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one thing that will cause prolor to skyrocket is if the EMEA comes to a decision on SGP's FSH-CTP. SGP finalized the application in january and released data from PhaseII/III work in july.
http://www.datamonitor.com/store/News/emea_validates_schering_ploughs_corifollitropin_alfa?productid=6CF2E7A6-6355-4A91-8CE7-7EAF5A84D7E8
EMEA validates Schering-Plough's corifollitropin alfaSchering-Plough has announced that the European Medicines Agency has validated its marketing authorization application for corifollitropin alfa, the company's experimental, sustained follicle stimulant. This application will follow the centralized procedure.
Corifollitropin alfa is being developed as a potential treatment in controlled ovarian stimulation (COS) for the development of multiple follicles and pregnancy in women participating in an assisted reproductive technology program.
Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as follicle stimulating hormone (FSH), but with a markedly prolonged duration of FSH activity, the company said. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of corifollitropin alfa may replace the first seven injections of FSH preparation in a COS treatment cycle.
If approved, corifollitropin alfa would extend Schering-Plough's fertility portfolio, which also includes Puregon.
http://www.fiercebiotech.com/press-releases/schering-plough-announces-phase-iii-data-sustained-follicle-stimulant-0
I need to remember some things.
wow, long time no speak.
still holding. did add some recently.
http://stockcharts.com/h-sc/ui?s=PBTH&p=D&yr=1&mn=6&dy=0&id=p78222117475
where the old shares split?
Where's the volume coming from
Name/Ticker change. This board needs updating
Form 8-K for MODIGENE INC.
22-Sep-2008
Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01 Regulation FD Disclosure.
On or about September 22, 2008, Modigene Inc. (the "Company") will be mailing a letter to the record holders of its common stock regarding the Company's operations and product development plans. A copy of the letter is attached hereto as Exhibit 99.1.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
September 22, 2008
Dear Fellow Shareholders:
We would like to take this opportunity to provide you with an update on the accomplishments achieved at Modigene over the last 12 months as well as our future plans. During this period, Modigene advanced its lead preclinical programs, increased the company’s financial resources through a capital infusion and the award of potentially sizeable non-dilutive development grants, witnessed a major clinical validation of the potential of the technology underlying its programs and strengthened its Board of Directors. Modigene is now well positioned to execute on its product development plans, which we believe have the potential to generate significant value for our shareholders.
Product & Clinical Development
We made substantial progress over the past year in advancing our lead product candidates based on our CTP technology that has the potential to significantly increase the duration of action of therapeutic proteins, and we anticipate filing an IND for our first human clinical trial in the first quarter of next year.
Long-Acting Human Growth Hormone: Currently available human growth hormone for treating growth hormone deficiency in children must be injected daily. Our human growth hormone drug candidate, hGH-CTP, has a potential to be injected only once every one or two weeks, providing a significant benefit to patients and their families. The market potential is large—the current estimated market size for short-acting growth hormones is $2.2 billion. During the past year, we successfully developed a small-scale production process for hGH-CTP in Modigene’s laboratories. The process is currently being scaled-up and product is now being prepared for pre-clinical and clinical development. We anticipate submitting an IND to the FDA for regulatory permission to initiate clinical trials in Q1/2009. We expect a Phase I trial to be completed in about 90 days.
Long-Acting Interferon-β: Interferon-ß is a mainstay of treatment for multiple sclerosis. Our drug candidate IFN-ß-CTP has an almost 10-fold duration in the blood in animal models compared to the current commercial product. The current estimated market for interferon-β is $4.3 billion. We are now completing the small-scale development process for IFN-ß-CTP. We expect to file an IND for our IFN-ß-CTP in Q3/2009, and to initiate clinical trials soon thereafter.
Long-Acting EPO: Despite an eventful year and some turmoil in the erythropoietin (EPO) market, EPO continues to be widely used for patients with cancer and kidney disease, and the annual EPO market is estimated at $10 billion. In validated animal models, our EPO-CTP drug candidate has a 33% greater longevity than Amgen’s commercial long-acting EPO - Aranesp®. We plan to continue the development of EPO-CTP in partnership with a leading pharmaceutical company. Negotiations with several potential partners are ongoing.
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Modigene Inc. 3 Sapir Street, Weizmann Science Park, Nes Ziona Israel 74140
1
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Exhibit 99.1
Additional Product Pipeline
Modigene is currently developing and testing long-acting versions of the following drug candidates:
GLP-1-CTP: The GLP-1 therapeutic peptide occurs naturally in the human body. It is derived from proglucagon - a hormone secreted by the intestines, and serves to maintain healthy blood sugar levels and control appetite. GLP-1 currently is marketed to treat Type 2 diabetes, acting to decrease both the weight gain and the incidence of hypoglycemia that can arise as side effects of current diabetes treatments. Its clinical use has likely been adversely impacted by the fact that in its current pharmaceutical form it has to be injected twice daily. GLP-1 also has potential in other indications such as obesity. The estimated market for short-acting GLP-1 is $0.5 million. A longer-acting version is expected to have considerably greater market potential.
Factor VII-CTP: The main function of Factor VII is to initiate the process of blood coagulation. It is currently indicated for use in chronic haemophilia patients to control bleeding. The estimated market for short-acting Factor VII is $1.0 billion.
Phase III Validation of CTP Technology
Schering-Plough announced on July 8, 2008 that its Phase III ENGAGE trial, which assessed the efficacy and safety of a long-acting fertility drug (that uses the same CTP technology being developed by Modigene) successfully met its two primary endpoints, including successful pregnancies. This clinical trial, which included 1,509 patients, was the largest double-blind fertility trial ever conducted. In earlier studies Schering-Plough has shown that linking the naturally-occurring peptide CTP to FSH, a fertility hormone, can successfully extend the activity of the hormone, enabling a single injection of FSH-CTP to replace seven consecutive daily injections of standard FSH. Modigene has rights to the CTP technology for all but four endocrine proteins previously licensed by Schering-Plough from Washington University in St. Louis.
Schering-Plough’s Phase I, II, and III studies demonstrated that attaching the CTP peptide did not affect the therapeutic activity of FSH or cause a negative immune system response. Modigene is using the same naturally occurring CTP peptide to extend the duration of action of other therapeutic proteins and peptides. We view these findings of great significance to Modigene as they provide further clinical validation of our technology. We look forward to initiation of our clinical studies of hGH-CTP and interferon-β-CTP.
OCS Grants
Modigene has been proactive in seeking sources of non-dilutive funding for our development programs. In November 2007, we received approval from the Office of the Chief Scientist of the Israeli government (OCS) for a grant supporting the product and clinical development of our long-acting human growth hormone drug candidate. The grant will provide cash reimbursements of 30% to 50% of our development expenses for the hGH-CTP product. The project budget is estimated at $10 million over four years. In addition, in August 2008 we received approval from the OCS for a second grant supporting the first year product and clinical development of our long-acting interferon-β drug, with cash reimbursements of 40% of our development expenses. The project budget is estimated at $25 million over four years.
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Modigene Inc. 3 Sapir Street, Weizmann Science Park, Nes Ziona Israel 74140
2
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Exhibit 99.1
Liquidity & Resources
Our company’s current financial position is sound. In March, Modigene completed an equity and debt financing by members of the Frost Group on terms that we considered favorable to the company. With over $11 million of cash as of August 1, 2008, and an option to borrow up to an additional $10 million from the Frost Group, along with the non-dilutive cash grants we have been awarded from the Israeli Office of the Chief Scientist, we believe that Modigene’s capital structure is robust. Our current resources are expected to provide the company with up to two years of liquidity to support our product and clinical development plans. According to our current plans, this should be adequate to take us through the end of Phase II clinical trials with at least one of our long-acting drug candidates.
Board of Directors
We have significantly reinforced our board of directors via the appointment in March of Dr. Phillip Frost as Executive Chairman, and new directors Dr. Marian Gorecki and Mr. Steven Rubin replacing Dr. Eugene Bauer and Mr. Joel Kanter.
Dr. Frost currently serves as Chairman and CEO of OPKO Health, Inc., a publicly traded specialty healthcare company. He also serves as Chairman of Ladenburg Thalmann & Co. Inc., as Vice Chairman of Teva Pharmaceuticals, and as a director of Northrop Grumman Corporation and Continucare Corporation. He is a trustee of the University of Miami, the Scripps Research Institute, the Miami Jewish Home for the Aged and the Mount Sinai Medical Center; a regent of the Smithsonian Institute, and Vice Chairman of the Board of Governors of the American Stock Exchange. Previously, Dr. Frost was Chairman and CEO of IVAX Corporation, which he founded in1987, until the company’s acquisition by Teva Pharmaceuticals in 2006.
Dr. Marian Gorecki, a 30-year veteran of the biotechnology industry, is currently Chairman of Thrombotech, a company developing a peptide to mitigate the side effects of standard stroke treatments. Previously, Dr. Gorecki co-founded and served as General Manager and Board member of Bio Technology General (BTG), now Savient Pharmaceuticals Inc. He also served as Chairman and CEO of Mediwound Ltd., a biotechnology company developing enzyme-based products in the fields of burn and wound management. Dr. Gorecki was responsible for overseeing the clinical development, regulatory approval and commercialization of five biotechnology drugs that are currently marketed, as well as two that are now in Phase III trials. Dr. Gorecki is the inventor of 21 issued patents and author of 73 peer-reviewed scientific articles.
