How can a renewed sense of optimism grow value in the ...

BioForum Edition 37

Quarter 1 FY12 October 2011

How can a renewed sense of optimism grow value in the biotechnology industry?

pwc.com.au/bioforum

Highlights

Every quarter, BioForum reports on the Australian and US pharmaceutical, biotechnology and medical devices markets and the broader life sciences industry. As well as reviewing market performance, BioForum covers initial and secondary capital raisings, clinical milestones, partnerships and mergers and acquisitions.

Highlights

2

Q1 FY12• The Life Sciences Index underperformed in-line

with the ASX ALL Ordinaries, falling 12.8 per cent. • The Biotech/ Pharma Index fell by 12.9 per cent

and the Medical Devices Index fell by 12.6 per cent. • The NASDAQ Composite fell by 12.9 per cent,

while the NASDAQ Biotech fell by 12.5 per cent.• There was one Australian IPO, GI Dynamics,

which raised A$80m during the quarter.• Australian secondary raisings A$90m, down from

$126m in Q4 FY11. Medical devices companies raised A$9m while biotechs raised A$81m.

PwC | BioForum: October 2011

Introduction

Craig Lawn PwC Private Clients

Manoj Santiago PwC Private Clients

pwc.com.au/privateclients

3

In the first quarter

Negative news in overseas markets stripped 12.8 per cent from the Life Sciences Index in the quarter to 30 September, cancelling out gains made in FY11. The broader ASX All Ordinaries lost 12.7 per cent in the first quarter of FY12. On an annual basis, the Life Sciences Index fell 8.6 per cent to 30 September while the All Ordinaries lost 12.2 per cent.

Sector performance in detail

The Biotech/Pharma Index and Medical Device Index posted losses of 12.9 per cent and 12.6 per cent respectively, continuing the trend of the previous quarter. More than half the companies in the broader Life Sciences Index posted losses during the quarter.

This result was in line with the performance of the NASDAQ Composite, which fell by 12.9 per cent, and the NASDAQ Biotech, which lost 12.5 per cent.

“Mainstream indices and life sciences sector indices decreased by similar levels both nationally and internationally,” PwC Life Sciences partner Manoj Santiago said. “This reflected volatility in the market and a downward trend worldwide driven by a lack of confidence due to significant global issues including the European debt crisis and the stalled US economy and its impact on China’s growth.”

IPOs and secondary listings

There was one Australian IPO during the quarter to 30 September, after none in the previous quarter. Gi Dynamics’ public offering raised A$80 million to fund development of non-surgical treatments for type 2 diabetes and obesity.

The 30 Australian secondary raisings in the first quarter of 2012 totalled A$90m, down from $126m in Q4 FY11, with medical devices companies raising A$9m and biotechs A$81m. On a positive note, totals raised were higher with pharma companies getting an average of A$3.4m, up from A$2.9m, and medical devices companies raising A$1.5m rather than A$0.5m.

In the US, one pharma/biotech IPO and one medical device IPO raised a total of $54m, continuing a downward trend, while 32 secondary raisings produced $536m in contrast to a total of $3.6 billion the previous quarter.

However, more US companies are looking to Australia to raise funds, PwC Life Sciences partner Manoj Santiago said.

“There is a continuing trend of US companies seeing the Australian market as an opportune place to raise funds,” he said. “We are aware of a number of company listings being planned for early 2012.”

PwC Life Sciences partner Craig Lawn also sees optimistic signs. “The main point to take from last quarter’s results is that when you dig a little deeper there are positive signs including top talent returning from overseas.

“Industry participants should not be distracted by market volatility, which is outside their control, and focus on how to best take advantage of structural changes in R&D and the growing confidence of foreign investment in Australia.

“Global volatility overall has overshadowed important structural developments for the life sciences industry. Most important of these is the R&D tax legislation which was passed in August. Life sciences companies are expected to be the major beneficiaries of the new scheme with companies that have less than A$20m turnover receiving 45 cents in the dollar rebate for all eligible R&D expenditure.”

Introduction

PwC Australia Life Sciences and Innovation Practice contacts

4

Australian Industry Leaders – Life Sciences

Craig LawnP: +617 3257 5672 E: [email protected]

Manoj SantiagoP: +612 8266 4494 E: [email protected]

Michelle ChiangP: +612 8266 7575 E: [email protected]

Brisbane

Troy MorganP: +617 3257 8934 E: [email protected]

Melbourne

Andy BarlowP: +613 8603 4230 E: [email protected]

Sam LobleyP: +613 8603 3689 E: [email protected]

Newcastle

Stephanie FabianP: +612 4925 1278 E: [email protected]

Sydney

Assurance

Manoj SantiagoP: +612 8266 4494 E: [email protected]

Transactions

Kate JuliusP: +612 8266 5835 E: [email protected]

Tax

Craig LawnP: +612 8266 0147 E: [email protected]

Corporate Finance

Dan CottonP: +612 8266 3053 E: [email protected]

Pharmaceutical Industry Leader

John CanningsP: +612 8266 6410 E: [email protected]

Licensing and Forensic Accounting

Cassandra MichieP: +612 8266 2774 E: [email protected]

R&D Tax

Sandra MasonP: +612 8266 0470 E: [email protected]


06 Quarterly key findings

08 Market performance

18 Announcements

29 Appendix

33 Methodology

35 Acknowledgements

Contents5

Contents

6

01Quarterly key findings


Quarterly key findings

7

Quarterly key findings

Market performance Q1 FY12 Page

Life sciences industry total MCap A$30,526m 9

Life sciences industry growth -12.8%

Pharma/biotech sector total MCap A$20,927m 11

Pharma/biotech sector growth -12.9%

Medical device sector total MCap A$9,599m 11

Medical device sector growth -12.6%

Individual company performance

Top individual performer Genetic Technologies Ltd 16

Change in market cap over the past four quarters 515%

Bottom individual performer Safety Medical Products Ltd 17

Change in market cap over the past four quarters -95%

Financing

Australian IPO count 1 12

Total raised (A$m) A$80m

US IPO count 2 12

Total raised A$54m

Australian secondary financing count 30 14

Total raised (A$m) A$90m

US secondary financing count 31 14

Total raised A$536m

Announcements Q1 FY12 Page

Australia

Total partnerships formed this quarter 34 19

Total mergers and acquisitions 9 21

Total announcement for clinical trials 42 22

Pre-clinical 5

Phase I 5

Phase II 5

Phase III 1

Total regulatory announcements 26 24

Other 63 26

8

02Market performance


ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences(market cap A$m)

Life Sciences ex majors (market cap A$m)

% Change (Mar-Jun) % Chang e (J un-Sep)

-5.5%

-0.3%

6.5%

-8.2%-

-

5.7%

14.8%-12.7% -12.9% -12.5% -12.8%

-20.0%

-15.0%

-10.0%

-5.0%

0.0%

5.0%

10.0%

ASX All Ordinaries NASDAQ Composite NASDAQ Biotech Life Sciences Life Sciences ex majors

-60%

-40%

-20%

0%

20%

40%

60%

80%

100%

30-Sep-09 30-Dec-09 30-Mar-10 30-Jun-10 30-Sep-10 30-Dec-10 30-Mar-11 30-Jun-11 30-Sep-11

Figure 1: Weekly performance over the quarter of the Australian life sciences compared to major indices

Table 1: Quarterly movements of the Australian life sciences sector compared to major indices

31-Mar-11 30-Jun-11 30-Sep-11% Change (Mar-Jun)

% Change (Jun-Sep)

ASX All Ordinaries (Index) 4,929 4,660 4,070 -5.5% -12.7%

NASDAQ Composite (Index) 2,781 2,774 2,415 -0.3% -12.9%

NASDAQ Biotech (Index) 1,041 1,108 970 6.5% -12.5%

Life Sciences (market cap A$m) 38,126 35,003 30,526 -8.2% -12.8%

Life Sciences ex majors (market cap A$m) 9,618 9,074 7,730 -5.7% -14.8%

--20%

--15%

-10%

-5%

0%

5%

ASX All Ordinaries Life Sciences Life Sciences ex majorsNASDAQ BiotechNASDAQ Composite

30-Jun 1-Jul 8-Jul 15-Jul 22-Jul 29-Jul 5-Aug 12-Aug 19-Aug 26-Aug 2-Sep 9-Sep 16-Sep 23-Sep 30-Sep

Graph 1: Quarterly movements of the Australian life sciences sector compared to major indices

Market perfrom

ance9

Performance overview

Figure 2: Two-year comparison of the Australian life sciences sector by market capitalisation compared to major indices

% Change (Sep10-Sep11)% Change (Jun10-Jun11)

7.7%

31.5%

38.6%

4.0%

49.3%

-12.2%

2.0%

8.3%

-8.6%

26.4%

-20.0%

-10.0%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences (market cap A$m) Life Sciences ex majors (market cap A$m)

