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valley of death

Top 25 insights: valley of death

There are two potential ‘valleys of death’ for R&D spin-off companies. One is in translating their research concepts into prototype products. The other is in maturing from prototype to full commercialisation.

Here, leaders of the Top 25 Science Meets Business R&D spin-off companies answer the question: Which valley of death was most difficult for your company, and what was key to getting over the hurdle?


ADMEDUS

Taking the prototype through to full commercialisation was probably more difficult for us due to the complexities involved.

This included high-tech scale-up manufacturing, which we do at our bio-manufacturing facility in Malaga. Today, we have the ability to expand production as necessary, as well as refine and develop our processes in-house to accommodate new products and product improvements.

There was also a focus on generating sales once CardioCel was commercialised. Just because a product is approved doesn’t necessarily mean that it will be used straight away by the intended customers.

We’ve focused on educating the market about the benefits of CardioCel, such as its biocompatibility and lack of calcification (hardening) at the site of surgery. We’ve also built a strong global sales and marketing team who work closely with our customers to understand their needs.

As a result, we’ve seen continued quarter-on-quarter growth in CardioCel sales, and the product is now used in over 135 heart centres globally.

venture capital

– Dr Julian Chick, Chief Operating Officer


PHARMAXIS LTD

“For pharmaceuticals the so called ‘second valley of death’ is by far the most significant.

Lack of funding often prevents companies from attempting to cross this valley and causes them to license their technology at an earlier stage and to realise rewards as the licensor takes their innovation to market.

For a small company with limited resources, the key to success here is to understand the commercialisation risks, link the higher-risk projects with partners and try to make that step themselves for markets with lower entry costs and higher clinical need.

If done well, they should end up with a portfolio approach with the risks mitigated but still significant opportunity for value appreciation.”

venture capital

– Gary J Phillips, Chief Executive Officer


SMARTCAP TECHNOLOGIES PTY LTD

SmartCap Technologies had substantial industry support to develop the prototype products, however even with this it was a very challenging process to deliver working prototypes. 

SmartCap was exceedingly fortunate in that CRCMining provided substantially more financial support for SmartCap than originally envisaged, enabling it to finally deploy the prototype products. Those prototypes were sufficiently effective to generate commercial interest from some large mining companies.

So despite having robust plans in place, it always helps to have access to further funding, via investors or other stakeholders with a high level of commitment as well as deep pockets, to overcome unforeseen eventualities.”

– Kevin Greenwood, Chief Operating Officer


CATAPULT GROUP INTERNATIONAL LTD

“The biggest hurdle may be the combination of the two – translating research concepts (i.e. technical information associated with the technology) following commercialisation into an immature market.

Catapult‘s technology is not a consumer product and therefore is very high touch in terms of its service and client support. Due to the perceived complexity of the information obtained from the technology, part of the trick is to simplify the underlying research concepts to new markets that need a low touch product.”

Shaun_intext

– Shaun Holthouse, Chief Executive Officer


iCETANA PTY LTD

“I would argue that you should have a prototype – before any spin-off. That way you can at least prove technical viability of your concept. Ideally you would also have done some level of customer validation.

The next step of full commercialisation is definitely the hardest.

In our case it was a matter of finding early customers that were willing to spend time assessing the product and its benefits – even though it was too early to commit to a purchase and full roll-out. This phase was key to understanding the market and adjusting our path.”

– Gary Pennefather, Chief Executive Officer


ACRUX DDS PTY LTD

“The first phase is the most difficult – a poor prototype will show its deficiencies later in development. A prototype needs to demonstrate a safe and efficacious profile, and that it will meet the need you have defined in the target market.”

Michael Kotsanis_intext

– Michael Kotsanis, Chief Executive Officer


SPINIFEX PHARAMCEUTICALS PTY LTD

“Translating research concepts into clinical proof-of-concept [was the most difficult] due to the dearth of venture capital available in Australia at that time.”

