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Bullboard - Stock Discussion Forum Liminal BioSciences Inc. LMNL

Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from fibrotic or inflammatory diseases that have a high unmet medical need. Liminal BioSciences operates on an integrated basis from our talent hubs in Laval, Quebec, Canada, and Cambridge, UK. Our common shares are listed... see more

NDAQ:LMNL - Post Discussion

Liminal BioSciences Inc. > IVIG STORY - FDA grants seven years of marketing exclusivi
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Post by stockman6767 on Aug 31, 2021 9:23pm

IVIG STORY - FDA grants seven years of marketing exclusivi

https://www.news-medical.net/news/20210831/FDA-grants-seven-years-of-marketing-exclusivity-for-Octapharmae28099s-Octagam-1025.aspx
 
FDA grants seven years of marketing exclusivity for Octapharma’s Octagam 10%
Reviewed by Emily Henderson, B.Sc.Aug 31 2021
Octapharma USA today announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis (DM).
The FDA approval of orphan drug status for Octagam® 10% to treat adults with DM should encourage patients to ask their physicians about the therapy because they no longer have to rely on treatments that have not been specifically evaluated by the FDA for DM. We expect that Octagam® 10% may become the first treatment option for the vast majority of adults with DM given the outstanding results from the ProDERM clinical trial."
Flemming Nielsen, President , Octapharma-USA
Related Stories
Dermatomyositis is a rare idiopathic autoimmune disorder of unknown cause affecting approximately 10 out of every million U.S. residents. Patients commonly suffer from skin rashes, chronic muscle inflammation, and progressive muscle weakness, usually affecting adults in their late 40s to early 60s and children between the ages of 5 and 15. Complications include difficulty swallowing, aspiration pneumonia, breathing problems, and calcium deposits on muscles, skin, and connective tissues.1, 2, 3, 4
The FDA grants orphan drug status to novel therapies that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 U.S residents. Aftermarket approval for the orphan designation, the FDA/OOPD will award seven years of market exclusivity.
The FDA approval is based on the results of ProDERM (ClinicalTrials.gov Identifier: NCT02728752), a pivotal randomized clinical trial and the first study to evaluate the long-term efficacy and safety of IVIg for adults with dermatomyositis. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., and is the largest study to evaluate intravenous immunoglobulin as a treatment option for DM. For more information, please visit OctapharmaUSA.com.
About Octagam® 10%
Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of:
  • Chronic immune thrombocytopenic purpura (ITP) in adults
  • Dermatomyositis (DM) in adults
Warnings
Thrombosis, renal dysfunction, and acute renal failure
Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 10%. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of immune globulin intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction, or renal failure, administer Octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Source:
Octapharma
Comment by wyndewest on Sep 01, 2021 1:29pm
Stockman, the IVIG story you posted this morning is very interesting. Already there have been over 130 reads.  You seem to have pushed a 'hot button'. Is this the same IVIG that Prometice was developing or has this been developed by a third party?  There are so many facets to the Prometic/Liminal story I have forgotten what happened with the IVIG developed by Prometic.   ...more  
Comment by stockbuphoon on Sep 01, 2021 2:38pm
While they were still doing phase 3 equivalency trials on IVIG for a slam dunk bunch of extra revenue producing a 2nd protein from Ryplazim production, mgmt decided to write down the ivig piece of business value to zero to financially engineer the recapitalization in April 2019. So, it is an important piece of the story of the theft of PLI from retail shareholders. Thomvest had full control over ...more  
Comment by wyndewest on Sep 02, 2021 11:57am
stockbuphoon, thanks for a reply. I hadn't thought of managements' lucrative salaries as a motivation to help scuttle PLI/LMNL so Thomvest could take the IP (intellectual property) for themselves  but YES it all makes sense now. Liminal mnagement has been receiving VERY generous slaries for basically doing very little to promote the science, just keeping the ship afloat. It's so ...more  
Comment by GoBBs on Sep 03, 2021 8:37am
wyndewest, you nailed it .."The lack of integrity is stunning"  and why they will lose in court.
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