0001387131-11-000643.txt : 20110421 0001387131-11-000643.hdr.sgml : 20110421 20110421170318 ACCESSION NUMBER: 0001387131-11-000643 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20110420 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110421 DATE AS OF CHANGE: 20110421 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adamis Pharmaceuticals Corp CENTRAL INDEX KEY: 0000887247 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820429727 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26372 FILM NUMBER: 11774037 BUSINESS ADDRESS: STREET 1: 2658 DEL MAR HEIGHTS RD STREET 2: #555 CITY: DEL MAR STATE: CA ZIP: 92014 BUSINESS PHONE: (858) 401-3984 MAIL ADDRESS: STREET 1: 2658 DEL MAR HEIGHTS RD STREET 2: #555 CITY: DEL MAR STATE: CA ZIP: 92014 FORMER COMPANY: FORMER CONFORMED NAME: CELLEGY PHARMACEUTICALS INC DATE OF NAME CHANGE: 19950615 8-K 1 adam8-k_420.htm CURRENT REPORT adam8-k_420.htm



UNITED STATES
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):  April 18, 2011
 
ADAMIS PHARMACEUTICALS CORPORATION
 
(Exact Name of Registrant as Specified in Charter)
 
Delaware
 
0-26372
 
82-0429727
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)
         
2658 Del Mar Heights Road, #555
Del Mar, CA
 
92014
(Address of Principal Executive Offices)
 
(Zip Code)
             
Registrant’s telephone number, including area code:  (858) 401-3984
 
(Former name or Former Address, if Changed Since Last Report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 

 

Item 1.01 
Entry Into a Material Definitive Agreement.
 
On April 19, 2011, Adamis Pharmaceuticals Corporation (the “Company”) issued a press release announcing that it had entered into an exclusive license agreement effective as of April 18, 2011, with the Regents of the University of California and the Dana-Farber Cancer Institute, Inc.  Pursuant to the agreement, the Company acquired a license to certain patents and related intellectual property rights relating to a telomerase-based cancer vaccine technology.  The licensed patents include a patent titled, “Composition and Method for Inducing and Enhancing a Telomerase Reverse Transcriptase-Reactive Cytotoxic T Lymphocyte Response.”  The technology was developed by Maurizio Zanetti, M.D., at the University of California, San Diego (“UCSD”).  In addition, the Company licensed a complementary patent, “Cancer Immunotherapy and Diagnosis Using Universal Tumor Associated Antigens, Including Human Telomerase Reverse Transcriptase,” based on technology from the Dana-Farber Cancer Institute, Inc.  The Company intends to pursue development of the technology initially as a vaccine product candidate for prostate cancer.
 
Under the terms of the license agreement, the Company licensed the patents and related intellectual property for a field that includes therapeutic and preventive cancer vaccines in humans, and for a territory that includes the United States.  The term of the license extends through the expiration date of the longest-lived patent rights covered by the agreement.
 
Under the agreement, the Company will pay to the universities a small upfront license issue fee in connection with the execution of the license agreement.  The Company will pay the universities a small annual maintenance fee on the first three anniversaries of the date of the agreement, increasing in an immaterial amount thereafter, until the Company or a permitted sublicensee is commercially selling a licensed product.
 
For first indication of a licensed product, the Company will make payments upon reaching specified milestones in clinical development and obtaining U.S. regulatory approval for a licensed product, potentially aggregating $1,875,000 if all milestone payments are made, including obtaining U.S. regulatory approval for a licensed product.  Similar payments apply to the second indication of a licensed product.
 
The agreement also provides that the Company will pay the universities royalties, in the low single digits, payable on net sales of licensed products.  The agreement includes customary provisions for adjusting the royalty rate in the case of a combination product that includes a licensed product and other products or product components.  The agreement includes customary royalty stacking provisions providing for a reduction in the royalty rate if the Company is required to pay royalties to other third parties to acquire patent rights necessary to make, use or sell licensed products, up to one-half of the amounts otherwise due to the universities.
 
The Company has the right to grant sublicenses to third parties, subject to certain restrictions.  If the Company enters into sublicenses of the licensed technology, then a portion of the sublicense fees received by the Company from the sublicensee is payable to the universities, with the exact percentage depending on the time during the product development, clinical trials and regulatory approval process that the sublicense is entered into.  If the Company receives product royalty payments from sublicensees, the Company is obligated to pay a percentage of those fees to the universities, with the exact percentage depending on the status of product development and commercialization.  Following commercial sales of a licensed product, the agreement provides for minimum annual royalties to the universities, with an increased amount starting with the third full year of sales.
 
The Company is responsible for payment of patent costs relating to the licensed patents, including patent costs previously incurred by the universities.  In the agreement, the Company agrees to diligently proceed with the development, manufacture and sale of licensed products, and to satisfy certain development and regulatory submission milestones by certain dates.  Failure to satisfy these obligations permits the universities to either terminate the license agreement or convert the license to a non-exclusive license.
 
The agreement includes a number of other customary provisions concerning patent prosecution and maintenance, patent infringement, representations and warranties of the parties, indemnification, and other matters.  The universities may terminate the agreement if the Company fails to perform or violates any term of the agreement and does not cure the default within 60 days of notice.  The Company may terminate the agreement upon 90 days notice to the universities.
 
Item 9.01 Financial Statements and Exhibits.
 
(c)  
Exhibits.
 
 

 
 

 

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 hereunto duly authorized.
 
   
ADAMIS PHARMACEUTICALS CORPORATION
 
       
Dated:  April 20, 2011   
By:
/s/Robert O. Hopkins
 
         
   
Name:
Robert O. Hopkins  
   
Title:
Chief Financial Officer  
 
EX-99.1 2 ex-99_1.htm PRESS RELEASE ex-99_1.htm


 
Exhibit 99.1
 
Adamis Completes Acquisition of a Technology for a Potential Universal Cancer Vaccine
 
Tuesday, April 19, 9:30am ET
 
San Diego, California – April 19, 2011Adamis Pharmaceuticals Corporation (OTCBB: ADMP.OB), today announced the completion of the acquisition of a unique patented cancer vaccine technology from the Regents of the University of California. The patent comprises “Composition and Method for Inducing and Enhancing a Telomerase Reverse Transcriptase-Reactive Cytotoxic T Lymphocyte Response.”  The technology was discovered and developed by Maurizio Zanetti, M.D. at the University of California, San Diego (UCSD).  In addition to this license, Adamis licensed a complementary patent, “Cancer Immunotherapy and Diagnosis Using Universal Tumor Associated Antigens, Including Human Telomerase Reverse Transcriptase,” based on similar technology from the Dana-Farber/ Harvard Cancer Center.  This technology constitutes the basis of a novel cell-based cancer vaccine, TeloB-VAX, which activates the body’s natural defense machinery to stimulate an immune response against one of nature’s universal tumor markers, i.e. telomerase.  The vaccine utilizes the patient’s own B cells as antigen producing and antigen presenting cells.  B cells represent approximately 12% of the circulating blood cells.

Dr. Zanetti, Professor of Medicine and Director of the Laboratory of Immunology at the UC San Diego Moores Cancer Center, stated of the TeloB-Vax vaccine, “It is the first concrete opportunity to program the immune system to mobilize killer lymphocytes to combat cancer cells, whether these are adult differentiated cells or progenitor cancer stem cells.  Since telomerase is increased in over 85% of all cancers, the vaccine can potentially be used to treat multiple cancer types, such as breast, lung, and colon cancer.  It can truly be considered a platform therapeutic vaccine technology.  It is like the polio vaccine for cancer.”

