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European Commission Approves Choriogonadotropin Alfa in Pre-Filled Syringe

GENEVA, Oct. 30 /PRNewswire-FirstCall/ -- Serono S.A. (virt-x: SEO and NYSE: SRA), announced today that the European Commission has approved its new pre-filled syringe for Ovitrelle® (choriogonadotropin alfa).

Designed to make infertility treatment easier for patients, the new Ovitrelle® Solution for Injection is designed so that patients can administer their r-hCG in one single step. Unlike other hCG treatments, the Ovitrelle® Solution for Injection does not require patients to mix medication prior to injection. It is also the only available recombinant version of human chorionic gonadotropin (hCG), one of three hormones required to treat infertility. Essentially equivalent in structure to naturally occurring hCG, Ovitrelle® triggers ovulation in women being treated for infertility.

"hCG administration is a single, once only injection and therefore getting it right is essential to the success of the cycle," said Professor Matts Wikland M.D, PhD of the Fertility Center at Carlanderska Hospital, Gothenburg, Sweden. "Having Ovitrelle® as a liquid in a ready to use pre-filled syringe will make the process significantly easier for patients and help to ensure that they do not incorrectly reconstitute or administer this crucial injection."

The new pre-filled syringe for Ovitrelle® will continue to carry the same indication as the currently marketed product for triggering ovulation and luteinization in women undergoing infertility treatment.

"We are extremely pleased that the European Commission has approved the Ovitrelle® Solution for Injection in a pre-filled syringe," said Hans Christian Rohde, Corporate Vice President, Reproductive Health, Serono. "We are constantly striving to introduce the most consistent products and to deliver them in the most accurate devices to help to increase the treatment efficiency in assisted cycles."

Serono expects Ovitrelle® Solution for Injection in a pre-filled syringe to be available in December, replacing the currently available powder form of Ovitrelle®.

Additional Product Information
Ovitrelle® is one of a complete line of widely prescribed Serono infertility therapies used to promote follicle growth, ovulation and maturation of eggs in the ovaries of women undergoing assisted reproductive technologies (ART), such as in vitro fertilization, and to induce ovulation in women with infertility due to anovulation.

Infertility is defined as the inability of a couple to achieve pregnancy after one year of regular, unprotected intercourse (six months if the woman is over 35). It affects about 10 million Europeans, representing about 10 percent of couples in their childbearing years. Infertility is just as likely to be related to male factors as female factors, which each account for about a third of infertility problems. The remaining third are either a combination of male and female factors or are unexplained.

Source: Serono S.A.

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