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Saturday, 05/22/2010 5:15:25 PM

Saturday, May 22, 2010 5:15:25 PM

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4-21-10: Affitech sub-licenses PPHM’s 2C3/R84 to Russia’s NTS-Plus – targets “speedy development”...

Recall, in 7-2009 PPHM licensed the Fully-Human version of its “2C3” Anti-VEGF mab (aka R84 & AT001) to Affitech for: $250k upfront, $1,000,000 “upon delivery of a pre-clin. dev. package”, and “up to $16,500,000 in future milestone payments based on the achievement of all clinical & regulatory milestones for initial product approval plus a royalty on net sales, as defined in the agreements” [ see pg.16 of PPHM’s 10-31-09 10-Q http://tinyurl.com/mfppjh ].

Affitech’s Chairman Aleksandr Shuster in a subsequent 5-19-10 update (see below) said:
“The speedy & efficient development of the anti-VEGF [R84=AT001 = FH2C3] and anti-CCR4 programs with NTS Plus is expected to fuel the next stage of the Company's growth. Developing these programs in Russia is expected to produce human clinical data faster than we could otherwise achieve and this provides a rapid path to value creation for our shareholders.”

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5-19-10: Affitech Announces Organizational Changes
• CEO Replaced by COO
Affitech Retains Focus on GPCR Targets and Speedy Development of Pipeline Programs with Russian Partner NTS Plus
https://newsclient.omxgroup.com/cdsPublic/viewDisclosure.action?disclosureId=402756&messageId=485139
Copenhagen & Oslo, May 19th, 2010: Affitech A/S [ http://www.affitech.com ], (Nasdaq OMX: AFFI), the antibody medicines company, today announced organizational changes. CEO Dr. Robert Burns is leaving the Company and will be replaced by Dr. Martin Welschof as Managing Director of Affitech A/S.

INTEGRATION OF DEVELOPMENT PLANS WITH NTS PLUS
Affitech recently announced a R&D Collaboration & Licensing Agreement with Russian NTS Plus (NauchTekhStroy Plus - a biotech company 50% owned by Pharmstandard, Russia's leading pharmaceutical company, and 50% owned by Dr. Aleksandr Shuster, a leading Russian drug dev. entrepreneur). Under the Collaboration Agreement, Affitech will receive license fees of E4.5 million and up to a further E18.5 million in dev. & regulatory milestone & advance royalty payments as well as high single figure % royalties on all net product sales of the Affitech licensed products in CIS territories. Commercialization of pharmaceutical products in Russia and CIS will be provided by Pharmstandard, the leading pharmaceutical company in Russia. The collaboration focuses on 2 potential therapeutic antibody products:

I. AT001 (also known as r84), a novel, patented therapeutic antibody to vascular endothelial growth factor (VEGF) which is being developed as a potential competitor to bevacizumab (Avastin) for the treatment of certain human cancers.
[ NOTE: the above Affitech/NTS-Plus Collab. was announced on 4-21-10 – here is the announcement PDF:
https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=303067
. . . which contains this desc. of the sub-licensing of PPHM’s fully-human Anti-VEGF “2C3” Mab “R84” (aka AT001):
AT001 (also known as r84), a novel, proprietary therapeutic antibody to vascular endothelial growth factor (VEGF) which is being developed as a potential competitor to bevacizumab (Avastin) for the treatment of certain human cancers. Bevacizumab (Avastin) has yet to become the major drug in Russia that it is in most other markets and the central purchasing characteristics of the Russian market coupled with Pharmastandard’s past success in rapid market launch and sales growth are considered to increase the probability of r84 becoming a significant product in the CIS markets.” ]
II. AT008, a novel, proprietary therapeutic antibody directed against CCR4. [“AT008 targets the G-protein coupled receptor (GPCR)”]. . .

With the immediate focus of the company being the speedy implementation of the 2 leading development programs in the collaboration with NTS Plus as well as the continued dev. of Affitech's anti-GPCR discovery pipeline, Dr. Robert Burns is leaving the company as CEO and is being replaced by Dr. Martin Welschof as Managing Director Affitech A/S. . . Dr. Welschof was formerly COO and before that Managing Director of Affitech AS in Oslo, Norway. Commenting on the changes, Aleksandr Shuster, Affitech's Chairman said: “Robert has successfully led the repositioning of Affitech through to the transaction with Trans Nova and the collaboration agreement with NTS Plus and now leaves the company in the capable hands of Martin Welschof as Affitech begins the next stage of its transformation - the building of a powerful and innovative development pipeline of novel therapeutic antibody products. The speedy & efficient development of the anti-VEGF and anti-CCR4 programs with NTS Plus is expected to fuel the next stage of the Company's growth. Developing these programs in Russia is expected to produce human clinical data faster than we could otherwise achieve and this provides a rapid path to value creation for our shareholders.”
…About Affitech [ http://www.affitech.com ] *snip*
[ Affitech’s Pipeline: http://www.affitech.com/product-pipeline/therapeutic-antibodies ]

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AFFITECH-PPHM Collab: Fully-Human Mabs, Anti-PS & Anti-VEGF/2C3 http://tinyurl.com/bxyfjk
• AT001 is Fully-Human 2C3 = R84 = PGN311.
• AT004 is Fully-Human BAVI=PGN635=1N11, and AT005 is the Duke-PPHM-HIV candidate PGN632=11.31.
…4-21-10: Affitech sub-licenses Anti-VEGF mabs (incl. R84) to Russian partner NTS-Plus: http://tinyurl.com/29tzen9
...7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/n67v57
...4-28-09 Affitech comments on PGN635 & PGN632 presented at AACR'09 http://tinyurl.com/cxkcb4

ANTI-ANGIOGENESIS AGENT ’2C3’ (ANTI-VEGF MAB):
4-21-10: Affitech sub-licenses Anti-VEGF mabs (incl. R84) to Russian partner NTS-Plus: http://tinyurl.com/29tzen9
11-3-09/PLoS: R.Brekken (PPHM SRB) on R84, increases “immune cell infiltration” in Breast Cancer: http://tinyurl.com/y8ooxah
7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/n67v57
6-30-09: R.Brekken article in Mol-Cancer-Ther on 2C3/R84+Avastin vs. Breast Cancer: http://tinyurl.com/mqv5ol
12-11-08: Dr. Brekken (PPHM SRB) presents F.H. 2C3 (R84/PGN311) at TX Breast-Cancer Conf. http://tinyurl.com/63utya
11-3-07: Dr. Brekken presents ‘R84’ (F.H. 2C3, aka PGN311) data at IBC-Conf: http://tinyurl.com/yp459d
4-16-07 AACR2007: Brekken [PPHM SRB] presents fully-human 2C3 (‘R3’) http://tinyurl.com/2udkgr
”The anti-tumor activity of 2C3, which only blocks VEGFR2 compared favorably to that of Avastin, which blocks both VEGFR1+2”
2-14-05: Humanized 2C3 Pre-Clin. data presented at "Anti-Angio. Symposium": http://tinyurl.com/85qy3
2-10-05: VEGF Pioneer Dr. Donald Senger joins PPHM’s SRB to assist with 2C3 pgm: http://tinyurl.com/yul72w
5-20-03: PPHM compares 2C3 vs. Genentech’s AVASTIN: http://tinyurl.com/37k2nl
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