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Ferring Pharmaceuticals Announces Immediate Availability Of Degarelix For The Treatment Of Advanced Prostate Cancer

Ferring Pharmaceuticals, USA announced the U.S. commercial availability of degarelix for injection (trade name pending), a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone sensitive advanced prostate cancer.

Degarelix is available for order through traditional and specialty pharmacy distributors. Degarelix provides fast, long-term suppression of testosterone, a hormone that stimulates prostate cancer growth.1-3 Clinical trials demonstrated that degarelix is effective in quickly reducing and sustaining castrate levels of testosterone.2,3 Degarelix works differently than a luteinizing hormone-releasing hormone (LHRH) agonist by binding immediately and reversibly to GnRH receptors in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone. In the Phase III study vs. leuprolide, the degarelix group achieved a 90 percent decrease in median testosterone levels at Day 3 of treatment, compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels. By Day 3, 96 percent of degarelix patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. In addition, degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2 percent of the degarelix patients maintaining medical castrate levels compared with 96.4 percent for leuprolide.

Study findings also showed that prostate specific antigen (PSA) levels were lowered by 64 percent two weeks after administration of degarelix, 85 percent after one month, 95 percent after three months, and remained suppressed throughout the one year of treatment.1,2 These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

"Degarelix, the lead product in our urology portfolio, demonstrated both a rapid onset of action and a profound long-term suppression of testosterone," said Wayne Anderson, President and CEO Ferring Pharmaceuticals Inc., USA. "Now, advanced prostate cancer can be treated with a direct-acting GnRH receptor antagonist inducing rapid reduction of testosterone and sustaining those levels over time, meeting the goals of systemic therapy. We are excited to provide this effective new treatment option for men fighting advanced prostate cancer."

Approved by the FDA on December 24, 2008, degarelix represents Ferring Pharmaceuticals' first global launch and the second urology product launch for Ferring Pharmaceuticals, USA. The European Commission granted marketing authorization for degarelix on February 19, 2009. Degarelix is awaiting approval in other key global markets.

Phase III Study Results

The 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelix compared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous (under the skin) injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intramuscular (into the muscle) injections of leuprolide depot 7.5 mg (n=201). The primary endpoint was testosterone suppression to ≤50 ng/dL during monthly measurements from Day 28 to Day 364. Degarelix was at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.

Suppression of testosterone levels to ≤50 ng/dL occurred significantly faster in patients receiving degarelix than in those receiving leuprolide. At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels, compared to the leuprolide group which experienced a 65 percent increase in median testosterone levels. The most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gammaglutamyltransferase (GGT). Ninety-nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of patients receiving degarelix.

Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Longterm androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

About Degarelix

Degarelix is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone sensitive advanced prostate cancer. As a receptor antagonist, degarelix reversibly binds to the GnRH receptors in the pituitary gland, immediately suppressing the secretion of the luteinizing hormone (LH), follicle-stimulating hormone (FSH), and subsequently, testosterone levels.4 Degarelix also reduces levels of prostate-specific antigen (PSA). Unlike LHRH agonists, such as leuprolide, an established treatment for prostate cancer, degarelix does not induce an initial testosterone surge. Degarelix is administered monthly by subcutaneous injection. The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg. Degarelix is available for order through traditional and specialty pharmacy distributors. The average monthly cost of one year of degarelix treatment is comparable to other hormone treatments for prostate cancer.

About Prostate Cancer

Prostate cancer is the most common cancer, excluding skin cancers, and the second leading cause of cancer death in American men. About one man in six will be diagnosed with prostate cancer during his lifetime, and one in 35 will die of this disease.5 Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man's life, although it can grow and spread quickly.6 The four types of standard treatment are: watchful waiting, surgery, radiation therapy, and hormone therapy, also called androgen deprivation therapy (ADT).

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of urology, orthopaedic and infertility products in the U.S. market. They include: EUFLEXXA® (1% sodium hyaluronic acid), BRAVELLE® (urofollitropin for injection, purified), MENOPUR® and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, ACTHREL® (corticorelin ovine triflutate for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), Degarelix for injection, and DESMOPRESSIN.

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology and infertility. For complete prescribing information, call 1-888-FERRING (1-888-337-7464) or visit http://www.FerringUSA.com.

1 Degarelix [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc; December 2008.

2 Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538.

3 Van Poppel H, Tombal B, de la Rosette JJ, Persson B-E, Jensen J-K, Olesen TK. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker-results from a 1-yr, multicentre, randomised phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008;54(4):805-813.

4 Doehn C. Immunotherapy of Prostate Cancer. Eur Uro. (2006);53-4:681-683.

5 American Cancer Society. How Many Men Get Prostate Cancer? http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_many_men_get_prostate_cancer_36.asp?sitearea=

6 American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=36; Last accessed 11/12/08.

About Degarelix

Degarelix (trade name pending), commercialized by Ferring Pharmaceuticals, is a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of hormone sensitive advanced prostate cancer.

