Prolacta develops niche delivering breast milk to hospitals

Twice a day, Jennifer Anderson sits down to pump her breast milk.

Anderson will set aside a little for those times when she isn’t around to nurse her 7-month-old daughter. But most will be shipped to a local processing facility and eventually will feed a stranger’s baby.

That arrangement is made possible by Prolacta Bioscience Inc., a Southern California company with a unique and growing niche.

Since 2005, Prolacta has pasteurized and delivered human milk to hospitals where it nourishes tiny infants born prematurely. The company developed the first human milk fortifier, which is derived from breast milk that replaces products based on cow’s milk. Think of it as a concentrated protein shake for the smallest preemies.

To meet increasing demand for its products, Prolacta on Thursday opened what it bills as the only pharmaceutical-grade processing facility for human milk. The City of Industry plant cost more than $18 million and covers 67,000 square feet. It replaces a Monrovia facility that was less than 10,000 square feet.

“The opening of this facility means that Prolacta can meet the nutritional needs of every extremely premature born infant in the country,” said Scott Elster, Prolacta’s chief executive.

Prolacta’s milk fortifier, early research suggests, can reduce the rate of life-threatening complications for preemies, curbing mortality rates and slashing healthcare costs.

Kaiser Permanente was among the early buyers of Prolacta’s fortifier.

“I was a little bit skeptical at first … but our incidence of [complications] are dramatically lower,” said Dr. Ralph Franceschini, medical director of Kaiser Permanente’s intensive-care nursery in Los Angeles. “This is a whole new shift in how preemies are treated.”

Prolacta has ridden a wave of enthusiasm for returning to the proven practice of feeding babies human milk instead of processed formula.

The company touts its stringent safety measures, which include extensive testing for diseases. That’s important considering a study published this week in the journal Pediatrics found that breast milk bought online was often contaminated with bacteria, including salmonella.

The Academy of American Pediatrics last year reaffirmed the benefits of exclusively breast-feeding infants for their first six months of life. The group also endorsed providing breast milk to premature infants. Doctors stopped short of recommending that donor milk be used because there’s not enough evidence yet.

Prolacta has pushed insurers to cover the cost of its products.

A 4-ounce bottle of pasteurized human milk costs $56, or $14 an ounce. A bottle of the fortifier can cost $125 to $312, depending on the caloric formulation. Prolacta estimates that the cost of feeding an infant the fortifier can range from $5,600 to $10,000 per hospital stay.

Those costs, however, are billed to insurers. The company does not sell directly to parents.

Company executives are negotiating with Medi-Cal, California’s Medicaid program, to ensure that Prolacta-processed milk and fortifier are covered. They’ve had success in states such as Kentucky, which in May passed a law requiring that premature infants be fed an exclusively human milk diet if a doctor has prescribed it.

For privately held Prolacta, which doesn’t disclose revenue figures, a big challenge is supply.

The firm relies at any given time on donations from about 300 mothers, reached primarily through hospitals, nonprofits and milk banks. Prolacta joined this year with a chain of Florida hospitals, BayCare Health System, to run a milk bank.

Hospitals make moms aware that they can donate excess milk, said Elster, Prolacta’s CEO. “The sad truth is thousands and thousands of liters of milk is just thrown away because moms don’t know what to do with it.”

As a further incentive, Prolacta gives $1 for each ounce of breast milk donated to charities it partners with to recruit mothers. They include the Susan G. Komen for the Cure foundation. Hospitals that refer donors also get $1 per ounce of milk received.

Prolacta plans next year to begin paying mothers who send the company milk, Elster said. Details aren’t available yet.

Elster said the company initially didn’t compensate mothers out of fear that some would tamper with the milk.

“What if they want to increase their pay by adding cow milk to their bags?” he said. “What if people add water?… We don’t assume all moms will do any of the above. But we have to be able to protect those kids.”

To that end, the company has developed tests for dilution or other tampering, Elster said.

Though healthcare experts praise the company for its innovation and are excited about the potential of its products, Prolacta has its critics.

Some lactation advocates complain that Prolacta competes with nonprofit milk banks in soliciting milk donations from nursing mothers.

“It’s unfortunate to have a for-profit company selling their milk for such a high cost,” said Kim Updegrove, president of the Human Milk Banking Assn. of North America. “Nonetheless, it’s a free country.”

Updegrove said some of Prolacta’s past marketing to nursing mothers didn’t plainly state that their donated milk would be processed and sold by a for-profit venture.

“There isn’t anything wrong with donating to a for-profit company,” she said. “It’s that you have to be able to make an informed choice.”

Elster said the company changed its materials to clarify what mothers were agreeing to.

To donate excess breast milk to Prolacta, women undergo an evaluation similar to that for donating blood. They’re screened for drug use and diseases such as HIV and hepatitis. A pediatrician must certify that the mother’s baby is being fed properly.

Anderson, who lives in Playa del Rey, said the process was easy, and soon she was shipping milk in ice chests that Prolacta sends through FedEx.

On a recent weekday, after calling for the shipper’s last pickup of the day, she quickly got to work. Anderson had two coolers to fill and a freezer full of frozen breast milk. The yellow-tinged milk was stacked in clear bags alongside the Trader Joe’s frozen meals and ice cream.

Anderson, 32, a former financial analyst who now works as a job recruiter, likes to keep a detailed record of how much milk she ships.

“By keeping a tally mark of how much I’m donating, it’s like my own personal success,” she said.

Since she began nursing this year, she has donated 5,900 ounces of milk, or about 46 gallons.

Prolacta has attracted the attention of Health Evolution Partners, a prominent healthcare private equity firm, which invested an undisclosed amount in 2011.

“We’re very, very picky,” said David Brailer, chief executive of Health Evolution Partners. “We want things that will have a big impact on the care of people.”

Most exciting, Brailer said, was the prospect that a diet of nothing but human milk for premature infants could dramatically cut the rate of complications, including necrotizing entrocolitis, a bowel inflammation that often requires surgery. Death is a risk, and necrosis often adds weeks to an infant’s hospital stay.

“The research showed there was not just a trivial gain in life expectancy,” Brailer said.

The prospect of making a difference attracted Anderson to become a donor. She recalls a friend whose daughter was born three months prematurely, describing those days as scary.

When she tallies up her bimonthly donations, Anderson tries to gauge how many families she’s helping.

“Two ounces for a preemie feeding is maybe a full feeding,” she said. “For every 2 ounces, that’s how many preemies, in my mind, I’ve helped that day.”

ricardo.lopez@latimes.com

Twitter: @rljourno