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Choriogonadotropin alfa

Human chorionic gonadotropin (hCG) is a peptide hormone produced in pregnancy, that is made by the embryo soon after conception and later by the trophoblast (part of the placenta). Its role is to prevent the disintegration of the corpus luteum of the ovary and thereby maintain progesterone production that is critical for a pregnancy in humans. hCG may have additional functions, for instance it is thought that it affects the immune tolerance of the pregnancy. Early pregnancy testing generally is based on the detection or measurement of hCG. more...

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The drugs Pregnyl®, Follutein®, and Ovidrel® use chorionic gonadoptropin as the active ingredient in their product. These preparations are used in assisted conception in lieu of luteinizing hormone to trigger ovulation.

Structure

hCG is a glycoprotein composed of 237 amino acids with a molecular mass of 36.7 kDa. It is heterodimeric, with an α (alpha) subunit identical to that of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone (TSH). Its β (beta) subunit is unique to hCG.

Function

hCG promotes the maintenance of the corpus luteum and causes it to secrete the hormone progesterone. Progesterone enriches the uterus with a thick lining of blood vessels and capillaries so that it can sustain the growing fetus.

Because of its similarity to LH and FSH, hCG can also be used clinically to induce ovulation in the ovaries as well as testosterone production in the testes. As the most abundant biological source is women who are presently pregnant, some organizations collect urine from gravidae to extract hCG for use in fertility treatment.

Pregnancy testing

Pregnancy tests measure the levels of hCG in the blood or urine to indicate the presence or absence of a fertilized egg. In particular, most pregnancy tests employ an antibody that is specific to the β-subunit of hCG (βhCG). This is important so that tests do not make false positives by confusing hCG with LH and FSH. (The latter two are always present at varying levels in the body, while hCG levels are negligible except during pregnancy.) The urine test is a chromatographic immunoassay that can detect levels of βhCG as low as 25-100 mIU/ml. The urine should be the first urine of the morning when hCG levels are highest. If the specific gravity of the urine is above 1.015, the urine should be diluted. The serum test, using 2-4 mL of venous blood, is a radioimmunoassay (RIA) that can detect βhCG levels as low as 5 mIU/ml and allows quantitation of the βhCG concentration. The ability to quantitate the βhCG level is useful in the evaluation of ectopic pregnancy and in monitoring germ cell and trophoblastic tumors.

Hydatiform moles ("molar pregnancy") may produce high levels of βhCG, despite the absence of an embryo. This can lead to false positive readings of pregnancy tests.

Tumor marker

βhCG is also secreted by some cancers including teratomas, choriocarcinomas and islet cell tumors. When a patient is suspected of harboring a teratoma (often found in the testes and ovaries but also in the brain as a dysgerminoma), a physician may consider measuring βhCG. Elevated levels cannot prove the presence of a tumor, and low levels do not rule it out (an exception is in males who do not naturally produce βhCG). Nevertheless, elevated βhCG levels fall after successful treatment (e.g. surgical intervention or chemotherapy), and a recurrence can often be detected by the finding of rising levels.

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Brooke Shields Lends Her Support to Encourage Women to Take Action Early if They Have Trouble Conceiving
From PR Newswire, 11/3/05

Actress Shares Personal Battle with Infertility and Urges Women to Get Informed

NEW YORK, Nov. 3 /PRNewswire/ -- Today Brooke Shields teams up with Fertility LifeLines(TM) to announce a national infertility awareness campaign encouraging women to know their options and take action early. Fertility LifeLines(TM), provided by Serono, Inc., is a free and confidential educational service with trained staff available to talk to people about their fertility concerns.

Ms. Shields, who tried unsuccessfully for over a year to have a baby before getting the help of a fertility specialist, is now the proud mother of daughter Rowan. She acknowledges that her experience with infertility was isolating, causing feelings of failure and frustration and says that until she and her husband consulted a fertility specialist, they didn't know how many options were available to them. Today, as she prepares to expand her family, Ms. Shields encourages women to address their challenges with fertility by reaching out for information and support.

"When you're having trouble conceiving, it's often tough to know where to turn for answers, and when you're undergoing fertility treatment, it's not always easy to find the support that you need," said Ms. Shields. "Today I am partnering with Fertility LifeLines to let women know that resources are available to help them understand their options for having a family."

Infertility is defined as the inability to achieve pregnancy after one year of regular, unprotected intercourse (six months if the woman is over 35). It affects about 6.1 million Americans, which represents about one in seven couples in their childbearing years. The majority of patients who complete treatment succeed in having a child.

"It is important for women to talk to their doctors early if they have concerns about their fertility," said Richard Scott, M.D., a reproductive endocrinologist (RE) and director of Reproductive Medicine Associates of New Jersey in Morristown, NJ. "Fertility declines with age in both men and women, which means the sooner couples seek information and talk to their doctor, the sooner they can learn about their options and make the decisions that are right for them."

Round-the-Clock Information and Support

Fertility LifeLines is a free and confidential educational service provided by Serono, Inc. Available toll-free at 1-866-LETS-TRY (1-866-538- 7879), it offers a single destination for information and support to people with concerns about infertility, including access to special benefits and potential savings on all Serono fertility products. Staffed with fertility nurses, insurance specialists and patient advocates, Fertility LifeLines is available Monday to Friday from 8 am to midnight ET and Saturday and Sunday from 8 am to 6 pm with 24-hour access to fertility nurses and Freedom Fertility Drug(TM) pharmacists. Fertility LifeLines is not meant to substitute for the advice provided by a medical professional. Callers should always consult a healthcare provider if they have health concerns. For more information about Fertility LifeLines, call toll-free 1-866-LETS-TRY (1-866- 538-7879) or visit http://www.fertilitylifelines.com/.

About Serono, Inc. and Fertility

Serono, Inc., a subsidiary of Serono S.A., is a leader in fertility health, dedicated to developing patient-friendly, innovative products that help people build families. It is the only company to offer a full portfolio of fertility medications for every stage of the reproductive cycle and recombinant versions of three hormones used in the treatment of infertility, including the Gonal-f(R) RFF Pen (follitropin alfa injection).

About Serono S.A.

Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global biotechnology leader, headquartered in Geneva, Switzerland. The Company has seven recombinant products, Rebif(R) (interferon beta-1a), Gonal-f(R) (follitropin alfa for injection), Luveris(R) (lutropin alfa), Ovidrel Prefilled Syringe(R)/Ovitrelle(R) (choriogonadotropin alfa injection), Serostim(R) [somatropin (rDNA origin) for injection], Saizen(R) [somatropin (rDNA origin) for injection] and Zorbtive(TM) [somatropin (rDNA origin) for injection] on the market in the U.S. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology. Currently, there are approximately 25 ongoing development projects.

In 2004, Serono achieved worldwide revenues of US $2,458.1 million, and a net income of US $494.2 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).

Package inserts for Serono's US marketed products are available at http://www.seronousa.com/ or by calling 1-888-275-7376.

Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 16, 2005. These factors include any failure or delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of government investigations and litigation and government regulations limiting our ability to sell our products. Serono has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release

Website: http://www.seronousa.com http://www.fertilitylifelines.com

CONTACT: Dana Jessup for Serono, Inc., +1-781-681-2443

COPYRIGHT 2005 PR Newswire Association LLC
COPYRIGHT 2005 Gale Group

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