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 April 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; (iii) the Registrant's
Registration Statement on Form F-3, Registration No. 333-135428; (iv)
the Registrant's Registration Statement on Form F-3, Registration
No. 333-141083; and (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091.
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:
April
19, 2007
| PSIVIDA LIMITED | ||
| |
|
|
| By: | /s/Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President, Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Press
Release: pSivida Managing Director Interviewed for corporatefile.com
in
Australia
|
pSivida
Managing Director Interviewed for corporatefile.com in
Australia
Amplifies
Recent News on Licensing Agreement, Funding and Sale of
AION
Boston,
MA and Perth, Australia, April 19, 2007 - pSivida Limited (NASDAQ:PSDV) today
released the text of an interview posted at corporatefile.com.au, in Australia.
The following is the text of that interview:
corporatefile.com.au
pSivida
Limited (ASX code PSD) recently announced a licensing agreement for its drug
delivery technology Medidur™ with Pfizer Inc worth up to A$203 million (US$165
million). The deal includes an immediate capital investment of A$6.1 million
(US$5 million), a possible further capital investment of another A$6.1 million
(US$5 million) and potential development and sales related milestones of A$191
million (US$155 million). What is the strategic rationale for entering a
licensing agreement at this stage of the technology’s development?
MD
Dr. Paul Ashton
Medidur™
is already licensed to Alimera Sciences for the treatment of diabetic macular
edema (DME) and now Pfizer has stepped in to license Medidur™ for ophthalmic
applications, we believe marking a significant validation of our drug delivery
technology.
This
is
our first major pharmaceutical company licensing deal and we’re free to license
this product beyond ophthalmic applications. We have evaluation agreements
relating to non-ophthalmic applications of our technologies with other
pharmaceutical companies and a leading medical device company and we’re hopeful
these will result in significant licensing deals.
Importantly,
this licensing deal resulted directly from Pfizer’s 12-month evaluation of
Medidur™, just one of our pharma evaluation agreements. Subsequently Pfizer
moved to an exclusive three-month negotiation period for which we received
A$1.3
million (US$1 million) and this has led to the A$203 million (US$165 million)
licensing deal.
corporatefile.com.au
Are
the
potential development and sales milestone payments from Pfizer to be applied
by
pSivida to fund the clinical trial program from this collaboration?
MD
Dr Paul Ashton
Pfizer
will be funding the cost of the trial program. Development and sales milestone
payments will be in addition to Pfizer's funding of the cost of the
program.
corporatefile.com.au
In
your
ASX announcement, you indicated the deal included a 60-day termination clause.
Can you clarify the significance of this?
MD
Dr Paul Ashton
In
my
experience, it’s common for large pharmaceutical licensing deals to permit the
pharma to terminate without cause. This is quite reasonable. For example, in
the
development of a particular product, it would be reasonable to make allowance
for the possible discontinuance of development in the event of failure at a
future stage.
Should
our collaboration with Pfizer be successful, we will receive development
milestone payments and sales related royalty payments.
corporatefile.com.au
Pfizer’s
A$6 million (US$5 million) investment is conditional upon the removal of Sandell
as a convertible note holder. How have you sought to address this
issue?
MD
Dr Paul Ashton
The
Pfizer funds will be held in escrow until the Sandell loan note has been fully
converted or redeemed. We now have sufficient funds available to redeem all
of
the Company’s convertible debt. The repayment of all of the company’s
convertible debt will simplify the company’s capital structure and we believe
put the company on a far stronger financial footing.
corporatefile.com.au
pSivida
also announced on April 5, 2007 an A$11million (US$9 million) private placement
of ordinary shares to allow you to retire the outstanding convertible notes.
To
what extent are the note holders converting to equity ahead of
redemption?
MD
Dr Paul Ashton
Since
the
announcement of the Pfizer licensing deal, approximately one third of the
company’s convertible debt has been converted into equity.
corporatefile.com.au
To
what
extent does the licensing deal with Pfizer underpin the company’s financial
position? What is the post-deal cash position and forecast cash burn in future
periods?
MD
Dr Paul Ashton
Our
current cash position will be disclosed in the March Quarterly Report due out
at
the end of April. Our cash position has improved as we’ve raised in excess of
A$28 million (US$23 million) this calendar year, recently sold our subsidiary
AION Diagnostics and our cash burn has been reduced following rationalization
of
the business to focus on our core drug delivery technologies.
corporatefile.com.au
The
Pfizer licensing deal covers ophthalmic applications for Medidur™. What is the
market potential for Medidur™, and how does it compare with other treatments for
chronic eye disease?
