07.21.14
Headquarters: Darmstadt, Germany
twitter.com/emdserono
www.merck.de
TOP SELLING DRUGS
Merck Serono’s core R&D fields of oncology, immunology and neurology, could use a breakthrough. With the increasing prevalence of biosimilars, the biologics market will begin to face significant pressures. According to research and consulting firm, GlobalData, in its latest report, biosimilars will capture the market share from biologics, despite an initial projected growth rate of 8%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019.
As several biologics are expected to come off patent protection starting in 2014, including flagship Rebif, and Ebitux in 2016, Merck Serono is developing biosimilars of its own in various disease areas including oncology and rheumatology.
In 2013, Merck Serono division sales grew organically by 3%, but suffered negative foreign exchange effects amounting to 5%. Increases largely came from the General Medicine franchise (including cardiometabolic care) and oncology drug Erbitux. In geographic terms, Emerging Markets and Japan fueled this growth, posting increases of 12% and 17%, respectively. However, royalty income took a hit of a 9%, as a result of the termination of two licensing agreements owing to the patent expiration for Avonex (May 2013) and one for Enbrel (November 2013).
Rebif suffered an organic sales decline of 2%, primarily in North America, while Erbitux grew 6%, including a foreign exchange impact of nearly 7%. Sales of Gonal-f declined slightly in 2013, largely attributable to adverse foreign exchange, but came out of the gate strong in 1Q14, as the company’s fastest-growing product, with sales up 11% to $209 million.
A pipeline weighted towards oncology
Merck Serono’s development pipeline continues to be weighted towards oncology. Several ongoing, early stage oncology collaborations include Phase I pimasertib trials in combination with Sanofi’s dual PI3K/mTOR inhibitor (SAR245409) in advanced solid tumors and pancreatic cancer, which showed tolerability and signs of activity. A partnership with Selvita is targeting key metabolic pathways with the goal of delivering potential first-in-class candidates for multiple indications. Also, an alliance with Spanish National Cancer Research Centre (CNIO) provides Merck with exclusive rights to develop and commercialize CNIO’s inhibitors of ATR kinase, an enzyme with an important role in the response to DNA damage and in facilitating cell survival.
Additionally, several candidates have advanced, including Sym004, a drug licensed from Symphogen, which is now being evaluated in head and neck cancer following evidence of clinical activity from a Phase II study in metastatic colorectal cancer. Also, positive Phase II data warranted further development of TH-302, an investigational hypoxia-targeted drug, entering a global Phase III study in patients with advanced pancreatic cancer.
However, a Phase III trial of the integrin inhibitor cilengitide in patients with newly diagnosed brain tumors failed to increase overall survival. Furthermore, the company decided to continue development of Tecemotide, a MUC1 antigen-specific cancer immunotherapy in Phase III development for non-small cell lung cancer, despite missing the primary endpoint of improving overall survival from a previous Phase III trial.
MS therapies showing promise
In its MS portfolio, several mid-stage trials including ONO-4641 (ceralifimod), showed positive results in patients with relapsing MS, and plovamer acetate, a second-generation peptide copolymer immunomodulator, advanced into Phase II development. Merck has the option to develop Opexa Therapeutics’s Tcelna, a potential first-in-class therapy in Phase IIb development as a personalized therapy tailored to individual MS profiles. Tcelna has received Fast Track Designation from the FDA to boot.
Finally, in the field of immunology, Merck decided to focus on the development of its investigational drug sprifermin in osteoarthritis, embarking on a new multinational Phase IIb study.
In its efforts to evolve, the company has created a couple new spin-offs, Calypso Biotech, formed around an R&D portfolio in the field of inflammatory bowel diseases, which will target niche indications, and TocopheRx, to continue fertility research efforts focused on an oral follicle-stimulating hormone (FSH) agonist for the treatment of infertility, which would be an upgrade from the current self-injection method.
Some biomarker research alliances aim to better define target patient populations for existing and future therapies. One with Pfizer is focused on profiling Systemic Lupus Erythematosus and Lupus Nephritis patients, and another with Sysmex Inostics aims to develop a blood-based RAS biomarker test for patients with metastatic colorectal cancer (mCRC). With about half of patients with mCRC having RAS wild-type tumors, antibody therapy Erbitux is shown to improve outcomes in RAS wild-type mCRC patients. This biomarker would boost potentially waning sales.
