SEC Filing | EyePoint Pharmaceuticals

View:

Download DOC

Download PDF

Download XLS

SECURITIES AND EXCHANGE COMMISSION

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 September 2005

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: September 6, 2005


	pSivida Limited

	By:	/s/ Aaron Finlay
		Aaron Finlay
		Chief Financial Officer and Company Secretary

EXHIBIT INDEX

EXHIBIT 99.1:	Collaboration with Cirrus Pharmaceuticals
EXHIBIT 99.2:	Appendix 3B - PIPE Share Issue

-2-

ASX/MEDIA RELEASE

6^th September 2005

Collaboration with Cirrus Pharmaceuticals

Development of specific reformulated drug products utilizing BioSilicon^TM

Global nanotechnology company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is pleased to announce that it has signed a contract with US based Cirrus Pharmaceuticals, Inc. to accelerate and expand development of a number of specific drug candidates formulated in BioSilicon^TMto expand a BioSilicon product pipeline of reformulated drugs.

The development contract will have an initial extendable term of one year and provide a dedicated team of scientists from Cirrus Pharmaceuticals. The relationship has been established to generate new products based on reformulating existing specific generic and proprietary drugs and their delivery utilizing BioSilicon^TM. To the extent that such new reformulations or delivery demonstrate improved efficacy, safety and/or compliance as compared to the original product, then pSivida will be able to claim patent protection on its new products. All intellectual property developed through this collaboration relating to BioSilicon^TM will be wholly owned by pSivida.

Cirrus Pharmaceuticals, Inc. is an independent R&D organization based in Research Triangle Park, North Carolina. Since its incorporation in 1997, Cirrus has expanded its capabilities to include many aspects of drug development, providing timely research and project development support to the pharmaceutical industry, and in particular, the development of pharmaceutical dosage form design.

pSivida has now appointed Dr Paul Bulpitt as Pharmaceutical Development Manager as a key internal resource to support this technical programme. Dr Bulpitt received his phD from the University Of Wisconsin in the area of drug delivery and has undertaken senior scientific and development positions in the US and UK biotech industry most recently with NuPharm Laboratories. Dr Bulpitt strengthens our internal expertise in drug delivery with his strong academic background in pharmaceutical sciences and industry experience both in Europe and the US. Dr Bulpitt will be located at pSivida’s UK operations, pSiMedica Limited.

Gavin Rezos, Managing Director of pSivida commented, “This new collaboration represents a further significant commitment and investment by pSivida in the core area of our business which leverages a critical US-based, FDA-experienced development resource.”

pSivida Limited is currently in negotiations to acquire a US based drug delivery company with the potential to create a global drug delivery company specializing in nanotechnology, with revenues from existing products and generating long-term value through its diversified late-stage product portfolio. This new collaboration is not connected with that planned acquisition. We currently expect to be able to provide full details on the acquisition within the next few weeks, when a formal acquisition agreement may be concluded, subject to shareholder approvals.

-ENDS-

Released by:

pSivida Limited

Brian Leedman

Investor Relations

pSivida Limited

Tel: + 61 8 9226 5099

brianl@psivida.com

US Public Relations

Beverley Jedynak

President

Martin E. Janis & Company, Inc

Tel: +1 (312) 9 1100 ext. 12

bjedynak@janispr.com

UK & Europe Public Relations

Mark Swallow / Helena Podd

Citigate Dewe Rogerson

Tel: +44 (0)20 7638 9571

mark.swallow@citigatedr.co.uk

NOTES TO EDITORS:

pSivida Limited

pSivida is a global nanotechnology company committed to the biomedical sector and the development of products in healthcare. The company’s focus is the development and commercialisation of a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon™. As a new and exciting biocompatible material, BioSilicon™ offers multiple potential applications across the high growth healthcare sector, including controlled release drug delivery, targeted cancer therapies (including brachytherapy and localized chemotherapy), tissue engineering and orthopedics. Potential diagnostics applications are being developed through its subsidiary AION Diagnostics Limited.

pSivida owns the intellectual property rights to BioSilicon™ for use in or on humans and animals. The IP portfolio consists of 26 patent families, 31 granted patents and over 80 patent applications. The core patent, which recognises BioSilicon™ as a biomaterial was granted in the UK in 2000 and in the US in 2001.

pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and in Germany on the Frankfurt Stock Exchange on the XETRA system (German Symbol: PSI. Securities Code (WKN) 358705). pSivida’s shares also trade in the United Kingdom on the OFEX International Market Service (IMS) under the ticker symbol PSD. pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index.

The Company’s strategic partner and largest shareholder is the QinetiQ group, the largest science and technology company in Europe. QinetiQ is the former UK government Defence Evaluation Research Agency and was instrumental in discovering BioSilicon™. pSivida enjoys a strong relationship with QinetiQ having access to its cutting edge research and development facilities. For more information on QinetiQ visit www.qinetiq.com.