– Professor Maree Smith, Executive Director of the Centre for Integrated Preclinical Drug Development and Head of the Pain Research Group at The University of Queensland


ENGENEIC LTD

“We are in the middle of our valley of death translating our platform into the clinic and we have not yet overcome it. Data is key, but one needs the funds to produce the results! So, we are seeking investors wherever we can find them and buddying up to big pharmaceuticals who have the muscle to progress our technology.”

HimanshuandJennifer_intext

– Dr Jennifer Macdiarmid, pictured above with Dr. Himanshu Brahmbhatt, joint Chief Executive Officers and Directors 


REDFLOW LIMITED

“Both were as difficult – but they had different hurdles. Key for both was having the right staff and people to address each hurdle.”

Stuart Smith_intext

– Stuart Smith, Chief Executive Officer


Click here to see the full list of Top 25 Science Meets Business R&D spin-off companies.

Top 25 insights: venture capital

Top 25 insights: venture capital

All research and development (R&D) spin-offs have significant risk attached to their commercialisation, but some cannot overcome the negative perception of that risk to attract the necessary capital.

Here, nine of the Top 25 Science meets Business R&D spin-off companies explain what it was about their product or business strategy that inspired confidence in their investors that theirs would be a viable business venture. 


ACRUX DDS PTY LTD

“An excellent intellectual property position is a key starting point. This is in addition to having a proven concept or great technology. A quality team to back up project execution is paramount. Understanding and being able to explain where your commercialised projects will fit into a market segment in terms of the need they will meet is also important.”

Michael Kotsanis_intext

– Michael Kotsanis, Chief Executive Officer


SMARTCAP TECHNOLOGIES PTY LTD

SmartCap Technologies is a spinoff from CRCMining. CRCMining carries out industry directed research, which ensured that the research into fatigue management technologies was a high priority for the mining industry at the project’s inception.

In SmartCap’s case, the industry support was sufficiently high that Anglo American, one of the world’s largest mining companies, in conjunction with CRCMining, co-funded the development of the prototype commercial SmartCap products.

This ‘incubation’ of the SmartCap technology by a significant end user was extremely important to advancing from research into prototype products. 

The prototype products performed sufficiently well for SmartCap to be selected by two other large mining companies for large supply contracts for fatigue monitoring technology.

So the support of significant end users, along with the commercial contracts the company had in place at that time, provided potential investors with the confidence to invest in SmartCap Technologies.”

– Kevin Greenwood, Chief Operating Officer


PHARMAXIS LTD

Pharmaxis has been restructured following a regulatory setback for our lead product. Rebuilding investor confidence has been critical to our longer term success. To do this we focused on three things:

1. transparency – explaining the business model and being clear about the risks as well as the opportunity;

2. building in meaningful milestones which marked development steps that significantly reduced risk and provided opportunities to realise value;

3. hitting milestones and delivering realistic objectives.”

venture capital

– Gary J Phillips, Chief Executive Officer


ADMEDUS

“I think there are a number of reasons investors are drawn to our business: Admedus has two technology platforms which diversifies the risk for investors; we have a product on market; and we are generating revenue.

The first of the two platforms is our regenerative tissue platform, where we use our proprietary ADAPT tissue engineering process to turn xenograft tissue into collagen bio-scaffolds for soft tissue repair. The second is our Immunotherapies platform, where we work with renowned scientist Professor Ian Frazer and his team to develop therapeutic vaccines for the treatment and prevention of infectious diseases and cancers.

Our lead regenerative tissue product CardioCel, which is used to repair and reconstruct congenital heart deformities and more complex heart defects, has made the journey from prototype to commercial product and is on the market in the USA, Europe and parts of Asia.

Frazer’s previous success with the human papillomavirus vaccine (HPV) program that lead to the USD$2 billion product, Gardasil, is well-recognised and gives investors further confidence in our immunotherapy work.

