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Innocrin Granted SME Status by European Medicines Agency

By Barry Teater, NCBiotech Writer

Durham-based Innocrin Pharmaceuticals, a clinical-stage company focused on developing new cancer treatments, has received a regulatory boost for its work in Europe.

The company was granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA). The designation is intended to spur innovation by smaller companies like Innocrin by streamlining European regulatory requirements and reducing fees.

Innocrin is developing an oral drug candidate, seviteronel, to treat castration-resistant prostate cancer and advanced breast cancer.  

"The granting of SME status is an important milestone for Innocrin, allowing us to work with the EMA in an efficient way to progress and expand our innovative development program for seviteronel in Europe,” Fred Eshelman, Innocrin’s chief executive officer, said in a news release.

SME status will provide Innocrin with financial incentives to advance clinical development of seviteronel in Europe, including a 90 to 100 percent fee reduction (depending upon orphan drug status) for scientific advice and quality inspections of facilities along with additional fee deferrals/waivers for selected EMA regulatory filings, the company said.

Streamlining cuts costs

Innocrin will be eligible for EMA certification of quality and manufacturing data prior to review of clinical data, and EMA-provided translation of regulatory documentation required for market authorization, further reducing the financial burden of regulatory approval.

The SME status follows Fast Track designation of seviteronel by the U.S. Food and Drug Administration in December 2015. The Fast Track status gives expedited review of investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.

“Granting of the SME status by the EMA, following FDA Fast Track designation for seviteronel in the treatment of breast and prostate cancer, continues to validate Innocrin and our clinical programs,” said Edwina Baskin-Bey, M.D., Innocrin’s chief medical officer. “The EMA decision, along with expansion of our Phase 2 clinical trials in Europe, will further grow our collaborative development program for seviteronel in androgen receptor-driven cancers.”

Once daily to target cancers in men and women

Seviteronel is a once-daily therapeutic that selectively inhibits CYP17 lyase, an enzyme needed for the synthesis of androgens and estrogens, hormones that can fuel cancer growth. The small molecule also blocks androgen receptors on the surface of cancer cells.

Seviteronel is being investigated in a Phase 2 clinical trial to treat women and men who have estrogen receptor-positive breast cancer or triple-negative breast cancer, and in men with castrate-resistant prostate cancer whose disease has progressed following treatment with abiraterone or enzalutamide, or both.  

Innocrin said its CYP17 lyase inhibitors may have high commercial potential for the treatment of other cancers including ovarian, liver, bladder, and head and neck.

The company also said it plans to develop CYP17 lyase inhibitors for the treatment of non-cancer syndromes that are due to hormone excess, including endometriosis, polycystic ovary syndrome and congenital adrenal hyperplasia.

The CYP17 lyase inhibitors were invented by Durham-based anti-fungals company Viamet Pharmaceuticals. Viamet spun out Innocrin in 2014 to commercialize the cancer treatments.

Innocrin’s investors include the Novartis Venture Fund, Eshelman Ventures, Lilly Ventures, Hatteras Venture Partners, Intersouth Partners, Lurie Holdings and Astellas Venture Management.

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