Specialised Therapeutics Strikes Deal with World Courier Australia to Manage Logistics for Specialty Pharma Products

World Courier Australia selected to manage all delivery, storage operations for STA’s growing portfolio of specialist healthcare products

Melbourne, Australia 16 June 2016: International biopharmaceutical company Specialised Therapeutics Australia has struck an important agreement with global logistics partner World Courier Australia (WCA) to manage and handle its growing portfolio of specialist healthcare products around the country.

Under the terms of the arrangement, WCA will undertake all critical logistics functions on behalf of STA, including receipt of pharmaceutical products, storage and delivery.

It will also assist STA with special labelling tasks and will prepare and deliver clinical trial products to key research sites in Australia and internationally as required.

Commercial terms are not being disclosed, but the arrangement formally takes effect in mid-July.

STA Chief Executive Officer Mr Carlo Montagner said WCA was carefully and strategically selected for its high standards, state of the art facilities and successful track record handling complex pharmaceutical products.

“No other specialty logistics company has the experienced personnel, global offices and in-market expertise required to ensure the optimal handling, transport and delivery of vital healthcare products,” he said.

“This deal comes as we seek to expand our business and bring new therapeutics to patients and doctors in Australia.

“It is imperative we have the right logistics support and we are confident that WCA has the capability and sophisticated technology (including redundancy and back up systems) to ensure our speciality products are optimally handled and managed from end to end.”

World Courier is a part of AmerisourceBergen Corporation – one of the world’s largest pharmaceutical sourcing and healthcare distribution services companies with revenues in excess of US $135 billion.

The Victorian World Courier Australia site is TGA-licensed for labelling, storage and secondary packaging. It has an ISO 9001 and ISO 14001 compliant quality management system.

Services provided include validated storage for drugs, diagnostic kits and medical devices. Further, WCA provides round-the-clock access to inventories, transport of all investigational drugs and supplies from country of origin to depot, as well as immediate delivery of specified drugs/kits from the depot to in-country locations.

WCA also has capability to oversee and manage drug return and destruction as required.

About Specialised Therapeutics Australia

Specialised Therapeutics Australia is an international biopharmaceutical company providing pioneering healthcare solutions to patients throughout Australia, New Zealand and South East Asia. Headquartered in Melbourne, Australia, STA and its affiliate company Specialised Therapeutics Asia Pte Ltd collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. STA is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, haematology, urology and ophthalmology. Additional information can be found at www.specialisedtherapeutics.com.au

About World Courier Australia

World Courier is a global specialty logistics company that designs world-class supply chain programs in complete alignment with customers’ business goals. The company delivers ultimate peace of mind for the transport and storage of time- and temperature-sensitive products. For more than 45 years, only World Courier has delivered the unsurpassed knowledge, global reach and flawless supply chain execution needed to become the most trusted specialty logistics company in the world. For more information, visit worldcourier.com.

About AmerisourceBergen

AmerisourceBergen is one of the largest global pharmaceutical sourcing and distribution services companies, helping both healthcare providers and pharmaceutical and biotech manufacturers improve patient access to products and enhance patient care. With services ranging from drug distribution and niche premium logistics to reimbursement and pharmaceutical consulting services, AmerisourceBergen delivers innovative programs and solutions across the pharmaceutical supply channel. With over $135 billion in annual revenue, AmerisourceBergen is headquartered in Valley Forge, PA, and employs approximately 18,000 people. AmerisourceBergen is ranked #16 on the Fortune 500 list. For more information, go to www.amerisourcebergen.com.

Herald Sun: 8 April, 2016

HERALD SUN (MELBOURNE)

By Carlo Montagner 8 April 2016

PBS Price Cuts Cruel Pharma Innovation

Earlier this week, pharmaceutical companies across the country received a substantial financial penalty, as the federal government’s Pharmaceutical Benefits Scheme cost-saving agenda took effect.

Under this plan, expected to save the government around $3.7 billion over the next five years, all branded medicines listed on the PBS for five years or more will be available to the government at 5 per cent less than the originally agreed reimbursed price.

While taxpayers will see a difference in the price of many high-volume generics under this plan, the 5 per cent price reduction to prescribed specialty branded medicines will not result in taxpayers seeing any difference at the pharmacy counter.

That’s because a patient’s co-payment will remain the same regardless of what the government pays for the specialty medicine.

This decision will affect dozens of branded medicines and almost every pharmaceutical company in Australia. A 5 per cent price cut might seem insignificant, but in reality it will potentially slash millions of dollars from some companies’ bottom lines.

