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[B]ArQule Provides Strategic Update[/B] [I]Company To Focus on Oncology Discovery and Development and To Exit Chemistry Services Business[/I] WOBURN, Mass.--(BUSINESS WIRE)--Sept. 27, 2005--ArQule, Inc. (Nasdaq: ARQL) today announced a strategic update reflecting progress in both its clinical and pre-clinical programs. The Company will focus on a corporate strategy of organic growth founded on a drug discovery capability combining strengths in proprietary biology and validated chemistry and a product portfolio that offers successive internally generated opportunities to develop innovative cancer therapeutics. As a result of its successful transition to an integrated research and development company and in order to focus operationally on developing its expanding and exciting oncology portfolio, [B]ArQule has made the decision to exit its chemistry services business.[/B] The Company intends to work closely with its remaining chemistry customers to ensure their needs are supported. [B]The Company's chemistry services will have contributed revenues of approximately $46 million and $49 million in 2005 and 2004, respectively.[/B] Based on its strong financial position, ArQule expects to retain ownership of a number of clinical and pre-clinical stage programs and to progress a number of these from discovery into clinical development in the coming years. ArQule will also continue to leverage the broad spectrum of its well-established chemistry capabilities in the discovery of compounds that act on its proprietary ACT(SM) targets and other related biological targets with key roles in the onset and spread of cancer. These chemistry capabilities are designed to integrate drug-like qualities into new product candidates at the earliest stages of their development. [B]ArQule is nearing completion of the first stage of clinical trials with ARQ 501,[/B] the lead compound from its E2F checkpoint activation platform. ARQ 501, [B]partnered with Roche[/B], is in a Phase 1 clinical trial as monotherapy and in two Phase 1b trials in combination therapy with docetaxel and gemcitabine. Based on findings presented at the American Society for Clinical Oncology (ASCO) earlier this year, as well as additional evidence of anti-cancer activity observed since then and an encouraging side effect profile, [B]ArQule is planning to advance ARQ 501 into Phase 2 testing within the next three to four months. [/B]The Company expects to present final Phase 1 results with ARQ 501 in a peer-reviewed forum. [B]ArQule also plans to submit an Investigational New Drug application (IND) by the end of 2005 for ARQ 197, the lead compound of a series of proprietary compounds generated through the Company's ARQ 650RP cancer survival pathway platform.[/B] Planning for the initiation of Phase 1 studies for this compound is currently underway. ArQule currently retains full ownership of all compounds in this program. Over the coming months, the Company expects to [B]update progress on three further pre-clinical stage programs[/B], comprising a second-generation E2F activator, a selective BRAF kinase inhibitor and a novel checkpoint activator, in addition to an extensive portfolio of discovery stage programs. The targets, mechanisms of action and chemistry related to compounds generated from ArQule's oncology programs differ, offering the potential for multiple therapeutic opportunities in each one. Throughout these programs, the Company's biology capabilities are enhanced by its strengths in chemistry technology applied to the design and optimization of small molecule compounds.

 

