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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.”




New Drug for Gastrointestinal Stromal Tumours (GIST) to be Launched in Australia, New Zealand and South East Asia Following Distribution Agreement

Singapore, 06 November 2020: A NEW therapy to treat advanced gastrointestinal stromal tumours (GIST) will be available to patients in Australia, New Zealand and in some parts of South East Asia, following an exclusive distribution agreement.

Independent pharmaceutical company Specialised Therapeutics Asia (STA) has signed an agreement with US-based Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) to commercialise the switch-control tyrosine kinase inhibitor QINLOCK (ripretinib) in key regions, including Australia, New Zealand, Singapore, Malaysia and Brunei.

The therapy was one of the first approved by Australia’s Therapeutic Goods Administration (TGA) earlier this year under Project Orbis, which enables concurrent review of oncology products by international regulators, including the TGA, FDA and Health Canada.

It is indicated “for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib”.

QINLOCK has also been approved by the US Food and Drug Administration (FDA) and Health Canada (HC) for the fourth-line treatment of GIST.

The TGA approval was based on efficacy results from the pivotal global Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15; 95% CI 0.09-0.25; p<0.0001). In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36; 95% CI 0.21-0.62).1

One of the INVICTUS study authors, Professor John Zalcberg who holds the Tony Charlton Chair of Oncology and is Head of the Cancer Research Program in the School of Public Health at Monash University as well as a  consultant medical oncologist at Alfred Health, described QINLOCK as an important new agent in the GIST treatment armamentarium, noting it was the first TGA approved fourth-line therapy to treat the disease.

“QINLOCK represents another step forward to improve outcomes for patients who are affected by this rare cancer,” Professor Zalcberg said.

“This is an area of high unmet need because of the poor prognosis of patients whose tumours continue to grow on prior treatment.

“We are further encouraged by data demonstrating that QINLOCK is well-tolerated, with patient-reported outcomes (PROs) suggesting that patients who received QINLOCK therapy in the INVICTUS study were able to maintain their quality of life in contrast to the fact that quality of life deteriorated in patients not receiving QINLOCK.”

STA Chief Executive Officer Carlo Montagner said QINLOCK would bolster the company’s already-robust oncology portfolio, and was synergistic with its mission to address areas of unmet clinical need.

“We are thrilled to introduce this valuable therapy to patients with GIST in our region, working in collaboration with our new international partner, Deciphera Pharmaceuticals,” Mr Montagner said.

“STA will expedite access to this important medicine, with a Patient Access Program to open in Q1 2021.  This will provide subsidised access for appropriate patients at the earliest opportunity, as we file for additional regulatory approvals in other key markets, including New Zealand, Singapore and Malaysia.”

Deciphera President and Chief Executive Officer Mr Steve Hoerter commented: “We are committed to ensuring QINLOCK’s global commercial availability and are proud to be executing on our plan to deliver this important medicine to patients with advanced GIST worldwide.

“We look forward to collaborating with STA as we bring a much-needed therapeutic option to patients living in locations where we do not anticipate setting up our own commercial activities near term.”

A submission to have QINLOCK reimbursed for eligible Australian patients has been lodged with the Pharmaceutical Benefits Advisory Committee in November for consideration at the March 2021 meeting. If successful, QINLOCK could be reimbursed for Australian patients in the latter half of 2021.

Ends.

Further inquiries: STA Senior Manager Communications and Corporate Affairs Emma Power +61 419 149 525.

 

About Specialised Therapeutics Asia

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.

ST Asia and its regional affiliates collaborate 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 targeting diseases where there remain unmet medical needs. STA’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care.

Additional information can be found at www.STAbiopharma.com

 

About Deciphera Pharmaceuticals

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. Deciphera is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from the company’s platform in clinical studies, QINLOCK is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Canada and Australia. For more information, visit www.deciphera.com and follow the company on LinkedIn and Twitter (@Deciphera).

 

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in the United States and a similar incidence rate in European and other countries. Most cases of GIST are driven by a spectrum of mutations. The most common primary mutations are in KIT kinase, representing approximately 80% of cases, or in PDGFRα kinase, representing approximately 6% of cases. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance and disease progression. Estimates for 5-year survival range from 48% to 90%, depending on the stage of the disease at diagnosis.

