About a month after reporting positive Phase II data for drug candidates in pediatric asthma and migraine, MAP Pharmaceuticals Inc. brought in $50 million in its Series D round to move both products into Phase III testing.

To date, the Mountain View, Calif.-based company has raised a total of $105 million. Funds from the latest round are expected to "get us well into Phase III" with two lead products, said Timothy Nelson, MAP's CEO. "Pending the results of end-of-Phase-II meetings with the FDA," set for later this quarter, "we hope to be entering into Phase III in the last half of this year."

As a firm focused on enhancing the profiles of existing drugs, MAP uses its technologies to create improved formulations that provide better safety and efficacy and more efficient administration. The company employed its submicron technology to develop Unit Dose Budesonide (UDB), a formulation of asthma drug budesonide designed specifically for children ages 5 and younger who aren't yet able to use a dose-metered inhaler. The product is being developed as a prophylactic product to be used twice a day.

Existing products often run into compliance problems because they require "asking a 2-year-old child to sit on your knee and put a mask over their face for several minutes," Nelson told BioWorld Today. UDB so far has shown more rapid nebulization time, he added. In fact, in studies to date, "we're seeing nebulization times at less than half."

UDB also has demonstrated early efficacy at half the steroid load of existing products, which means it could reduce the incidence of local and systemic issues, Nelson said.

Results from a Phase II study reported in late February showed that UDB met its primary endpoints of asthma control in pediatric patients. Asthma control was measured by changes in morning asthma symptom scores compared to placebo and trends in forced expiratory volume in one second (FEV1).

A few days after reporting data from that trial, MAP had more positive news when its second product, Tempo Migraine, also met its primary endpoint in a Phase II study.

An inhaled formulation of dihydroergotamine (DHE), the product is a next-generation metered-dose inhaler developed using the company's Tempo Inhaler platform. Phase II data indicated that Tempo Migraine was well tolerated in subjects with impaired pulmonary function.

The product is designed with a simple administration that allows patients to simply "take a puff" if they feel a migraine coming on, Nelson said. An efficient delivery of DHE, a pharmaceutical ingredient that has been known as a safe and effective product for decades, will help patients "get away from the triptans, which take a long time to work, and get away from the more invasive therapies."

Tempo Migraine is in testing for acute migraine, though Nelson said the company has plans for long-term studies that could support a potential label expansion to treat chronic migraine sufferers.

Earlier in its pipeline, the company has an inhaled insulin program, also based on the Tempo technology. That product features a multidose system with a formulation that does not need to be refrigerated to remain stable and that does not contain the additives found in Exubera, the approved inhaled insulin product from New York-based Pfizer Inc. A proof-of-concept Phase I study demonstrated that MAP's product could be dosed successfully, and its formulation would "allow Type II diabetic patients to carry [the inhaler] in their pockets to use as needed," Nelson said.

At this time, MAP holds sole rights to all of its programs. "That was something we did on purpose," Nelson said, adding that the company intends to pursue commercialization on its own, especially in the U.S. In the area of migraine, the company easily could market to specialists with its own sales team, though it might need to partner to reach the larger general practitioner market, he said. In that case, it likely would seek a co-promotion opportunity, he added.

Outside the U.S., "we recognize there are certain advantages to a partner," Nelson said, though the company has not disclosed any collaboration or licensing deals to date.

The Series D round culled investments by D.E. Shaw group, of New York, which joined all of MAP's previous investors, including the Perseus-Soros Biopharmaceutical Fund, Pequot Ventures, Brookside Capital, Bay City Capital and Skyline Ventures.

MAP's last financing round closed in January 2006, when it added $25.5 million in a Series C. (See BioWorld Today, Jan. 26, 2006.)

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