0001204459-12-000142.txt : 20120127 0001204459-12-000142.hdr.sgml : 20120127 20120127080640 ACCESSION NUMBER: 0001204459-12-000142 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20120127 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120127 DATE AS OF CHANGE: 20120127 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PediatRx Inc. CENTRAL INDEX KEY: 0001362703 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 202590810 STATE OF INCORPORATION: NV FISCAL YEAR END: 0228 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52218 FILM NUMBER: 12549177 BUSINESS ADDRESS: STREET 1: 405 TRIMMER ROAD, SUITE 200 CITY: CALIFON STATE: NJ ZIP: 07830 BUSINESS PHONE: (908) 975-0753 MAIL ADDRESS: STREET 1: 405 TRIMMER ROAD, SUITE 200 CITY: CALIFON STATE: NJ ZIP: 07830 FORMER COMPANY: FORMER CONFORMED NAME: Striker Energy Corp DATE OF NAME CHANGE: 20060515 8-K 1 form8k.htm FORM 8-K PediatRx Inc.: Form 8-K - Filed by newsfilecorp.com

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) January 26, 2012

PEDIATRX INC.
(Exact name of registrant as specified in its charter)

Nevada 000-52218 20-2590810
(State or other jurisdiction of (Commission File Number) (IRS Employer Identification No.)
incorporation)    

405 Trimmer Road, Suite 200, Califon, NJ 07830
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (908) 975-0753

N/A
(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:

[   ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[   ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[   ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[   ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 1.01      Entry into a Material Definitive Agreement.

On January 26, 2012, we entered into a binding term sheet (the “Term Sheet”) with Apricus Biosciences, Inc. (“Apricus Bio”) for (1) a Co-Promotion Agreement in the United States for Granisol® and the assignment of our Co-Promotion Agreement with Bi-Coastal for Aquoral™ and (2) a Sale Agreement for Granisol® outside of the United States (the “Sale Agreement”). Also in the Term Sheet, we entered into a non-binding arrangement (the “Arrangement”) for the sale of our company to Apricus Bio in a proposed merger transaction (the “Acquisition”).

Under the Term Sheet, we and Apricus Bio have agreed to enter into a definitive Co-Promotion Agreement by February 13, 2012, which will provide Apricus Bio with (i) a non-exclusive license to market and sell Granisol® and Aquoral™ throughout the United States and (ii) exclusive promotion rights in a number of major U.S. states. In addition, we and Apricus Bio also agreed in the Term Sheet to enter into a definitive Sale Agreement by February 13, 2012, pursuant to which we will sell to Apricus Bio all of our rights and intellectual property rights in Granisol® in all the countries and territories outside the United States. As consideration for entering into the Co-Promotion Agreement, Sales Agreement and no shop provision, as more particularly described below, the Term Sheet provides that we will receive from Apricus Bio $325,000, plus a percentage royalty on Apricus Bio’s net sales of Granisol® and Aquoral™ in the U.S.

We have also agreed not to solicit any other offers from third parties and have agreed to discontinue other business discussions regarding U.S. co-promotion and sale of non-U.S. rights to Granisol until March 1, 2012 or merger, sale or license of our company or its assets until May 15, 2012.

In addition, if the Acquisition does not occur, the Term Sheet provides that we will receive $1,000,000 in shares of Apricus Bio, subject to certain conditions, and such shares will include registration rights.

Pursuant to the Arrangement, we have agreed to non-binding terms on which our company would be acquired by Apricus Bio. We expect to be acquired by Apricus Bio in a merger in exchange for $4,000,000, to be paid in the common stock of Apricus Bio, with $3,600,000 distributed to our shareholders immediately and $400,000 held back from shares that would be distributed to our Chief Executive Officer and Chief Financial Officer for a period of six months as an indemnity for breaches by us of our representations and warranties. Additionally, the Term Sheet contemplates that Apricus Bio will assume certain debt of our company up to $675,000.

