Washington,
D.C. 20549
FORM
6-K
REPORT
OF
FOREIGN ISSUER
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of January 2007
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12 BGC Centre
28
The Esplanade
Perth
WA 6000
Australia
(Address
of principal executive offices)
(Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F).
Form
20-F x Form
40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o No
x
If
"Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
The
document attached as Exhibit 99.1 to this Report on Form 6-K is hereby
incorporated by reference herein and into the following registration statements:
(i) the Registrant's Registration Statement on Form F-3, Registration
No. 333-132776; (ii) the Registrant's Registration Statement on
Form F-3, Registration No. 333-132777; and (iii) the Registrant's
Registration Statement on Form F-3, Registration
No. 333-135428.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant,
pSivida Limited, has duly caused this report to be signed on its behalf by
the
undersigned, thereunto duly authorized.
Date:
January
30, 2007
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PSIVIDA
LIMITED
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|
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| By: | /s/Michael J. Soja | |
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Michael J. Soja |
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Vice
President, Finance and Chief Financial
Officer
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EXHIBIT
INDEX
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EXHIBIT
99.1:
|
Press
Release: Retisert® Drug Implant Receives Product Specific Bill Code and
Medicare Reimbursement Rate; Streamlines process for Retisert
reimbursement
|
Retisert®
Drug Implant Receives Product Specific Bill Code and Medicare Reimbursement
Rate
Streamlines
process for Retisert reimbursement
Boston, MA. and Perth, Australia (January 29, 2007) - Global bio-nanotech company pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI) today announced that Retisert®, developed jointly by pSivida and Bausch & Lomb, has been allocated a product specific J-Code by the Centers for Medicare and Medicaid Services (CMS) in the United States.
The
Retisert implant was approved as a single indication orphan drug by the United
States Food and Drug Administration for the treatment of chronic noninfectious
posterior segment uveitis, a sight threatening inflammatory disease and a major
cause of blindness. Retisert is surgically placed into the back of the eye
and
releases the steroid, fluocinolone acetonide at a constant rate over a period
of
up to 30 months. Marketed in the United States by Bausch & Lomb, pSivida
receives royalties on sales.
The
new
J-Code, J7311 replaces the Medicare hospital outpatient code, C9225, which
had
been available to hospitals for billing Medicare when the Retisert implant
is
implanted in a hospital outpatient setting. The J7311 code should be recognized
by all health care insurers as they add this code to their respective billing
systems. CMS also has published a payment rate for J7311 of $19,345, or 106%
of
the average sales price for the product.
In
a
recent press release, Michael O’Rourke, General Manager of the U.S.
Pharmaceutical business for Bausch & Lomb said, “This is an important
milestone, which recognizes the national utilization of the Retisert implant
and
the critical and unique role it may play in preventing cumulative damage to
the
visual system caused by recurrent episodes of inflammation. Importantly, the
establishment of a product-specific J-Code should help patients get timely
access to this innovative therapy. It will also help hospitals and physicians
bill accurately and uniformly for the product across the country.”
Dr
Paul
Ashton, Managing Director of pSivida Limited said, “The actions taken by the CMS
should make it easier for the thousands of sufferers of this dehabilitating
and
chronic disease to find relief with this novel and innovative
therapy.”
The
J-Code and Medicare payment rate are effective as of January 1, 2007. Private
insurers may pay at different rates than Medicare.
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Director
of Investor Relations
pSivida
Limited
Tel:
+ 61 412 281 780
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
(312) 943 1100 ext. 12
bjedynak@janispr.com
|
European
Public Relations
Accent
Marketing Limited
Eva
Reuter
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
NOTES
TO EDITORS:
pSivida
is a global bio-nanotech company committed to the biomedical sector and the
development of drug delivery products. Retisert® is FDA approved for the
treatment of uveitis. Vitrasert® is FDA approved for the treatment of
AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert and
Retisert. pSivida has licensed the technologies underlying both of these
products to Bausch & Lomb. The technology underlying Medidur™ for diabetic
macular edema is licensed to Alimera Sciences and is in Phase III clinical
trials.
pSivida
owns the rights to develop and commercialize a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopedics, and tissue
engineering.
pSivida’s
intellectual property portfolio consists of 76 patent families, 95 granted
patents, including patents accepted for issuance, and over 300 patent
applications.
pSivida
conducts its operations from offices and facilities near Boston in the United
States, Malvern in the United Kingdom, Perth in Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and on
the Frankfurt Stock Exchange on the XETRA system (German Symbol:
PSI. Securities Code (WKN) 358705).
pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
This
document contains forward-looking statements that involve risks and
uncertainties including with respect to potential products, including a new
product specific reimbursement code for one of our products, the potential
size
of certain markets, our ability to raise funds and the successful marketing
and
commercialization of our products and potential products. Although we believe
that the expectations reflected in such forward-looking statements are
reasonable at this time, we can give no assurance that such expectations will
prove to be correct. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. Actual results could
differ materially from those anticipated in these forward-looking statements
due
to many important factors including:
Failure
of the J7311 code to be recognized by all health care insurers or to make it
easier for patients suffering from uveitis to find relief with or get timely
access to Retisert; our inability to raise additional funds at favourable terms
or any terms; our inability to repay the amended notes and new convertible
notes; our inability to develop proposed products or to develop new applications
for our technologies due to financial, regulatory, recruitment, scientific
or
other issues; failure of our evaluation agreements to produce favorable results
and/or result in license agreements. Other reasons are contained in cautionary
statements in the Annual Report on Form 20-F filed with the U.S. Securities
and
Exchange Commission, including, without limitation, under Item 3.D, "Risk
Factors" therein. We do not undertake to update any oral or written
forward-looking statements that may be made by or on behalf of
pSivida.