By Anne O’Connor
AYER — A marvelous thing happened after a jeweler, her architect husband and her businessman brother put their heads together.
“We made a difference,” Lynn Paolella said. “It really started with an inspiration to feed my kids.”
Thousands of children across the world are leading a healthier life thanks to Cambrooke Therapeutics.
Lynn and her husband David have three children, the two youngest, Cameron and Brooke, were born with a rare disease, phenylketonuria or PKU.
The only way to manage the disease that can cause intellectual disability and other health problems is a diet that minimizes exposure to phenylalanine, an amino acid in protein, yet provides enough protein for the body.
The amino acid is present in many foods even things like potatoes. It is also a main ingredient of the sweetener Aspartame.
Until 2009, the accepted treatment for the disease was based on synthetic protein without phenylalanine. “They protected our kids’ brains,” David Paolella said, but the diet was unpalatable.
Lynn set to work, developing recipes that her children would want to eat. “I love to cook and I absolutely loved the challenge of this low-protein diet,” she said.
In 2000, those early attempts led to a new business, Cambrooke Therapeutics. It started out as a family business with just the Paolellas and Lynn’s brother Don Patterson. They developed the food, outsourced manufacturing and made connections all around the world.
Now, the Ayer-based medical food manufacturer is increasingly automated with clients across the globe. It employs over 50 people between manufacturing sites in Ayer and Brockton and a European office in Cyprus.
Development of PKU treatment is covered under the Orphan Drug Act, David Paolella said. The act covers drugs and treatment for diseases affecting small numbers of people.
PKU, an inborn error of metabolism, occurs in about 1 in every 10,000 births in the United States. When caught at birth and managed successfully, the children can thrive. If left untreated, mental retardation results.
The disease is easy to catch in newborns. The screening test was developed by a Massachusetts doctor, Robert Guthrie, in the 1960s. His photo is on the wall of the ground floor conference room in Ayer.
Cambrooke is at the cutting edge of medical nutrition. In 2009, the University of Wisconsin in Madison developed a way to make a protein without phenylalanine from whey, a cheese-making byproduct.
“They approached us,” Lynn Paolella said.
The protein tasted lots better than the synthetic product and Cambrooke licensed the technology. A peer-reviewed study funded by the National Institutes of Health and the Food and Drug Administration proved the safety and effectiveness of the protein.
Along the journey, the company worked with the Small Business Development Center at Clark University in Worcester. “I knew this was bigger than me,” Lynn Paolella said.
They moved into a former electronics plant in Ayer, drawn to the area by the other beverage and food companies. The building required a multi-million dollar makeover to become a sterile place to manufacture and package beverages.
Food is made in Brockton. “We make all of our products from scratch,” Lynn Paolella said.
The liquids products are put into sterile packaging, David Paolella said. The product will not spoil at room temperature. However, over time, the nutrients in the liquid will degrade.
Their equipment is the only setup in the county that can turn out cost-effective, sterile packages in small batches of 20 to 30 cases, he said. Most beverage manufacturers will produce the same product for days before changing.
Cambrooke makes food products for other inborn error of metabolism diseases. They also make high-fat food that can manage and sometimes even completely stop seizures for those with intractable epilepsy that is not controlled by drugs.
The products allow people who must follow strict diets in order to remain healthy the chance to live a life just like everyone else.
“In essence, we’re a grocery store of products they can eat,” David Paolella said. Some want flour to make cookies, others would rather have cookie dough to bake and some want packages of cookies.
When Cameron and Brook who are now 24 and 19, their older brother Bryce, 26, sit down to eat with the family, everyone might eat Cambrooke products. Or maybe not. The PKU diet is vegetarian, but mom and dad like their meat.
The company works to bring their product to the people who need it.
Three of the hospitals where families are sent after receiving a diagnoses of a disease that can be treated by diet are in Massachusetts. They go home with information about Cambrooke after their first visit.
Working with the Massachusetts Export Center and The U.S. State Department, Cambrooke established overseas markets. The incidence of PKU is higher in other countries.
They just met with a Chinese mother, who began manufacturing PKU-friendly food after her child was diagnosed. Until recently, if a child in China had PKU, there was no government help. Babies were left by the side of the road to die, Lynn Paolella said.
An export deal could be in the works. The market would be huge. The disease is more common there than it is in the U.S., she said.
The test kitchen, with two sinks, large ovens and seating for a crowd, sees everyone from groups of dietitians to families learning to deal with the restrictive diet. A playroom upstairs keeps little ones busy while older folks learn.
Enabling people and families to live with the diagnoses is another challenge Cambrooke took on.
Some of the diseases treated by diet must require lifelong management. An iPhone app helps patients keep track of their nutrition.
Cambrooke can bill insurers directly, making it easier for their clients.
Schools are required to supply special diets when needed. The school lunch program Lynn Paolella developed is used in about 400 schools, the closest one in Groton.
The meals just need to be heated up and the child with a restricted diet can eat with friends.
The Paolellas are strong and caring advocate for patients. They know their food works. Cameron has graduated from university and Brooke is a sophomore.
Health care benefits are not consistent across the country, David said. Some states do not even require newborn testing for PKU. The test might be sent out of state to be read. If the lab will include PKU results, out-of-state health care providers might not give them to parents.
Some states limit support until age 6. That means children can start to lose IQ points, David said.
Lynn went to Washington, D.C. to advocate for the Medical Food Equity Act, requiring insurance plans to cover formula and low protein foods. The act died in committee.
The business remains a family business at heart. Bryce Paolella helped with developing a new product.
Lynn and David Paolella are the founders and work with the company daily.
Don Patterson is the vice president of operations.
Lynn and Don’s mother gives the products her own blessing. Marilyn Patterson helps out with packaging; she plants a kiss and a prayer of goodwill in each box she prepares.
Follow Anne O’Connor on Twitter and Tout @a1oconnor.