The European Commission granted marketing authorization for privately-held HRA Pharma's novel emergency contraceptive ellaOne in 27 countries May 15, with the first wave of product launches expected this fall.
HRA plans to emphasize that ellaOne (ulipristal acetate), also trademarked ella, can be used up to five days after unprotected sex, CEO Erin Gainer said in an interview. This is a longer window of time than HRA's currently marketed emergency contraceptive NorLevo (levonorgestrel), known as Plan B in the U.S., which is most effective within 12 to 24 hours after unprotected sex, and approved for use up to 72 hours.
EllaOne will be priced at a premium to levonorgestrel, given its greater potency, Gainer said. She did not release pricing details, but said HRA is evaluating whether to launch without reimbursement. An attempt to gain reimbursement could prolong launch efforts and is not a likely win, considering levonorgestrel is not reimbursed in countries where it is sold by prescription.
The EMEA granted ellaOne, a new chemical entity, a positive recommendation in March, shortly after HRA entered into an agreement with the Hungarian pharma Gedeon Richter to market the drug in seven Central Eastern European countries ("The Pink Sheet" DAILY, Feb. 19, 2009).
HRA expects ellaOne will face the most competition in markets where levonorgestrel is approved for over-the-counter sales, such as France, the UK, Portugal, Spain and Scandinavia. While in markets such as Germany, "we have good reason to think ellaOne will take a sizeable share," Gainer said, noting that there levonorgestrel is a prescription product.
A pan-European approval is a sort of Catch-22 for drug makers - at once a welcome OK for companies to market in several countries under one approval while, at the same time, agreeing to comply with often tedious country-specific regulations for new drugs. Labeling, for example, must be translated and approved in local languages for each country, in addition other requirements.
"The launch of ellaOne will be a progressive roll-out for this reason," Gainer said, adding that the drug should be available throughout the EU by early 2010, following the initial launches this fall.
Pharmacists' role important, even with Rx sales
In marketing ellaOne, HRA hopes emergency contraceptives will resurface as a mainstay in physician-patient conversations.
"This is an opportunity to bring emergency contraception back to the doctor's office. In a lot of countries, physicians have stopped talking about emergency contraceptives because they see them as an OTC method," Gainer added.
In addition to reaching out to physicians, HRA also plans to educate pharmacists. Though ellaOne is not yet approved for OTC sales, HRA is hoping to tap into some existing programs where physicians grant specially-trained pharmacists the right to distribute a limited number of prescription contraceptives as they see fit. Programs like this are in place in the UK, with legislation pending for similar measures in France, Gainer said.
"Pharmacists have really become an important factor in providing emergency contraceptives," Gainer said, noting the importance of educating pharmacists.
U.S. filing expected late 2009
In the U.S., HRA is "in the process" of wrapping up a second Phase III trial for ellaOne, Gainer also said. Preliminary results are slated to be released at the European Society of Gynecology annual meeting in Rome this September. That study evaluated approximately 1,000 women who asked for emergency contraception three to five days following unprotected sex.
HRA plans to file an NDA with the FDA before the end of 2009, Gainer said. If approved, ellaOne would be the first competitor to Plan B, which is the only FDA-approved emergency contraceptive available in the U.S.
Ulipristal acetate also is in development for indications outside of emergency contraception, including uterine fibroids.
-Carlene Olsen (c.olsen@elsevier.com)
This article also appeared in "The Pink Sheet" DAILY – May 27, 2009
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