Cirrus Pharmaceuticals

Cirrus Pharmaceuticals is a contract product development company assisting biotechnology and pharmaceutical companies with dosage form development projects. Cirrus assist or manage projects as needed by providing a broad array of R&D services including physical and chemical characterization, formulation development, stability testing, container/closure selection, process development, scale-up and technical transfer to manufacturing for inhaled, oral, topical and parenteral products.

For more information, visit www.psivida.com

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: our failure to develop applications for BioSilicon^TM due to regulatory, scientific or other issues. Other reasons are contained in cautionary statements in the Registration Statement 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.

Appendix 3B

New issue announcement

Rule 2.7, 3.10.3, 3.10.4, 3.10.5

Appendix 3B

New issue announcement,

application for quotation of additional securities

and agreement

Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.

Introduced 1/7/96. Origin: Appendix 5. Amended 1/7/98, 1/9/99, 1/7/2000, 30/9/2001, 11/3/2002, 1/1/2003.

Name of entity

PSIVIDA LIMITED

ABN

78 009 232 026

We (the entity) give ASX the following information.

Part 1 - All issues

You must complete the relevant sections (attach sheets if there is not enough space).


1	⁺Class of ⁺securities issued or to be issued	Ordinary Fully Paid Shares to be issued as American Depositary Shares (1) Unquoted Options to be issued as warrants over American Depositary Shares (2)

2	Number of ⁺securities issued or to be issued (if known) or maximum number which may be issued	6,650,000 (1) 780,000 (2)

3	Principal terms of the ⁺securities (eg, if options, exercise price and expiry date; if partly paid ⁺securities, the amount outstanding and due dates for payment; if ⁺convertible securities, the conversion price and dates for conversion)	Options expiring 5 August 2008 exercisable at US$1.25 each (2)

+ See chapter 19 for defined terms.

1/1/2003

Appendix 3B Page 1

Appendix 3B

New issue announcement


4	Do the ⁺securities rank equally in all respects from the date of allotment with an existing ⁺class of quoted ⁺securities?		Yes (1) All fully paid ordinary shares issued on the exercise of the options will rank equally in all respects with the Company’s then issued fully paid ordinary shares. (2)
	If the additional securities do not rank equally, please state:
	·	the date from which they do
	·	the extent to which they participate for the next dividend, (in the case of a trust, distribution) or interest payment
	·	the extent to which they do not rank equally, other than in relation to the next dividend, distribution or interest payment

5	Issue price or consideration		$0.86 (USD 65 cents) (1) Nil (2)

6	Purpose of the issue (If issued as consideration for the acquisition of assets, clearly identify those assets)		Further expansion into the US.


7	Dates of entering +securities into uncertificated holdings or despatch of certificates	5 September 2005

		Number	⁺Class
8	Number and ⁺class of all ⁺securities quoted on ASX (including the securities in clause 2 if applicable)	225,962,166	Ordinary Fully Paid Shares 6,650,000 Ordinary Fully Paid Shares subject to voluntary escrow ending on the effectiveness of a registration statement or prospectus.

+ See chapter 19 for defined terms.

Appendix 3B Page 2

1/1/2003

Appendix 3B

New issue announcement


		Number	⁺Class
9	Number and ⁺class of all ⁺securities not quoted on ASX (including the securities in clause 2 if applicable)	4,375,000	Option expiring 31 December 2007 exercisable at $0.61 each (ESOP).

		2,050,000	Option expiring 5 August 2008 exercisable at $1.09 each.

		9,054,713	Option expiring 5 August 2009 exercisable at $1.18 each (ESOP).

		115,000	Option expiring 31 December 2008 exercisable at $0.80 each.

		200,000	Option expiring 31 December 2008 exercisable at $1.02 each.

		4,427,000	Option expiring 31 December 2010 exercisable at $0.80 each (ESOP).

		780,000	Option expiring 5 August 2008 exercisable at US$1.25 each, over ordinary fully paid shares subject to voluntary escrow ending on the effectiveness of a registration statement or prospectus.

10	Dividend policy (in the case of a trust, distribution policy) on the increased capital (interests)	N/A

Part 2 - Bonus issue or pro rata issue


11	Is security holder approval required?	N/A

12	Is the issue renounceable or non-renounceable?	N/A

13	Ratio in which the ⁺securities will be offered	N/A

+ See chapter 19 for defined terms.

1/1/2003

Appendix 3B Page 3

Appendix 3B

New issue announcement


14	⁺Class of ⁺securities to which the offer relates	N/A

15	⁺Record date to determine entitlements	N/A

16	Will holdings on different registers (or subregisters) be aggregated for calculating entitlements?	N/A

17	Policy for deciding entitlements in relation to fractions	N/A

18	Names of countries in which the entity has +security holders who will not be sent new issue documents Note: Security holders must be told how their entitlements are to be dealt with. Cross reference: rule 7.7.	N/A

19	Closing date for receipt of acceptances or renunciations	N/A

20	Names of any underwriters	N/A

21	Amount of any underwriting fee or commission	N/A

22	Names of any brokers to the issue	N/A

23	Fee or commission payable to the broker to the issue	N/A

24	Amount of any handling fee payable to brokers who lodge acceptances or renunciations on behalf of ⁺security holders	N/A

25	If the issue is contingent on ⁺security holders’ approval, the date of the meeting	N/A

26	Date entitlement and acceptance form and prospectus or Product Disclosure Statement will be sent to persons entitled	N/A

+ See chapter 19 for defined terms.

