Exact Name of Registrant as Specified in its Charter.
State or other jurisdiction of. Address of principal executive offices.
Title of Each Class. Name of Each Exchange on Which Registered. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. These forward-looking statements involve a number of risks and uncertainties. Reference is made in particular
Apaziquone fdating forward-looking statements regarding the success, safety Apaziquone fdating efficacy of our drug products, product approvals, product sales, revenues, development timelines, product acquisitions, liquidity and capital resources and trends.
Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified.
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In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. We primarily conduct all our activities as Spectrum Pharmaceuticals. All other trademarks and trade names are the property of
Apaziquone fdating respective owners.
We are a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology. Our strategy is comprised of acquiring, developing and "Apaziquone fdating" a broad and diverse pipeline of late-stage clinical and commercial products.
In the United States, or the U. We have assembled an integrated in-house scientific team, including formulation development, clinical development, medical affairs, regulatory affairs, biostatistics and data management, and have established a commercial infrastructure for the marketing of our drug products.
We also leverage the expertise of our worldwide partners to assist in
Apaziquone fdating execution of our strategy.
Apaziquone is presently being studied in two large Phase 3 clinical trials for non-muscle invasive bladder cancer, or NMIBC, under strategic collaborations with Allergan, Inc. Our business strategy is comprised of the following initiatives: Our near-term outlook largely depends on sales and marketing successes for our two marketed drugs.
We have "Apaziquone fdating" and continue to build appropriate infrastructure and additional initiatives to facilitate broad customer reach and to address other market requirements, as appropriate. We have formed a dedicated commercial organization comprised of highly experienced and motivated sales representatives, account managers, and a complement of other support marketing
Apaziquone fdating to manage the sales and marketing of these drugs.
In addition our scientific department supports field activities through various M. There has been
Apaziquone fdating history of recurring and unreliable supply of generic leucovorin. Optimizing our development portfolio and maximizing the asset values of its components. While over the recent few years, we have evolved from a development-stage to a commercial-stage pharmaceutical company, we have maintained a highly focused development portfolio.
Our strategy with regard to our development portfolio is to focus on late-stage drugs and to develop them safely and expeditiously to the point of regulatory approval.
We plan to develop some of these drugs ourselves or with our subsidiaries and affiliates, or secure collaborations with third parties such that we are able to suitably monetize these assets. Table of Contents We have assembled a drug development infrastructure that is comprised of highly experienced and motivated M.
Duringwe achieved our goal of completing enrollment in the two Phase 3 apaziquone trials with more than 1, patients enrolled and finished the evaluation of the last patient in December We expect to file an NDA for apaziquone in We continue to work
Apaziquone fdating maximize the value of apaziquone through further developmental efforts and Apaziquone fdating trials. denuncias policia nacional online dating....
With regard to our anti-cancer drug belinostat, a novel HDAC inhibitor, we have to date opened more than clinical sites. Food and Drug Administration, or the FDA, which means, if the FDA agrees, we can start filing a rolling new-drug application even before the clinical package is ready, beginning with the filing of pre-clinical data and Chemistry Manufacturing and Control.
We have several other exciting compounds in earlier stages of development in our portfolio. Based upon a criteria-based portfolio review, we are in
Apaziquone fdating process of streamlining our pipeline drugs, allowing for greater focus and Apaziquone fdating of our development and commercial goals.
Apaziquone fdating our pipeline of development stage and commercial drugs through business development activities. It is our goal to identify new strategic opportunities that will create strong synergies with our currently marketed drugs and identify and pursue partnerships for out-licensing certain of our drugs in development.
To this end, we will continue to explore strategic collaborations as these relate to drugs that are either in clinical trials or are currently on the market. We believe that such opportunistic collaborations will provide synergies with respect to how we deploy our internal resources.
In this regard, we intend to identify and secure drugs that have significant growth potential either through enhanced marketing and sales efforts or through pursuit of additional clinical development.
Apaziquone fdating follow-on biologics, are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry. Under the agreement, we paid a nominal upfront payment and are required to make additional payments based on certain development, regulatory and sales milestones should we elect to continue development efforts.
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We believe our in-licensing of belinostat, a novel histone deacetylase, or HDAC, inhibitor, is also demonstrative of such business development efforts outlined above. Managing our financial resources effectively. We remain committed to fiscal discipline, a policy which has allowed us
Apaziquone fdating become well capitalized among our peers, despite a very challenging capital markets environment
Apaziquone fdating in and continuing through This policy includes the pursuit of non-dilutive funding options, prudent expense management, and the achievement of critical synergies within our operations in order to maintain a reasonable burn rate.
