In six different phase 2 trials enrolling 355 women, the Pill-Plus increased frequency of sexual activity, arousal, responsiveness to partner, and other measurements of satisfaction. BioSante licensed the rights to the combination in pill form to Netherlands-based Pantarhei Bioscience, which is looking for a pharma partner to run the larger, more expensive phase 3 trials.
Good luck with that. Boehringer Ingelheim, Pfizer
The Pill-Plus could run into the same issue that LibiGel did. The subjective nature of the readout for sexual desire can result in a high placebo effect that is hard to overcome. If a pharma partner is going to foot the bill for the late-stage trials, it'll want to leave that risk in the hands of BioSante and Pantarhei by linking most of the milestone payments to clinical and regulatory success.
Even though it'll only get royalties on sales of the Pill-Plus, the combo pill could be a big money maker for BioSante. And the biotech still owns rights to the transdermal-patch form of the product, which it could license out as well.
Just keep in mind that BioSante is still playing in a very high-risk, high-reward indication. Keep your expectations for getting lucky in check.
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