Dare Bioscience Investor Presentation Deck
ADARE 204/214*
Novel 6 & 12-month injectable formulations of etonogestrel being developed as a longer-acting, reversible method of
contraception with a more predictable return to fertility.
There are currently no FDA approved injectable contraceptives available indicated for 6-12 months protection.
-65M women in U.S. are in the reproductive health and contraception market segment¹
The only approved injectable contraceptive product in the U.S. is DEPO-PROVERA CI (medroxyprogesterone acetate) injectable suspension,
which is indicated as every 3 months (13 weeks) administered by deep, intramuscular injection in the gluteal or deltoid muscle.²
Some of the limitations with DEPO-PROVERA include the following: ², 3
1. Requires an injection 4 times per year.
2. Unpredictable return to fertility. After stopping Depo-Provera, the median time to conception for those who do conceive is 10 months
following last injection (range is 4 to 31 months).
3.
Research suggests that Depo-Provera and Depo-SubQ Provera 104 might cause a loss of bone mineral density. This loss might be especially
concerning in teens who haven't reached their peak bone mass. And it's not clear whether this loss is reversible. Thus, Depo-Provera is not
indicated for longer term use (i.e. more than 2 years).
The target product profile potential for ADARE204/214 are 6- and 12- month formulations, minimizing the number of injections required
per year, and with a predictable return to fertility relative to the 6- or 12- month contraceptive window. Active is etonogestrel which does
not have same black box warning regarding bone loss as medoxyprogesterone acetate.4
*505(b)(2) candidate
^Anticipated regulatory pathway. Daré has not had any communications with the
FDA regarding the specific marketing approval requirements for ADARE 204/214
1-CDC National Survey for Family Growth, 2013-2015 dataset, cdc.gov.
2- https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/0202465036lbl.pdf
3- https://www.mayoclinic.org/tests-procedures/depo-provera/about/pac-20392204#:-:text-Among%20the%20things%20to%20consider,birth%20control%20method%20for%20you.
4- https://www.organon.com/product/usa/pi_circulars/n/nexplanon/nexplanon_pi.pdf
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