Globally renowned US body Clinical and Laboratory Standards Institute (CLSI) awards high susceptibility breakpoints to Zaynich (Zidebactam/Cefepime- WCK 5222). This is 1st time ever that an antibiotic has been granted a susceptible breakpoint of as high as 64 mg/L for all the three families of Gram negative pathogens; Enterobacterales, Pseudomonas and Acinetobacter.
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I also loved this one.
WCK 5222 has been used successfully for a US patient!
Cleared out a nasty infection of metallo-β-lactamase-harbouring P aeruginosa in a young cancer patient, who was administered the drug on compassionate grounds, since there were no other treatment options left. 4 weeks, all clear, and well tolerated.
Feel proud that an Indian company has innovated like this.
Disclosure: Invested from lower levels, this is one of my investments âfrom the heartâ (though I know one should never do this, whatâs the fun if you donât listen to your heart?)
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Hi Shreya28, tell me one thing, if WCK5222 being NCE, if gets all clinical trials through, will it get PRODUCT PATENT and exclusivity of 15-20-25 years for global markets?
Short answer, the patent for WCK5222 expires in 2031-32.
Longer answer â the game of patents.
The patent system is very complex. In general companies file for multiple patents for any potential drug protecting different aspects of the chemical, e.g. its composition, X-ray diffraction, uses, delivery devices, process for manufacturing, etc. For example, the patent for composition, preparation and antimicrobial use of bicyclic-acyl hydrazides expires in 2032. One member of this family of hydrazides is zidebactam - the patent for zidebactam/cefepime expires in 2034. There are many other patents related to this family of chemicals, all of which are publicly available information.
However, the interesting game starts once a patented drug is approved by the FDA. Companies file hundreds of patents to keep their drugs out of the hands of generic competition and prolong their profits â this is called âevergreeningâ which is unethical but widely accepted tactics. Competitors sue the original drugmakers to get small tweaks and generics to the market. Moreover, if the drug is a blockbuster, then the game becomes more competitive: Multi-billion dollar companies will go through every line of their patent filings to find loopholes to get their hands on the drug, often using hostile takeovers or out-of-court settlements. The main question is not the actual expiry date of the patents, but whether the company can stand up to this âgameâ.
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whats the implication of this approvalâŚwould appreciate some clarity on this
So the future sebi chief should have nothing to do with anybody who has less than 6 degrees of separation from any past , present and future listed company . Renting premises to a subsidiary of a listed company(probably notâŚonly same owner) can not be legally or morally corrupt unless one can show that the rent is bribe . Very similar to the ICICI allegation, investors should ignore the noise unless they are invested in Madhabi Buch instead of the company being dragged into the political mudbath.
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