Additional data for MENOPUR* (HP-hMG)

Lausanne, Switzerland – January 22, 2004 –

The new data was based on a sub-analysis of the landmark trial EISG (European-Israeli Study Group) which was designed to demonstrate non-inferiority of MENOPUR¹ (HP-hMG) when compared with rFSH² in nearly 700 IVF and ICSI patients.

Further analysis showed impressive results: the ongoing pregnancy rate in the 233 women who underwent IVF was significantly higher in the MENOPUR group (31%) compared with the rFSH group (20%), (p=0.037) . – a difference of 50%.

The results from the study which were published in an abstract at the American Society for Reproductive Medicine in October 2003, were presented in more depth today at the Updates in Infertility Congress in Marco Island, Florida. The study analysis also showed that although fewer oocytes were retrieved in the MENOPUR group vs. rFSH group, MENOPUR had a clear beneficial effect on the pregnancy rates in women undergoing IVF.

IVF procedures make up more than 60 percent of all ART (assisted reproduction treatment) procedures.

The conclusions from this analysis will be confirmed in a state-of-the-art prospective, multi-national, comparative study powered to demonstrate superiority of MENOPUR vs rFSH in IVF patients. The trial will be launched next month.

Researchers are confident that the results of EISG will be confirmed as MENOPUR and that LH activity will be an important contributor to pregnancy. Several studies conclude that the LH activity/hCG has several positive effects: it stimulates the development of high quality large follicles and it diminishes the number of small follicles which hypothetically could reduce the risk of Ovarian Hyperstimulation Syndrome (OHSS).

Interestingly new data also suggests that LH/HhCG activity may have a beneficial effect on the blood flow in the endometrium consequently improving the chances of successful egg implementation.

Adequate hCG levels during treatment with MENOPUR appear to have a favourable impact on ongoing pregnancy rates in IVF and ICSI patients, but more markedly in IVF.

The authors suggest that the beneficial effect of the LH activity in MENOPUR seen in IVF patients could also be mediated by “cumulus oophorus” cells which are present during the IVF and not during the ICSI procedure.

“It is becoming increasingly evident that MENOPUR will challenge and will likely replace rFSH in the treatment of infertility with IVF,’ said Dr. Pascal Danglas, vice-president of Clinical and Product Development at Ferring. ”Studies like this are important because they provide evidence to identify the gonadotropin most likely to work best in which procedure. With the result of the new study, MENOPUR must be considered one of the most effective treatments in IVF therapy today. ”

“And from a patient’s perspective this is also big news. What this means is that with MENOPUR, you have a higher chance of pregnancy if your procedure is IVF, he said.

EISG Study Details

The EISG (European-Israeli Study Group) was an open-label, randomised, multi-center, multinational study to demonstrate non-inferiority of HP-hMG compared to rFSH on going pregnancy rates

• Patient’s: In this study, 727 women were exposed to gonadotrophin treatment, of whom 691 had either IVF (n = 233) or ICSI (n = 458) performed.
• Intervention: Three-hundred and seventy-three women received HP-hMG (Menopur®, Ferring Pharmaceuticals A/S) and 354 received rFSH (Gonal-F®, Serono) according to a long protocol with a GnRH agonist.
• HP-hMG (MENOPUR) vs rFSH (GONAL-F), subcutaneous route.
• IVF/ICSI and embryo transfer procedures according to center practice. Transfer of 1-3 developed embryos.
• Luteal support according to center practice.

Infertility on the Rise

Globally, 14% of couples are facing problems with infertility and the number is increasing, mainly because many women are opting to postpone motherhood. In the group of 30-35 year olds, the infertility rate increases to 25%. One third of births are by women above 30 years of age.

Today, reproductive medicine offers a variety of procedures to assist couples in achieving pregnancy, but more than half of the couples with more than two years of infertility still fail to achieve pregnancy. With advances in infertility research and wider availability of newer techniques, the success rate of infertility treatment is rising but there is a continuous need for new and more effective treatments.

About Ferring Pharmaceuticals

Ferring is a research driven, speciality biopharmaceutical group active in global markets.  The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynecology, infertility and urology. In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.

To learn more about Ferring or our products please visit us at
www.ferring.com.

For more information, please contact

Sharmi Albrechtsen
Corporate Communication Manager, Ferring International Center
+45 28 78 72 09
sharmi.albrechtsen@ferring.com

References

1. MENOPUR is a registered trademark of Ferring BV and/or one of its affiliates.
2. GONAL-F is a registered trademark of Serono.

Ferring grants Dr. Frederik Paulsen Memorial Award in Japan

Copenhagen, Denmark – 22 September, 2003 –

Earlier this month, Ferring Pharmaceuticals granted the Dr. Frederik Paulsen Memorial Award in Neurosciences. The award winner, Dr. Yamashita from the Tokyo Medical and Dental University, received the award for the best poster at the World Congress of Neurohypophysis Research (WCNR) in Tokyo, Japan.

Dr. Yamashita’s poster described her research in identifying several proteins in the kidney that are involved in regulation of water transport in the kidney and concentration of urine.

‘Research in this area will hopefully in the future make it possible for us to further determine ways of modulating urine production, giving us safer and more predictable medicines in voiding dysfunction as Nocturia, bedwetting and possibly also incontinence,’ said Dr. Jens Peter Nørgaard, Executive Director, Medical Sciences, Urology.

