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 July 2006
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12
BGC Centre
28
The
Esplanade
Perth
WA
6000
(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
ý 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
ý
If
"Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
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:
July 17, 2006
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
pSivida
amends subordinated convertible debentures
|
|
ASX/MEDIA
RELEASE
|
17
July 2006
|
pSivida
amends subordinated convertible debentures
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) has today signed a term sheet with Sandell Asset
Management Corporation, investment advisor to Castlerigg Master Investments
(the
Note Holder) to revise the terms of the Note Holder’s US$15,000,000 subordinated
convertible debentures (the Notes).
The
Notes
will continue to have a three year term and bear 8% interest payable quarterly.
The Company may, at its sole discretion, choose to make interest payments in
cash and/or the Company’s NASDAQ listed American Depositary Receipt Securities
(ADSs). The Note Holder will retain its existing warrants to purchase
approximately 633,000 additional ADSs. Those warrants are exercisable for six
years at a current exercise price of US$7.17 per ADS (AU$0.98 per ordinary
share).
The
amended terms, which are subject to the completion of definitive documentation,
consist of the following:
|
·
|
The
Notes will be secured by the Company’s current royalties, subject to
release of that security upon any disposition by the Company of the
royalty stream and the consequent collateral partial payment of the
Notes.
|
|
·
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The
existing conversion price on the Notes will be reset to US$2.00 per
ADS,
subject to anti-dilution adjustments relating to future share issuances
by
the Company, if any, and will be reset based on the market price,
if
lower, on April 30, 2007.
|
|
·
|
The
Note Holder will have an option to have up to US$6.25 million of the
Notes redeemed on each of July 31, 2007 and January 31, 2008, with
the
original 15 November 2006 put option and subsequent put options being
struck from the Notes.
|
|
·
|
The
Company may redeem all or any part of the Notes at any time at its
option
at 108% face value accompanied by an additional five year warrant
for 30%
of the redemption amount with an exercise price equal to the lower
of the
conversion price or 75% of the then market price. This new term permits
refinancing by the Company at any
time.
|
|
·
|
The
existing minimum cash retention requirement will be struck from the
Notes
upon the later of aggregate capital raisings of US$15 million or
effectiveness of the registration statement filed with US Securities
and
Exchange Commission (SEC) relating to the Notes and warrants (Registration
Statement).
|
In
connection with the amendments, the Company has agreed with the investor as
follows:
|
·
|
The
Company will have a further 60 days for the Registration Statement
to be
declared effective by the SEC, with increased penalties if that deadline
is missed, subject to the completion of definitive documentation
concerning the amendments by 21
July.
|
|
·
|
The
investor will release the Company from any restrictions involving
future
fundraising efforts maintaining only its right to participate in
exchange
for redemption of Notes.
|
|
·
|
The
Company will grant the Note Holder an additional warrant over
approximately 5.7 million ADSs exercisable for five years with
US$1.80 per ADS strike price.
|
|
·
|
The
Company will prepay US$2.5 million of the existing debt prior to the
end of the term of the Notes by means of a US$3.5 million
payment.
|
“These
actions taken by the Company free the Company to continue the development of
its
technology and products without some of the future financial risks and
restrictions it had previously under these Notes,” said Gavin Rezos, CEO of
pSivida Limited.
“The
Company is making operational changes to bring about significant cost savings
to
make more efficient use of our resources, in particular making better use of
our
Boston facilities and in keeping with our strategy of moving corporate functions
to Boston. Focus will be shifted from any early stage or non-core research
and
development to completion of late stage clinical trials and subsequent expected
commercial returns. Non core areas and early stage programs will only be
undertaken with external funding from research or development partners,” said Mr
Rezos.
“The
Company also has externally funded and self funded programs with biotech
companies and large pharmaceutical companies, including evaluation programs
with
four of the top five large pharmaceutical companies to evaluate the use of
our
drug delivery technologies to deliver therapeutic compounds of those companies.
Some of these evaluation agreements may lead to Licensing arrangements,” Mr
Rezos added.
The
Company’s core focus is the development
of drug delivery products
in the
healthcare sector, particularly in Ophthalmology and Oncology.
