Orexigen Weight-Loss Pill Shows Surprise Heart-Safety Benefit

LA JOLLA, Calif. (TheStreet) -- Obese Americans taking Orexigen Therapeutics' (OREX) Contrave to lose weight cut their risk of having a heart attack, stroke or dying from heart disease by almost half compared to people taking a placebo, according to results from a large heart-safety study disclosed for the first time Tuesday.

The new data were culled from a relatively early, interim analysis and may change as the study continues, but for now, the news is very good for Orexigen and its weight-loss pill Contrave. When Orexigen began this study, the goal was to rule out significant heart safety risk tied to Contrave. Instead, the data so far show Contrave may actually contribute to a heart-safety benefit for those who use it.

Orexigen used the new Contrave heart-safety data to win a new patent which extends intellectual protection for the drug another seven years to 2034. If published or included in Contrave's label, the data could also provide a big marketing advantage over competitors Arena Pharmaceuticals  (ARNA) and Vivus (VVUS)

Orexigen shares reacted positively to the new Contrave data, jumping 53% to $8.86 in Tuesday trading, a new 52-week high for the stock.

OREX Chart

The 9,000-patient LIGHT study is being conducted to determine the heart-safety profile of Contrave. Orexigen had previously announced that an interim analysis at 25% of events ruled out an increased risk in heart-related events tied to Contrave.

On Tuesday, Orexigen revealed for the first time that Contrave patients experienced 35 MACE events compared to 59 MACE events for placebo patients. A MACE event is defined as a heart attack, stroke or heart-related death. From a statistical standpoint, the interim analysis showed a 41% reduction in the risk of a heart-related adverse event for Contrave compared to placebo. The benefit was statistically significant.

Orexigen will conduct a second, interim look at the study at 50% of events, which is expected in a few weeks. The company is also required to conduct a second heart-safety study as a condition of Contrave's U.S. approval.

RBC analyst Simos Simeonidis says the heart-safety benefit shown with Contrave is important and surprising, especially because the patients enrolled are representative of the types of people who would use Contrave in the real world. He cautions, however, that the interim analysis was based on relatively few events, so as the study continues, the benefit tied to Contrave may decrease or disappear altogether. Even if the heart-safety benefit of Contrave dissipates as the LIGHT study progresses, Orexigen's ability to leverage the data into additional patent protection is a win, Simeonidis adds.

The U.S. launch of Contrave, handled by the Japanese drug company Takeda, has been strong, with significant market share gains made against competitors Arena and Vivus in a relatively short period of time.

European regulators have recommended Contrave's approval and Orexigen is awaiting a final decision there.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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