8-K

 UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 15, 2012

REGENERX BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-15070	52-1253406
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

15245 Shady Grove Road, Suite 470 Rockville, MD	20850
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (301) 208-9191

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01 Entry into a Material Definitive Agreement.

On July 15, 2012, RegeneRx Biopharmaceuticals, Inc. (the “Company”) entered into an agreement (the “License Agreement”) with Lee’s Pharmaceutical (HK) Limited (“Lee’s”) for the license of Thymosin Beta 4-based products, including the Company’s RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan (collectively, the “Territory”). The Company is entitled to receive a payment of $200,000 from Lee’s upon the execution of the License Agreement. With these funds, together with the $200,000 the Company previously received upon execution of a term sheet with Lee’s in March 2012, the Company expects to be able to fund limited operations into August 2012, without giving effect to any other sources of funding.

Under the License Agreement, the Company is eligible to receive aggregate potential milestone payments of up to $3.6 million, consisting of (i) $500,000 upon the first commercial sale of a licensed product in China, (ii) $1.5 million upon the achievement of $50 million in aggregate commercial sales in the Territory and (iii) $1.6 million upon the achievement of $80 million in aggregate commercial sales in the Territory. In addition, the Company is eligible to receive royalties ranging from low double digit to high single digit percentages of any commercial sales of the Company’s product candidates that are the subject of the agreement. Lee’s will pay for all developmental costs associated with each product candidate. The Company will provide Tβ4 to Lee’s at no charge for a Phase 2 ophthalmic clinical trial and will provide Tβ4 to Lee’s for all other developmental and clinical work at a price equal to the Company’s cost. RegeneRx will also have the right to exclusively license any improvements made by Lee’s to RegeneRx’s products outside of the licensed territory.

The two firms will create a joint development committee to discuss and agree on the development of the licensed products and share information relating thereto. Both companies will also share all non-clinical and clinical data and other information related to development of the licensed product candidates.

Sigma-Tau Finanziaria S.p.A, together with its subsidiaries and its affiliates, beneficially own approximately 25.9% of Lee’s and 38.6% of the Company. Mauro Bove is a member of the board of directors of both companies.

The foregoing summary of the License Agreement is not complete and is qualified in its entirety by reference to the full text of the License Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2012.

Item 7.01. Regulation FD Disclosure.

On July 16, 2012, the Company issued a press release announcing the execution of the License Agreement. A copy of this press release is furnished as Exhibit 99.1 to this Current Report.

Forward-Looking Statements

Certain statements in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include our forecast of the period of time through which our financial resources will be adequate to support our operations. For such statements, the Company claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from the Company’s expectations. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include risks related to uncertainties inherent in the Company’s business, including, without limitation, the risk that the milestone payments and royalties described in the this report may not be triggered, the risk that Lee’s may be unable to, or may elect not to complete the development of the product candidates in one or more of the licensed regions, the risk that the Company’s product candidates do not demonstrate safety and/or efficacy in clinical trials; risks related to the Company’s ability to obtain financing to support its operations on commercially reasonable terms; the progress, timing or success of the Company’s clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing the Company’s product candidates; regulatory developments; the size and growth potential of the markets for the Company’s product candidates and its ability to serve those markets; the scope and validity of patent protection for the Company’s product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2011, filed with the SEC on April 4, 2012, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this report represent the Company’s views only as of the date of this report and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit
Number	Description
99.1	Press Release, dated July 16, 2012.

SIGNATURE

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

REGENERX BIOPHARMACEUTICALS, INC.
By:	/s/ J.J. Finkelstein
	J.J. Finkelstein
	President and Chief Executive Officer

Date: July 19, 2012

EXHIBIT INDEX

Exhibit
Number	Description
99.1	Press Release, dated July 16, 2012.

