MetroWest495 Biz

22 MetroWest495 Biz | February 2014 WHaT IT TakeS marc Tewey CEO, Cambrooke Therapeutics, Ayer An insider's view of how to build and sustain a business. P h o t o / S u S a n S h a l h o u b "our specialty is to focus on very, very unique disease states and build nutritional products around that." c ambrooke Foods recently changed its name to cambrooke thera- peutics to reflect a broader focus. the company was founded in 2000 by lynn and David Paolella after two of their children, cameron and brooke, were diagnosed with phenylketonuria, or PKu — an inability to metabolize the essential amino acid phenylalanine. the ge- netic disease is generally detected at birth. left unchecked, PKu results in developmental disabilities. cambrooke therapeutics provides medical formulas and foods for PKu patients' "diet for life," specially formulated foods free of phenylalanine. marc tewey has been cEo since may. How prevalent is this disease? Only about 20,000 in the U.S. have PKU. About 8,000 of those are treated. About 3,000 to 4,000 are under the age of 18. How is (PkU or similar conditions) like a food allergy, like a peanut or gluten allergy? Peanuts are not necessary. There's no health consequences to not eating gluten. You obviously cannot not eat protein. There's no scenario where you can't eat protein. So that's what really makes PKU (patients') products medical foods, as opposed to just specially modified foods. Gluten-free bread wouldn't be considered a medical food, because it's not specially formulated. Just excluding something isn't a special formulation. What has been the most recent accomplishment for your company? The ready-to-drink product, definitely. That's the protein supplement product people take every day. The challenge (was that you had) to mix it. The challenge is to take all the nutrients that are required … and jam them into a little tiny package and prevent them from fighting with each other, cross-reacting and causing all sorts of stability problems. In order to do that, generally what manu- facturers have done is make very, very high-acid products. This tastes great, this is going to be the first product with neutral acidity … it kind of resembles a chocolate Muscle Milk. We think this is going to be a bit of a game changer, and it's in a con- venient package kids can take to school. It seems like you really do try to appeal to children, like it's about them not feeling different. A lot of the focus is kids. Over time, it will start to shift. Essentially what hap- pened is, anyone over the age of 40 just didn't get diagnosed. Anybody that's today between 40 and 30, what happened to those kids is they were on the phenylalanine- free diet until they were five or six. The logic was, as long as you get through that developmental stage, then you're OK. They would then take them off the diet. Big mistake … because now they've regressed. We know some of those patients and they are definitely affected by the disease. So what happens to your core market? The market gets bigger. At some point they'll basically all be on the diet for life. The cutoff point right now is basically 40; everybody older than 40 did not get diag- nosed. So they're not patients that are treated with low-protein foods. In the future ... everyone will be diagnosed. Talk to me about the events you participate in. Patients are generally treated at big-time academic institutions … so they'll do an educational event about whatever educational studies are going on with PKU, in- formation about different formulas of products … cooking demonstrations, so we're able to tie in nicely with those. As soon as your kid's diagnosed with this, you're part of a community pretty quick. You mentioned a PkU organization that handles lobbying efforts. I imagine lobbying is a pretty important piece. Some states mandate that insurance companies cover these foods. Unfortunately the coverage is better in some areas than in others. In some cases families have to move to a different state. Massachusetts is great. Even if there is a mandate, you're exempt from the mandate if it's a federal program or if it's tied to a federal program of if it's a self-funded plan … it's up to the employer to figure out what they're going to cover and what they're not. Sometimes we even call employers directly. What kind of growth plans do you have moving forward? (We're exploring things like) tyrosinemia, (which is) similar to PKU disease. We hope to have more formula products, drinks and bars. n This interview was conducted by Susan Shalhoub

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