 

About the INVICTUS Phase 3 Study

INVICTUS is a Phase 3 randomized, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK or placebo once daily. The primary efficacy endpoint is progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). QINLOCK also demonstrated a median OS of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).

 

About QINLOCK (ripretinib)Specialised

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation involved in systemic mastocytosis, or SM. QINLOCK also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

QINLOCK is approved by the U.S. FDA for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

Deciphera Pharmaceuticals is developing QINLOCK for the treatment of KIT and/or PDGFRα-driven cancers, including GIST, and maintains global development and commercial rights except for select geographies. Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of QINLOCK in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). Deciphera Pharmaceuticals has an exclusive distribution agreement with Specialised Therapeutics Asia (STA) for the commercialization of QINLOCK in Australia, New Zealand, Singapore, Malaysia and Brunei.

  • • Specialised Therapeutics Asia (STA) to make QINLOCK® (ripretinib) available to appropriate patients in Australia, New Zealand, Singapore, Malaysia and Brunei following exclusive distribution agreement
  • • QINLOCK is already approved by the Therapeutics Good Administration (TGA) and US Food and Drug Administration (FDA)
  • • In the INVICTUS study, QINLOCK reduced the risk of disease progression by 85% in advanced GIST patients who have received three prior therapies1

 

References

1. Blay J-Y  et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020; 21: 923-934

 




Specialised Therapeutics Signs Exclusive Deal for New Haematology Drug

Singapore, 18 December, 2019: Independent pharmaceutical company Specialised Therapeutics Asia (STA) has signed an exclusive license deal with US-based Onconova Therapeutics (NASDAQ: ONTX), securing commercialisation rights to a new therapy for the treatment of Myelodysplastic Syndrome (MDS).

The drug, known as rigosertib, is currently in a Phase 3 clinical trial to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who have progressed on, failed to respond to, or relapsed after first-line treatment. The trial is over 90% enrolled and has clinical trial sites open in Australia.

STA Chief Executive Officer, Mr Carlo Montagner, said patients with high-risk MDS had limited treatment options following currently available first-line treatment.

“There is no currently approved treatment following failure of standard chemotherapy with hypomethylating agents. Patients are left with the option of entering clinical trials if available, or supportive care,” he said.

“If approved, rigosertib would address a clear unmet medical need and may be a valuable inclusion to the STA therapeutic portfolio.”

“We are delighted to enter into this collaboration with Onconova and look forward to the results of the ongoing phase III INSPIRE trial of intravenous (IV) rigosertib.”

MDS includes a group of diseases which impact the production of normal blood cells in the bone marrow. MDS is more common in elderly people, with 90% of patients diagnosed over age 60, although it can present at any age.1

Onconova Therapeutics’ President and Chief Executive Officer Dr Steven Fruchtman commented: “We are pleased to partner with Specialised Therapeutics Asia, which has a strong track record of commercialising new products in oncology and haematology across Australia and New Zealand, We look forward to working together and following a successful readout of the ongoing INSPIRE Trial, potentially providing rigosertib as a new therapeutic option for patients diagnosed with MDS.”

 

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care.

Additional information can be found at www.stbiopharma.com

 

About Onconova Therapeutics, Inc.

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company discovering and developing novel small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS). Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com.

 

About Myelodysplastic Syndromes

MDS is a group of blood disorders that affect bone marrow function, whereby the bone marrow cells appear dysplastic and their capacity to produce cells is defective. As a result, patients with MDS have low blood cell counts and require frequent blood transfusions. In approximately one-third of patients, higher-risk MDS can progress to acute myeloid leukaemia (AML).