The Acquisition is subject to customary due diligence procedures, approval by our board of directors and the board of directors of Apricus Bio and the execution of a mutually agreeable definitive merger agreement (the “Merger Agreement”). The Term Sheet contemplates that the Merger Agreement will be subject to customary closing conditions, including the approval of our shareholders and certain termination provisions.

There is no assurance that we will be able to complete the Acquisition as contemplated above, or on terms acceptable to our company.

There is no prior relationship between our company and its affiliates on the one hand and Apricus Bio and its affiliates on the other hand.

Item 8.01      Other Events.

A copy of our press release dated January 27, 2012 is furnished herewith.


Item 9.01      Financial Statements and Exhibits.

(d)        Exhibits.

10.1

Binding term sheet for (1) Granisol and Aquoral US Co-promotion Agreement, (2) Sale of ex-US rights for Granisol and non-binding term sheet for merger of PediatRx Inc. and Apricus Biosciences, Inc. dated January 26, 2012

   
99.1

PediatRx Inc. Press Release dated January 27, 2012



SIGNATURES

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

PEDIATRX INC.

 

/ss Cameron Durrant                                             
Cameron Durrant
President, Chief Executive Officer and Director

Date: January 27, 2012


EX-10.1 2 exhibit10-1.htm EXHIBIT 10.1 PediatRx Inc.: Exhibit 10.1 - Filed by newsfilecorp.com

CONFIDENTIAL

BINDING TERM SHEET FOR (1) GRANISOL® AND AQUORAL™ US CO-
PROMOTION AGREEMENT, (2) SALE OF EX-US RIGHTS FOR GRANISOL
AND
NON-BINDING TERM SHEET FOR THE ACQUISITION OF PEDIATRX INC.
BY APRICUS BIOSCIENCES, INC.
January 26, 2012

1. Parties

(1) Apricus Biosciences, Inc., a Nevada corporation with its principal address at 11975 El Camino Real, Suite 300 San Diego, CA 92130 (“APRICUS”); and

  

  

(2) PediatRx Inc., a Nevada corporation with its principal address at 405 Trimmer Rd., Suite 200, Califon, NJ 07830 (“PEDIATRX”).

  

2. Co-Promotion
Agreement in U.S. for Granisol and Aquoral

PEDIATRX owns or has co-promotion rights to the U.S. Products (as defined below), including (a) the U.S. Abbreviated New Drug Application (“ANDA”) to the branded generic drug Granisol (the “Granisol U.S. Regulatory Filing”) (granisetron HCl) oral solution, ANDA #078334 and (b) Aquoral (Oxidised Glycerol Triester (OGT) based liquid delivered by an oral spray for the management of Xerostomia) US NDC No. NHRIC 8546.0001.40 (collectively, the “U.S. Products”).

  

  

PEDIATRX desires to enhance the marketing of the U.S. Products in the U.S. by enlisting the support and participation of APRICUS in the U.S. Products promotion and detailing effort.

  

  

APRICUS and PEDIATRX agree to enter into a definitive Co- Promotion Agreement (“Co-Promotion Agreement”) for Granisol and to assign the PEDIATRX Co-Promotion Agreement with Bi-Coastal for Aquoral in the U.S. to APRICUS by February 13, 2012 according to the terms and conditions as described in Exhibit A attached hereto.

 

  

The Co-Promotion Agreement shall also include a covenant by PEDIATRX not to license to any third party any additional co- promotion rights in the non-exclusive states as defined in Schedule A, Section 1, for a period of five (5) years from the Effective Date of the Co-Promotion Agreement if the Merger described in Section 4 herein does not occur. For clarity, APRICUS will continue to have full co- promotional rights in the non-exclusive territories.

 

  

Upon execution of this Term Sheet by both Parties, PEDIATRX will place an order for a full commercial batch of Gransiol (“Commercial Batch”) that has three full years of shelf life left with Therapex. APRICUS will pay to Therapex directly the cost of the Commercial Batch. APRICUS will receive the Commercial Batch as soon as

1


CONFIDENTIAL

  

possible after the date of the closing of the Co-Promotion Agreement. APRICUS will provide to PEDIATRX up to 500 bottles of Granisol from the Commercial Batch for PEDIATRX to replace that product whose shelf-life will expire currently with distributors and wholesalers.

