Newsmaker Q&A: TOLMAR: On a growth tear

TOLMAR, a Fort Collins-based pharmaceutical research, development and manufacturing company, was recently named Colorado BioScience Association’s Company of the Year for 2012 — just a few months after the company announced an expansion to Windsor. We caught up with TOLMAR CEO Mike Duncan to find out more about what’s going on.

Question: Tell us about your plans for the new facility in Windsor. How many new jobs do you expect it will create, and what will be happening there?

A: Right now we’re just under 400 people here in Fort Collins, and that’s at the seven facilities we have here now, and this one will be our eighth. We really don’t know how many jobs we will create yet because we’ll have several people moving down there, but you know I would guess by 2014 it will be between 50 and 75 at least.

SPONSORED CONTENT

Empowering communities

Rocky Mountain Health Plans (RMHP), part of the UnitedHealthcare family, has pledged its commitment to uplift these communities through substantial investments in organizations addressing the distinct needs of our communities.

TOLMAR develops drugs and makes drugs. We don’t sell them. So the place in Windsor will be a pharmaceutical manufacturing plant. And what TOLMAR also does, which is very different than most pharmaceutical companies, most of the medicines we make are for topical disease or for cancer. Two very different spectrums of disease. We also have products for skin cancer. We make creams, gels, ointments, liquids and injectables. There are two cancer injectable products that will be made in Windsor, and the rest will be topical prescription medicines for diseases like acne, psoriases and a precursor to skin cancer.

Our cancer drug is sold to urologists and oncology clinics. Our biggest drugs are for prostate cancer. And then all of our dermatology products are for dermatologists. Fifteen to 16 percent of all prescription topical medicines are made here in Fort Collins. Most people don’t know that because we don’t have a brand, and no one has ever heard of TOLMAR because again, we’re just an R&D and manufacturing company.

Q: You announced the new Windsor facility last summer, but have said not to expect any real production there until 2014. Why is getting the new facility up and running taking so long?

A: It takes a long time to get a pharmaceutical company online. We started construction in Windsor in June and we’ll be really lucky to have that facility producing products by the end of 2014. All facilities are inspected by the Food and Drug Administration around a product submission. So if you hear someone say that a facility is FDA-approved, that’s not true. A drug is approved to be made in a facility by the FDA. So if you have 10 drugs in a facility, all 10 have to be cleared by the FDA. Just because you have a facility that the FDA has inspected doesn’t mean you can make whatever you want to in there. It’s product-specific. In the facility in Windsor, we’ll have at least 20 products, and each one of those products has to be cleared by the FDA in that plant. For the FDA to even inspect it, you have to make the product, you have to put the product on stability, which is making sure it holds its labeled potency, and it’s tested at four different temperature and humidity settings for six months. Then you have to submit that data to the FDA and then that triggers their review. Once you file that data with the FDA, it’s about 18 months to approval. So the first two phases of the construction of that facility will be completed by July or August of this year, and when I say completed, that’s when we’ll make those batches, in July/August, and from that time point about 18 months. We hope it’s much faster, but we don’t know.

Q: As an employer in the bioscience industry that serves pharmaceutical companies, what are your concerns regarding the future of health care in our country?

A: I don’t really have any. I think the healthcare reforms are really to provide expanded medical coverage. If you really look at the Obamacare program it’s going to expand medical coverage and prescriptions, and again the market is always going to be open to new medicines. TOLMAR is a unique company in that we make new drugs and we also make generic drugs. So we’re on both ends of the spectrum. We develop new products and we also develop generic products. The good side of the generics side is that you get many prescriptions, but the price is usually lower. So the patient usually has access to the medication and the company has a lot of volume. And then on the new side, if you come out with a new drug that improves health, there’s always going to be a market for that.

Q: What is the biggest challenge in your field right now, and how are you trying to overcome it?

A: The biggest challenge is the substantial investment before you can market a product. Like I said, in this Windsor facility, it could be two years after we’ve started construction before we can actually use it. We’ve decided to make the investment, and because we’re a private company we have private funding sources. But that’s always a challenge for a company. You can come up with a great idea, but a lot of consumers don’t understand what it takes to get a new product approved. A new product will easily take eight to 10 years and easily take a $100 million to get to market. And that’s excluding facilities. That’s just clinical costs and product development costs. In a generic drug, it takes about three years and costs between $5 million and $7 million to get it to market. So you invest that $5 million to $7 million for three years before you see a penny. So that’s always the balance, especially with a company of our size, is that you have to invest. We balance our risk between the generic and the new drugs.

Q: What current projects/innovations are you most excited about? What can we expect from your company in the next five years?

A: We will launch at least a dozen new products in the dermatology space with generic and new drugs. We’ll be close to having at least three, if not five, injectable products approved. And we’ll be making a substantial investment in research and development, to the tune of $50 million to $60 million dollars a year.

Q: According to CBSA, one of the reasons TOLMAR received its company of the year award was because of your company’s community engagement. In what ways is TOLMAR engaged in Northern Colorado, and how has its location benefited the community?

A: At a very basic level, we give everybody at least one day off for community service, outside of their vacation and sick days. We want them to spend at least one day a year as a volunteer for whatever organization they want to. And if you think about that, with over 400 people, that’s a lot. We also try to carve out monies to give to local charities. We’ve always done that. It’s tough though because we are in a stage of rapid growth, so last year only 40 percent of people took their day. But we want everyone to. We’ve always supported Respite Care and the local Boy Scouts. We make a lot of donations to those kinds of organizations. United Way we are a big supporter of. We also do a drive for the Larimer County Food Bank. We’ve placed in the top two or three in the last three or four years. And then every year we do a big drive for the Salvation Army.

– Maggie Shafer