Ferring Pharmaceuticals Reports on hFSH Presentations at the Pacific Coast Reproductive Society Meeting

Apr 30, 2001, 01:00 ET from Ferring Pharmaceuticals Inc.

    RANCHO MIRAGE, Calif., April 30 /PRNewswire/ -- Results of three studies
 evaluating Ferring Pharmaceuticals' highly purified, human-derived follicle
 stimulating hormone (hFSH), which is currently under investigation, were
 presented at the 49th Annual Pacific Coast Reproductive Society Meeting and
 post-graduate course in Rancho Mirage, CA, April 25 to 29, 2001.  This is the
 first public presentation of hFSH data from Phase III clinical trials.
     Ferring's hFSH was evaluated in two separate prospective, randomized,
 open-label, parallel-group, multicenter studies that compared hFSH delivered
 subcutaneously (SC) and intramuscularly (IM) to Follistim(R), a recombinant
 (genetically engineered) FSH administered SC.  One study tested
 oligoanovulatory patients undergoing ovulation induction, with an
 intent-to-treat population of 111; the other study, testing patients
 undergoing in vitro fertilization (IVF), had an intent-to-treat population of
 177.
     The primary measure of activity in the ovulation induction study was the
 percentage of patients achieving ovulation.  Key secondary variables included
 peak mean serum E2 levels, the percentage of patients receiving human
 chorionic gonadotropin (hCG) and percentage achieving chemical, clinical and
 continuing pregnancy.  Results showed that Ferring's hFSH, administered SC and
 IM, was comparable to Follistim administered SC.
     In the IVF study, the primary measure of activity was the mean number of
 oocytes retrieved per patient in each treatment group.  Secondary variables
 included peak mean serum E2 levels, the percentage of cycles with oocyte
 retrieval, embryo transfer and chemical, clinical and ongoing pregnancy rates.
 Results showed that all three treatments were well tolerated, but hFSH SC and
 IM caused significantly less injection site pain than Follistim.  Ongoing
 pregnancy rates were 41.7% for hFSH administered SC compared to 29.3% for
 Follistim SC.
 
 Pharmacokinetic Profile Study
     An open-label, parallel-group, single-center study was conducted to
 determine the single- and multiple-dose pharmacokinetic profiles of hFSH SC
 and IM.  After down regulation, 29 patients were randomly assigned to receive
 a single dose SC or IM, after which baseline FSH levels were measured.  Seven
 days after the single dose, patients received 7 daily doses.  Sixteen SC and
 12 IM subjects completed both portions of the study.  The study showed that
 hFSH SC or IM produced consistent, measurable levels of serum FSH after single
 and multiple doses following down-regulation.  Subcutaneously administered
 hFSH was significantly more bioavailable (22%) than hFSH IM.
     "These studies demonstrate that Ferring's human-derived FSH, now under
 investigation, is as active and as well tolerated as recombinant FSH," said
 Wayne Anderson, president of Ferring Pharmaceuticals Inc.  "We look forward to
 this important addition to Ferring's family of human-derived hormones."
 
     Ferring Pharmaceuticals Inc., headquartered in Tarrytown, NY, is part of
 the Ferring Group, a privately owned, international biopharmaceutical company
 that 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 the Ferring Web site at http://www.ferringusa.com.
 
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                http://tbutton.prnewswire.com/prn/11690X34251667
 
 

SOURCE Ferring Pharmaceuticals Inc.
    RANCHO MIRAGE, Calif., April 30 /PRNewswire/ -- Results of three studies
 evaluating Ferring Pharmaceuticals' highly purified, human-derived follicle
 stimulating hormone (hFSH), which is currently under investigation, were
 presented at the 49th Annual Pacific Coast Reproductive Society Meeting and
 post-graduate course in Rancho Mirage, CA, April 25 to 29, 2001.  This is the
 first public presentation of hFSH data from Phase III clinical trials.
     Ferring's hFSH was evaluated in two separate prospective, randomized,
 open-label, parallel-group, multicenter studies that compared hFSH delivered
 subcutaneously (SC) and intramuscularly (IM) to Follistim(R), a recombinant
 (genetically engineered) FSH administered SC.  One study tested
 oligoanovulatory patients undergoing ovulation induction, with an
 intent-to-treat population of 111; the other study, testing patients
 undergoing in vitro fertilization (IVF), had an intent-to-treat population of
 177.
     The primary measure of activity in the ovulation induction study was the
 percentage of patients achieving ovulation.  Key secondary variables included
 peak mean serum E2 levels, the percentage of patients receiving human
 chorionic gonadotropin (hCG) and percentage achieving chemical, clinical and
 continuing pregnancy.  Results showed that Ferring's hFSH, administered SC and
 IM, was comparable to Follistim administered SC.
     In the IVF study, the primary measure of activity was the mean number of
 oocytes retrieved per patient in each treatment group.  Secondary variables
 included peak mean serum E2 levels, the percentage of cycles with oocyte
 retrieval, embryo transfer and chemical, clinical and ongoing pregnancy rates.
 Results showed that all three treatments were well tolerated, but hFSH SC and
 IM caused significantly less injection site pain than Follistim.  Ongoing
 pregnancy rates were 41.7% for hFSH administered SC compared to 29.3% for
 Follistim SC.
 
 Pharmacokinetic Profile Study
     An open-label, parallel-group, single-center study was conducted to
 determine the single- and multiple-dose pharmacokinetic profiles of hFSH SC
 and IM.  After down regulation, 29 patients were randomly assigned to receive
 a single dose SC or IM, after which baseline FSH levels were measured.  Seven
 days after the single dose, patients received 7 daily doses.  Sixteen SC and
 12 IM subjects completed both portions of the study.  The study showed that
 hFSH SC or IM produced consistent, measurable levels of serum FSH after single
 and multiple doses following down-regulation.  Subcutaneously administered
 hFSH was significantly more bioavailable (22%) than hFSH IM.
     "These studies demonstrate that Ferring's human-derived FSH, now under
 investigation, is as active and as well tolerated as recombinant FSH," said
 Wayne Anderson, president of Ferring Pharmaceuticals Inc.  "We look forward to
 this important addition to Ferring's family of human-derived hormones."
 
     Ferring Pharmaceuticals Inc., headquartered in Tarrytown, NY, is part of
 the Ferring Group, a privately owned, international biopharmaceutical company
 that 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 the Ferring Web site at http://www.ferringusa.com.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X34251667
 
 SOURCE  Ferring Pharmaceuticals Inc.