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ARIAD Announces Filing of Lawsuit Against Eli Lilly Alleging Infringement of Pioneering NF-kappa-B Treatment-Method Patent.


Business/Technology Editors & Health/Medical Writers

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Lawsuit addresses Lilly's osteoporosis drug, Evista(R), and

septic shock Septic Shock Definition

Septic shock is a potentially lethal drop in blood pressure due to the presence of bacteria in the blood.
Description

Septic shock is a possible consequence of bacteremia, or bacteria in the bloodstream.
 drug, Xigris(R)

ARIAD ARIAD Allison Research Index of Art and Design  Pharmaceuticals, Inc. (Nasdaq: ARIA) announced that ARIAD, Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , the Whitehead Institute for Biomedical Research, and the President and Fellows of Harvard College The President and Fellows of Harvard College (also known as the Harvard Corporation) is the more fundamental of Harvard University's two governing boards. (The other is the Harvard Board of Overseers.  today filed a patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver.  lawsuit against Eli Lilly and Co. ("Lilly"), alleging infringement of their newly issued U.S. patent covering methods of treating human disease by regulating NF-(kappa)B cell signaling activity. The lawsuit, filed in the United States District Court for the District of Massachusetts The United States District Court for the District of Massachusetts is the Federal district court whose jurisdiction is the Commonwealth of Massachusetts. The first court session was held in Boston in 1789.  in Boston, alleges infringement by Lilly through its sale of Evista(R) and Xigris(R) and seeks monetary damages from Lilly.

Evista, Lilly's selective estrogen receptor modulator se·lec·tive estrogen receptor modulator
n. Abbr. SERM
A nonsteroidal compound, such as raloxifene or tamoxifen, designed to mimic the effect of estrogen on a specific tissue or body part by binding only to that part's estrogen receptors.
 known as raloxifene hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid.

hy·dro·chlo·ride
n.
A compound resulting from the reaction of hydrochloric acid with an organic base.
, is indicated for the treatment and prevention of osteoporosis in postmenopausal post·men·o·paus·al
adj.
Of or occurring in the time following menopause.


postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
 women. In a published World Intellectual Property Organization patent application, Lilly scientists disclose that Evista inhibits NF-(kappa)B activity (No. WO 96/40137). Xigris, Lilly's version of recombinant human activated protein C Human activated protein C is a serine protease which is derived from the two chain vitamin K dependent zymogen.

It is used to inhibit blood coagulation thought the selective inactivation of the cofactors Va and VLLA.
, is indicated for the reduction of mortality in adult patients with severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status  who have a high risk of death. Lilly scientists published papers highlighting the molecular basis for the efficacy of Xigris in septic shock and have demonstrated that Xigris inhibits NF-(kappa)B activity (Joyce DE, et al, J. Biol. Chem. 276: 11199-11203, 2001; Joyce DE, Grinnell BW, Crit. Care Med. 30:S288-S293, 2002). Industry analysts have projected that both drugs eventually may exceed $1 billion in annual sales.

"Lilly has ignored our prior efforts to initiate discussions concerning a license to our family of NF-(kappa)B patents, even as Lilly scientists were publishing scientific proof that the use of Evista and Xigris are covered NF-(kappa)B treatment methods. Consequently, we were left with no option other than initiating this litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
. ARIAD will be managing the litigation on behalf of the plaintiffs and has engaged a seasoned litigation team from Clifford, Chance, Rogers & Wells in 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
 to handle our case," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.

Dr. Berger added, "As the exclusive licensee of this pioneering technology, we are committed to creating value for the distinguished team of inventors and their institutions. Our share of any proceeds from Lilly will be used to support the development of ARIAD's innovative treatments for cancer and other life-threatening diseases."

"Lilly has been at the forefront of the industry in advocating strong patent protection for pharmaceutical products and treatment methods and in lobbying Congress for legislation to strengthen patent law. Lilly has filed hundreds of patent applications on treatment methods similar to our newly issued patent on NF-(kappa)B. Like Lilly, we believe that such patents are one of the cornerstones of pharmaceutical R&D and that they represent a recognized way of rewarding innovation," commented Dr. Berger.

The newly issued patent is one of a family of patents awarded to the distinguished team of inventors led by Dr. David Baltimore, Dr. Phillip Sharp and Dr. Thomas Maniatis. These patents are core holdings in ARIAD's portfolio of intellectual property relating to the development and use of medicines that regulate cell signaling. Further information about the newly issued NF-(kappa)B patent is available in a separate press release issued earlier today, which can be accessed at ARIAD's website (http://www.ariad.com/news_releases).

A copy of the newly issued U.S patent, "Nuclear Factors Associated with Transcriptional Regulation" (No. 6,410,516), is available at the website of the U.S. Patent and Trademark Office (http://164.195.100.11/netahtml/srchnum.htm) or at a link from ARIAD's website (http://www.ariad.com/patents). Links to selected NF-(kappa)B scientific papers, including the referenced Lilly patent and papers, are also available at ARIAD's website (http://www.ariad.com/related_resources).

ARIAD is engaged in the discovery and development of breakthrough medicines that regulate cell signaling with small molecules. The Company's development pipeline includes: a drug candidate that controls cell proliferation and nutrient uptake by tumors to treat cancer; a bone-targeted drug candidate to treat the complications of cancer that has spread to bone; a regulated protein therapy product candidate to treat anemia in which the production of erythropoietin erythropoietin /eryth·ro·poi·e·tin/ (-poi´e-tin) a glycoprotein hormone secreted by the kidney in the adult and by the liver in the fetus, which acts on stem cells of the bone marrow to stimulate red blood cell production  is controlled in vivo using an orally administered drug; a T cell immunotherapy product candidate in which a non-immunosuppressive drug may be used to treat graft-vs-host disease following donor bone marrow transplantation Bone Marrow Transplantation Definition

The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets.
 - a therapy for cancer and other immune and blood diseases; and dual-action drug candidates that block bone resorption and stimulate bone formation to treat osteoporosis. ARIAD also has an exclusive license to pioneering technology and patents related to the discovery, development and use of drugs that regulate NF-(kappa)B cell-signaling activity, which has been implicated im·pli·cate  
tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates
1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot.

2.
 in many major diseases.

Additional information about ARIAD can be found on the web at http://www.ariad.com.

Some of the matters discussed herein are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such statements are identified by the use of words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such statements are based on management's current 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 forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding the Company's ability to conduct preclinical and clinical studies of its product candidates and the results of such studies, regulatory oversight, intellectual property claims, the timing, scope, cost and outcome of legal proceedings, future capital needs, key employees, dependence on the Company's collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement rates, competition and other risks detailed in the Company's public filings with the Securities and Exchange Commission, including ARIAD's Annual Report on Form 10-K for the fiscal year ended December 31, 2001. The information contained in this document 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
Geographic Code:1USA
Date:Jun 25, 2002
Words:1066
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