10

-25%

-20%

-15%

-10%

-5%

0%

5%

10%

15%

Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD

30-Jun-11 07-Jul-11 14-Jul-11 21-Jul-11 28-Jul-11 04-Aug-11 11-Aug-11 18-Aug-11 25-Aug-11 01-Sep-11 08-Sep-11 15-Sep-11 22-Sep-11 29-Sep-11

Figure 3: Quarterly performance of the Australian life sciences sector and subsectors

Table 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices

% Change (Year to June 2011) % Change (Year to September 2011)

30-Jun-10 30-Jun-11 % Change 30-Sep-10 30-Sep-11 % Change

ASX All Ordinaries (Index) 4,325 4,660 7.7% 4,637 4,070 -12.2%

NASDAQ Composite (Index) 2,109 2,774 31.5% 2,369 2,415 2.0%

NASDAQ Biotech (Index) 800 1,108 38.6% 895 970 8.3%

Life Sciences (market cap A$m) 33,671 35,003 4.0% 33,381 30,526 -8.6%

Life Sciences ex majors (market cap A$m) 6,078 9,074 49.3% 6,114 7,730 26.4%

Table 3: Quarterly summary of the Australian life sciences indices’ performance

MCap (A$m)

% of total value

Companies with share price gains

Proportion of subsector

up

Companies with share

price losses


down

Companies with share

price flat


flat

Total number of companies

Pharma/Biotech 20,927 69% 12 57% 46 61% 2 67% 60

Pharma/Biotech ex CSL 5,345 69% 12 60% 45 61% 2 67% 59

Med Device 9,599 31% 9 43% 30 39% 1 33% 40

Med Device ex COH, RMD

2,385 31% 8 40% 29 39% 1 33% 38

Life Sciences 30,526 100% 21 21% 76 76% 3 3% 100

Life Sciences ex majors 7,730 100% 20 21% 74 76% 3 3% 97

Graph 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices

Market perfrom

ance


Market perfrom

ance11

Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD

40%

20%

0%

20%

40%

60%

80%

100%

120%

30-Sep-09 30-Dec-09 30-Mar-10 30-Jun-10 30-Sep-10 30-Dec-10 30-Mar-11 30-Jun-11 30-Sep-11

Figure 4: Two-year comparison of the Australian life sciences indices’ performance by market capitalisation

Graph 3: Quarterly performance of the Australian life sciences sector and subsectors by market capitalisation

Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD Life Sciences Life Sciences ex majors

% Change (Mar-Jun) % Change (Jun-Sep)

-20.0%

-18.0%

-16.0%

-14.0%

-12.0%

-10.0%

-8.0%

-6.0%

-4.0%

-2.0%

0.0%

-7.7%

-1.8%

-9.3%

-16.6%

-8.2%

-5.7%

-12.9%

-18.6%

-12.6%

- 4.8%

-12.8%

-14.8%

Table 4: Quarterly performance of the Australian life sciences sectors by market capitalisation A$m

31-Mar-11 30-Jun-11 30-Sep-11% Change (Mar-Jun)

% Change (Jun-Sep)

Pharma/Biotech 26,024 24,023 20,927 -7.7% -12.9%

Pharma/Biotech ex CSL 6,687 6,569 5,345 -1.8% -18.6%

Med Device 12,102 10,980 9,599 -9.3% -12.6%

Med Device ex COH, RMD 3,004 2,505 2,385 -16.6% -4.8%

Life Sciences 38,126 35,003 30,526 -8.2% -12.8%

Life Sciences ex majors 9,618 9,074 7,730 -5.7% -14.8%

12

0

100

200

300

400

500

600

Capi

tal R

aise

d (A

$m)*

Medical Devices Biotech

Q1FY11 Q2FY11 Q3FY11 Q4FY11 Q1FY12

360

145145

0 0 00

80

0

100

200

300

400

500

600

Capi

tal R

aise

d (A

$m)



7

156

353

76

100

54

159

Med Device: $7m

Figure 5: Quarterly comparison of IPOs in Australia

Figure 6: Quarterly comparison of IPOs in the US

Table 6: Quarterly Australian IPO listings

Company Listing date

Capital raised

(A$m) Sector

GI Dynamics Inc 7/09/2011 80 Med Devices

Total 80

Table 5: Number of quarterly IPO Australian listings

Biotech Med Devices ASX

Q1FY12 0 1 27

Q4FY11 0 0 29

Q3FY11 1 1 29

Q2FY11 0 0 50

Q1FY11 0 0 19

Table 7: Total of quarterly US IPO listings

Biotech Med Devices

Q1FY12 1 1

Q4FY11 2 0

Q3FY11 1 3

Q2FY11 3 4

Q1FY11 0 1

Table 8: Quarterly US IPO listings

Company Listing dateCapital raised

(A$m) Sector

Horizon Pharma Inc

28/07/2011 54 Biotech

Discount Dental Materials Inc

20/09/2011 0.012 Med Devices

Total 54,120,000

Market perfrom

ance

Quarterly financing

IPO financing


Market perfrom

ance13

0

100

200

300

400

500

600

Capi

tal R

aise

d (A

$m)


118

105

24 7

145

360

80

FY08 FY09 FY10 FY11 FY12

Biotech: $7m

Capi

tal R

aise

d (A

$m)


31

325

588

6

1,662

251

391

461

0

500

1,000

1,500

2,000

2,500


Biotech: $54mMed Device: $0.012mMed Device: $6m

54

Figure 7: Annual comparison of IPOs in Australia

Figure 8: Annual comparison of IPOs in the US

Table 9: Number of IPO listings in Australia

Biotech Med Devices ASX

FY12 0 1 27

FY11 1 1 127

FY10 1 0 53

FY09 1 0 24

FY08 4 3 79

Table 10: Number of IPO listings in the US

Biotech Med Devices

FY12 1 1

FY11 6 8

FY10 7 2

FY09 0 1

FY08 8 8

Yearly financing

Quarterly financing

Secondary finance market

14

Capi

tal R

aise

d (A

$m)



1314

91

56

154

22

123

3

81

9

0

20

40

60

80

100

120

140

160

180

200

Capi

tal R

aise

d (A

$m)


Q1FY11 Q2FY11 Q3FY11 Q4FY11 Q1FY1246 31

409110

105

2,128

1,518 1,490

2,088

127

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

Med Device: $110m

Figure 9: Quarterly comparison of secondary financing in Australia

Figure 10: Quarterly comparison of secondary financing in the US

Table 11: Number of secondary deals (AU)

Biotech

Avg. amount

raised ($m)

Med Devices

Avg. amount

raised ($m)

Q1FY12 24 3.4 6 1.5

Q4FY11 43 2.9 7 0.5

Q3FY11 39 3.9 12 1.8

Q2FY11 41 2.2 13 4.3

Q1FY11 31 0.4 11 1.3

Table 12: Number of secondary deals (US)

Biotech Med Devices

Q1FY12 25 6

Q4FY11 43 18

Q3FY11 8 43

Q2FY11 17 51

Q1FY11 2 9

Market perfrom

ance


Yearly financing

Market perfrom

ance15

9

Capi

tal R

aise

d (A

$m)


0

500

1,000

1,500

2,000

2,500


274

229

2,081

71

248

271

381

96

81

Capi

tal R

aise

d (A

$m)


31 0 0


8,603

1,699

719

3,330

5,974

2,400

5,845

1,672

2,000

4,000

6,000

8,000

10,000

12,000

127

409

Figure 11: Annual comparison of secondary financing in Australia

Figure 12: Annual comparison of secondary financing in the US

Table 13: Number of Australian secondary raisings

Biotech Med Devices

FY12 24 6 43

FY11 154 43 39

FY10 107 39 41

FY09 87 41 66

FY08 99 66 75

Table 14: Number of US secondary raisings

Biotech Med Devices

FY12 25 6 121

FY11 70 121 57

FY10 122 57 24

FY09 48 24 29

FY08 80 29 59

01Genetic Technologies Ltd (GTG)

Return: 515% Closing price: $0.16 MCap: A$74.34m

Genetic Technologies announced that its maiden profit for the financial year ended 30 June 2011 was $901k with positive cash flows of $2.2m. It also announced the successful completion of a $117m capital raising to institutional and sophisticated investors in Australia and the US. Its Australian laboratory was also recentlycertified under the US Clinical Laboratories Improvements Amendments, which implies that GTG’s BREVAgen breast cancer risk test will be launched in the US soon.

02 Mesoblast Ltd (MSB)

Return: 215% Closing price: $8.09 MCap: A$2,268.64m

Mesoblast acquired 100% ownership of Angioblast while broadening its product pipeline across a wide range of clinical indication areas. Mesoblast also entered into a strategic alliance to commercialise novel therapeutic products for degenerative neurologic and cardiovascular conditions. Its CEO Professor Silviu Itescu was named BioSpectrum Asia Pacific Person of the Year 2011.

