Avid Bioservices Inc (CDMO): 12-14-11: New Avid customer WILEX/IBA (G...

Reply Private New

Replies (1) Next 10 Prev Next

Send PM Follow Ignore

Followers	72
Posts	4827
Boards Moderated	0
Alias Born	01/24/2004

cjgaddy

Re: cjgaddy post# 67607

Thursday, 12/15/2011 9:31:00 AM

Thursday, December 15, 2011 9:31:00 AM

12-14-11: New Avid customer WILEX/IBA (Germany/Belgium) reports that Avid has “successfully completed the production run of the 3rd consecutive consistency lot for process validation of the naked antibody Girentuximab”, which the FDA requested in June’11 be made an “integral part of the Wilex’s BLA filing for REDECTANE (PET Tracer)”…

12-14-11: “WILEX & IBA Update on Development of REDECTANE PET Tracer”
http://medicalphysicsweb.org/cws/article/newsfeed/48102
MUNICH & BELGIUM, 14Dec2011: …WILEX & IBA also report today on the progress made on the CMC issues discussed in the Pre-BLA Meeting in Q2-2011. WILEX’s manufacturing partner Avid Bioservices, Inc., Tustin, CA, USA, has successfully completed the production run of the third consecutive consistency lot for process validation of the naked antibody Girentuximab. IBA, responsible for radioactive labelling of the antibody, is assembling the data on the commercial production of REDECTANE…
About REDECTANE
The drug candidate REDECTANE (INN: 124I-Girentuximab) is the radioactively labeled form of the antibody Girentuximab and is being developed for the pre-surgical diagnosis of clear cell Renal Cell Cancer (ccRCC)… In May 2010 WILEX published final data of the Phase III REDECT trial with REDECTANE. REDECTANE fulfilled expectations in distinguishing clear cell from non-clear cell renal cell carcinoma. The results of the study demonstrate that PET/CT with REDECTANE lead to a significantly improved diagnosis in comparison to CT alone. . .
- - - - - - - - - - - -
• German drug developer WILEX: http://www.wilex.de/index.htm
• Belgium Radiopharmaceutical developer Ion Beam Applications (IBA): http://www.iba-worldwide.com

6-17-11: Avid producing "Redectane" (girentuximab) for WILEX/IBA (Germany/Belgium): http://tinyurl.com/3kre928
...S.King 9-8-11/Stifel: "Wilex is completing their Ph.3 studies and we're anticipating being their commercial launch facility." http://tinyurl.com/3sbvf2h

= = = = = = = = = = = = = = = =
8-31-11 : New Avid customer IBA/WILEX working on getting REDECTANE approved in the U.S (“two issues remain”). Avid now producing a 3rd lot of the component antibody Girentuximab, which the FDA wants “to be made an integral part of the BLA filing”…
http://tinyurl.com/3kre928
8-31-11/Belgium: IBA (Ion Beam Applications) today released its consolidated results for the H1-2011…
Pg5: In June 2011, during a joint press conference, IBA and its partner WILEX AG commented on the letter from the FDA following the "Pre-BLA meeting" (preparatory meeting for the introduction of the application for marketing authorization of a pharmaceutical product) for REDECTANE®.. . . The FDA also discussed manufacturing process issues and requested that the 3rd lot of the antibody Girentuximab being produced on site at Avid Bioservices, Inc., (Tustin, CA) and be made an integral part of the filing (and not submitted in the course of the approval process as hoped) and also requested additional information on the product characterization and the validation processes by IBA, responsible for the marking of the antibodies. It is important to remember that the phase 3 trial of on the product showed that the PET/CT associated with REDECTANE® leads to a much better diagnosis than with the CT alone…