is 2012 the year for australian biotechs to shine? · 12/31/2011 · is 2012 the year for ....

BioForum Edition 38

Quarter 2 FY12 February 2012

Is 2012 the year for Australian biotechs to shine?

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

Q2FY12• The Life Sciences Index outperformed the ASX All

Ordinaries, rising 2.9 per cent compared to a one per cent increase in the All Ordinaries Index.

• The Biotech/Pharma Index rose 4.5 per cent and the Medical Devices Index lost 0.6 per cent.

• The NASDAQ Biotech sharply rose 11.9 per cent, while the NASDAQ Composite rose 7.9 per cent.

• There were no Australian IPOs during the quarter.• Australiansecondaryraisingsweresignificantly

higher at A$203 million, up from A$90 million in Q1FY12. Medical devices companies raised A$9 million while biotechs raised A$194 million.

PwC | BioForum: February 2012

Introduction

Craig Lawn PwC Private Clients

Manoj Santiago PwC Private Clients

pwc.com.au/privateclients

3

In the second quarter.....

The second quarter of FY12 saw improved performance from the majority of local and international market indices. The Life Sciences Index rose 2.9 per cent compared to a one per cent increase in the All Ordinaries Index.

The Nasdaq Biotech Index performed strongly towards the close of the quarter rising 11.9 per cent while the Nasdaq Composite Index rose by 7.9 per cent.

“Biotechs ended the year on a positive note, recovering most of the losses experienced in the September 2011 quarter despite the impact of the continuing European debt crisis,” said Manoj Santiago, PwC Life Sciences partner.

“A comparison of the performance of the US and Australian Life Science indexes over the past several years demonstrates a loose correlation, with the Australian index lagging US performance by six to nine months. While results for this quarter were dominated by the strong showing in the US, the trends point to more positive times ahead for the Australian market. However, the volatility in Europe and global economic uncertainty remain as dark clouds on the horizon.”

Sector performance in detail

In Q2FY12, the Life Sciences ex-majors fell by 1.4 per cent continuing its decline from the September quarter of 14.8 per cent.

Both Biotech/Pharma and Medical Devices Indices experienced improved results from Q1FY12. Biotech/Pharma rose 4.5 per cent (loss of 12.9 percent Q1FY12) while Medical Devices fell 0.6 per cent (loss of 12.6 per cent Q1FY12).

Medical devices (ex-majors) remained steady with a nil change for the quarter whilst pharma/biotech (ex-CSL) fell two per cent.

IPOs and secondary financing

There were no Australian IPOs during the quarter.

In the US, eight IPOs took place in Q2FY12, with two in the medical device sector ($103 million) and six in the Biotech sector ($293 million) totalling $396 million. This is a solid increase on the last quarter when two IPOs occurred raising $54 million.

In Australia, Q2FY12 saw the highest amount of secondary capital raised in the past two years due to the large number of biotech/pharma raisings.

Pharma/biotech increased secondary raisings by 140 per cent from $81 million (Q1FY12) to $194 million. The average amount raised increased from $3.5 million to $5.1 million.

The medical device sector maintained the same level of secondary raisings as in Q1FY12 at $9 million although the average amount raised fell from $1.3 million to $0.7 million.

In the US, 38 secondary raisings took place totalling $123 million (Q1FY12 31 raisings at $536 million).

“The current quarter has seen a sharp rise in the number of secondary raisings undertaken as biotechs are seeing this as an avenue to top up cash reserves heading into the new year.”

“While overseas markets are still experiencing volatility and fluctuations, companies in Australia have the resources to continue on a business as usual basis after riding out the tough times over the past few years.”

Introduction

PwC Australia Life Sciences and Innovation Practice contacts

4

Australian Industry Leaders – Life Sciences

Craig LawnP: +612 8266 0147 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

James McElvogueP: +612 8266 8384 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

32 Appendix

36 Methodology

38 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$31,420m 9

Life sciences industry growth 2.9%

Pharma/biotech sector total MCap A$21,874m 11

Pharma/biotech sector growth 4.5%

Medical device sector total MCap A$9,546m 11

Medical device sector growth -0.6%

Individual company performance

Top individual performer Genetic Technologies Ltd 16

Change in market cap over the past four quarters 233%

Bottom individual performer Safety Medical Products Ltd 17

Change in market cap over the past four quarters -96%

Financing

Australian IPO count 0 12

Total raised (A$0m) A$m

US IPO count 8 12

Total raised A$396m

Australian secondary financing count 50 14

Total raised (A$m) A$203m

US secondary financing count 38 14

Total raised A$1,234m

Announcements Q1 FY12 Page

Australia

Total partnerships formed this quarter 35 19

Total mergers and acquisitions 10 21

Clinical trials - pre-clinical, phase I, phase II, phase III 45 22

Regulatory 38 25

Other 76 28

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 (Jun-Sep) % Change (Sep-Dec)

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

1.0%

7.9%

11.9%

2.9%

-1.4%

-20.0%

-15.0%

-10.0%

-5.0%

0.0%

5.0%

10.0%

15.0%

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

-60%

-40%

-20%

0%

20%

40%

60%

31-Dec-09 31-Mar-10 30-Jun-10 30-Sep-10 31-Dec-10 31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-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

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

% Change (Sep-Dec)

ASX All Ordinaries (Index) 4,660 4,070 4,111 -12.7% 1.0%

NASDAQ Composite (Index) 2,774 2,415 2,605 -12.9% 7.9%

NASDAQ Biotech (Index) 1,108 970 1,085 -12.5% 11.9%

Life Sciences (market cap A$m) 35,003 30,526 31,420 -12.8% 2.9%

Life Sciences ex majors (market cap A$m) 9,074 7,730 7,622 -14.8% -1.4%

-4%

-2%

0%

2%

4%

6%

8%

10%

12%

14%

16%

30-Sep 07-Oct 14-Oct 21-Oct 28-Oct 04-Nov 11-Nov 18-Nov 25-Nov 02-Dec 09-Dec 16-Dec 23-Dec 30-Dec 31-Dec

ASX All Ordinaries Life Sciences Life Sciences ex majorsNASDAQ BiotechNASDAQ Composite

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 (Dec10-Dec11)% Change (Sep10-Sep11)

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

-12.2%

2.0%

8.3%

-8.6%

26.4%

-15.2%

-1.8%

11.8%

-16.6%

-4.8%

-20.0%

-15.0%

-10.0%

-5.0%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

10

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

-6%

-4%

-2%

0%

2%

4%

6%

8%

10%

12%

30-Sep-11 07-Oct-11 14-Oct-11 21-Oct-11 28-Oct-11 04-Nov-11 11-Nov-11 18-Nov-11 25-Nov-11 02-Dec-11 09-Dec-11 16-Dec-11 23-Dec-11 30-Dec-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 (Sep 2010-Sep 2011) % Change (Dec 2010-Dec 2011)

30-Sep-10 30-Sep-11 % Change 31-Dec-10 31-Dec-11 % Change

ASX All Ordinaries (Index) 4,637 4,070 -12.2% 4,847 4,111 -15.2%

NASDAQ Composite (Index) 2,369 2,415 2.0% 2,653 2,605 -1.8%

NASDAQ Biotech (Index) 895 970 8.3% 970 1,085 11.8%

Life Sciences (market cap A$m) 33,381 30,526 -8.6% 37,655 31,420 -16.6%

Life Sciences ex majors (market cap A$m) 6,114 7,730 26.4% 8,005 7,622 -4.8%

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 21,874 70% 20 34% 34 58% 5 8% 59

Pharma/Biotech ex CSL 5,238 69% 19 33% 34 59% 5 9% 58

Med Device 9,546 30% 21 53% 16 40% 3 8% 40

Med Device ex COH, RMD

2,385 31% 20 53% 15 39% 3 8% 38

Life Sciences 31,420 100% 41 41% 50 51% 8 8% 99

Life Sciences ex majors 7,622 100% 39 41% 49 51% 8 8% 96

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%

31-Dec-09 31-Mar-10 30-Jun-10 30-Sep-10 31-Dec-10 31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-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 (Jun-Sep) % Change (Sep-Dec)