EX-99.1

  RegeneRx Biopharmaceuticals Inc. 15245 Shady Grove Road, Suite 470 Rockville, Maryland20850   PHONE 301.208.9191 FAX 301.208.9194 WEB www.regenerx.com  

News Release

RegeneRx and Lee’s Pharmaceutical (HK) Complete License Agreement for Development of RegeneRx Product Candidates in China (including Hong Kong and Macau) and Taiwan

ROCKVILLE, Md. (July 16, 2012) – RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that it has entered into a licensing agreement with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong (“Lee’s”), for the license to Lee’s of RegeneRx's Thymosin Beta 4-based products, including the Company’s RGN-259, RGN-352 and RGN-137 product candidates, in China (including Hong Kong and Macau) and Taiwan. Lee’s previously paid RegeneRx $200,000 upon signing of a term sheet and will pay RegeneRx an additional $200,000 with the completion of this license agreement.

The terms of the deal include aggregate potential milestone payments of up to $3.6 million and royalties ranging from low double digit to high single digit royalties on commercial sales. RegeneRx also has the right to exclusively license any improvements made by Lee’s to RegeneRx’s products outside of the licensed territory.

Lee’s will pay for all development costs associated with each product candidate. RegeneRx will provide Tβ4 to Lee’s at no charge for a Phase 2 ophthalmic clinical trial and will provide Tβ4 to Lee’s for all other development and clinical work at a price equal to RegeneRx’s cost.

The two firms will create a joint development committee to discuss and agree on the development of the licensed products and share information relating thereto. Both companies will also share all non-clinical and clinical data and other information related to the development of the licensed product candidates.

“We look forward to working closely with Lee’s Pharmaceuticals to develop our Tβ4-based product candidates in China, Hong Kong, Macau and Taiwan, as Lee’s has demonstrated an impressive track record of pharmaceutical product development and growth, including in the ophthalmology and cardiovascular areas. We believe this opportunity should enable us to accelerate the development of our product candidates in and outside of the licensed territory,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer.

“Keratoconjunctivitis sicca, commonly known as dry eye syndrome, affects a great number of people in China and can sometimes lead to severe consequences such as cornea damage and ocular inflammation. There is clearly an unmet medical need in this area. RegeneRx demonstrated in their successful phase II studies that their Tβ4-based product is a promising agent in alleviating dry eye syndrome by addressing the underlying pathology with a unique mechanism of action. We are excited to work with RegeneRx on this opportunity. We look forward to developing the product expediently in China,” commented Benjamin Li, chief executive officer of Lee’s Pharmaceutical Holdings Limited.

Sigma-Tau, through its affiliates and subsidiaries beneficially own approximately a 38.6% equity stake in RegeneRx and a 25.90% equity stake in Lee’s. Mauro Bove is a member of the board of directors of both companies.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in Phase 2 clinical development and has an extensive worldwide patent portfolio covering its products.

RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on two Phase 2 clinical trials in patients with moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases, as well as other medical indications, and is Phase 2-ready. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack. RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a Phase 2 clinical trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue.

About Lee’s Pharmaceutical

Lee’s Pharmaceutical (HK) Ltd is a wholly owned subsidiary of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharm), a public biopharmaceutical company with over 18 years operation in China’s pharmaceutical industry. Lee’s Pharm is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing in China with global perspectives, and currently markets 13 products in the PRC. It focuses on several different areas such as cardiovascular, dermatology, oncology, gynecology, ophthalmology, and others. It has more than 30 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various U.S., European and Japanese companies.

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Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995, including statements concerning the future development and commercialization of the Company’s product candidates and the future payment of milestone payments or royalties to RegeneRx and. Additionally, you are urged to consider statements that include the words “expect,” “will,” “should,” “may,” “potential” or the negative of those words or other similar expressions to be uncertain and forward-looking. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include risks related to uncertainties inherent in our business, including, without limitation the risk that the milestone payments and royalties described in the release may not be triggered, the risk that Lee’s may be unable to, or may elect not to complete the development of the product candidates in one or more of the licensed regions, the risk that our product candidates do not demonstrate safety and/or efficacy in clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2011, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

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For RegeneRx:

Lori Smith

301.208.9191

las@regenerx.com

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