We believe we’ll have several compounds in development in 2017. en.wikipedia.org/wiki/New_chemical_entityAn NCE (New Chemical Entity) is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a treatment for some disease. Synthesis of an NCE is the first step in the process of drug development. Once the synthesis of the NCE has been completed, companies have two options before them. They can either go for clinical trials on their own or license the NCE to another company. In the latter option, companies can avoid the expensive and lengthy process of clinical trials, as the licensee company would be conducting further clinical trials and subsequently launching the drug. Companies adopting this model of business would be able to generate high margins as they get a huge one-time payment for the NCE as well as entering into a revenue sharing agreement [royalty] with the licensee company.Under the Food and Drug Administration Amendments Act of 2007, all new chemical entities must first be reviewed by an advisory committee before the FDA can approve these products. I expect several licensees in the next 2 years.
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Post by lakers on Dec 8, 2016 0:01:08 GMT -5
www.loopnet.com/xNet/Looplink/Profile/Profile.aspx?LID=19218181&STID=CB0003&LL=trueIndustrial Property For Sale Price:$20,732,000Building Size:146,000 SFPrice/SF:$142Property Type:IndustrialProperty Sub-type:R&DProperty Use Type:Vacant/Owner-UserNo. Stories:2Year Built:1999Clear Ceiling Height:30 ft.Dock-High Doors/Loading:10Drive In/Grade-Level Doors:2Lot Size:324,552 SFAPN / Parcel ID:3271-026-067Parking Ratio:2.30 / 1,000 SFListing ID19218181Last Updated26 days ago Find Out More... Highlights State-of-the-Art R&D / Tech Center in the Heart of Valencia Gateway50,000 SF of High Image Corporate/Admin Office40,000 SF of Laboratory and Support Facilities Including 30,000 SF of General Lab Space52,000 SF of Warehouse Space Which Could Accommodate Additional Office and Lab SpaceExtensive Mechanical Systems to Allow for Full Operational Redundancy Description ** State-of-the-Art Class "A" Building ** ** Extensive Laboratory and Office Improvements ** ** Large Equipment Yard ** Excess Land Area** ** Potential of 5/1,000 Parking** ** Adjacent 3.96 Acre Land Also Available for $18.00 PSF ** ** Prime Valencia Commerce Center Location ** ** Excellent Access to the Golden State (I-5) & 126 Freeways ** ** Proximity to Amenities ** Commercial property information by LoopNet Map of 28903 Avenue Paine, Valencia, CA 91355 (Los Angeles County) 3.96ac= 172497.6ft² *18/sq ft + $20,732,000= 23,836,957
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Post by lakers on Dec 7, 2016 16:22:28 GMT -5
EMA approval takes almost a year. Canada, Australia, Mexico approval is much shorter. Canada was Pfizer's first and only ex-US mkt for Exubera.
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Post by lakers on Dec 6, 2016 18:18:32 GMT -5
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Post by lakers on Dec 6, 2016 18:08:23 GMT -5
Brand
Source
Status
Relevance
Origin
Holder
Number
App. Date
Image Class
Nice Cl.
Image
Mark CATM.1810093-00 OUTSULIN CA TM Pending 11 CA MannKind Corporation 1810093 2016-11-18 5, 44
Mark AUTM.1808539 OUTSULIN AU TM Pending 11 AU MannKind Corporation a Delaware corporation 1808539 2016-11-10 5, 44
Mark USTM.87042197 OUTSULIN US TM Pending 11 US MannKind Corporation 87042197 2016-05-18 5, 44
Mark MXTM.0119851820282 OUTSULIN MX TM Pending 11 MX MANNKIND CORPORATION 0119851820282 44
Mark MXTM.0119851820281 OUTSULIN MX TM Pending 11 MX MANNKIND CORPORATION 0119851820281 5
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Post by lakers on Dec 1, 2016 17:49:04 GMT -5
Pharmaceutical preparations for human use for the treatment of pain, central nervous systems, metabolic disorders, gastrointestinal disorders, for use in side effects from chemotherapy; inhalers sold pre-filled with pharmaceutical preparations; namely, pharmaceutical preparations with plant extracts for the treatment of pain, central nervous systems [Epilepsy, Multiple sclerosis], metabolic disorders, gastrointestinal disorders and for use in side effects from chemotherapy [Mnkd is developing CINV, Palonosetron TS for chemotherapy-induced nausea and vomiting]; plant extracts for pharmaceutical purposes. Migraine sufferer finds relief in cannabis-derived oil Treatment has replaced patient’s painkillers but remains unlicensed in Ireland Wed, Nov 30, 2016, 01:00 www.irishtimes.com/news/social-affairs/migraine-sufferer-finds-relief-in-cannabis-derived-oil-1.2886770Frawley has been so impressed with CBD oil that she has read up on the medicinal use of cannabis and says though the oil is “very good”, it is “missing” the psychoactive ingredient in cannabis, tetrahydrocannabinol (THC), which she says has a stronger pain-killing effect. One cannabis-based medicine, Sativex, containing both CBD and THC, is licensed for use in the State, but only in very limited circumstances and only for multiple sclerosis. “If I had a medicine with the THC as well I’d be on the pig’s back,” she says. “ I am horrified to know that there is a safe product out there that could turn my life around completely and my Government will not allow me to have it. If they suffered with this pain, or they had a child suffering with extreme pain or epileptic seizures they wouldn’t be slow about making it available.” She has talked to her neurological consultant about medicinal cannabis to help manage her pain. “I wanted some advice but she absolutely refused to even discuss it with me. She wouldn’t even allow the word cannabis to be used,” she says. Frawley says she has become so passionate about the benefits of cannabis for medical purposes, that she is using “all my pain-free hours spreading the knowledge to everyone out there who does not know about it, just like I didn’t”. Woonsocket company introduces marijuana alternative for pain www.valleybreeze.com/2016-11-16/woonsocket-north-smithfield/woonsocket-company-introduces-marijuana-alternative-pain#.WECtyvkrLmE
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Post by lakers on Nov 30, 2016 20:05:59 GMT -5
More than 2 yrs have passed w/o achieving any FDA label improvement, Ped approval. Sny sandbagged big time. Afrezza would have much better fighting chance w/ proper label, peds FDA approval. That said, ironically I believe TS, RLS may save Afrezza, not the other way around.
