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FDA Approves Pre-Mixed Fertility Treatment, Delivered Via Pen Device

ROSELAND, N.J., March 24 /PRNewswire/ -- The Food and Drug Administration (FDA) today announced approval of Follistim(R) AQ Cartridge (follitropin beta injection). Follistim(R) AQ Cartridge is the first follicle stimulating hormone (FSH) treatment available in a pre-filled, pre-mixed solution, approved in the U.S., eliminating the need for patients to mix one or more vials of medication. Follistim(R) AQ Cartridge is designed to be used only with the Follistim Pen(TM), an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, a highly effective and widely used prescription fertility medication made from state of the art recombinant DNA technology. Follistim(R) AQ Cartridge, for use with the Follistim Pen(TM), is prescribed for women undergoing assisted reproductive treatments (ART) such as in vitro fertilization (IVF), and for the induction of ovulation to achieve pregnancy. Follistim(R) AQ Cartridge for use with the Follistim Pen(TM), provides women with a discreet, convenient method to self-administer fertility treatment with ease and confidence using the unique dial-a-dose feature. Organon USA Inc. markets Follistim(R) AQ Cartridge and Follistim Pen(TM).

"Fertility treatment can create anxiety for patients, in large part because they have to mix, measure and inject the medicine themselves," said Samuel Pang, MD, Associate Medical Director, Reproductive Science Center of Boston, and an investigator in the Follistim(R) AQ Cartridge/Follistim Pen(TM) clinical trials. "This innovative method of delivering FSH makes the process go smoothly, because the medicine is already mixed and the patient just has to dial the correct dose. Also, the micro-needle and small volume of medication may contribute to patient tolerability of the injection."

Follistim(R) AQ Cartridge for use with the Follistim Pen(TM) provides physicians with the flexibility to fine-tune a drug protocol for each patient. While at the same time, patients can be assured that they are receiving an accurate dose when self-administering Follistim(R) AQ Cartridge using Follistim Pen(TM), which was rated as easy to use by patients who participated in clinical trials.

The Follistim(R) AQ Cartridge is available in two convenient strengths of 300 and 600 IU, providing multiple doses from one single cartridge. Unlike other FSH products on the market, Follistim(R) AQ Cartridge does not require mixing.

"Organon is pleased that the FDA has approved Follistim(R) AQ Cartridge for patients experiencing infertility," said Michael Novinski, President, Organon USA Inc. "The introduction of Follistim(R) AQ Cartridge for use with the Follistim Pen(TM), enhances Organon's position as a leader in the development, production and marketing of innovative, patient friendly fertility treatment."

Results of clinical studies have shown that self-injection with Follistim(R) AQ Cartridge for use with Follistim Pen(TM), is safe, convenient and well tolerated by patients. According to a recent study conducted by Samuel Pang, MD et al.(1), the lead author for the Follistim Pen(TM) COH Study Group, of the 60 women who participated in the study, 98.3 percent rated the overall experience of self-injecting with the Follistim Pen(TM) as "very-good" to "good" on day six of treatment.

Follistim(R) AQ Cartridge administered with Follistim Pen(TM), delivers on average an 18 percent higher amount of follitropin beta compared to lyophilized preparations administered by a conventional syringe and needle. The difference is due to the accurate dosing obtained with the Follistim Pen(TM) compared to a conventional syringe and needle.

Like all gonadotropins, Follistim(R) AQ Cartridge is a potent substance capable of causing mild to severe side effects including ovarian hyperstimulation syndrome (OHSS), with or without pulmonary or vascular complications. Treatment with Follistim AQ(R) Cartridge may result in multiple gestations. Follistim(R) AQ Cartridge should be used only by physicians who are experienced in infertility treatment and should advise their patients of treatment risks, including OHSS and multiple births. Please refer to the package insert for a complete list of side effects.

Infertility affects about six million American couples, approximately 10 percent of the reproductive age population. The Centers for Disease Control reports there were nearly 110,000 cycles of assisted reproductive technology in year 2001.

Source: Organon USA Inc.

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