03 Calzada Limited (CZD)


Calzada signed a licensing deal with Phosphagenics to launch a cosmeceutical product containing Calzada’s anti-obesity peptide, known as AOD9604, in combination with Phosphagenics’ TPM technology. Calzada also signed an agreement with CuroNZ to develop and commercialise its neural regeneration peptides technology in return for royalties or a share of any sub-licensing income. PolyNovo Biomaterials, a wholly owned subsidiary, was allowed its first patent in the US.

04Telesso Technologies Limited (TEO)


During the period to 31 December 2010, the company’s investment in Vascular Pathways (VPI) was converted to equity after it raised US$14m from four US-based venture capital firms active in medical technology. Proceeds of the raising will be used to complete further clinical studies and to commercialise the technology.

05Optiscan Imaging Limited (OIL)


Optiscan, in conjunction with collaboration partner Carl Zeiss, has been granted a key US patent over its microscopic imaging system to be used in macroscopic surgical imaging systems. The patent includes developments in the fields of neurosurgery, otolaryngology and spinal surgery, which Optiscan has licensed to Carl Zeiss.

06Tissue Therapies Limited (TIS)


Tissue Therapies announced that the EU human trial of VitroGro has been completed and the final report is expected during October 2011. The EU regulatory consultant is confident that the results already achieved are sufficient for EU approval for sale. It announced that commercial negotiations are proceeding well and expects to start sales during the second quarter of 2012.

07Starpharma Holdings Limited (SPL)


Starpharma Holdings announced a major phase 2 clinical study demonstrated VivaGel is effective in treating bacterial vaginosis and signed an agreement granting marketing rights over the VivaGel-coated condom in Japan to Okamoto Industries. Further, the company announced that GlaxoSmithKline has been awarded a grant to advance a dermal treatment and the funds will be used to support Starpharma’s synthesis of dendrimer-based drug candidates.

08Medical Developments International Limited (MVP)


MVP reported strong earnings and profit growth throughout the year, revising second-half earnings and profit figures twice in 2011. The company concluded an incentive plan with CEO John Sharman to encourage his long-term commitment to the business.

09 Bionomics Limited (BNO)


Bionomics successfully concluded two phase Ib clinical trials of BNC210, a new treatment for anxiety and depression. The phase 1 clinical trial data of BNC105 were published in a prestigious international cancer journal. CEO Dr Deborah Rathjen agreed to extend her employment contract for five years and Bionomics completed an institutional placement of 25m shares at $0.57 with strong interest from domestic and international institutions.

10 ITL Limited (ITD)


ITL Limited announced progress in its restructure and said it has returned a profit (unaudited) for the 2011 financial year of approximately $1m.

Market perfrom

ance

16

Performers over past four quarters

Top 10

GTGMSB

CZDTEO

OILTIS

SPLMVP

BNOITD

0% 100% 200% 300% 400% 500% 600%


01AustofixGroup Limited (AYX)

Return: -70% Closing price: $0.29 MCap: A$3.77m

Austofix proposed to issue shares to a director whereby $400k in debt funds will be convertible at $0.325 per share on 31 July 2012. Also, a funding agreement was entered into whereby directors of certain parties related to directors will advance $270k to be paid back on 31 July 2012.

02Genera Biosystems Limited (GBI)


Genera Biosystems announced that its research partner would discontinue further development of the modified HPV test.

03 Bone Medical Limited (BNE)


Bone Medical executed a convertible note funding agreement with La Jolla Cove Investors for US$6m at a rate of 4.75% a year payable monthly in cash or fully paid ordinary shares with maturity of three years. Dr Barry Walker resigned from the board after serving the company for several years.

04 Medivac Limited (MDV)

Return: -71% Closing price: $0 MCap: A$3.81m

Medivac announced a number of funding arrangements including long-term funding from a new US-based institutional investor. It signed an MOU through its Sri Lankan distributor, CME Medical, with the Sri Lanka Ministry of Health to establish clinical waste management systems in Sri Lankan hospitals.

05 HealthLinx Limited (HTX)


HealthLinx issued options to Springtree Special Opportunities Fund in return for funding totalling up to $7.23m, which was subsequently terminated by mutual consent. Stephen Copulos resigned as a non-executive director and John Chiplin was appointed a non-executive director. A Chinese partner was appointed for the OvPlex diagnostic study and a non-exclusive licensing agreement was signed with Sigma Aldrich for the IgY Immunodepletion technology.

06 Actinogen Limited (ACW)


Shareholders of Actinogen voted to acquire the shares in Celgenics, a West Australian biotechnology company. Mark Killmier resigned as company secretary and Suraj Sanghani has been appointed in his place. The company announced that while revenues were up 1.8% to $94,453, it made a net loss of $719,960 for the year ended 30 June 2011.

07 Imugene Limited (IMU)


Imugene announced that Novartis terminated a global agreement to develop and commercialise vaccines for pigs and poultry.

08 Cordlife Limited (CBB)


Cordlife carried out a capital reduction which resulted in the demerger of Cordlife Singapore from CBB. Further, Jeremy Lee resigned as a director and CFO of the company.

09Tyrian Diagnostics Limited (TDX)

Return: -92% Closing price: $0 MCap: A$1.02m

Tyrian Diagnostics terminated agreements with Bayer CropScience AG to develop and commercialise agriculture diagnostic products using Tyrian’s proprietary DiagnostIQ platform. This decision was made following continuing delays in commercialising the agriculture products, combined with lower-than-expected sales forecasts.

10Safety Medical Products Limited (SFP)


During the period ended 30 June 2011 Safety Medical Products announced successfully finalised its administration and completed its recapitalisation and reinstatement on the ASX. While the company is still assessing demand for its SecureTouch syringe it recently finalised an option agreement to acquire key tenements in the Three Rivers area of Western Australia. In August 2011 it negotiated an extension to this tenements option.

Market perfrom

ance17

Performers over past four quarters

Bottom 10

AYXGBI

BNEMDV

HTXACW

IMUCBB

TDXSFP

-100% - 90% -80% -70% - 60% - 50% - 40% -30% -20% -10% 0%

Announcements

18

03


Company Pharma/ biotech partner

Application Value (A$m) Comments

Biotechnology Total 17

Antisense Therapeutics (ANP)

Afandin Cancer Not disclosed Antisense Therapeutics granted Afandin an option to develop and commercialise the ATL1101 compound for cancer applications subject to Afandin securing an agreed amount of development funding.

Avita Medical (AVH)

MENA United Skin diseases Not disclosed Avita has entered into a joint venture with Kuwait-based MENA United to sell and market Avita Medical’s regenerative product ReCell Spray-On Skin in the Middle East and North Africa (MENA).

BioDiem (BDM) World Health Organization

Infectious disease and cancer indications

Not disclosed BioDiem has agreed to transfer an egg-based live attenuated influenza vaccine (LAIV) production technology to developing country manufacturers under WHO’s Global Pandemic Influenza Action Plan. This agreement replaces the LAIV licence granted to the WHO by Nobilon International.

BioDiem (BDM) Serum Institute of India


US$1m The company has licensed its egg-based live attenuated influenza vaccine (LAIV) technology to the Serum Institute of India.

Genetic Technologies (GTG)

Attomol GmbH Non-coding DNA technology

Not disclosed Genetic has granted Attomol GmbH non-exclusive rights to a number of GTG patents relating to its non-coding DNA technology.

HealthLinx (HTX) Sigma Aldrich IgY Imunodepletion technology

Not disclosed HealthLinx has licensed its IgY Immunodepletion technology to Sigma Aldrich in Europe and Australia, with an option to expand into the US.

Holista CollTech (HCT)

Hi-Tech Biosciences Herbal medicine Not disclosed Holista CollTech and HTB formed a joint venture to develop, patent and commercialise herbs for medical applications worldwide.

IDT Australia (IDT)

Swift Pharmaceuticals

Cancer $3.1m IDT has partnered with Indian pharmaceutical manufacturer Swift to develop oral anti-cancer drugs for local and international markets and has secured a Victorian government innovation grant towards this project.

Imugene (IMU) Novartis Product development and commercialisation

Not applicable Imugene said Novartis terminated an agreement to develop and commercialise vaccines for pigs and poultry.

iSonea (ISN) A Fortune 500 company

Asthma Not disclosed iSonea signed a non-binding MOU with a global fortune 500 company to commercialise its asthma monitoring and management technology in the US.

Mesoblast (MSB) Lonza Group Stem cell therapy Not disclosed Mesoblast and Lonza Group entered into a strategic alliance for clinical and long-term commercial production of Mesoblast’s off-the shelf (allogeneic) adult stem cell products.

NuSep (NSP) United Laboratories

Development of plasma fractionation facility

Not disclosed United Laboratories signed a letter of intent regarding investment in NuSep’s Singapore plasma fractionation facility and a new facility in the Philippines subject to due diligence.

Phosphagenics (POH)

Sungate Supplies

Product distribution in Singapore

Not disclosed Phosphagenics agreed to supply Sungate’s Elixia personal care range in the Asia Pacific.