 

3. Sale of Ex-US Rights to Granisol

PEDIATRX desires to sell and assign to APRICUS all non-U.S. Granisol intellectual property owned or controlled by PEDIATRX (including trade secrets, know-how, patent applications, patents, trademarks and trademark applications and all other intellectual property of any kind whatsoever) (collectively, the “Non-US IP”) and including the rights to all regulatory approvals and the rights to make, have made, offer to sell, sell, import, pursue regulatory filings and commercialize Granisol in all countries and territories of the world outside of the U.S. (“Non-US Rights”).

 

  

APRICUS and PEDIATRX agree to enter into a definitive Sale Agreement (“Sale Agreement”) for GRANISOL for the Non-US IP and the non-US Rights by February 13, 2012.

 

  

The Sale Agreement shall also include a covenant not to compete in the non-US Territory in the field of anti-emetic drugs by PEDIATRX, its officers and board members for a period of seven (7) years from the Effective Date of the Sales Agreement along with other terms and conditions that are standard for such agreements.

 

4. Merger of PEDIATRX and APRICUS

APRICUS is a public US company whose shares are traded on the NASDAQ Capital Market and PEDIATRX is a public US company whose shares trade on the OTCBB.

 

  

APRICUS expects to acquire 100% of the outstanding voting common stock of PEDIATRX from the PEDIATRX Shareholders (the “Shares”) through a merger (the “Merger”) that will occur in the following manner:

 

  

(a) Signing of this Term Sheet by APRICUS and PEDIATRX (collectively, the “Parties”);

  

(b) Due diligence occurs and a definitive merger agreement (“Merger Agreement”) is negotiated and signed by the Parties;

  

(c) APRICUS to prepare and file with the SEC a Form S-4 registering its common shares to be exchanged for the Shares;

  

(d) PEDIATRX to prepare, file with the SEC and mail a proxy to send to its shareholders to approve the Merger;

(e) The PEDIATRX shareholders approve the Merger;

(f) The Merger closes (the “Merger Closing”); and

(g) PEDIATRX will become a wholly-owned subsidiary of APRICUS through a reverse triangular merger or in the most tax efficient method determined by PEDIATRX and APRICUS.

2


CONFIDENTIAL

  

Depending on whether or not SEC review occurs for the S-4 or the Proxy, the Merger is currently estimated to close by no later than April 30, 2012, or another date as mutually agreed by APRICUS and PEDIATRX.

 

 

  

Pursuant to the Merger, all outstanding voting common stock of PEDIATRX will be exchanged for the right to receive APRICUS’s registered shares of common stock described in Paragraph 5(b) herein and PEDIATRX will receive certain cash consideration as described in Paragraph 5(b) at the Merger Closing. David Tousley will terminate all 690,000 of his stock options and PEDIATRX will make best efforts to gain agreement to terminate the remaining 112,500 options and 515,000 warrants of PEDIATRX by or before the Merger Closing. In no case, however, will the Merger compensation described in Section 5 (b) herein increase.

 

 

  

APRICUS expects that PEDIATRX will have no other net company liabilities at the Merger Closing other than $675,000, which may include unpaid employment, consulting and PEDIATRX start-up costs, notes payable and other debt after considering working capital assets and working capital liabilities on a net basis. APRICUS agrees to assume up to $675,000 in net company liabilities and to pay such liabilities within a) with regard to the notes payable, 5 calendar days from the Merger Closing and, b) with regard to the other liabilities, 15 calendar days of the Merger Closing.

 

 

  

Within sixty days after the Merger Closing, APRICUS and PEDIATRX shall undertake a working capital adjustment and the Holdback Common Stock Merger Consideration (as defined in Section 5 herein) will be adjusted accordingly by the amount by which the current assets of PEDIATRX less the current liabilities of PEDIATRX at the time of the Closing Date (the “Net Working Capital”) differs from the $675,000.

