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8-K - FORM 8-K - SPECTRUM PHARMACEUTICALS INC | c95815e8vk.htm |
Exhibit 99.1
COMPANY CONTACTS
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
SPECTRUM PHARMACEUTICALS LICENSES BELINOSTAT, A NOVEL ANTICANCER DRUG IN A PIVOTAL REGISTRATIONAL TRIAL
| Belinostat, a HDAC Inhibitor, is Currently in a Multicenter, Registrational Trial Under
a Special Protocol Assessment for Peripheral T-Cell Lymphoma (PTCL) |
| NDA Filing Expected Next Year (in 2011) |
||
| Granted Fast Track and Orphan Drug Designation by FDA |
| Multiple Phase 2 Trials Are Being Pursued In Various Oncology Indications Including
Carcinoma Of Unknown Primary (CUP) For Which No Drug Has Yet Been Approved |
||
| National Cancer Institute (NCI) is Conducting Multiple Trials With Belinostat |
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| More Than 700 Patients Have Been Treated With Belinostat |
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| Spectrum and TopoTarget Will Jointly Fund the Future Clinical Development Activities In
a Ratio Of 70:30 |
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| Spectrum to Host Conference Call on Thursday, February 4, 2010 at 1pmET/10amPT |
IRVINE, California February 2, 2010 Spectrum Pharmaceuticals (NasdaqGM: SPPI), a
commercial-stage biotechnology company with a primary focus in oncology, today announced that it
has entered into a co-development and commercialization agreement with TopoTarget A/S for
Belinostat, a novel histone deacetylase (HDAC) inhibitor. Belinostat is currently in a
registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or
refractory Peripheral T-Cell Lymphoma (PTCL), an indication in which it has been granted Orphan
Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). Belinostat is also
under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and
paclitaxel, for cancer of unknown primary (CUP). Additionally, the NCI is currently conducting
several clinical trials of Belinostat in a variety of hematological and solid tumors, both as
monotherapy as well as combination therapy.
The addition of Belinostat addresses our key strategic goal of in-licensing a late-stage
anti-cancer compound, said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and
President of Spectrum Pharmaceuticals. With this collaboration, we have now completed our
strategic initiatives relating to in-licensing of compounds with near term commercialization
opportunities. Belinostats current registrational program is comprehensive and focused in that it
targets key hematological indications such as PTCL and other solid tumor indications. Belinostat
has the potential to be a best-in-class HDAC inhibitor for both hematological and solid tumors. We
look forward to advancing Belinostat in PTCL and other solid tumor indications, with the goal of
providing cancer patients with more effective treatment options as quickly and efficiently as
possible. With that goal in mind, we currently expect to file the NDA in PTCL in 2011. TopoTarget
has laid a solid foundation from which we will further develop Belinostat.
So far, Belinostat has demonstrated some unique and differentiating attributes. If approved, it
would give Spectrum access to potentially large markets while allowing for enhanced coordination
with our marketed drugs, ZEVALIN and FUSILEV, added Amar Singh, Spectrums Chief Commercial
Officer. The recent expansion of our commercial infrastructure positions us to prepare for another
successful launch in the near future.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
We believe that this partnership will bring together synergies in our combined capabilities that
will result in significant efficiencies in Belinostats development, said Professor Peter Buhl
Jensen, MD,
Chief Executive Officer of TopoTarget A/S. Spectrum as a partner is ideally suited to exploit the
full benefits of the drug for cancer patients.
Under terms of the agreement, Spectrum licensed the rights to Belinostat for North America and
India, and an option for China, in exchange for an upfront cash payment of $30 million, potential
milestone payments of up to $320 million, and one million shares of Spectrum common stock based
upon the successful achievement of certain development, regulatory and commercial milestones, as
well as double-digit royalties on net sales of Belinostat. Spectrum and TopoTarget will jointly
fund development activities, whereby clinical trial costs will be 70% borne by Spectrum, and 30% by
TopoTarget for new trials to be initiated.