Mal wieder was neues ArQule Announces Third Quarter Fiscal 2005 Results; Conference call scheduled today at 9 a.m. eastern time WOBURN, Mass., Oct 27, 2005 (BUSINESS WIRE) -- ArQule, Inc. (NASDAQ: ARQL) today reported its results of operations for the fiscal quarter ended September 30, 2005. The Company reported total revenues of $13,194,000 for the quarter ended September 30, 2005, compared to revenues of $14,594,000 for the third quarter of 2004. Revenues for the nine months ended September 30, 2005 were $40,591,000, compared to revenues of $40,367,000 for the same period in 2004. The Company reported a net loss of $916,000, or $0.03 per share, for the quarter ended September 30, 2005, compared to a net profit of $1,472,000, or $0.05 per share, for the quarter ended September 30, 2004, which included a one-time restructuring credit of $1,496,000 associated with a lease commitment. For the nine-month period ended September 30, 2005, the Company reported a net loss of $4,787,000, or $0.14 per share, compared to a net loss of $3,912,000, or $0.14 per share, for the nine-month period ended September 30, 2004. For the quarter ended September 30, 2005, the Company reported total costs and expenses of $15,255,000, compared with $13,442,000 for the third quarter of 2004. Total costs and expenses for the nine months ended September 30, 2005 were $47,275,000, compared to $45,014,000 for the same period in 2004. ArQule ended the third quarter of fiscal 2005 with approximately $134,000,000 in cash and marketable securities. "As we near the end of 2005, ArQule is approaching a number of milestones which will increasingly define us as a product-focused company with an exciting and rapidly expanding portfolio," said Dr. Stephen A. Hill, president and chief executive officer of ArQule. "Our strong commitment to oncology, which has fueled the expansion of this promising portfolio, also guided our recent decision to exit our chemistry services business in an orderly fashion, as we announced last month. We will work closely with our remaining chemistry customers to ensure their needs are supported. We are retaining our core chemistry expertise, however, which I believe differentiates us from other biotechnology companies and allows us to integrate drug-like qualities into new product candidates from the earliest stages of their development," said Dr. Hill. "We expect to begin the first of several Phase 2 trials by the end of the year or early next year with ARQ 501, our lead product, which is partnered with Roche," said Dr. Hill. "Phase I clinical trials with ARQ 501 as monotherapy and in combination therapy continue to demonstrate anti-cancer activity with an acceptable side effect profile," said Dr. Hill. "We have completed GLP toxicity testing with ARQ 197, a proprietary compound discovered through our 650 RP program, and we plan to file an Investigational New Drug (IND) application by year-end," said Dr. Hill. "We are also making exciting progress in pre-clinical programs that target additional critical pathways in the development of cancer, including those involving BRAF kinase and mitotic checkpoints." "Finally, our financial position allows us the flexibility to retain ownership over a number of our key programs and to add value to these programs through additional clinical development activities planned for initiation in the near future," said Dr. Hill. Investor Conference Call ArQule will host an investor conference call today at 9:00 a.m. eastern time. Dr. Stephen A. Hill, president and chief executive officer, and Louise A. Mawhinney, vice president and chief financial officer, will lead the call. Date: Thursday, October 27, 2005 Time: 9:00 a.m. eastern time Conference Call Numbers Toll free: 866.314.4483 Toll: 617.213.8049 Participant Passcode: ArQule Webcast: [URL]http://www.ArQule.com[/URL] A replay of the conference call will be available for five days and can be accessed by dialing 888.286.8010 from the U.S. and Canada, and 617.801.6888 from outside the U.S. For archived calls, the access code is 16419710.

 

