Allos Therapeutics Inc - Free Writing Prospectus - Filing under Securities Act Rules 163/433 (FWP)
21 Maio 2008 - 7:02AM
Edgar (US Regulatory)
Free Writing Prospectus
Filed Pursuant to Rule 433
Registration Statement No. 333-143198
(Supplementing
Preliminary Prospectus Statement
dated May 19,
2008)
On
May 20, 2008, a portfolio manager for an institutional investor sent an
e-mail communication to our vice president of investor relations that included
an inquiry regarding intellectual property or other exclusivity for
pralatrexate, or PDX, our lead product candidate. Our vice president of
investor relations responded to the portfolio managers inquiry by reply
e-mail.
STATEMENTS
INCLUDED IN THE E-MAIL COMMUNICATION
The
reply e-mail includes the following inquiry from the institutional investor and
the response of our vice president of investor relations:
Inquiry:
Please remind me the IP
or other exclusivity for PDX.
Response:
Here is a summary of PDX
exclusivity. Please let me know if you
have any additional questions.
UNITED STATES
Patent Protection
July 16, 2017 for
PDX substantially free of 10-deazaaminopterin (pure PDX), related
compositions, and methods of treatment
Additional applications
pending for treatment of T-cell lymphoma with PDX, methods to assess
sensitivity to PDX and combinations of PDX with gemcitabine or erlotinib
Regulatory Exclusivity
5-year new chemical entity
exclusivity after NDA approval
7-year orphan drug
exclusivity for T-cell lymphoma after NDA approval
Potential for pediatric
exclusivity
EUROPE
Patent Protection
July 16, 2017 for
pure PDX, related compositions, and methods of treatment
Patent allowed in Europe;
regionalization in process
Patents pending in Japan
and Canada
Applications pending
worldwide for treatment of T-cell lymphoma with PDX
Patent allowed in Europe;
regionalization in process
Regulatory Exclusivity
10 or 11-year data exclusivity after regulatory
approval
10-year orphan medicinal
product exclusivity for T-cell lymphoma after regulatory approval
IMPORTANT
INFORMATION ABOUT THE E-MAIL CONTENTS
The
contents of the e-mail should be balanced against the more complete information
provided in our registration statement (including the prospectus and
preliminary prospectus supplement thereto) and the further clarification set
forth below.
United States Regulatory
Exclusivity
The
statement above regarding 5-year new chemical entity exclusivity assumes that
no drug product containing pralatrexate or any ester or salt or other
noncovalent derivative of pralatrexate is approved before our PDX.
European Patent Protection
With
respect to both our European patent application directed to pure PDX, as
defined in the foregoing e-mail, and our European patent application directed
to the treatment of T-cell lymphoma with PDX, the reference to allowed means
that the European Patent Office has issued communications informing us that the
Examining Division intends to grant a European patent on the application. Both applications are awaiting grant. Regionalization with respect to such patent applications
is occurring to the extent that we have notified European counsel where we
intend to regionalize the patent and to the extent regionalization is part of
the allowance/grant process.
In
addition, investors should read the statements contained herein together with
the disclosures made in our preliminary prospectus supplement describing PDX
and the section in our preliminary prospectus supplement entitled RISK
FACTORS.
We have
filed a registration statement (including a prospectus and a preliminary
prospectus supplement thereto) with the Securities and Exchange Commission, or
the SEC, for the offering to which this communication relates. Before you invest, you should read the
prospectus and the preliminary prospectus supplement in that registration
statement and other documents we have filed with the SEC for more complete
information about us and this offering. You may obtain these documents for free
by visiting EDGAR on the SEC web site at www.sec.gov. Alternatively, we, any
underwriter or any dealer participating in the offering will arrange to send
you the prospectus if you request it by calling toll free at
(866) 500-5408.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024