Phosphagenics (POH)

Leading global cosmetic and dermatology company

Cosmetic and pharmaceutical use

Not disclosed Phosphagenics has agreed with a leading global cosmetic and dermatology company to conduct a human study on a new product incorporating its TPM transdermal delivery system.

Progen Pharmaceuticals (PGL)

Prima BioMed and Phosphagenics

Cancer Not disclosed Progen has secured new contracts to manufacture mannosylated fusion protein for Prima BioMed and to manufacture TPM for Phosphagenics.

pSivida (PVA) Hospital for Special Surgery

Orthopaedic surgery

Not disclosed pSivida agreed with Hospital for Special Surgery to investigate bio-erodible sustained release systems in orthopaedic surgery.

Starpharma Holdings (SPL)

Ansell and Reckitt Benckiser

Sexually transmitted disease

Not disclosed Starpharma ended an agreement with Reckitt Benckiser to commercialise the VivaGel coated condom due to unsatisfactory progress. The company has now granted the marketing rights to Ansell.

Announcem

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Partnerships

Company Pharma/ biotech partner

Application Value (A$m) Comments

Medical Devices Total 17

Advanced Surgical Design and Manufacture (AMT)

Orthofix Spinal Implants

Spine solutions Not disclosed Orthofix Spinal Implants, a subsidiary of Orthofix International, appointed AMT the exclusive Australian distributor for the full range of its spinal products.

Allied Healthcare Group (AHZ)

The Ohio State University

Infectious disease and cancer

Not disclosed Coridon, in which Allied has a substantial holding, has agreed with Ohio State University to undertake research on the prevention and treatment of a range of infectious diseases and cancers in humans, using the company’s patented technology.

AtCor Medical (ACG)

Major international pharmaceutical company

Central blood pressure monitoring

$1.25m The company has expanded contracts to supply SphygmoCor systems and clinical trial support services to a major international pharmaceutical company.

AtCor Medical (ACG)

SunTech Medical Blood pressure data monitoring

Not disclosed Under a multi-year worldwide agreement the companies agreed to offer clinical trials customers a portfolio of services with support from AtCor Medical.

Clover Corporation (CLV)

Multinational infant formula company

Infant formula and food products

Not disclosed Clover and its subsidiary Nu-Mega Ingredients signed a three-year agreement with a major multinational infant formula company to supply Omega 3 and Omega 6, Hi-DHA tuna fish oil and microencapsulated Driphorm powders.


CSIRO Infant formula and medical food applications

$1.2m Clover has agreed to undertake a three-year research program with CSIRO to develop encapsulation technology for infant formula and medical food applications.


Corn Products International

Develop market for products

N/A Clover’s subsidiary, Nu-Mega Ingredients, has terminated its distribution and agency agreements with Corn Products International in the Americas and Europe.

CogState (CGS) International pharmaceutical company

Major depressive disorder

US$1.10m An international pharmaceutical company has agreed to a phase 3 clinical trial in which CogState will provide its cognitive testing technology and associated services for the treatment of major depressive disorder.

Genera Biosystems (GBI)

Undisclosed research partner

To detect and genotype HPV in a cervical specimen

N/A Genera Biosystems’ research partner advised that it will discontinue development of the modified HPV test.

Medical Australia Limited (MLA)

MediVet Stem cell regenerative medicine for animals

Not disclosed Global animal healthcare company MediVet made MLA the sole distributor of MediVet products in England, Wales, Scotland and Ireland.

Medical Australia (MLA)

Smith & Nephew Surgical irrigation Not disclosed The company signed a new distribution agreement under which the Canadian arm of medical device company Smith & Nephew will distribute TUTA irrigation products on an exclusive basis throughout Canada.

MediVac (MDV)

Critical Dental Personal hygiene Not disclosed The company appointed Critical Dental as the Australian distributor for its hand sanitising gels and workplace wipes.

ResMed (RMD)

CareFusion Respiratory problems

Not disclosed Under a five-year agreement CareFusion will exclusively distribute the ResMed Stellar 100 and 150 non-invasive ventilators (NIV) and their related accessories in the US institutional healthcare market.

Tyrian Diagnostics (TDX)

Bayer CropScience AG

Agriculture diagnostic products

N/A Tyrian Diagnostics decided to terminate agreements with Bayer CropScience AG for the development and commercialisation of agriculture diagnostic products using Tyrian’s proprietary DiagnostIQ platform.

Universal Biosensors (UBI)

LifeScan Diabetes N/A Universal Biosensors amended a 2002 agreement with LifeScan in 2002 to clarify and more clearly detail UBS’s rights and obligations with respect to licensing its technology outside the field of diabetes.


Siemens Healthcare Diagnostics

Coagulation testing Not disclosed Universal Biosensors and Siemens Healthcare Diagnostics formed a strategic partnership to develop and commercialise products for the point-of-care coagulation testing market.


SpeeDx Molecular diagnostics

Not disclosed Universal Biosensors agreed to give SpeeDx access to its proprietary MNAzyme technology and will use SpeeDx’s proprietary technology with its own diagnostic biosensor to access the rapidly growing molecular diagnostics market.

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Dominant company Target company Type of deal Value (A$m) Comments


Actinogen (ACW) Celgenics Acquisition Not disclosed Shareholders of Actinogen voted to acquire the shares in Celgenics, a West Australian biotechnology company.

Apollo Consolidated (AOP)

Aspire Minerals Acquisition 100m Apollo shares and 3 tranches of performance shares

Apollo agreed to acquire 100% of the issued shares of Aspire Minerals, which holds rights over 3,000 sq km of Birimian greenstone belts in northern and central Cote d’Ivoire.

BioProspect (BPO) Frontier Gasfields Share acquisition

$1.25m BioProspect acquired 50% of the shares in privately owned Australian oil and gas explorer Frontier Gasfields and plans to increase its stake to 75% contingent on commencement of exploration well on SC55.

Novogen (NRT) Pharm-a-Care Laboratories

Divestment A$10.1m Novogen sold its consumer products business to Pharm-a-Care Laboratories.

Novogen (NRT) Marshall Edwards Investment US$2m Novogen agreed to purchase 1.33m shares of subsidiary Marshall Edwards’ common stock in a private placement for US$2m.

Qiagen Australia Holdings

Cellestis (CST) Acquisition $3.74 per share The Supreme Court of Victoria approved Qiagen’s acquisition of Cellestis via a scheme of arrangement.


CogState (CGS) Axon Sports Acquisition $1,268,511 CogState acquired 100% ownership of Axon Sports and will pursue sports concussion markets outside North America.

ResMed (RMD) BiancaMed Acquisition Not disclosed ResMed acquired leading Irish medical technology company BiancaMed by purchasing all its outstanding shares in cash.

ResMed (RMD) Gründler GmbH Acquisition Not disclosed ResMed acquired German-based Gründler GmbH, a developer of innovative medical humidification products.

Mergers, acquisitions and divestment

Company Drug Application Comments

Pre-clinical Total 5

Novogen (NRT) NV-128 Ovarian cancer The company had encouraging results showing activity in chemotherapy resistant ovarian cancer cells. The data provided gave sufficient proof of concept to warrant further study in ovarian cancer patients.

Patrys (PAB) Anti-cancer product Multiple myeloma The study produced promising results in treating multiple myeloma and supports the further study in multiple myeloma patients.

Patrys (PAB) PAT-SM6 Cancer The company announced additional positive results from a range of cancer models with its lead product PAT-SM6. The best results were seen in a pre-clinical study that examined PAT-SM6’s efficacy against ovarian cancer. A prostate cancer model also showed promise.

Prana Biotechnology (PBT)

PBT434 Parkinson’s disease A grant from The Michael J. Fox Foundation will fund pre-clinical studies ahead of human trials of a novel treatment for Parkinson’s disease, PBT434.

Viralytics (VLA) Cavatak Melanoma Studies showed that Cavatak displays potent oncolytic activity in cells resistant to new melanoma treatment.

Phase I Total 5

Bionomics (BNO)

BNC210 Anxiety treatment The company presented results which described the molecular link between the neurotropic effects of BNC210 and its anti-anxiety properties and the results of the trial which compared BNC210 to Lorazepam and found that BNC210 had none of the key side effects of Lorazepam.

Biotron (BIT) BIT225 HIV The company began a landmark phase 1b/2a proof-of-concept human trial of its lead HIV drug candidate, BIT225.

Novogen (NRT) ME-143 Refractory solid tumours

Novogen’s subsidiary Marshall Edwards began a phase I clinical trial to evaluate the safety and tolerability of intravenous ME-143 in patients with refractory solid tumours.


PG545 Cancer A phase 1a PG545 human clinical trial in advanced cancer patients was put on hold due to unexpected local injection site reactions seen in patients. The PG545-101 study will close once the current cohort of patients is complete.

pSivida (PVA) Corticosteroid fluocinolone acetonide

Uveitis pSivida made an investigational new drug application for a phase I/II clinical trial of corticosteroid fluocinolone acetonide for the treatment of uveitis affecting the posterior segment of the eye.

