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ARIAD Reports Second Quarter 2007 Results.


Significant Milestones Achieved Year-to-Date

CAMBRIDGE, Mass. -- ARIAD ARIAD Allison Research Index of Art and Design  Pharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ARIA) today announced financial results for the quarter and six months ended June 30, 2007 and provided an update on corporate developments.

"With our recently announced strategic collaboration with Merck & Co., we have embarked on a markedly expanded global development program for deforolimus in which substantial clinical trials and biomarker studies will be conducted concurrently in multiple cancers. Importantly, we anticipate that the combination of the up-front payment received from Merck plus the significant future milestone payments triggered by the start of pre-specified Phase 2 and Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study.  will fund our portion of the remaining development costs of deforolimus," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "As a result, our financial position has been greatly strengthened, enabling us to invest more fully in building our oncology product pipeline, including our next clinical candidate, AP24534."

Financial Highlights

For the quarter ended June 30, 2007, the Company reported a net loss of $17.0 million, or $0.25 per share, as compared to a net loss of $17.0 million, or $0.27 per share, for the quarter ended June 30, 2006. For the six months ended June 30, 2007, the Company reported a net loss of $32.0 million, or $0.48 per share, as compared to a net loss of $32.4 million, or $0.52 per share, for the six months ended June 30, 2006. These results reflect the continued development of the Company's lead product candidate, deforolimus, and its next clinical candidate, AP24534.

For the six months ended June 30, 2007, cash used in operations was $26.4 million, as compared to $27.4 million for the six months ended June 30, 2006. The Company ended the second quarter 2007 with $25.7 million in cash, cash equivalents and marketable securities Marketable Securities

Very liquid securities that can be converted into cash quickly at a reasonable price.

Notes:
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has
, compared with $39.8 million at the end of 2006.

In July 2007, the Company received an up-front payment of $75 million from Merck in connection with the execution of the deforolimus collaboration agreement. In addition, the Company expects to receive a milestone payment of $13.5 million for the commencement of the Phase 3 clinical trial of oral deforolimus in patients with metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 sarcomas Sarcomas Definition

A sarcoma is a bone tumor that contains cancer (malignant) cells. A benign bone tumor is an abnormal growth of noncancerous cells.
Description

A primary bone tumor originates in or near a bone.
 in third quarter 2007.

After taking into account the estimated impact of the collaboration agreement with Merck, the Company expects positive cash flow from operations Cash flow from operations

A firm's net cash inflow resulting directly from its regular operations (disregarding extraordinary items such as the sale of fixed assets or transaction costs associated with issuing securities), calculated as the sum of net income plus noncash expenses
 for the year ending December 31, 2007 in the range of $30 to $35 million. Based on these estimates, the Company expects that its cash, cash equivalents and marketable securities at December 31, 2007 will be in the range of $72 to $76 million.

Corporate and Development Highlights

The Company has made substantial progress this year on multiple fronts, including:

Novel mTOR Inhibitor -- Deforolimus

* Global Collaboration with Merck & Co. to Jointly Develop and Commercialize Deforolimus. The Company believes this partnership should maximize the commercial and clinical potential of deforolimus and enable ARIAD to realize its vision of becoming a fully integrated oncology company. The all-cash agreement provides for an initial payment of $75 million to ARIAD, up to $452 million more in milestone payments to ARIAD based on the successful development of deforolimus in multiple cancer indications (including up to $128 million for the initiation of Phase 2 and Phase 3 clinical trials), up to $200 million more based on achievement of significant sales thresholds, and at least $200 million in estimated contributions by Merck to global development. If the global development program is expanded further and ARIAD pays over $150 million in global development costs, ARIAD can access up to $200 million in interest-bearing repayable development-cost advances from Merck to cover ARIAD's share of these global-development costs. ARIAD's potential commercial returns will be based on 50/50 profit sharing profit sharing, arrangement by which employees receive, in addition to their wages, a share of the net profits of a business. The purpose is to give them an incentive to increase their output through enhanced morale, less wasteful use of materials, better care of  in the U.S. and royalties paid by Merck on sales of deforolimus outside the U.S.