-12.9%

-18.6%

-12.6%

-4.8%

-12.8%-14.8%

4.5%

-2.0%-0.6% 0.0%

2.9%

-1.4%

-20.0%

-15.0%

-10.0%

-5.0%

0.0%

5.0%

10.0%

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

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

% Change (Sep-Dec)

Pharma/Biotech 24,023 20,927 21,874 -12.9% 4.5%

Pharma/Biotech ex CSL 6,569 5,345 5,238 -18.6% -2.0%

Med Device 10,980 9,599 9,546 -12.6% -0.6%

Med Device ex COH, RMD 2,505 2,385 2,385 -4.8% 0.0%

Life Sciences 35,003 30,526 31,420 -12.8% 2.9%

Life Sciences ex majors 9,074 7,730 7,622 -14.8% -1.4%

12

0

100

200

300

400

500

600

Capi

tal R

aise

d (A

$m)*

Medical Devices Biotech

Q2FY11 Q3FY11 Q4FY11 Q1FY12 Q2FY12

360

145

312

Capi

tal R

aise

d (A

$m)*


156

76

159

54

293

353

100

103

0

100

200

300

400

500

600


Figure 5: Quarterly comparison of IPOs in Australia

Figure 6: Quarterly comparison of IPOs in the US

Table 6: Listing of quarterly Australian IPO listings

There have been no Australian IPOs during the quarter.

Table 5: Number of quarterly IPO Australian listings

Biotech Med Devices ASX

Q2FY12 0 0 20

Q1FY12 0 1 29

Q4FY11 0 0 29

Q3FY11 1 1 50

Q2FY11 0 0 19

Table 7: Total of quarterly US IPO listings

Biotech Med Devices

Q2FY12 6 2

Q1FY12 1 1

Q4FY11 2 0

Q3FY11 1 3

Q2FY11 3 4

Table 8: Listing of quarterly US IPO listing

Company Listing date

Capital raised

(A$m) Sector

Synergy Pharmaceuticals Inc

04/10/2011 3 Biotech

ZELTIQ Aesthetics Inc 18/10/2011 97 Biotech

NewLink Genetics Corp 10/11/2011 43 Biotech

Clovis Oncology Inc 15/11/2011 129 Biotech

Novelos Therapeutics Inc 01/12/2011 6 Biotech

Synergy Pharmaceuticals Inc

01/12/2011 15 Biotech

ZELTIQ Aesthetics Inc 18/10/2011 97 Med Devices

Lucid Inc (Datacolor Intl) 27/12/2011 6 Med Devices

Total 396

Market perfrom

ance

Quarterly financing

IPO financing

Note: * Amount shown is total market cap addition to the LS Index from IPOs on first day of trading

Note: * Amount shown is total market cap addition to the LS Index from IPOs on first day of trading


Market perfrom

ance13

0

100

200

300

400

500

600

Capi

tal R

aise

d (A

$m)


118

105

24 7

145

360

312

FY08 FY09 FY10 FY11 YTDFY12

347

103

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


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 49

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 7 3

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)


91

154

12381

194

56

22

3

9

9

0

50

100

150

200

250


Capi

tal R

aise

d (A

$m)


105 31

1,490

409

1,162

2,128

1,518

2,088

127

72

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000


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)

Q2FY12 38 5.1 12 0.7

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

Table 12: Number of secondary deals (US)

Biotech Med Devices

Q2FY12 30 8

Q1FY12 25 6

Q4FY11 43 18

Q3FY11 8 43

Q2FY11 17 51

Market perfrom

ance


Yearly financing

Market perfrom

ance15

275

18

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

1,571

199

Capi

tal R

aise

d (A

$m)


31 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

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 62 18

FY11 154 43

FY10 107 39

FY09 87 41

FY08 99 66

Table 14: Number of US secondary raisings

Biotech Med Devices

FY12 55 14

FY11 70 121

FY10 122 57

FY09 48 24

FY08 80 29

Market perfrom

ance

16

Performers over past four quarters

Top 10

01 Genetic Technologies Limited

Return: 233% Closing price: $0.11 MCap: A$51.11m

Genetic Technologies announced a maiden profit for the financial year ended 30 June 2011 of $901k, with positive cash flows of $2.2m, in addition to an $11.7m capital raising. Its Australian laboratory was certified under the US Clinical Laboratories Improvements Amendments, which implies that GTG’s BREVAgen breast cancer risk test will be launched in the US soon. Immunaid, GTG’s European subsidiary, was granted a patent in November for its cancer treatment products.

02 Antisense Therapeutics Limited


The Japanese Patent Office granted Antisense Therapeutics a patent covering the growth hormone receptor targeting drug ATL1103 and its use until February 2024. The company also exercised options to issue a large amount of new shares.

03 Calzada LimitedReturn: 115% Closing price: $0.06 MCap: A$19.41m

Calzada completed an animal study comparing its NovoSkin Bioresorbable Temporising Matrix with a dermal replacement product and was awarded a US patent for chain extenders.

04 Bionomics LimitedReturn: 87% Closing price: $0.59 MCap: A$203.42m

Bionomics completed two phase Ib trials for BNC210, its depression and anxiety treatment. The company also appointed a new CFO.

05Neuren Pharmaceuticals Limited


Neuren enrolled its first patient cohort of 30 in a phase II trial for Intrepid-2556, its stroke and head injury treatment. The company’s share price surged in a largely unexplained gain in October, which it has claimed may be due to recent media coverage.

06 Phosphagenics LimitedReturn: 75% Closing price: $0.21 MCap: A$213.69m

Phosphagenics began the second stage of an agreement with a global dermatology company to develop a prescription treatment for acne. It announced the launch of a new anti-cellulite technology and completed the optimisation of its oxycodone patch, in preparation for commencement of clinical trials.

07 Optiscan Imaging Limited


Optiscan Imaging was granted a key US patent over its microscopic imaging system, to be used with macroscopic surgical imaging systems, in addition to completing a strategic review.

08 Mesoblast Limited

Return: 48% Closing price: $6.89 MCap: A$1,932.13m

FDA cleared Mesoblast for advanced trials of its back pain treatment, and approved a bone marrow transplant phase III trial. The company entered a strategic alliance with Lonza Group for clinical and long-term production of adult stem cell products.

09 Medical Developments International Limited


Medical Developments International announced a 2011 NPAT of $1.74m, compared to a 2010 profit of $879k, and declared a fully franked 3c dividend.

10 ITL LimitedReturn: 39% Closing price: $0.11 MCap: A$14.48m

ITL posted a NPBT of $1.2m, a turnaround of $15.2m from the prior year’s loss as part of a restructure. Net debt was reduced from $6.9m to $2.6m.

0% 50% 100% 150% 200% 250%

GTGANP

CZDBNONEU

POHOIL

MSBMVP

ITD


01 Medigard LimitedReturn: -71% Closing price: $0.02 MCap: A$1.46m

Medigard’s CEO and company secretary Peter Emery resigned and at the time of writing there was no replacement. The company raised a little over half of its required $2m capital investment.

02 Tyrian Diagnostics Limited

Return: -71% Closing price: $0.00 MCap: A$2.04m

Tyrian announced that revenue from continuing activities had slipped 35%, leading to a $4.37m loss for 2011. Tyrian’s partner Bayer CropScience said it would cease further development and commercialisation opportunities with Tyrian.

03 pSivida Corp.Return: -74% Closing price: $1.25 MCap: A$26.00m

The FDA demanded two more clinical trials for pSivida’s Iluvien treatment. pSivida posted a net loss of $2.4m for FY2011.

04 Uscom LimitedReturn: -77% Closing price: $0.07 MCap: A$3.49m

Uscom increased its loss by 45% on the prior year. The company continues to suffer from the collapse of its relationship with Spacelabs in December 2010.

05 Cordlife LimitedReturn: -78% Closing price: $0.07 MCap: A$10.26m

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.

06 Imugene LimitedReturn: -78% Closing price: $0.01 MCap: A$1.72m

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

07 Healthlinx LimitedReturn: -85% Closing price: $0.01 MCap: A$3.05m

Healthlinx posted a net loss for the year of $2.3m. The company issued several packets of shares during the period in attempted secondary capital raisings. CEO Nick Gatsios resigned in November.

