BANGALORE - Results of a late-stage trial of MAP Pharmaceuticals Inc's inhaled migraine drug will represent a critical moment for the company given the recent failure of its other key drug to treat asthma in children.
Analysts say the balance is tipped in favor of the drug, MAP0004, which provides faster pain relief than the current standard-of-care, meeting its goals.
A postive outcome will give a much-needed boost to MAP shares that have shed more than 81 percent since Feb. 23, when the company reported the failure of its pediatric asthma drug, Unit Dose Budesonide (UDB).
It could also attract partnership interest from pharma majors, given the drug's key advantages over existing ones.
I think it should work but with the caveat of industry standards, Wedbush PG Life Sciences analyst Liana Moussatos said, referring to the industry standard of a 33 percent success rate for initial Phase III trials.
She gives the trial a 75 percent chance of success based on the statistically significant reduction in migraine pain seen in MAP0004's mid-stage trial.
The phase II efficacy study showed that the drug provided pain relief as early as within ten minutes, and that this relief was sustained through at least 24 hours.
Moussatos expects the completion of a second late-stage study in the second quarter of 2010, approval in the fourth quarter of 2011 and launch by the first quarter of 2012.
MAP0004 is an orally inhaled version of dihydroergotamine (DHE), which is currently available as an intravenous therapy used to treat migraines for over 50 years.
Given DHE's track record in treating migraine and the positive MAP0004 Phase II data, we are optimistic about the Phase III data, said Ladenburg Thalmann's Matthew Kaplan.
He sees a 50 percent to 80 percent probability of success for the current trial.
If approved, Kaplan says, MAP0004 could bring in more than $200 million in annual sales by 2014. Moussatos estimates gross peak U.S. sales of about $300 million in 2016.
CONCERN ON NAUSEA ENDPOINT
According to the National Headache Foundation, about 28 million people in the United States suffer from migraine, which is characterized by episodic attacks often involving symptoms such as pain, abnormal sensitivity to sound and light, and nausea.
The main efficacy endpoints for MAP's late-stage migraine trial is pain relief and freedom from the other symptoms at two hours.
Phase II data suggest that MAP0004 improves the first three components very well, Leerink Swann's Joseph Schwartz said.
However, the fourth item (nausea) is more difficult to impact.
Ladenburg's Kaplan explains another concern: They need to hit on all four of the endpoints at the two-hour time point. You could have an impact on all of these but if you hit it at three hours, you miss the endpoint.
Both analysts are projecting a 2011 launch for the drug, assuming success of the late-stage trials.
However, MAP would need a partner to market the drug and a promising first late-stage trial should help it get one.
This would be a broadly marketed drug and you would need an experienced salesforce, Kaplan said.
Leerink's Schwartz agreed.
The company would probably be able to reach specialists on their own but they would want a partner to reach a broad prescriber base, said Schwartz, who sees a 70 percent chance of the current trial succeeding.
MAP0004 could be attractive to a big pharma company given its advantages over existing drugs, such as low incidence of side effects and the rapid onset of pain relief -- as early as about 10 minutes while standard-of-care takes about an hour.
Triptans, often prescribed for migraines, may constrict arteries, while nausea is a common side effect of intravenous DHE administration, according to MAP's website. Nasal administration of DHE may cause inflammation of the nasal membrane, the website said.
The drug's differentiating factors may draw out partnership offers from the largest players in the pain market like Pfizer Inc (PFE.N), GlaxoSmithKline, Johnson & Johnson and King Pharmaceuticals Inc, analysts said.
Moussatos also expects AstraZeneca Plc, which already has an agreement with MAP for UDB's development and marketing, to be interested in partnering MAP0004.
Schwartz said a $60 million partnership for the product in the fourth quarter of 2009 was a possibility. (Editing by Vinu Pilakkott)