Staff Writer

In its first deal with a major drugmaker, MAP Pharmaceuticals Inc. has joined with London-based AstraZeneca to develop and commercialize a nebulized form of budesonide, a potential treatment for pediatric asthma that could work more quickly and at a lower dose than AstraZeneca's blockbuster asthma drug Pulmicort.

MAP's unit dose budesonide currently is in Phase III testing and is designed to work in three to four minutes compared to the 10-15 minutes that it can take for the asthma drug Pulmicort to kick in.

Under the deal, AstraZeneca will pay MAP Pharmaceuticals an up-front cash payment of $40 million and an additional $35 million if the study's main endpoint is achieved and it has good safety results in the ongoing Phase III trial.

MAP also may be eligible to receive up to $240 million in other potential development and regulatory milestones as well as sales performance-related milestone payments of up to $585 million if the product is a considerable success plus double-digit royalties.

In MAP's Phase III study, the last patient is expected to complete the 12-week treatment period by the end of the year. A second confirmatory Phase III trial would be required to seek U.S. marketing approval for unit-dose budesonide (UDB).

Both Pulmicort and MAP's product candidate contain the same core ingredient, budesonide, which has been in use clinically for more than two decades. Mountainview, Calif.-based MAP hopes to take this fairly well understood medicine and make it work better, Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals, told BioWorld Today.

Using technology licensed from Dublin, Ireland-based Elan Corp. plc, MAP has come up with a way to make budesonide - a medicine that doesn't dissolve in water - "act more like a solution" by making the drug particles smaller, Nelson explained.

MAP's reformulated budesonide could provide a new option for treating children with asthma, David Brennan, CEO of AstraZeneca, said in a statement. By joining forces with MAP, he said, "new areas of opportunity" could open up for both companies and "bring significant medical benefit to the wider community."

MAP and AstraZeneca will develop UDB in the U.S., and AstraZeneca has rights to develop and commercialize UDB outside of the U.S. Under the agreement, AstraZeneca will be responsible for future UDB development costs and AstraZeneca will reimburse MAP for the costs of future UDB development activities with respect to U.S. registration incurred by MAP.

If UDB ultimately is approved, AstraZeneca will fund the establishment of a MAP Pharmaceuticals' sales force to co-promote it in the U.S. for a certain period of time after the product launch.

Founded in 2004, MAP went public just over a year ago and employs about 100 people. Its deal with AstraZeneca could fulfill the company's goal of being a commercial company, Nelson said. He said his firm hopes to learn the ropes of building a sales infrastructure from its experienced partner.

AstraZeneca would fund MAP's sales force of up to 60 representatives. For the first three years, the U.K. drugmaker would fund 100 percent of those costs, decreasing to 75 percent and 50 percent in the fourth and fifth years, respectively, Nelson said.

MAP ended the third quarter with $63 million, and its cash burn rate has been $15 million a quarter.

Shares in MAP Pharmaceuticals (NASDAQ:MAPP) were up $1.06, or 23 percent, closing Friday at $5.65.

Published  December 22, 2008