Adamis’ therapeutic cancer vaccine is conceptually distinct from the only FDA approved cell-based cancer vaccine, Provenge, developed by Dendreon Corporation (NASDAQ: DNDN).  Adamis’ TeloB-VAX vaccine is composed of the patients’ own circulating B lymphocytes harboring a unique patented engineered plasmid DNA.  The transfection (plasmid DNA entering the B cell) procedure is “spontaneous”, requiring no facilitating molecules or devices.  After 60 minutes of incubation with the plasmid, the cells can be re-infused back into the patient.  TeloB-VAX prostate cancer vaccine has been shown to induce a potent cellular immune response against the first truly common cancer marker, the telomerase reverse transcriptase (TERT).  Telomerase was the subject of the Nobel Prize for Medicine in 2009.

A Phase 1 study completed at UCSD in castrate resistant prostate cancer (CRPC) patients demonstrated this vaccine to be safe, non-toxic and immunogenic.  Two injections of TeloB-VAX, spaced one month apart, was shown to induce a specific CD8 T cell response.  More important, the T cells induced post vaccination were shown to specifically kill prostate cancer cells.

Adamis believes the UCSD and Harvard technology offers some significant advantages over the existing FDA approved vaccine, Provenge.  Some of the advantages include: 1) prolonged antigen presentation by B cells (5 days) as compared to the short presentation time by dendritic cells (12 hours); 2) a unique patented platform technology using a universal cancer antigen (marker) that is increased in approximately 85% of all tumors; 3) induces an immune response after a single injection; 4) no need for complicated culture procedures; 5) much fewer steps; and, 6) lower cost.  TeloB-VAX may prove to be called a “universal cancer vaccine” that could induce immunity against multiple cancer types as well as targeting the specific cancer stem cell.
 
 
 

 

Telomerase is an enzyme that adds DNA sequence repeats (e.g., "TTAGGG") to the 3’ end of DNA strands in the telomere regions of chromosomes at every cell division.  Telomerase confers the immortality trait that converts normal cells into cancer cells and prevents the erosion of telomeres and end-to-end chromosomal fusion.  As such, telomerase is over-expressed in the vast majority of differentiated cancer cell types.  Importantly, telomerase is also necessary for self-renewal of cancer stem cells and cancer cell progenitors.  Based on the foregoing, TERT is an antigen or tumor marker expressed in both differentiated and progenitor cancer cells making vaccination against TERT a potentially effective measure to induce an immune response against cancer cells at both stages of differentiation.

Dr. Dennis J. Carlo, President and CEO of Adamis Pharamceuticals stated “We continue to add significant assets to our cancer franchise.  Our telomerase therapeutic cancer vaccine could very well prove to be pivotal in the treatment of many types of cancer.  Telomerase is probably the closest to any universal tumor marker that we know of today.  Attacking telomerase and effectively interfering with its biologic activity could very well be the key to the treasure in inhibiting the growth of cancer cells”.

Adamis has recently contracted for the manufacture of additional plasmid in preparation for expanding the clinical studies in prostate cancer patients.  Please see Adamis’ website for a short animated video describing and explaining the TeloB-VAX process and procedure (www.adamispharma.com).
 
Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995.  These statements relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the company’s beliefs concerning the safety and effectiveness of the compounds and drug product candidates described in this press release; the results of any future clinical trials that the company may conduct relating to the licensed compounds; the ability to fund future product development; future revenues expected from any of the licensed compounds, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; future revenues from the company’s other products; the ability to acquire other compounds and product candidates; and the intellectual property protection that may be afforded by any patents or patent applications relating to the licensed compounds.  Statements in this press release concerning future milestone events depend on several factors beyond the company’s control, including receipt of adequate funding to support these activities.  These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis’ actual results to be materially different from these forward-looking statements.  Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov.  Adamis expressly disclaims any intent to update any forward-looking statements.
 
 
 

 
 
For Additional Information
 
Capital Group Communications, Inc.
Mark Gundy     mark.gundy@capitalgc.com
Tel: 415.332.7200

Heritage First Capital & Equity Research
Jeffrey D. Brown   jeff@heritagefirst.com
Tel: 603 343-4269

Equititrend
Brian Barnes     bbarnes@equititrend.com
Tel: 1-800-953-3350