 

 

5. Consideration

(a) For Co-Promotion Agreement and Sale Agreement and No Shop Provision. PEDIATRX will receive the following consideration from APRICUS for the signing and closing of the Co-Promotion Agreement, Sale Agreement and as consideration for the No Shop Provision contained in Section 22:

 

 

  

     (i) $325,000 in cash to be paid to PEDIATRX on the date that both the transactions described in the Co-Promotion Agreement and Sale Agreement have been executed.

3


CONFIDENTIAL

  

(b) For Merger. PEDIATRX Shareholders will receive the following consideration from APRICUS for the Merger at the Merger Closing (unless indicated below) as follows:

 

  

      (i) $3,600,000 in common stock of APRICUS (the “Common Stock Merger Consideration”); and

  

      (ii) $400,000 in common stock of APRICUS that will be held back for a period of six (6) months (the “Holdback Period”) from the PEDIATRX shares held by Cameron Durrant and David Tousley (collectively the “Holdback Shareholders”) as an indemnity for breaches of PEDIATRX’s representations and warranties and for any shortfall in the Net Working Capital (the “Holdback Common Stock Merger Consideration”).

 

  

PEDIATRX Shareholders will receive $3,600,000 of the Common Stock Merger Consideration at the Merger Closing. Once the Holdback Period has expired, then PEDIATRX will be required to distribute the remaining portion of its Holdback Common Stock Consideration to the Holdback Shareholders, net of any claims or pending claims.

 

  

The share exchange ratio of the PEDIATRX Shares and the APRICUS shares will be set based on the average of the closing prices of APRICUS common stock on the Nasdaq Capital Market for the ten trading days from either as applicable (a) the fifteenth trading day before the agreed Merger Closing Date to the sixth trading day before the Merger Closing Date or (b) the fifteenth trading day before the termination day of the Holdback Period to the sixth trading day before the termination day of the Holdback Period.

 

6. Merger Agreement Non- Compete

The Merger Agreement shall include a covenant not to compete in (a) the US Territory in the field of antiemetic drugs and (b) in the world in the field of Xerostomia or dry mouth by the PEDIATRX officers and board members each for a period of seven (7) years from the Effective Date of the Merger Agreement along with other terms and conditions that are standard for such agreements.

 

7. PEDIATRX and APRICUS Efforts

PEDIATRX and APRICUS will make reasonable efforts to enter, sign and close the Co-Promotion Agreement, Sales Agreement and the Merger.

 

8. Conduct of PEDIATRX prior to the Merger

After the date of this Term Sheet, and until this Term Sheet either terminates or is replaced by the Merger Agreement, PEDIATRX shall continue to operate its business and its underlying assets in the ordinary course according to its past commercial practices and shall

4


CONFIDENTIAL

  

not sell, license or otherwise dispose of any of its assets other than in the ordinary course of business according to its past commercial practices.

 

  

PEDIATRX shall not issue any additional securities or pay any dividends, bonuses or other distributions, or grant stock or stock options or warrants to its stockholders, employees, officers or directors or enter into any new employment, consulting, licensing, partnership or other agreements, or settlements or enter into any litigation outside the ordinary course of its business and according to its past commercial practices.

 

  

PEDIATRX shall maintain the cash on the financial books of the company in the ordinary course and shall not dividend any cash to any party or declare any stock repurchase that is not in the ordinary course of business.

 

  

Prior to the Closing of the Merger, the Company shall terminate the lock-up of any shares of PEDIATRX held by Cameron Durrant and David Tousley and permit them to be exchanged for the Common Stock Merger Consideration described herein, subject to the Holdback.

  

9. Merger Tax & Accounting Treatment

It is expected that the Merger will constitute a tax-free reorganization for U.S. Federal income tax purposes. Final structure of the transaction may be modified as a part of tax planning but will not change any of the economic terms outlined in this term sheet.

 

10. Merger Securities Law Matters/Stock Sale Plan

APRICUS and PEDIATRX will agree on a sale plan for the orderly distribution of the shares of APRICUS’s common stock to be sold by the officers and directors of PEDIATRX.