The Leukemia Foundation of Australia estimates that an incidence of between four to five per 100,000 of the population. However, in patients over the age of 60, this increases to anything from 20 to 50 per 100,000.1

 

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model described rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: “A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling.” Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

 

About the INSPIRE Phase 3 Clinical Trial

The INternational Study of Phase 3 IV RigosErtib, or INSPIRE, clinical trial was finalised following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomised, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. This time frame optimises the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomised at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

  • • STA secures exclusive commercialisation rights for AU and NZ
  • • Rigosertib is a promising new compound to treat Myelodysplastic Syndrome, which has limited treatment options

 

Further Inquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

 

References

  1. Leukaemia Foundation website accessed 17 December 2019 https://www.leukaemia.org.au/disease-information/myelodysplastic-syndromes/

 




Collaborate: We work closely with global business partners

Collaborate: We work closely with our global business partners and take care of their products as if they were our own. We also manage complex regulatory landscapes in our regions. Here’s Ulrich Kosciessa from photonamic GmbH discussing our successful partnership.

Click on the image above to view.




10 Years of Partnering

ST began with a single drug and a single global partner in 2008. Today, our company collaborates with several high-class biotechnology and pharma partners around the globe. All have been prudently selected because their products fulfill an unmet medical need.

 

In 10 years, ST has executed a strategy of identifying promising mid-to-late-stage compounds for full commercial development. So successful was our initial collaboration with Spanish pharmaceutical company PharmaMar, that this partner has now licensed a second proprietary compound to ST for full development.

Here, PharmaMar’s Vice-President of Business Development and Licensing Mr Heiner Pieper discusses our business relationship.

When you were seeking a partner in the region, what were your pre-requisites and what drew you to ST?

“We saw that ST had successfully commercialised global brands such as Abraxane, Iclusig, and Aloxi.

We studied market research reports (ie IMS) and saw that drugs commercialised by ST had performed well in Australia, normally leading the pack even after loss of exclusivity.

We also analysed customer recall data and noticed that STA scored highly most of the time. This is of course important when introducing new treatment modalities to the market.

Once we met ST´s management we were impressed by their track record and felt very comfortable to enter into license discussions and then, a partnership arrangement.

Today no licensor is searching for ‘distributors only’. Rather, we seek partners able to provide a full service and take a drug from late stage clinical development to market.

This means we need a partner with expertise in regulatory affairs, market access and all pre-launch activities including investigator management and KOL identification.

Once a product is launched, marketing and sales functions are of utmost importance, as is a reliable supply chain – because most of PharmaMar´s products are to be handled as ‘cold chain’. To this regard, the concept of ‘distributor only’ is a long time over.

For all functions, a partner needs the best talents. Once approved, an ideal partner should be able to execute a global brand strategy, and more importantly, make it fit to the special characteristics of the local market.

Results are important to us: a drug can only help patients if it gets sold and used to the benefit of patients.

 

You have now selected ST to commercialise more than one product. What does this say about ST?

We have licensed two products to STA – Aplidin for multiple myeloma as well as Zepsyre, which is in Phase 3 development for small cell lung cancer.

This is confirmation and recognition of the fact that we are very pleased with our partnership in Australia so far.

Aplidin was our first drug licensed to STA. We are delighted with the level of excellence in execution and speed at which this product has been introduced to market.

Australia is the first country in the world that has introduced an expanded access program (EAP) for Aplidin for multiple myeloma patients where there is an unmet need.”

 

In your experience, what have been the best things about working with ST? What has impressed you to date?

What our team in PharmaMar headquarters likes most is ST´s ‘hands-on’ attitude and the great communication. If issues appear in daily operations, we rely on ST to problem solve, rather than seek solutions from us.

This is valuable for a mid-cap biotech like ours which has limited resources. It builds trust.

 

Some pharma companies require a lot of assistance from their international partner. What has been the experience with ST?

It goes without saying that when it comes to new drug approval you need to get the buy-in of many stakeholders: doctors, health authorities, the TGA, payors, and of course, patients.  ST had implemented a well thought-out program of activities, starting with face-to-face meetings and round table forums, through to an expanded special access program to prepare the market for launch.

 

 

Globally speaking, Australia, New Zealand and South East Asia is quite a small market. Why is it important to PharmaMar?

It is true that when it comes to spend in pharmaceuticals, the territory is only a few percent of the total world market.  However, it still offers an important opportunity and also provides a great growth potential for the future.