Phase II Total 5

Alchemia (ACL) HA-Irinotecan Lung cancer Alchemia began a phase II clinical study of its lead cancer drug HA-Irinotecan, which utilises Alchemia’s patented HyACT technology to target the anti-cancer drug irinotecan to the tumour.

CBio (CBZ) XToll Rheumatoid arthritis

The company announced that XToll did not meet its primary endpoint but showed statistically significant or clinically meaningful improvement in a number of important measures (secondary endpoints) of improvement in rheumatoid arthritis.

Living Cell Technologies (LCT)

Diabecell Diabetes The company implanted the first two patients taking part in a phase II Diabecell clinical trial in Buenos Aires, Argentina after its earlier studies validated this treatment and showed it can greatly benefit patients with unstable diabetes.

Mesoblast (MSB) Mesenchymal Precursor Cell

Lower back pain The first minimally-invasive lumbar disc procedure was successfully performed in the phase 2 clinical trial of Mesoblast’s proprietary adult Mesenchymal Precursor Cell (MPC) product for the treatment of lower back pain and degenerative disc disease.

Mesoblast (MSB) Revascor Heart failure The European Medicines Agency said Mesoblast could begin a phase 2 clinical trial in Europe of its lead cardiovascular product Revascor in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack.

Phase III Total 1

QRxPharma (QRX)

MoxDuo IR Moderate to severe acute pain

The company has successfully completed the pivotal phase 3 study involving MoxDuo IR and is planning a new drug application filing.

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Other Total 26

Agenix (AGX) ThromboView Acute pulmonary embolism

The company announced positive results of a study to evaluate the efficacy and accuracy of its lead diagnostic, ThromboView. The study found ThromboView was well tolerated by patients and enhanced the ability to accurately diagnose acute pulmonary embolism.

Agenix (AGX) ThromboView In detecting blood clots

At the 4th Annual Congress of Molecular Diagnostics in China the company highlighted the multiple clinical advantages of ThromboView over standard imaging tests used in hospitals worldwide.

Analytica (ALT) AutoStart Burette Intravenous medication delivery system

The company announced that a major clinical trial using the AutoStart Burette has been successfully completed in Sydney, Australia at Concord Repatriation and General Hospital.


ATL1102 Stem cell mobilisation agent

Antisense announced a potential new application of ATL1102 as a stem cell mobilisation agent in stem cell transplantation, based on data generated from previous studies, and lodged an international patent application to protect its use.

Bionomics (BNO) BNC105 Solid tumours (cancer)

Bionomics said data from a renal cancer trial supported progression of the trial as the combination of Afinitor and BNC105 is safe and well tolerated. The company is also conducting a clinical trial of BNC105 as a treatment for metastatic mesothelioma and said this yielded important information about first line therapy in combination with Alimta and Cisplatin.

Circadian Technologies (CIR)

VGX-100 Dry eye disease The journal Archives of Ophthalmology has identified Circadian’s lead development molecule VGX-100, a human antibody against the angiogenic and lymphangiogenic molecule VEGF-C, as a potential new therapy in treating inflammation and corneal tissue damage associated with dry eye disease.

Clinuvel Pharmaceuticals (CUV)

Scenesse Erythropoietic protoporphyria (EPP)

The company has completed its pre-clinical program for its first-in-class drug Scenesse (afamelanotide) and the data, from four pre-clinical studies, confirm results from earlier trials. The European Medicines Agency agreed with Clinuvel that carcinogenicity studies of afamelanotide were not required.

Eastland Medical Systems (EMS)

ART004 trial Not given In response to the confusion created in relation to a trial of ART004 in Tanzania and Ghana, the company confirmed the trial is still progressing and EMS is fully funded to meet its contractual obligations to ProtoPharma.

HeartWare (HIN) MVAD pump Heart failure Good Laboratory Practice animal studies of HeartWare’s next generation MVAD pump showed that it attained the objectives for system performance, haemocompatability and biocompatibility.

Immuron (IMC) Travelan Food poisoning In vitro testing has demonstrated that Travelan binds strongly to E. coli O104 surface antigen and could help reduce the risk of infection in those exposed to the European outbreak strain.

ImpediMed (IPD) L-Dex technology Breast cancer A critical review article supporting the use of L-Dex technology in Red Journal finds L-Dex testing superior to traditional techniques of measure for arm-related lymphoedema in breast cancer patients.

MediVac (MDV) MetaMizer 240SSS Hospital waste management system

Rigorous in-house testing of MetaMizer 240SSS produced results that exceeded expectations including faster throughput, higher capacity and ability to treat alternative feedstock (eg quarantine, food waste etc).

Mesoblast (MSB) Bone marrow transplant

Blood cancer The company received clearance from the US FDA to start its phase 3 clinical trial for bone marrow regeneration in patients with blood cancer.

OBJ (OBJ) eMPatch magnetic micro-array technology

Common musculoskeletal pain

After extended testing of eMPatch magnetic micro-array technology, the company aims to develop a range of next generation patches to relieve common musculoskeletal pain.

Patrys (PAB) PAT-SM6 Melanoma The company announced PAT-SM6 was detected in tumours taken from patients in both the first and second dose groups, which is very encouraging, and thus the recruitment of third group of patients has started.

Phosphagenics (POH)

TPM/oxycodone patch

Pain medication Phosphagenics in collaboration with 3M completed the optimisation of the TPM/oxycodone patch, clearing the way for pivotal oxycodone clinical trials.


PBT2 Alzheimer’s and Huntington’s disease

Prana presented research on its planned trial of PBT2, which it hopes will treat both Alzheimer’s and Huntington’s disease, to the World Congress on Huntington’s Disease in Melbourne and received a positive reaction from international patient groups and researchers.

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Company Product Application Comments


Acrux (ACR) N/A N/A ASX advised that the company is no longer required to file Appendix 4C quarterly cash flow reports under Listing Rule 4.7B.

Agenix (AGX) AGX-1009 Hepatitis B Agenix has filed an international method of manufacture patent application under the Patent Cooperation Treaty for its hepatitis B drug AGX-1009.

Alchemia (ACL) Fondaparinux sodium injection

Not given The US FDA approved Dr Reddy’s Abbreviated New Drug Application for fondaparinux sodium injection and Dr Reddy’s will manufacture the drug under licence using a patented process developed by Alchemia.

Alchemia (ACL) HyACT platform Cancer The company was granted a Japanese patent covering its HyACT platform, which has been shown to increase the effectiveness of cancer drugs.


ATL1101 Cancer The company was granted a Japanese patent covering its second generation antisense drug ATL1101 and received a notice that a Canadian patent application will be granted in coming months.

Avita Medical (AVH)

ReCell Spray-On-Skin

Hypertrophic dyspigmented scars

The US FDA approved an investigational device exemption (IDE) feasibility study for the use of ReCell Spray-On-Skin in treating scars.

Benitec (BLT) DNA-directed RNA interference technology

Human therapeutic application

The US PTO issued a notice of allowance for Benitec’s DNA-directed RNA interference, thus providing it with greater protection.

Benitec (BLT) Gene silencing technology

Viral diseases The company’s patent estate has been strengthened further with another gene silencing Graham family patent allowed in the US.

Regulatory



PBT2 Alzheimer disease The Journal Of Neurochemistry published an update on the mechanism as to how PBT2 is able to restore cognition in Alzheimer’s disease sufferers through repair of affected brains.

Prima BioMed (PRR)

CVac clinical program

Ovarian cancer The company has won a €4.1m grant to fund parts of the CVac clinical program in Europe, which will decrease Prima’s cash requirements by approximately A$5.35m.

Sirtex Medical (SRX)

SIR-Spheres microspheres

Liver cancer A six-year retrospective analysis of 325 patients treated with radioactive SIR-Spheres microspheres therapy showed it is safe and effective in a range of patients with early to advanced stages of the disease.


Priostar dendrimer Improvement of agrochemicals

Results from studies of Priostar dendrimer technology found it helps to improve the effectiveness of agrochemicals including glyphosate.

Sunshine Heart (SHC)

C-Pulse system Heart failure Ohio State released early results of a C-Pulse feasibility trial showing a positive efficacy trend and strong safety profile.

UniLife Corporation (UNS)

Unifill EZMix multiple-chamber ready-to- fill syringes

To deliver lyophilised drugs and vaccines

The company developed and patented the first of its Unifill EZMix multiple-chamber ready-to-fill (prefilled) syringes for the reconstitution and administration of lyophilised drugs and vaccines.

UniLife Corporation (UNS)

Auto-injectors Self-administration of injectable drugs

The company has developed auto-injectors which are compact in size and enable patients to inject a fixed dose of medication with the simple push of a button, without ever seeing the needle.

Unilife Corporation (UNS)

Auto infuser portfolio

Self-administration of drugs

The company has developed a proprietary portfolio of wearable subcutaneous infusion devices for the self-administration of a large volume of drugs.

