EXECUTIVE INTERVIEW - Unither Pharmaceuticals: Premeasured Dosage Forms to Improve Medication Adherence

As medicines continually evolve, so does the technology used to deliver them to the patient. Unither Pharmaceuticals is a world-leading provider of sterile blow-fill-seal, and liquid stickpack dosage forms. Each provides several advantages over traditional delivery systems at about the same cost per dose. The company’s vision is to make affordable and user-friendly products that everyone in the world can use to improve their lives. These products are created as a result of its singular focus on convenient, modern dosage forms that are preferred by patients to whom they are offered. Whether a customer works with Unither from an early stage to develop a custom product, brings their own product to them for fill-finish, or brands and markets one of its many ready-to-go formulations, the following single unit doses offer numerous advantages over legacy delivery forms: blow-fill-seal (BFS) technology for sterile unitdoses, liquid or powder stick-pack technology, improved dry formulations, and patented drug delivery systems for per-buccal mucous administration. CEO Eric Goupil recently spoke frankly with Drug Development& Delivery about medication adherence, Unither’s technology, and some of the challenges that they face.

Q: Can you provide our readers more information about the company, its history, and what makes it unique?

A: A brilliant and fearless friend of mine founded the company in 1993. He purchased a small production plant in Amiens, France, with 17 people and just $2.7 million in annual revenue. He had a singular idea to focus on BFS, and to price the first vial to come off the line the same as the ten-millionth. This was a completely novel and unique proposition, and it was genius because it completely avoids the “chicken and egg” discussion between marketing and manufacturing. The marketing guy will say, “tell me the cost, and I will build the quantity” and the manufacturing guy says, “tell me the quantity, and I will give you the cost.” Unither’s bet was that charging a small price for first vial would lower the barrier to getting customers in the door, business would develop briskly, and the machines would begin to run profitably. It worked! Initial growth was approximately 30% annually for the first 7 years, and right now, we are at a healthy 15% between organic growth and acquisitions.

We are a contract manufacturing organization (CMO) focused on a few premeasured dosage forms that are preferred by patients. In the US, these are currently sterile blow-fill-seal (BFS), and Unistick^® liquid stick-packs. We help our customers develop products that we manufacture and fill, and we also create pharmaceutical products that our customers can immediately brand, market, and sell. There are great market opportunities for our customers worldwide.

We are fully aligned with our customers; when they grow their business, we grow our business, so we work very hard to help ensure their success. We believe that that we are unique among CMOs because we are focused on improving the patient experience, and this makes sense to us because if the patient is happy, the product is successful, the customer is happy, and we are happy.

Q: What are some advantages of sterile BFS and liquid stick-pack?

 A: Both stick-packs and BFS vials are more convenient, safer, easier to handle, and more portable than bottles. In the US, most liquid products contain preservatives, but there is an increasing realization that many patients are sensitive to these preservatives, particularly in something designed for use in the eye. As a result, we are beginning to see a move toward “preservative-free” formulations, and BFS is an ideal way to achieve this. We help our customers provide a superior product that patients prefer, at no additional cost.

 Q: Do you see that “preservative-free” shift and preference coming to the US?

 A: We are convinced that our business model and the early adopters of single-unit dose products will be successful in the US. Awareness is definitely growing. We are already seeing a preservative-free preference evolving in the food industry, and this is exactly how the market evolved in Europe: first in food and beverage, and then in cosmetics and pharma. Several preservatives are now banned for use in cosmetics in Europe.

When key opinion leaders are made aware of the advantages of preservative-free formulations, others will follow. The sales data in Europe clearly shows that patients prefer these delivery forms, and we have ready-to-use products that our customers can bring to market right away.

Big advantages are convenience, ease-of-use, and portability, and these significantly help patients to take their medication at the right time, in the right amount (medication adherence).

Adherence is an enormous problem: in the US, up to 50% of prescribed medications are taken incorrectly, contributing to 125,000 early deaths, and costing the healthcare system over $200 billion annually. Our products can help to mitigate some of these issues, and that makes me feel very good.  

Q: Single-unit dosage forms have a longer history in Europe, how are they received there?

 A: Extremely well, let me share a couple of example launches in Europe. A popular and established eyewash was formulated with preservatives and sold only in bottles. In 1999, a preservative-free BFS single-unit dose form was brought to market as a box of twenty 5-ml vials (the same amount of product as in the bottle) at the exact same price. The single-unit dose now has four times the sales volume of the bottle; both sales and market share have increased, as well as the market itself.

We have seen the same thing happen with a heartburn medication that after introducing a liquid stick-pack captured 80% of the market in France.

Our products not only increase the market share of the customer’s product versus competitors, they actually increase the total amount of product sold, so there is no cannibalization of existing sales.

 Q: How do you typically work with your clients?

 A: Ideally, we are involved at the start of a project and are approached with a problem rather than a solution. We love to help customers create new markets and new opportunities. We make products for the customers of our customers – the patients. Whenever a new project comes in the door, we look at it through a very patient-centric lens and ask ourselves if it is useful and is it something a patient would pay for. If the answer is no, then we will have a frank discussion about why we believe not, and how the product and patient experience could be improved. We always listen to our customers, but we are invested in their success, and we don’t want to simply take their money for a product that we don’t believe will succeed.

We are often making products that haven’t been seen in the marketplace before, so forecasting sales can be a challenge. A customer may predict sales of 1 million units, and they may end up at 50 thousand or 10 million. Because of this, we approach volume guarantees very differently from other CMOs. Others require customers to commit to specific minimums; we do not. We eliminate the stress of forecasting. Again, we are fully aligned with our customers. We worry about our capacity so they can focus on sales and marketing. Our profitability comes from volume, so if we can help make our customers successful, the volume will be there and everyone benefits.

Q: What are some of the challenges your company is facing?

 A: Our products are novel and different, so we need to find innovators willing to become first-adopters. But innovation carries perceived risk. We believe the risk is minimal because there is strong evidence in the marketplace that when customers are offered unit dose at an affordable price, they invariably prefer it. In our experience, there is a tremendous pay-off for innovators. The first-adopter generally captures about 60% of the market, and the total market size grows.

Our job is to make affordable and user-friendly products for everybody in the world, but we have to be price competitive. Because the products are superior to standard forms, many assume they are more expensive to produce. This was perhaps true in the past, but through advanced manufacturing, we have passed the tipping point.

I like to use the analogy of the flat screen television. When they were introduced, everyone immediately realized they were vastly superior to standard CRT TVs, but adoption was slow because of the high cost. As more and more were sold, economies of scale kicked in, and when the cost came down enough, they began to dominate, and now, of course, the market for CRTs is inconsequential.

 Q: What’s your leadership style?

 A: I very much favor autonomy in each division. It’s not independence, because there is great collaboration and alignment throughout the organization, but everyone is accountable. The natural tendency in a large company is to centralize decision-making, but to best serve customers and patients, decisions must be made at the local level. This becomes a tremendous benefit because site managers know their customers better than anyone, and they are empowered to make decisions that benefit them. It also allows us to be very nimble – we are now a large global company, but we can move as quickly as a small startup. Decisions that would entail weeks of presentations in a traditional, centralized organization can be made in an afternoon.

 Q: What are Unither’s growth plans for the future?

 A: We are committed to bringing superior products to everyone in the world, so having a global footprint is important. We need to be local at the continent level, and in addition to Europe and the Americas, we already have clients in Asia and Australia.

Growth will continue both organically and by acquisition. As I mentioned, we have grown 15% annually since 2000, and we expect that trend to continue. Organic growth is extremely important. We see some CMOs growing primarily through acquisitions, but robust organic growth means that the organization and business are healthy. We have eight world-class locations on three continents, including our recently acquired plant in Rochester, NY.

 Q: How is the Rochester acquisition progressing?

 A: We are very much on track. We have invested $15.7 million in phase one to install stick-pack and BFS. Stick-pack is ready to go, and we are already running cGMP batches. BFS construction is progressing well and will be ready in 2016.

I am extremely happy with our US team; they have the customer-focused mindset needed in a successful CMO. Sometimes in Big Pharma the focus is too much on the parent company. When we hire, we ask ourselves “is this the best person to satisfy the customers’ needs?” We are fortunate to very frequently answer “yes” to that question.

 To view this issue and all back issues online, please visit www.drug-dev.com.