08 Bone Medical LimitedReturn: -89% Closing price: $0.01 MCap: A$.66m

Bone Medical posted a $1.5m loss for 2011, including a 75% drop in revenue from continuing operations. The company released several packets of shares through a convertible note facility.

09 Medivac LimitedReturn: -91% Closing price: $0.02 MCap: A$2.10m

The company posted an operating loss of $1.97m in FY11 and completed a 1:20 share consolidation. The company issued various share packets in an attempt to raise finances.

10 Safety Medical Products Limited

Return: -96% Closing price: $0.01 MCap: A$2.78m

During the period ended 30 June 2011 Safety Medical Products announced that the group 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 negotiated and 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

-120% -100% -80% -60% -40% -20% 0%

MGZ

TDX

PVA

UCM

CBB

IMU

HTX

BNE

MDV

SFP

Announcements

18

03


Announcem

ents19

PartnershipsCompany Pharma/biotech

partnerApplication Value (A$m) Comments

Biotechnology Total 26

Agenix (AGX) Institute of Pharmacology and Toxicology and Institute of Medicinal Biotechnology

To advance lead drug candidate and new product pipeline

Not disclosed Agenix signed agreements with strategic partners in China to commercialise new drug candidates, share resources and expertise and complete pre-clinical toxicology tests for its new hepatitis B drug.

Antisense Therapeutics (ANP)

Afandin Antisense inhibitor of IGF-IR

N/A ANP has agreed to extend Afandin’s licence for ATL1101 for six months to enable Afandin to progress ATL1101’s development into Phase I/II clinical trials.

AtCor Medical (ACG)

Global pharmaceutical company

New contract and expansion to supply contract

US$1.86m AtCor signed new contracts to supply SphygmoCor systems and clinical trial support services to major international pharmaceutical companies.

AtCor Medical (ACG)

Global pharmaceutical company

Expansion to supply contract

US$0.9m AtCor expanded a contract to supply SphygmoCor systems and clinical trial support services to a major international pharmaceutical company.

Avita (AVH) DS Medigroup Srl (DSMG)

JV to market ReCell N/A The company signed a joint venture partnership with DS Medigroup in Italy to pursue sales and marketing of Avita Medical’s regenerative product ReCell Spray-On Skin throughout Italy.

Benitec (BLT) Royal Holloway University London

To develop a new drug

Not disclosed Benitec and Royal Holloway University London agreed to develop a novel therapy to treat a fatal genetic muscle disease, oculopharyngeal muscular dystrophy.

Bioniche Life Sciences (BNC)

MedTrade and Mueller Medical

Two distribution agreements

Not disclosed Bioniche entered into distribution agreements to expand its product offerings for equine and companion animal health products in North America.

CBio (CBZ) Novo Nordisk Termination of agreement

N/A Novo Nordisk A/S declined its option to license XToll for development and commercialisation, giving CBio the rights to develop XToll independently or with third parties.

Genetic Technologies (GTG)

Hologic Settlement of infringement suit

Not disclosed Genetic settled a claim with Hologic, a counterparty to GTG’s patent infringement suit filed in the District Court of Colorado.


AutoImmun Diagnostika

Licence agreement Not disclosed Genetic granted AutoImmun Diagnostika GmbH non-exclusive access to the technology for AIDS products.

Healthlinx (HTX) Oryzon Genomics Heads of agreement Not disclosed The company signed a legally binding agreement with Oryzon Genomics for the distribution of OvPlex in Spain, with the option to extend exclusive licence rights to Portugal, Andorra, France and Italy.

Holista Colltech (HCT)

Quick Service Restaurant Holdings

Exclusivity agreement

Not disclosed The company signed a two-year exclusivity agreement with leading fast-food operator Quick Service Restaurant Holdings.

Immuron (IMC) Paladin Labs Exclusivity agreement

C$500,000 with potential milestone payments up to C$115,000,000

Immuron signed a deal with Paladin for exclusive rights to market and sell Travelan in territories including Canada, Latin America and sub-Saharan Africa.

Paladin has also agreed to provide $1,500,000 in secured convertible debentures to Immuron.

Immuron (IMC) Dana-Faber Cancer Institute and Children’s Hospital Boston

Partnership agreement

N/A The companies agreed to research Immuron’s antibody-rich colostrum product and test its efficacy in treating side effects of cancer.

Immuron (IMC) Harvard University Partnership agreement

N/A Immuron will work with the paediatric department of Harvard Medical School to develop preparations of Immuron’s antibody-rich colostrums product.

Living Cell Technologies (LCT)

Centocor Research & Development

Termination of agreement

N/A Living Cell Technology terminated its research collaboration and option to licence encapsulation technology agreement with Centocor Research & Development has terminated.


Otsuka Pharmaceutical Factory

Commercialisation of Diabecell

A$25 m Living Cell Technologies and Otsuka Pharmaceutical Factory has formed a joint venture company to complete the clinical trials in New Zealand, Russia and Argentina, and bring Diabecell to market.

20

Announcem

ents Company Pharma/biotech partner

Application Value (A$m) Comments

Novogen (NRT) Ausio Pharmaceuticals

Product development and marketing rights

Not disclosed Novogen subsidiary Marshall Edwards and Ausio Pharmaceuticals signed a licence agreement which gives Ausio exclusive, worldwide rights to develop, manufacture and sell products utilising the isoflavone metabolite known as equol for non-oncology applications.

Phosphagenics (POH)

Themis Medicare Licensing agreement Undisclosed The company licensed TPM/diclofenac, its topical non-steroidal pain formulation, to Themis Medicare of Mumbai for the Indian market. This represents Phosphagenics’ first commercial deal in India and its first licensing agreement for the product.

Prima BioMed (PRR)

The City Hospital Commercialisation of CVac

Not disclosed Prima BioMed launched a partnership with The City Hospital in Dubai Healthcare City to commercialise CVac in the Middle East.

Probiomics (PCC) Nestec Termination of licensing agreement

N/A Probiomics and Nestec agreed to terminate a development and licence agreement to allow both parties to focus on other research opportunities.

ProBiotec (PBP) United Dairy Power (UDP)

Partnership agreement

N/A The company entered into an agreement with United Dairy to relocate its protein fractionation plant and recommence production of products through its Australian Dairy Protein subsidiary.

pSivida (PVA) Anonymous Global Pharmaceutical Company

Funding agreement Undisclosed The company signed a funded technology evaluation agreement with a leading global pharmaceutical company to evaluate pSivida’s bioerodible Durasert drug delivery technology in ophthalmology.

QRxPharma (QRX)

Actavis Partnership agreement

N/A The company signed a binding letter of intent to form a strategic partnership to commercialise MoxDuo IR in the US acute pain marketplace.

Starpharma (SPL) Eli Lilly Expanded development program

Undisclosed The parties agreed to an expanded development program, including in vivo studies and clinical testing, as well as potential commercial terms.

Tissue Therapies (TIS)

Quintiles and Movianto

Commercial partnerships

Undisclosed The company signed sales and marketing and logistics agreements with Quintiles and Movianto.

Medical Devices Total 8

AtCor Medical (ACG)

Major international companies

Product supply agreements

US$1.86m AtCor signed two new contracts to supply SphygmoCor systems and clinical trial support services to major international companies.

BrainResource (BRC)

Malta Trading Platform

Attention deficit hyperactivity disorder

Not disclosed A new joint venture will develop an attention deficit hyperactivity disorder portal called Focus for the key issues relating to ADHD. This website will leverage Brain Resource

Medical Australia (MLA)

Various Supply agreements $1.5m The company secured new product supply contracts that will add a further $1.5m in annualised revenue in FY2012 and beyond.

OBJ (OBJ) Global FMCG company

Access rights for beauty care products

Not disclosed OBJ is in talks with a global company to develop and commercialise new products in the consumer health and beauty fields using OBJ’s three core technologies.