Virax (VHL) TG1042 Skin cancer The company completed and released the final manufacturing batch for the TG1042 skin cancer immunotherapy treatment product to be used in the phase I/II trial. This is an important milestone in Virax making a clinical trial exemption to initiate the TG1042 trials in basal cell carcinoma.



BioDiem (BDM) Live attenuated influenza vaccine


BioDiem has regained the rights to its live attenuated influenza vaccine (LAIV) candidate from Nobilon International and gained worldwide licensing rights (excluding Russia and CIS) for the LAIV vaccine vector project.

Bioniche Life Sciences (BNC)

N/A N/A ASX has granted the company an exemption from listing rule 4.7B on quarterly reporting and listing rule 14.2.1 on voting.

Calzada (CZD) NovoSorb Wound healing PolyNovo Biomaterials, a subsidiary of Calzada, has received approval from a human research ethics committee to conduct a first human trial to study the safety and efficacy of NovoSorb.

Cellestis (CST) N/A N/A The company has been removed from the ASX as Qiagen Australia Holdings is the sole shareholder of the company.


Mousticide Mosquito borne diseases

Holista and its partner EntoGenex Industries have registered with Malaysian authorities Mousticide, which starves mosquito larvae to death without harming humans. It is the first approval of the bio-pesticide.

Mayne Pharma Group (MYX)

Doryx Oral antibiotic The US FDA approved a dual-scored 150mg delayed-released tablet and the company expects to begin its US launch immediately.

Mayne Pharma Group (MYX)

Doryx Oral antibiotic The US District Court has granted a preliminary injunction against Mylan and its affiliate Mylan Pharmaceuticals which prevents them from launching a generic version of a Doryx 150mg product before a decision is given by the court.

Novogen (NRT) ME-143 (formerly NV-143)

Cancer The company announced that its subsidiary, Marshall Edwards, has US FDA approval for its investigational new drug (IND) application for ME-143 (formerly NV-143) and plans a phase I clinical trial of intravenous ME-143.

Pharmaxis (PXS) Bronchitol Cystic fibrosis The company resubmitted an application for its cystic fibrosis product Bronchitol to the Pharmaceutical Benefits Advisory Committee for reimbursement through the Australian Pharmaceutical Benefits Scheme.

QRxPharma (QRX)

MoxDuo IR Pain therapy The company submitted clinical data from MoxDuo IR’s successful phase 3 clinical program to the US FDA and thus completed its new drug application filing. This NDA filing is the basis for US regulatory approval.

Viralytics (VLA) Evatak Ovarian cancer A Chinese patent has been granted for use of Evatak in ovarian cancer.


Allied Healthcare Group (AHZ)

Adapt tissue engineering process

To develop implantable tissue

IP Australia granted Allied’s Celxcel business a patent for its proprietary Adapt tissue engineering process.

Anteo Diagnostics (ADO)

Mix&Go technology

Binding antibodies to various surfaces

The European Patent Office granted a “Generation of Surface Coating Diversity” patent that covers the IP that led to the discovery of the Mix&Go technology. The Australian Patent Office accepted Anteo’s application for the “Use of Metal Complexes” Australian patent.

CathRx (CXD) Catheter Atrial fibrillation The company has applied for CE marking of its variable loop catheter, which will be the first catheter in the company’s second generation device range.

OBJ (OBJ) Dermaportation Drug delivery technology

The US Patent Office issued a note of allowance for the company’s powered electromagnetic fields drug delivery technology and a full patent will be granted soon.

Optiscan (OIL) Microscopic imaging system

Neurosurgery, ENTand spinal surgery

The company, with partner Carl Zeiss, has been granted a key US patent over its microscopic imaging system to be used in conjunction with macroscopic surgical imaging systems.

SomnoMed (SOM)

SomnoDent line of products

Dental use Official registration and assignment of PDAC code 0486 for billing the SomnoDent line of products will allow Medicare-registered dentists to receive reimbursement for treating patients covered by Medicare.


OneTouch Verio Blood glucose measurement

The company announced that LifeScan has received 510(k) clearance from the US FDA to market its OneTouch Verio blood glucose system.

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Acrux (ACR) N/A N/A Company founder Professor Barrie Finnin has retired from the board after 12 years as a non-executive director.

Agenix (AGX) AGX-1009 Hepatitis Agenix showcased its promising new low-risk hepatitis B drug, AGX-1009, at Bio Korea 2011.

Alchemia (ACL) Fondaparinux sodium

Cancer The company’s marketing partner Dr Reddy’s Laboratories launched a generic fondaparinux sodium injection in the US.

Analytica (ALT) N/A N/A The company appointed Warren Stephen Brooks as a non-executive director and announced the retirement of David Gooch.

Avexa (AVX) Apricitabine HIV The company engaged PharmaVentures to advise and assist in seeking an out-licensing partner for apricitabine (ATC), its late-stage novel treatment for HIV infection.

Avita Medical (AVH) N/A N/A The company appointed Dr Michael Mendicino as R&D program manager, regenerative medicine. Dr Mendicino will be based in the California office.

Benitec (BLT) N/A N/A The company has changed its principle place of business and also its contact number to F6A/1 -15 Barr Street, Balmain NSW 2041, Australia but its registered office remains at Melbourne.

Benitec (BLT) N/A N/A CFO and company secretary John Rawling has resigned and Greg West will take over as CFO.

Bioniche Life Sciences (BNC)

N/A N/A The company announced its plan to achieve profitability by reducing expenses and increasing revenues and profits from new animal health products Cue-Mare and Tri-Otic Ointment in Australia, and Peridan Concentrate in North America.

BioProspect (BPO) N/A N/A The company appointed James Parry as its COO and Anthony Langdon resigned as non-executive director. Dr Michael Quinlan resigned as non-executive director and chairman. Winton Willesee was appointed a non-executive director and chairman.

BioProspect (BPO) Agripro Animal health product

The company entered into the Middle East market by signing an agreement for the testing and supply of active ingredients and market development of Agripro natural animal health products.

BioProspect (BPO) Progress in SC52 gas exploration and SC69 oil projects

N/A BioProspect’s associate, Frontier Gasfields, in which BioProspect holds a 25% stake, has completed the 3D seismic program over SC69, offshore Visayas, Philippines. Frontier Gasfields also made progress in re-entry and testing of Nassiping-2, a well containing a previously discovered but untested gas discovery at SC52 in Cagayan Valley in Philippines. Freddie Rillera was appointed Frontier’s exploration manager to strengthen its management team.

Biota Holdings (BTA) Inavir Influenza antiviral drug

The company has received written notification from Daiichi Sankyo that royalties from sales of Inavir for the three months ended 30 June 2011 were A$160k.

Biota Holdings (BTA) N/A N/A Dr John Domagala agreed to join Biota’s scientific advisory board. He has over 30 years of experience in pharmaceutical anti-infective research and has held senior management positions in the US.

Bone Medical (BNE) N/A N/A Roger New, PhD, co-founder, chief scientific officer and inventor of the company’s technologies, has been named chairman. Barry Walker MD resigned from the board.

Bone Medical (BNE) N/A N/A The company changed its registered and principal office to c/- Ledger Corporate, Level 3, 46 Ord Street, West Perth, WA, 6005 and contact details to + 61 8 9468 0154.

Cellmid (CDY) MK ELISA To determine midkine levels in blood (serum)

The company has become a GMP-compliant manufacturer of MK ELISA by completing its technology transfer and the test kits have been successfully produced in a GMP-compliant environment in AsureQuality’s fully accredited facility in Melbourne.

ChemGenex Pharmaceuticals (CXS)

N/A N/A Brett Heading and Greg Collier resigned as directors, James Campbell resigned as company secretary and Tony Johnson was appointed a director.

Circadian Technologies (CIR)

N/A N/A Dr Ian Leitch was appointed to the newly created position of director clinical research.

CSL (CSL) N/A N/A Chairman Elizabeth Alexander and director David Simpson retired from the board and Professor John Shine, currently a director of CSL, took over as chairman. Bruce Brook was appointed a director.

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Collagen nanoparticles

Application on human skin

Holista CollTech and India’s Hamdard University developed collagen nanoparticles which maintain their integrity, effects and safety and qualify as halal (approved for use by Muslims) consumption.


N/A N/A The company announced its chairman Paul Rengel passed away after an ongoing struggle with illness.

KarmelSonix (KSX) N/A N/A Michael Thomas was appointed CEO and Stephen Tunnell as senior vice-president for global operations.

KarmelSonix (KSX) N/A N/A The company has changed its name to iSonea Ltd and adopted the ASX ticker code ISN after it was approved at its general meeting on 10 August 2011.


N/A N/A Susanne Clay resigned as alternate director of the company and Professor Robert Elliott was appointed in her place. Director Roy Austin was appointed chairman and Dr Bernie Tuch as a director.


N/A N/A LCT and SpringTree Special Opportunities Fund terminated a share purchase and convertible security agreement by mutual consent and SpringTree retains a convertible security of $175k.