Australia’s pharma industry invests over $1 billion every year in health and medical research, exports billions in manufactured goods and indirectly employs around 20,000 Australians. But behind the scenes, and what many Australians don’t realise, is that pharmaceutical companies are innovators, educators and philanthropists. They consistently fund clinical trials of new drugs that may change lives, educate the medical community about new technologies and provide millions of dollars in financial support to health programs.

Pharmaceutical companies also frequently support extensive compassionate programs enabling patients access to specialty medicines — not yet approved or reimbursed on the PBS — that might otherwise be unaffordable or unavailable. Not every drug makes it to market. For every innovative therapy that changes lives, there are hundreds that fail — in some cases, after many millions of dollars have been spent by pharma companies in development. This is not a waste. Many a brilliant discovery was made on the back of supposed failures. The reality is innovation is risk-laden, and the financial investment required is not for the faint-hearted.

Everyone I have worked with at global pharmaceutical companies, from lab researchers to senior executives, is striving to make a difference. They constantly balance the need for commercial viability against a genuine drive to innovate and bring new life-saving medicines and technologies to their communities. So while positive for the federal Budget, these latest PBS cost-saving measures pose an unprecedented commercial challenge for innovator pharma companies.

The prices of many drugs in Australia were originally negotiated at levels that result in some of the lowest prices in the world. Further, the opportunity to increase prices once a drug has been listed on the PBS is virtually non-existent. We wear the costs of any manufacturing price rises or any significant currency devaluations from the time a drug is listed — unlike private health insurers, for example, who are accustomed to achieving increases in excess
of CPI each year. It is vital the risk companies take on behalf of all patients is financially supported.

This is the first forced price cut introduced by the government — we don’t know if it will be the last. If prices are further reduced, there is a real
possibility pharma companies will remove some specialty branded medicines from the PBS because it will not be commercially viable given the current pricing.

If this happens, cuttingedge, life-saving drug therapies currently listed and being used to treat Australian patients may become unavailable and future
breakthrough treatments may never be brought to Australia.

There is little doubt PBS pricing changes will impact innovation. Pharma companies will simply not have the same commercial incentive to include Australian sites in global studies of new drugs and technologies. I was relieved and emboldened by the Prime Minister’s Innovation Statement. However, the reality is that to remain competitive and progressive, the pharmaceutical industry must be incentivised to continue investing in Australia. I ask the
government to remember its commitment to innovation.

Novel Multiple Myeloma Drug APLIDIN® Shows Positive Results in Pivotal Phase 3 Study

Phase 3 trial of APLIDIN^®/dexamethasone combination showed “statistically significant” 35% reduction in risk of disease progression or death compared to dexamethasone alone
Drug expected to be available in Australia, SE Asia 2018
APLIDIN^®is a novel drug to treat multiple myeloma, which has one of the lowest survival rates in cancer

Singapore, Madrid and Melbourne, Australia, 31 March 2016: International biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST Asia) will seek regulatory approvals for novel multiple myeloma drug Aplidin^® (plitidepsin) following the release of positive results in a pivotal Phase 3 study.

A randomised, open label multi-centre clinical trial known as the ADMYRE study examined the efficacy of Aplidin® (plitidepsin) in combination with dexamethasone versus dexamethasone alone.

More than 250 patients were enrolled in the study at 83 medical centres across 19 countries in the United States, Europe and in the Asia Pacific. All patients enrolled in the trial had relapsed or refractory multiple myeloma following a minimum of 3 and no more than 6 prior therapeutic regimens.

The efficacy of Aplidin^® (plitidepsin) in combination with dexamethasone versus dexamethasone alone was evaluated by means of PFS calculated using the IMWG (International Myeloma Working Group) criteria and other secondary efficacy endpoints.

Investigators are reporting a “statistically significant” 35% reduction in the risk of disease progression or death over the comparator arm (p=0.0054). The study met its primary endpoint.

ST Asia Chief Executive Officer Mr. Carlo Montagner described the latest trial results as “highly encouraging” and said he eagerly awaited the full results of the study data to be disclosed.

“We look forward to working with our European partner PharmaMar to ensure this valuable multiple myeloma therapy is available as soon as possible to patients in key South East Asia regions, as well as in Australia and New Zealand,” he said.

“All data to date now suggests Aplidin^® may be an important new therapeutic for patients affected by this difficult to treat cancer.

“While multiple myeloma remains relatively rare, it is an insidious disease and patients typically exhaust treatment alternatives. ST Asia has been established to provide new therapeutics like this one to patients where there is a high unmet need.”

