Assistant Managing Editor

Swiss specialty biopharmaceutical firm PregLem SA closed a Series B round, raising CHF36 million (US$32.2 million) to support development and regulatory activities for a late-stage selective progesterone receptor modulator (SPRM) it recently in-licensed from Paris-based HRA Pharma.

The financing round is the company's second major cash infusion since its founding in mid-2006 to develop a portfolio focused on benign gynecological conditions, such as uterine fibroids, and infertility. Geneva-based PregLem pulled in CHF32 million in a Series A round in June, concurrent with in-licensing its first products from another French firm, Ipsen SA, for use in reproductive medicine.

The latest funding should provide the "necessary resources to conduct Phase III trials" and bring to market the company's most recent acquisition of ulipristal, a SPRM compound in development for uterine myomas, said CEO Ernest Loumaye.

Also called uterine fibroids, uterine myomas represent the most common type of noncancerous hormone-dependent tumor, affecting anywhere between 20 percent and 50 percent of women, usually between the ages of 30 and 50, with excessive bleeding as the most prevalent symptom. Drug therapy generally is limited to the gonadotropin-releasing hormone (GnRH) class, such as leuprolide, but those drugs carry "very significant drawbacks," Loumaye said. "They induce hot flashes in three-quarters of women, [and can result] in mood disturbances, vaginal dryness and, most importantly, can lead to loss of bone mineral density."

Ulipristal, however, is designed to work by "modulating the progesterone receptor," Loumaye told BioWorld Today. That mechanism results in "several relevant effects," such as the suppression of uterine bleeding and the shrinking of uterine fibroids.

Prior to licensing the product, HRA completed a Phase II proof-of-concept study of ulipristal, showing the drug can be administered orally - as opposed to by injection, as with GnRH drugs - without the side effects observed with the GnRH class, and "we expect to have similar efficacy in a Phase III study," Loumaye said. PregLem anticipates starting that trial next year and completing it by 2010.

At this time, the company holds only European rights to ulipristal, though Loumaye said the firm is in discussions to potentially gain U.S. rights. He declined to disclose specific financial terms of the licensing but said it included milestones and royalty payments.

PregLem also continues to advance the rest of its pipeline. It has PGL2001, a steroid sulfatase inhibitor in development for endometriosis. Steroid sulfatase has been linked to estrogen-dependent conditions, including breast cancer, the indication pursued by licensor Ipsen. The French pharma firm already completed testing in more than 100 healthy volunteers, allowing PregLem, which holds rights to the compound for benign conditions, to go right into Phase Ib testing in January.

In the area of infertility, the company has PGL3001, a synthetic peptide in Phase II development for noninvasive luteal support in patients undergoing assisted-reproductive technology treatment for infertility, and PGL1001, a synthetic peptide for ovarian reserve modulation that has so far shown promise in preclinical models in promoting the transition of primordial follicles into growing follicles. Both of those drugs also were added via the Ipsen deal.

PregLem hopes to expand its pipeline even further. "We are continuing to look and assess opportunities," Loumaye said, adding that the firm is interested in products ranging from early stage to late-stage in the development process.

The company anticipates marketing its own products, at least in Europe, though it might seek distribution arrangements to reach the full 27-member European Union. For marketing in the U.S., the firm likely will look for partnerships, Loumaye said. For now, the company of 12 employees - to expand to the 16-18 range in January - will remain "a very lean organization," he said.

PregLem's Series B round was led by San Francisco-based Sofinnova Ventures, with participation from returning investors Paris-based Sofinnova Partners, London-based MVM Life Science Partners LLP and Geneva-based NeoMed Management.

James Healy, of Sofinnova Ventures, was appointed to the firm's board, joining Loumaye, as well as Rafaele Tordjman, of Sofinnova Partners; Martin Murphy, of MVM; and Claudio Nessi, of NeoMed. PregLem recently expanded the board to include Christian Chavy and named Werner Henrich chairman.

In other financings news:

• Cell Therapeutics Inc., of Seattle, received about $6.5 million from the sale of its 7 percent convertible preferred stock and warrants in a previously announced registered offering to institutional investors. Rodman & Renshaw LLC acted as exclusive placement agent. CTI's stock (NASDAQ:CTIC) closed at $2.57 Tuesday, down 4 cents.

• EpiCept Corp., of Tarrytown, N.Y., priced a public offering of 3.3 million shares of common stock priced at $1.50 each and five-year warrants to buy up to 1.7 million shares priced at $1.50 each for net proceeds of about $4.7 million. Those funds are expected to support general corporate purposes. Rodman & Renshaw LLC acted as placement agent. Shares of EpiCept (NASDAQ:EPCT) closed at $1.30 Tuesday, down 15 cents.