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): August 27, 2013
Aradigm Corporation
(Exact name of registrant as specified in its charter)
California | 000-28402 | 94-3133088 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
3929 Point Eden Way, Hayward, California | 94545 | |||
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (510) 265-9000
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 (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01 | Entry into a Material Definitive Agreement. |
On August 27, 2013, Aradigm Corporation, a California corporation (the Company) issued and sold a total of 333,968,104 shares of its Common Stock (the Common Stock) to Grifols, S.A. (Grifols) and certain other investors (the Investors) for a purchase price of $0.124 per share (the Company Stock Sale) pursuant to the terms of a previously publicly announced Stock Purchase Agreement, dated May 20, 2013. In connection and concurrently with the closing of the Company Stock Sale, the Company entered into a License Agreement and an Option Agreement with an affiliate of Grifols, into a Governance Agreement and Registration Rights Agreement with Grifols, and into a Registration Rights Agreement with the Investors, all in forms previously described in and filed with a Form 8-K filed by the Company on May 24, 2013 (the Transactions).
On August 28, 2013, the Company issued a press release announcing the closing of the Transactions. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 1.01.
Item 3.02 | Unregistered Sales of Equity Securities. |
The Common Stock sold in the Company Stock Sale was sold to Grifols and the Investors without registration under the Securities Act, or any state securities laws. The Company is relying on the exemption from the registration requirements of the Securities Act afforded by Section 4(2) thereof and Rule 506 of Regulation D promulgated thereunder.
Item 5.02 | Departure of Directors or Principal Executive Officers; Election of Directors; Appointment of Principal Officers. |
On August 27, 2013, Frank H. Barker resigned, effective immediately, as a member of the board of directors (the Board) of the Company. Mr. Barker did not have any disagreements with the Company.
Effective August 27, 2013 and in connection with the Company Stock Sale, Lafmin Morgan and David Bell were elected by the Board to serve as directors of the Company. Mssrs. Morgan and Bell were nominated to the Board by Grifols pursuant to its rights to designate two directors for consideration for election to the Board in accordance with the Governance Agreement. The Company has not yet determined on which, if any, committees of the Board Mssrs. Morgan and Bell will serve.
Mr. Bell serves as General Counsel and Vice President of Corporate Operations and Development of Grifols, Inc. and Corporate Vice President of Grifols. He joined Grifols when it entered the U.S. market in 2003. Prior to joining Grifols, Mr. Bell was general counsel to Alpha Therapeutic Corporation following a 23-year career as a corporate litigator.
Mr. Morgan serves as President of Global Marketing of Grifols, Inc. and Corporate Vice President of Grifols. Previously, he served as Vice President of U.S. Product Management of Talecris Biotherapeutics Holdings Corp, a wholly owned indirect subsidiary of Grifols (Talecris). Mr. Morgan joined Talecris from GlaxoSmithKline, where he served for more than twenty years in finance, sales, commercial strategy and marketing roles across multiple therapeutic areas.
Mssrs. Bell and Morgan will be eligible to receive the standard compensation paid to non-employee directors as described in the Companys Proxy Statement filed on Schedule 14/A on March 29, 2013, to the extent that payment of such compensation is consistent with the internal policies of Grifols.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
EXHIBIT INDEX
99.1 | Press release dated August 28, 2013 |
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.
ARADIGM CORPORATION | ||||||
Dated: August 28, 2013 | By: | /s/ Nancy Pecota | ||||
| ||||||
Name: Nancy Pecota | ||||||
Title: Vice President, Finance and Chief Financial Officer |
Exhibit 99.1
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Grifols and Aradigm Corporation Complete the Closing of
Worldwide Licensing Agreement to Develop and
Commercialize Pulmaquin®
Aradigms Proprietary Inhaled Antibiotic for the Chronic Therapy of Patients with
Severe Respiratory Disease is Advancing Into Phase III
Barcelona, Spain and Hayward, CA August 28, 2013 Grifols, S.A. (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS) (Grifols) and Aradigm Corporation (OTC BB:ARDM.OB) (Aradigm) today announced the closing of the transaction that includes the exclusive, worldwide license for Aradigms proprietary formulations of inhaled ciprofloxacin (Pulmaquin and Lipoquin®) for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). Aradigm has completed Phase 2b clinical trials in BE patients with Pulmaquin and Lipoquin.
BE is a chronic condition that affects more than 110,000 people in the United States and many more in other countries and is characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic respiratory infections. Aradigm has been granted orphan drug designation for BE in the U.S. and there is currently no drug specifically approved for the treatment of this condition.
Under the terms of the transaction:
| The parties have agreed to advance Aradigms proprietary inhaled ciprofloxacin formulations into Phase III clinical trials in BE. |
| Grifols will be responsible for all development and clinical expenses up to a maximum of $65 million for the BE indication. |
| Aradigm is entitled to receive cash payments of up to $25 million upon achievement of development milestones. |
| Grifols is responsible for all commercialization activities and will pay Aradigm tiered royalties on worldwide sales of products utilizing Aradigms proprietary inhaled ciprofloxacin formulations. |
| Grifols was granted an option to license Aradigms AERx® pulmonary drug delivery platform for use with another molecule. |
| In conjunction with the licensing agreement, Grifols acquired 35% of Aradigms common stock on a fully diluted basis at a price per share of $0.124 for a total investment of approximately $26 million. |
| Existing Aradigm shareholders, including Tavistock Life Sciences Company and accounts managed by First Eagle Investment Management, LLC, and new investor Great Point Partners, LLC co-invested in the stock purchase transaction and purchased an additional approximately $15.4 million in Aradigm common stock. Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services (NYSE MKT:LTS) acted as placement agent for this transaction. |
With the closing of the transaction Grifols is entitled to designate two directors to serve on the Aradigm Board of Directors.
