Emerging Drug Developer: MAP Pharmaceuticals

 

MAP Pharma plots a course toward commercialization

As the CEO of a public company, there are things Tim Nelson can't talk about, such as just about everything that MAP Pharmaceuticals hasn't disclosed to investors.

But every new advance that MAP does make along its clearly plotted business plan has to help equip the developer to reach the next stage of its development. And one of the big goals now is to prepare to start commercializing on its research successes.

So when AstraZeneca committed up to $900 million to partner on MAP's nebulized formulation of budesonide--Unit Dose Budesonide for pediatric asthma--late last week, Nelson was careful to highlight some new support MAP had engineered for itself to help launch the company's commercial operations.
 
"To help us get going they'll be supporting our sales force," Nelson told analysts in a conference call on Friday. If MAP does take the co-promotion option built into the pact, AstraZeneca will fund 60 MAP sales reps for three years and offer tiered funding for the fourth and fifth year. And as AstraZeneca winds down its commercial support, the sales force can pick up on other products that MAP gains approvals for.

With another program in late-stage development, that extra work could start arriving relatively quickly once a new partner signs on.

Says Nelson about the prospect of an additional pact: "I can see that as one potentially positive way to go."

Nelson was sounding particularly upbeat when he took time to discuss the AstraZeneca deal with FierceBiotech. The CEO had to feel good Friday about $40 million in fresh cash AstraZeneca is providing in an upfront fee and the prospect of a $35 million payday on an FDA approval.

And there was another tangible reason for Nelson's positive outlook. MAP's stock value jumped 52 percent Friday as investors got the chance to respond to a rare bit of uplifting industry news.

For MAP, the jump came just weeks after investors bailed on the company, sending its shares down by about half after rising R&D expenses had inflicted a higher-than-expected loss for the quarter. Such is the roller coaster public companies ride today.

Nelson wants to keep the good news coming.

"We started Phase III in pediatric asthma last January and completed enrollment in September," says the CEO. "The last patients will be completing treatment at the end of the year. We'll have the data in the first half of next year."

Another Phase III for migraine--the inhaled MAP0004--started enrolling 850 patients in July, and that work is ongoing. Patients will be studied for response to a single migraine and then enrolled in a long-term follow-up study.

"Realistically, that product is one that would benefit from a partnership," says Nelson, noting the large number of primary care doctors that they would need to market to. But don't expect any specifics. There's been no public discussion identifying a potential new partner for the migraine product.

"I can say that both products have had strong interest," he notes. "They are drugs that are well understood and we're making them better medicines."

MAP has been reformulating well known drugs and then delivering them with its Tempo inhaler in a way that allows researchers to reduce dosage levels, improving responses and lowering the risk of side effects. Budesonide, for example, has been used for more than 20 years.

MAP has two other programs in the clinic--a mid-stage therapy for COPD and an early-stage program for diabetes. But the emphasis right now is on pediatric asthma and migraine.

Says Nelson: "We're going to focus bringing those two products to the market."

Beyond that, the 100 staffers at MAP are also beavering away on additional preclinical programs. But Nelson is keeping his early research cards close to his vest.

"We haven't given guidance on new programs" bound for the clinic, he says. "But we do have a very deep pipeline, with a lot of talented scientists, developing a lot of interesting ideas."

 

Emerging Drug Developer: MAP Pharmaceuticals
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