The award was launched this year in the field of Neurohypophysis Research to commend scientific endeavours of special interest to Dr. Paulsen, the founder of Ferring. Dr. Paulsen was particularly intrigued by the pituitary gland and the use of neuropeptide hormones in medicines.

“Dr. Frederik Paulsen was a pioneer in this area. He welcomed the freedom to explore new avenues of research especially with regards to peptides,” said Dr. Nørgaard.

Many of Ferring’s products today are related to neurohypophysis work including vasopressin, oxytocin, growth hormone, ACTH, FSH and GNRH. “Ferring has been involved with multidisciplinary research since 1952 and has contributed to defining the impact that urinary production has for social continence”, said Dr. Nørgaard.

The WCNH aims to promote and advance the fields neurohypophysial hormones and related active substances in the brain, kidney and reproductive organs and to enhance the ties among scientists in the world.

About Ferring Pharmaceuticals

Ferring is a research driven, speciality biopharmaceutical group active in global markets.  The company identifies, develops and markets innovative products in the areas of urology, obstetrics and infertility, gastroenterology and endocrinology.  In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.

To learn more about Ferring or our products, please visit us at www.Ferring.com.

For more information, please contact

Sharmi Albrechtsen
Ferring International Center
+45 28 78 72 09
sharmi.albrechtsen@ferring.com

FDA APPROVES BRAVELLE™ (urofollitropin for injection, purified)

Tarrytown, NY, USA – May 6, 2002 –

FERRING’S NEW HUMAN-DERIVED FOLLICLE-STIMULATING HORMONE FOR INFERTILITY TREATMENT

New Highly Purified Alternative To Genetically Engineered
Infertility Treatments

Ferring Pharmaceuticals, a world leader in naturally occurring protein hormones, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Bravelle™ (urofollitropin for injection, purified), a highly purified, human-derived follicle-stimulating hormone (hFSH) for the treatment of infertility. Bravelle™, in conjunction with human chorionic gonadotropin, is indicated for ovulation induction following pituitary suppression.

“With the introduction of Bravelle™, Ferring has expanded its family of human-derived hormones to include a highly purified, well-tolerated hFSH with proven efficacy in ovulation induction, a critical step in many infertility treatment protocols,” said Wayne Anderson, president of Ferring Pharmaceuticals.

“Based on the fact that recombinant technology has shown no meaningful advantage in either efficacy or safety in the clinic, Ferring remains committed to the development of human-derived products in order to seek improvements in ovarian stimulation protocols. Ferring has submitted an application to the FDA seeking additional indications for Bravelle™ in infertility treatment. This application, which is supported by additional clinical studies, brings the total number of patients studied to 577. This application is currently under review by the FDA.”

A Human-Derived FSH Proven as Safe and Effective as Genetically Engineered FSH

Bravelle™ was compared to follitropin beta, a recombinant FSH, in a prospective, parallel group, multicenter trial in 111 oligo-anovulatory patients undergoing ovulation induction. Patients underwent pituitary suppression with a GnRH agonist prior to being randomized to Bravelle™ SC, Bravelle™ IM or follitropin beta SC. Results showed that there were no significant differences in efficacy and safety between the treatment groups.

In addition to the studies supporting the new drug application, Ferring has recently completed two Phase 3B clinical trials involving 24 centers. These trials evaluated the use of Bravelle™ together with Repronex® (mixed protocol), Ferring’s human menopausal gonadotropin, in the same syringe, in two age groups. The first study evaluated the use of a mixed protocol in 108 women ages 18 to 33 years; the second trial evaluated 120 women ages 34 to 40 years. This is the first time a prospective, systematic clinical evaluation of single daily dose mixed protocols has been conducted anywhere in the world.

Bravelle™: The Natural Choice

Bravelle™ is affordably priced, an important benefit since infertility treatment is generally not fully covered by insurance. It is available for both subcutaneous and intramuscular injection. Most patients prefer SC administration because it is more convenient and causes less discomfort.

Added Anderson, “Bravelle™ is ideally suited to meet the needs of infertility specialists and their patients by providing an affordable solution that combines human derived hormone efficacy with recombinant hormone-like purity.”

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe Bravelle™. Like all gonadotropins, Bravelle™ is a potent substance capable of causing mild to severe adverse reactions, including ovarian hyperstimulation syndrome (incidence of 8.2%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

Background on Human-Derived Hormones

The key differences in human-derived and genetically engineered infertility treatments are raw material sources and cost. Human-derived FSH treatments are highly purified follitropins extracted from the urine of postmenopausal women. By comparison, genetically engineered products are derived from the secretions from Chinese hamster ovary cells that are cultured in fetal calf or other mammalian serum, and approximate human hormones. Both are manufactured in compliance with extremely strict standards (including viral inactivation and confirmatory testing), but human-derived products are generally less expensive than their genetically engineered counterparts.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle™, Repronex® and Novarel® in the U.S. to infertility specialists and their patients.  The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility.

For more information, call 1-888-337-7464 or visit www.ferringusa.com.

For more information, please contact

Marilyn Seiger
Kovak-Likly Communications
203.762.8833
mseiger@klcpr.com

Sharmi Albrechtsen
Communication Manager, Ferring International Center
+45 28 78 72 09
sharmi.albrechtsen@ferring.com