MD
Dr Paul Ashton
The
ophthalmic pharmaceutical market is rapidly expanding. Pfizer's Xalatan
treatment for glaucoma generates over US$1 billion per year. The recently
approved drug Lucentis, a treatment for age-related macular degeneration, is
achieving significant sales volumes and is likely to become the next
billion-dollar-plus product. However, Lucentis requires regularly repeated
injections directly into the eye. A sustained release delivery system requiring
less frequent administration should generate strong sales and take significant
market share in the treatment of chronic eye diseases.
corporatefile.com.au
What
other applications are being progressed for Medidur™? Will you be seeking
additional licensing opportunities for Medidur™?
MD
Dr Paul Ashton
Medidur™
is presently in Phase III clinical trials for the treatment of DME. DME is
one
of the leading causes of vision loss in the United States and potentially a
multibillion dollar market, with presently no approved drug treatments.
We’re
also free to license Medidur™ for non-ophthalmic applications. Given the eye is
a very sensitive organ, if Medidur™ can be injected into the back of the eye, we
believe you can inject the device almost anywhere for the controlled delivery
of
drugs.
corporatefile.com.au
What
are
the key milestone achievements being targeted for pSivida during the 2007
calendar year?
MD
Dr Paul Ashton
Having
now delivered a key milestone, being our first global pharmaceutical licensing
agreement, the company expects to progress our clinical trials of Brachysil™ in
pancreatic cancer. We plan to complete enrollment for the present Phase IIa
trial by mid-calendar 2007, and have data available by the end of the 2007
calendar year. We also hope to complete enrolment in our Phase III trials for
Medidur™ in DME during the same period.
Finally,
we’ll continue to pursue evaluation and collaboration agreements for our
technologies with global pharmaceutical and medical device companies to deliver
further licensing deals for our shareholders.
corporatefile.com.au
Thank
you
Paul.
For
previous Open Briefings by pSivida, or to receive future Open Briefings by
email, visit www.corporatefile.com.au.
For
more
information about pSivida, visit www.psivida.com.au
or call
Brian Leedman, Director of Investor Relations on +(61-8) 9226
5099.
CORPORATE FILE DISCLAIMER: Corporate File Pty Ltd has taken reasonable care in publishing the information contained in this Open Briefing®. It is information given in a summary form and does not purport to be complete. The information contained is not intended to be used as the basis for making any investment decision and you are solely responsible for any use you choose to make of the information. We strongly advise that you seek independent professional advice before making any investment decisions. Corporate File Pty Ltd is not responsible for any consequences of the use you make of the information, including any loss or damage you or a third party might suffer as a result of that use.
PSIVIDA
LIMITED DISCLAIMER: This document contains forward-looking statements
that involve risks and uncertainties. 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: the risk that we may not meet any of the milestones in the Pfizer
agreement or may not successfully develop or commercialize the products under
development or our proposed products; the risk that Pfizer terminates the
license agreement; the risk that we will not be able to exploit our drug
delivery technologies outside of the eye; the risk that our evaluation
agreements for our products may not produce favorable results and/or result
in
license agreements or partnerships and the risk of our failure to otherwise
establish partnerships; the risk that we will be unable to repay all amounts
outstanding under our convertible notes or other liabilities; failure of the
results of the Retisert™ for DME trial to be a good indicator of the results of
pSivida’s ongoing phase III Medidur™ for DME trial; failure of the Medidur™
trials in DME to show a very similar improvement in visual acuity and diabetic
retinopathy severity score as Retisert™ for DME; failure of Medidur™ to release
fluocinolone acetonide at the same rate as Retisert™; our inability to recruit
patients for the phase III Medidur™ for DME trial or the phase II
BrachySil™ trials; failure to develop applications for BioSiliconTM due to
regulatory, scientific or other issues; failure of the pSivida Inc’s products to
achieve expected revenues; failure to achieve cost savings generally; our
inability to penetrate the Uveitis or other markets, our inability to continue
to develop products currently in our pipeline or to continue to feed our
product pipeline; our failure to achieve our stated 2007 milestones or to
execute on our stated U.S. growth strategy. 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.
| Contact: |
Beverly
Jedynak
|
President
Martin
E.
Janis & Company, Inc.
312-943-1100
ext. 12
bjedynak@janispr.com