* Additional Positive Efficacy Data in Sarcomas. In June, at the annual meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas.  (ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
), ARIAD reported positive efficacy data on single-agent deforolimus from further analysis of its ongoing Phase 2 trial in patients with advanced soft-tissue and bone sarcomas. The expanded analysis focused on the 60 patients with a deforolimus clinical-benefit response (CBR (1) (Computer-Based Reference) Reference materials accessible by computer in order to help people do their jobs quicker. For example, this database on disk!

(2) (Constant Bit Rate) A uniform transmission rate.
) - the primary endpoint of the 212-patient trial - and its relationship to overall survival. The new results demonstrated that documented disease stabilization and/or tumor regression with deforolimus is a strong predictor of improved overall survival. Patients with a deforolimus CBR had a median overall survival of approximately 17 months, nearly double that of the overall trial population (vs. approximately 9 months).

* Positive Efficacy Results in Endometrial Cancer Endometrial Cancer Definition

Endometrial cancer develops when the cells that make up the inner lining of the uterus (the endometrium) become abnormal and grow uncontrollably.
. Also at ASCO, ARIAD reported that deforolimus demonstrated efficacy and was well tolerated as a single agent in a multi-center Phase 2 trial in metastatic endometrial cancer involving 45 patients, all of whom had progressive disease. The primary end-point of the trial - evidenced by significant clinical-benefit response (CBR) rates - was achieved. Twenty-nine percent (29%) of patients had a CBR - tumor regression or disease stabilization - including 10% with partial responses.

* Positive Safety and Tolerability Data in Combination with Paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); . ARIAD also presented results from a Phase 1b dose-escalation trial evaluating the safety and tolerability, pharmacokinetics and anti-cancer activity of deforolimus in combination with paclitaxel in patients with progressive solid tumors. Anti-tumor activity was seen in patients with advanced pharyngeal pharyngeal /pha·ryn·ge·al/ (fah-rin´je-al) pertaining to the pharynx.

pha·ryn·geal or pha·ryn·gal
adj.
Of, relating to, located in, or coming from the pharynx.
, pancreatic, ovarian, thyroid and breast cancers when treated with the combination. Deforolimus combined with paclitaxel was well-tolerated, with predictable and manageable side-effects, which provides the basis for additional trials of this important combination regimen in several tumor types.

Novel Bcr-Abl Inhibitor for Drug-Resistant CML 1. CML - A query language.

["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986].
2. CML - Concurrent ML.
 - AP24534

* Progress with Pipeline. The Company has completed extensive preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
 on the efficacy of AP24534 in chronic myeloid leukemia myeloid leukemia
n.
See myelogenous leukemia.
 and its potential utility in other cancers. The investigational new drug (IND) application for this multi-targeted kinase inhibitor is on track for filing in the fourth quarter 2007.

Corporate Activities

* Strengthened Senior Leadership Team. Pierre F. Dodion, M.D. joined the Company as senior vice president, oncology, which includes leadership of medical research, medical affairs, clinical operations, drug safety and pharmacovigilence and biostatistics and outcomes research. Dr. Dodion has over twenty-five years of experience in the global pharmaceutical industry and academia, most recently as executive director, oncology at Pfizer, Inc.

Scientific and Medical Meetings

ARIAD expects to have presentations at the following scientific and medical meetings:

* AACR-NCI-EORTC International Conference on Molecular Targets & Cancer Therapeutics, San Francisco, California “San Francisco” redirects here. For other uses, see San Francisco (disambiguation).

The City and County of San Francisco (EN IPA: [sænfrənˈsɪskoʊ] 
, October 22 to 26, 2007.

* 13th Annual Connective Tissue Oncology Society Meeting, Seattle, Washington This page is protected from moves until disputes have been resolved on the .
The reason for its protection is listed on the protection policy page.
, November 1 to 3, 2007.

* American Society Hematology 49th Annual Meeting, Atlanta, Georgia, December 8 to 11, 2007.

