[Background from 2010.] Here is a small part of the press, out of Research Triangle, North Carolina -- KBI's home base:
. . . .KBI BioPharma will continue to provide services and development to Merck as part of the deal.
"We are very pleased to continue to advance our partnership with Merck, and to welcome this very highly regarded team of scientists in Boulder to the KBI team," said Joe McMahon, KBI’s President and CEO. "KBI will now offer expanded microbial development and manufacturing services up to 1500 Liter scale, as well as continuing to offer our current full range of process development, analytical and formulation development and mammalian manufacturing services up to 2000 Liter [scale]. . . ."
KBI also works with Merck through its two operations in North Carolina.
The company has worked with clients to develop more than 220 molecules across 55 potential health applications. . . .
Merck continues to cull its estimable herd. Makes sense. Far more sense than a $120 billion hostile inversion deal -- opposed nearly worldwide.
8 comments:
Would like to know what the terms were. KBI is now in trouble with the FDA.
I am on the case -- and will report back, Anon!
Check this space -- or if juicy enough, look for a new post!
Namaste... either way, I'll let you know here, in a few days.
One must wonder why KBI Biopharma Boulder had an FDA PAI inspection in December 2016 but the FDA has never posted any results (NAI, VAI, OAI). Results for up to March 31, 2017 have been posted so where is KBI's? Did they pass or did they fail and are facing action by the FDA?
Yes -- very astute, Anon.
It is my experience that not all FDA inspections get reported out, by FDA.
Obviously, the most common way we all read about FDA inspection outcomes that do not result in adverse administrative (or judicial) action is via press release, from the affected company -- but that pretty much only happens in '34 Act registered public companies (usually because it is required under applicable rules, as a material event).
It is the rare private company that would announce a "quiet file closure" from FDA. It is an even rarer private company that would proactively announce that things "weren't going well" with FDA -- related to potential draft 483 warning letters, being discussed.
And to close the loop on the first topic from two days ago -- thus far, I've had no luck in figuring out how much was paid -- private terms are rarely easy to discern.
Namaste, and do stop back -- for our part, we will keep looking. . . .
KBI received 9 483 observations from their FDA inspection. However, the FDA returned to their Boulder plant a month later with more observations and question. I have not heard what happened after that. There are questions concerning what commercial products KBI Boulder produced for Merck over the last three years and if KBI was approved to manufacture those products. There is a great deal of scuttlebutt about KBI on CafePharma.
Lest I be misunderstood -- I am also asking the readership to chime in, if any of you know anything recent, about the state of the play with FDA, relative to KBI's Boulder property.
I am looking to help a friend here -- no one will be identified. Ever.
Namaste
I do not know the details but do know the FDA returned several times this year (KBI's PAI was in Dec. 2016) to "investigate." Obviously, someone from KBI contacted the FDA about GMP/GDP violations hidden from the FDA. This could potentially cost KBI contracts/clients. All I can say.
The few professional people at KBI are concerned about their jobs and the utter dearth of professionalism in management. KBI's management's goal is to promise clients the impossible to get them to sign contracts. KBI's schedule is impossible to keep up with, especially when the plant can only work on one product at a time, and the clients are upset when their schedules are never met and their products are not made according to batch records. However, the majority of KBI Boulder employees are wholly apathetic about the situation...they only want a paycheck as KBI pays well as they are Japanese owned (JSR) and the company does not care about profit/loss. JSR plans to lose money now and profit as the biosimilar market grows.
The FDA "inspection" is suspect. Seven FDA inspectors at KBI Boulder for five days and they barely even walked into the plant! Sure, they found 9 483 observations but missed all else. Furthermore, the FDA inspectors asked almost no questions about the plant, processes, etc. I believe I know who the whistleblower was and that person had paid a hefty price for telling the truth. I know they told management in e-mails to Manufacturing (70+ people) some of the GMP, GDP, and safety violations and documented daily violations/problems on KBI forms. Management did not care and hid the problems, and these are serious violations of 21 CFR. Imagine...250 KBI employees and only a handful ever enter the plant, QA/QC almost never enter the plant!
I would also say more but KBI has eyes everywhere.
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