Steven D. Rubin, J.D., is currently Executive Vice President-Administration and a director of OPKO Health, Inc. He currently also serves as a director of SafeStitch Medical Inc., a medical device company, of Dreams Incorporated, a manufacturer and provider of licensed sports products, of Ideation Acquisition Corp., a special purpose acquisition company, of Kidville, Inc., an owner and operator of upscale learning and play facilities for children, and of Cardo Medical, an orthopaedic medical device company. Previously, he was Senior Vice President and General Counsel of IVAX.
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Modigene Inc. 3 Sapir Street, Weizmann Science Park, Nes Ziona Israel 74140
3
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Exhibit 99.1
12-Month Operating Plan
We are focused on executing our operating plan to meet a number of important milestones, with the priority of beginning Phase I clinical trials for our long acting human growth hormone and then submitting the IND for our long-acting interferon-β candidate. With a strong capital position, dedicated and experienced board and management team, and with the exciting results we have seen to date from our drug candidates, we believe Modigene is now well positioned to execute our product development plans and to begin to realize the full potential of our innovative technology. We appreciate your continuing support of Modigene and look forward to updating you on our progress in the coming months.
Sincerely,
Dr. Abraham Havron
Chief Executive Officer
Dr. Phillip Frost
Chairman
Modigene Inc.
Safe Harbor Statement: This letter contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene’s long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene’s business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long-acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from the OCS is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene’s filings with the Securities and Exchange Commission.
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Modigene Inc. 3 Sapir Street, Weizmann Science Park, Nes Ziona Israel 74140
something is hot about this. started to add, today, wish I had the funds in early august for $1 shares.
Form 10KSB/A for MODIGENE INC.
13-Aug-2008
Annual Report
Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operation
The following discussion should be read in conjunction with the consolidated financial statements and the related notes thereto that appear in Item 7 of this Annual Report on Form 10-KSB/A.
Management's Discussion and Analysis
Results of Operation
The section "Results of Operation -- Critical Accounting Policies" under Item 6 of the Form 10-KSB as filed on March 31, 2008, is replaced in its entirety by the following section:
Critical Accounting Policies
The historical financial statements of the Company included with this Annual Report have been prepared in accordance with accounting principles generally accepted in the United States. The significant accounting policies followed in the preparation of the financial statements, on a consistent basis, are described below.
Use of Estimates: The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
Financial Statements in United States Dollars: The functional currency of the Company is, and of Modigene Delaware prior to the Merger has been, the U.S. dollar, as the U.S. dollar is the primary currency of the economic environment in which Modigene Delaware has operated and in which the Company expects to continue to operate in the foreseeable future. The majority of ModigeneTech's operations are currently conducted in Israel, and most of the Israeli expenses are paid in new Israeli schekels; however, most of the expenses are denominated and determined in U.S. dollars. Financing and investing activities, including loans and equity transactions, are made in U.S. dollars.
Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with Statement No. 52 of the Financial Accounting Standards Board ("FASB"), "Foreign Currency Translation." All transaction gains and losses from the remeasurement of monetary balance sheet items are reflected in the statements of operations as financial income or expenses, as appropriate.
Principles of Consolidation: The consolidated financial statements include the accounts of Modigene Delaware and its wholly-owned subsidiary, ModigeneTech. Intercompany transactions and balances have been eliminated upon consolidation.
Cash Equivalents: Cash equivalents include short-tem liquid investments that are readily convertible to cash with original maturities of three months or less.
Property and Equipment: Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated by the straight-line method over the estimated useful lives of the assets. The annual depreciation rates are as follows:
%
Office furniture and equipment 6
Laboratory equipment 15
Computers and electronic equipment 33
Leasehold improvements 25
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The Company's long-lived assets have been reviewed for impairment in accordance with Statement of Financial Accounting Standard No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets," whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets.
Research and Development Costs and Participation: Research and development ("R&D") costs are expensed as they are incurred and consist of salaries, benefits and other personnel related costs, fees paid to consultants, clinical trials and related clinical manufacturing costs, license and milestone fees, and facilities and overhead costs. R&D expenses consist of independent R&D costs and costs associated with collaborative R&D and in-licensing arrangements. Participation from government for development of approved projects are recognized as a reduction of expenses as the related costs are incurred.
Severance Pay: The liability of ModigeneTech for severance pay is calculated pursuant to the Severance Pay Law in Israel, based on the most recent salary of the employees multiplied by the number of years of employment as of the balance sheet date and is presented on an undiscounted bases. ModigeneTech's employees are entitled to on month's salary for each year of employment or portion thereof. Severance expenses for the twelve month periods ending December 31, 2007 and 2006 and for the period from May 31, 2005 (inception date) through December 31, 2007 amounted to $6,911, $1,956, and $8,867 respectively.
Income Taxes: The Company accounts for income taxes in accordance with Statement of Financial Accounting Standard No. 109, "Accounting for Income Taxes." This statement prescribes the use of the liability method, whereby deferred tax assets and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company has provided a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value.
Concentrations of Credit Risk: Financial instruments that potentially subjected the Company, Modigene Delaware and ModigeneTech to concentrations of credit risk consist principally of cash and cash equivalents.
Cash and cash equivalents are invested in major banks in Israel and the United States. Such deposits in the United States are not insured. Management believes that the financial institutions that hold the Company's investments are financially sound and, accordingly, minimal credit risk exists with respect to these investments.
The Company has no off-balance sheet concentration of credit risk such as foreign exchange contracts or other foreign hedging arrangements.
Fair Value of Financial Instruments: The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments: The carrying amounts of cash and cash equivalents, other receivables, trade payables and liabilities approximate their fair value due to the short-term maturity of such instruments.
Royalty-bearing Grants: Royalty-bearing grants from the Government of Israel for participation in development of approved projects are recognized as a reduction of expenses as the related costs are incurred. Funding is recognized at the time ModigeneTech is entitled to such grants, on the basis of the costs incurred.
Research and development grants received by ModigeneTech for the twelve month periods ending December 31, 2007 and 2006 and for the period from May 31, 2005 (inception date) through December 31, 2007 amounted to $272,282, $99,868, and $372,150 respectively.
Loss per Share: Basic and diluted losses per share are presented in accordance with Statement of Financial Accounting Standard No. 128 "Earning per Share." Outstanding share options and warrants have been excluded from the calculation of the diluted loss per share because all such securities are antidilutive. The total weighted average number of ordinary shares related to outstanding options and warrants excluded from the calculations of diluted loss per share were 5,262,819, 2,641,900 and 3,095,891 for the years ending December 31, 2007 and 2006 and for the period from May 31, 2005 (inception date) through December 31, 2007, respectively.
Modigene Awarded Israeli Government Grant to Support Development of Its Longer-Acting Interferon Beta
Tuesday August 5, 8:00 am ET
- $25 Million Interferon-Beta-CTP Development Program Has Been Approved For First Year Funding Through a Special Grant From the Israeli Office of the Chief Scientist -
NES-ZIONA, Israel, Aug. 5 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG - News) today reported that its Israeli-based R&D subsidiary has received approval for a special grant from the Israeli Office of the Chief Scientist ("OCS") in support of the company's development program for interferon-beta-CTP (IFN-Beta-CTP), its longer-acting version of interferon beta. Interferon-beta is an injectable treatment for multiple sclerosis (MS).
In preclinical experiments, IFN-Beta-CTP has shown durability of therapeutic effect, or half-life, almost seven times greater (6.7-fold longer) than the durability of effect of commercial interferon beta. The data demonstrated the potential to significantly reduce the number of required injections of interferon beta, which would greatly increase patient convenience.
The OCS has approved a special grant to support Modigene's IFN-Beta-CTP program for 2008-2009. The grant will provide cash reimbursements of 40% of expenses paid for IFN-Beta-CTP product development during this period. Modigene's full IFN-Beta-CTP development program, as submitted to the OCS, is based on an estimated development budget of $25 million for calendar years 2008-2011. IFN-Beta-CTP is currently in preclinical development, with clinical trials expected to begin in 2009.
Interferon beta is a drug used to reduce the frequency and severity of relapses afflicting people suffering from MS, an autoimmune neurological disorder affecting the insulating myelin layers of the brain and spinal cord. If unchecked, over time the immune system attack on myelin leads to poor coordination, severe disabilities and premature death. Annual sales of interferon beta were estimated to be $4.3 billion in 2007.
"This generous new grant from the OCS is an important non-dilutive cash resource for Modigene and represents another validation of the potential of our technology and of our second lead candidate," said Abraham Havron, Ph.D., Chief Executive Officer of Modigene. "The OCS has already awarded Modigene funds in support of our human growth hormone (hGH-CTP) product candidate and we are delighted that our IFN-Beta-CTP program has now also been selected for support. This visionary OCS program is particularly attractive for Modigene because it does not require any repayment until the product is generating revenue. We are grateful for this valuable source of non-dilutive capital."
Under the terms of the grant, Modigene is required to repay the OCS the sum of the grant plus accrued interest through a series of payments that begin only upon successful commercialization of the IFN-Beta-CTP product, or other products developed at the company with its CTP technology.