The
Company owns
the
rights to develop and commercialize a modified form (porosified or
nano-structured) of silicon known as BioSilicon™ which we believe has versatile
applications in drug delivery. The lead BioSilicon™ product in oncology is
BrachySil™, a brachytherapy product in pivotal Phase IIb clinical trials, which
is being developed for the treatment of inoperable primary liver cancer and
in a
soon to commence phase IIa clinical trial in pancreatic cancer. The Company
has
a licensing agreement with Beijing Med-Pharm Corporation for the clinical
development, marketing and distribution of BrachySil™ in China.
The
Company receives royalties from the sale of its Ophthalmology products,
Vitrasert®
and
RetisertTM,
the
only two FDA approved sustained release back of the eye treatments for chronic
eye disease. Both products are manufactured and sold by global ophthalmology
company, Bausch & Lomb (B&L). RetisertTM
is also
promoted by Novartis Ophthalmic, a business unit of Novartis Pharmaceuticals,
in
collaboration with B&L. A next generation product, MedidurTM
in Phase
III clinical trials, is licensed to Alimera Sciences for the treatment of
Diabetic Macular Edema, the leading cause of vision loss for Americans under
the
age of 65.
Wholly-owned
subsidiary, AION Diagnostics Inc. recently announced that BioSilicon™ has been
shown to be effectively visualized on four key imaging modalities; x-ray,
ultrasound, CT and MRI. This discovery could eventually lead to AION Diagnostics
being competitively positioned in the multi-billion dollar imaging agent market.
It is expected that AION Diagnostics will be a separately funded independent
entity in the near term. pSivida will receive royalty payments from AION
Diagnostics on successfully commercialised BioSilicon™ diagnostic products under
Licence from pSivida.
This
announcement does not constitute an offer of any securities for sale or the
solicitation of an offer to buy any securities. The securities offered have
not
been registered under the U.S. Securities Act of 1933, as amended, and may
not
be offered or sold in the United States absent registration or an applicable
exemption from registration requirements.
-ENDS-
|
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 943 1100 ext. 12
bjedynak@janispr.com
|
European
Public Relations
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™, a treatment
for diabetic macular edema, is licensed to Alimera Sciences and is in Phase
III
clinical trials.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopaedics, and tissue
engineering. pSivida’s subsidiary, AION Diagnostics Limited is developing
diagnostic products and the subsidiary pSiNutria is developing food technology
products both using BioSilicon™.
pSivida’s
intellectual property portfolio consists of 70 patent families, 74 granted
patents and over 290 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.
The
Company's largest shareholder and a strategic partner is QinetiQ, a leading
international defence, security and technology company, formed in 2001 from
the
UK Government's Defence Evaluation & Research Agency (DERA). QinetiQ (QQ.)
was instrumental in discovering BioSiliconTM
and pSivida enjoys a strong relationship with, including access to its cutting
edge research and development facilities.
For
more
information, visit www.psivida.com
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications and
regulatory approvals. 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: our inability to raise additional funds at favourable terms or any
terms; our inability to repay the amended debentures; issues relating to share
registration in the U.S. that may delay our registration; our inability to
develop proposed products, including without limitation, in the drug delivery,
wound healing, orthopaedics, and tissue engineering, diagnostics and food
technology fields; failure of our evaluation agreements to result in license
agreements; failure to develop applications for BioSilicon™ due to regulatory,
scientific or other issues; failure to complete negotiations for new centers
for
the BrachySil™ phase IIb clinical trial for inoperable primary liver
cancer; failure of our discussions with the FDA for BrachySil™ to continue or to
lead to FDA approval; failure of the BrachySil™ phase IIb clinical trial
for inoperable primary liver cancer to determine the optimal dose, provide
key
safety data or support future pivotal efficacy trials or product registration
or
approval; failure of the BrachySil™ primary liver programme that is in
phase IIb clinical trials to provide a valuable platform for the
development and commercialisation of BrachySil™ for pancreatic cancer and other
indications; failure to commence phase IIa BrachySil™ trials for the
treatment of pancreatic cancer; failure of the findings of the pancreatic
cancer phase IIa trial to provide a platform for further multicentre
efficacy and safety trials; failure of there to be optimisation and
standardisation between our two pancreatic cancer study centres;
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;. 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.