   
11. Seller’s Board & Stockholder Approval

PEDIATRX will obtain the approval of its Board to enter into a) the Co-Promotion Agreement and Sale Agreement, and b) the Merger and c) will be required to obtain the approval of its shareholders for the Merger.

 

  

APRICUS will obtain the approval of its Board to enter into the Co- Promotion Agreement and Sale Agreement and the Merger. APRICUS is not required to obtain approval from its stockholders for Co-Promotion Agreement, Sales Agreement or Merger.

5


CONFIDENTIAL

 
12. Merger Agreement Representations, Warranties, Indemnities & Other Provisions

In the Merger Agreement, each party will make customary representations and warranties (which would survive the Closing), and will provide customary indemnities relating to the business, financial condition, contracts, liabilities and employees as applicable. The Merger Agreement will also contain customary covenants, closing conditions, warrantees, indemnification and other provisions.

 

13. Due Diligence/Access   

The Parties shall use reasonable commercial efforts to conduct joint due diligence relating to the Co-Promotion Agreement and Sale Agreement and the Merger in a timely manner.

 

The Parties shall afford each other reasonable access to personnel, properties, contracts, books and records and all other documents and data, in each case, to the extent relating to their assets.

 

14. Consents

The Parties agree to cooperate with each other and proceed, as promptly as is reasonably practicable, to use commercially reasonable efforts to prepare and file, if necessary, any notifications required by any governmental or private entity and to seek to obtain all necessary consents and approvals from lenders, landlords, government entities and any other thirty party whose consent to the Co-Promotion Agreement, Sale Agreement and Merger might be required, and to comply with all other legal or contractual requirements for, or preconditions to, the execution and consummation of the Co- Promotion Agreement, Sale Agreement and the Merger.

 

15. Confidentiality

The Parties entered into a Confidentiality Agreement, dated November 18, 2011 (“CDA”). The existence, status and terms of their negotiations and agreements regarding the Co-Promotion Agreement, Sale Agreement and the Merger shall also be subject to the CDA. Upon the signing of this Term Sheet, the Parties would make a joint public announcement concerning the Co-Promotion Agreement, Sale Agreement and Merger.

 

16. Signings & Closings   

The date for the signing and closing of the Co-Promotion Agreement and Sale Agreement are described in Paragraphs 2 and 3 herein.

 

The Parties shall use their reasonable commercial efforts, subject to the terms and conditions contained herein and subject to uncertainties of review time, if any by the SEC, if any, to execute the Merger Agreement and to close the Merger at a mutually agreed date.

 

17. Governing Law/Venue

This Term Sheet shall be governed by the law of the State of California, except for its conflicts of law provisions. All disputes hereunder shall be adjudicated by the applicable state and federal courts in San Diego County, California.
 

6


CONFIDENTIAL

18. Binding/Non- binding Provisions   

Paragraphs 2, 3, 5(a), 7, 8, 11(a), 11(b), 13, 14, 15, 17, 18, 19, 20, 21 and 22 shall be binding obligations of the Parties.

 

Except for the above paragraphs described in this Paragraph 18, the remaining paragraphs of this Term Sheet relating to the Merger should be viewed as an indication of good faith interest only regarding a transaction on the general terms and conditions outlined herein and does not create a binding obligation, fiduciary relationship or joint venture between the parties.

 

19. Termination

This Term Sheet and the obligations hereunder relating hereto may be terminated:

 

 

 

      (a) by mutual written consent of APRICUS and PEDIATRX; or

 

 

 

      (b) by APRICUS by written notice to PEDIATRX if:

 

 

  

            (i) the Co-Promotion Agreement or Sale Agreement has not been signed and closed by February 
                 13, 2012 or by a mutually agreed upon date by APRICUS and PEDIATRX; or

 

 

  

            (ii) APRICUS’s finding of a material adverse matter during its due diligence review; or

 

 

 

            (iii) APRICUS’s Board does not approve the Merger; or

 

 

  

            (iv) the Merger Agreement has not been signed by a mutually agreed upon date by APRICUS and PEDIATRX.