Upcoming Investor Meetings

ARIAD management will present updated overviews of the Company's progress and business plans at several investor conferences:

* Credit Suisse The Credit Suisse Group (SWX:CSGN, NYSE: CS) is a financial services company, headquartered in Zürich, Switzerland. It is the second-largest Swiss bank, behind UBS AG.  Boston Biotech Forum, Boston, Massachusetts “Boston” redirects here. For other uses, see Boston (disambiguation).
Boston is the capital and most populous city of Massachusetts.[3] The largest city in New England, Boston is considered the unofficial economic and cultural center of the entire New
, September 5, 2007.

* Bear Stearns 20th Annual Healthcare Conference, New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
, New York, September 10 to 11, 2007.

* ThinkEquity Partners 5th Annual Growth Conference, San Francisco, California, September 17 to 20, 2007.

* UBS UBS Union Bank of Switzerland
UBS United Bible Societies
UBS United Blood Services
UBS United Buying Service
UBS Used Bookstore
UBS University Business Services
UBS Universal Building Society (UK)
UBS Ulaanbaatar Broadcasting System
 2007 Global Life Sciences Conference, New York, New York, September 24 to 27, 2007.

* Lazard Capital Markets Lazard Capital Markets is a New York-based investment bank founded in 2005 in a spin-off from its parent Lazard.

Lazard Capital Markets focuses its activities on equity research, sales and trading; fixed income and convertible bond sales and trading; and securities
 Annual Life Sciences Conference, New York, New York, November 27 to 28, 2007.

Today's Conference Call Reminder

ARIAD will hold a live webcast of its quarterly conference call today at 8:30 a.m. (EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
). The live webcast can be accessed by visiting the investor relations Investor relations

The process by which the corporation communicates with its investors.
 section of the Company's website at http://www.ariad.com/investor. The call can be accessed by dialing 1-866-831-6270 (domestic) or 617-213-8858 (international) five minutes prior to the start time and providing the passcode 54320658. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for two weeks.

About ARIAD

ARIAD is engaged in the discovery and development of breakthrough medicines to treat cancer by regulating cell signaling with small molecules. ARIAD is developing a comprehensive approach to patients with cancer that addresses the greatest medical need - aggressive and advanced-stage cancers for which current treatments are inadequate. ARIAD has a global partnership with Merck to develop and commercialize deforolimus, ARIAD's lead cancer product candidate. Medinol Ltd. also is developing stents and other medical devices that deliver deforolimus to prevent reblockage at sites of vascular injury following stent-assisted angioplasty. ARIAD has an exclusive license to pioneering technology and patents related to certain NF-kB treatment methods, and the discovery and development of drugs to regulate NF-kB cell-signaling activity, which may be useful in treating certain diseases. Additional information about ARIAD can be found on the Web at http://www.ariad.com.

This press release contains "forward-looking statements," including statements related to the expected timing of the Phase 3 clinical trial of deforolimus in metastatic sarcoma sarcoma (särkō`mə), highly malignant tumor arising in connective- and muscle-cell tissue. It is the result of oncogenes (the cancer causing genes of some viruses) and proto-oncogenes (cancer causing genes in human cells). , expanded development plans for deforolimus in collaboration with Merck, financial terms of our collaboration with Merck, plans for and the expected timing of the filing of an IND for AP24534 and our financial projections. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the costs associated with our research, development, manufacturing and other activities, the conduct and results of pre-clinical and clinical studies of our product candidates, difficulties or delays in obtaining regulatory approvals to market products resulting from our development efforts, our reliance on partners, including Merck and Medinol, and other key parties for the successful development, manufacturing and commercialization of products, the adequacy of our capital resources and the availability of additional funding, patent protection and third-party intellectual property claims relating to our and any partner's product candidates, the timing, scope, cost and outcome of legal and patent office proceedings concerning our NF-kB patent portfolio, the potential acquisition of or other strategic transaction regarding the minority stockholders' interests in our 80%-owned subsidiary, ARIAD Gene Therapeutics, Inc., future capital needs, key employees, markets, economic conditions, prices, reimbursement rates, competition and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.
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Publication:Business Wire
Article Type:Financial report
Date:Aug 6, 2007
Words:1752
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