The region licensed to ST is very diverse. On the one hand, you have countries like Australia, and to a lesser extent Singapore, which are very similar to the pharmaceutical markets of Europe, Canada or the United States.

Generally speaking, you will find health systems provide broad coverage and there is an increasing focus on affordable drug pricing and reimbursement for everybody.

It is our firm belief that in the future those developing countries in South-East Asia will have to work with us, the pharma industry, to make effective cancer medicines available for a broader group of patients.

 

On a commercial level, why do international companies like PharmaMar need to select a company that understands the particular needs of this region?

Europe and US-based biotech companies have to focus on Europe and the US first in order to succeed. Together these two markets represent around 70% of the world pharma market.  Though culturally very close, Australia is geographically remote.

Given the size of the total territory and the market rewards today, we believe it is more cost efficient to partner with a local and regional specialist.  If a specialist company, such as STA, does cover several countries and also provides the right expertise in those countries, this becomes a win-win for everybody.

 

What would you say now to other global biotechnology companies seeking a pharmaceutical partner to commercialise products in this region?

When it comes to high cost proprietary products for the institutional markets, ST is one of the first addresses to consider.

 

What is your expectation for the future of this partnership?

We hope to see successful launches of our frontrunners Aplidin and Zepsyre and a continuation of our trustful partnership with ST.

In addition, we look forward to working with ST to bring our products to those markets in South- East Asia which currently do not have access to innovative medicines.”

 

PharmaMar’s Heiner Pieper provided these insights in June 2018.

 

 




CEO Carlo Montagner Discusses Recent Partnership Deal

This article appeared on page 36 in Pharma Asset Insights (a Scrip industry publication). Click on the Fullscreen button in the middle of the magazine below to read it or scroll down to read the article within this webpage.

 

 

“Our most recent partnership deal was with US-based Puma Biotechnology (NASDAQ: PBYI).

This novel early breast cancer drug first came to our attention in 2011 when Puma acquired the rights from Pfizer.

Following a successful FDA ODAC hearing in 2017, we reached out to Puma for an initial exploratory discussion on commercialising NERLYNX  in our region.  Less than 6 months later, we not only struck an exclusive license agreement , but we have submitted the New Drug Application dossier to the Therapeutic Goods Administration (TGA) and have made NERLYNX  available to appropriate Australian patients via a strictly-controlled patient access program using our proprietary access program platform.

We were able to move quickly because, as I am  the 100% owner and CEO of the company, our internal review and approval processes are not subject to multiple internal senior management and board reviews. This means decision making and post-deal product commercialisation execution can be rapid.

If we make a commitment to filing a dossier on a particular date — subject to external influences beyond our control — we have always achieved that commitment.

We were looking for a drug that fulfilled an unmet need and provided a reasonable commercial opportunity.

NERLYNX overwhelmingly met these criteria. It is the first FDA-approved drug for extended adjuvant therapy in women with early stage HER2+ breast cancer and is clearly not a ‘me-too’ product.

In this case, due diligence processes were also expedited.  Our team is comprised of senior pharma executives with many years of regulatory and commercialisation experience. With NERLYNX, we were able to rapidly assess the commercial opportunity as well as the likelihood of regulatory and reimbursement success.

Once due diligence was completed, negotiations commenced on the license terms.

Like all our agreements, the Puma deal was tailored to meet the needs of our partner.  These arrangements need to be customised as our partners all have different requirements and operate in different jurisdictions.

Making  NERLYNX available to women prior to TGA approval has required particular commercialisation skill.

In addition to the usual advisory boards and meeting with key stakeholders, ST also launches early access programs to potential prescribers.

These programs ensure our customers become familiar with the product, but more importantly, they enable appropriate access to patients in need at the earliest opportunity.

Our NERLYNX access program was launched in Australia in late March – four months post-deal.

We have developed a rigorous process for managing these access programs pre and post regulatory approval, and are currently operating several simultaneously.

With NERLYNX, we are targeting a reimbursement approval within 18 months of submitting our regulatory dossier.

Again, we have a strong track record of achieving these critical milestones and now look forward to making this important medicine available to appropriate Australian women.”