Serono is one of the world’s top three biotechnology companies, with sales of USD 1.147 billion (2000) and invests more than 20% of its sales in R&D. They currently have over 30 projects that are in pre clinical or clinical development, and 13 new molecules in development. These projects target their core therapeutic areas, as well as diseases in other areas such as oncology, gastroenteritis and rheumatology. In addition, they have over 20 discovery projects aiming to identify new drug candidates. Their state-of-the-art production The Serono Biotech Center in Switzerland, inaugurated in 1999, is one of the largest and most advanced technology production facilities in the world.
They currently focus on four core therapeutics areas:
Gonal-F® human FSH, is the first recombinant drug developed for the treatment of infertility to receive marketing approval anywhere in the world. Gonal-F® is the leading treatment for fertility world-wide. It is now available in over 96 countries. It is indicated for the treatment of patients suffering from ovulation disorders. Gonal-F® also stimulates the development of multiple follicles in women being treated with assisted reproductive technologies, such as In Vitro fertilization. Gonal-F® is also approved in the European Union and the United States for treating a form of male infertility.
Crinone® is a progesterone product with an advanced delivery technology that permits it to be self-administered as a vaginal gel. The gel is used in connection with certain assisted reproductive technologies, including In Vitro fertilization. Crinone® is associated with high clinical pregnancy rates and is convenient for patients, because it is user friendly and does not require painful intramuscular injections. It is the only progesterone product with marketing authorization for infertility treatment in the United States, Germany and the United Kingdom.
Cetrotide® is the first LHRH antagonist in the world to be approved for the prevention of the LH surge, which is desirable in assisted reproductive technologies. Treatment with Cetrotide® is generally more practical than treatment with LHRH agonists, which involves prolonged therapy to achieve pituitary down-regulation
Luveris® will be the first pure luteinizing hormone available for treatment of female infertility. Luveris® 75 IU will be used in combination with a follicle-stimulating hormone (FSH), like Serono’s Gonal-F®, for the treatment of women with an endocrine form of infertility, characterized by a severe LH and FSH deficiency.
Ovidrel® (choriogonadotropin alfa) is the world’s first recombinant chorionic gonadotropin (r-hCG) for the treatment of anovulation, the most common cause of infertility in women. Anovulation is brought about by irregularities in the hormones needed to produce and release healthy eggs.
Rebif® is a leading treatment for Relapsing-Remitting MS, outside the US. Key studies have shown that interferon beta in general, including Rebif®, are the only disease modifying treatment in relapsing remitting MS. The studies relating to Rebif®, most notably the PRISMS study which is the largest and most comprehensive, have shown that Rebif® slows progression of the disability. It reduces the extent of disease activity in the brain and nervous system, and reduces the number and severity of relapses. They have submitted a Biologics License Application to the United States FDA. However, because of the orphan drug status of competing products granted under the U.S. Orphan Drug Act, they may not sell Rebif® in the United States for the treatment of RRMS until their competitors’ orphan drug status expires or such earlier time that they are able to differentiate their product from those of their competitors within the requirements of the U.S. Orphan Drug Act.
There are treatments for GHD (Growth Hormone Deficiency) by replacing the growth factors the body normally emits. Serono has produced two major growth promoting products.
Saizen®: for children with growth hormone deficiency (GHD) generally.
Geref®: a new treatment, for a more specific group of children, whose pituitary gland can be stimulated to secrete growth hormone, known as Growth Hormone-Releasing Hormone Therapy (GHRH).
Serostim® is the high-dose recombinant human growth hormone formulation that is the leading treatment for AIDS wasting. Serostim® reverses the underlying metabolic disturbance that occurs in AIDS wasting through its protein building and protein sparing activity, which promotes a significant increase in patient lean body mass and weight.
New Therapeutic Areas
Recombinant human chorionic gonadotropin (r-hCG), is being developed as a novel treatment for metastic breast cancer.
Two new molecules are in preclinical development as potentials for the treatment of prostate cancer:
a type 1 5-alpha-reductase inhibitor; and a nanosphere formulation of iturelix. Rheumatoid Arthritis
Serono’s r-IFN-beta-1a (recombinant interferon beta-1a) and r-TBP-1 (Tumor Necrosis Factor Binding Protein) are being tested for the effectiveness in modulating the activity of the immune system resulting in an anti-inflammatory effect to control rheumatoid arthritis.
Ulcerative Colitis and/or Crohn’s Disease
Continuing developments with r-TBP-1 for the treatment of Crohn’s disease are on-going, based on positive data announced in November 2000. Positive results were also announced in May 2001 for the trials of Serono’s r-IFN beta-1a in the treatment of both Crohn’s disease and ulcerative colitis.
Short Bowel Syndrome
Treatments for short bowel syndrome include HGH supplements, intravenous feeding, and drugs to relieve the symptoms of the condition. Serono’s recombinant human growth hormone (r-GH), is being tested to reduce the need for intravenous feeding in these patients suffering from short bowel syndrome.
IFN beta-1a, like interferon alpha, is currently being tested in patients with chronic hepatitis C infection.
Acute Myocardial Infarction
r-TBP-1 is being developed as a treatment to minimize the damage to heart muscle following acute myocardial infarction.
8th October 2001 – Serono Confirms Submission of Rebif® Bla Amendment To FDA
Serono S.A. confirmed that during the third quarter ending September 30, 2001 it submitted an amendment to its original Biologics License Application (BLA) to the US FDA seeking U.S. marketing approval for Rebif® (interferon beta – 1a) for the treatment of relapsing remitting multiple sclerosis.
This submission includes clinical data from the EVIDENCE (EVidence for Interferon Dose-effect : European-North American Comparative Efficacy) Study, a direct, head-to-head comparative study of Rebif® (44 mcg 3 times per week) and Avonex® (30 mcg 1 time per week) in the treatment of relapsing remitting multiple sclerosis.