Appendix 3B Page 4

1/1/2003

Appendix 3B

New issue announcement


27	If the entity has issued options, and the terms entitle option holders to participate on exercise, the date on which notices will be sent to option holders	N/A

28	Date rights trading will begin (if applicable)	N/A

29	Date rights trading will end (if applicable)	N/A

30	How do ⁺security holders sell their entitlements in full through a broker?	N/A

31	How do ⁺security holders sell part of their entitlements through a broker and accept for the balance?	N/A

32	How do ⁺security holders dispose of their entitlements (except by sale through a broker)?	N/A

33	⁺Despatch date	N/A

Part 3 - Quotation of securities

You need only complete this section if you are applying for quotation of securities

34	Type of securities (tick one)
(a)	x	Securities described in Part 1

(b)

All other securities

Example: restricted securities at the end of the escrowed period, partly paid securities that become fully paid, employee incentive share securities when restriction ends, securities issued on expiry or conversion of convertible securities

Entities that have ticked box 34(a)

Additional securities forming a new class of securities

Tick to indicate you are providing the information or documents

+ See chapter 19 for defined terms.

1/1/2003

Appendix 3B Page 5

Appendix 3B

New issue announcement

35	o	If the ⁺securities are ⁺equity securities, the names of the 20 largest holders of the additional ⁺securities, and the number and percentage of additional ⁺securities held by those holders

36	o	If the ⁺securities are ⁺equity securities, a distribution schedule of the additional ⁺securities setting out the number of holders in the categories 1 - 1,000 1,001 - 5,000 5,001 - 10,000 10,001 - 100,000 100,001 and over

37	o	A copy of any trust deed for the additional +securities

Entities that have ticked box 34(b)


38	Number of securities for which ⁺quotation is sought

39	Class of ⁺securities for which quotation is sought


40	Do the ⁺securities rank equally in all respects from the date of allotment with an existing ⁺class of quoted ⁺securities?
	If the additional securities do not rank equally, please state:
	·	the date from which they do
	·	the extent to which they participate for the next dividend, (in the case of a trust, distribution) or interest payment
	·	the extent to which they do not rank equally, other than in relation to the next dividend, distribution or interest payment


41	Reason for request for quotation now Example: In the case of restricted securities, end of restriction period (if issued upon conversion of another security, clearly identify that other security)

+ See chapter 19 for defined terms.

Appendix 3B Page 6

1/1/2003

Appendix 3B

New issue announcement


		Number	+Class
42	Number and ⁺class of all ⁺securities quoted on ASX (including the securities in clause 38)

+ See chapter 19 for defined terms.

1/1/2003

Appendix 3B Page 7

Appendix 3B

New issue announcement

Quotation agreement

1	⁺Quotation of our additional ⁺securities is in ASX’s absolute discretion. ASX may quote the ⁺securities on any conditions it decides.

2	We warrant the following to ASX.

The issue of the ⁺securities to be quoted complies with the law and is not for an illegal purpose.

There is no reason why those ⁺securities should not be granted +quotation.

An offer of the ⁺securities for sale within 12 months after their issue will not require disclosure under section 707(3) or section 1012C(6) of the Corporations Act.

Note: An entity may need to obtain appropriate warranties from subscribers for the securities in order to be able to give this warranty

Section 724 or section 1016E of the Corporations Act does not apply to any applications received by us in relation to any ⁺securities to be quoted and that no-one has any right to return any ⁺securities to be quoted under sections 737, 738 or 1016F of the Corporations Act at the time that we request that the ⁺securities be quoted.

We warrant that if confirmation is required under section 1017F of the Corporations Act in relation to the ⁺securities to be quoted, it has been provided at the time that we request that the ⁺securities be quoted.

If we are a trust, we warrant that no person has the right to return the ⁺securities to be quoted under section 1019B of the Corporations Act at the time that we request that the ⁺securities be quoted.

3	We will indemnify ASX to the fullest extent permitted by law in respect of any claim, action or expense arising from or connected with any breach of the warranties in this agreement.

We give ASX the information and documents required by this form. If any information or document not available now, will give it to ASX before ⁺quotation of the ⁺securities begins. We acknowledge that ASX is relying on the information and documents. We warrant that they are (will be) true and complete.

Sign here:		Date:	6 September 2005
	(Director/Company secretary)

Print name:	Aaron Finlay

== == == == ==

+ See chapter 19 for defined terms.

Appendix 3B Page 8

1/1/2003