November 3, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Palatin Technologies announced on November 1 that its Phase III study of bremelanotide met its co-primary endpoints in hypoactive sexual desire disorder, or low sex drive in women. What is not completely clear is whether the company moved the target.
In the most recent release, Palatin indicated that “Based on discussions with the FDA, it was decided that the co-primary endpoints for the Phase III clinical trials were the Female Sexual Function Index: Desired Domain (FSFI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO) Item 13. Satisfying sexual events is a second endpoint.”
As TheStreet points out, that’s not what Palatin has claimed before. “ClinicalTrials.gov lists ‘satisfying sexual events’ and FSFI-D as co-primary endpoints of the bremelanotide Phase III studies. FSDS-DAO is the secondary efficacy endpoint. Moreover, the co-primary endpoints are supposed to be measured after 32 weeks, not 24 weeks as claimed by Palatin on Tuesday night.”
“We could not be more pleased with the bremelanotide Phase II co-primary endpoint results,” said Carl Spana, president and chief executive officer of Palatin, in a statement. “Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis.”
But the company has emphasized the drug’s effectiveness in improving desire and decreasing distress associated with sex, but not discussed frequency of sex. But frequency was originally supposed to be one of two co-primary efficacy measurements in the trial.
Adam Feuerstein, writing for TheStreet, says, “When you add in the inability to increase the frequency at which women are engaging in satisfying sex and the requirement that women inject themselves 45 minutes before engaging in sex, bremelanotide’s libido-boosting qualities look decidedly less hot.”
Palatin’s took a slight bounce at the news, although that’s probably not saying much. Shares traded on November 4, 2015 for $0.55. They dropped to $0.39 on March 15, 2016, rose to a high of $0.81 on July 29, and on November 1, 2016 were trading for $0.48. They are currently trading for $0.55.
Although the stock probably moved up because of the news release, which should raise a few questions, it was also affected by rumors that the company may be an acquisition target. The company hired Greenhill & Co. to explore a potential sale, although there’s no particular news about who might acquire the company.
Joshua Rodriguez, writing for CNA Finance writes optimistically of Palatin’s news, saying, “The loss of sexual desire is a serious matter, and the complications that come with that loss include low self-esteem, relationship problems, divorce, low self-image and a lesser quality of life. What those with a strong libido may take for granted is a debilitating hardship for others. And, it is Palatin’s hope that what Viagra did for men bremelanotide will do for women.”
One way or the other, despite the current $0.55 share price, three analysts have given the stock a “Buy” rating with an average price target of $4.67.
