|
|
Post by mango on Oct 23, 2017 22:56:26 GMT -5
BIOMM SA—CVM Filing October 23, 2017 BIOMM SARELEVANT FACTBIOMM SA ("Company" or "Biomm"), in compliance with the provisions of CVM Instruction 358 of January 3, 2002, as amended, hereby informs its shareholders and the market in general that, as of the date of the rejection by ANVISA of the application for registration of the product Glargilin® (insulin glargine). The Company informs that this decision is still subject to appeal and will take the appropriate measures to try to reverse it, as well as keep its stockholders and the market in general updated on future developments of the subject matter of this relevant fact. Belo Horizonte, October 23, 2017. ir.biomm.com/default_download.asp?NArquivo=(Biomm)%20Fato%20Relevante%20-%20Indeferimento%20Glargina.pdf&arquivo=E3AC457E-AB7A-4258-9E0D-190DE03181F3 |
|
|
|
Post by mango on Oct 23, 2017 23:49:17 GMT -5
The company that is partnered with BIOMM SA that developed and manufactures this insulin is the Chinese company called, Gan & Lee Pharmaceuticals.
In 2002 they developed the first long-acting insulin analog (insulin glargine) in China and called it Basalin. This is what was rejected by ANVISA I presume, but in this case is called Glargilin, which is the brand name it is sold under in the Philippines. Never heard of this Glargilin.
Now I am curious. Will look at Gan & Lee patents (if they exist) and see what these folks are up to.
|
|
|
|
Post by mango on Oct 24, 2017 1:54:13 GMT -5
Gan & Lee have what seems to be an extremely small number of patents for a company that was established in 1998. WIPO is showing 5. Justia is showing 2 (same one on WIPO).
Their current interest appears to be in protein kinase inhibitors.
Hmm. I'm not impressed.
I seem to recall a MannKind patent that talked about using Technosphere technology with other insulins. Something about stabilization. Wonder if a basal insulin was in there, will have to look.
Anyways, I would imagine that Afrezza will be approved by the Brazilian drug authority. MannKind has a state-of-the-art facility, has never received an FDA warning letter, and has a very stable insulin formulation. Maybe a new study can be done with BIOMM on the stability of Afrezza in the Brazilian climate without refrigeration. Maybe there is no need to do that.
BIOMM seems interested in establishing themselves as a leader in the Brazilian pharmaceutical arena. BIOMM did partner with a company and developed a dermocosmetic cream that utilizes nanoparticles to potentiate the essential oils in the product. It will be interesting to see how well this product works for people.
BIOMM also seems interested in vaccines. Interestingly, they point out in a page on their website that the currently available streptococcus pneumoniae vaccines lack safety and efficacy data, particularly in diabetics. Hmm. I recall a 2012 paper featuring several authors, notably Andras Toro of MannKind Corporation, that discusses the development of a class of selective bacterial protein synthesis inhibitors (4H-pyridopyrimidines) and S. pneumoniae was one the several bacteria tested in this study. I wonder how interested in vaccines BIOMM is? Jose M. Galarza of TechnoVax I believe is from SA. Possibly Argentina.
Side note: A few days ago BIOMM and Celltrion Healthcare (South Korea) announced a partnership to distribute Cellitron's monoclonal antibody biosimilar in Brazil. The drug is called Herzuma, and apparently used in treating HER2-positive breast tumors. I think MannKind is also interested, a little, in monoclonal antibodies and also cancer.
This definitely seems plausible. Attracting the interests of other companies to use in biosimilars. Apparently the FDA is encouraging something to do with biosimilars according a Tweet from the Commissioner. Mike knows something about that. Wonder what the value is to a company doing biosimilars when you figure in the patent protection of Technosphere and the inhalers along with the expertise MannKind now has via Mike. Wonder if someone will make an offer to use Technosphere for biosimilars? Of course that would probably put all other biosimilars out of use and establish an alternative to the biosimilar injections. Considering how significant biosimilars will become in the future, I would guess that MannKind becomes pretty valuable, possibly establishing a position of strength when having a negotiation.
🦉
|
|