ABOUT CTP
Modigene's technology was discovered by researchers at Washington University in St. Louis and is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in humans and when attached to a therapeutic protein, extends the time that the protein is active in the body. The potential utility of the technology has been demonstrated by Schering-Plough, which licenses the CTP technology for fertility applications only. On July 8, 2008 it announced successful top-line data from its Phase III ENGAGE trial demonstrating that women receiving a single injection of the fertility drug FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive daily injections of commercial FSH. This 1,509 patient trial was the largest double-blind fertility trial ever conducted. Modigene is using the same CTP technology to extend the duration of action of other therapeutic proteins. It has an exclusive license from Washington University to the CTP technology for use with all therapeutic proteins except for the four endocrine hormones licensed to Schering-Plough.
ABOUT MODIGENE
Modigene Inc. is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene's long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long-acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from the OCS is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission.
MODIGENE CONTACT: MEDIA CONTACT:
Shai Novik, President Barbara Lindheim
Modigene Inc. GendeLLindheim BioCom Partners
Tel: +1 866 644-7811 +1 212 918-4650
Email: shai@modigeneinc.com
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Source: Modigene Inc.
Form 8-K for MODIGENE INC.
18-Jul-2008
Change in Directors or Principal Officers, Financial Statements and Exhibits
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(e) On July 17, 2008, the Compensation Committee of the Board of Directors of Modigene Inc. (the "Company") approved certain amendments to the employment agreements, as previously amended, of four of its Israeli executives, namely Shai Novik (President), Avri Havron (Chief Executive Officer), Fuad Fares (Chief Scientific Officer) and Eyal Fima (VP Product Development) (together, the "Israeli Executives"). The employment agreements with the Israeli Executives are referred to collectively as the "Israeli Executive Employment Agreements."
The amendments to the Israeli Executive Employment Agreements were entered into to provide that effective June 1, 2008, the compensation of the Israeli Executives would be modified from United States Dollars (US$) to Israeli Shekels (IS), calculated using an IS/US$ exchange rate of 3.86 IS/US$. As to the compensation of each of the Israeli Executives, the compensation payable in IS is as follows:
Avri Havron: Salary of 829,900 IS, Bonus of 231,600 IS
Shai Novik: Salary of 965,000 IS, Bonus of 328,100 IS
Eyal Fima: Salary of 386,000 IS, Bonus of 193,000 IS
Fuad Fares: Salary of 138,960 IS
The amendments were entered into because under the Israeli Executive Employment Agreements, the salary was previously stated in US$, but was paid in IS based on the prevailing IS/US$ exchange rate. All of the Israeli Executives reside in Israel and perform substantially all of their services to the Company in Israel. Accordingly, the Compensation Committee adopted the amendments in order to reflect the intention of the Company that the Israeli Executives be paid in the currency of the country in which they reside, and to avoid any fluctuations in salary that could potentially result from currency exchange rate fluctuations.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
Exhibit No. Description
10.1 Amendment to Consulting Agreement
between the Company and Avri Havron
10.2 Amendment to Employment Agreement
between the Company and Shai Novik
10.3 Amendment to Consulting Agreement
between the ModigeneTech Ltd. and Fuad
Fares
10.4 Amendment to Employment Agreement
between the ModigeneTech Ltd. and Eyal
Fima
glad I waited. sometime's it's fun to shop when you can't afford to buy yet. I really like what I've seen.
CTP is "best-of-breed" for enhancing protein longevity
By Gareth Macdonald
16-Jul-2008 - Modigene says that data from a trial of a Schering-Plough's (SP) fertility stimulation hormone (FSH-CTP) confirms that carboxyl terminal peptide (CTP) modification can extend the therapeutic duration of protein drugs.
Techniques to boost the half-life of therapeutic proteins fall into two main categories with developers choosing to either increase the size of the drug molecule or alter its physical structure in an effort to extend its durability in circulation.
Such approaches are fraught with technical difficulties and, to date, only a handful of extended-release drugs have been commercialized. Despite this, products that have been launched, such as SP's Pegintron (peginterferon alfa-2B), Amgen's Aranesp (Darbepoetin alfa) and Neulasta (PEGfilgrastim), generate revenues of around $8bn a year.
The CTP approach, which was developed by researchers working at Washington University in St. Louis, Missouri, attaches a small portion of the female pregnancy maintenance hormone chorionic gonadotropin (hCG) to the molecule under development, markedly improving its circulatory half-life.
Shai Novik, Modigene's president, told in-PharmaTechnologist.com that: "The CTP peptide is basically a best-of-breed technology to enhance protein longevity. PEGylation, DNA mutations and Albumin fusion are the technologies that have mainly been used to date, and CTP has the positive properties encapsulated in each, but is a natural peptide we all carry in our bodies and therefore non-immunogenic."
"The three main important properties of a technology to extend protein longevity are: Create a durable protein; that maintains comparable biological activity; and is non-immunogenic. The CTP offers all three in a small peptide that can be attached once or multiple times to a protein of choice to extend durability. Unlike technologies like PEGylation and DNA mutation, which involve trial-and-error to find the right combination that may work, the CTP technology is a simple attachment of the CTP peptide to the authentic molecule," Novik explained.
He added that because: "the CTP platform is applicable to all therapeutic proteins and peptides. The market for the proteins we are currently going after is $2.2bn for human growth hormone, and $4.3bn for interferon beta. There are many other therapeutic proteins representing over $50bn in annual sales."
Clinical trials due next year
SP's Phase III trial, known as ENGAGE, compared the effectiveness of a single FSH-CTP in 1,509 women suffering from a variety of fertility problems. The results showed that pregnancy rates in subjects who received the single injection were comparable with those who received seven consecutive FSH injections.
Modigene is applying the CTP technology to its human growth hormone (hGH) and interferon beta (IFN-beta) programmes. Specifically, the firm is seeking to establish products that require only once-a-week administration, in contrast with the three to seven times a week injections demanded by currently available competitor treatments.
Company CEO, Avri Havron, said that the: "The success of Schering-Plough's Phase III trial of its long-acting FSH fertility hormone marks a major milestone for the CTP platform technology that is the basis for our new drug pipeline."
"We believe these positive results provide independent support of our own plans for clinical trials of Modigene's CTP-enhanced versions of human growth hormone and interferon beta that we intend to initiate next year," he added.
now you know why the chart is looking good
MODIGENE PLATFORM VALIDATED IN INDEPENDENT
PHASE III TRIAL OF CTP TECHNOLOGY
--Validates the Clinical Utility of Modigene’s CTP Technology for
Extending the Duration of Action of Therapeutic Proteins--
Nes-Ziona, Israel -- July 10, 2008 -- Modigene Inc., (OTCBB: MODG) today noted the
successful completion of a Phase III clinical trial by Schering-Plough of long-acting fertility
hormone corifollitropin alfa (FSH-CTP). FSH-CTP uses the naturally occurring CTP peptide
to extend the duration of action of the hormone. Modigene is using the same naturally
occurring CTP peptide to extend the duration of action of other therapeutic proteins and
peptides. Schering-Plough licensed the CTP technology from Washington University for use
only with four endocrine hormones. Modigene has an exclusive license from Washington
University to the CTP technology for use with all other proteins and peptides. Modigene is
currently applying the CTP technology to extend the duration of action of human growth
hormone and interferon beta, with the goal of reducing the number and frequency of
injections required to treat patients requiring continual injections of these proteins.
“The success of Schering-Plough’s Phase III trial of its long-acting FSH fertility hormone
marks a major milestone for the CTP platform technology that is the basis for our new drug
pipeline,” said Avri Havron, Ph.D., CEO of Modigene. “We believe these positive results
provide independent support of our own plans for clinical trials of Modigene’s CTP-enhanced
versions of human growth hormone and interferon beta that we intend to initiate next year.”
On July 8, 2008 Schering-Plough announced successful top-line data from its Phase III
ENGAGE trial demonstrating that women receiving a single injection of FSH-CTP achieved
the same pregnancy rates as women receiving seven consecutive daily injections of FSH, a
primary endpoint of the study. This 1,509 patient trial was the largest double-blind fertility
trial ever conducted.
Human growth hormone (hGH), which is used to treat growth failure in children and frailty in
adults, must currently be injected between three and seven times per week, while interferon
beta (IFN-Beta), which is prescribed for the treatment of multiple sclerosis, must be injected
between one and three times per week. Neither of these therapies has a commercial longacting
version available, and their current market sizes are estimated at $2.2 billion and $4.3
billion, respectively.
Modigene’s hGH-CTP and IFN-Beta-CTP are in late preclinical development. Based on
studies in relevant animal models, researchers project once-weekly administration of hGHCTP
compared to the multiple daily injections required for commercial hGH, and once-every
two-to-four weeks administration of IFN-Beta-CTP, compared to the one-to-three times per
week injections currently required for commercial interferon beta.
ABOUT MODIGENE
Modigene Inc. is a biopharmaceutical company applying its patented CTP technology to
develop longer-acting, proprietary versions of already approved therapeutic proteins that
currently generate billions of dollars in annual global sales. The CTP technology is
applicable to virtually all proteins, and Modigene is currently developing long-acting versions
of human growth hormone, interferon beta and erythropoietin, which are in late preclinical
development, as well as GLP-1. For more information on Modigene, visit
www.modigeneinc.com.
starting my homework on this one, chart looks good.
http://stockcharts.com/h-sc/ui?s=MODG&p=D&yr=1&mn=0&dy=0&id=p21238080991
Form 10-Q for MODIGENE INC.
http://biz.yahoo.com/e/080513/modg.ob10-q.html>
Modigene's Shot in the Arm
By Rachel Neiman
April 09, 2008
No one likes getting jabbed, but for many there isn't a choice. Millions of people get daily injections of therapeutic proteins, a group that encompasses everything from insulin to fertility drugs.