Conference Call
Thursday, February 4, 2010 @ 1:00p.m. Eastern/10:00 a.m. Pacific
Domestic: |
888-204-4520 | |||
International: |
913-312-0953 |
Webcast and replays: www.sppirx.com
Audio replays will be available through February 24, 2010
Domestic: International: |
888-203-1112, passcode 5055446 719-457-0820, passcode 5055446 |
About Peripheral T-Cell Lymphoma
The American cancer Society estimates that approximately 66,000 new cases of non-Hodgkins lymphoma (NHL) were diagnosed in 2009 and of these, approximately 5,600 are classified as Peripheral T-cell lymphoma (PTCL). PTCL is a group of 13 diverse types of T-cell lymphoma. Most cases of PTCL occur during adulthood, are aggressive in nature and are difficult to manage with current chemotherapies. Many patients with PTCL are treated with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or a CHOP-like regimen, but often patients will stop responding to these therapies. Studies show that only 25-40% of patients will be alive five years after treatment for PTCL, creating a real need for more effective therapies.
The American cancer Society estimates that approximately 66,000 new cases of non-Hodgkins lymphoma (NHL) were diagnosed in 2009 and of these, approximately 5,600 are classified as Peripheral T-cell lymphoma (PTCL). PTCL is a group of 13 diverse types of T-cell lymphoma. Most cases of PTCL occur during adulthood, are aggressive in nature and are difficult to manage with current chemotherapies. Many patients with PTCL are treated with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or a CHOP-like regimen, but often patients will stop responding to these therapies. Studies show that only 25-40% of patients will be alive five years after treatment for PTCL, creating a real need for more effective therapies.
About Belinostat
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have overcome drug resistance to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have overcome drug resistance to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
About the Belinostat Registrational Study
Belinostat is currently in registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for Peripheral T-Cell Lymphoma (PTCL), an indication which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). The registrational trial is in an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. The primary endpoint is objective response rate (ORR).
Belinostat is currently in registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for Peripheral T-Cell Lymphoma (PTCL), an indication which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). The registrational trial is in an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. The primary endpoint is objective response rate (ORR).
About TopoTarget
TopoTarget A/S is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer and developing improved cancer therapies. The company was founded and is run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. For more information, please refer to www.topotarget.com.
TopoTarget A/S is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer and developing improved cancer therapies. The company was founded and is run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. For more information, please refer to www.topotarget.com.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Companys strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. Spectrum markets two oncology drugs, FUSILEV® and ZEVALIN® and now has two drugs in late stage development, Apaziquone (EOquin®) and belinostat, along with a diverse pipeline. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Companys website at www.sppirx.com.
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Companys strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. Spectrum markets two oncology drugs, FUSILEV® and ZEVALIN® and now has two drugs in late stage development, Apaziquone (EOquin®) and belinostat, along with a diverse pipeline. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Companys website at www.sppirx.com.
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 Spectrums business and its future, Spectrums ability to identify, acquire, develop
and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, NDA
filing for PTCL in 2011, that Belinostat has the potential to be a best-in-class HDAC inhibitor for
both hematological and solid tumors, that we look forward to advancing Belinostat in PTCL and other
solid tumor indications, that if approved, it would give Spectrum access to potentially large
markets while allowing for enhanced coordination with our marketed drugs, Zevalin and Fusilev, 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 Spectrums existing and new drug candidates may not prove
safe or effective, the possibility that Spectrums 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 Spectrums existing and new drug candidates, if approved, may not be more effective, safer or
more cost efficient than competing drugs, the possibility that Spectrums efforts to acquire or
in-license and develop additional drug candidates may fail, Spectrums lack of significant
revenues, limited marketing experience, dependence on third parties for clinical trials,
manufacturing, distribution and quality control and other risks that are described in further
detail in Spectrums reports filed with the Securities and Exchange Commission. Spectrum does 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.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum, TURNING INSIGHTS
INTO HOPE and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals,
Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI