Move over Viagra. New Zealand’s Douglas Pharmaceuticals is hot on its heels, chasing a slice of the erectile dysfunction drug market (ED) currently dominated by Pfizer’s Viagra. Douglas Pharmaceuticals’ version is called Silvasta.

Douglas Pharmaceuticals recently successful applied to Medsafe to reclassify Silvasta (sildenafil) for sale over-the-counter sale without a prescription. What this means is Kiwi men (35-70 bracket) are the first in the world to access ED treatment direct from pharmacists without a prescription.

Currently, the ED drugs dominant players include Pfizer (Viagra), Eli Lily (Cialis) and Bayer AG (Levitra). Pfizer’s patent on Viagra’s bio active ingredient, also sildenafil, ran out in 2013, paving the way for other companies to use the same ingredient.

Douglas Pharmaceuticals can share a tale or two about not giving up after being knocked down. Its first application to sell the Silvasta over the counter (OTC) was turned down by Medsafe, the New Zealand authority overseeing the approval process.

That didn’t deter the company, which went back to the drawing board, absorbed the feedback, redesigned its approach and reapplied. The second application was successful.

ED is said to affect around 50% of men over 40 years old but only about 10% of them seek help from their doctors. The success has given the company a boost, sales of Silvasta has jumped around 400% since. 

According to Transparency Research, the global market value for ED drugs is expected to fall to US$3.4 billion in 2019 from $4.3b in 2012. Viagra accounted for the largest share (45%) of the total market for ED drugs in 2012. However, due to the loss of the drug’s patent exclusivity in Europe and other countries in 2013, the overall market revenue is expected to decline during the forecast period. Pfizer is expected to continue maintaining its US market share with Viagra due to its extended patent exclusivity till 2020.

Douglas Pharmaceuticals’ marketing triumph was celebrated in April when it won the Nicholas Hall Most Innovative Global OTC Marketing Campaign for 2015. Nicholas Hall is an international specialist in OTC marketing specialising in consumer healthcare and associated industries. According to Douglas Pharmaceuticals, this was the first time a Kiwi company has won the accolade.

The company has a turnover of over $136 million. It employs 450 staff primarily in West Auckland. Douglas is a family-owned company started in 1967 by Sir Graeme Douglas. The company invests more than $20 million in R&D per year and has seen significant growth in both its domestic and international sales. 

Idealog asked Douglas Pharmaceuticals’ marketing manager, Mike Siermans, to talk about the process leading to the successful conversion of Silvasta to an OTC product.

Q: You recently won a Nicholas Hall OTC Marketing Award (The Most Innovative Global OTC (over-the-counter). Tell us a bit about the lead up to this recognition? What work went into this process, why is it important?

A: Throughout the reclassification process with Medsafe, I was in personal contact with Nicholas Hall and he was fascinated that a small, generic company in NZ was taking this bold move, rather than the multinationals, to open access of sildenafil to men in NZ. Nicholas is a great supporter and believes that one of the greatest OTC/pharmacy opportunities available is within the Men’s Health market and in particular the ED market. Since the launch in October, we have been in contact with each other and we have supplied details on the campaign and sales progress. To win this international award is a huge accolade to my team here in NZ and to pharmacy in NZ who have wholeheartedly supported our hard work. Without the support of our pharmacists and the dedication from my sales and marketing team we would not have had the ‘switch’ to Silvasta and success in the market.

Q: What were some of the challenges involved in this conversion? And what were the solutions applied?

A: The first challenge was obviously the reclassification with Medsafe. The MCC (Medicines Classification Committee) consists of representatives from Medsafe, pharmacy and the medical community. They needed to be convinced that the product was safe and effective and that the pharmacy channel was ready and appropriate for OTC supply. We worked with a group of specialists, doctors and pharmacists both here in NZ and in the UK to prepare our submission and the materials which would support pharmacists and customers through the change.  Our first submission was declined but we took the feedback and redesigned our approach, plan and materials and we reapplied and we were successful.

The second challenge was to implement the plan into the pharmacy channel. We deployed our medical sales teams to engage with pharmacy and gain their commitment to our brand, our training and the promotional plan. It was important for pharmacy to understand that this was an opportunity for them to use and develop their professional skills.

(Left: Douglas Pharmaceuticals’ marketing manager, Mike Siermans at the awards.)

Q: So, basically, Medsafe reclassified Silvasta, used by men (for erectile dysfunction) for over the counter sale? And sales of the drug skyrocketed? Who has been buying this drug?

A: The initial market data implied that 52% of men over 40 suffer from some sort of erectile dysfunction and we knew only about 10% of men present to their doctor for treatment. So there is a huge gap in the market and some of that resistance to seek treatment was the barrier of visiting the doctor. We have seen a significant increase in the market size since we launched so we believe we have seen “new” patients visiting the pharmacy to have discussions with their pharmacists about ED.

Q: The drug Silvasta, made by Douglas Pharmaceutical, how different is it from Viagra?  Is it the cheaper version of Viagra? How do you compete with a brand such as Viagra, is it purely on price points?

A: Silvasta is bio-equivalent to Viagra and uses the same active ingredient, sildenafil. It is a registered medicine and part of the registration process through Medsafe is that you have to undertake studies to show the products have the same therapeutic effect. The price of Silvasta is set by the pharmacists and the interesting part of this programme is that we have not seen a reduction in the price but rather a significant increase in the number of men seeking the product. We have seen a 400% increase in Silvasta sales and significant growth in the total ED market. Douglas prides itself on working with pharmacy. We have focused on great resources, training and POS (point of sale) to drive business for the pharmacist. That has proven to be our advantage.

Q: ED it is a highly sensitive topic. Tell us a little bit about how you took Silvasta to the market? The marketing spend on this drug, the media you used, and the challenges of marketing sensitive information? What were the key messages you used in reaching your target audience?

A: Pharmacists deal with a great deal of sensitive issues like the emergency contraceptive pill  and urinary tract infections. Many pharmacies have private consultation rooms or areas in the pharmacy where they can have discreet discussions with customers. We concentrated our initial marketing spend on training and helping pharmacists understand the market and gave them the tools and procedures to deal with men visiting for a discussion about ED. We then focused heavily on driving men into pharmacy to talk with their pharmacist. We used a combination of prime-time TV and drive-time radio to hit our target audience. The key message to the audience was that there had been a change in the way you could access “the little Blue Pill” and that the pharmacist was now your first point of call.