Spectrum Pharmaceuticals Poised to Acquire 100% Interest in RIT Oncology LLC[TM] Joint Venture upon CTI's Fulfillment of Closing Conditions.* Cell Therapeutics Exercises Its Option To Sell Its Interest In ZEVALIN([R]) JV; Spectrum Has Up to 30 Days to Close
* FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. Sets July 2, 2009 as New PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) Action Date For ZEVALIN in First Line Consolidation Therapy After Additional Data Was Received on February 5, 2009
* FUSILEV Sales to Date Are Expected To Substantially Fund the Acquisition Cost of Up To $18 Million
* Plans for ZEVALIN on Track; Strong Synergies with FUSILEV Anticipated
* Spectrum Will Host a Conference Call on Thursday, February 26(th) at 1:30pmET/10:30amPT
IRVINE, Calif. -- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI SPPI Sprague's Pipit (bird species Anthus spragueii )
SPPI Stormin Protection Products Inc.
SPPI Structure of Policy Provisioning Information ) today announced that Cell Therapeutics exercised its option to sell its 50% ownership interest in RIT RIT,
n See therapy, regenerative injection. Oncology LLC (Logical Link Control) See "LANs" under data link protocol.
LLC - Logical Link Control [TM] to Spectrum for up to $18 million, in three installments (closing, 45 days from closing, 90 days from closing). Per the agreement, Spectrum will have up to 30 days in which to close, assuming CTI (Computer Telephone Integration) Combining data with voice systems in order to enhance telephone services. For example, automatic number identification (ANI) allows a caller's records to be retrieved from the database while the call is routed to the appropriate party. fulfills all closing conditions. After the close of the transaction, Spectrum Pharmaceuticals will have 100% ownership in RIT Oncology LLC, and will be responsible for all manufacturing, sales, marketing, and commercialization activities for ZEVALIN([R]) (ibritumomab tiuxetan ibritumomab tiuxetan Warning - Hazardous drug!
Pharmacologic class: Monoclonal antibody
Therapeutic class: Antineoplastic
Pregnancy risk category D ).
ZEVALIN is currently approved for the treatment of patients with relapsed or refractory, low-grade or follicular fol·lic·u·lar
1. Relating to, having, or resembling a follicle or follicles.
2. Affecting or growing out of a follicle or follicles. B-cell non-Hodgkin's lymphoma non-Hodg·kin's lymphoma
Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells.
Non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ), including patients who have rituximab-refractory follicular NHL.
"We are very excited at the prospect of a 100% ownership in RIT Oncology," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Following the anticipated approval of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma, we expect the combination of compelling new clinical data, together with anticipated regulatory and reimbursement changes and a robust sales and marketing effort, to substantially improve patient access to ZEVALIN. Securing full rights to ZEVALIN following the close of this transaction should also increase the return on our investment, and facilitate synergies with our FUSILEV franchise. Additionally, we expect FUSILEV sales to date to substantially fund the ZEVALIN acquisition."
On November 28, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.
An amendment to the sBLA was received by FDA on February 5, 2009. This submission was considered to be a major amendment, and because the receipt date was within three months of the user fee goal date, FDA extended the goal date by three months to July 2, 2009, to allow for a full review of the amendment.
Webcast and replays: www.spectrumpharm.com.
ZEVALIN[R] (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab-refractory
follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naove, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex symptom complex
A group of symptoms that occur together and are characteristic of a certain disease, disorder, or condition. have occurred within 24 hours of rituximab (Rituxan([R])) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin.
Of, relating to, or affecting the skin.
Pertaining to the skin. and mucocutaneous mucocutaneous /mu·co·cu·ta·ne·ous/ (-ku-ta´ne-us) pertaining to or affecting the mucous membrane and the skin.
Of or relating to the skin and a mucous membrane. reactions have been reported. The most serious adverse reactions adverse reactions,
n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. of the ZEVALIN therapeutic regimen were primarily hematologic hematological, hematologic
pertaining to or emanating from blood cells.
total and differential white cell counts, hematocrit estimation, erythrocyte count. , including neutropenia Neutropenia Definition
Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. , thrombocytopenia Thrombocytopenia Definition
Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia acute myelogenous leukemia
n. Abbr. AML
Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells White blood cells
A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system.
Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies and normally spreads through the lymphatic system lymphatic system (lĭmfăt`ĭk), network of vessels carrying lymph, or tissue-cleansing fluid, from the tissues into the veins of the circulatory system. , a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms - aggressive NHL, a rapidly spreading acute form of the disease, and indolent indolent /in·do·lent/ (in´dah-lint)
1. causing little pain.
2. slow growing.
1. Disinclined to exert oneself; habitually lazy.
2. NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
About First-Line Consolidation Therapy
Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.
About RIT (Radioimmunotherapeutics) Oncology, LLC
Spectrum Pharmaceuticals and Cell Therapeutics are the sole members of the LLC, whose sole purpose is to commercialize ZEVALIN in the United States. The LLC is governed by a Board of Managers comprised of an equal number of members from both companies. Both parties are to equally provide for the future capital requirements Capital requirements
Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. of the LLC and share equally in the profits and losses of the LLC.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum's website at http://www.spectrumpharm.com.
Forward-looking statements -- 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 Spectrum's business and its future, the safety and effectiveness of ZEVALIN, that we anticipate approval of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin's lymphoma, that CTI will fulfill all of its obligations to close the transaction, that we expect the combination of compelling new clinical data, together with anticipated regulatory and reimbursement changes and a robust sales and marketing effort, to substantially improve patient access to ZEVALIN, that securing full rights to ZEVALIN following the close of this transaction should also increase the return on our investment, and facilitate synergies with our FUSILEV franchise, that we expect FUSILEV sales to date to substantially fund the ZEVALIN acquisition 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 Spectrum's existing and new drug candidates, may not prove safe or effective, the possibility that its 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 its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. 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.[R] is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN[R] is a registered trademark of RIT Oncology LLC, and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.
[c] 2009 Spectrum Pharmaceuticals, Inc.