Medical Developments International (MVP)

N/A N/A The company concluded a long term incentive plan with CEO John Sharman.

Mesoblast (MSB) Revascor Heart failure The company’s heart failure placebo-controlled phase 2 trial of Mesoblast's allogeneic, Revascor, will feature at the American Heart Association conference in Florida.

NuSep (NSP) N/A N/A The Singapore Economic Development Board agreed to provide financial and economic support for NuSep’s Singapore plasma fractionation facility.


N/A N/A Lawrence Gozlan, a leading biotechnology investor and advisor, joined the board of directors.

Prima BioMed (PRR) N/A N/A The company changed its registered office and Phillip Hains resigned as joint company secretary. The company announced it has been included in the Standard & Poor's S&P/ASX 300 Index from 19 September 2011.


N/A N/A Thomas Burt retired as non-executive director of the company.

Starpharma (SPL) Dendrimer drug delivery technology

Dermal treatment Starpharma announced that GlaxoSmithKline has been awarded a grant to advance a dermal treatment. The funds will be used to support Starpharma’s synthesis of dendrimer-based drug candidates which will then be tested by Stiefel, a GSK company, with a view to further development.


N/A N/A The company appointed Zita Peach as a non-executive director and announced its inclusion in the S&P/ ASX 300 index effective 19 September 2011.

Viralytics (VLA) N/A N/A The company adopted a new public company constitution at an extraordinary general meeting on 2 August 2011. Jennie Yuen resigned as company secretary and Tom Rowe was appointed in her place.

Virax Holdings (VHL) N/A N/A Tim Cooper has resigned as director of the company and its subsidiaries.


Anteo Diagnostics (ADO)

N/A N/A The company appointed Mark Bouris as non-executive chairman.

Austofix Group (AYX) N/A N/A Dr Jurgen Michaelis resigned from the board.


N/A N/A Clover announced that both ASIC and ASX had allowed it to change its financial year from 1 July to 30 June to 1 August to 31 July. As a result, its 2010-11 accounts will encompass 13 months to 31 July 2011.

Cochlear (COH) Nucleus CI500 Hearing sound processor

Cochlear is undertaking a voluntary recall of the unimplanted Nucleus CI500 cochlear implant range and is notifying healthcare professionals and regulatory authorities of a recent increase in implant failures.

CogState (CGS) N/A N/A Toyota will work closely with Axon Sports to provide the same CogState concussion testing used by AFL clubs to over 25,000 grassroots footballers as part of the Toyota Good for Footy program.

CogState (CGS) N/A N/A The company appointed Rudy Chapa to its board of directors. Mr Chapa is a principal of US-based Quixote Investments LLC, the holder of 12.96m CogState Ltd ordinary shares (17.37% of issued capital).

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Compumedics (CMP) N/A N/A The company clarified to the market that it has not received any takeover offer after misinterpretation of an interview given by its executive chairman Dr David Burton.

Compumedics (CMP) DWL products Brain ultrasonography

The company’s German ultrasonography division, Compumedics Germany Gmbh, has secured orders of about €0.6m (A$900k) from Beijing Beike Digital Medical Technology for the purchase of DWL Elektronische Systeme GmbH products.

CordLife (CBB) N/A N/A The company announced that Jeremy Lee has resigned as director and CFO.

Cyclopharm (CYC) N/A N/A Alexander Beard resigned as non-executive director.

Ellex Medical Lasers (ELX)

N/A N/A Professor John Marshall resigned as a non-executive director.

Genera Biosystems (GBI)

N/A N/A Chairman Fernando Careri and non-executive director Bill Tapp resigned from the board. CEO Dr Allen Bollands has left the company and Lou Panaccio, previously a non-executive director, has been appointed as executive chairman and will assume Dr Bollands’ responsibilities.

ImpediMed (IPD) N/A N/A The company appointed Dr Cherrell Hirst as deputy chair. Dr Hirst is a non-executive director and has served on the board since 24 March 2005.

iSonea (ISN), formerly KarmelSonix

N/A N/A The company announced that Paul Eisen, senior vice-president and managing director for Asia-Pacific, has stepped down from the board but will continue as a senior member of the leadership team.

iSonea (ISN) formerly KarmelSonix

N/A N/A The company has signed an agreement with Global Opportunity Fund to provide up to $10.6m in funding over a two-year period for iSonea’s Acoustic Respiratory Monitoring (ARM) technology in the US and other key asthma markets.

LBT Innovations (LBT)

N/A N/A The company has relocated its registered office and principal place of business to 300 Flinders Street, Adelaide, SA 5000.

Medical Australia (MLA)

N/A N/A Gary Lewis resigned as director of the company and Mark Donnison, CEO, was appointed as director and managing director of the company.

MedTech Global (MDG)

N/A N/A Ross Murray Tanner was appointed non-executive director of the company.

Nanosonics (NAN) Trophon EPR Disinfect ultrasound transducers

GE Healthcare has started the launch of Trophon EPR in the US market and the initial market acceptance has been very good.

ResMed (RMD) N/A N/A The company appointed Robert Douglas as chief operating officer effective 1 September 2011.

SomnoMed (SOM) N/A N/A The company has made record sales of 7,323 units of SomnoDent in Q4, an increase of 32% over the same period last year.

SomnoMed (SOM) N/A N/A Paul Hopper resigned as a director of the company and Lee Ausburn and Robert Scherini will be joining the SomnoMed board.


N/A N/A Gregory Waller was appointed an independent non-executive director. He is the second US-based board member to be appointed this year following the appointment of Paul Buckman in January. Crispin Marsh, a director of the company since its inception in 2000, retired from the board. Mark Harvey was appointed a non-executive director.


N/A N/A The company announced that it has changed the date of its financial year end from 30 June to 31 December, effective from 1 July 2011.


N/A N/A The company has signed a $10m equipment financing agreement with Varilease Finance. This agreement will strengthen the company’s cash position.


N/A N/A The company announced that its CEO, Alan Shortall, would buy US$500k in shares of the company by 30 September 2011. The company announced that COO Dr Ramin Mojdeh would buy more than $250k in shares of the company’s common stock.

Uscom (UCM) N/A N/A Bruce Rathie resigned as a director of the company. Joe Trygar was appointed senior vice-president of global sales and chief executive.

28

Announcem

ents


Appendix

04

29

Closing MCap (A$m) Quarterly returnAnnual return

(Sept 10 - Sept 11)

Medical device

ACG Atcor Medical Holdings Limited 8.72 -57% -43%

ADO Anteo Diagnostics Limited 44.98 -16% 16%

AHZ Allied Healthcare Group Ltd 18.30 -60% 52%

AMT Advanced Surgical Design & Manufacture Limited 5.29 -35% -59%

ATW ATOS Wellness Ltd 2.13 0.07 0.25

AYX Austofix Group Limited 3.77 -51% -70%

BRC Brain Resource Company Limited (The) 19.72 -33% 2%

CGS Cogstate Ltd 11.94 -6% -38%

CLV Clover Corporation Limited 49.55 5% -10%

CMP Compumedics Limited 11.82 -11% -48%

COH Cochlear Limited 2,638.54 -34.5% -32%

CXD Cathrx Ltd 20.78 38% -47%

CYC Cyclopharm Limited 6.16 -25% -46%

ELX Ellex Medical Lasers Limited 9.34 -39% -67%

EMS Eastland Medical Systems Ltd 8.32 -42% -69%

FER Fermiscan Holdings Limited 7.89 1.00 -0.60

GBI Genera Biosystems Limited 9.11 -28% -70%

GID GI Dynamics Inc 226.82 - -

HIN Heartware International Inc 921.20 -7% -10%

IPD Impedimed Limited 70.42 -21% -44%

ISN Karmelsonix Limited 12.70 25% 25%

ITD ITL Limited 11.19 21% 70%

LBT Labtech Systems Limited 4.07 -9% -53%

MDG Medtech Global Limited 7.02 75% 40%

MDV Medivac Limited 3.81 -60% -71%

MGZ Medigard Limited 2.37 -7% -50%

MLA Medical Australia Limited 9.53 -22% 31%

NAN Nanosonics Limited 119.86 -32% -34%

NDL Neurodiscovery Limited 3.20 -18% 10%

OBJ OBJ Limited 19.25 -24% -38%

OIL Optiscan Imaging Limited 11.75 43% 105%

RMD RESMED Inc 4,575.35 2% -13%

RVA REVA Medical 197.63 -40% -

SFP Safety Medical Products Limited 3.96 -38% -95%

SHC Sunshine Heart Inc 56.58 -6% 61%

SOM Somnomed Limited 45.89 -10% 19%

TDX Tyrian Diagnostics Limited 1.02 -80% -92%

UBI Universal Biosensors Inc 147.03 -9% -36%

UCM USCOM Limited 7.56 -34% -55%

UNS Unilife Corporation 276.73 -7% -31%

30

Companies in the Pw

C Life Sciences Index

Companies in the PwC Life Sciences Index



(Sept 10 - Sept 11)

