-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DA1kEXMDJ6ZoTpcnJXEQkP7NQvx9aNdOY409ljPLqp61gO2ka/2wbeFfabyyrXM5 GEhOhsL7Z/aCTKYya4MvLA== 0000950135-02-003120.txt : 20020626 0000950135-02-003120.hdr.sgml : 20020626 20020625204622 ACCESSION NUMBER: 0000950135-02-003120 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20020625 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020626 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-76486 FILM NUMBER: 02686998 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 b43471are8vk.htm ARIAD PHARMACEUTICALS, INC. ARIAD PHARMACEUTICALS, INC. REPORT ON FORM 8-K
 

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

Date of Report
(Date of earliest event reported): June 25,  2002

ARIAD PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)

         
Delaware   0-21696   22-3106987
  
 
(State or Other Jurisdiction
of Incorporation)		   (Commission File Number)   (I.R.S. Employer Identification No.)

26 LANDSDOWNE STREET
CAMBRIDGE, MASSACHUSETTS 02139
(Address of principal executive offices and zip code)

Registrant's telephone number, including area code:
(617) 494-0400

 

 

   ITEM 5.   OTHER EVENTS

On June 25, 2002, the Registrant publicly disseminated a Press Release announcing the issuance of a pioneering U.S. patent covering methods of treating human disease by regulating NF-kB cell-signaling activity.

In a separate Press Release also on June 25, 2002, the Registrant announced that the Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology, the President and Fellows of Harvard College, and the Registrant filed a patent infringement lawsuit against Eli Lilly and Co., alleging infringement of the newly issued U.S. patent referred to above.

In a third Press Release, also on June 25, 2002, the Registrant announced that it will host a live analyst conference call on Thursday, June 27, 2002 at 9:00 a.m. Eastern time to discuss the press releases issued this day.

The information contained in the Press Releases dated June 25, 2002 is incorporated herein by reference and attached hereto as Exhibits 99.1, 99.2 and 99.3.

   ITEM 7.    FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

  (c)   Exhibits.
 
      99.1      The Registrant's Press Release dated June 25, 2002, regarding the issuance of a patent.
      99.2      The Registrant's Press Release dated June 25, 2002, regarding the filing of a lawsuit.
      99.3      The Registrant's Press Release dated June 25, 2002, regarding an investor conference call.

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

     
  ARIAD PHARMACEUTICALS, INC.
 
  By:    /s/ Edward M. Fitzgerald
Edward M. Fitzgerald
Senior Vice President and
  Chief Financial Officer

Date: June 25,  2002




2

 

EXHIBIT INDEX

             
Exhibit            
Number   Description   Sequential Page Number
  
 
99.1   The Registrant's Press Release dated June 25, 2002.      
99.2   The Registrant's Press Release dated June 25, 2002.      
99.3   The Registrant's Press Release dated June 25, 2002.      

3 EX-99.1 3 b43471arexv99w1.htm PRESS RELEASE DATED JUNE 15, 2002 exv99w1

 

Exhibit 99.1          
(Corporated Logo) News Release     
         
FOR IMMEDIATE RELEASE
   CONTACT:   Tom Pearson
        Kathy Lawton
        (617) 621-2345

ARIAD ANNOUNCES ISSUANCE OF PIONEERING PATENT ON TREATING
HUMAN DISEASE BY REGULATING NF-kB CELL SIGNALING

Implications for treatment of inflammation, cancer and osteoporosis

Cambridge, MA, June 25, 2002 -- ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced the issuance of a pioneering U.S. patent covering methods of treating human disease by regulating NF-kB cell-signaling activity. The use of many currently marketed drugs and products in development are examples of such NF-kB treatment methods. These drugs collectively have markets of several billion dollars annually. The newly issued U.S. patent is one of a family of patents, three in the U.S. and one in Europe, awarded to a team of distinguished scientists from the Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology, and Harvard University in recognition of their pioneering research on NF-kB as a master regulator of cell signaling. ARIAD has an exclusive license to these patents. The latest patent includes 203 claims and provides coverage relating to NF-kB treatment methods through the year 2019.

The NF-kB protein, encoded by two of the estimated 35,000 genes in the human genome, is among the body's most important known regulators of cellular function. The activity of NF-kB has been implicated in several difficult-to-treat disease conditions, including inflammation (e.g., atherosclerosis, arthritis, inflammatory bowel disease, rheumatoid arthritis, and septic shock), malignant transformation and tumor growth (e.g., certain blood cancers and solid tumors), and bone breakdown and rebuilding (e.g., osteoporosis). NF-kB can be generally thought of as a "biological switch" that can be turned off in cells to treat these diseases.

"Landmark science has been the guiding principle of ARIAD since its founding. When we obtained an exclusive license to the NF-kB technology in 1991, few in the pharmaceutical industry recognized the profound clinical and commercial implications of this pioneering work. Ten years and thousands of scientific papers later, the impact of this discovery on treating human disease has become widely appreciated," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.

Dr. Berger added, "We are committed to creating value for the team of inventors and their institutions and are actively pursuing a licensing program for our portfolio of patents on NF-kB. Our goals are to acknowledge the important contributions made by

 

our academic colleagues and to help underwrite the cost of developing and commercializing our portfolio of breakthrough medicines that regulate cell signaling. Many of today's top-tier biotech companies, such as Biogen, have successfully used patent-licensing revenues to help build their leadership positions in our industry."

