PregLem Weighs Financing Options Well Ahead Of Uterine Fibroid Drug Launch

Esmya, an oral therapy being developed for symptomatic uterine fibroids, showed non-inferiority to GnRH agonists in a Phase III study.

Geneva-based PregLem will decide on an initial public offering or a Series C financing round by the third quarter in preparation for the expected launch of Esmya (ulipristal acetate) for the treatment of symptomatic uterine fibroids in some countries late next year.

PregLem, founded in 2006 to focus on women's reproductive health issues, plans to make the call for a public or private financing push before it files a marketing authorization application for the drug in Europe around the fourth quarter. Ulipristal acetate is being studied to shrink and alleviate symptoms of uterine fibroids at small daily doses of 5 mg and 10 mg for use up to three months prior to surgery.

Raising more funds is critical for the pharma, which does not yet have a commercial team but is determined to build one. "Our preferred option is to go for commercialization by our own sales force in the main European countries, including the U.K., France, Spain, Germany and Italy," CEO and Founder Ernest Loumaye said in an interview. "To do that we need proper financing ... the market conditions will mainly determine whether we decide to go public."

PregLem raised a total of CHF 68 million ($64.4 million) in its earlier Series A and B funding rounds, the last of which was completed around the time it first in-licensed ulipristal acetate from HRA Pharma in 2007. Its investors include Sofinnova Ventures, MVM Life Sciences Partners and NeoMed.

But the IPO market has been a tough one for biotechs to break into. Slightly more than a handful of companies have gone public so far this year and most of these had to take significant haircuts (Also see "Alimera Raises $72 Million In IPO; Clips Share Price To $11 From Initial $15-$17 Range" - Pink Sheet, 22 Apr, 2010.). Meanwhile, the average value of Series C financings is down as well. The average of Series C financings raised between January and May of this year was $19.77 million, up from $13.58 million in first half of 2009, but down from $25.02 million in 2008 and $36 million in 2007, according to Elsevier's Strategic Transactions Database.

PregLem initially licensed EU rights to develop and market ulipristal acetate for uterine fibroids and other benign reproductive disorders from HRA Pharma in 2007. Then, in April, HRA also agreed to sell PregLem rights to commercialize ulipristal acetate for such uses in the U.S. and Canada (Also see "HRA Pharma Offloads Commercial Rights To Uterine Fibroid Therapy In U.S. And Canada" - Pink Sheet, 15 Apr, 2010.).

Ulipristal acetate already is approved by the European Medicines Agency for use as an emergency contraceptive, sold for this indication under the name ellaOne . In the U.S., HRA has a distribution agreement with Watson Pharmaceuticals, and a new drug application for the novel emergency contraceptive is pending at FDA with an advisory committee review scheduled for mid-June.

But FDA has indicated that PregLem will need to conduct an additional Phase III study for use of ulipristal acetate to treat uterine fibroids with participants from North America before filing in the U.S. A design for that study is expected to be finalized by the end of 2010, with a potential U.S. filing date of late 2012 or early 2013, Loumaye added.

Waiting On Another PEARL

On May 18, PregLem announced that Esmya achieved its primary endpoint in a Phase III study, PEARL II - demonstrating a positive change from baseline in a bleeding intensity (based on a Pictorial Blood Assessment Chart) score after three months of treatment. This is measured according to a patient's report of vaginal bleeding day-by-day.

Using this assessment, Esmya showed non-inferiority in reducing excessive uterine bleeding caused by uterine myomas compared to the standard of care, injectable GnRH (gonadotropin-releasing hormone) agonist, Leuprorelin. The study enrolled 307 patients with symptomatic uterine fibroids who were eligible for surgery and given either once-daily oral 5mg or 10mg doses of Esmya,or Leuprorelin 3.75 mg monthly injections.

Esmya also met two safety secondary endpoints and demonstrated less severe side effects than GnRH agonists, which can cause menopause-like effects. The principle measures of this were serum oestradiol levels and hot flushes.

Now PregLem is awaiting results from the PEARL I study, comparing Esmya to placebo in women with symptomatic fibroids who also have anemia, expected out in June.

Uterine fibroids affect approximately 40 percent of women between the ages of 35 and 55, including 24 million women in Europe and over 20 million women in North America.

-Carlene Olsen ([email protected])