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ArQule Files IND for Selective Oral c-Met Inhibitor, ARQ 197; Company Moves Toward Clinical Testing with Second Product WOBURN, Mass.--(BUSINESS WIRE)--Dec. 1, 2005--ArQule, Inc. (NASDAQ: ARQL) today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ARQ 197, an orally administered, proprietary small molecule c-Met inhibitor to treat cancer. "Filing of this IND marks the achievement of a major corporate goal for 2005 as scheduled," said Dr. Stephen A. Hill, president and chief executive officer of ArQule. "Pending review and clearance by the FDA, we plan to initiate a Phase 1 clinical trial with ARQ 197 in early 2006." ARQ 197 inhibits and kills cancer cells by selectively targeting c-Met, a receptor tyrosine kinase that plays multiple key roles in human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. c-Met is inappropriately expressed in almost all types of human cancer, with a definitively established role in tumor development. Activating mutations of c-Met have been increasingly identified in human cancer. "c-Met is one of the most compelling molecular targets for cancer therapy," said Dr. Chiang J. Li, chief scientific officer and vice president, head of ArQule Biomedical Institute. "In our studies, ARQ 197 selectively and potently inhibits c-Met with broad-spectrum activity against cancer cells, and it has shown potent anti-tumor activity against several types of xenografted human tumors in mice. "Despite the promise of c-Met as a cancer target, the discovery of a selective c-Met inhibitor has posed a difficult challenge to our industry," said Dr. Li. "The discovery of ARQ 197 and our rapidly expanding pipeline reflect the synergy between our combined strengths in biology and small molecule chemistry." About c-Met c-Met is a member of a class of molecular targets known as receptor tyrosine kinases (RTKs) that have emerged with significant potential for anti-cancer therapy. The encouraging results with agents such as Imatinib against cancers with the constitutively active Bcr-Abl mutation, as well as Erlotinib, an inhibitor of mutated and over-expressed EGF receptor kinase, have provided an important proof-of-principle that molecularly targeted RTK inhibitors can have an important and broad impact against various cancers. c-Met mediates the signals for a variety of physiological processes that have implications for oncogenesis, including migration, invasion, cell proliferation, apoptosis and angiogenesis. A wide variety of human cancers exhibit constitutively dysregulated c-Met activity, either through over-expression of the c-Met kinase, activating mutations in c-Met, or increased autocrine or paracrine secretion of the c-Met ligand, hepatocyte growth factor/scatter factor (HGF/SF). These alterations have been strongly implicated in tumor progression and metastasis in a variety of cancers, and a high constitutive activation of the c-Met RTK has been correlated with poor clinical prognosis. The inappropriate expression of c-Met in most cancers and its role in controlling multiple signal transduction pathways involved in tumor growth and metastasis render this enzyme a highly compelling therapeutic target for human cancer. About ARQ 197 ARQ 197 was discovered through proprietary chemical biology research at ArQule and is based on the Company's ARQ-650RP (research program) cancer survival pathway (CSP) platform, one of several major platforms for oncology drug discovery at the company. The Company applies its chemistry capabilities to incorporate drug-like qualities into product candidates from the earliest stages of development after they have been shown to be active against biological targets, such as c-Met, that play pivotal roles in the onset and growth of cancer. ARQ 197 and its related CSP program are unrelated to ArQule's ongoing E2F program. The latter (E2F) program is partnered with Roche, and Phase 2 testing of its most advanced compound, ARQ 501, is due to begin by the end of 2005 or early 2006. The targets, mechanisms of action and chemistry related to compounds generated from the E2F and CSP programs differ, offering the potential for multiple therapeutic opportunities in each one. In both programs, ArQule's molecular biology capabilities are enhanced by the Company's strengths in chemistry technology leveraged in the design and optimization of small molecule compounds. ArQule currently retains all rights to compounds derived from its CSP program, including ARQ 197. About ArQule ArQule, Inc. is a biotechnology company engaged in research and development of next-generation small-molecule cancer therapeutics based on its innovative Activated Checkpoint Therapy(SM) (ACT(SM)) platform. ACT(SM) and related compounds are intended to improve the way cancer patients are treated because they selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints that are defective in cancer. ArQule's lead program based on E2F elevation is partnered with Roche. For more information, please visit [URL]www.arqule.com.[/URL] This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, which provides a safe harbor for forward-looking statements made by or on behalf of ArQule. ArQule and its representatives may from time to time make written or oral forward-looking statements, including statements contained in this press release. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "will" and similar expressions identify forward-looking statements. All statements which address operating performance, events or developments that ArQule expects or anticipates will occur in the future, such as projections about its future results of operations or its financial condition, research, development and commercialization of its products and anticipated trends in its business are forward-looking statements within the meaning of the Reform Act. Actual results may differ materially from those projected in the forward-looking statements or historical performance due to numerous risks and uncertainties that exist in ArQule's operations, development efforts and the business environment, including without limitation: the ACT(SM) platform or other, proprietary platforms may not improve efficacy or reduce toxicity, and compounds resulting from these platforms may not operate as intended; the current and future clinical studies may encounter enrollment difficulties and unexpected toxicity; the commencement of the anticipated clinical trials may be delayed or the trials may never commence; the preclinical efforts associated with the product pipeline may fail or prove disappointing; the animal xenograft preclinical studies may be unpredictive of human response; collaborators may terminate their agreements with ArQule because ArQule may fail to satisfy the collaborators' needs or for other reasons; and, the risks and uncertainties described in ArQule's filings with the Securities and Exchange Commission. The forward-looking statements contained herein represent the judgment of ArQule as of the date of this report. ArQule disclaims any intent or obligation to update any forward-looking statement except to the extent required by law.

 

ArQule Updates Plans for Chemical Technologies Business WOBURN, Mass.--(BUSINESS WIRE)--Dec. 6, 2005--ArQule, Inc. (Nasdaq: ARQL) today updated its previously announced plans to exit its Chemical Technologies business, as originally communicated in a press release on September 27, 2005. Pursuant to the Company's agreement with Pfizer dating from December, 2001 and amended in January, 2004, ArQule will continue to provide chemistry services to Pfizer until May 22, 2006. "I would like to thank our Chemical Technologies team for maintaining such a high level of achievement and commitment during our seven-year partnership with Pfizer," said Dr. Stephen A. Hill, president and chief executive officer of ArQule. "The orderly conclusion of the Chemical Technology service business, and the Pfizer agreement in particular, has allowed us to anticipate the associated reduction in revenues and expenses accordingly and to enable us to focus on our core mission as an oncology company." ArQule is committed to exit the Chemical Technologies business and has engaged Young and Partners, a New York-based investment bank, to explore a potential sale of its Chemical Technologies operations. The decision to exit this business is consistent with the Company's previously communicated intent to focus exclusively on the development of its oncology portfolio. As a consequence of this transition and due to increased clarity on the timing of certain research and development payments, ArQule is providing revised financial guidance for 2005 as follows. Year-end cash is expected to range between $135 million and $140 million, up from prior guidance of between $116 million and $121 million. All other financial guidance is unchanged from that provided on the Company's July 28, 2005 earnings conference call. ArQule also reiterates its previously communicated guidance of having sufficient cash to support its portfolio at least into Q1, 2008. More detailed financial guidance for 2006 will be provided, as usual, on the Company's fiscal year-end conference call.