Tyrian Diagnostics (TDX)

NeoClone Exclusive distribution agreement

N/A The company signed an exclusive distribution agreement with NeoClone for the manufacture and distribution of antibodies to detect TB proteins, including antibodies to Tyrian’s lead TB protein biomarker.


SpeeDx Exclusive licence agreement

N/A Tyrian entered an exclusive licence agreement with SpeeDx to develop and commercialise tests to diagnose active tuberculosis (TB) using Tyrian’s patented molecular biomarker.

Unilife (UNS) Anonymous Global Pharmaceutical Company

Targeted organ delivery

US$1.4m Unilife signed a clinical development and supply agreement with a global pharmaceutical company for a novel device for targeted organ delivery to be used in a drug clinical trial that is scheduled to commence in early 2012.

Universal Biosensors (UBI)

Cilag GmbH International

Diabetes US$4.5 m Universal Biosensors has begun a new research and development project for LifeScan affiliate Cilag GmbH International to test a new blood glucose product.


Announcem

ents21

Mergers, acquisitions and divestmentDominant company

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


Acuvax (ACU) BioHealth Acquisition N/A The company acquired a potential controlling ownership stake in an unlisted company, BioHealth, subject to due diligence and regulatory approval. BioHealth focuses on medicines made with natural non-toxic ingredients.

Avita Medical (AVX)

McComb Foundation

IP acquisition N/A Avita Medical acquired intellectual

property licensed through the McComb Foundation of WA for two patent families.

BioDiem (BDM) Savine Therapeutics

Acquisition N/A BioDiem acquired Savine Therapeutics and its key asset, the patented Scrambled Antigen Vaccine (SAVINE) technology, used to design antigens to be incorporated into vaccines for different diseases.

CBio (CBZ) BLB nominees Repayment of convertible notes

$2m The company repaid in cash convertible notes to the value of $2m. This redeems in full the notes issued to BLB Nominees which were due to expire on 31 December 2011.

Probiomics (PCC) Hunter Immunology

Takeover N/A Probiomics issued a bidder’s statement for Hunter Immunology which was accepted. The bid offered nine Probiomics shares for each target share.

Probiotec (PBP) Rivadis Australia Divestment $6.75m Probiotec has completed the sale of the Milton brand, including all intellectual property and business assets associated with this brand to Rivadis Australia, with proceeds to be used to reduce debt levels.

Probiotec (PBP) N/A Divestment $1m A sale of the company’s production site in Bundaberg is expected to be settled in January 2012 to repay debt facilities.

SciGen (SIE) FDS Pharm Divestment $2m and 5% royalties on future sales

SciGen’s board approved the sale of SciGen’s 100% interest in SciGen (IL) Ltd.


Atos Wellness (ATW)

Fitgenes Acquisition Issue of 344,300,940 fully paid shares in ATW to Fitgenes

Atos agreed to acquire 100% ownership in Fitgenes, an Australian company integrating cutting-edge genetic profiling with currently existing health Systems and methodologies.

ResMed (RMD) N/A Expansion N/A The company doubled the lease at its San Diego facility to 37,000 square feet to support manufacturing activities.

22

Announcem

ents

Clinical trialsCompany Drug Application Comments

Pre-clinical Total 5

Allied Healthcare Group (AHZ)

Herpes Simplex Virus 2

HSV-2 infection Coridon completed pre-clinical efficacy testing of its prototype Herpes Simplex Virus 2 (HSV-2) vaccine and is now looking to progress the program into clinical studies. Allied Healthcare has increased its holding in Coridon to 37.27%.


Adapt Tissue Engineering technology

Heart valve implants

The pre-clinical trial of Adapt Tissue Engineering technology in heart valves demonstrated a reduction in visible calcification of implanted tissue heart valves and potential to offer patients and surgeons ‘longer life’ tissue valves.

Benitec (BLT) Gene silencing technology

Severe and chronic pain

Benitec announced that independent researchers has found that in addition to reducing pain, Benitec’s gene silencing technology significantly reduces morphine tolerance in a pre-clinical pain model.

Mesoblast (MSB)

Mesenchymal precursor cell (MPC) technology

Type 2 diabetes The company announced that a single intravenous injection of its proprietary adult stem cells resulted in significant lowering of blood sugar levels for up to eight weeks in a controlled, randomised pre-clinical trial in non-human primates with Type 2 diabetes.

Viralytics (VLA) Cavatak Cancer treatment The company announced pre-clinical results showing that both pancreatic and lung cancer cells display high levels of ICAM-1 receptors and that its lead investigational drug Cavatak invades and destroys these cancer cells through targeting ICAM-1.

Phase I Total 1


ATL1103 Growth hormone receptor targeting

The ATL1103 phase I trial successfully met its primary endpoint, deemed safe and well tolerated. The next step is a phase II trial in patients with the growth disorder, Acromegal.

Phase II Total 10

Biotron (BIT) BIT225 Hepatitis C A landmark trial of Biotron’s lead drug candidate, BIT225, in Hepatitis C virus infected patients shows good results on tolerability and efficacy and thus validates the novel drug.

CBio (CBZ) XToll Rheumatoid arthritis

The final report for a phase IIa clinical trial in rheumatoid arthritis patients shows XToll is a potential new therapy for autoimmune and inflammatory diseases.

Clinuvel (CUV) Scenesse UV induced skin damage

There are positive early clinical observations from the company’s open label phase II pilot trial (CUV102) of the novel drug Scenesse (afamelanotide) in patients with non-segmental vitiligo.

Clinuvel (CUV) Scenesse UV induced skin damage

The company reported encouraging interim safety results of Scenesse in a phase II study in organ transplant recipients.

CogState (CGS) Cognitive testing technology

Schizophrenia and Alzheimer’s disease

The company signed a contract with an international pharmaceutical company to participate in a phase 2 clinical trial for the treatment of schizophrenia negative symptoms.

Mesoblast (MSB)

Allogeneic cells with anti-VEGF agent

Wet age-related maculardegeneration

Mesoblast received regulatory clearance from the Singapore Health Sciences Authority to begin a phase 2 trial for a wet age-related macular degeneration trial..

Mesoblast (MSB)

Revascor Heart failure The company announced positive phase 2 heart failure trial results of its allogeneic, or off-the-shelf, adult stem cell product Revascor after all patients completed a minimum follow-up of 12 months, and a mean follow-up of 22 months.

Mesoblast (MSB)

Mesenchymal precursor cell (MPC) technology

Type 2 diabetes Mesoblast has an agreement with the FDA to begin Phase 2 trial for using intravenous delivery of its proprietary allogeneic, or off-the-shelf, mesenchymal precursor cell (MPC) technology in patients with Type 2 Diabetes.

Prana Biotechnology (PBT)

PBT2 Alzheimer’s disease

The company has received permission from the Austin Health Research Ethics Committee to recruit and screen patients for a 12 month phase II imaging trial testing its Alzheimer’s drug PBT2.

Viralytics (VLA) Cavatak Melanoma Viralytics obtained approval from a series of review boards to commence its US phase II Cavatak melanoma trial and patient recruitment has also started.

Phase III Total 5

Clinuvel (CUV) Scenesse Erythropoietic protoporphyri

Clinuvel announced positive results from a European phase III study. Patients receiving Scenesse were able to expose skin to direct sunlight without burns and pain and recorded an improved quality of life.


Company Drug Application Comments

Cyclopharm (CYC)

Technegas Imaging The US Food and Drug Administration approved Cyclopharm to begin phase 3 clinical trials with Technegas based on the successful review of Cyclopharm’s investigational new drug application.

Pharmaxis (PXS)

Inhaled Bronchitol Bronchiectasis The company announced that its phase III, DPM-B-305 study of inhaled Bronchitol, for the treatment of people with bronchiectasis, has reached its recruitment target.

Starpharma (SPL)

VivaGel Bacterial vaginosis A phase 3 clinical trial had been agreed with the European Medicines Agency.

Starpharma Holdings (SPL)

VivaGel Bacterial vaginosis A phase III clinical trial program for the VivaGel bacterial vaginosis treatment has been agreed with US FDA following recent positive trial results and subsequent end of phase II meeting.