 

 

       

      (c) by PEDIATRX by written notice to APRICUS if:

 

 

  

            (i) the Co-Promotion Agreement or Sale Agreement has not been signed and closed by February 
                 13, 2012 or by a mutually agreed upon date by APRICUS and PEDIATRX; or

 

 

  

            (ii) the Merger Agreement has not been signed by a mutually agreed upon date by APRICUS and PEDIATRX; or

 

 

  

            (iii) the PEDIATRX Shareholders do not approve the Merger.

 

 

20. Consideration if No Merger Closing Occurs

If the Merger does not occur then PEDIATRX shall keep the $325,000 to be paid to it pursuant to Paragraph 5(a) herein and it shall also receive a payment of $1,000,000 of APRICUS’s unregistered common stock, other than as a result of (a)

7


CONFIDENTIAL

  

PEDIATRX filing for bankruptcy or (b) if the GRANISOL asset has otherwise been materially impaired, in which case the payment of $1,000,000 of APRICUS’s unregistered common stock shall not be paid.

   
   The unregistered common stock will be issued pursuant to an exemption from the Securities Act of 1933, as amended, and will include resale S-3 registration rights if qualified or other registration rights if not. APRICUS and PEDIATRX will agree on a sale plan for the orderly distribution of the shares of APRICUS’s common stock to be sold by such persons or entities.
   
   The APRICUS shares will be set based on the average of the closing prices of APRICUS’s common stock on Nasdaq Capital Market for the ten trading days from the fifteenth trading day before the agreed Closing Date to the sixth trading day before the termination date of the Merger.
   
   If the Merger does not occur, then APRICUS will retain all rights it has under the Co-Promotion Agreement (including the assigned Bi- Coastal Co-Promotion Agreement) and the Sale Agreement.
   
21. Expenses Each party will be responsible for their own business, legal and regulatory counsels and other expenses in consummating the Co- Promotion Agreement, Sale Agreement and the Merger and none of either Party’s expenses in consummating these transactions will become obligations of the other Party.
   
22. No- Shop Seller agrees not to solicit any other offers from third parties and will discontinue any other business discussions regarding the Co- Promotion Agreement and the Sale Agreement until March 1, 2012 or sale of the Company or license of its assets until May 15, 2012 if the Merger closing has not yet occurred by that time (the “No-Shop Period”).
   
   In the case PEDIATRX receives an unsolicited offer during the No- Shop Period, PEDIATRX will send the received offer to APRICUS within 2 business days.
   
23. Merger Agreement The Merger Agreement shall contain additional customary terms and conditions for merger agreements as agreed by the parties.
   
24. Disclosure The existence and terms of the Term Sheet are confidential and shall not be publicly disclosed, except to the extent required under the Securities Exchange Act of 1934.

8


CONFIDENTIAL

          Unless signed this Term Sheet will expire on January 26, 2012. If the terms and conditions described above are acceptable to the parties below, please so indicate by your signatures below.

APRICUS BIOSCIENCES, INC

 

By:   ss/ Bassam Damaj__________________
Name: Bassam Damaj, Ph.D.
Title: President and Chief Executive Officer
Date: January 26, 2012

 

Agreed and Accepted:

PEDIATRX INC

 

By:   ss/ Cameron Durrant                                   
Name: Cameron Durrant, MD, MBA
Title: President and Chief Executive Officer
Date: January 26, 2012

9


EX-99.1 3 exhibit99-1.htm EXHIBIT 99.1 PediatRx Inc.: Exhibit 99.1 - Filed by newsfilecorp.com
 

   
11975 El Camino Real, Suite 300 Phone: +1-858-222-8041
San Diego, CA 92130 Fax: +1-858-587-2131

FOR IMMEDIATE RELEASE

APRICUS BIOSCIENCES EXPANDS COMMERCIAL ONCOLOGY OFFERINGS
THROUGH AGREEMENT WITH PEDIATRX FOR U.S. CO-PROMOTION OF
GRANISOL® (GRANISETRON) ORAL SOLUTION AND AQUORAL™ SPRAY AND
PURCHASE OF NON-U.S. RIGHTS TO GRANISOL®

SAN DIEGO, CA, and CALIFON, NJ, January 27, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) and PediatRx, Inc. (“PediatRx”) (OTCBB: PEDX) (http://www.pediatrx.com) announced today the execution of a binding term sheet for (1) the U.S. co-promotion of, and sale of non-U.S. rights to PediatRx’s GRANISOL (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron and (2) the assignment of U.S. co-promotion rights to AQUORAL, an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva).

