The best of both

In January 2007, Merck Serono was launched as a subsidiary of Merck KGaA. NGP met with Hans Christian Rohde, Anthony Coombs and François Feig to discuss how Merck Serono is utilizing the best of both companies. Rohde, Coombs and Feig are each responsible for the global marketing strategy of key Merck Serono franchises. This includes providing leadership for products, leading the cross functional strategy team and ensuring marketing input to the R&D pipeline, for their respective franchises.

Serono experienced significant operating margin and revenue growth during 2006, leading to a strong bottom line performance. Merck, too, reported a successful year 2006 with ROS improving to 12.8 percent and ROCE to 14.2 percent. It is hoped that the synergy between both companies will create a powerful union of pharmaceutical chemistry and biotechnology.

Merck Serono currently has a total of 28 projects in clinical development, a combined R&D budget of approximately €1 billion and the two key growth drivers Erbitux for oncology and Rebif for the treatment of multiple sclerosis. Rebif sales were up 14 percent to €1.063 million in 2006 and increased by 16 percent to €284 million in the fourth quarter.

Fertility treatments

In June 2007, the European Commission granted marketing authorisation for Pergoveris, which is intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency. The drug is the first biotechnology product based on the combination of recombinant human FSH (r-hFSH or follitropin alfa 150IU) and recombinant human LH (r-hLH or lutropin alfa 75IU), which allows administration of both substances in a single subcutaneous injection.

“Severe LH and FSH deficiency (hypogonadotropic hypogonadism) is a rare condition and represents less than two percent of the overall infertility population. We have developed Pergoveris for this patient group as a priority based on unequivocal evidence of the needs for both FSH and LH. However, we recognize that other patient subgroups with an inadequate response to r-hFSH alone might benefit from supplementation with r-hLH, ” says Hans Christian Rohde, Head of Global Therapeutic Area Reproductive Health at Merck Serono.

Rohde adds: “As Merck Serono has always been interested in providing optimal treatment to meet infertility patient needs, we follow closely developments in this area. No matter how rare the condition may be, we are committed to providing patients with the greatest range of fertility treatments. With Pergoveris, we provide patients with the first biotechnology fertility treatment combining the purity and consistency of two gonadotrophins, recombinant human FSH and recombinant human LH in a single injectable vial presentation.”

Pergoveris is unique in combining the benefits of two consistent and pure biotechnology substances, r-hFSH and r-hLH. Except for GONAL-f, a highly pure human FSH manufactured by recombinant DNA technology and prescribed to supplement or replace naturally occurring FSH, and Luveris, the first and only recombinant human luteinizing hormone (r–hLH) approved in the world, currently marketed single injection combinations of FSH and LH are based on urine-derived human menopausal gonadotrophins (hMG). “Recombinant products,” says Rohde, “are the state-of-the-art preparations replacing biological extracts and Pergoveris has been designed to offer the advantages of recombinant products, including purity and consistency.”

Multiple sclerosis treatments

Merck Serono has also revised the formulation of its top selling multiple sclerosis treatment Rebif, designed to improve tolerability and immunogenicity profiles. Rebif, which was originally approved in Europe in 1998, has been proven effective on the following three key measures of treatment effectiveness: MRI lesion area and activity, relapse rates, and disability progression.

In August 2007, the European Commission granted a marketing authorization for the new formulation of Rebif. “We are very pleased to have received European approval for our new formulation,” says Anthony Coombs, Merck Serono’s Head of Global Therapeutic Area Neurology. “The European approval of the new formulation of Rebif is an important step in our efforts to continuously provide enhanced therapeutic solutions for patients with MS. This new formulation has been especially designed to improve tolerability and we look forward to the benefits it will offers patients.,” explains Coombs.

The new formulation of Rebif has been developed in the same strengths and pharmaceutical forms as currently registered as a solution for injection in pre-filled syringes. It originates from an innovative approach, using state-of-the-art technologies. Previous enhancements of the convenience and tolerability of Rebif include an auto-injector to facilitate injections; a 29 gauge-5 bevel needle pre-filled syringe, the thinnest needle in a ready-to-use pre-filled syringe for the treatment of MS; and a titration pack designed to make starting on Rebif therapy easier and more convenient.

Growth hormone treatments

Merck Serono also has a long-term commitment to children and adults with disorders requiring growth hormone (GH) treatment. François Feig, Head of Global Therapeutic Area Endocrinology and Cardio-Metabolic Care at Merck Serono, believes that besides the scientific investment, for example in pharmacogenomics, compliance is an area where improvements can be made in order to maximize therapeutic efficacy.

“One way to improve compliance to growth hormone therapy is to provide drug delivery systems that are more patient-friendly. Our latest development in this area is easypod, the first electronic device for the treatment of GH diseases, which is currently being launched. easypod allows an easy daily injection for the patient and provides to the physician a close monitoring of the injections,” says Feig. Designed to deliver Merck Serono’s growth hormone product Saizen, easypod won the Gold Medical Design Excellence Award (MDEA), a medical technology premier award, in June 2007.

Another way to improve compliance to growth hormone therapy is to reduce the frequency of injections by improving the pharmacological properties of the growth hormone molecule. For this reason, Merck Serono entered into a collaboration with US biopharmaceutical company Ambrx, Inc., to develop and
commercialize Ambrx’s long-acting growth hormone products. The collaboration will focus initially on the development of ARX201, the most advanced product candidate.

Feig: “ARX-201 is still at an early stage of development as it is in phase I/II but I believe it has the potential to establish a new standard of care in growth hormone therapy. ARX201 has improved pharmacological properties, which should allow less frequent administration than the daily dosing regimen of currently available growth hormones. We believe that this product has the potential to be administered once weekly or potentially even less frequently.”

If successfully developed, ARX-201 would represent a very significant advance for patients in terms of convenience, and therefore in terms of improvement of their quality of life and compliance to treatment.
This is particularly important as most of the patients treated with GH are children.

Merck Serono’s new global head office in Geneva, Switzerland, represents an investment of nearly €214 million. The site, which currently employs 1000 people, has been designed to maximise the use of renewable energy sources. The site’s inauguration in June 2007 united the identity of the Merck group and the Merck Serono division. “We are all set up to become a leading global supplier of biopharmaceutical products,” agree Rohde, Coombs and Feig. With pro forma sales (2005) of around €3.6 billion, about 14,500 employees worldwide and an R&D budget that amounts to about €1 billion, Merck Serono may well reach its goal.

BIOS

Hans Christian Rohde is Head of Global Therapeutic Area Reproductive Health at Merck Serono. He has almost 20 years of pharma and biotech experience, worked in sales management and held senior marketing and management positions in Denmark, Germany, USA, Portugal, France and now Switzerland. Rohde joined Serono in March 2003.

Anthony Coombs is Head of the Global Therapeutic Area Neurology at Merck Serono. A scientist by training, Coombs has over 20 years commercial experience in the pharmaceutical and biotech industries, mainly in global marketing.

François Feig is Head of Global Therapeutic Area Endocrinology and Cardio-Metabolic Care at Merck Serono. A pharmacist by training, Feig joined the Merck group in 1992 and has held several positions in sales and marketing both at local and international levels. Recently he built up the commercial services unit and expanded portfolio management within the company as Vice President and Head of Portfolio Integration and Commercial Services.