NF-kB may be activated by any one of several different signals originating outside the cell, including various inflammatory cytokines (e.g., TNF-a, IL-1, and IL-6), bacterial and viral infections (e.g., lipopolysaccharide), and cancer-causing proteins (e.g., oncogenic proteins). NF-kB generally resides in the cell bound to its naturally occurring inhibitor, which prevents NF-kB from entering the nucleus. When cells are activated, the inhibitor protein usually becomes modified and subsequently is broken down by proteasomes - enzyme complexes in the cell responsible for breaking down such proteins. This frees NF-kB to move into the nucleus where it regulates the expression of key genes involved in immune and inflammatory responses, as well as cellular growth, control and death. Specific genes encoding certain cytokines, cytokine receptors, cell adhesion molecules, chemo-attractant proteins, oncoproteins, and growth factors may be regulated by NF-kB.

Built upon the initial discoveries by the distinguished team of inventors, this fundamental understanding of the role of NF-kB in human disease has facilitated the discovery of drugs that inhibit or modulate NF-kB cell signaling activity for use in both chronic and acute diseases.

The team of NF-kB inventors was led by Dr. David Baltimore, former Director of the Whitehead Institute and Institute Professor at M.I.T., now President and Professor of Biology at the California Institute of Technology; Dr. Phillip Sharp, Institute Professor and Director of the McGovern Institute for Brain Research at M.I.T.; and Dr. Thomas Maniatis, Thomas H. Lee Professor of Molecular and Cell Biology at Harvard. Drs. Baltimore and Sharp are recipients of the Nobel Prize in Medicine or Physiology, and Dr. Baltimore is a founding member of ARIAD's board of scientific and medical advisors. Their laboratories have worked for over twenty years on NF-kB and related areas of cell signaling and gene regulation.

Other NF-kB inventors and their current affiliations include: Dr. Patrick Baeuerle, Professor of Immunology at the University of Munich; Dr. Albert Baldwin, Professor of Biology, Genetics and Molecular Biology at the University of North Carolina; Dr. Roger Clerc, Senior Scientist at F. Hoffmann-LaRoche Ltd.; Dr. Lynn Corcoran, Senior Research Fellow at The Walter and Eliza Hall Institute of Medical Research; Dr. Chen-Ming Fan, Adjunct Professor of Biology and Embryology at the Carnegie Institution of Washington; Dr. Jonathan LeBowitz, Associate Professor of Biochemistry at Purdue University; Dr. Michael Lenardo, Section Head, Laboratory of Immunology at the National Institutes of Health; Dr. Ranjan Sen, Professor of Biology at Brandeis University; Dr. Harinder Singh, Professor of Molecular Genetics and Cell Biology at the University of Chicago; and Dr. Louis Staudt, Senior Investigator, Center for Cancer Research at the National Institutes of Health.

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). A list of selected NF-kB scientific papers and references is 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 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 - 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-kB cell-signaling activity, which has been implicated 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 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.

### EX-99.2 4 b43471arexv99w2.htm PRESS RELEASE DATED JUNE 15, 2002 exv99w2

 

Exhibit 99.2          
(Corporated Logo) News Release     
         
FOR IMMEDIATE RELEASE
   CONTACT:   Tom Pearson
        Kathy Lawton
        (617) 621-2345

ARIAD ANNOUNCES FILING OF LAWSUIT AGAINST ELI LILLY ALLEGING
INFRINGEMENT OF PIONEERING NF-kB TREATMENT-METHOD PATENT

Lawsuit addresses Lilly's osteoporosis drug, Evista®, and
septic shock drug, Xigris®

Cambridge, MA, June 25, 2002 -- ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced that ARIAD, Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and the President and Fellows of Harvard College today filed a patent infringement 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-kB cell signaling activity. The lawsuit, filed in the United States District Court for the District of Massachusetts in Boston, alleges infringement by Lilly through its sale of Evista® and Xigris® and seeks monetary damages from Lilly.

Evista, Lilly's selective estrogen receptor modulator known as raloxifene hydrochloride, is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In a published World Intellectual Property Organization patent application, Lilly scientists disclose that Evista inhibits NF-kB activity (No. WO 96/40137). Xigris, Lilly's version of recombinant human activated protein C, is indicated for the reduction of mortality in adult patients with severe sepsis 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-kB 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-kB patents, even as Lilly scientists were publishing scientific proof that the use of Evista and Xigris are covered NF-kB treatment methods. Consequently, we were left with no option other than initiating this 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 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-kB. 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-kB 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-kB 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 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 - 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-kB cell-signaling activity, which has been implicated 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 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.

### EX-99.3 5 b43471arexv99w3.htm PRESS RELEASE DATED JUNE 15, 2002 exv99w3

 

Exhibit 99.3          
(Corporated Logo) News Release     
         
FOR IMMEDIATE RELEASE
   CONTACT:   Tom Pearson
        Kathy Lawton
        (617) 621-2345

ARIAD ANNOUNCES ANALYST CONFERENCE CALL
ON THURSDAY, JUNE 27, 2002 AT 9:00 A.M., EASTERN TIME

Cambridge, MA, June 25, 2002 -- ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced that it will host a live analyst conference call on Thursday, June 27, 2002 at 9:00 a.m., Eastern Time. ARIAD management will discuss today's announcements of the issuance of a U.S. patent covering methods of treating human disease by regulating NF-kB cell-signaling activity and the filing of a patent infringement lawsuit against Eli Lilly and Co. Further information about these announcements was reported in separate press releases issued earlier today, which are available on ARIAD's website (http://www.ariad.com/news_releases).

The web cast conference call can be accessed by going to the Company's website at http://www.ariad.com/investor. The call will be archived on the Company's website and available for replay beginning approximately two hours after completion of the call until 5:00 p.m., Eastern Time on July 9, 2002.

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 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 - a therapy for cancer and other immune and blood diseases; and dual-action drug candidates that block bone resumption 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-kB cell-signaling activity, which has been implicated 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 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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