Biotech Values

[cjgaddy]

PCrutch, Peregrine is indeed making a serious move into Biosimilars, under the leadership of Dr. Robert Garnick, who joined Peregrine in Oct. 2009 as Head of Regulatory Affairs ( http://tinyurl.com/yga7z4x ). Rob was formerly Genentech’s Senior VP of Regulatory, Quality & Compliance, and was responsible for DNA’s obtaining marketing approval for 17 drug products including Rituxan, Herceptin, Avastin, and Lucentis, and 3 mfg. facilities…

The following Mgt. comments will give you an overview of Peregrine’s plans to go after Biosimilars, centered around their CMO subsidiary, Avid Bioservices.

5-18-10, CEO STEVE KING, R&R/LONDON: http://tinyurl.com/23wqam9
“On the operational side. . . In addition, we’re looking at a number of new initiatives to drive our commercial potential – things such a Biosimilars, which are now becoming more possible as part of the Healthcare Reform, are very attractive when you have an infrastructure built around biologics & biologics development, so we can really take advantage of our infrastructure as well as our strong Mgt. Team with experience in the development of drugs.”

7-14-10 CONF. CALL: http://tinyurl.com/3a4p66c
CEO STEVE KING: “On the Biosimilars program, I think we do have a high level of interest in that. Again, I think just as a follow-up to the question that George had on Avid and its potential growth in the future, having your own GMP mfg. facility in the U.S. that has been through at this point many different FDA & European inspections has a lot of potential utility. Biosimilars is certainly an area we have a high level of interest in because again it fits the nature of our business, and our infrastructure. And it’s something we can tackle without really having a significant impact on our burn rate whatsoever.
So we’ve been very actively reviewing the opportunities in the biosimilars space, which ones best fit with our core capabilities, as well as our capacity. And I think we’re quite excited at the appropriate time to be able to roll out our plans in that area, and so you can see the progress that we are planning on making there. And Rob, I don’t know if you want to expand on that at all.”

HEAD/REG., ROB GARNICK: “…in parallel with the bavituximab dev. pgm that we discussed earlier, we’ve been working equally hard I think on the Biosimilars program and really have made an astonishing amount of progress in an area, which as you can imagine is quite convoluted and difficult. But I think we’re nearing our final decisions as to which candidates to bring forward, and really probably our next step will be to solidify our final decision, and then begin discussions with the FDA about how to proceed forward with this program because as you know, the FDA now has under the Patient Protection Health Care Act that was signed into law in March, and that was a pathway for biosimilars in the U.S. and we plan to take full advantage of that pathway as soon as possible. So, a very exciting project actually.”

CEO STEVE KING: “And just to finish off here, I think one of the things that fits very nicely with our overall operations is due to the nature of the early work on Biosimilars being in the early upstream development, cell line development, assay development and what have you, it fits in very nicely with our infrastructure, our ability to take on those sort of projects with really a minimal impact on any burn rate or any significant expenses, it really makes it very appealing to us and just fits in perfectly with our overall business model for both Avid, and as well as Peregrine. So, thanks again for the question.”

= = = = = = = = = FYI:
3-31-09, DR. ROB GARNICK, BIOSIMILARS PRESENTATION:
“We recently gave a presentation to the American Society for Chemical Engineering on the latest developments on Biosimilars. This is a major area of interest for us (Lone Mountain). We are very involved with Comparability studies for Biosimilars with the Barnett institute. If you are interested in a copy of this presentation, please send an e-mail request and we will send you a copy.”
-Rob
http://lonemountainbiotechnology.com