The problem faced by patients enduring multiple injections is how to get these therapies to last longer. The danger faced by drug developers wishing to increase "persistence", is that the body will develop an immune response to the molecule, rendering it useless.
Therapeutic proteins are defined as proteins engineered in the laboratory for pharmaceutical use. These fall roughly into two categories: replacement therapies for people whose bodies can't produce the proteins or produce insufficient amounts; and therapies that don't exist naturally in the body but - as in the case of monoclonal antibodies - can be cloned from a single cell to bind to and destroy antigens.
Once in the bloodstream, therapeutic proteins are quickly broken down and filtered out, so injections must be administered frequently to be effective.
Israel's Modigene, which just raised an additional $12 million from its investors, deals with replacement and enhancement therapies, and intends to develop longer acting versions of already-approved therapeutic proteins that will dramatically reduce the number of injections needed (i.e. from daily to weekly or less).
To that end, Modigene licensed intellectual property (IP) from Washington University of St. Louis. The technology is based on a short amino acid sequence, the carboxyl terminal peptide (CTP) that occurs naturally in humans. When attached to a therapeutic protein, CTP extends the time the protein is active in the body.
Modigene's license is for rights relating to human therapeutics including all therapeutic proteins and peptides, excluding four endocrine proteins. These were licensed, for fertility applications only, to Dutch company Organon, a unit of Schering-Plough. Organon's Phase II trials are encouraging: CTP follicle stimulating hormone product (FSH-CTP) required only one injection, compared with seven injections required for regular FSH.
The two companies are the only licensees of the technology, notes Modigene president Shai Novik, and while there is no formal relationship, "We follow them very closely because they are a clinical validation of the technology. We use the exact same CTP peptide but they are fusing it to FHS and we fuse it to other molecules."
Modigene currently has four CTP-enhanced compounds in development: MOD-701 - Erythropoietin to stimulate red blood cell production; MOD-901 - Interferon ß to treat multiple sclerosis (MS); MOD-1001 - GLP-1 for treatment of Type 2 diabetes and MOD-401 - Human Growth Hormone, to treat children with growth hormone deficiency, kidney disease, Prader-Willi Syndrome, and Turner's Syndrome. Israel's Office of the Chief Scientist awarded Modigene development grants for HGH-CTP in 2007 and for EPO-CTP in 2006.
HGH-CTP could have an additional market; it is being touted as a fountain of youth for adults that could increase energy, enhance sexual performance, lower cholesterol, and plump aging skin.
Novik says Modigene is watching but not targeting the lifestyle market, preferring to stay on track for FDA approval with human trials for HGH-CTP scheduled for the first quarter of 2009, and hopes of market launch in five years. "That's not a long time for drug development as we're seeking approval for an existing drug. Fast time-to-market at lower cost is part of our strategy."
In addition to commercializing its core therapeutic proteins, Modigene is also seeking licensing deals with biotechnology companies interested in developing longer-lasting versions of their existing drugs.
Modigene, which is publicly traded on Wall Street (MODG), operates an R&D subsidiary at the Weizmann Science Park, Ness Ziona.
Modigene's chairman and lead investor is Miami-based entrepreneur Dr. Phillip Frost, listed among Forbes 400 Richest Americans for 2007. Frost is chairman of Ladenburg Thalmann & Co. Inc. and a director of Continucare Corp. (CNU) and Teva Pharmaceutical Industries.
The $12 million investment consists of a $2 million equity investment by Frost, Dr. Jane Hsiao and Steven Rubin, who are also directors at Modigene and members of The Frost Group LLC, which extended the additional $10 million line of credit.
source: http://www.israel21c.org/bin/en.jsp?enDispWho=Articles%5El2062&enPage=BlankPage&enDisplay=view&enDispWhat=object&enVersion=0&enZone=Health>
Form 8-K for MODIGENE INC.
27-Mar-2008
Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligati
Item 1.01 Entry into a Material Definitive Agreement.
On March 25, 2008, Modigene Inc. (the "Company") entered into a Securities Purchase Agreement (the "Purchase Agreement") with Frost Gamma Investments Trust (the "Frost Trust"), Jane Hsiao, M.B.A., Ph. D., Steven D. Rubin, and Subbarao Uppaluri (collectively, the "Investors"). Dr.Phillip Frost, the Chairman of our board of directors, is the sole trustee of the Frost Trust. Frost Gamma, L.P. is the sole and exclusive beneficiary of the Frost Trust, and Dr. Frost is one of two limited partners of Frost Gamma, L.P. The general partner of Frost Gamma, L.P. is Frost Gamma, Inc. and the sole stockholder of Frost Gamma, Inc. is Frost-Nevada Corporation. Dr.Frost is the sole stockholder of Frost-Nevada Corporation. Dr. Hsiao and Mr. Rubin are also directors of Modigene.
The Securities Purchase Agreement provides that the Company will sell to the Investors, and the Investors will purchase from the Company, 800,000 shares of Series A preferred stock, $0.00001 par value per share (the "Series A Preferred Stock"), at $2.50 per share, for an aggregate purchase price of $2,000,000. Of the 800,000 shares of Series A Preferred Stock purchased under the Securities Purchase Agreement, the Frost Trust purchased 632,000 shares for $1,580,000, Dr. Hsiao purchased 152,000 shares for $380,000 and Mr. Rubin purchased 8,000 shares for $20,000.
The rights and preferences of the Series A Preferred Stock are described in Item 3.03 below.
On March 25, 2008, the Company also entered into a line of credit with The Frost Group, LLC, as described under Item 2.03 below.
A copy of a Press Release, dated March 27, 2008, issued by the Company relating to the issuance of the Series A Preferred Stock and the entry into the line of credit is attached as Exhibit 99.1 and is incorporated herein by reference.
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
(a) On March 25, 2008, simultaneously with the closing of the transaction under the Securities Purchase Agreement, the Company entered into a Credit Agreement and a Note and Security Agreement with The Frost Group, LLC ("TFG"), a Florida limited liability company whose members include the Frost Trust, Dr. Hsiao and Mr. Rubin.
Under this line of credit, the Company may, at its discretion, borrow up to $10,000,000, which proceeds may be used for working capital or general corporate purposes of the Company, as approved by our board of directors. The maturity date for the line of credit is March 25, 2009, unless (i)the Company has borrowed any funds under the line of credit prior to March 25, 2009, or (ii)the Company elects to extend the line of credit. In either of such events the maturity date will be extended until March 25, 2013. Upon the maturity date, as the same may be extended, the Company is obligated to repay to TFG all outstanding borrowings, together with any accrued interest, and the line of credit will terminate. The Company is obligated to pay interest on outstanding borrowings under the line of credit at a 10% annual rate. In the event the Company determines to draw on the line of credit, or the Company elects to extend the maturity date until March 25, 2013, the Company will issue to TFG 5-year warrants (the "TFG Warrants") to purchase 1,500,000 shares of the Company's common stock, $0.00001 par value per share (the "Common Stock"), having an exercise price of $0.99 per share.
Item 3.02 Unregistered Sales of Equity Securities.
(a) On March 25, 2008, the Company issued 800,000 shares of the Series A Preferred Stock as described in Item 1.01 above. In addition, the Company may become obligated to issue the TFG Warrants as described in Item 2.03 above. The terms of conversion of the Series A Preferred Stock are described in Item 3.03 below, and the terms of exercise of the TFG Warrants are described in Item 2.03 above.
None of the Series A Preferred Stock, the TFG Warrants or the Common Stock issuable in connection with any conversion of the Series A Preferred Stock or exercise of the TFG Warrants will be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws, and will be issued to the Investors pursuant to the exemption from registration under
Section 4(2) of the Securities Act and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission. No general solicitation was made by us or any person acting on our behalf with respect to the issuance of the Series A Preferred Stock to the Investors or with respect to the issuance of the TFG Warrants to TFG. The Series A Preferred Stock and the TFG Warrants are being issued pursuant to transfer restrictions, and the certificates for shares of Series A Preferred Stock and any warrant certificate representing the TFG Warrants will contain appropriate legends stating that such securities are not registered under the Securities Act and may not be offered or sold absent registration or an exemption from registration. Each of the Investors and TFG is an "accredited investor," as that term is defined by Rule 501 of Regulation D under the Securities Act.
Item 3.03 Material Modification to Rights of Security Holders.
(a) In connection with the Securities Purchase Agreement described in Item 1.01 above, the Company has approved the designation of 800,000 shares of its preferred stock as the Series A Preferred Stock. The following is a summary of material provisions of the Series A Preferred Stock, the terms of which are set forth in detail in the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the "Certificate of Designations") filed with the Secretary of State of the State of Nevada upon the consummation of the transactions under the Securities Purchase Agreement. The Certificate of Designations is attached to this Report as Exhibit 4.1.
Right to Convert. Each holder of shares of Series A Preferred Stock shall be entitled, at the option of such holder, to convert all, but not less than all, of the shares of Series A Preferred Stock then held by such holder, at any time and from time to time beginning on March 1, 2009 and ending at 5:00 p.m., Eastern time, on March 25, 2012 (the "Conversion Deadline"), without the payment of any additional consideration, into Common Stock at the applicable conversion price discussed below.