How Degarelix Works

GnRH binds to the GnRH receptor in the pituitary gland and plays a key role in suppressing the production of testosterone. As a GnRH receptor antagonist, degarelix reversibly binds to GnRH receptors in the pituitary gland, immediately suppressing the secretion of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and subsequently, testosterone levels.1 Degarelix also reduces levels of prostate-specific antigen (PSA). Unlike LHRH agonists, such as leuprolide, an established treatment for prostate cancer, degarelix does not induce an initial testosterone surge.

Administration

Degarelix is administered monthly by subcutaneous (under the abdominal skin) injection. The starting dose is 240 mg, followed by monthly maintenance doses (every 28 days) of 80 mg.

Phase III Study Results

Prostate cancer is known to grow in the presence of testosterone. Degarelix causes a rapid, sustained reduction in testosterone to castrate levels (<50 ng/dL). Phase III studies showed that degarelix is effective in sustaining castrate levels of testosterone and had a significantly faster reduction of testosterone compared with leuprolide.2,3 The 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelix compared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intramuscular injections of leuprolide depot 7.5 mg (n=201).

The primary endpoint was testosterone suppression to ≤50 ng/dL during monthly measurements from Day 28 to Day 364. Degarelix was at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.

Suppression of testosterone levels to ≤50 ng/dL occurred faster in patients receiving degarelix than in those receiving leuprolide. At Day 3, the degarelix group achieved a 90 percent decrease in median testosterone levels. Conversely, the leuprolide groups experienced a 65 percent increase in median testosterone levels at Day 3. Degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364). Degarelix also reduced PSA levels.

After 14 days of degarelix treatment, median PSA levels had declined by 64 percent from baseline. After one month, PSA levels had dropped 85 percent and after 3 months levels were lowered 95 percent, and then remained suppressed through the study period (one year).2,3 These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

Important Treatment Considerations

The most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gammaglutamyltransferase (GGT). Ninety nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of patients receiving degarelix.

Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

Development and Marketing

Ferring Pharmaceuticals developed degarelix through a collaboration with the Salk Institute for Biological Studies in San Diego, CA. Degarelix received FDA approval on December 24, 2008. Potential trade names are still under review with the FDA. The European Commission granted marketing authorization for degarelix on February 19, 2009. Degarelix is awaiting approval in other key global markets.

About Ferring Pharmaceuticals, USA

Ferring Pharmaceuticals, USA is part of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. In urology, Ferring markets Degarelix and PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate).

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 888-FERRING (888-337-7464) or visit http://www.FerringUSA.com.

1 Doehn C. Immunotherapy of Prostate Cancer. Eur Uro. (2006);53-4:681-683.
2 Degarelix [prescribing information]. Parsippany, NJ : Ferring Pharmaceuticals Inc ; December 2008.
3 Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538. 03/09

About Ferring Pharmaceuticals, USA

- Headquarters
4 Gatehall Drive, Third Floor
Parsippany, NJ 07054
Phone: 973-796-1600; Fax: 973-796-1660
Web site: www.FerringUSA.com

- Established in the U.S. in 1981. The parent company, Ferring Pharmaceuticals, was founded in Sweden in 1950.

- An international biopharmaceutical company, Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds and innovative products in the areas of urology, gastroenterology, endocrinology, orthopaedics, obstetrics/gynecology and infertility. Founded in Sweden by Dr. Frederik Paulsen, the company name honors the Friesian Island of his birth, Föhr, the inhabitants of which are called "Ferrings."

Ferring Pharmaceuticals, which is privately owned, has more than 3,200 employees worldwide and maintains a corporate presence in most of the world's largest markets. The company operates in more than 45 countries; its products are distributed in more than 70 countries. When Ferring Pharmaceuticals, USA was established in 1981, its mission was to develop innovator compounds and then license the marketing rights to other pharmaceutical companies. By the end of the 1980s, the Company decided to begin marketing under its own name, with its own marketing force.

Ferring-discovered structures closely resemble those found naturally in the body to minimize undesirable side effects and help achieve desired results with low doses. Traditionally, Ferring has concentrated its research on modifying posterior pituitary hormones to develop new peptide-based pharmaceuticals, but recent years have led to work with other substances such as GnRH analogues, enzyme inhibitors and oxytocin receptor blockers.

For full prescribing information on all Ferring products, visit http://www.FerringUSA.com.
- Product Line
Urology

DEGARELIX

Degarelix (generic name) is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of hormonallysensitive advanced prostate cancer. Degarelix binds reversibly to the GnRH receptors on cells in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone. Clinical study results showed that degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364). At Day 3 of treatment, 96 percent of degarelix patients attained castrate levels of testosterone, compared with zero percent receiving leuprolide.

