It was acquired by Gedeon Richter Plc., in October 2010. PregLem is located in Geneva and currently has a 32-member-strong team with expertise in Pre-Clinical and Clinical Product Development, CMC, Regulatory Affairs, Sales and Marketing and Corporate Finance.
PregLem’s pipeline consists of five products that focus on women’s reproductive medicine with significant unmet medical needs that severely impact a patient’s quality of life and fertility such as uterine fibroids (myoma), endometriosis, and post-surgical adhesions. Since its inception, PregLem has in-licensed several products, which are at clinical and pre-clinical stages of development, from Ipsen Pharma (France) (PGL1 & PGL2), HRA Pharma (France) (ESMYA™/PGL4) and Merck Serono (PGL5).
Esmya™ (ulipristal acetate) - PGL4001
In November 2010, PregLem submitted the Marketing Authorization Application (MAA) for Esmya™ (ulipristal acetate), its lead product. Esmya™ is a first-in-class oral selective progesterone receptor modulator (SPRM) which reversibly blocks the progesterone receptor in its target tissues (uterus, cervix, ovaries, hypothalamus) and acts as a potent, orally active antiprogestational agent. It has the potential to be the first of a new class of products for the treatment of Uterine Fibroids (Myoma) and other benign gynaecological conditions. ESMYA™ has successfully completed two Phase III clinical trials in Europe, and pending a positive opinion from the Committee for Human Medicinal Products (CHMP) it is planned to enter the European market with Esmya™ in 2012. In December 2010, PregLem signed an exclusive licensing agreement with Watson Pharmaceuticals Inc., to develop and commercialize Esmya™ in the US and Canada.
PGL1 is a somatostatin antagonist (SST-ATG) with the potential to accelerate the recruitment of resting follicles from the ovarian follicular reserve. This way, more follicles could be made responsive to gonadotrophin stimulation and could eventually produce an oocyte (egg). PGL1 has the potential to become the first treatment for increasing the number of gonadotrophin-sensitive follicles in patients with a diminished or aging ovarian reserve, who undergo Assisted Reproductive Techniques (ART).
PGL2 is an oral once-a-week steroid sulfatase inhibitor (STS) being developed for the management of endometriosis, including pain relief. Steroid sulfatase inhibitors (STS) are enzymes expressed in tissues whose growth is oestrogen dependent. In these tissues, STS converts inactive oestrogens and androgens into their corresponding biologically active forms. PGL2 has the potential to be the first of a new class of products for the treatment of endometriosis and other benign gynaecological conditions.
PGL3 is a marketed, synthetic peptide that Preglem is developing in a proprietary indication as a new, patient-friendly, non-invasive luteal support for patients undergoing Assisted Reproductive Technology (ART) treatment for infertility.
In August 2010, PregLem announced the signing of a world-wide exclusive in-licensing agreement with Merck Serono for a Bentamapimod, a novel and orally active Jun Kinase Inhibitor (JNK-I AS602801), renamed PGL5001 within PregLem. PregLem intends to develop PGL5 for the prevention of post-surgical abdominal adhesions and endometriosis in patients with tubal ligation or comparable effective contraception.