Gedeon Richter, the Hungarian pharma giant, entered into an agreement with privately-held HRA Pharma to market ellaOne , a more potent emergency contraceptive, which can be used up to five days after unprotected sex, the firms announced Feb. 17. The drug is pending EMEA approval.

Under the licensing agreement, HRA (based in Paris) will supply the drug to Gedeon Richter for marketing and distribution in seven Central Eastern Europe countries (Bulgaria, Czech Republic, Hungary, Poland, Romania, Serbia and Slovakia) and 12 Commonwealth of Independent States nations (Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine). HRA, which will retain product rights, did not disclose further terms of the deal.

"We targeted Gedeon Richter early on since they are a major player in the field of women's health in Central and Eastern Europe," R&D director Erin Gainer-Monange said in a Feb. 19 interview. Budapest-based Gedeon Richter's gynecological product portfolio - including contraceptives, hormone replacement preparations and treatments for women's health infections - reaches 30 Central Eastern European countries.

HRA also expects to submit a regulatory filing for ellaOne in the U.S. before the end of the year, said Gainer-Monange. If approved, ellaOne would give Plan B (levonorgestrel) its first taste of competition here. Plan B is the only FDA-approved emergency contraceptive available in the U.S. HRA is the original developer of levonorgestrel 1.5 mg.

Outside of the U.S., HRA sells the drug under the brand name NorLevo , though it is marketed in more than 50 countries under other names, as well. In the U.S., rights to Plan B are licensed to Duramed, which became part of Barr Pharmaceuticals, now owned by Teva Pharmaceutical.

In the U.S., emergency contraceptives, and Plan B in particular, have been highly controversial because of anti-abortion opposition. Barr obtained FDA approval in August 2006 to sell the contraceptive over-the-counter (¹ Also see "Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing" - Pink Sheet, 28 August, 2006., p. 3), following a drawn-out political battle that resulted in the resignation of FDA's Office of Women's Health Director Susan Wood.

Classic launch plans for Ella

Levonorgestrel is a synthetic progesterone that inhibits or slows down ovulation when taken within 72 hours of unprotected sex. EllaOne (CDB-2914) is a next-generation, single-dose emergency contraceptive based on the new chemical entity - ulipristal acetate, which is more potent than synthetic progesterone. As such, it will be marketed as a prescription product. HRA, though, is not ruling out a possible OTC switch, which can require five years of post-market experience in some countries.

"Ulipristal acetate is more effective in preventing unplanned pregnancies [than progesterone] even closer to the time of ovulation," said Gainer-Monange. "It can block ovulation at time when Plan B may not."

Despite the compound's potency, studies have shown no increase in side effects compared to progesterone. "What we're seeing in our clinical studies is very run of the mill, common side effects," Gainer-Monange noted. HRA expects an approval decision by the EMEA in the first half of the year.

Once approved, sales reps will take a classical marketing approach, detailing the drug to gynecologists and women's health specialists, and spreading awareness through symposiums. Launch plans will vary on a country-by-country basis to account for local requirements.

"We're planning to spearhead the launch activities in September here in Europe," Gainer-Monange offered. HRA currently leads emergency contraception with more than a 50 percent market share hold in the countries it reaches. Net sales for the firm exceeded €33 million ($41.8 million) in 2008.

A second study

The firm anticipates a U.S. approval in 2010 for ellaOne, the first compound developed solely for emergency contraception, following the completion of a second Phase III study.

The additional study, being conducted in 16 Planned Parenthood clinics, will evaluate about one thousand women who ask for emergency contraception three to five days following unprotected sex - a window of time that stretches beyond Plan B's indication - and opt to participate. The trial, initially expected to be completed in 2007, is now anticipated to end within the next few months.

-Carlene Olsen (c.olsen@elsevier.com)

Gedeon Richter To Market HRA Pharma’s Novel Emergency Contraceptive, ellaOne

More from Archive

More from Pink Sheet