Uterine fibroids (myoma) are the most common benign, solid tumours of the female genital tract in women of reproductive age. The cardinal symptoms of uterine fibroids are excessive uterine bleeding, heavy menstrual bleeding, anaemia, abdominal pain and pressure, increased urinary frequency and infertility1. Beyond its physical morbidity, the condition is a frequent cause of significant impairment of quality of life2 and a leading reason for hysterectomy3. The main therapy for uterine fibroids is surgery (with hysterectomy as the most invasive option), myomectomy and uterine artery embolisation, and in some cases endometrial ablation. As a medical approach to treating symptomatic uterine fibroids, GnRH agonists have been shown to be effective but their use is restricted due to their side effects (bone mineral density loss, castration symptoms). Gynaecologists have long called for an effective medical treatment which can alleviate the symptoms related to fibroids and reduce fibroid volume.
Patients of Uterine fibroids (UFs) represent a large, underserved market due to the absence of satisfactory medical treatments. UFs affect approximately up to 40% of women between the ages of 35 and 55, including 24 million women in EU and 20 million in North America with over 7 million patients currently under various symptom management regimens. Several hundred thousand women undergo surgery every year for UFs in the EU and North America.
Esmya® (Ulipristal Acetate / PGL4001)
PregLem’s most advanced product, ESMYA® (Ulipristal Acetate/PGL4001), 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® (Ulipristal Acetate/PGL4001) has successfully completed two Phase III clinical trials in Europe and has confirmed its efficacy and safety for the treatment of symptomatic uterine fibroids in patients prior to surgery. PregLem filed a European Marketing Authorisation Application (“MAA”) for ESMYA® (Ulipristal Acetate/PGL4001) with the European Medicines Agency (“EMA”) in late 2010 and received a Positive Opinion by the CHMP for the pre-operative treatment of moderate to severe symptoms of fibroids in December 2011. The European Commission (EC) granted marketing authorization to Esmya® 5mg tablet as a pre-operative treatment of moderate to severe symptoms of uterine fibroids in February 2012.
1 Vercellini P, Bocciolone L, Colombo A, Vendola N, Meschia M, Bolis G, Gonadotropin releasing hormone agonist treatment before hysterectomy for menorrhagia and uterine leiofibroids, Acta Obstet Gynecol Scand. 1993 Jul;72(5):369-73
2 Spies JB, Coyne K, Guaou GN, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease specific symptom and health related quality of life questionnaire for leiomyomata. Obstet. Gynecol. 2002; 99:209-300
3 Jacobson GF, Shaber RE, Armostrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet. Gynecol. 2006; 107:1278-1283