Important Safety Considerations

Overall, the most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). Ninety nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving degarelix. Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

PROSED® DS

PROSED® DS is indicated for the relief of discomfort of the lower urinary tract caused by hypermobility resulting from inflammation or diagnostic procedures and in the treatment of cystitis, urethritis and trigonitis when caused by organisms which maintain or produce an acid urine and are susceptible to formaldehyde.

Important Safety Considerations:

Prosed DS is contraindicated in patients with hypersensitivity to any of its ingredients. Risk-benefit should be considered when the following medical problems exist: glaucoma, urinary bladder neck obstruction, pyloric or duodenal obstruction or cardiospasm. Prosed DS is not for use in patients under the age of 12. Prosed DS is generally well tolerated. Adverse reactions include: cardiovascular: rapid pulse, flushing; central nervous system: blurred vision, dizziness; respiratory: shortness of breath or troubled breathing; genitourinary: difficult micturition, acute urinary retention; gastrointestinal: dry mouth, nausea/vomiting.

Orthopaedic

EUFLEXXA® (1% sodium hyaluronate)

EUFLEXXA® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics (e.g, acetaminophen)

Important Safety Considerations:

EUFLEXXA should not be used in people who have had any previous allergic reaction to hyaluronate preparations or who have knee joint infections or skin diseases in the area of the injection site. Common adverse events reported were arthralgia (joint pain) and back pain. Temporary knee pain and swelling may occur after injection. Strict aseptic technique must be followed to avoid joint infection.

Fertility Treatments

ENDOMETRIN® (progesterone) Vaginal Insert, 100mg

ENDOMETRIN® administered as progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

Important Safety Considerations:

Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to two percent included: uterine spasms (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than two percent. ENDOMETRIN is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness)

MENOPUR® (menotropins for injection, USP)

MENOPUR® administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.

Important Safety Considerations:

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe MENOPUR. MENOPUR, like all gonadotropins, is a potent substance capable of causing mild to severe reactions, including OHSS (overall incidence of 3.8%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

BRAVELLE® (urofollitropin for injection, purified)

BRAVELLE® administered SC in conjunction with human chorionic gonadotropin (hCG) is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. Bravelle administered SC or IM, in conjunction with hCG, is indicated in patients who have previously received pituitary suppression.

Important Safety Considerations:

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe BRAVELLE. BRAVELLE, like all gonadotropins, is a potent substance capable of causing mild to severe reactions, including OHSS (overall incidence of 6.0%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

REPRONEX® (menotropins for injection, USP)

REPRONEX®, in conjunction with hCG, is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.

Important Safety Considerations:

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe REPRONEX. It is a potent gonadotropic substance capable of causing mild to severe adverse reactions in women. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and its use requires the availability of appropriate monitoring facilities. In female patients it must be used with a great deal of care. REPRONEX, like all gonadotropins, is a potent substance capable of causing mild to severe adverse reactions, including OHSS (incidence of 3.5%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.

NOVAREL® (chorionic gonadotropin for injection, USP)

NOVAREL® is designed to mimic the action of pituitary luteinizing hormone (LH) and is used during ovulation induction therapy to trigger egg release. NOVAREL is indicated for induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Important Safety Considerations:

NOVAREL should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births and (4) Arterial thromboembolism.

Devices for fertility treatment

Q•CAP™ needle-free reconstitution device

Q•CAP™ enables needle-free reconstitution (process of dissolving medication in diluent) of fertility treatments. It is for exclusive use with Ferring's line of fertility treatments. The device allows user-friendly reconstitution of medication(s) in a single vial, in single or mixed protocols, simplifying preparation for injection and eliminating product waste and accidental needle sticks.

Other Ferring products

ACTHREL® (corticorelin ovine triflutate for injection)

ACTHREL® is the first stimulation diagnostic agent for the differential diagnosis of Cushing's syndrome. It is indicated for differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome. ACTHREL, administered in a single IV dose in the physician's office or lab, provides new levels of sensitivity, specificity, and convenience to meet the diagnostic challenges of this category.

Important Safety Considerations:

Adverse effects reported with 1 mcg/kg or 100 mcg/patient include flushing of the face, neck, and upper chest (16%; 45/276), beginning almost immediately and lasting 3 to 5 minutes. Recipients have also reported an urge to take a deep breath (6%; 3/49), which occurs with a timing similar to, but less frequently than, that of flushing. ACTHREL is indicated for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome.

Research and Development Pipeline

Ferring has numerous pharmaceutical projects in late-stage R&D in the areas of nocturia, infertility, and growth hormone deficiency. Early development projects are in areas such as pre-term labor, Crohn's disease, rheumatoid arthritis, post-operative pain and incontinence.