twitter.com/emdserono
www.merck.de
Headcount: | 38,000 | |
Year Established: | 1668 | |
Biopharma Revenues: | $8,708 | -1% |
Total Revenues: | $15,273 | 8% |
Net Income: | $1,655 | -8% |
R&D Budget: | $2,070 | -1% |
TOP SELLING DRUGS
Drug | Indication | 2013 Sales | (+/- %) |
Rebif | multiple sclerosis | $2,567 | 1% |
Erbitux | oncology | $1,214 | 6% |
Gonal-f | fertility | $806 | -1% |
Concor | cardiovascular disease | $552 | 11% |
Glucophage | type 2 diabetes | $542 | -1% |
Saizen | growth hormone disorders | $323 | -2% |
Merck Serono’s core R&D fields of oncology, immunology and neurology, could use a breakthrough. With the increasing prevalence of biosimilars, the biologics market will begin to face significant pressures. According to research and consulting firm, GlobalData, in its latest report, biosimilars will capture the market share from biologics, despite an initial projected growth rate of 8%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019.
As several biologics are expected to come off patent protection starting in 2014, including flagship Rebif, and Ebitux in 2016, Merck Serono is developing biosimilars of its own in various disease areas including oncology and rheumatology.
In 2013, Merck Serono division sales grew organically by 3%, but suffered negative foreign exchange effects amounting to 5%. Increases largely came from the General Medicine franchise (including cardiometabolic care) and oncology drug Erbitux. In geographic terms, Emerging Markets and Japan fueled this growth, posting increases of 12% and 17%, respectively. However, royalty income took a hit of a 9%, as a result of the termination of two licensing agreements owing to the patent expiration for Avonex (May 2013) and one for Enbrel (November 2013).
Rebif suffered an organic sales decline of 2%, primarily in North America, while Erbitux grew 6%, including a foreign exchange impact of nearly 7%. Sales of Gonal-f declined slightly in 2013, largely attributable to adverse foreign exchange, but came out of the gate strong in 1Q14, as the company’s fastest-growing product, with sales up 11% to $209 million.
A pipeline weighted towards oncology
Merck Serono’s development pipeline continues to be weighted towards oncology. Several ongoing, early stage oncology collaborations include Phase I pimasertib trials in combination with Sanofi’s dual PI3K/mTOR inhibitor (SAR245409) in advanced solid tumors and pancreatic cancer, which showed tolerability and signs of activity. A partnership with Selvita is targeting key metabolic pathways with the goal of delivering potential first-in-class candidates for multiple indications. Also, an alliance with Spanish National Cancer Research Centre (CNIO) provides Merck with exclusive rights to develop and commercialize CNIO’s inhibitors of ATR kinase, an enzyme with an important role in the response to DNA damage and in facilitating cell survival.
Additionally, several candidates have advanced, including Sym004, a drug licensed from Symphogen, which is now being evaluated in head and neck cancer following evidence of clinical activity from a Phase II study in metastatic colorectal cancer. Also, positive Phase II data warranted further development of TH-302, an investigational hypoxia-targeted drug, entering a global Phase III study in patients with advanced pancreatic cancer.
However, a Phase III trial of the integrin inhibitor cilengitide in patients with newly diagnosed brain tumors failed to increase overall survival. Furthermore, the company decided to continue development of Tecemotide, a MUC1 antigen-specific cancer immunotherapy in Phase III development for non-small cell lung cancer, despite missing the primary endpoint of improving overall survival from a previous Phase III trial.
MS therapies showing promise
In its MS portfolio, several mid-stage trials including ONO-4641 (ceralifimod), showed positive results in patients with relapsing MS, and plovamer acetate, a second-generation peptide copolymer immunomodulator, advanced into Phase II development. Merck has the option to develop Opexa Therapeutics’s Tcelna, a potential first-in-class therapy in Phase IIb development as a personalized therapy tailored to individual MS profiles. Tcelna has received Fast Track Designation from the FDA to boot.
Finally, in the field of immunology, Merck decided to focus on the development of its investigational drug sprifermin in osteoarthritis, embarking on a new multinational Phase IIb study.
In its efforts to evolve, the company has created a couple new spin-offs, Calypso Biotech, formed around an R&D portfolio in the field of inflammatory bowel diseases, which will target niche indications, and TocopheRx, to continue fertility research efforts focused on an oral follicle-stimulating hormone (FSH) agonist for the treatment of infertility, which would be an upgrade from the current self-injection method.
Some biomarker research alliances aim to better define target patient populations for existing and future therapies. One with Pfizer is focused on profiling Systemic Lupus Erythematosus and Lupus Nephritis patients, and another with Sysmex Inostics aims to develop a blood-based RAS biomarker test for patients with metastatic colorectal cancer (mCRC). With about half of patients with mCRC having RAS wild-type tumors, antibody therapy Erbitux is shown to improve outcomes in RAS wild-type mCRC patients. This biomarker would boost potentially waning sales.