Lead Australian investigator on the ADMYRE study and Director of Haematology at the Royal Melbourne Hospital, Professor Jeff Szer, said: “These results are welcome as Aplidin^® appears to be another active agent with unique mechanisms of action in the management of multiple myeloma. While the outcomes for patients with multiple myeloma have improved greatly in recent years, they are still not ideal and this could pave the way for another treatment option for this difficult to manage disease. We are hopeful that Aplidin^® may soon provide another treatment option for those patients who have failed prior therapies and are running out of alternatives.

“We look forward to the release of full trial data which will give us a clearer picture of just how effective Aplidin^® may be for patients with refractory disease.”

The trial data will be presented at an upcoming scientific meeting.

ST Asia has exclusive rights to market and distribute Aplidin® in Australia, Singapore and 12 other South East Asian countries under the terms of an arrangement with European partner PharmaMar.

Aplidin^® was the first drug licensed by ST Asia for the broader SE Asian market and is a first in class compound developed for the treatment of multiple myeloma and a type of T cell lymphoma. It is PharmaMar’s second anti-cancer drug candidate obtained from a marine organism.

The total population of South East Asian regions including Australia and New Zealand is approximately 650 million, with an estimated 300,000 people living with multiple myeloma overall and between 30,000 and 40,000 new cases of the disease diagnosed annually.

About Specialised Therapeutics Australia

Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international biopharmaceutical company established to provide pioneering healthcare solutions to patients throughout South East Asia, as well as in Australia and New Zealand. The company is a close affiliate of Specialised Therapeutics Australia (STA), which also collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. ST Asia is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, urology and ophthalmology. Additional information can be found at www.specialisedtherapeutics.com.au

About PharmaMar

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS^® in Europe and has three other clinical stage programs under development for several types of solid and hematological cancers PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States. PharmaMar fully owns three other companies: GENOMICA, Spain’s leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAI); and two other chemical enterprises, Zelnova and Xylazel. To learn more about PharmaMar, please visit us at www.pharmamar.com.

About APLIDIN^® (plitidepsin)

Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase III study in relapsed or refractory multiple myeloma, a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

About Multiple Myeloma

Multiple myeloma is a relatively uncommon type of blood cancer that accounts for 10% of all hematological malignancies and that is caused by malignant plasma cells that very rapidly multiply.¹ Normal plasma cells are white blood cells found in the bone marrow that form part of the immune system and produce the antibodies necessary to fight infections.² Abnormal cells produce a type of antibody that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. Almost all patients with multiple myeloma progress from an initial, asymptomatic pre-malignant stage to established disease. In 2015, 26,850 new cases will be diagnosed in the US, and about 11,200 people will die of this disease.³ In Europe, there will be 4.5–6.0 out of 100,000 people diagnosed per year.⁴ In Australia, approximately 1,200 Australians are diagnosed each year.⁵

This webpage is a press release, not a prospectus. This webpage does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this webpage for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.

References

From Big Pharma to Small Starts: Risking it All on a Life-Saving Cancer Drug to Win

SARAH-JANE TASKER | THE AUSTRALIAN| MARCH 19, 2016 12:00AM

From Big Pharma to Small Starts:
Risking it All on a Life-Saving Cancer Drug to Win

Bozena Zembrzuski and Carlo Montagner reflect on their decision to found Specialised Therapeutics and bring Abraxane to Australia. Picture: Aaron Francis

After years working for big pharma in the US, Carlo Montagner and Bozena Zembrzuski risked their life savings to bring a leading cancer drug to Australia.

The two, who met at university, sold everything almost eight years ago — share portfolios and investment properties — and lived in rented accommodation when they returned to Australia to start their own pharmaceutical company, Specialised Therapeutics.

Montagner, who became chief executive, says he and his wife — parents to three children — took a risk on the Melbourne start-up. The early days of the business were a stark reminder of these risks.

The first drug they wanted to bring into Australia, Abraxane, developed to treat breast cancer, was originally rejected by the Pharmaceutical Benefits Scheme — the system under which the government subsidises the cost of medicine.

“I called my wife after I was told the PBS had rejected it and her first words were ‘we’re — ruined’,” Montagner says.

“I said we weren’t because ‘it is too good a drug not to get through, so let’s play it through’.”

The couple, like most Australians, have watched friends and family battle cancer. Montagner’s father died last September from mesothelioma and the oncology expert says that, given his role, he is often approached by friends and family for advice on the deadly disease.

“When I receive a call from a friend for advice, it’s usually not for financial advice, so I generally tense up,” he says.

“For most patients given cancer diagnosis, and I went through this myself with my father last year, it’s just mind numbing, you don’t know where to turn and there’s a lot of information out there,” Montagner says.

The privately owned company — Montagner has no interest in attracting third-party investors — generated more than $35 million in revenue last year but he says it isn’t just about money.

