-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FpcUQQ9TIX0s/8yfER4LcA8bqxynVrkqM1lexMS3Uzi+OeI4WnRWFpVzR6tSO8kT 9WEkKZa/V//SMQ+rC9JsLQ== 0001104659-08-021607.txt : 20080401 0001104659-08-021607.hdr.sgml : 20080401 20080401150333 ACCESSION NUMBER: 0001104659-08-021607 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080328 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080401 DATE AS OF CHANGE: 20080401 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACUSPHERE INC CENTRAL INDEX KEY: 0001115143 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043208947 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50405 FILM NUMBER: 08729011 BUSINESS ADDRESS: STREET 1: 500 ARSENAL ST CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 6175778800 MAIL ADDRESS: STREET 1: 500 ARSENAL ST CITY: WATERTOWN STATE: MA ZIP: 02472 8-K 1 a08-9671_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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):  March 28, 2008

 

Acusphere, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

000-50405

 

04-3208947

(Commission File Number)

 

(IRS Employer Identification No.)

 

 

 

500 Arsenal Street

 

 

Watertown, MA

 

02472

(Address of Principal Executive Offices)

 

(Zip Code)

 

(617) 648-8800

(Registrant’s Telephone Number, Including Area Code)

 

 

 

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 March 28, 2008, Acusphere Inc., a Delaware corporation (“Acusphere”) entered into a license agreement (the “License Agreement”) with Cephalon, Inc., a Delaware corporation (“Cephalon”).  The License Agreement provides Cephalon with an exclusive, worldwide license to Acusphere’s Hydrophobic Drug Delivery System (HDDS) for oncology applications, along with the rights to AI-850, Acusphere’s formulation of paclitaxel, in exchange for a cash payment of $10 million upon execution of the License Agreement.  The term of the License Agreement extends until expiration of the last of the patent rights licensed under the License Agreement.

 

Item 7.01           Regulation FD Disclosure

 

On March 31, 2008, Acusphere issued a press release announcing that it had entered into a license agreement with Cephalon to license Acusphere’s intellectual property rights to its Hydrophobic Drug Delivery System (HDDS) for oncology applications, along with the rights to AI-850, its formulation of paclitaxel, in exchange for a cash payment of $10 million. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.

 

This Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and 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 filing.

 

Item 9.01           Financial Statements and Exhibits.

 

The following exhibit is furnished as part of this Report on Form 8-K.

 

(d)  Exhibits.

 

Exhibit No.

 

Description

 

 

 

 99.1

 

Press Release dated March 31, 2008

 

 

2



 

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.

 

 

ACUSPHERE, INC.

 

 

 

Dated: April 1, 2008

By:

/s/ Lawrence A. Gyenes

 

 

Name:

Lawrence A. Gyenes

 

 

Title:

Senior Vice President, Chief Financial

 

 

 

Officer and Secretary

 

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated March 31, 2008

 

 

4


EX-99.1 2 a08-9671_1ex99d1.htm EX-99.1

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Acusphere Licenses Hydrophobic Drug Delivery System to

Cephalon for $10 Million

Cephalon to use Technology for Oncology Applications

 

Watertown, MA, March 31, 2008 — Acusphere Inc. (NASDAQ: ACUS) announced today that it has signed an agreement to license the intellectual property rights to its Hydrophobic Drug Delivery System™ (HDDS) for oncology applications, along with the rights to AI-850, its formulation of paclitaxel, to Cephalon, Inc., in exchange for a cash payment of $10 million.

 

“We are very pleased with the terms of this transaction, which establishes a strong value for part of our technology platform that is at an early stage of development,” said Sherri C. Oberg, President and CEO of Acusphere.  “We are confident that Cephalon is the right partner for one application of this important technology, given its strong focus on oncology. Just six months ago, we announced that AI-850 was a potential bio-equivalent to the one of the fast-growing anti-cancer drugs, Abraxane®. This transaction confirms the potential for our technology in the oncology arena, which is one of many potential applications for our HDDS technology.”

 

Frank Baldino, Jr., Chairman and CEO of Cephalon, stated, “Cephalon has a growing oncology business with a deep and diverse portfolio of marketed products and pipeline compounds. The addition of the HDDS technology, and AI-850 in particular, will build on our expertise and expand our oncology portfolio.”

 

About Acusphere, Inc.

 

Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that over 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. Imagify and the Company’s other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company’s web site at www.acusphere.com.

 

About Cephalon, Inc.

 

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products.  Cephalon is a leader in the discovery and development of products to treat central nervous system and oncologic

 



 

disorders. The company’s scientific exploration has led to the creation of new chemical entities focused on G-Protein Coupled Receptors and cell signaling pathways that are involved in the pathogenesis of disease.

 

The company’s proprietary products in the United States include: TREANDA® (bendamustine hydrochloride) for Injection, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), PROVIGIL® (modafinil) Tablets [C-IV], FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

 

“Acusphere” and “Imagify” are trademarks of Acusphere, Inc.

 

“Abraxane” is a registered trademark of Abraxis Bioscience, Inc.

 

The above press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding the development and commercialization of HDDS and AI-850 and the development of the Company’s other potential products in the area of oncology.  The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company’s statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company’s commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company’s filings with the U.S. Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.

 

CONTACT:

Conway Communications

 

Mary T. Conway, 617-244-9682

 

or

 

Acusphere, Inc.

 

Investors: 617-925-3444

 

IR@acusphere.com

 

or

 

Media: 617-648-8800

 

 

#  #  #


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