• 4 December 2007
    PregLem annoucnes CHF 36 million Series B funding and new licensing agreement with HRA Pharma

    PregLem, a Swiss specialty biopharmaceutical company focused on the development and commercialization of innovative therapeutic compounds for female reproductive medicine, today announced the closing of a CHF 36 million Series B financing round (€22.5 million). The lead investor is Sofinnova Ventures from San Francisco (CA) and returning investors include Sofinnova Partners (Seed Investor and Series A Lead Investor - Paris), MVM Life Science Partners LLP (London), and NeoMed Management (Geneva). The Series B will enable the development of a molecule licensed-in from privately- held French company, HRA Pharma, for the pre-operative treatment of uterine myoma. PregLem has successfully raised CHF 68 million in less than one year.

    Concurrently, PregLem’s Board of Directors has expanded to include Werner Henrich, as Chairman of the Board and independent Director, and Christian Chavy as independent Director. Werner Henrich is Chairman of the Board of Basilea and a member of the Board of Directors of Actelion Ltd, and Addex Pharmaceuticals. An experienced biopharmaceutical executive, Christian Chavy was recently President Business Operations and Member of the Actelion Executive Committee. James Healy MD, PhD, General Partner at Sofinnova Ventures has also been appointed to the Board. Rafaèle Tordjman MD, PhD, Partner at Sofinnova Partners, Dr. Martin Murphy, Partner at MVM, and Dr. Claudio Nessi, Partner at NeoMed, will continue to serve on the Board along with Ernest Loumaye MD, PhD, Chief Executive Officer (CEO).

    “We view the entry of our new lead investor Sofinnova Ventures as confirmation that we have a well-focused strategy, a promising pipeline and the capacity to move forward to meet our planned milestones,” said Ernest Loumaye, MD, PhD, CEO of PregLem SA. “The combined experience of strong investors and seasoned biopharmaceutical executives should support the company in its strategic development and assist us in bringing our compounds to market rapidly in the next few years.”

    “In less than one year, PregLem has demonstrated its ability to in-license a portfolio of promising compounds to improve the treatment of a number of benign female reproductive health disorders,” stated James Healy MD, PhD, General Partner at Sofinnova Ventures.

    PregLem has entered into a licensing agreement with HRA Pharma to develop and commercialize ulipristal, a novel selective progesterone receptor modulator (SPRM) in Europe for various gynecological indications excluding contraception. PregLem is planning the initiation of a pivotal Phase III program for a first indication of uterine myoma in 2008. The agreement allows for the possibility for PregLem to obtain rights for other markets.

    Uterine fibroids (also known as leiomyoma, uterine myoma or myomata) are the most common type of non-cancerous hormone-dependent tumors in the female reproductive system. The condition affects between 20 – 50% of women, and is most common in women between the ages of 30 and 50. Approximately 8-16 million women in Europe have fibroids, of which some 800,000 to 3.2 million have symptoms which could require treatment ranging from heavy bleeding, and pain to urinary incontinence and infertility. It is an under-diagnosed and under- treated condition. Treatment most frequently consists of surgery, and interventional radiology.

    “Every year millions of women suffer from myoma and there is as yet no entirely effective and well-tolerated pharmacological treatment for this condition,” commented André Ulmann, MD, PhD, CEO of HRA Pharma. “I strongly believe that PregLem has the expertise to develop our drug into a convenient, orally-active and well-tolerated treatment and bring it to market successfully.”

    The overall market for PregLem’s pipeline of drugs to treat benign gynecological conditions is estimated around € 2.8 billion, while the market for infertility drugs is estimated to amount around €1.2 billion.