“I’m very passionate about this. I really do believe that this (Abraxane) is the chemotherapy that all Australian women should receive.”

Bringing a drug to the Australian market is usually reserved for those with deep pockets and time on their side. Drugs have to be licensed, which involves significant testing to secure the right local approvals. The testing needs to be done regardless of a drug’s use or approval in other jurisdictions.

Montagner tells The Weekend Australian the original financial risk they took as a family was worth it because he had a strong belief in Abraxane, which he had launched in the US in his previous role as president of the drug’s developer, Abraxis Bioscience.

Prior to the introduction of that drug into Australia in 2009, Montagner said breast cancer patients were using older chemotherapies that had been around for 20 years.

He says that today, Abraxane is one of the leading therapies for metastatic breast cancer and pancreatic cancer. Since the drug became available in Australia, more than 10,000 cancer patients have been treated with Abraxane.

The drug, which is now owned by US pharma Celgene, has been approved for distribution in about 50 countries, including the US, Europe, Japan and India.

Montagner says the early take-up of the drug in Australia had exceeded their expectations “several fold”.

“We got caught in the first 18 months never really having enough stock,” he says.

“I couldn’t believe how quickly it was being adopted. We put the manufacturing plant in Phoenix under pressure … the plant once pulled out all stops, working 24-7 for a week to make a batch for Australia because we were selling so much of it.”

Zembrzuski says while the company was started with some trepidation, they took the view that if it didn’t work, they would simply get jobs again.

“We had a lot of faith in all the training and experience we’d built up in our previous roles in Australia and overseas,” she says.

The company co-founder, who previously worked for global drug giant Novartis, says it’s a different dynamic to have a married couple as the bosses, which she said had the potential to go terribly wrong.

“We were very aware right from the start that being married should not cause any confusion or stress to people,” she says.

“If this was going to be a credible and professional venture then that couldn’t happen.”

Zembrzuski jokes that she was worried if she could take direction from her husband given he had taken on the CEO role. She says she decided to treat him at work as she would any of her previous managers.

“We both have strong opinions, are both self-motivated and have always worked for other people, never together,” she says. “But we bring different strengths to the table and we do complement each other.”

The company was originally started because Montagner says it was difficult to get a role in Australia that matched the remuneration he was accustomed to in the US as the president of a Nasdaq-listed biotech. He and his wife are passionate about conveying that they don’t take the success of the company for granted.

“We feel very lucky that we are able to provide for the kids and are our own bosses,” Zembrzuski says.

Teaching their three children, aged 9, 12 and 14, about giving and not just taking is central to the values they want to pass on as parents.

Montagner says that before they went to the US, they were like most Australians and saw people who sprouted philanthropic endeavours as “show-offs”.

“Then we went to the US and there it’s in the DNA of all successful people. We saw that and we completely changed our view and bought into the concept that people who do well and have the opportunity to give back should give back,” he says.

“Plus, we both grew up in working class families that didn’t have the opportunities to do what we do now, so the last thing we want is our kids to grow up in a privileged household where they became too materialistic and focused on themselves than others in greater need.”

The family started its philanthropic efforts with a $1m donation to the Olivia Newton-John cancer research centre based at Melbourne’s Austin Hospital. They have also donated $US250,000 ($328,000) to build a trade school in East Timor.

Zembrzuski adds they are a “proud” Australian-owned company and while they will always maintain their head office in Melbourne, part of being entrepreneurial was looking at new options.

They expanded into Southeast Asia last year with the distribution of a drug to treat myeloma, a type of blood cancer.
“We aim to bring drugs to Australia and South East Asia that fulfil unmet medical needs,” Montagner says.

“We say no to drugs that don’t provide a unique benefit because then it becomes a pure marketing exercise if it doesn’t and we’re not interested in that.”

The company was founded on oncology drugs but it is also targeting haematology, urology and supportive care.

The rapid growth of Specialised Therapeutics has put it on the radar of larger companies but Montagner says he has no plans to sell.

“I love the fact we’re in a position where we can help others with some of the wealth we are generating and I love coming to the office each day and doing what we do. I see Rupert Murdoch and Warren Buffett … what I take from them is they love what they do, it’s not a job, it’s what you do every day.”

The Australian: 19 March, 2016

THE AUSTRALIAN

By Sarah-Jane Tasker 19 March 2016

From Big Pharma to Small Starts:
Risking it All on a Life-Saving Cancer Drug to Win

Bozena Zembrzuski and Carlo Montagner reflect on their decision to found Specialised Therapeutics and bring Abraxane to Australia. Picture: Aaron Francis