PB:
Just some quick notes to provide "ten years ago" perspective. This may be useless.
:-)
Campath was invented in the labs of Herman Waldmann, M.D., Ph.D. When I first met him, he was exclusively committed to consulting for Wellcome. Campath was Welcome's for all indications, I believe.
I begged him to, upon expiration of his agreement with Wellcome, go non-exclusive on the renewal and to join the Scientific Advisory Board at XOMA. FYI, that's also how XOMA initially got into humanization (apart from the independent program that was subsequently acquired in Santa Monica...... :-), as Waldmann was collaborating with Greg Winter. Winter had a tiny office off of a small, crowded lab..... amazing science that has derived from that single building at MRC.
10-K snippet......
In addition, LeukoSite has an exclusive license from BTG under United
States and foreign patents and patent applications, variously covering certain
humanized antibodies against the CAMPATH antigen, pharmaceutical compositions,
host cells useful in the production of such antibodies, processes of producing
such antibodies and medical uses of such antibodies. The Company also has a
non-exclusive sublicense from BTG under additional U.S. and foreign patents and
patent applications, including U.S. patents which cover a method of treating a
human suffering from a disease or disorder, such as a cancer or a T
cell-mediated disorder.
Sorry, but I can't find any reference to indications other than CLL. It *could* be that Wellcome and/or BTG has retained rights to NHL, and that LKST's exclusive rights are for CLL only? Damn 10-K really doesn't clear up much..... guess it's a question to bounce off of IR.
BTW..... some at SI have expressed interest in the patents underlying antibody humanization. Here's the relevant snip from the old 10-K, for a company that licensed a MAb that was humanized in Europe.....
The Company's product candidates LDP-01, LDP-02 and LDP-03 are recombinant
humanized, complementarity determining region ("CDR")-grafted, monoclonal
antibodies. The Company is aware that patents have been issued in the United
States to third parties which relate to processes for producing recombinant
antibodies, compositions such as vectors and host cells useful in the production
of recombinant antibodies, CDR-grafted humanized antibodies, processes for
producing CDR-grafted humanized antibodies and compositions such as vectors and
host cells useful in the production of CDR-grafted humanized antibodies. Patents
have also been granted to these parties in Europe, but the European patents have
been opposed by third parties. The Company may be required to seek licenses
under these patents for its humanized antibody products.
The Company is also aware of patents which have been issued to a third
party in the United States and Europe variously relating to "chimeric"
immunoglobulins and immunoglobulin chains, processes for production of such
chimeric molecules and compositions such as vectors and host cells useful in the
production of chimeric molecules. The European patent has been opposed by third
parties and a decision by the Opposition Division revoking this patent has been
appealed, which reinstates the patent during the appeal process. The Company,
based on the analysis of Hamilton, Brook, Smith & Reynolds, P.C., the Company's
patent counsel, believes that, properly construed, the United States claims do
not cover the Company's LDP-01, LDP-02 or LDP-03 product candidates. It is
uncertain whether any claims in the European patent will survive, or if they do,
whether such claims will cover the Company's product candidates.
The Company is also aware of patents which have been issued to third
parties in the United States and/or Europe variously relating to certain
humanized immunoglobulins, pharmaceutical compositions comprising such
immunoglobulins, methods of producing such humanized immunoglobulins,
compositions such as nucleic acids, vectors and host cells useful in the
production of such humanized immunoglobulins and
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methods of using of modified humanized immunoglobulins. The European patents in
these areas have also been opposed by third parties. The Company, based on the
analysis of Hamilton, Brook, Smith & Reynolds, P.C., the Company's patent
counsel, believes that, properly construed, the U.S. patent claims do not cover
the Company's LDP-01 and LDP-03 product candidates. The Company is uncertain
about the validity and scope of claims which have issued in the United States.
If it is finally determined that one or more valid claims do encompass LDP-02,
the Company will be required to seek a license or cease development, manufacture
and sale of such product. It is uncertain whether any claims in the European
patents will survive the opposition proceedings, or if they do, whether such
claims will cover the Company's product candidates.
The Company is also aware of other third party published applications
relating to altered antibodies, methods of use of altered antibodies and methods
of production of altered antibodies. To the Company's knowledge, neither these
applications nor possible unpublished counterpart applications have proceeded to
grant in Europe or have issued as U.S. patents. There can be no assurance that
the Company will not be required to seek a license to some or all of the patents
which might issue from these patent applications.
The Company may be required to seek or choose to seek licenses to some or
all of these or other patents in order to develop and commercialize certain
product candidates or potential products incorporating the Company's technology
in the United States, Europe and other markets. There can be no assurance that
such licenses, if required, will be available to the Company, or if available,
will be obtainable on commercially acceptable terms, and the failure to obtain
such licenses could have a material adverse effect on the Company. In the
absence of required licenses, the patent owners may obtain an injunction, which
could prevent the manufacture, sale and use of the Company's products, with
material adverse effects on the Company. In addition, assuming such patents are
valid and enforceable, the Company can provide no assurances that, if
enforcement actions are brought by the patent owners against the Company, such
actions would be resolved in the Company's favor. The Company may also choose to
challenge the validity of one or more patents or patent claims. Any such action
or challenge could result in substantial costs to the Company and diversion of
Company resources and could have a material adverse effect on the Company.
Moreover, there can be no assurance that the Company would be successful in
defending against an infringement action or in challenging any such patents or
patent claims, and the failure to do so could have a material adverse effect on
the Company. If the Company does not obtain any required license, it could
encounter delays in product development while it attempts to design around the
patents, or it could find that the development, manufacture or sale of products
requiring such licenses could be foreclosed. |