Other Total 24

BioProspect (BPO)

GI-guard Oral paste for horses

BioProspect has postponed a trial with GI-guard oral paste for horses in the UAE due to concerns over product quality.

Calzada (CZD) Cultured composite skin treatment

Skin burns The company said first animal results testing NovoSkin’s cultured composite skin (CCS) have been extremely encouraging.

Calzada (CZD) NovoSorb Treatment of full thickness burns and wounds

PolyNovo has now received interim reports advising of the satisfactory completion of all required ISO10993 safety studies. The Calzada board has given qualified approval to commence two pilot human clinical trials on NovoSorb.

CBio (CBZ) XToll Cutaneous lupus CBio announced that treatment of mice with XToll entirely prevented cutaneous lupus and significantly suppressed nephritis in the kidneys, prolonging life span. The above results were published in the Oxford Journal.

Cellmid (CDY) Anti-midkine antibody, hu91

Inflammatory and autoimmune disorders

The company has completed humanisation of its “first in class” anti-midkine antibody, hu91, in collaboration with Antitope. Functionality and binding characteristics were fully retained during humanisation and this has resulted in a drug that can enter clinical development.

Cellmid (CDY) Anti-midkine antibody, hu91

Inflammatory and autoimmune disorders

The company completed its diagnostic study in Japan, measuring the blood midkine levels of 233 healthy volunteers. The results confirmed findings from previous research.

Circadian Technologies (CIR)

Novel diagnostic technology

Cancers of unknown primary

Circadian’s development partner Healthscope has completed development and validation of a commercial test candidate and is commencing a beta test trial among Australian oncologists before making the test commercially available.


Schizophrenia and Alzheimer’s disease

CogState has signed two sales contracts for clinical trials, both with international pharmaceutical companies, that will generate US$1.66m of revenue for CogState.


Major depressive disorder

CogState signed a contract with an international pharmaceutical company to participate in another phase 2 clinical trial for the treatment of depression. The contract will generate $2.6m in revenue.


Major depressive disorder

The company signed a contract with an international pharmaceutical company to participate in another phase 2b clinical trial to treat major depressive disorder. The contract will generate $900k in revenue.

Genera Biosystems (GBI)

PapType HPV The company achieved positive results in an independent study in a London-based medical research institute.

GI Dynamics (GID)

EndoBarrier gastrointestinal liner

Diabetes and obesity

Data results from two studies showed sustained benefits of the EndoBarrier gastrointestinal liner on glycemic control and weight loss following removal of the device.

HealthLinx (HTX)

OvPlex Ovarian cancer HealthLinx has completed part 2 of its biomarker trial for the OvPlex ovarian cancer diagnostic with results confirming greater diagnostic efficiency than CA125 alone. These results include the samples analysed in part 1 as well as new data analysed in part 2 of the trial.

HealthLinx (HTX)

OvPlex Ovarian cancer The company expects to finalise patient recruitment for its second multi-centre, multi-national OvPlex biomarker trial by the end of the first quarter 2012 due to strong interim results from parts one and two of the trial already analysed.

Announcem

ents23

24

Announcem

ents Company Drug Application Comments

HeartWare International (HIN)

HeartWare Ventricular Assist System

Heart failure The company presented positive data from its bridge to heart transplantation study and the continued access protocol. The updated data shows improved survival rate in patients suffering from heart disease.

Impedimed (IPD)

Early intervention paradigm

Lymphoedema The company presented a preliminary report summarising five year follow up data from a study published in Cancer supporting the belief that early intervention is important for improving clinical outcomes in lymphoedema.

Imugene (IMU) PRRS vaccine and coccidiosis vaccine

Lung lesions in pigs and coccidiosis in poultry

A preliminary review is that trial results did not satisfy requirements for commercial progression of either vaccine.

Neuren (NEU) Intrepid 2566 Traumatic brain injury

The company enrolled a second cohort in the Intrepid 2566 traumatic brain injury (TBI) trial and a third cohort has been opened for enrolment. There were no serious adverse events (SAEs) in cohort patients reported as being drug-related.

Patrys (PAB) PAT-SM6 Melanoma treatment

The company announced a clinical trial program in multiple myeloma (MM) patients of its lead clinical candidate PAT-SM6, which is in the final stages of a phase I melanoma study in Australia. Pre-clinical studies have shown that PAT-SM6 is able to specifically target bone marrow cells sourced from MM patients.

Phosphagenics (POH)

TPM/oxycodone patch

Chronic pain The company was granted approval to approval to begin clinical trials on its to test its leading pharmaceutical product, a TPM/oxycodone patch to manage chronic pain, at the end of November 2011.

pSivida (PVA) Iluvien Ocular diseases The FDA told Alimera that it was unable to approve the Iluvien NDA because it did not provide sufficient data to support that Iluvien is safe and effective in the treatment of patients with DME. Alimera will need to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication.

Solagran (SLA) CGNC Poultry production and disease management

In a poultry trial in Asia it was noticed that CGNC, an ingredient in Bioeffective A, has tremendous positive effects on the general performance of commercial broilers.

Sunshine Heart (SHC)

C-Pulse System Heart failure Results of the approved FDA feasibility clinical trial with the C-Pulse System produced statistically significant improvements in standard heart failure measures.


VitroGro Venous ulcers A final report from an international clinical trial of VitroGro ECM for the treatment of venous ulcers achieved its objectives. This data will be used for submission for EU approval for sale.


Company Product Application Comments


Acrux (ACR) Axiron Testosterone therapy Acrux announced that the Australian patent office has granted a new patent that will protect Acrux’s testosterone therapy Axiron until 2 June 2026.

Acrux (ACR) Recuvyra Postoperative pain in dogs

The European Medicines Agency has granted the marketing authorisation for commercial use of Recuvyra for the control of postoperative pain associated with major orthopaedic and soft tissue surgery in dogs.

Analytica (ALT) N/A N/A Analytica has been granted an exclusive option to receive the assignment of the intellectual property for the pelvic floor exercise system. The option will expire on 25 October 2014.


ATL1103 Antisense drug The Japanese Patent Office has granted Antisense a patent entitled ‘Modulation of Growth Hormone Receptor Expression and Insulin Like Growth Factor Expression’ which covers the company’s growth hormone receptor targeting drug ATL1103 and its use until February 2024.

Apollo Consolidated (AOP)

N/A N/A ASX has granted Apollo a waiver from listing rule 7.3.2 in respect of the 7.5m shares proposed to be issued to Aspire Minerals, allowing shares to be issued more than three months after the shareholder meeting granting approval.

Avexa (AVX) ATC HIV Avexa announced that it has filed two new patents covering the company’s Apricitabine program. The two patents are based around the clinical findings identified by the company following the full analysis of the phase II/III data set.

Avita Medical (AVX) N/A N/A Hong Kong SAR Patent Registry granted Avita a patent titled ‘Cell Suspension Preparation Technique and Use”.

Benitec (BLT) N/A N/A The company’s hepatitis programs received a boost with grant of a US patent and it has also received a notice of allowance for another patent application.

Benitec (BLT) N/A N/A Benitec has been granted additional gene silencing patents in Europe and the US.


N/A N/A ASX granted the company a waiver from ASX Listing Rule 14.3.


N/A N/A The New York court granted a summary judgment in the company’s favour by dismissing all claims in a lawsuit brought by a former licensing advisor, Ferghana Partners.


NexHA Joint dysfunction Bioniche Life Sciences received Canadian regulatory approval for an equine anti-inflammatory product for horses.


EconicheTM

E. coli O157 cattle vaccine

The Australian Quarantine and Inspection Service (AQIS) granted an import permit for Econiche, a necessary first step in gaining access to the Australian market.

Cellmid (CDY) MK ELISA Quantifying serum midkine concentrations

The company has completed CE marking of its diagnostic midkine ELISA kit (MK ELISA). This means that ELISA conforms to European regulations.

Cellmid (CDY) CAMI103 Ischemic diseases The US Patent and Trademark Office has approved Cellmid’s patent application, entitled ‘Pharmaceutical composition for preventing or treating ischemic disease’.

