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 16, 2010

 


 

OSIRIS THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

 

Maryland

 

001-32966

 

71-0881115

(State or other jurisdiction of
 incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

7015 Albert Einstein Drive, Columbia, Maryland

 

21046

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (443) 545 - 1800

 

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 240.14d-2(b))

 

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 8.01. Other Events.

 

The Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the Registrant’s New Drug Submission of Prochymal (remestemcel-L) for the treatment of graft vs. host disease (GvHD).  Health Canada has notified the Registrant that the application has been granted Priority Review, shortening the scheduled examination period from 300 to 180 days.  Health Canada also informed the Registrant that it plans to add Prochymal to its Register of Innovative Drugs, subject to a final review upon approval.  This registration would confer eight years of market exclusivity to the Registrant, beginning on the date of Prochymal’s approval for commercial sale.  This registration also generally provides that, during such period of market exclusivity, no submission for a generic version of Prochymal would be approved by Health Canada for GvHD.

 

Information presented in this Current Report on Form 8-K may contain forward-looking statements and certain assumptions upon which such forward-looking statements are in part based.  Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements.  Risks and that could cause our actual results to differ materially from those anticipated in forward-looking statements, include the factors described in the sections entitled “Risk Factors” in our Annual Report on Form 10-K filed with the United States Securities and Exchange. You should not unduly rely on forward-looking statements.

 

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SIGNATURES

 

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

 

 

OSIRIS THERAPEUTICS, INC.

 

 

Dated: July 21, 2010

By:

/s/ PHILIP R. JACOBY, JR.

 

 

Philip R. Jacoby, Jr.

 

 

Chief Financial Officer (Principal Financial Officer)

 

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