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Belviq Finally Hits the Market

Arena Pharmaceuticals’ highly anticipated weight-loss drug, Belviq, will go on sale on Tuesday, the San Diego company announced today.

Arena’s marketing partner, the Japanese pharmaceutical company Eisai, will actually sell the drug, which received approval from the U.S. Food and Drug Administration nearly a year ago.

Arena says it will use the revenue to develop more drugs in its pipeline. Belviq is Arena’s first product to reach the market, a crucial milestone for a biotech company.

Eisai has said Belviq will cost $200 a month wholesale; the price patients pay will vary depending

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Arena makes Belviq at its manufacturing plant in Switzerland, and sells it to Eisai for a purchase price starting at 31.5 percent of Eisai's annual net product sales. The price rises to 36.5 percent of the annual net sales exceeding $750 million. Arena said it is also eligible to get $1.19 billion in other payments based on Eisei's annual net sales of Belviq.

Belviq is to be used along with diet and exercise under a doctor’s guidance. The drug suppresses appetite in a way similar to the neurotransmitter serotonin, but more selectively. That selectivity makes Belviq safer than existing drugs, says Arena co-founders Jack Lief, chief executive, and Dominic Behan, executive vice president and chief scientific officer.

However, newness in a drug has disadvantages. It took much longer for Belviq to reach the market than a rival drug from Mountain View-based Vivus, even though both were approved by the FDA at about the same time.

The FDA approved Belviq on June 27, and the Vivus drug, Qsymia, on July 17. Vivus started selling Qsymia on Sept. 18. Because Belviq is new, it received months of scrutiny from the U.S. Drug Enforcement Administration, which is required to rank drugs on a schedule for potential abuse.

The DEA ranked Belviq on May 7 as a Schedule 4 drug, indicating a relatively low risk for abuse. Qsymia is also rated Schedule 4. Qsymia is a combination of two existing drugs, phentermine, a stimulant and appetite suppressant; and topimirate, an anti-seizure medication.

However, Qsymia’s head start hasn’t closed the door on Belviq. Sales of Qsymia have been modest to slow, according to quarterly reports from Vivus. In the quarter ended March 31, Vivus reported Qsymia net revenue of $4.1 million. On the whole, the company had a net loss of $53.6 million, or 53 cents per share. Arena lost $18.9 million, or 9 cents per share, in that quarter.

Shares of both Arena and Vivus are down from last summer, when their drugs were approved, with Vivus falling more sharply.

Vivus shares closed at $29 on July 18, the day after approval; the stock closed Thursday at $14.10. Arena shares closed at $9.33 on July 30, the trading day after approval. On Thursday, the stock closed at $8.66.

Moreover, Arena’s market value of $1.89 billion currently surpasses that of Vivus, valued at $1.42 billion.

Arena and Vivus aren’t the only competitors with new weight-loss drugs. San Diego-based Orexigen has produced its own contender, Contrave.

However, the FDA declined to approve Contrave in 2011, sending the drug back for more testing. Orexigen is in the process of gathering that evidence in a new clinical trial called the Light Study.

Behan led development of Arena's drug discovery technology. The technology targets molecules on cell surfaces called G-Protein Coupled Receptors. These GPCRs are among the most common cell receptors, and so present a big target for drugs for various diseases.

Behan has co-authored many scientific papers, including one published in 2002 about the use of GPCRs to discover drugs affecting the central nervous system.


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