Ernesto Bertarelli, CEO of Serono commented “The submission to the FDA of the EVIDENCE data represents another step forward in bringing Rebif®, an important therapy for relapsing remitting multiple sclerosis, to patients in the United States.”
Rebif® is registered in 72 countries worldwide and is currently the fastest growing interferon beta-1a treatment for MS outside the USA. In 2000, Rebif® achieved worldwide sales of $254.2m. Rebif® is currently not approved in the USA because another product holds Orphan Drug exclusivity.
4th September, 2001 – Serono and Zymogenetics Establish Collaboration For Co-Development Of Products For Autoimmune Disease
Serono S.A. and ZymoGenetics announced that they have entered into an exclusive co-development and commercialization agreement focused on two pre-clinical product candidates derived from ZymoGenetics’ discovery research. ZymoGenetics’ scientists using a genomics-driven approach have discovered the two candidates, termed TACI and BCMA. The two protein molecules are cell-surface receptors found on B-lymphocytes, that when stimulated induce the production of antibodies. The companies intend to focus their activities on the development of one or more products based on these receptors for the treatment of autoimmune diseases.
Under the terms of the agreement, ZymoGenetics could receive license fees and milestone payments of up to $52.5 million linked to the development and approval of products, and will receive undisclosed royalties on product sales. R&D activities will take place at both companies with shared costs worldwide, excluding Japan where Serono will cover all expenses. ZymoGenetics retains an option to co-promote products with Serono in North America. If ZymoGenetics exercises this option the two companies will share commercialization expenses and profits equally. Serono will have exclusive rights to market products in the remainder of the world. Serono will manufacture all products for both clinical trials and commercial sale.
Silvano Fumero, Head of Research and Pharmaceutical Development at Serono commented, “This agreement between Serono and ZymoGenetics is another example of Serono’s collaborative approach to access novel protein based therapeutic technologies and emphasizes our commitment to the treatment of autoimmune and serious inflammatory diseases. ZymoGenetics’ expertise in functional genomics combined with our own experience in product development and commercialization will help take these pre-clinical product candidates through development.”
19th August 2001- Serono Free to Communicate Results Of Study to Healthcare Professionals
Serono announce that contrary to a previous press release by Biogen (August 18th, 2001), the preliminary injunction of June 21st obtained by Biogen was not upheld by the Geneva court. Serono believes that this press release by Biogen claiming victory is outrageous, egregious and completely misleading, and wishes to correct the public record as follows:
The court authorizes Serono to state that the EVIDENCE study has been conducted in accordance with parameters approved by the US Food and Drug Administration (FDA). It also affirmed that the EVIDENCE study is a serious and properly conducted scientific study, with the clear objective of showing the superiority of Rebif® over Avonex® on the agreed endpoints needed to gain access to the US market in the context of the Orphan Drug Act. The court enables Serono to now distribute without promotion to healthcare professionals the EVIDENCE study and its summary, including such distribution on any secure Internet site. Contrary to Biogen’s press release, the court has not found any of Serono’s comparative statements to be misleading or false. The court has simply reminded Serono of its obligation not to make comparative claims to the general public under the terms of the Swiss advertising regulations.
In conclusion, these findings by the Geneva court support Serono’s right to communicate the scientific data of the EVIDENCE study to healthcare professionals.
Nathalie Joannes, General Counsel for Serono commented, “This decision by the Geneva court endorses Serono’s clear right to communicate the EVIDENCE study to healthcare professionals. Biogen can no longer impede our right to communicate effectively, which is all that we have ever sought to do,”
15th August 2001 – Serono – Receives European Approval for the use of Saizen® in the Treatment of Adult Growth Hormone Deficiency
Serono S.A. announced today the positive conclusion of the Mutual Recognition Procedure for use of Saizen® [somatropin (rDNA origin) for injection] in the treatment of adult growth hormone deficiency. Serono is planning to launch Saizen® in this new indication in several European countries by the end of 2001, based on national approval procedures. Adult growth hormone deficiency (GHD) is a condition caused by the reduced secretion of growth hormone from the pituitary gland. Adult growth hormone deficiency is associated with reduced life expectancy and impaired quality of life. Common symptoms of GHD in adults include: · abnormal body composition (reduced lean body mass and increased abdominal fat), · reduced bone mineral density resulting in an increased fracture risk · reduced exercise capacity and vitality, · increased cardiovascular risk · impaired psychological wellbeing (depression, social isolation, anxiety, etc.).
Although, growth hormone deficiency affects approximately 50,000 adults in the US and 50,000 in Europe, it is still often regarded as a condition affecting only children. The adult GHD population includes two types of patients: those who had growth hormone deficiency as children, and who will require treatment throughout adulthood, and patients with adult onset deficiency due to damage to the pituitary gland (arising from various causes including tumors and their treatment with radiotherapy or surgery or head injuries). Serono has conducted one of the largest trials ever done in the field of adult growth hormone deficiency, showing the beneficial effects of Saizen® in the adult population 2. Saizen® has been shown to improve cardiac performance and body composition in GH deficient adults
Recombinant growth hormone, was introduced by Serono in 1989 (If you would like more information regarding Serono’s Recombinant growth hormone call 866-483-7867), and is currently approved for the treatment of growth retardation due to growth hormone deficiency (81 countries), Turner Syndrome (68 countries) and chronic renal failure (29 countries). Human Growth Hormone Research.com has no direct affilation with Serono. We recommend them soley based on the information generated from there clinical trials. They are one of the world’s top three biotechnology companies and their Biotech Center in Switzerland is one of the largest and most advanced technology production facilities in the world.