Automatic Conversion. If any holder of shares of Series A Preferred Stock has not exercised his, her or its right to convert the shares of Series A Preferred Stock then held by such holder on or prior to the Conversion Deadline, then at the Conversion Deadline all such shares of Series A Preferred Stock will automatically convert, without the payment of any additional consideration, into Common Stock at the applicable conversion price discussed below.
Conversion Ratio. Each holder of Series A Preferred Stock may, at such holder's option, convert all, but not less than all, of his shares of Series A Preferred Stock into shares of our Common Stock, at any time and from time to time, without the payment of any additional consideration. Each share of Series A Preferred Stock is convertible into our Common Stock based upon a conversion ratio equal to (x) the $2.50, divided by (y) the conversion price in effect at the time of conversion, which conversion price is subject to adjustment as set forth below. The conversion price will initially be $2.50. Accordingly, the initial conversion ratio will be one share of Common Stock for one share of Series A Preferred Stock.
The conversion price will change in the event that a Market Capitalization Contingency occurs. A "Market Capitalization Contingency" shall occur if the aggregate market value of the Common Stock, obtained by multiplying (a) the number of shares of Common Stock outstanding (on a fully-diluted basis, as follows: taking into account the shares of Common Stock issuable upon the exercise of all outstanding warrants and other convertible securities or instruments issued by the Company, but excluding all shares of capital stock issued, issuable or reserved for issuance pursuant to or under the Company's 2005 Stock Incentive Plan and the Company's 2007 Equity Incentive Plan and excluding the shares of Common Stock issuable upon conversion of the Series A Preferred Stock), by (b) the closing sale price of a share of Common Stock, as reported on the over-the-counter bulletin board, or, if the Common Stock has been admitted to trading on a nationally recognized stock exchange or market quotation system (including, without limitation, the American Stock Exchange), as reported on such exchange or market quotation system, shall, during any forty-five (45) trading days within any consecutive ninety (90) day period, equal or exceed one hundred fifty million dollars ($150,000,000.00). Upon a Market Capitalization Contingency, the number of shares of Common Stock into which the outstanding Series A Preferred Stock is convertible shall be determined by dividing (x) 2.50, by (y) $0.50 (the "Market Cap Conversion Price"). Accordingly, the initial conversion ratio using the Market Cap Conversion Price will be five shares of Common Stock for one share of Series A Preferred Stock. The Basic Conversion Price and the Market Cap Conversion Price may be referred to herein as the "Conversion Price." The Conversion Price may be adjusted as set forth below.
Adjustments to the Conversion Ratio. In the event of the subdivision of our Common Stock (by forward stock split, stock dividend or other similar occurrence) into a greater number of shares of Common Stock, and no equivalent subdivision or increase is made with respect to the Series A Preferred Stock, the Conversion Price that in effect will be proportionately decreased. In the event of the combination (by reverse stock split or otherwise) or consolidation of our Common Stock into a lesser number of shares of Common Stock, and no equivalent combination or consolidation is made with respect to the Series A Preferred Stock, the conversion ratio then in effect will be proportionately increased. In the event of the issuance of rights or warrants to holders of Common Stock entitling them to subscribe for or purchase Common Stock, or the distribution of capital stock (other than shares of Common Stock) to holders of Common Stock, evidences of indebtedness of the company, assets, rights or warrants to subscribe for or purchase any securities, the holders of Preferred Stock will be entitled to receive, upon any conversion, the amount of the securities, assets, rights or warrants that they otherwise would have received had the Preferred Stock been converted at the time of such. issuance. Upon receipt of such issuance or distribution, no adjustment shall be made in the Conversion Price.
In the event of any capital reorganization or reclassification of our Common Stock (other than as a result of a stock dividend, subdivision, combination of shares or any other event described in the immediately preceding paragraph), or any sale or merger of our Company effected in such a way that holders of Common Stock become entitled to receive capital stock, other securities or property with respect to or in exchange for shares of Common Stock, the holders of Series A Preferred Stock will be entitled to receive, upon any conversion, the kind and number of shares of capital stock, other securities or property to which such holders of Series A Preferred Stock would have been entitled had they held the number of shares of Common. Stock into which the shares of Series A Preferred Stock then convert.
Automatic Conversion upon Certain Reorganizations, Mergers, etc. If there is any reorganization, recapitalization, consolidation, sale or merger involving the Company (i) that results in the stockholders of the Company immediately prior to such transaction owning less than 50% of the outstanding voting securities of the Company (or the surviving company in a merger) or (ii) in which transaction the Company is valued at at least one hundred fifty million dollars ($150,000,000.00) (in either case, a "Market Cap Transaction") in which the Common Stock (but not the Series A Preferred Stock) is converted into or exchanged for capital stock, other securities or property with respect to or in exchange for shares of Common Stock, then, immediately prior to any such Market Cap Transaction, all outstanding shares of Series A Preferred Stock will, without any further action by the Company or any holder of Series A Preferred Stock, automatically be converted into Common Stock at the then-applicable Market Cap Conversion Price, assuming a Market Capitalization Contingency had occurred, such that, upon the conversion or exchange of Common Stock in connection with such Market Cap Transaction, each holder of Series A Preferred Stock will be entitled to receive the kind and number of shares of capital stock, other securities or property to which such holders of Series A Preferred Stock are entitled taking into account such conversion of the Series A Preferred Stock as provided herein.
Treatment of the Series A Preferred Stock in the Event of Certain Mergers or Reorganizations, etc. If there is any reorganization, recapitalization, consolidation, sale or merger involving the Company that is not a Market Cap Transaction (a "Basic Transaction") in which the Common Stock (but not the Series A Preferred Stock) is converted into or exchanged for capital stock, other securities or property with respect to or in exchange for shares of Common Stock, then, immediately prior to any such Basic Transaction, all outstanding shares of Series A Preferred Stock will, as applicable: (i) remain outstanding if the Company is the surviving Company in such Basic Transaction, or (ii) be converted into shares of preferred stock of the surviving corporation in such Basic Transaction (if not the Company), with such shares of preferred stock to have the same powers, preferences and rights and relative, participating optional or other rights, preferences, restrictions and other matters relating to such series of preferred stock as provided herein
Fractional Shares. No fractional shares of Common Stock will be issued upon the conversion of the Series A Preferred Stock. Instead, all shares of Common Stock (including fractions thereof) issuable upon conversion of more than one share of Series A Preferred Stock by a holder thereof shall be aggregated and then will be rounded up to the nearest whole share. We will not pay any cash adjustment for fractional shares.
Voting Rights. The holders of Series A Preferred Stock (and the holders of any other class or series of preferred stock that may have similar voting rights) will vote on an as-if-converted basis with the holders of our Common Stock and any other class or series of preferred stock or Common Stock that by its terms, votes on an as-if-converted basis with the holders of our Common Stock on all matters to be voted on by stockholders of our company, subject to the provisions of the Nevada Revised Statutes. In addition, the holders of the Series A Preferred Stock shall vote as a separate class when required by Nevada law.
Dividends. Dividends will be payable only if, when and as declared by our Board of Directors, and, if declared, any such dividends will be non-cumulative. Such dividends, if any, will be paid out of, and to the extent of, any assets legally available therefor. No dividends will be declared or paid on the Common Stock, unless a dividend, payable in the same consideration or manner, is simultaneously declared or paid, as the case may be, on each share of Series A Preferred Stock.
Liquidation. In the event of any liquidation, dissolution or winding-up of our company (each, a "Liquidation"), whether voluntarily or involuntarily, the entire remaining assets and funds of the Company legally available for distribution, if any, shall be distributed pro rata among the holders of the Series A Preferred Stock (based upon the number of shares of Common Stock that such holders would have the right to acquire upon conversion of the Series A Preferred Stock at the Market Cap Conversion Price, assuming a Market Capitalization Contingency had occurred), the Common Stock and any other classes entitled to participate with Common Stock in proportion to the shares of Common . . .
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
Exhibit No. Description
4.1 Certificate of Designations of Preferences, Rights
and Limitations of Series A Convertible Preferred
Stock (filed herewith)
10.1 Securities Purchase Agreement among Modigene Inc.,
Frost Gamma Investments Trust, Jane Hsiao, Steven D.
Rubin and Subbarao Uppaluri (filed herewith)
10.2 Credit Agreement between Modigene Inc. and The Frost
Group, LLC (filed herewith)
Exhibit No. Description
10.3 Note and Security Agreement between Modigene Inc.
and The Frost Group, LLC (filed herewith)
99.1 Press Release, dated March 27, 2008.
Modigene Announces Closing of $12 Million Financing by Members of The Frost Group
Thursday March 27, 8:00 am ET
- Financing Includes Equity Investment and Line of Credit -
NES-ZIONA, Israel, March 27 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG - News), a biopharmaceutical company applying its patented technology to develop longer-acting versions of already-approved therapeutic proteins, today announced that it has closed a $2 million equity investment by a group of private investors and has entered into a line of credit agreement that provides for the availability of an additional $10 million financing. The equity investors consist of a group led by Dr. Phillip Frost, who is also the Chairman of the Board of Modigene, and the line of credit has been extended by The Frost Group LLC. Two other directors of Modigene, Dr. Jane Hsiao and Steven Rubin, are participants in the equity financing and are members of The Frost Group.
In the equity financing, Modigene issued a convertible series A preferred security at a price of $2.50 per preferred share and under the line of credit it received an option to borrow up to $10 million at an interest rate of 10% per annum that includes warrant coverage if utilized.
