DEA Scheduling Helps Arena
Reza is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.
Patients, doctors, and investors endured a six-month wait for the United States Drug Enforcement Agency (DEA) to schedule Belviq (lorcaserin hydrochloride), the first weight loss drug approved in 13 years by the FDA. Arena Pharmaceuticals (NASDAQ: ARNA) stands to substantially benefit from the success of Belviq as the obesity epidemic effects more than 100 million Americans, an estimated 500 million patients globally. Belviq is also effective in treating type 2 diabetes (T2DM), which is another huge market in itself. Even a 1% market penetration means a much higher valuation than its current one.
"Schedule 4 drugs, such as Xanax, Valium, and Ambien, have the next-to-lowest potential for abuse on the DEA's five-part schedule. Schedule 1 drugs, such as LSD and marijuana, are considered by the DEA to have a high potential for abuse and no accepted medical use. Schedule 5 drugs, such as Robitussin, contain low amounts of narcotics."
Prior to the announcement, a representative from the DEA told me that they have received so many calls inquiring about Belviq that they have assigned a liaison to take those calls. Many people also wrote emails to the DEA. Some of these can be found here.
The strong public anticipation for Belviq may be indicative of a strong launch that will occur as soon as Belviq's scheduling is finalized by the DEA. The next step in the process is a 30-day public comment period which ends on January 18, followed by a period in which the DEA reviews the comments, and a standard waiting period before the drug can be marketed. However, Federal regulation allows for exceptions due to "conditions for public health or safety necessitate an earlier effective date."
The DEA should, and I am cautiously optimistic that it will, grant an exception for Belviq so that the average wait time of 49 days since filing of the proposed rule (which started on December 18th), can be shortened to the minimum of 30 days, which means Eisai could theoretically initiate the launch late January instead of late March. This two-month expedition can have a significant positive impact on millions of lives.
Belviq would not be the first drug to receive expedited treatment, and surely, after a 6-month wait, patients and doctors seriously deserve the expediting. The DEA has granted an expedited process for other drugs such as zopiclone, pregabalin, ezogabine; and Belviq's necessity is much more important than all those drugs given the crippling epidemic of obesity. Arena's partner, Eisai, has filed a petition with the DEA to grant an earlier effective date, presenting a strong argument.
With completion of scheduling Arena will collect a $65 million milestone payment from Eisai which will boost Arena's already strong balance sheet.
Other obesity drug makers, i.e., Vivus (NASDAQ: VVUS) and Orexigen Therapeutics (NASDAQ: OREX) don't need to go through the DEA scheduling process because unlike Arena whose drug is a single noble agent, a newly discovered molecule, Vivus and Orexigen's drugs, Qsymia and Contrave, are combinations of existing compounds which are either not, or have already been scheduled as, controlled substance. Arena has already announced that it will pursue a number of trials involving combination therapies, and use of Belviq for other indications such as smoking cessation.
Eisai has been busy preparing for the launch. Eisai is no stranger to blockbuster launches as it has launched other blockbusters in the past and partnered with other Big Pharmas in boosting its sales presence.
Craig Audet, Arena's Senior VP of Operations & Head of Global Regulatory Affairs said in a recent presentation that he was flabbergasted at Eisai's preparedness for launch using an "army" of sales people.
Dr. Steven Vig who has thousands of patients and has been in internal medicine practice in Tucson, AZ since 1982, told me recently that many of his patients are eagerly waiting for Belviq, and he believes Belviq will have a very strong launch. He was one of the first doctors who was convinced Belviq would get approved while Wall Street was busy shorting ARNA. For Arena investors, a strong launch could mean substantial gains in market cap.
The views expressed above are NOT investment advice and are NOT medical advice. Please always do your own research. I am long ARNA and have no positions in the other stocks mentioned above. To find out more about my interests please visit www.rezamusic.com. If you like to join my private Arena-related mailing list send an email to (info -- at -- rezamusic -- dot -- com).
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