FAQ

FEBRUARY 2015

The Business Development team has had a busy 12 months. We go behind the scenes with SUDA’s Chief Business Officer, Nick Woolf, to understand the opportunities and challenges.

Q: How large is the business development team at SUDA?

A: “Our in-house team is just two, being myself in Perth and our European BD manager in London, Lorenza Castellon. We also work with Torreya Partners, a leading BD consultancy based in New York.”

Q: What is the process for approaching pharmaceutical companies?

A: “We target high-profile business matching events such as BIO-Europe and the American BIO International Convention. These are great forums to connect with the industry and have been highly productive for us.”

Q: How successful have you been in attracting companies?

A: “More successful than I expected. At the three conferences we attended in 2014, all of our time slots were filled and we had to turn down companies because the meetings couldn’t be scheduled.”

Q: You have 65 ongoing discussions. How do you manage such a large number?

A: “Some of the discussions are more intensive than others. Most of them are at the stage of evaluating non-confidential information on our pipeline products or our OroMist technology platform.”

Q: Can you tell me more about the intensive discussions?

A: “Discussions become more intensive when formal due diligence begins. We have 14 prospective partners reviewing our data rooms under confidentiality. The interest spans the entire pipeline as well as opportunities to co-develop new sprays and product line extensions.”

Q: How long does it take to get deals done?

A: “The Amherst deal took 9 months from start to finish. The general rule of thumb is 9-12 months, but some deals can take longer. There are several companies that are waiting on us to provide them with the costed development plan before they proceed to full due diligence.”

Q: Why did you miss your guidance for deals in CY2014?

A: “It is inherently difficult to give guidance on events if the timing is out of our control. When we have competitive interest, then we can drive the process. With ArTiMist®, one of our lead prospective partners suspended their review to focus on Ebola. We are talking to them again now.”

Q: Do we have competitive interest?

A: “Yes. There is competitive interest across several products, including ArTiMist®.”

Q: Great, so when is the next deal?

A: “We anticipate multiple deals in CY2015 including ArTiMist® and our first co-development and product line extension partnership.”

 

SEPTEMBER 2014

The three senior scientists in our laboratory, led by Dr. Carol Worth, SUDA’s Technical Manager, bring over 65 years of chemistry experience to SUDA. We put them under the microscope with some questions.

Q: Tell us about the laboratory?

A: “Our laboratory features an array of modern equipment and advanced scientific instruments; a dynamic team of experienced scientists; and an outstanding quality system meeting rigorous quality standards of documentation demanded by the pharmaceutical industry.”

Q: What is the purpose of the laboratory?

A: “We are the engine room of the Company, providing in-house formulation and analytical capabilities to support our existing pipeline of OroMist oral sprays, but also to expand the pipeline with new reformulations, and to work with pharmaceutical partners to reformulate drugs of interest to them.”

Q: Can you elaborate on your formulation experience?

A: “Our formulation experience is second to none. We have patents covering over 300 active drugs in oral spray formulations. Depending on the drug and dosage, we use different solvents and excipients to solubilise the active agent and to stabilise the solution. We have expertise with a range of flavoring and taste modifying agents - peppermint, spearmint, citrus oils, fruit flavours and honey. We can also add penetration enhancers to increase permeability via the mucosa.”

Q: How do you test your formulations?

A: “The three essential tests that we undertake are Taste, Stability and Permeability. Naturally patients want a pleasant taste so we engage a panel of volunteers to test and rank the formulations. Our stability testing is conducted under accelerated conditions and we use porcine and synthetic mucosal models to evaluate permeation efficiency.”

Q: Who decides on what device to use?

A: “We do. There is a lot of science required to match a formulation with the optimal components for the container, pump and closure system. We use different containers depending on the product - multi-dose or single-unit, glass or plastic. Our experience spans both air-activated pumps and propellant-driven aerosol sprays, as well as nozzles for delivering directly under the tongue or onto the cheek.”

Q: What are you working on currently?

A: “We have several ongoing projects. These include optimising our sildenafil oral spray (SUD-003) for erectile dysfunction. We are adding spearmint and peppermint flavouring, together with enhanced permeation characteristics to quicken the onset of action. This is important for the product’s market potential. Separately, we are optimising the taste of our sumatriptan formulation (SUD-001) for migraine before meeting with the FDA in CY2015.”

Q: Are you working on any new products?

A: “Yes, but we cannot disclose specifics until patents are filed. We are also conducting several feasibility assessments with prospective pharmaceutical partners in relation to new product opportunities. These could be the subject of collaborative agreements in which SUDA receives fee-for-service income for formulation work, plus milestones and royalties if the products are successful.”

 

FEBRUARY 2014

Mr Michael Stewart took on the role of SUDA’s Chairman on 1 January 2014. We have a fireside chat with Mr Stewart about the Company.

Q: What initially attracted you to join the Board in 2009?

A: “The Company looked very different in 2009 than it does today. I was attracted by the potential of our ArTiMist® anti-malarial spray to make a meaningful difference to the treatment of children with severe malaria. Just look at the successful results from the Phase III trial reported in 2013!”

Q: In addition to ArTiMist®, SUDA had some underperforming businesses back in 2009. What was your game plan?

A: “I realised from the outset that we needed to completely restructure certain aspects of our operations. I also believe that good people build good businesses and that a team has to have a clear vision. That starts with clearly articulating what we stand for and Our Values. That was essentially the starting point. Of course the challenge is always how to build a company using a limited capital base.”

Q: It’s been a fantastic turnaround in 4 years. What’s the secret of this success?

A: “Success is a choice not a chance. I knew that with the right management and resources in place, we could reshape the Company with the aim of delivering exceptional shareholder returns. We brought in Stephen Carter in 2010 to orchestrate the turn around and he has shown excellent judgement in all respects.”

Q: Please elaborate on Stephen’s judgement?

A: “Stephen has recruited a first-rate team to support him. He was instrumental in finalising the acquisition of the NovaDel oro-mucosal assets and in restructuring the ArTiMist® ProtoPharma alliance.”

Q: What triggered the split of Chairman and CEO roles?

A: “Having an independent Chairman brings us into line with corporate governance best practise. The timing was essentially Stephen’s decision. Having restructured SUDA into an oro-mucosal drug delivery company, Stephen, in the CEO role, can now focus on our operational goals.”

Q: What do you consider to be the key operational goals?

A: “The focus for 2014 is on business development. We now have a portfolio of oral sprays, each of which offers advantages over current standard treatments. Our goal this year is to divest ArTiMist® to a major pharmaceutical company and to partner at least one of our mainstream therapies.”

Q: Which of the products acquired from NovaDel excites you most?

A: “You probably expect me to say SUD-003, our oral spray of Viagra®. In fact, SUD-001 for migraine is the one that I think has the potential to really change prescribing habits. The clinical data suggests that SUD-001 has a much quicker onset of action and requires less active drug to have the same therapeutic effect as the gold standard Imitrex® tablet. These attributes are important for migraine patients.”

Q: Do you have a closing message for our shareholders?

A: “It is an honour to take on the role of Chairman at this exciting time in the Company’s evolution. I am very confident that our management team can achieve the goals we have set. I would like to thank our shareholders for their support and I look forward to our journey ahead.”