As a result, Admedus has a good balance of validated science via approved products and an exciting product pipeline working with successful scientists. This balance, along with our diversified program portfolio, gives investors confidence in our business. “

venture capital

– Dr Julian Chick, Chief Operating Officer


REDFLOW

“1. Marketing Potential

2. Uniqueness of the product

3. Difficult to replicate”

Stuart Smith_intext

– Stuart Smith, Chief Executive Officer


CATAPULT GROUP INTERNATIONAL LTD

Catapult‘s initial funding came from the Australian Institute of Sport (AIS), the birthplace of the project that led to the commercialisation of Catapult, and the Australian government

Because the technology was engineered to take elite athlete monitoring from the laboratory to the field, value was seen in the data immediately as there was no precedent for this type of information. A new product category had been formed and Australian Olympians were now able to train in their performance sweet spot without getting injured because their coaches had objective data to guide their lead up to big events.

So this combination of pioneering a new industry in a popular space (elite sport), with the ability to create immediate value, certainly helped with the initial funding.”

Shaun_intext

– Shaun Holthouse, Chief Executive Officer


SPINIFEX PHARAMCEUTICALS PTY LTD

“Neuropathic pain is a large unmet medical need because the currently available drug treatments either lack efficacy and/or have dose-limiting side-effects.

Due to this, my patent-protected angiotensin II type 2 (AT2) receptor antagonist technology – encompassing a potentially first-in-class novel analgesic for the treatment of often intractable neuropathic pain conditions – attracted initial seed capital investment from the Symbiosis Group, GBS Ventures and Uniseed Pty Ltd. In total $3.25M was raised and in mid-2005 the spin-out company, Spinifex Pharmaceuticals was formed by UniQuest Pty Ltd, the main commercialisation company of The University of Queensland.

The raison d’etre for Spinifex Pharmaceuticals at that time was to develop AT2 receptor antagonists as efficacious, well-tolerated first-in-class novel analgesics for relief of neuropathic pain. 

In 2006, I discovered that AT2 receptor antagonists also alleviated chronic inflammatory pain in a rat model. This was quite unexpected as clinically available drug treatments for neuropathic pain, such as tricyclic antidepressants and newer work-alikes as well as gabapentin and pregabalin, do not alleviate chronic inflammatory pain conditions such as osteoarthritis. Thus the potential for small molecule AT2 receptor antagonists to alleviate chronic inflammatory pain conditions was patent protected by UniQuest Pty Ltd in 2006 and subsequently in-licensed to Spinifex Pharmaceuticals for commercialisation. 

As both neuropathic pain and chronic inflammatory pain are large unmet medical needs, Spinifex Pharmaceuticals was able to raise additional venture capital from the initial investors as well as from Brandon Capital to fund Investigational New Drug (IND)-enabling Good Laboratory Practice (GLP) toxicology and safety pharmacology studies, as well as early phase human clinical trials. “

– Professor Maree Smith, Executive Director of the Centre for Integrated Preclinical Drug Development and Head of the Pain Research Group at The University of Queensland


iCETANA

“A different technique or approach to tackling a large and growing global market opportunity.”

– Gary Pennefather, Chief Executive Officer


ENGENEIC LTD

“Investors understood that the intellectual property would be generated in-house and there was no “stacking” from the beginning.

We were fortunate at the outset to meet two venture capitalists and a number of high net worth individuals who saw the potential upside in our business plan, had already had some success with investing in biotech – e.g. Biota – and did not ask ‘who else is in?’.  

That being said, we had very limited time and money to show proof of concept, and only after that and our first patent, did we convince those investors that we had something viable.”

HimanshuandJennifer_intext

– Dr Jennifer Macdiarmid, pictured above with Dr. Himanshu Brahmbhatt, joint Chief Executive Officers and Directors 


Click here to see the full list of Top 25 Science meets Business R&D spin-off companies.