See the official slide on buckets.
mnkd.proboards.com/thread/9037/mannkind-formulations-bucketsTop bucket is known compounds already delivered to the lung, not a lot of work and we have been at FDA to pass on this one, know exactly what’s required, very simple development program, very high predictability of success.
Undisclosed: likely bucket-1 Inhaled DNase (deoxyribonuclease) for cystic fibrosis
Tobra-T (replaces TOBI pod haler) is for CF. Both are parts of SoC.
med.stanford.edu/cfcenter/education/english/Meds-Nebs.html
Inhaled Medications and Nebulizers
SoC: The Cystic Fibrosis Foundation and the Stanford CF Center staff recommend the following sequence for inhaled medications:
Bronchodilators (Albuterol, Combivent, Xopenex) to open the airways
Hypertonic Saline (7%) to mobilize mucus and improve airway clearance
Pulmozyme (DNase) to thin mucus*Airway Clearance Technique: Vest, Flutter, Chest PT, IPV, etc.
Antibiotics (TOBI, Colistin, Cayston). The previous therapies open and clear the airways of mucus, allowing these antibiotics to work on remaining bacteria.
Steroids (Flovent, Pulmicort, QVAR)
* When using the Vest for airway clearance, make sure there is aerosol delivery during the entire vest session.
If you start coughing blood, temporarily stop Pulmozine, saline, airway clearance technique, and inhaled antibiotics. Call your CF doctor or nurse for further advice.
With a respiratory illness or change in symptoms:
Begin or increase airway clearance techniques.
Use breathing treatments as ordered; you can use bronchodilators every three to four hours, and often additional Vest and/or hypertonic saline treatments are useful.
Contact your CF doctor or nurse to see if antibiotics or additional intervention is needed.
Read more:
mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=6#ixzz5c0FcqSXDwww.marketresearch.com/product/sample-8026537.pdfShows potential partners on page 15, Appendix.
Bucket two, known compounds non-lung delivery, acute use, those aren’t going to have as much work to be done because you’re acute in nature, not a lot of chronic administration and tox studies.
Palonosetron for CINV, Rizatriptan (Merk), or Sumatriptan (GSK) for Migraine will likely round out the four compounds moving forward.
As per the latest research citings of National Cancer Institute, in 2016 there were approximately 15.5 million cancer survivors due to early intervention of chemotherapy. Business analysts predict the rise in survivors to 20.3 million by 2030. The etiology of CINV is not very well understood, however the involvement of the chemo trigger zone and gastrointestinal mucosa have been reported in multiple studies. Chemotherapy induced nausea and vomiting are classified as acute, refractory and delayed. The intensity of CINV depends on the use of drugs in chemotherapy and patient factors. The challenges associated with the antiemetic prescribed for CINV are nonadherence and lack of effective guidelines for CINV treatment. Newer antiemetic drugs such as palonosetron and aprepitant have shown good pharmacokinetic properties in adult cancer patients, still more clinical trials are required for its safety in children.
The
major players steering the chemotherapy induced nausea and vomiting treatment market are Baxter Pharmaceuticals, Eisai, Inc., Helsinn Healthcare, GlaxoSmithkline, Plc, Merck & Co., Inc., ProStrakan, Inc., Pfizer, Inc., Sanofi-Aventis, Solvay Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd.
www.tampabayreview.com/news/business/chemotherapy-induced-nausea-vomiting-treatment-market-expected-reach-us-3626-1-mn-2026/38010/Potentially,
Merk can partner with Mnkd for Inhaled Palonosetron and Rizatriptan. Alternatively, GSK could partner with Mnkd for Inhaled Palonosetron, Sumatriptan, and Tobra-T. It has preclinical GSK-2225745 for CF. This would be similar to multi-molecule deal with UTHR.
Read more:
mnkd.proboards.com/thread/10513/cantor-conf-10-pipeline-update?page=6#ixzz5c0IKqEJL