Even with the continued build-up in operational infrastructure to facilitate the marketing of our two commercial drugs, we intend to be fiscally prudent in any expansion we undertake. In terms of revenue generation, we rely on sales from currently marketed drugs and intend to pursue out-licensing of select pipeline drugs in select territories, as discussed above.
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When appropriate, we may pursue other sources of financing, including non-dilutive financing alternatives. While we are currently focused on advancing our key drug development programs, we anticipate that we will make regular
Apaziquone fdating as to which other programs, if any, to pursue and Apaziquone fdating much funding to direct to each program on an ongoing basis, based on clinical success and commercial potential, including termination of our existing development programs, especially if we do not expect value being realized from continued development.
We have highly experienced staff in pharmaceutical operations, clinical
Apaziquone fdating, regulatory and commercial functions who previously held positions at both small to mid-size biotech companies, as well as large pharmaceutical companies. We have strengthened the ranks of our management team, and will continue to pursue talent on an opportunistic basis.
Finally, we remain committed to running a lean and efficient organization, while effectively leveraging our critical resources.
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In and earlywe have continued to execute on our business strategy described above. We discuss below the key developments during that period. In "Apaziquone fdating"we entered into an agreement with Viropro, Inc. Of these, 5 papers were selected by the program committee of ASH for oral presentation. One oral presentation was recognized with special distinction as having the potential impact of changing the standard of care from current therapeutic approaches.
All studies presented at this meeting were investigator-sponsored studies. Spectrum intends to utilize a combination of company resources and partnerships to support the product outside the U. We expect to initiate Phase 2 trials in collaboration with Hanmi in We expect to receive top-line data in from two Phase 3 pivotal clinical trials for apaziquone. The two trials enrolled more than 1, patients with non-muscle invasive bladder cancer.
Through the above-referenced agreements and our continued efforts, we strive to continue to build a global pharmaceutical organization in For two of our non-U. Table of Contents Product Portfolio. We have a product portfolio consisting of both commercial stage and development stage products. While we are committed to growing the sales of our marketed products, we strive to maintain a robust pipeline of products under development to bring to market.
Some of our drugs may prove to be beneficial in additional disease indications as we continue their study and development.
In addition, we have intellectual property
Apaziquone fdating to neurology compounds that we Apaziquone fdating out-license to third parties for further development. Table of Contents Overview of Cancer. Accordingly, there is significant demand for improved and novel cancer treatments. Cancer develops when
Apaziquone fdating in a part of the
Apaziquone fdating begin to grow "Apaziquone fdating" of control.
Although there are many kinds of cancer, they all start because of out-of-control growth of
Apaziquone fdating cells. Normal body cells grow, divide, and die in an orderly fashion. After that, cells in most parts of the body divide only to replace worn-out or dying cells and to repair injuries. Because cancer cells continue to grow and divide, they are different from normal cells.
Instead of dying, they outlive normal cells and continue to form new abnormal cells. Cancer cells may develop because of damage to DNA. Most of the time, when DNA becomes damaged, the body is able to repair it. In cancer cells, the damaged DNA is not repaired.
People can inherit damaged DNA, which accounts for inherited cancers. Cancer usually forms as a tumor. Some
Apaziquone fdating, like leukemia, do not form tumors. Instead, these cancer cells involve the blood and blood-forming organs and circulate through other tissues where they may grow. Often, cancer cells travel to other parts of the body where they begin to grow and replace normal tissue. months after the expiration of...
This process is called metastasis. Regardless of where a cancer may spread, however, it is always named for
Apaziquone fdating place it began. For instance, breast cancer that spreads to the liver is still called breast cancer, not liver cancer.
Different types of cancer can behave very differently. For example, lung cancer and breast cancer are very different diseases.
Apaziquone fdating grow at different rates and respond to different treatments. That is why people with cancer need treatment that is aimed at their particular kind of cancer.
Cancer is currently treated by surgery, chemotherapy, radiation therapy, hormonal therapy, biological therapy and immunotherapy.
Cancer is referred to as refractory when it has not responded, or is no longer responding, to a treatment.
We are seeking novel drugs that address cancer or cancer related indications with significant unmet medical need, that: The CD20 antigen is found on malignant and normal B-cells. anakinra, apaziquone, aprepitant, aripiprazole, atazanavir
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