Pharma and Biotech

ACL Alchemia Limited 69.11 -41% -26%

ACR Acrux Limited 532.79 -6% 61%

ACU Acuvax Limited 2.46 0% -67%

ACW Actinogen Limited 1.09 -29% -77%

AGX Agenix Limited 11.96 14% -51%

ALT Analytica Limited 8.22 -33% -9%

ANP Antisense Therapeutics Limited 8.56 13% -25%

AOP Apollo Consolidated Limited 3.50 -17% -76%

AVH Avita Medical Ltd 22.63 -14% -5%

AVX Avexa Limited 35.60 0% 35%

BDM Biodiem Limited 8.93 10% -37%

BIT Biotron Limited 14.50 -7% 53%

BLT Benitec Limited 18.53 -29% -38%

BNC Bioniche Life Sciences 71.53 -22% -

BNE Bone Medical Limited 2.01 14% -71%

BNO Bionomics Limited 165.47 -14% 75%

BPO Bioprospect Limited 7.97 -38% -37%

BTA Biota Holdings Limited 146.27 -16% -16%

CBB Cordlife Limited 10.56 -30% -78%

CBZ CBIO Limited 42.29 -68% 15%

CDY Cellmid Limited 7.52 -17% -5%

CIR Circadian Technologies Limited 21.81 -19% -16%

CSL CSL Limited 15,581.91 -9% -8%

CTE Cryosite Limited 4.66 18% 0%

CUV Clinuvel Pharmaceuticals Limited 45.59 -9% -27%

CZD Calzada Limited 20.80 -8% 150%

GEN Genesis Research and Development Corporation Limited 1.37 -25% 30%

GTG Genetic Technologies Limited 74.34 -24% 515%

HCT Holista Colltech Limited 17.50 80% 35%

HTX Healthlinx Limited 4.20 -35% -76%

IDT Institute of Drug Technology Australia Limited 14.90 -1% -43%

IMC Immuron Limited 18.99 -10% -32%

IMU Imugene Limited 2.87 -33% -78%

LCT Living Cell Technologies Limited 18.55 -15% -69%

MSB Mesoblast Limited 2,268.64 -6% 215%

MVP Medical Developments International Limited 23.11 18% 84%

MYX Mayne Pharma Group Limited 56.16 -29% -34%

NEU Neuren Pharmaceuticals Limited 17.12 7% -3%

NLS Narhex Life Sciences Limited 6.45 -48% -

NRT Novogen Limited 14.81 -26% 16%

NSP Nusep Limited 9.92 16% -54%

Companies in the Pw

C Life Sciences Index31

32

Companies in the Pw

C Life Sciences Index


(Sept 10 - Sept 11)

Pharma and Biotech (continued)

PAB Patrys Limited 13.46 -40% -28%

PBP Probiotec Limited 18.26 -3% -64%

PBT Prana Biotechnology Limited 43.46 -21% 24%

PCC Probiomics Limited 1.77 -33% -40%

PGL Progen Pharmaceuticals Limited 3.34 -41% -61%

POH Phosphagenics Limited 123.54 20% 61%

PRR Prima Biomed Ltd 166.49 -43% 65%

PVA Psivida Corp 91.10 10% -10%

PXS Pharmaxis Ltd 166.11 -14% -67%

PYC Phylogica Limited 23.11 -21% 12%

QRX Qrxpharma Limited 170.13 -29% 18%

SIE Scigen Limited 37.55 -9% -61%

SLA Solagran Limited 24.05 -46% -53%

SPL Starpharma Holdings Limited 265.39 -29% 91%

SRX Sirtex Medical Limited 239.80 -11% -11%

TEO Telesso Technologies Limited 1.38 28% 130%

TIS Tissue Therapies Limited 77.62 -20% 98%

VHL Virax Holdings Limited 3.85 -10% -38%

VLA Viralytics Limited 29.06 -33% 48%

Notes:KSX Karmelsonix Limited changed its name to iSonea Limited (ISN)

GID Gi Dynamics Incorporated listed on the 7th September 2011

ATW Atos Wellness Limited has been reinstated to the index following a restructure and reinstatement to the ASX

FER Fermiscan Holdings Limited has been reinstated to the index following a restructure and reinstatement to the ASX

FLS Company has been removed from the index following a change of focus into the resources sector

HXL Company has been removed from the index following being delisted from the ASX

APH Company has been removed from the index following being delisted from the ASX

CXS Chemgenex Pharmaceuticals Limited has been removed from the index as it has been delisted following a takeover by Cephalon

CST Cellestis Limited has been removed from the index as it has been delisted following acquisition by Qiagen Australia Holding Pty Ltd

STI Stirling Products Limited has been removed from the index as it has been delisted following being placed into voluntary administration

AOP Apollo Consolidated Limited will be removed from the index next quarter following a movement into the resources sector


05Methodology

33

34

Methodology

SourcesBioForum draws on historical data from the following sources:• Bloomberg• Connect 4• The ASX• Company websites• PwC Global Pharma and Life Science

Quarterly Newsbriefs.

Market performanceThe Australian life sciences sector’s market performance is tracked through two indices:1. PwC Life Sciences Index2. PwC Life Sciences Index ex majors

(CSL, ResMed and Cochlear).

Analysis is provided without the large-capitalisation stocks (majors) so the performance of smaller-capitalisation stocks can be observed.

The PwC Life Sciences Index is based on the performance of life sciences companies listed on the Australian Securities Exchange (ASX). It comprises two subsectors:1. Pharmaceutical/biotechnology2. Medical devices.

These sectors have been classified according to the Global Industry Classification Standard. The index includes life sciences companies primarily involved in research, development, commercialisation and manufacturing of pharmaceutical and biotechnology products and medical devices. It excludes healthcare, medical software and distribution companies. Companies included in the PwC Life Sciences Index are listed at the end of each issue of BioForum.

The PwC Life Sciences Index is based on the combined market capitalisation of the listed companies and calculates the change of their value over the quarter and change over the previous year. These changes are compared to the changes in the market performance of the following indices:• ASX All Ordinaries• NASDAQ Composite• NASDAQ Biotech.

Different formulae are used to calculate the value of these indices and track their performance. These formulae use a combination of company market prices and a weighted average of market capitalisation. Because of these different methods of calculating value, the absolute value of the indices cannot be directly compared. Only their changes over time can be sensibly compared.

Top and bottom performersAnnual data on these companies is sourced from Bloomberg each quarter. Company announcements are sourced from company websites.

IPO and secondary finance marketsIPO and secondary financing data is sourced from the Connect 4 database’s health-care industry category. We include data from companies on the PwC Life Sciences Index only. Data on options, rights and bonus issues is excluded. The US IPO and secondary financing data is sourced from Thompson Reuters SDC.

AnnouncementsThese are from companies listed on the PwC Life Sciences Index only. They are sourced from Connect 4 using the health-care industry category. We include announcements on partnerships, mergers and acquisitions and divestments, clinical results, regulatory activity and other information. Examples of other information include management and board changes, the closing or opening of offices, and successful grant applications.

Announcements on the following are excluded:• trading halts• capital raisings• proposed (versus actual) mergers,

acquisitions and partnerships• progress reports on clinical trials

(results only are included)• market registration approval.

Methodology


06Acknowledgements

35

Written and edited by:PwC (pwc.com.au), a global professional services organisation serving the life sciences sector and other industries, with the help of editor and proofreader Karen Hunt.

External contributors:PwC Global Pharmaceutical Team

Quantitative research and analysis by the PwC BioForum team:Joe Adendorff, Senior Consultant

Stephen Hearne, Consultant

PwC Life Sciences Practice contributors:Craig Lawn, Partner, National Life Sciences Industry Leader

Manoj Santiago, Partner, Sydney Life Sciences Industry Leader

36

Acknow

ledgements

Acknowledgements

This document is provided by PwC as general guidance only and does not constitute the provision of accounting, legal advice, tax services, investment advice, or professional consulting of any kind. The information is provided “as is” with no assurance or guarantee of completeness, accuracy or timeliness of the information and without warranty of any kind, express or implied, including but not limited to warranties of performance, merchantability and fitness for a particular purpose. In no event will PwC or its professionals be liable in any way to you or to anyone else for any decision made or action taken in reliance on the information or for any direct, indirect, consequential, special or other damages related to you or your use of information, even if advised of the possibility of such damages. Before making any decision or taking any action, you should consult a professional adviser who has been provided with all the pertinent facts relevant to your particular situation.

© 2011 PricewaterhouseCoopers. All rights reserved. In this document, “PwC” refers to PricewaterhouseCoopers a partnership formed in Australia, which is a member firm of PricewaterhouseCoopers International Limited, each member firm of which is a separate legal entity.

PricewaterhouseCoopers201 Sussex StreetSydney NSW 2000+61 2 8266 0000

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pwc.com.au/bioforum

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