"Protein therapeutics represent an increasingly significant segment of the biopharmaceutical market, and we believe that Modigene's unique technology has great potential to deliver the longer-acting drugs sought by patients and their health providers," said Dr. Frost. "We welcome this opportunity to further support this promising company."
The convertible series A preferred security automatically converts into Modigene unregistered common stock after four years at a price that will be set depending on the company's market capitalization at that time. The price targets are structured to offer more favorable terms to the investors if the company is able to significantly increase its market capitalization by at least four times during this period - a market capitalization that would benefit all shareholders.
"This financing is a winning combination for Modigene and its shareholders," said Avri Havron, CEO of Modigene. "It provides the company with an immediate $2 million in cash and an option to borrow up to another $10 million at very attractive terms. We believe that Modigene's current cash position, our anticipated cash grants from the Israeli government for our human growth hormone program and the option for a $10 million five-year loan provide us with a robust capital structure. We anticipate that these resources will be sufficient to enable us to complete Phase II clinical studies for our two most advanced long-acting protein therapeutics and also provide us with at least three years of operating cash."
The line of credit extended by The Frost Group is initially for a one-year period. If Modigene draws down cash from the line of credit during the one-year period, Modigene will issue to The Frost Group 1.5 million warrants to purchase unregistered common stock of the company. The warrants have a five-year term and a $0.99 exercise price. Although the line of credit is secured, the intellectual property of the company is not part of any lien or security provided to The Frost Group under the line of credit.
"The attractive terms of this financing further demonstrate the strong commitment of the Frost investor group to Modigene," added Mr. Havron. "The structure of the transaction is well-aligned with the interests of all our shareholders. We view the option to borrow up to $10 million at favorable terms an important strategic advantage for a preclinical stage biotechnology company such as Modigene, providing management and our shareholders with the flexibility of significant potential leverage."
For more information on the financing, visit the SEC filings link at our website at www.modigeneinc.com.
nice volume - today again
6-Mar-2008
Termination of a Material Definitive Agreement, Change in Directors or Principal Of
Item 1.02 Termination of a Material Definitive Agreement.
(a) As disclosed in Item 5.02 below, effective March 4, 2008, Robert F. Mauer, the part-time Chief Financial Officer and principal financial officer of Modigene Inc. (the "Company"), resigned. At the time of his resignation, his employment agreement with the Company was terminated by the mutual agreement of the parties with no further liability of either party, other than the payment by the Company of Mr. Mauer's salary through the effective date of his resignation.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
(b) On February 29, 2008, each of Dr. Eugene Bauer and Mr. Joel Kanter delivered written notice to Modigene Inc. (the "Company") stating that he was resigning from his position as a member of the Board of Directors of the Company effective February 29, 2008. Each of Dr. Bauer and Mr. Kanter resigned for personal reasons.
Effective March 4, 2008, Robert F. Mauer, resigned as the Company's part-time Chief Financial Officer and principal financial officer.
(c) On March 4, 2008, Mr. Steven D. Rubin and Mr. Marian Gorecki were appointed to the Board of Directors of the Company. Mr. Rubin and Mr. Gorecki were appointed by the remaining current members of the Board (Dr. Abraham (Avri) Havron, Mr. Shai Novik, Dr. Fuad Fares, Dr. Phillip Frost, Dr. Jane Hsiao and Mr. Adam Stern) pursuant to Section 4 of Article II of the Company's amended and restated bylaws, which allows the Company's directors to fill any vacancy in the Board.
Mr. Rubin was also appointed to serve on the Audit and Compensation Committees of the Board of Directors and in addition was appointed as chairman of the Audit Committee and was designated as the "audit committee financial expert" as defined in the Securities Exchange Act of 1934, as amended. Mr. Gorecki was appointed to serve on the Audit, Compensation and Governance Committees of the Board of Directors.
On May 9, 2007, simultaneously with the Company's closing of its acquisition of Modigene Inc., a Delaware corporation, the Company sold a total of 5,377,660 shares of its common stock, plus warrants to purchase 333,333 shares of common stock, to four strategic investors led by Dr. Phillip Frost and Dr. Jane Hsiao, who were appointed as directors upon the closing of merger and related transactions, for total consideration of US$2,000,000. On May 21, 2007, the Company issued an additional 155,673 shares of common stock for no additional consideration to these investors, for a total of 5,533,333 shares issued to this investor group. Mr. Rubin was one of the investors participating in this transaction, and he individually purchased a total of 27,666 shares, and warrants to purchase an additional 1,666 shares, of common stock in this offering, for total consideration of US$10,000.
At the time of his appointment to the Board of Directors, Mr. Gorecki was awarded an option to purchase 25,000 shares of common stock of the Company at an exercise price of $0.93. The options vest in equal annual installments over a three-year period, and will expire ten years from the date of grant. These options were awarded under the Company's 2007 Equity Incentive Plan.
In connection with the changes to the Company's Board of Directors discussed above, the Board appointed Dr. Phillip Frost as Chairman of the Board.
Effective March 5, 2008, we engaged Mr. Steve Schaeffer as Chief Financial Officer and the principal financial officer of the Company. Mr. Schaeffer, 58, has over 30 years of accounting and tax experience. He is a principal and founder of Cohen & Schaeffer, P.C., a full service CPA firm co-founded by Mr. Schaeffer in 1993. Prior to forming Cohen & Schaeffer, Mr. Schaeffer was a tax partner at BDO Seidman and a principal at Laventhol & Horwath. Mr. Schaeffer has no family relationships with any director or executive officer of the Company. During the last two years, there have been no transactions, or proposed transactions, to which the Company was or is a party, in which Mr. Schaeffer had or is to have a direct or indirect material interest.
(e) On February 29, 2008, the Compensation Committee approved amendments to the employment and consulting agreements between the Company and each of Dr. Abraham (Avri) Havron, its Chief Executive Officer, and Mr. Shai Novik, its President. Also on that date, ModigeneTech Ltd., a wholly-owned subsidiary of the Company, entered into an amendment of its Employment Agreement with Dr. Eyal Fima.
Under his amended consulting agreement, (i) Dr. Havron's annual consulting fee has been increased from US$140,000 to US$215,000, effective retroactively to January 1, 2008, (ii) the structure of his potential performance bonus has been changed from up to 25% of his annual consulting fee to up to US$60,000 (approximately 28% of his new annual consulting fee), and (iii) Dr. Havron has been granted the use of a Company car.
Under Mr. Novik's amended employment agreement, (i) his annual base salary has been increased from US$205,000 to US$250,000, effective retroactively to January 1, 2008, (ii) his performance bonus parameters have been changed from up to 50% of his annual base salary to up to US$85,000 (34% of his annual base salary), and (iii) Mr. Novik has been granted the use of a Company car.
Dr. Fima's amended employment agreement increases his annual base salary from NIS 300,000 (approximately US$82,800 at the current conversion rate) to US$100,000, effective retroactively to January 1, 2008, and increases his potential maximum performance bonus from 25% of his annual base salary to 50% of his annual base salary.
On February 29, 2008, the Compensation Committee of the Board of Directors approved cash performance bonuses for the 2007 fiscal year as follows: (i) Dr. Havron was granted a performance bonus of US$60,000, which included a US$25,000 bonus granted pursuant his consulting agreement and a special bonus of US$35,000 awarded by the Compensation Committee in recognition of Dr. Havron's work in accomplishing the preclinical development milestone's for the Company's drug candidates, while conserving cash and ending the year significantly under budget; and (ii) Dr. Fima was granted a performance bonus of US$37,500, which included US$20,000 pursuant to his employment agreement, and a special bonus of US$15,500 awarded by the Compensation Committee in recognition of Dr. Fima's work in accomplishing the preclinical development milestones for the Company's drug candidates, while conserving cash and ending the year significantly under budget.
On March 5, 2008, Mr. Schaeffer, Cohen & Schaeffer LLP ("CS") and the Company entered into an Agreement (the "Agreement") reflecting the terms and conditions of Mr. Schaeffer's engagement with the Company.
Pursuant to the Agreement, Mr. Schaeffer will serve as the Company's Chief Financial Officer and the designated principal financial officer on a part-time basis, and CS and Mr. Schaeffer will provide services to the Company including creating and maintaining sound accounting policies and procedures, managing books and records, preparing and reviewing quarterly and financial statements as well as reviewing the Company's financial and disclosure controls and procedures. The Agreement provides for a quarterly payment of $12,000 to CS, together with reimbursement of reasonable out-of-pocket expenses incurred by CS or Mr. Schaeffer in the course of service to the Company. Mr. Schaeffer is not entitled to participate in any welfare or benefit plans generally made available to full time employees of the Company. The Agreement is for a two-year period and may be extended by the mutual agreement of the parties for additional subsequent 12-month periods, and may be earlier terminated by either the Company or Mr. Schaeffer and CS on 30 days' notice. The Agreement may also be terminated by the Company in the event of a breach by Mr. Schaeffer or CS, but if such breach is curable Mr. Schaeffer and CS will have 30 days following notice in which to cure the breach. In the event of any termination of the Agreement, CS will be entitled only to payments accrued through the date of termination. The Agreement contains a customary agreement by Mr. Schaeffer and CS relating to non-disclosure of confidential information. The foregoing description of the Agreement is qualified in its entirety by reference to the provisions of the Agreement attached to this Current Report as Exhibit 10.1.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
Exhibit No. Description
10.1 Agreement among Modigene Inc., Cohen &
Schaeffer LLP and Steve Schaeffer (filed
herewith)
Modigene Announces Appointment of Dr. Phillip Frost as Chairman of Its Board of Directors
Wednesday March 5, 8:00 am ET
-In Other Board Changes, Two Pharmaceutical Industry Veterans Join to Fill Vacancies Created by Recent Departures-
NES-ZIONA, Israel, March 5 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG - News) today announced the appointment of Phillip Frost, M.D., as Chairman of its Board of Directors. Modigene also announced the appointments of two new directors, Dr. Marian Gorecki and Steven D. Rubin, and the departures of current Board Chairman and director Dr. Eugene Bauer and current director Joel Kanter.
