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Biotech / Medical : AMEV-Applied Molecular Evolution

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To: rkrw who started this subject4/3/2001 1:05:22 PM
From: tuck   of 164
 
Stock recovery fueled by MEDI starting trials with Vitaxin per this excerpt from a PRnewswire of March 13th:

>>A Phase I pharmacokinetic study has been initiated with Vitaxin(TM). This non-randomized, open-label, dose-escalating study will be conducted in 24 patients with refractory solid tumors. The objectives of the study are to determine the safety and pharmcokinetics of single and multiple doses of Vitaxin when administered intravenously. Further, the study will determine the Phase II dose and schedule for Vitaxin, and observe any evidence of anti- tumor activity. Vitaxin will be administered intravenously at up to six dose levels.
Vitaxin is a humanized monoclonal antibody that may have broad clinical applicability, including the potential to inhibit angiogenesis (the growth of new blood vessels) by binding to alpha-v-beta-3, an integrin expressed by endothelial cells and critical to new blood vessel growth. Angiogenesis is critical in the development of several diseases, including rheumatoid arthritis and psoriasis. In addition, angiogenesis is required for the growth and metastasis of malignancies.
MedImmune licensed Vitaxin from Applied Molecular Evolution, Inc. (Nasdaq: AMEV - news) in February 1999. During 2000, the two companies worked together to prepare a more potent version of the original Vitaxin molecule using AME's proprietary technology.<<

Thanks to nigel for the above from the MEDI thread.

From the recently posted 10-K:

>>Vitaxin, the Company's angiogenesis inhibitor, was exclusively licensed to
MedImmune in return for an equity investment, milestone payments and royalties.
Under the agreement, MedImmune is responsible for all future clinical
development, manufacturing and commercialization of Vitaxin. MedImmune made a
$5.15 million equity investment in the Company in February 1999 (Note 3), and
pursuant to the terms of the agreement and will pay milestones and royalties
related to the development and commercialization of any resulting products.<<

From the same document, some amendments to the MEDI antibody agreement. Haven't found the original yet to see if the initiation of trials triggers a milestone payment, but I would think it would . . .

>>1. Section 1.1 of the Agreement is restated in its entirety to read as
follows:

1.1 Within thirty six (36) months after the EFFECTIVE DATE, MEDIMMUNE
shall designate by written notice to AME, one (1) antibody for which
MEDIMMUNE desires to have AME perform a separate research and development
programs (each, a "PROGRAM") to modify such antibody. Within forty eight
(48) months after the EFFECTIVE DATE, MEDIMMUNE shall designate by written
notice to AME, one (1) additional antibody for which MEDIMMUNE desires to
have AME perform a PROGRAM to modify such antibody.

2. Section 1.3 of the Agreement is restated in its entirety to read as
follows:

1.3 Within thirty (30) days after MEDIMMUNE delivers to AME the
written notice described in Section 1.1 for a PROGRAM, provided that the
parties mutually agree upon the antibody and the target ligand, the parties
shall duly execute and deliver a Research and Assignment and License
Agreement in the form attached hereto as Appendix A, with the blanks on
Exhibit 1 thereto completed as provided above and only those modifications
as the parties mutually agree in writing.

This Amendment and the Agreement set forth the entire agreement and
understanding between the parties as to the subject matter thereof and
supercedes all prior agreements and understandings in this respect. There shall
be no amendments or modifications to this Amendment or the Agreement, except by
a written document which is signed by both parties.<<

Still looking for related documents. This is enough for one post.

Cheers, Tuck
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