Regulatory

Announcem

ents25



VGX-100 Cancer Circadian has received FDA approval to begin clinical trials with VGX-100 for the treatment of cancer patients with solid tumours.

HealthLinx (HTX) OvPlex Ovarian Cancer The company has been granted a trademark for OvPlex in China, Singapore, the US, South Korea, Malaysia and Israel. This will strengthen the company’s Intellectual Property while furthering its plan to launch OnPlex in China.

Immuron (IMC) IMM-124E Treatment of fatty liver disease, including NASH

Immuron has submitted an application for an investigational new drug for IMM-124E with the FDA.

Mayne Pharma (MYX)

Doryx Oral antibiotic The US Court of Appeals for the Federal Circuit vacated a preliminary injunction granted against Mylan and its affiliate and remanded the matter back to the District Court. Mayne Pharma and Warner Chilcott will pursue their legal rights in pending suits against Mylan and the others.

Neuren (NEU) NNZ-2566 Treatment of chronic neurological conditions such as Rett Syndrome

The US FDA has authorised Neuren to initiate human clinical trials under an investigational new drug application for the oral formulation of NNZ-2566, enabling a phase I trial to proceed.

Novogen (NRT) N/A Cancer treatments Novogen subsidiary Marshall Edwards received a new US patent covering a number of its isoflavone-based compounds.

NuSep (NSP) InstantBlue stain Not disclosed The company settled its US patent infringement case with Expedeon and has been granted the worldwide distribution of the Expedeon InstantBlue stain under its own name.

OBJ (OBJ) Dermaportation patent Various The company received a Dermaportation patent from the US Patent Office, following the allowance of claims announced on 23 August 2011, giving it licensing options in key market sectors.

Pharmaxis (PXS) Bronchitol Cystic fibrosis The Committee for Medicinal Products for Human Use has recommended granting of a marketing authorisation for Bronchitol and allowing it to be used in Europe.

Prima BioMed (PRR) N/A N/A Prima’s manufacturing partner for Europe has received authorisation to produce CVac, allowing Prima’s regulatory application to commence a planned Canvas trial in Europe.

Progen Pharmaceuticals (PGL)

PI-88 Hepatocellular carcinoma

Progen’s licensee Medigen Biotechnology has received investigational new drug approval in Korea for PI-88. This will allow Medigen to commence patient enrolment under its Patron phase III study in PI-88.


Various Various The US PTO issued a notice of allowance for a composition of matter patent for selected 8-hydroxy quinazolinone compounds, including its lead Parkinson’s disease (PD) drug candidate, PBT434.

QRxPharma MoxDuo IR Pain relief The FDA said it will review the MoxDuo IR new drug application (NDA) filed earlier this year. The FDA also set June 25, 2012 as the target date for approval of the MoxDuo IR NDA.


VitroGro Various The VitroGro protein has been classified as a biologic product by the FDA – meaning there is no change to clinical trial, approval or reimbursement plans. The company also announced a successful compliance audit with EU Notified Body.

26

Announcem

ents


Announcem

ents27


Viralytics (VLA) Cavatak Treatment of cancer The US PTO issued a patent covering a Coxsackie A virus capable of infecting cancer cells substantially in the absence of intercellular adhesion molecule-1 (ICAM-1).

Viralytics (VLA) Picornavirus administration Blood cancer treatment and/or prevention

The Australian Patent Office issued a patent covering a method for treating and/or preventing hematologic (blood) cancer via a therapeutically effective amount of a Picornavirus.



N/A N/A ASX notified Allied of a breach of the listing rules in relation to the issue of options outside the time period prescribed and the late lodgment of Appendix 3Y for directors. The company has taken remedial actions for it.

Anteo Diagnostics (ADO)

Mix&Go N/A The Japanese Patent Office granted a patent for Mix&Go which is expected to strengthen its protection and commercial position.

AtCor Medical (ACG) N/A N/A The Office of Medicare Hearings and Appeals judge found in all three cases that the Medicare contractor for the state of New York must reimburse physicians for SphygmoCor tests performed on Medicare patients.

Impedimed (IPD) LDex U400 Unilateral lymphoedema

The US FDA cleared the company’s LDex U400 device to aid in the clinical assessment of unilateral lymphoedema of the arm in women, and legs for both men and women. The claim was also broadened beyond just cancer and is no longer linked to any one specific cancer.

ResMed (RMD) N/A N/A The ASX approved a change in the admission category of ResMed from an ASX listing to an ASX foreign exempt listing effective on October 6, 2011. ResMed will continue to be listed on the ASX through CHESS units of foreign securities.

Sunshine Heart (SHC)

N/A N/A The ASX waived listing rules relating to the reporting obligations of Sunshine Heart and the rotation of its directors.

Uscom (UCM) N/A N/A Uscom has been joined as a party to proceedings in the Supreme Court of NSW brought by Rob Phillips and relate to his eligibility to vote shares registered in his and related parties’ names at the 2011 AGM in his absolute discretion.

28

Announcem

ents

Other news

Biotechnology Product Application Comments

Total 49

Actinogen N/A N/A Actinogen has made a new discovery in making and optimising production of cellulase, a product crucial in making biofuels.

Analytica (ALT) N/A N/A Jennie Yuen resigned as company secretary and was replaced by Tom Rowe.

Austofix N/A N/A The board removed its CEO and will review senior executive requirements over six months with Mark Balnaves as executive chairman.

Avita (AVH) N/A N/A The company extended CEO Dr William Dolphin’s contract for a further three years until 30 June 2014.

Avita Medical (AVH) ReCell Chronic leg ulcers The company launched ReCell Spray-On Skin for the treatment of chronic leg ulcers, a market estimated at over US$1bn.

Benitec (BLT) N/A N/A The company changed its name to Benitec Biopharma and registered the change with ASIC and ASX.

BioProspect (BPO) N/A N/A The company transferred its registered office and of all of its subsidiaries to Suite 4, Level 1, 50 Bourke Street, Melbourne, Victoria 3000.

Biotron (BIT)Cathrx (CXD)

N/A N/A The directors advised that Dr Michael Hirshorn passed away after a serious illness.

Brain Resource Company (CBB)

N/A N/A Brain Resource announced that the joint venture created to develop its ADHD drug is now funded.

Calzada (CZD) N/A N/A CEO Dr Stewart Washer resigned and as a result business unit heads Laurent Fossaert and David Kenley will report directly to the board.

Cathryx (CXD) Variable Loop Catheter

N/A TUV Süd approved Cathryx’s application for a CE Mark of its variable loop catheter.

CBio (CBZ) N/A N/A Executive chairman Stephen Jones resigned from his executive role but will remain as non-executive chairman. Jason Yeates and James Greig resigned from their executive roles with Dr Daina Vanags appointed COO and company secretary Ben Graham appointed to the role of CFO.

CBio (CBZ) N/A N/A Ben Graham resigned as CFO. The company announced the resignation of directors James Grieg, Stephen Jones, Jason Yeates and non-executive director Professor John Funder. The company appointed five new non-executive directors: Dr Ralph Craven, Warren Brown, Helen Cameron, Ross Mangelsdorf and Warren Brook.

CBio (CBZ) N/A N/A The company announced the resignations of directors Dr Peter Corr, Dr Goran Ando, Dr Michael Monsour, Ross Mangelsdorf, and Warren Brooks. Dr Ralph Craven was appointed chairman and Helen Cameron as interim managing director.

CBio (CBZ) N/A N/A The company announced the resignations of non-executive directors Dr Terje Kalland and Dr Thomas Lonngren from the Board.


N/A N/A Dr Jonathan Skipper and Carlo Montagner resigned from the board.

Clinuvel Pharmaceuticals (CUV)

Afamelanotide and CUV9900

Alpha-Melanocyte stimulating hormone

The US PTO granted Clinuvel pivotal patent protection for the delivery of melanocortins as photoprotective agents in transdermal formulations.

Cochlear (COH) N/A N/A The company updated clinicians on its voluntary recall of unimplanted Nucleus CI500 series implants, specifically information on root cause of the loss of hermeticity.

Compumedics Neovo Egg monitoring system

Neurology The company reached a significant milestone in its contract to supply Yale university with its software, with a sale of US$1m.