I also agree that Afrezza needs a deep-pocket, patient partner like Tresiba owner. D+A+T is a potent combo.
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Post by lakers on Nov 28, 2016 18:27:34 GMT -5
Fabulous Afrezza Ads in this year World Series was confirmed. Mike now has his own sale force. One recently hired Director has been diabetic for 30 years. He has used Afrezza long before he was hired and was amazed by its efficacy. He would make a great sale evangelist. The company seems excited about this great hire. EpiHale on track for NDA in 1Q17. Partnership ? will know the answer next time. On track for RLS milestones.
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Post by lakers on Nov 26, 2016 3:27:27 GMT -5
RECEPTOR LIFE SCIENCES Trademark Information RECEPTOR LIFE SCIENCES, INC. pharmaceutical preparations for human use; inhalers sold pre-filled with pharmaceutical preparations; plant extracts for pharmaceutical purposes scientific and medical research relating to the diagnosis and treatment of medical conditions; scientific and medical research relating to plant extracts for pharmaceutical purposes providing a website featuring information relating to the diagnosis and treatment of medical conditions On Thursday, February 04, 2016, a U.S. federal trademark registration was filed for RECEPTOR LIFE SCIENCES by RECEPTOR LIFE SCIENCES, INC., Seattle, WA 98199. The USPTO has given the RECEPTOR LIFE SCIENCES trademark serial number of 86898208. The current federal status of this trademark filing is NON-FINAL OFFICE ACTION ISSUED - CLARIFICATION NEEDED. The correspondent listed for RECEPTOR LIFE SCIENCES is FRANCES M. JAGLA of LANE POWELL PC, 601 S.W. SECOND AVENUE, SUITE 2100, PORTLAND, OR 97204 . The RECEPTOR LIFE SCIENCES trademark is filed in the category of Pharmaceutical Products , Computer & Software Services & Scientific Services , Medical, Beauty & Agricultural Services . The description provided to the USPTO for RECEPTOR LIFE SCIENCES is pharmaceutical preparations for human use; inhalers sold pre-filled with pharmaceutical preparations; plant extracts for pharmaceutical purposes. NON-FINAL OFFICE ACTION ISSUED - CLARIFICATION NEEDED 5/29/2016 Estimated Response Deadline: 11/29/2016 See Trademark response services www.trademarkia.com/receptor-life-sciences-86898208.html
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Post by lakers on Nov 26, 2016 3:12:58 GMT -5
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Post by lakers on Nov 26, 2016 2:33:50 GMT -5
Mnkd copies a page from Dance Biopharm's China Licensee, Harmony Biopharm, Enters into New Joint Venture with Tonghua Dongbao Pharmaceutical, a Leading China Insulin Producer www.prnewswire.com/news-releases/dance-biopharms-china-licensee-harmony-biopharm-enters-into-new-joint-venture-with-tonghua-dongbao-pharmaceutical-a-leading-china-insulin-producer-300264087.htmlSAN FRANCISCO, May 6, 2016 /PRNewswire/ -- Dance Biopharm Inc. ("Dance"), a privately-held biotechnology company focused on the development of Dance 501, an inhaled insulin product to treat diabetes, is pleased to announce that Harmony Biopharm Limited, Dance's licensee for Dance 501 in Asia, has recently formed a joint venture with Tonghua Dongbao Pharmaceutical Co. and Shanghai Dongbao Biological Pharmaceutical Co. (collectively, "Dongbao"). The joint venture will focus on obtaining regulatory approval in China and, if approval is obtained, preparing for commercialization of Dance 501. According to the International Diabetes Federation, there are more than 110 million diabetes patients in China, the highest of any country in the world. Dongbao, Dance's global insulin supplier, has been making and selling injectable insulin for more than 25 years. Its high-capacity insulin factory in Northern China has been inspected and qualified by the European Medicines Agency. Through the new joint venture, Dongbao has committed to shared responsibility with Harmony Biopharm to develop and commercialize Dance 501 in Greater China. The initial capitalization of the joint venture is U.S. $11 million. About Dongbao Dongbao Enterprise Group is a China conglomerate with more than 20 subsidiaries focused on the production and manufacture of recombinant therapeutics, especially human insulin, and is a leading manufacturer of insulin in Asia. Tonghua Dongbao Pharmaceutical, one of the 20 subsidiaries, is a public company listed on the Shanghai Stock Exchange. Shanghai Dongbao Biological Pharmaceutical Co, also a subsidiary of Dongbao Enterprise Group assists Tonghua Dongbao Pharmaceutical Co. in the registration and operation of its overseas insulin products market. About Harmony Biopharm Ltd Harmony Biopharm, a private Hong Kong company, has licensed Dance Biopharm's technology for development and commercialization in the Asia Pacific market. About Dance 501, an Inhaled Insulin