GRANISOL is a proprietary formulation of granisetron indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin, as well as nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. The most common side effects observed during clinical trials of granisetron tablets were headache, muscle weakness (asthenia), constipation, diarrhea, upset stomach (dyspepsia), and abdominal pain. For additional safety information about GRANISOL, please see the “About GRANISOL” section below.

AQUORAL is currently being co-promoted by PediatRx on behalf of Bi-Coastal Pharmaceutical Corp. Xerostomia can be a debilitating medical condition and is estimated to impact between 35 and 40 million Americans. It is especially prevalent in patients undergoing various treatments for cancer and those with Sjögren’s syndrome. It is also common in the elderly and in patients who are taking prescription medications. For additional safety information about AQUORAL, please see the “About AQUORAL” section below.

Under the term sheet for the Co-Promotion and Sale Agreement, Apricus Bio will receive rights to co-promote GRANISOL and AQUORAL in the U.S., with exclusive promotion rights in certain states, and will purchase all non-U.S. rights and intellectual property to GRANISOL owned or controlled by PediatRx (including patents, patent applications, trade secrets, know-how, trademarks and trademark applications) in exchange for a cash payment of $325,000 and a tiered co-promotion fee equal to a percentage of Apricus Bio’s net operating income from U.S. sales of GRANISOL. Apricus Bio expects to use the Oncology Supportive Care sales force and infrastructure, which Apricus acquired with its recent acquisition of Topotarget USA, Inc. (now Apricus Pharmaceuticals USA, Inc.) in December 2011, to promote GRANISOL and AQUORAL in the United States. The potential market in the U.S. for GRANISOL is estimated

www.apricusbio.com




   
11975 El Camino Real, Suite 300 Phone: +1-858-222-8041
San Diego, CA 92130 Fax: +1-858-587-2131

at approximately $100 million and the potential market in the U.S. for AQUORAL is estimated to be approximately $50 million.

Apricus Bio also announced that it has signed a non-binding term sheet with PediatRx under which Apricus Bio may acquire PediatRx through a merger. Pursuant to the term sheet, Apricus Bio expects to pay approximately $4 million in stock and assume up to $675,000 in debt of PediatRx. The parties expect to negotiate a definitive merger agreement on the foregoing terms, which will be subject to customary closing conditions, including approval by PediatRx Board and shareholders and by Apricus Bio’s Board and certain termination provisions. The term sheet includes a payment of $1,000,000, payable in Apricus Bio common stock, if Apricus elects not to pursue the merger, subject to certain conditions.

Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio, stated, “PediatRx is an ideal strategic fit for Apricus Bio, as it provides us with two additional marketed oncology products with significant worldwide sales potential, and, in the US, clear synergy with our Oncology Supportive Care sales organization from Apricus Pharmaceuticals USA. This agreement also demonstrates our team’s unwavering focus on execution of the Apricus Bio growth strategy, which includes adding approved, revenue generating drugs within our core therapeutic areas to our product portfolio, and developing, commercializing and partnering products that incorporate our NexACT® technology. We will continue to pursue smart acquisitions, both in the U.S. and in important international markets that synergize with our commercial infrastructure and offer the potential to generate substantial revenue over the long-term."

“Our agreement with Apricus Bio offers PediatRx the opportunity to simultaneously accelerate the commercial value of GRANISOL in the U.S., monetize the value of GRANISOL in non-U.S. territories and, once consummated, realize shareholder value through the merger,” said Dr. Cameron Durrant, Founder, Chairman, President and CEO of PediatRx. “With these agreements, PediatRx gains access to both a growing commercial organization and, following approval of the merger, the potential of Apricus Bio and its multifaceted growth strategy.”

