Navigation Links
Schering-Plough Announces European Submission of Fertility Medicine Corifollitropin Alfa

Corifollitropin alfa, a sustained follicle stimulant, extends options for patients and Schering-Plough's leadership in fertility

KENILWORTH, N.J., Dec. 31 /PRNewswire-FirstCall/ -- Schering-Plough Corp., (NYSE: SGP), a leading provider of fertility treatments, announced today that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS). This application will follow the Centralized Procedure.

Corifollitropin alfa is being developed as a potential treatment in Controlled Ovarian Stimulation (COS) for the development of multiple follicles and pregnancy in women participating in an Assisted Reproductive Technology (ART) program. Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (recombinant)Follicle Stimulating Hormone (FSH), but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of corifollitropin alfa may replace the first seven injections of (recombinant)FSH preparation in a COS treatment cycle.

If approved, corifollitropin alfa would extend Schering-Plough's leading fertility portfolio, which also includes PUREGON(R).

Corifollitropin alfa Important Safety Information

The most frequently reported adverse drug reactions during treatment with corifollitropin alfa in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS), pelvic pain and discomfort, headache, nausea, fatigue and breast complaints (including tenderness). They are reported with an incidence between 1% and 6%.

PUREGON(R) Important Safety Information

Always use PUREGON exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Do not use PUREGON if you:

  • are allergic (hypersensitive) to follitropin beta or any of the other ingredients of PUREGON
  • have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus
  • are pregnant or breast-feeding
  • have heavy or irregular vaginal bleeding where the cause is not known
  • suffer from primary ovarian failure
  • have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD)
  • have malformations of the sexual organs which make a normal pregnancy impossible
  • have fibroids in the uterus which make a normal pregnancy impossible.

Take special care with PUREGON

Please inform your doctor if you have experienced an allergic reaction to neomycin and/or streptomycin (antibiotics) in the past.

Close supervision by your doctor is very important. Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken. The results of these tests allow your doctor to choose the correct dose of PUREGON from day to day. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become overstimulated. This may be noticed as pain in the abdomen. Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation. So contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given.

Treatment with PUREGON (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).

Please discuss this with your doctor, before starting treatment, especially if:

  • you already know you have an increased risk of thrombosis
  • you, or anyone in your immediate family, have ever had a thrombosis
  • you are severely overweight.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use PUREGON if you are already pregnant, or suspect that you might be pregnant, or if you are breast-feeding.

After treatment with gonadotropin preparations, there is an increased risk of having multiple pregnancies. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities. There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.

In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.

Possible side effects

Like all medicines, PUREGON can cause side effects, although not everybody gets them.

Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection. Occasionally, more widespread reactions like rash have been observed.

A complication with FSH treatment is unwanted overstimulation of the ovaries. This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment. The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea. In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest, weight gain and the occurrence of blood clots in the circulation. Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.

Rarely, blood clots may also occur in the absence of unwanted overstimulation of the ovaries (see also "Take special care with PUREGON").

Other side effects observed include headache and nausea.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Additional Important Product Information

Complete product information can be found at:

About Schering-Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer healthcare products. Schering-Plough's vision is to Earn Trust, Every Day with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for corifollitropin alfa. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item IA. "Risk Factors" in Schering-Plough's 2008 Q3 10-Q, filed Oct. 29, 2008.

SOURCE Schering-Plough
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
2. Schering-Plough Schedules Conference Call and Webcast for 2007 Third Quarter Earnings
3. Schering-Plough Reports Financial Results for Third Quarter of 2007
4. Schering-Plough CEO Calls for Four-Pronged Approach to Improving Current Health Care Environment
5. Schering-Plough Reports U.S. District Court for District of Massachusetts Finds No Liability for Subsidiary in AWP Case
6. Schering-Plough to Webcast CFO Robert J. Bertolinis Presentation at 2007 Credit Suisse Health Care Conference
7. Schering-Plough Receives Clearance From U.S. Federal Trade Commission for Planned Acquisition of Organon Biosciences N.V.
8. Schering-Plough Declares Quarterly Dividends on Common Shares and 2007 Mandatory Convertible Preferred Stock
9. Centocor, Schering-Plough Revise Agreement Covering REMICADE, Golimumab
10. Schering-Plough Board Elects Dr. Craig B. Thompson as a Director
11. Schering-Plough CEO to Buy $2 Million in Common Shares
Post Your Comments:
(Date:6/25/2016)... ... 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his ... David Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps ... in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of ... recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at Work ... Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
Breaking Medicine Technology: