- The U.S. Food and Drug Administration has just agreed to review Tamsulosin DRS, under the rubric of an expedited regulatory pathway. Tamsulosin DRS is Aspen Park Pharmaceuticals' lead drug candidate, a powder formulation of the widely-sold alpha blocker, Flomax, that is meant for the treatment of men with benign prostatic hyperplasia (BPH).
- Aspen Park and The Female Health Company (FCHO), which is best known for the female condom, announced their merger earlier this year.
- While both companies seem to be banking on the success of Tamsulosin DRS, naysayers are wary about the progress that will be made when the two companies combine.
Despite optimism from the companies, the reality is that there is only one FDA-approved product in the entire combined portfolio—the FC2 Female Condom, which generated $33 million in net revenues last year. The hope is that the FDA will clear the way for the company to file Tamsulosin DRS in the near future as the company attempts to stabilize its finances and make good on its commitment to broadening its approved portfolio.
"FDA’s decision to allow us to utilize its 505(b)(2) regulatory pathway is a significant milestone for the accelerated development of our BPH product," said Mitchell Steiner, CEO and president of APP. "The U.S. market for Flomax and its generic equivalents which are currently only available in tablet or capsule form is about a $3.5 billion market. The 505(b)(2) pathway allows us to reference previous findings of safety and efficacy for an already approved product (Flomax®), which substantially reduces our time and cost to further develop the product."
Steiner noted that the companies will only have to conduct a single bioequivalence study to support the filing of a New Drug Application with the FDA. The plan is to begin a three-week study in the fourth quarter and submit the product for approval in early-2017.
The merger will create a company that has a strong presence in both women's and men's sexual health that will operate under the name Veru Healthcare and be led by Steiner. Most of the products in development on the men's health side, including products for prostate cancer-related hot flashes, gout and male infertility, are also intended to provide a novel oral formulation for patients.
On the women's health side, products in development are focused on breast and ovarian cancers, as well as sexual health-related needs, such as lubricants. Both companies have expressed excitement about the potential to leverage their synergies.
"APP brings numerous late and early stage product candidates focused in the areas of oncology and men’s and women’s health, as well as a first-class experienced management team. Importantly, the strategic benefits of the transaction deliver on our objective to add a diversified and complementary mix of products that has the potential to substantially expand our revenue base and grow our business," said O.B. Parrish, chairman and CEO of The Female Health Company in a statement at the time of the merger announcement.