5 Companies Awaiting FDA Approval Decisions In Q1 2012

 |  Includes: AFFY, ALXA, BMY, MAPP, TKPHF
by: David Zanoni

“I will lift up mine eyes unto the pills. Almost everyone takes them, from the humble aspirin to the multi-colored, king-sized three deckers, which put you to sleep, wake you up, stimulate and soothe you all in one. It is an age of pills.” ~Malcolm Muggeridge

For those who missed my previous post on Q4 FDA decision dates for 2011, I have now compiled a list of the FDA decision dates for Q1 2012. I’m pleased to see the ongoing progress in the field of biotechnology to help improve the lives of individuals.

Amylin Pharmaceuticals (AMLN) – Bydureon for diabetes - Decision Date: January 28, 2012

Originally Amylin was partnering with Eli Lilly (NYSE:LLY) to develop Bydureon for diabetes. However, the two companies have recently agreed to end their partnership, with Amylin paying Eli Lilly $250 million and revenue sharing payments of $1.2 billion plus interest. The deal gives Amylin the rights to Bydureon, which is a once-weekly version of its already-FDA-approved Byetta for the treatment of type-2 diabetes. Bydureon looks intriguing because the once weekly dose is a significant improvement over the current Byetta, which needs to be injected twice daily.

Alexza Pharmaceuticals (NASDAQ:ALXA) – Adasuve (staccato loxapine) for schizophrenia-induced agitation – Decision Date: February 4, 2012

There are 2.4 million schizophrenia patients and 5.7 million bipolar disorder patients in the United States. Agitation is a common and severe symptom of these disorders. There are currently eight drugs already on the market to treat the same condition according to WebMD.

Alexza also has the same drug in Phase 2 clinical trial for migraine headaches. It also has four additional drugs in early clinical stages of its pipeline to treat: Breakthrough pain, acute panic attacks, insomnia, and smoking cessation.

MAP Pharmaceuticals (NASDAQ:MAPP) - Levadex for migraine – Decision Date: March 26, 2012

Levadex is a unique inhaled therapy for the potential treatment of migraine. It is designed to provide fast onset of action and sustained pain relief. It has the advantage over oral medicines in that it provides relief within a few minutes.

According to the National Headache Foundation (NHF), approximately 30 million people suffer from migraines, a chronic and debilitating neurological disorder in the United States.

Map has also has a drug for pediatric asthma in Phase 3 clinical trial, a drug for asthma/COPD in Phase 2, and a drug for diabetes in Phase 1.

Affymax (NASDAQ:AFFY) and Takeda (OTCPK:TKPYY) - peginesatide for anemia associated with chronic kidney disease - Decision Date: March 27, 2012

Peginesatide is being co-developed by Affymax and Takeda who plan to commercialize the drug in the United States. The same drug is also in Phase 2 clinical trial for the treatment of anemia in patients with pure red cell aplasia (PRCA). Affymax currently has no other drugs in its pipeline. Takeda currently has nine FDA approved drugs and six drugs in developmental stages.

According to the CDC, there are 4.5 million non-institutionalized people in the United States diagnosed with kidney disease. This accounts for 2% of the non-institutionalized population.


The standout drug in this list in my opinion is Map Pharmaceutical’s Levadex. With 30 million people suffering from migraines in the U.S., I see a lot of potential for a fast-acting inhaled solution for such a debilitating disease. A migraine is more than just a headache: Sufferers can also experience nausea, vomiting, and increased sensitivity to light and sound. I know if I were a migraine sufferer I would welcome a fast-acting inhaled drug over waiting for an oral drug to kick in.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.