With one set of positive phase III data under its belt and the next expected later this month, completing a European filing for its lead product, private Swiss company Preglem certainly looks like it could be a much-needed success story in the sector.
Last month, the Geneva-based group which specialises in female reproductive health, reported positive results from its Pearl II phase III study of Esmya (PGL4001), its product for uterine fibroids. The drug was pitched head-to-head with the only other currently approved product on the market, leuprorelin.
Esmya not only showed non-inferiority against leuprorelin in terms of reduced excessive bleeding ahead of operative treatment, but also outperformed with regard to safety and tolerability and demonstrated fibroid shrinkage.
Uterine fibroids are thought to affect 44 million women in Europe and the US and are characterised by excessive bleeding that can be so severe it causes anaemia. It is also often accompanied by pain and can cause infertility. In the absence of effective treatments in severe cases some women have hysterectomies to put an end to symptoms.
Speaking to EP Vantage Ernest Loumaye, founder and chief executive, reveals the group is now gearing up to submit Esmya for European filing in the fourth quarter of this year and hoping for a possible launch in 2011, all depending on the outcome of the Pearl I study, which is expected this month.
Explaining his plans for the future Mr Loumaye is looking to establish a sales force for the drug to crystallise as much profit as possible. “Our ambition from the beginning was to commercialise PGL4001 ourselves in the top five European countries,” he says.
What should help with approval is the fact that the drug, which was developed by HRA Pharma, is already approved for use as an emergency contraception in Europe under the name EllaOne.
Established in 2007 Preglem was spun out of Ipsen, where Mr Loumaye was head of endocrinology. The business was founded using PGL2001, an endometriosis treatment, and fertility drug PGL1001, which were supplemented by lead product PGL4001, that Preglem licensed from HRA in December 2007.
The company raised SFr68m ($59m) from two funding rounds, which coupled with a convertible loan is expected to last until mid 2011.
Preglem believes that it has found a sweet spot in the women’s reproductive medicine market that as a whole is estimated to be worth €4bn ($4.9bn) annually. Rather than targeting the over-the-counter and largely generic oral contraception market or the menopausal, HRT and osteoporosis market Preglem is instead focusing on uterine fibroids and endometriosis, which has been traditionally underserved and has a easily identifiable physician population.
If the reaction of Neurocrine Bioscience’s shares are anything to go by following its report of positive phase II data for its treatment for endometriosis, another hard-to-treat female reproductive disorder, then Preglem certainly looks as if it is onto a winner (Positive endometriosis data could be start of Neurocrine resurrection, May 27, 2010).
European and beyond
Esmya’s benign safety profile should also help it do well given that GnrH agonists are the only approved treatment for uterine fibroids, but have limited use due to their severe side effects. In effect they drop oestrogen to castration levels resulting in hot flushes, depression, mood swings and loss of bone density.
As such, Mr Loumaye has high hopes for European revenues. “We are estimating that we will exceed a couple of hundred million euros of sales,” he says.
These sales could grow even further if the group manages its other ultimate goal for Esmya, to get it into chronic use rather than just pre-surgical.
But first the group must show positive results in the phase III Pearl I trial expected this month, which will test the efficacy of Esmya in reducing excessive bleeding and shrinking fibroids compared with placebo. If the group can replicate the phase II data, which showed more than 90% of patients reporting reduced bleeding and a 60% reduction in fibroid volume after 12 weeks of treatment, it stands a good chance of approval.
The trial data could also help Preglem with its plans to partner the product in the US. The group is hoping that the ink could be dry on a deal by the end of the year, which should usefully add to its cash runway.
However, given that Esmya is not expected to launch in Europe until the end of 2011 there will be a funding gap.
What observers of the private company will be most eager to find out is how this will be filled. At the moment Preglem says it is keeping its options open. But with one phase III product that is expected to be filed this year and another in phase II, some will surely be speculating that an IPO, depending on market conditions, could be on the cards.