About GRANISOL
Granisetron is indicated for the prevention of:

  • Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
  • Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Selected Safety Information

  • GRANISOL is contraindicated in patients with known hypersensitivity to the drug or any of its components.

www.apricusbio.com




   
11975 El Camino Real, Suite 300 Phone: +1-858-222-8041
San Diego, CA 92130 Fax: +1-858-587-2131
  • QT prolongation has been reported with granisetron. Therefore, GRANISOL Oral Solution should be used in caution with patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.
  • Safety and effectiveness in pediatric patients have not been established.

Please also see the GRANISOL full prescribing information at:
http://www.pediatrx.com/products/pdf/granisol_pi.pdf

About AQUORAL
AQUORAL is an FDA-cleared, prescription-only device for Xerostomia, the medical term for dry mouth due to a lack of saliva. AQUORAL is a non-systemic, non-water based solution and novel formulation of Oxidized Glycerol Triesters delivered in a convenient pump-spray format to both aid in rehydration and help heal and restore damage done to the mouth and mucus membranes by a lack of saliva. Patients should not take AQUORAL if they have a sensitivity or allergy to corn oil, silicon dioxide, aspartame, or artificial flavorings (citrus).

About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology. Apricus Bio currently markets Totect®(dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. Apricus Bio’s current pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.

The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.

For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.

Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the

www.apricusbio.com




   
11975 El Camino Real, Suite 300 Phone: +1-858-222-8041
San Diego, CA 92130 Fax: +1-858-587-2131

Company, including, but not limited to, the ability to consummate the acquisition of PediatRx, its ability to further develop its and their products and product candidates, to have its products and product candidates approved by relevant regulatory authorities, to successfully commercialize such NexACT® products and product candidates, to achieve its development, commercialization and financial goals in the U.S. and in other countries and to close the acquisition of PediatRx among other potential future acquisitions of companies and products. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.

About PediatRx
PediatRx, Inc. (www.pediatrx.com) is a hospital specialty pharmaceutical company which focuses on treatments for patients suffering from serious conditions requiring hospitalization. PediatRx trades on the OTCBB under the ticker symbol PEDX.

PediatRx Forward Looking Statement
This press release contains forward-looking statements. Forward-looking statements are projections of events, revenues, income, future economics, research, development, reformulation, product performance or management's plans and objectives for future operations. In some cases you can identify forward-looking statements by the use of terminology such as "may", "should", "anticipates", "believes", "expects", "intends", "forecasts", "plans", "future", "strategy", or words of similar meaning. Forward-looking statements in this press release include those concerning the potential market in the U.S. for GRANISOL and AQUORAL and PediatRx’s belief that the transactions with Apricus will accelerate the commercial value of GRANISOL and AQUORAL in the U.S., monetize the value of GRANISOL in non-U.S. territories, realize shareholder value through a merger, gain access to both a growing commercial organization and, following approval of the merger, the potential of Apricus Bio.While these forward-looking statements and any assumptions upon which they are based are made in good faith and reflect current judgment regarding the direction of the business operations of PediatRx, actual results will almost always vary, sometimes materially, from any estimates, predictions, projections, assumptions or other future performance suggested in this press release. These statements are predictions and involve known and unknown risks, uncertainties and other factors, including the risk that PediatRx cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities, as well as the risks described in the periodic disclosure documents filed on EDGAR by PediatRx, copies of which are also available on the company’s website. Any of these risks could cause PediatRx or its industry's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this press release. Except as required by applicable law, including the securities laws of the United States, PediatRx does not intend to update any of the forward-looking statements to conform these statements to actual results.

www.apricusbio.com




   
11975 El Camino Real, Suite 300 Phone: +1-858-222-8041
San Diego, CA 92130 Fax: +1-858-587-2131

###

Apricus Bio Investor Relations:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

PediatRx Inc. Contact:
Research & Business Development
E-mail: info@pediatrx.com

Shareholder Relations
+1 908-975-0753
E-mail: ir@pediatrx.com

www.apricusbio.com


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