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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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Serono Announces Formal Conclusion of Serostim Settlement
From PR Newswire, 12/15/05

GENEVA, and ROCKLAND, Mass., Dec. 15 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO; NYSE: SRA) announced today that one of its U.S. affiliates has voluntarily entered a guilty plea and the company has formally concluded the previously announced settlement of the government investigation led by the U.S. Attorney's office in Massachusetts into commercial practices related to Serostim(R) [somatropin (rDNA origin) for injection]. The comprehensive settlement, announced in October, with federal and state agencies concludes all liabilities to the government in connection with the investigation.

The company's U.S. products are Rebif(R) (interferon beta-1a), Novantrone(R) (mitoxantrone for injection concentrate), Gonal-f(R) (follitropin alfa for injection), Luveris(R) (lutropin alfa for injection), Ovidrel(R) (choriogonadotropin alfa injection), Crinone 8%(R) (progesterone gel), Cetrotide(R) (cetrorelix acetate for injection), Serostim(R) [somatropin (rDNA origin) for injection], Saizen(R) [somatropin (rDNA origin) for injection] and Zorbtive(TM) [somatropin (rDNA origin) for injection]. These products continue to be available in the U.S. through Serono Inc., and are eligible for reimbursement under federal and state health care programs.

Settlement Background

In April 2005, the company announced that it had taken a $725 million provision to cover the settlement and related costs. The provision, which was recorded as an exceptional charge in the company's earnings report for the first quarter of 2005, is sufficient to cover the comprehensive settlements and related costs and the settlement amount will be paid in 2005.

About Serono

Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology. Currently, there are approximately 30 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).

Forward-looking statement

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

CONTACT: Media Relations, USA, +1-781-681-2481, or Investor Relations, USA, +1-781-681- 2552, or Corporate Media Relations, +41 22 739 36 00, Corporate Investor Relations, +41 22 739 36 01, all of Serono

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