SAN DIEGO, Calif. (
released new weight-loss data Wednesday from the second of two obesity drugs in the company's development pipeline.
Empatic is a pill that combines the antidepressant bupropion and the anti-seizure medicine zonisamide.
In a phase II study, obese patients treated with a high-dose form of Empatic lost an average of 7.5% of their body weight compared to an average weight loss of 1.4% for patients treated with a placebo.
Patients treated with a lower dose of Empatic in the study lost an average of 6.1% of their body weight.
The trajectory of weight loss from both dosages of Empatic over six months suggests that patients could lose more weight in one-year studies, the company said.
The weight loss observed in Empatic patients was also greater than the weight loss of patients treated with the individual components of the drug -- something the FDA requires for combination therapies, the company said.
Orexigen called the mid-stage study of Empatic a success and said it plans to meet with Food and Drug Administration officials to discuss a phase III study program.
The most commonly reported adverse events for all Empatic patients were headache, insomnia and nausea. The most common adverse events leading to discontinuation were insomnia, headache and urticaria (hives). There were no statistically or clinically meaningful differences between Empatic and placebo on measures of cognitive function, depression, suicidality or anxiety, the company said.
Orexigen has already
of its first obesity drug, Contrave, and expects to seek FDA approval in the first half of next year. Contrave consists of two currently approved drugs combined together to suppress appetite and fight food cravings. One of the drugs in Contrave is naltrexone, currently used to fight opioid and alcohol addiction; the other drug is the antidepressant bupropion.
Orexigen faces competiton in the weight-loss drug arena from
, both of which are also seeking regulatory approval for their respective obesity drugs.
New Breast Cancer Data from Onyx Pharma
(At 6:53 AM EDT)
announced Wednesday results from another mid-stage study of their drug Nexavar in breast cancer, but the new data is not as good as data presented last week.
Technically speaking, this latest phase II study failed to achieve its primary endpoint. Patients treated with Nexavar plus the chemotherapy drug paclitaxel demonstrated a positive trend in progression-free survival compared to patients treated with paclitaxel alone, although the result was not statistically significant, the companies said.
The 237 patients enrolled in this Nexavar study were diagnosed with metastatic Her2-negative breast cancer and had not received prior treatment with chemotherapy.
Onyx and Bayer are withholding details from the study until they can be presented at an upcoming medical meeting. Patients in this study continue to be followed to determine if Nexavar can improve their overall survival.
Wednesday's data is not as strong as results from a
that was presented last week at a medical meeting in Germany.
Onyx is holding a conference call at 10 AM EDT to discuss the Nexavar breast cancer data -- a call that the company
Novartis' Data on Oral MS Drug
reported top-line results Wednesday from a new two-year study of its oral multiple sclerosis drug FTY720 that may assuage some of the concerns about the drug's safety.
A 0.05 mg dose of FTY720 reduced the annualized relapse rate by 54% compared to a placebo and lowered disability progression by 30%. These efficacy results are generally in-line with a competing oral MS drug from
but are not as strong as comparable data generated by Tysabri, the MS drug from
The biggest improvement for FTY720 is on the safety side, where the low dose of the drug showed no increase in infection risk compared to placebo. The cancer rate for FTY720 was lower in this new trial than in a previous trial, including no reported cases of breast cancer.
Analyst Survey: Bullish on Amgen's Osteoporosis Drug
Sanford Bernstein analyst Geoffrey Porges published a research note Wednesday with results of a doctor survey suggesting a strong outlook for
osteoporosis drug Prolia. Porges has an outperform rating on Amgen with a $76 price target.
Most doctors plan to use Prolia in osteoporosis patients who can't tolerate or otherwise can't use oral osteoporosis drugs, or in patients with severe osteoporosis, Porges said, adding that doctors are excited about the convenience of Prolia's twice-a-year dosing.
Porges does caution that he expects the FDA to approve Prolia with a relatively cautious and restrictive label, adding that the agency may miss the drug's Oct. 19 approval decision date because negotiations with the company may take longer than expected.
-- Written by Adam Feuerstein in Boston
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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