Grifols is pleased to have finalized this transaction. We look forward to working with Aradigm to bring this important treatment to patients and healthcare providers. Pulmaquin will build on the existing presence Grifols has in Pulmonary treatment with Prolastin C said Ramon Riera, President Global Commercial.
The completion of this transaction is a major milestone for Aradigm. We look forward to working with Grifols to finalize the Pulmaquin global development by completing the Phase III program and filing a New Drug Application that could result in approval of a much needed therapy for bronchiectasis patients, said Igor Gonda, President and CEO, Aradigm Corporation.
About inhaled ciprofloxacin (Pulmaquin and Lipoquin)
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections. Aradigms once-a-day novel inhaled formulations of ciprofloxacin are encapsulated in liposomes, allowing for a sustained release of the drug within the lung and improving airway tolerability. The formulations are to be used for chronic maintenance therapy as they achieve much higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. Lipoquin is a liposomal formulation of ciprofloxacin. Pulmaquin is a dual release formulation that is a mixture of Lipoquin with unencapsulated ciprofloxacin.
Pulmaquin has been tested extensively in preclinical tests, as well as in the ORBIT-2 Phase 2b bronchiectasis study in which outstanding antimicrobial activity coupled with good safety and tolerability was found, and, most importantly, the positive impact on prevention of exacerbations compared to placebo was also observed. Pulmaquin is ready to begin Phase 3 clinical trials. Aradigm has been granted orphan drug designation for liposomal ciprofloxacin for cystic fibrosis in the U.S. and the E.U., and for the combination of liposomal ciprofloxacin and free ciprofloxacin for BE in the U.S. Aradigms inhaled ciprofloxacin has been also successfully tested in animal models of the bioterrorism infections inhalational tularemia, pneumonic plague and Q-fever.
About Grifols
Grifols is a global healthcare company with a 70-year legacy of improving peoples health and well being through the development of life-saving plasma medicines, hospital pharmacy products and diagnostic technology for clinical use.
As a leading producer of plasma medicines, Grifols has a presence in more than 100 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S. Grifols is committed to increasing patient access to its life-saving plasma medicines through significant manufacturing expansions and the development of new therapeutic applications of plasma proteins. The company is headquartered in Barcelona, Spain and employs more than 11,000 people worldwide.
In 2012, Grifols sales exceeded 2,620 million euros. The companys class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit www.grifols.com
About Aradigm
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases. Aradigm has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation tularemia and anthrax infections, and prevention of respiratory and other diseases in tobacco smokers through smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Disclaimer and Forward-Looking Statements
The facts and figures contained in this news release which do not refer to historical data are projections and forward-looking statements. The words and expressions like believe, hope anticipate, predict, expect, intend, should, try to achieve, estimate, future and similar expressions, insofar as they are related to Aradigm, Grifols, the prospects for Aradigms inhaled ciprofloxacin product formulations to successfully complete clinical trials and to result in approved products, and the ability of Grifols to successfully commercialize these products, are used to identify projections and forward-looking statements. These expressions with respect to Aradigm reflect the assumptions, hypothesis, expectations and anticipations of the management team of Aradigm at the date of preparation of this news release, which are subject to a number of factors that could make the real results differ considerably, such as the uncertainties associated with clinical trials including lack of effectiveness, lack of statistical significance of results, adverse side effects or other safety issues, uncertainties regarding the process of obtaining regulatory approval for the sale of new drugs, uncertainties concerning the development of demand for new products, uncertainties regarding the level of reimbursement for new products, manufacturing and supply issues and the like. The future results of Grifols Group could be affected by events related to its own activity, such as shortages of raw materials for the manufacture of its products, the launch of competitive products or changes in the regulations of markets in which it operates, among others. At the date of the preparation of this news release Grifols Group has adopted measures it considers necessary to offset the possible effects of these events. Grifols, S.A. does not assume any obligation to publicly inform, review or update any projections and forward-looking statements to adapt them to facts or circumstances following the preparation of this news release, except as specifically required by law.
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the closing of the transaction, as well as the other risks detailed from time to time in Aradigms filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2012 filed with the SEC on March 27, 2013, and Aradigms Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin, Lipoquin, AERx and the Aradigm Logo are registered trademarks of Aradigm Corporation.
SOURCE: Aradigm Corporation and Grifols S.A.
Contact: | Nancy Pecota, Aradigm Chief Financial Officer, 510-265-8800 |
Punkaj Amin, Grifols North American Corporate Communications, 919-316-6664 |
Raquel Lumbreras , Grifols Global Press Office, +34 91 311 92 89 |