Cryosite (CTE) N/A N/A Andrew Kroger has been appointed as a non-executive director and chairman. On the appointment of Mr Kroger, Mr Onisforou has elected to resign as a director of Cryosite.

Genesis Research and Development Corporation (GEN)

N/A N/A Genesis does not intend to proceed with any further business dealings with UBNZ after the person who was the principal of UBNZ, when the discussion occurred about investing in Genesis, has been charged for giving bribes and a warrant has been issued for the arrest of Jack Chen on related charges.



Genesis Research and Development Corporation (GEN)

N/A N/A Graham Chin has resigned as a director and appointed Dr Mel Bridges as chairman and non-executive director. Mr Bridges has over 30 years’ experience in the diagnostic and healthcare industries.


N/A N/A The company appointed Dr Mervyn Cass as a non-executive director.


BREVAGen Breast cancer The company reported its US regional launch of BREVAGen is on track.

HealthLinx (HTX) OvPlex Ovarian cancer HealthLinx expanded its OvPlex distribution to Malaysia through its distribution partner INEX Innovations.

HealthLinx (HTX) N/A N/A HealthLinx’s founding director Nick Gatsios will resign as CEO.

Holista CollTech (HCT)

N/A N/A The company appointed Benjamin Donovan as a non-executive director.


Diabecell Type 1 Diabetes Living Cell Technologies announced that transactions relating to joint venture company Diatranz Otsuka and Otsuka Pharmaceutical Factory have been completed.

Mayne Pharma (MYX)

N/A N/A Scott Richards was appointed CEO in early February 2012 and will join the board as managing director.

Medical Developments International (MVP)

N/A N/A CEO John Sharman became entitled to the first tranche of his long-term Incentive plan, three tranches of 513,577 shares, at 25 cents a share.

Mesoblast (MSB) N/A N/A Mesoblast and its strategic alliance partner Cephalon have won an award for a licensing and intellectual property-related deal.

Narhex (NLS) N/A N/A The company entered into three additional option agreements over four additional tenements in Queensland considered prospective for coal. No equity is to be issued until the company is able to confirm the quantity and quality of coal resources in accordance with JORC standards.

Novogen (NRT) N/A N/A Novogen subsidiary Marshall Edwards announced the appointment of Charles Baltic to its board.

Novogen (NRT) N/A N/A The company modified the provisions of its American Depository Receipt program. The conversion ratio of five Novogen Limited ordinary shares for each ADR share will now be 25 Novogen Limited ordinary shares for each ADR share.

NuSep (NSP) N/A N/A The company appointed John O’Connor, David Roffe and Ward Wescott as directors and Tom Rowe as company secretary.

Patrys (PAB) N/A N/A The company appointed Dr Marie Roskrow, CEO, as managing director.

Patrys (PAB) N/A N/A The company appointed Suzy Jones as a non-executive director.

Pharmaxis (PXS) Bronchitol Cystic fibrosis The company’s new drug for treating cystic fibrosis, Bronchitol, has not been recommended for listing on the Australian Pharmaceutical Benefits Scheme (PBS).

Phosphagenics (POH)

Oxycodone patch

Chronic pain Based on results of a physician survey in the US, the company has made the decision to commercialise its oxycodone patch to be administered twice weekly for the management of chronic pain.

Phylogica (PYC) N/A N/A The company changed its registered office to 15 Lovegrove Close, Mount Claremont WA 6010.

Phylogica (PYC) N/A N/A Phylogica complete the first stage of its collaboration with Pfizer to discover novel peptide-based vaccines. Under the terms of the agreement, Phylogica will receive an undisclosed milestone payment.


PBT 2 Ageing brain Prana research scientist Paul Adlard has been awarded an NHMRC project grant of $762,975 to study the benefits of PBT2 and other compounds in age-related cognitive impairment.


PBT 2 Excitotoxicity Prana’s research scientist Kevin Barnham has been awarded an NHMRC project grant of $ 419,925 to study the benefits of PBT2 and other compounds in preventing excitotoxicity.

Announcem

ents29


pSivida (PVA) N/A N/A pSivida has been ranked 59th on the Deloitte 2011 Technology Fast 500 ranking of the 500 fastest growing companies.

Sirtex Medical (SRX)

N/A N/A Shareholders approved the adoption of a new constitution.

Solagran (SLA) N/A N/A Solagran formally launched Bioeffective A in the United Arab Emirates and advised that its application for membership of the Innovation Centre of Skolkovo was successful. Skolkovo promotes the development of scientific and technological innovations


N/A N/A The company’s registered office has been changed to Level 19, 179 Turbot St, Brisbane QLD 4000, but its postal address remains as GPO Box 1596, Brisbane QLD 400.

Viralytics (VLA) N/A N/A Viralytics appointed Dr Kevin Harrington and Dr Jeffrey Weisberg to its scientific advisory board and Dr Leonard Post as a non-executive director.

Viralytics (VLA) N/A N/A Dr Leonard Post has been appointed as a Non-Executive Director of Viralytics Ltd. Dr Post has extensive experience in oncolytic viruses and virotherapy.


Advanced Surgical Design and Manufacture (AMT)

N/A N/A The company appointed as a director Peter Welsh.


N/A N/A The company appointed Mr Robert Towner as a non-executive member of the company’s board and the current CFO, Stephen Mann, as company secretary in place of Darren Bromley who will remain with Allied as a consultant.


N/A N/A AHZ’s tissue engineering and regenerative medicine division, Celxcel, appointed Bob Atwill as CEO.


N/A N/A Dr Julian Chick was appointed chief operating officer and will retain his position as non-executive director of Coridon, the DNA vaccine development company led by Professor Ian Frazer, and part of the Allied Group.

Atos Wellness (ATW)

N/A N/A Ernest Boswarva was appointed as non-executive director while Lloyd Halvorson resigned as a chairman and director. Conrad Crisafulli is the new chairman.

Austofix (AYX) N/A N/A The company appointed to the board John Nielsen while Greg Bittar resigned from the board. Dion Silvy was appointed company secretary.

Compumedics (CMP)

EEG technology Routine clinical EEG and surgical monitoring

The neurology laboratory at the Royal Children Hospital at Melbourne, which will be opened shortly, is equipped with Compumedics EEG technology valued at more than $500K. It was awarded a contract to supply EEG equipment worth $1m for the Neurology Department at Yale School of Medicine.

Ellex Medical Lasers (ELX)

Integre Pro system

Retinal disease The company said it would launch an innovative laser platform to treat retinal disease at a meeting of the American Academy of Ophthalmology.

GI Dynamics (GIC) N/A N/A The company appointed Mark Twyman as chief commercial officer reporting to president and CEO Stuart Randle. GI Dynamics also appointed Robert Solomon as its vice president of finance.

HeartWare International (HIN)

N/A N/A CFO and COO David McIntyre resigned for personal reasons.

Impedimed (IPD) N/A N/A Cherrell Hirst will take over from Mel Bridges as chairman.

Impedimed (IPD) N/A N/A ImpediMed will support the Stanford University Medical Center’s new breast cancer lymphoedema registry, which will collect and analyse data from breast centres across the US.

iSonea (ISN) N/A N/A Brad Slade resigned as joint company secretary and Peter Vaughan has been appointed in his place.

LBT Innovations (LBT)

N/A N/A Dr Michael Hirshorn resigned from the board. The company’s constitution was amended to reduce the number of maximum directors from 10 to 6. Dr Andrea Grant was appointed chief executive officer.

30

Announcem

ents




N/A N/A The company advised its register of securities will be kept at Boardroom Pty Limited, Level 7, 207 Kent Street, Sydney 2000.


N/A N/A The company announced the passing of chairman Tom Hartigan.

MediVac (MDV) N/A N/A The company said its SunnyWipes will be distributed across Australasia through Bunzl Outsourcing Services, and said testing of the new MetaMizer MM 240 SSS is now complete and the first new MetaMizer is ready for sale and shipping.

Nanosonics (NAN) Trophon EPR High-level disinfection The company has leased additional premises adjacent to its manufacturing facility to scale up production of its flagship Trophon EPR unit by more than 50%.