Product Dance 501 consists of a high purity liquid formulation of recombinant human insulin stored in a dispenser for administration with a small handheld electronic inhaler. The electronic inhaler utilizes a patented vibrating mesh technology, designed to produce consistently sized particles of liquid insulin in the form of a smooth mist, allowing the efficient and consistent delivery of insulin into the lungs in a few breaths. Dance 501 has not yet been approved by any regulatory authority. About Dance Biopharm Inc. Dance Biopharm is a privately-held company based in the San Francisco Bay Area focused on the clinical development of inhaled insulin products to treat diabetes patients worldwide. The company began operations in 2010, founded by Dr. John Patton, who has over 25 years of experience developing inhaled insulin and other inhaled therapies.
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Post by lakers on Nov 25, 2016 13:07:30 GMT -5
As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission? I am not that convinced that the label change to ultra fast insulin will sell it to endos. A label change for reduced hypos would stand a far better chance of selling it. Ultra fast without being superior is a feature, not a benefit whereas reduced hypos is a clear benefit. My #RealWorldAfrezza Observations Last time I shared my Afrezza experiences was during the summer. Not much has changed, for the most part -- aside from now having Tresiba on board, too. I recently found myself in a meeting room with a few other Afrezza users, and noticed that I was the only one who stepped out to inhale. Despite the fact that the inhaler is small and discreet, I personally just find the dosing procedure a bit too loud and distracting when sitting in a board room or other quiet public space. Opinions may vary on that, but I would rather be step away for a quick moment to inhale to avoid drawing attention to myself. As to my #RealWorldAfrezza results, I find that I usually start seeing it impacting my blood sugars within 30 minutes, if not a bit sooner -- which is great for quick corrections. I've also noticed that I can "turbo-charge" the action by adding exercise to the mix. Similar to injectable insulin, if I inhale just prior to starting a moderate walk or bike ride, or during that exercise, the Afrezza kicks in much faster. I've heard others describe this same experience, and MannKind Corp tells me they've heard numerous users describe that same "exercise effect" with Afrezza. Yet that hasn't led to low blood sugars. In fact, I've had fewer hypos over the course of these past six months using this inhaled insulin.
Fewer Hypos? You bet. I would say without a doubt, that Afrezza (along with Tresiba) has slashed my hypoglycemia rate, and although I still experience them at times thanks to my own mismanagement, this is a huge selling point, IMHO. (Note that FDA restricted MannKind from adding 'less hypoglycemia' to its product labeling, even though studies showed it was a significant effect; MannKind is planning to ask for a label change on this point before long, too.)I'm now using Afrezza mostly during the day and am going back to NovoLog in the evening hours, in large part due to what I refer to as my "Afrezza Resistance." There are just times when it doesn't work as effectively for me. Sometimes, not at all. It can be very frustrating, especially since sometimes Afrezza works so magically but at other times it doesn't seem to work at all (almost like when my insulin is water.) No, it's not a basal issue and isn't specific to carbs on board -- I have trial-tested and eliminated those factors, by bumping up my basal and not eating at specific times. Generally, I notice that my Afrezza needs are higher than they were in the early months of using it, and sometimes the 4-unit (blue) cartridge doesn't seem to work as well as it did previously, so I've bumped up to the 8-unit (green) variety more often. (Note to MannKind: the blue and green cartridges are very difficult to tell apart, especially in dark places and for those of us who are even partially color-blind -- can you make them more distinct please?!) I have yet to try out the 12-unit (yellow) cartridges that MannKind Corp is now selling, but that's about to change as I have a pending Rx to obtain a box of those soon. I'm also happy that my co-pay isn't be more than $30, thanks to the Afrezza savings card that makes this much more affordable than what I'd normally be paying for this highest tier medication. I remain quite concerned about the survival prospects of manufacturer MannKind Corp, but that's a concern for another day... In the meantime, I'm inhaling like a champ and enjoying the experience for as long as I can. Read more: mnkd.proboards.com/thread/6532/afrezza-on-twitter-ii?page=8#ixzz4R2pDZrDw
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