"The addition of Dr. Frost as Chairman and Dr. Gorecki and Mr. Rubin as directors is a very positive development for Modigene," said Avri Havron, CEO of Modigene. "As the company now transitions into a clinical stage biopharmaceutical company, we believe the enhanced commitment of Dr. Frost and the diverse, real-world clinical and commercial experience that he, Dr. Gorecki and Mr. Rubin bring will be of great value to Modigene and its shareholders."
Dr. Frost has been a member of the Modigene Board of Directors since May 2007.
"After working closely with the Modigene team as a director over the past year, I am very pleased to be expanding my involvement in the company at this exciting time in its development," said Dr. Frost. "In my new role as Chairman, I look forward to providing further leadership in working with the Board and management to build Modigene into a significant player in the therapeutic proteins market."
Dr. Frost currently serves as Chairman and CEO of OPKO Health, Inc., a publicly-traded specialty healthcare company. He also serves as Chairman of Ladenburg Thalmann & Co. Inc., as Vice Chairman of Teva Pharmaceuticals, and as a director of Northrop Grumman Corporation and Continucare Corporation. He is a trustee of the University of Miami, the Scripps Research Institute, the Miami Jewish Home for the Aged and the Mount Sinai Medical Center; a regent of the Smithsonian Institute, and Vice Chairman of the Board of Governors of the American Stock Exchange. Previously, Dr. Frost was Chairman and CEO of IVAX Corporation, which he founded in 1987, until the company's acquisition by Teva Pharmaceuticals in 2006. Dr. Frost holds a B.A. from the University of Pennsylvania and an M.D. degree from the Albert Einstein College of Medicine.
Dr. Marian Gorecki, a 30-year veteran of the biotechnology industry, is currently Chairman of Thrombotech, a company developing a peptide to mitigate the side effects of standard stroke treatments. Previously, Dr. Gorecki co- founded and served as General Manager and Board member of Bio Technology General (BTG), now Savient Pharmaceuticals Inc. He also served as Chairman and CEO of Mediwound Ltd., a biotechnology company developing enzyme-based products in the fields of burn and wound management. Dr. Gorecki was responsible for overseeing the clinical development, regulatory approval and commercialization of five biotechnology drugs that are currently marketed, as well as two that are now in Phase III trials. Dr. Gorecki is the inventor of 21 issued patents and author of 73 peer-reviewed scientific articles. He earned his Ph.D. in biochemistry and molecular biology from the Weizmann Institute of Science and served as a Research Fellow at the Massachusetts Institute of Technology.
Steven D. Rubin, J.D., is currently Executive Vice President- Administration and a director of OPKO Health, Inc. He currently also serves as a director of SafeStitch Medical Inc., a medical device company, of Dreams Incorporated, a manufacturer and provider of licensed sports products, of Ideation Acquisition Corp., a special purpose acquisition company, and of Longfoot Communications Corp. Previously, he was Senior Vice President and General Counsel of IVAX. Prior to IVAX, Mr. Rubin was Senior Vice President and General Counsel of Telergy Inc. Mr. Rubin holds a B.A. from Tulane University and a J.D. degree from the University of Florida, Gainesville.
Dr. Frost added, "On behalf of the Board, we also want to thank Dr. Eugene Bauer and Joel Kanter for their many past contributions as Board members of Modigene." Dr. Bauer and Mr. Kanter have submitted their resignations from the Modigene Board to pursue other personal and professional interests.
Modigene's technology is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in humans, and when attached to a therapeutic protein, extends the time that the protein is active in the body. The potential utility of the technology has been demonstrated by Organon, a unit of Schering-Plough, which licenses the CTP technology for fertility applications only. Phase II trials of its CTP follicle stimulating hormone product (FSH-CTP) demonstrated that a single injection provides the same clinical effect as seven consecutive daily injections of standard FSH. These trials also demonstrated that attaching the CTP peptide did not affect the therapeutic activity of FSH or cause a negative immune system response. Modigene has an exclusive license from Washington University for use of CTP with all therapeutic proteins except four fertility proteins. Modigene currently has three CTP-enhanced compounds in preclinical testing and a fourth in earlier stage development.
ABOUT MODIGENE
Modigene Inc. (OTC Bulletin Board: MODG - News) is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit www.modigeneinc.com.
Change in Directors or Principal Officers
Form 8-K for MODIGENE INC.
4-Jan-2008
Change in Directors or Principal Officers
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
(b) On December 30, 2007, Mr. Alastair Clemow delivered written notice to Modigene Inc. (the "Company"), stating that he was resigning from his position as a member of the Board of Directors of the Company effective January 1, 2008. Mr. Clemow resigned for personal reasons.
Effective December 21, 2007, Mr. Clemow also tendered his resignation as a member of the Compensation Committee of the Board of Directors. In addition, prior to his resignation from the Board, Mr. Clemow served as a member of the Audit Committee.
Press Release Source: Modigene Inc.
Modigene Awarded Israeli Government Grant to Support Development of Its Longer-Acting Human Growth Hormone
Tuesday November 27, 8:36 am ET
- $10 Million hGH-CTP Development Program has Been Approved for Funding Through a Special Grant from the Israeli Office of The Chief Scientist -
VIENNA, Va., Nov. 27 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG - News) today reported that its Israeli-based R&D subsidiary has received approval for a special grant from the Israeli Office of the Chief Scientist ("OCS") in support of the company's development program for hGH-CTP, its longer-acting version of human growth hormone (hGH). In preclinical models, a single injection of hGH-CTP has shown the potential to replace 7 to 10 daily injections of commercial hGH.
The OCS has approved a special grant to support Modigene's hGH-CTP program, based on an estimated development budget of $10 million for calendar years 2007-2009. The grant will provide cash reimbursements of 30% to 50% of expenses paid for hGH-CTP product development during this period, including materials, GMP production, salaries and clinical trials. hGH-CTP is currently in preclinical development, with clinical trials expected to begin in 2008.
Human growth hormone is a natural protein produced by the pituitary gland in the brain. It fuels growth of the body's bone and muscle and has a variety of therapeutic uses. Patients with an hGH deficiency currently receive subcutaneous hGH injections on a near-daily basis. Approximately 95% of children diagnosed with a growth hormone deficiency receive treatment, with costs ranging from $10,000 to $30,000 per year. The current annual market for hGH therapies exceeds $2 billion.
"This generous new grant from the OCS is an important non-dilutive cash resource for Modigene and represents another validation of the potential of our lead candidate," said Abraham Havron, Ph.D., Chief Executive Officer of Modigene. "The OCS has already awarded Modigene funds in support of our EPO- CTP product candidate and we are delighted that our hGH-CTP program has now also been selected for support. This visionary OCS program is particularly attractive for Modigene because it does not require any repayment until the product is generating revenue. We are grateful for this valuable source of non-dilutive capital."
Under the terms of the grant, Modigene shall repay the OCS the sum of the grant plus accrued interest through a series of payments that begin only upon successful commercialization of the hGH-CTP product, or other products developed at the company with its CTP technology.
Modigene's technology is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in humans, and when attached to a therapeutic protein, extends the time that the protein is active in the body. The potential utility of the technology has been demonstrated by Organon, a unit of Schering-Plough, which licenses the CTP technology for fertility applications only. Phase II trials of its CTP follicle stimulating hormone product (FSH-CTP) demonstrated that a single injection provides the same clinical effect as seven consecutive daily injections of standard FSH. These trials also demonstrated that attaching the CTP peptide did not affect the therapeutic activity of FSH or cause a negative immune system response. Modigene has an exclusive license from Washington University for use of CTP with all therapeutic proteins except four fertility proteins. Modigene currently has three CTP-enhanced compounds in preclinical testing and a fourth in earlier stage development.
ABOUT MODIGENE
Modigene Inc. (OTCBB: MODG - News) is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit http://www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene's long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long- acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from the OCS is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission.
MODIGENE CONTACT: MEDIA CONTACT:
Shai Novik, President Barbara Lindheim
Modigene Inc. GendeLLindheim BioCom Partners
Tel: +1 866 644-7811 +1 212 918-4650
Email: shai@modigeneinc.com
Source: Modigene Inc.
Quarterly Report
http://biz.yahoo.com/e/071113/modg.ob10qsb.html
Modigene to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
VIENNA, Va., Oct. 31 /PRNewswire-FirstCall/ -- Modigene Inc. today announced that senior management will present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference on Wednesday, November 7, 2007 at 1:40 pm ET. The conference will be held at the New York Palace Hotel in New York City.
Modigene CEO Abraham Havron and President Shai Novik will attend. Management will provide a company overview and review of corporate developments.
The presentation will be webcast live and can be accessed by visiting the Investors section of the Modigene website at www.modigeneinc.com. An archived version of the webcast will be available for approximately 90 days. The live and archived webcast can also be accessed at www.wsw.com/webcast/rrshq12/modg.ob.
