
July 25th, 2007
SPECTRUM
PHARMACEUTICALS ACQUIRES FROM INDENA WORLDWIDE RIGHTS TO
ORTATAXEL, A PHASE 2 THIRD GENERATION TAXANE
- More Than 350 Patients
Have Been Treated In Phase 1 & 2 Studies - Ortataxel
Is Orally Bioavailable - May Have Activity In Taxane-Refractory
Tumors
IRVINE, Calif. and MILAN, Italy, July 25, 2007 - Spectrum Pharmaceuticals,
Inc., (Nasdaq: SPPI) and Indena S.p.A. today announced the
signature of a worldwide license agreement for ortataxel,
a third-generation taxane classified as a new chemical
entity (NCE) that has demonstrated clinical activity in
taxane-refractory tumors. Spectrum Pharmaceuticals has
acquired worldwide rights from Indena S.p.A., the Italian
company which discovered ortataxel, and will make an
upfront payment plus regulatory and sales milestones, and
royalties on future net sales.
"Ortataxel has demonstrated activity in taxane-refractory
tumors in Phase 2 trials, and has shown oral
bioavailability. It is a perfect fit for our risk-reduced
business model, as we further strengthen our diversified
portfolio with late stage drugs and continue to add value
to our Company," said Rajesh C. Shrotriya, M.D.,
Chairman, President and Chief Executive Officer of
Spectrum Pharmaceuticals, Inc. "We believe that with
further clinical development, ortataxel could be an
effective treatment option within the multi-billion dollar
taxane market."
Commenting the news, Dario Bonacorsi, President and CEO
of Indena S.p.A., said: "We are proud of this
agreement that confirms the success of one of our research
lines dedicated to the discovery of NCEs in the
anti-cancer area. We trust Spectrum's expertise and
knowledge for the further study of the product and taking
it to the market".
Under the terms of the agreement, Spectrum
Pharmaceuticals gains exclusive worldwide development and
commercialization rights to ortataxel and will take the
lead in developing the drug. Spectrum is to provide an
upfront payment to Indena S.p.A., and will also make
additional payments based on the achievement of certain
regulatory and sales milestones. Spectrum Pharmaceuticals
will also pay Indena single digit royalties on worldwide
sales of ortataxel.
About Ortataxel
Ortataxel (14-beta-hydroxydeacetylbaccatin) belongs to
a new generation of taxanes with the potential to be
active in tumors resistant to Bristol-Myers Squibb's
Taxol(R) (paclitaxel) and Sanofi-Aventis' Taxotere(R) (docetaxel).
The bioavailability of ortataxel following oral
administration has been confirmed in previous studies.
Phase 2 studies in taxane-refractory solid tumors have
indicated a substantial level of activity. The safety
profile of ortataxel so far has been comparable to that of
paclitaxel and docetaxel.
About Indena S.p.A.
Indena is the world's leading company dedicated to the
identification, development and production of active
principles derived from plants, for use in the
pharmaceutical, health-food and cosmetics industries.
Indena, a privately owned Italian company, has around 700
employees, including 10% dedicated to full-time research.
Backed up by over 80 years of botanical experience, the
phyto-chemical research is carried out in Indena's own
Settala Research Center, near Milan. Indena is currently
focusing on the development of anti-cancer drugs,
following the successes of paclitaxel. Indena's
decades-long global presence in the botanical extraction
industry is a guarantee of its production reliability,
market and regulatory worldwide environment knowledge. The
company has more than 150 primary patents and has
published around 700 scientific studies. For more
information, please visit our website http://www.indena.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and
commercializes a diversified portfolio of oncology drug
candidates that meet critical health challenges for which
there are few other treatment options. Spectrum's
expertise lies in identifying undervalued drugs with
demonstrated safety and efficacy, and adding value through
further clinical development and selection of the most
efficient methods of commercialization. The company's
pipeline includes promising early and late-stage drug
candidates with unique formulations and mechanisms of
action that address the needs of seriously ill patients,
such as at-home chemotherapy and new treatment regimens
for refractory disease. For more information, please visit
our website at http://www.spectrumpharm.com.
Forward-looking statement - This press release may
contain forward-looking statements regarding future events
and the future performance of Spectrum Pharmaceuticals
that involve risks and uncertainties that could cause
actual results to differ materially. These statements
include but are not limited to statements that relate to
our business and its future, Spectrum's ability to
identify, acquire, develop and commercialize its portfolio
of drug candidates, the Company's promising pipeline, our
team's ability to identify promising drugs and move these
drugs through development and toward commercialization,
that ortataxel may have activity in taxane-refractory
tumors, the oral bioavailability of ortataxel, that
ortataxel could be an effective treatment option within
the multi-billion dollar taxane market, the safety and
efficacy of ortataxel, that ortataxel belongs to a new
generation of taxanes with the potential to be active in
tumors resistant to Bristol-Myers Squibb's Taxol(R) (paclitaxel)
and Sanofi-Aventis' Taxotere(R) (docetaxel). and any
statements that relate to the intent, belief, plans or
expectations of Spectrum or its management, or that are
not a statement of historical fact. Risks that could cause
actual results to differ include the possibility that our
existing and new drug candidates, may not prove safe or
effective, the possibility that our existing and new drug
candidates may not receive approval from the FDA, and
other regulatory agencies in a timely manner or at all,
the possibility that our existing and new drug candidates,
if approved, may not be more effective, safer or more cost
efficient than competing drugs, the possibility that our
efforts to acquire or in- license and develop additional
drug candidates may fail, our lack of revenues, our
limited marketing experience, our dependence on third
parties for clinical trials, manufacturing, distribution
and quality control and other risks that are described in
further detail in the Company's reports filed with the
Securities and Exchange Commission. We do not plan to
update any such forward-looking statements and expressly
disclaim any duty to update the information contained in
this press release except as required by law. Information
provided by Indena S.p.A. has not been independently
verified by Spectrum.