Nanosonics (NAN) N/A N/A The company appointed Dr Ronald Peter Weinberger as managing director and CEO.

Neurodiscovery (NDL)

N/A N/A Bret Mattes and David McAuliffe were appointed as board members while Michael Robson resigned as non-executive chairman. Mr Mattes will take the role of non-executive chairman and Mr McAuliffe a non-executive director.

ResMed (RMD) N/A N/A Stein Jacobsen resigned as president, Europe.

Reva Medical (RVA) N/A N/A T Eric Schmid resigned as vice-president of advanced technologies.


N/A N/A The company’s registered office has changed to:Level 10, 167 Macquarie Street, Sydney NSW 2000. Itsnew postal address is PO Box 449, Dee Why 2099.


N/A N/A Michael Vamos resigned as chief financial officer and assistant company secretary.

Unilife Corporation (UNS)

1mL syringes Used when drawing medication from a vial or ampoule

Premier Purchasing Partners signed a two-year contract to supply Unitract 1mL syringes to US healthcare facilities.

USCOM N/A N/A Daniel Fah resigned as company secretary and chief financial officer. Sheena Jack and Christian Bernecker were appointed to the board and Tom Rowe as the new company secretary.

Announcem

ents31


Appendix

04

32

Closing MCap (A$m) Quarterly return Annual return

Medical device

ACG Atcor Medical Holdings Limited 11.00 26% 0%

ADO Anteo Diagnostics Limited 56.41 25% -13%

AMT Advanced Surgical Design & Manufacture Limited 6.71 27% -45%

AYX Austofix Group Limited 4.74 0% -53%

AHZ Allied Healthcare Group Ltd 26.26 25% 25%

BRC Brain Resource Company Limited (The) 21.09 7% 15%

CGS Cogstate Ltd 17.95 50% 2%

CLV Clover Corporation Limited 49.55 5% -23%

CMP Compumedics Limited 14.58 23% -53%

COH Cochlear Limited 3,527.95 33.6% -23%

CXD Cathrx Ltd 16.37 -28% -64%

CYC Cyclopharm Limited 8.94 18% -53%

ELX Ellex Medical Lasers Limited 11.04 18% -58%

EMS Eastland Medical Systems Ltd 12.48 50% -59%

GBI Genera Biosystems Limited 10.16 12% -68%

HIN Heartware International, Inc 929.69 0% -22%

IPD Impedimed Limited 82.16 17% -35%

ITD ITL Limited 14.48 29% 39%

ISN Karmelsonix Limited 14.05 -50% -67%

LBT Labtech Systems Limited 3.78 -7% -42%

MDG Medtech Global Limited 5.01 -29% -23%

MDV Medivac Limited 2.10 -53% -91%

MGZ Medigard Limited 1.46 -38% -71%

MLA Medical Australia Limited 8.17 -14% 38%

NAN Nanosonics Limited 138.33 15% -31%

NDL Neurodiscovery Limited 3.10 -3% -26%

OBJ Obj Limited 21.66 13% -22%

OIL Optiscan Imaging Limited 16.32 39% 69%

RMD Resmed Inc 3,633.18 -16% -29%

RVA Reva Medical 190.41 3% -50%

SHC Sunshine Heart, Inc. 43.34 -23% 0%

SOM Somnomed Limited 37.50 -19% -7%

SFP Safety Medical Products Limited 2.78 -30% -96%

TDX Tyrian Diagnostics Limited 2.04 100% -71%

UBI Universal Biosensors, Inc. 119.21 -19% -51%

UCM Uscom Limited 3.49 -54% -77%

UNS Unilife Corporation 221.93 -29% -42%

GID Gi Dynamics Inc 261.04 0.16 -

ATW Atos Wellness Ltd 2.13 - -

FER Fermiscan Holdings Limited 7.23 -0.08 -0.63

33

Companies in the Pw

C Life Sciences Index

Companies in the PwC Life Sciences Index



Pharma and Biotech

ACL Alchemia Limited 84.19 -17% -52%

ACR Acrux Limited 477.85 -10% -19%

ACU Acuvax Limited 2.46 0% -75%

ACW Actinogen Limited 4.02 127% -41%

AGX Agenix Limited 9.08 -25% -50%

ALT Analytica Limited 9.82 -4% -27%

ANP Antisense Therapeutics Limited 22.60 156% 229%

AVH Avita Medical Ltd 29.77 32% 14%

AVX Avexa Limited 26.28 -26% -21%

BDM Biodiem Limited 8.53 -5% -35%

BIT Biotron Limited 18.55 28% 14%

BLT Benitec Limited 14.21 -25% -26%

BNC Bioniche Life Sciences 66.63 -7% -

BNE Bone Medical Limited 0.66 -69% -89%

BNO Bionomics Limited 203.42 23% 87%

BPO Bioprospect Limited 6.37 -20% -60%

BTA Biota Holdings Limited 145.36 -1% -19%

CBZ CBIO Limited 15.07 -68% -71%

CDY Cellmid Limited 6.78 -15% -47%

CIR Circadian Technologies Limited 21.81 0% -18%

CSL CSL Limited 16,636.63 8% -12%

CTE Cryosite Limited 6.76 45% 32%

CUV Clinuvel Pharmaceuticals Limited 47.81 3% -25%

CZD Calzada Limited 19.41 -7% 115%

GEN Genesis Research And Development Corporation Limited 1.37 0% 0%

GTG Genetic Technologies Limited 51.11 -31% 233%

HCT Holista Colltech Limited 14.90 -15% -4%

HTX Healthlinx Limited 3.05 -40% -85%

IDT Institute Of Drug Technology Australia Limited 16.84 13% -35%

IMC Immuron Limited 17.09 -12% -24%

IMU Imugene Limited 1.72 -40% -78%

LCT Living Cell Technologies Limited 15.60 -16% -66%

MSB Mesoblast Limited 1,932.13 -15% 48%

MVP Medical Developments International Limited 30.92 29% 45%

MYX Mayne Pharma Group Limited 59.19 5% -45%

NEU Neuren Pharmaceuticals Limited 31.21 80% 86%

NLS Narhex Life Sciences Limited 4.73 -27% -

NRT Novogen Limited 10.21 -31% -17%

NSP Nusep Limited 7.55 -36% -70%

Companies in the Pw

C Life Sciences Index34

35

Companies in the Pw

C Life Sciences Index


Pharma and Biotech (continued)

PAB Patrys Limited 9.76 -37% -65%

PBP Probiotec Limited 21.17 16% -40%

PBT Prana Biotechnology Limited 44.29 0% 19%

PCC Probiomics Limited 2.94 67% 0%

PGL Progen Pharmaceuticals Limited. 4.94 48% -33%

POH Phosphagenics Limited 213.69 40% 75%

PRR Prima Biomed Ltd 166.67 -3% -6%

PVA pSivida Corp. 26.00 -72% -74%

PXS Pharmaxis Ltd 318.13 51% -65%

PYC Phylogica Limited 17.84 -30% -38%

QRX Qrxpharma Limited 217.86 28% 8%

SIE Scigen Limited 37.55 0% -48%

SLA Solagran Limited 19.92 -17% -57%

SPL Starpharma Holdings Limited 319.92 7% 37%

SRX Sirtex Medical Limited 249.84 4% -26%

TEO Telesso Technologies Limited 1.14 -17% -5%

TIS Tissue Therapies Limited 65.01 -16% -46%

VHL Virax Holdings Limited 2.22 -44% -62%

VLA Viralytics Limited 25.14 -32% 2%

CBB Cordlife Limited 10.26 -3% -78%

Notes:AOP Company has been removed from Index following a move into the Resources Sector


05Methodology

36

37

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


06

38

Acknowledgements

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:Aman Singh, Manager

Joe Adendorff, Senior Consultant

Max Oke, Consultant

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

Manoj Santiago, Partner, Sydney Life Sciences Industry Leader

39

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.

© 2012 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

WL228770

pwc.com.au/bioforum

is 2012 the year for australian biotechs to shine? · 12/31/2011 · is 2012 the year for ....

Documents