For more information about this conference, visit: www.rodmanandrenshaw.com/conferences?id=6
About Modigene
Modigene Inc. is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit www.modigeneinc.com.
MODIGENE CONTACT: MEDIA CONTACT:
Shai Novik, President Barbara Lindheim
Modigene Inc. GendeLLindheim BioCom Partners
Tel: +1 866 644-7811 +1 212 918-4650
Email: shai@modigeneinc.com
September 24, 2007 - 6:01 AM EST
Study Published in Endocrinology Reports Potential of Modigene Technology to Extend Duration of Protein Drugs
- Publication in Leading Peer-Reviewed Journal Represents Further Scientific Validation of the Potential Utility of Modigene's CTP Technology -
VIENNA, Va., Sept. 24 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG) today reported that researchers will publish a study in the October edition of the journal Endocrinology showing that erythropoietin (EPO) linked to Modigene's carboxyl terminal peptide (CTP) technology significantly increased the half-life of standard EPO in animal models.(1) The study, which assessed an early version of EPO-CTP, showed that a single weekly injection was as effective in raising hematocrit levels as the same total dose of standard EPO administered in three injections over the course of a week.
The current version of EPO-CTP in preclinical development at Modigene has further extended the duration of the drug, demonstrating in animal models an approximately 33% longer half-life and greater biological activity than Aranesp(R), Amgen's long-acting EPO.
'The publication of this study in the respected journal Endocrinology further validates the growing body of clinical and preclinical data supporting the ability of CTP technology to significantly extend the half-life and duration of action of therapeutic proteins,' said Dr. Fuad Fares, lead author of the study and Chief Scientific Officer of Modigene. 'Long-acting therapeutic protein drugs are increasingly important treatments for a variety of diseases, and we believe the demonstrated ability of our CTP technology to reduce the frequency of required injections could provide important benefits to the many patients who depend on these drugs. We look forward to advancing our first CTP-enhanced drug candidates into clinical trials next year.'
Modigene is conducting late-stage preclinical studies of CTP-enhanced protein drugs including human growth hormone, interferon beta and EPO. All three have demonstrated significantly longer duration of effect and comparative biological efficacy in studies in the most common and relevant animal models. The CTP technology has been validated in human studies by Akzo Nobel's healthcare division, Organon International, which has rights to the technology for four endocrine proteins. Organon recently advanced its CTP follicle-stimulating hormone (FSH) product into Phase III trials after Phase II studies showed that a single injection provided the same clinical effect as seven daily injections of standard FSH.
ABOUT CTP
Modigene's technology was discovered by researchers at Washington University in St. Louis and is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in humans, and when attached to a therapeutic protein, extends the time that the protein is active in the body. The potential clinical utility of the technology has been demonstrated by Organon International, a unit of Akzo Nobel, which has a license to the CTP technology for certain endocrine proteins. Organon recently initiated Phase III trials of its CTP follicle stimulating hormone product (FSH-CTP), after Phase II results demonstrated that a single injection of FSH-CTP provides the same clinical effect as seven consecutive daily injections of standard FSH. The Phase II trials also demonstrated that attaching the CTP peptide did not affect the therapeutic activity of FSH or cause a negative immune system response.
1. Development of a Long-Acting Erythropoietin by Fusing the Carboxyl-
Terminal Peptide of Human Chorionic Gonadotropin b-Subunit to the
Coding Sequence of Human Erythropoietin,' Fuad Fares, Sherif Ganem,
Taleb Hajouj, and Ester Agai, Endocrinology 148(10):5081-5087. The
study is currently available in the on-line edition of the journal.
ABOUT MODIGENE
thanks -biotechs: much better.
Parabolic SAR Buy Signals (MODG)
will send a message to Matt
MODG listed under Media-TV ?
http://investorshub.advfn.com/boards/boards.asp?cat_id=70
Need to fix that.
Source: Modigene Inc.
Modigene to Present at UBS 2007 Global Life Sciences Conference
Tuesday September 18, 8:00 am ET
VIENNA, Va., Sept. 18 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG - News) today announced that senior management will present at the UBS 2007 Global Life Sciences Conference on Wednesday, September 26, 2007 at 12:00 pm EDT. The conference will be held at the Grand Hyatt New York in New York City.
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Modigene CEO Abraham Havron and President Shai Novik will attend. Management will provide a company overview and review of corporate developments.
The audio portion of the company's presentation will be webcast live. It can be accessed at the Investors section of the Modigene website at www.modigeneinc.com. An archived version of the webcast will be available for 30 days beginning three hours after the start of the presentation. The live and archived audio webcast can also be accessed at the UBS website at http://events.streamx.us/us/event/eventdetails.aspx?id=ubs20070924
For more information about the UBS 2007 Global Life Sciences Conference, visit www.presentationsmedia.com/globallifesciencesev/about.html.
ABOUT MODIGENE
Modigene Inc. (OTC Bulletin Board: MODG - News) is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene's long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long- acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission.
MODIGENE CONTACT: MEDIA CONTACT:
Shai Novik, President Barbara Lindheim
Modigene Inc. GendeLLindheim BioCom Partners
Tel: +1 866 644-7811 +1 212 918-4650
Email: shai@modigeneinc.com
--------------------------------------------------------------------------------
Source: Modigene Inc.
I already looked at the tarot cards...all was good!
I ended up with only 5k shares and will wait for $1.80 and then review the charts, stars and my tarot cards before making any others moves on MODG.
SB2 from 9-05 for 8 million shares caused the sell off imo......in the long run this will do well.....BRIG
moving up....low volume but up is up....BRIG
Ladder Bottom Formation Developed yesterday, and Matching low formation might develop today if the price closes at 1.36, which would suggest a bottom support level.
Full Stochasticics suggests bulls are regaining control, while RSI suggests this is nearly oversold.
However, this moves slower than a turtle.
you know me...anything Dr. Frost is directly involved in and owns a big chunk of i like......BRIG
Only bought a couple thousands yesterday, but I may add 10k shares this morning(thoughts)
Roth webcast is in progress now (eom).
added you as assistant......BRIG
Your right MODG, may be at a trading bottom right now(buying a couple thousand shares)
added shares on this sell off.....BRIG
Modigene to Present at the Roth 2007 New York Investor Conference
Wednesday August 29, 7:00 am ET
- Presentation to be Webcast Live and Archived -
VIENNA, Va., Aug. 29 /PRNewswire-FirstCall/ -- Modigene Inc. (OTC Bulletin Board: MODG - News) today announced that senior management will present at the Roth 2007 New York Investor Conference on Thursday, September 6, 2007 at 3:00 pm EDT. The conference will be held at the Westin New York at Times Square in New York City.
Modigene CEO Abraham Havron and President Shai Novik will provide a company overview and review of corporate developments.
"As a relatively new public company, we look forward to this opportunity to inform additional investors about our innovative technology that has the potential to significantly extend the duration of virtually any therapeutic protein drug," noted Dr. Havron. "We believe our product pipeline has great clinical and commercial promise as a result of our ability to increase the utility and convenience of a wide range of protein therapeutics currently used by millions of patients each year."
The Modigene presentation will be webcast live and can be accessed by visiting www.wsw.com/webcast/roth13/modigene/. An archived version of the presentation webcast will also be available following the conclusion of the conference at the same address for approximately 90 days.
For more information about the Roth 2007 New York Investor Conference, visit www.roth.com/main/Page.aspx?PageID=7015.
ABOUT MODIGENE
Modigene Inc. (OTC Bulletin Board: MODG - News) is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. Modigene is currently developing long-acting versions of human growth hormone, erythropoietin, interferon beta, and GLP-1, which are in late preclinical development. For more information on Modigene, please visit www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene's long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long- acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission.
MODIGENE CONTACT: MEDIA CONTACT:
Shai Novik, President Barbara Lindheim
Modigene Inc. GendeLLindheim BioCom Partners
Tel: +1 866 644-7811 +1 212 918-4650
Email: shai@modigeneinc.com
--------------------------------------------------------------------------------
Source: Modigene Inc.
2 heavy hitters have been added to the board of directors.....BRIG
http://money.cnn.com/news/newsfeeds/articles/prnewswire/NYTU06214082007-1.htm
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http://www.prolor-biotech.com/
http://finance.yahoo.com/q/ks?s=PBTH+Key+Statistics
PROLOR Biotech, Inc., a development stage biopharmaceutical company, develops proprietary versions of already-approved therapeutic proteins. The company's technology, Carboxyl Terminal Peptide technology could be attached to an array of existing therapeutic proteins, stabilizing the therapeutic protein in the bloodstream and extending its life span without additional toxicity or loss of desired biological activity. Its products under development include Human Growth Hormone, which is used for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone; Erythropoietin for individuals with chronic kidney failure, chemotherapy patients, and HIV/AIDS patients on AZT, as well as for patients who may require a blood transfusion or undergo surgery where blood loss is expected; and Interferon ß that is used to reduce the frequency and severity of relapses afflicting people suffering from multiple sclerosis, as well as Factor VIIa, Factor IX; Anti-Obesity Peptide; and Glucagon-Like Peptide-1. The company was formerly known as Modigene Inc. and changed its name to PROLOR Biotech, Inc. in June 2009. PROLOR Biotech, Inc. was founded in 2001 and is based in Nes-Ziona, Israel.
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