Alnara Bags $35M B Round, Plans to Seek FDA Approval for Cystic Fibrosis Drug

1/28/10

[Corrected 1/28/10, 3:15 pm. See below] Alnara Pharmaceuticals has received a big financial boost at a critical time. The Cambridge, MA-based biotech firm says it has nabbed $35 million in a Series B funding round as it puts the finishing touches on the paperwork it needs to complete before asking the FDA for permission to sell its first product, an enzyme-replacement drug for patients with cystic fibrosis.

The firm’s new investor, MPM Capital, led the second-round financing, which included contributions from Bessemer Venture Partners, Frazier Healthcare Ventures, and Third Rock Ventures. Ashley Dombkowski, a managing director at MPM, is joining the board at Alnara as part of the funding round. With the new capital, the company has now raised $55 million since it was founded in 2008.

Alnara has ambitious plans for how to use its latest infusion of cash. By the end of the first quarter, the firm plans to file a new drug application to get U.S. approval of liprotamase, a pancreatic enzyme-replacement therapy that helps patients with cystic fibrosis to digest fats, proteins, and carbohydrates, according to Alexey Margolin, the company’s co-founder and CEO. The money will be needed to complete the application and prepare for the potential commercial introduction of liprotamase, which could hit the U.S. market as early as the fourth quarter of this year.

Robert Gallotto, the chief operating officer of Alnara, said that the firm expects to rapidly capture a significant portion of the estimated $400 million annual market for pancreatic enzyme replacement therapies in the U.S.

Liprotamase could provide big benefits to both cystic fibrosis patients as well as Alnara’s investors. Pancreatic enzyme treatments have been used for decades by patients whose pancreases are unable to produce enough of certain enzymes that people need to break down and digest certain fats and proteins. Traditionally, the enzymes are harvested from pig pancreases, and patients swallow a few capsules with their meals. Alnara, on the other hand, makes liprotamase with microbial enzymes in a process that is similar to how synthetic insulin is made. [Editor's note: The original version of this paragraph erroneously described liprotamase as a "genetically engineered copy of a natural human enzyme," though it is a recombinant microbial enzyme that is not a copy of human enzyme, according to a spokeswoman for Alnara.]

Alnara believes its treatment has several advantages over those made with pig enzymes. For one, the engineered, or recombinant, enzymes don’t carry the same risk of harboring viruses that the pig enzymes do. (However, Alnara acknowledges this safety risk is largely theoretical, because there have been no reported viral contamination in the previous treatments with pig enzymes.) Also, liprotamase can be taken in much lower doses than existing treatments, because the treatment is designed to prevent the digestive system from degrading its enzymes before they are needed. The company says that its research shows that patients need about five capsules of liprotamase per day, compared with 20 capsules per day for people who take competing treatments. The dominant competitor in this market is … Next Page »

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