Merck inc.

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Company Headquarters

Frankfurter Straße 250, 64293 Darmstadt, Germany

Driving Directions

Brand Description

We are Merck, a leading global science and technology company headquartered in Germany. 

We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics. 

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet. 

Key Personnel

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JOB TITLE

Yearly results

Sales: 19.4 Billion

Headcount: 64,243
Pharma Revenues: $19,449 (+13%)
Net Income: $3,564 (+9%)
R&D: $2,691 (+4%)

Science and technology company, Merck KGaA, Darmstadt, Germany, delivered profitable growth in 2022 despite challenges and uncertainties worldwide, as well as a decline in COVID-19-related demand. Group net sales increased by 12.9% to $23,732 million compared with the previous year. While Merck KGaA holds the rights to the company name and brand, it operates as MilliporeSigma in the Life Sciences business and EMD Serono in the Healthcare business in the U.S. and Canada.

In 2022, the group continued with the global expansion of its capacities. The company is thus creating the basis for further organic growth, while at the same time diversifying and regionalizing its production and supply chains. The investments announced included the expansion of the Life Science sites in Cork, Ireland, Rockville, MD, Molsheim, France, as well as Wuxi, China. Healthcare laid the cornerstones for the Translational Science Center and the Launch & Technology Center in Darmstadt, Germany.

Additionally, the group invested in inorganic growth in 2022, successfully completing the acquisition of the biopharmaceutical contract development and manufacturing organization Exelead in the U.S. The business combination is expected to enable the Life Science business of Merck KGaA to provide its customers with comprehensive end-to-end contract development and manufacturing organization (CDMO) services across the mRNA value chain. The group plans to further invest over $533 million to scale up Exelead’s technology over the next ten years.

In Healthcare, Merck presented strong data from its pipeline in 2022 with regard to Phase II studies for xevinapant (head and neck cancer) and evobrutinib (multiple sclerosis). In addition, in September, the company announced a collaboration agreement with licensing option with Nerviano Medical Sciences (NMS) for the next-generation highly selective and brain-penetrant PARP1 (poly (ADP-ribose) polymerase) inhibitor, NMS-293, which has strong potential in combination with a wide variety of DNA-damaging agents, including systemic or targeted chemotherapy (antibody-drug conjugates) or with DNA damage response inhibitors, in numerous tumor types. NMS-293 is in early clinical development for the treatment of patients with BRCA-mutated tumors as a single agent and in combination with temozolomide in recurrent glioblastoma.

In December, the group announced a research collaboration and commercial license agreement with Mersana Therapeutics to discover novel antibody-drug conjugates (ADCs). In June, the group entered into a clinical trial collaboration with Innovent Biologics, a biopharmaceutical company that develops, manufactures and commercializes medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, for the combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX) as a potential treatment for NSCLC patients.

 

Sales: 15.8 Billion

Headcount: 50,000
Revenues: $15,828 (+13%)
Net Income: $1,716 (+41%)
R&D: $2,081 (+11%)

TOP SELLING DRUGS

Drug Indication 2016 Sales (+/-%)
Rebif multiple sclerosis $1,834 -7%
Erbitux oncology $927 -6%
Gonal-f fertility $793 6%
Concor cardiovascular disease $454 -10%
Glucophage type 2 diabetes $409 -14%
Euthyrox hormone therapy $350 3%

In Merck KGaA’s Healthcare division, it discovers, develops and manufactures prescription medicines used to treat cancer, multiple sclerosis, and infertility, among other things, as well as over-the-counter pharmaceutical products for colds and pain.

The Healthcare business sector comprises four businesses: Biopharma, Consumer Health, Biosimilars, and Allergopharma. In 2016, Healthcare generated 45% of group sales, or $15.8 billion. Europe and North America generated 60% of Healthcare’s sales in 2016, while in recent years the company has steadily expanded its presence in growth markets. In 2016, Asia-Pacific and Latin America accounted for 33% of sales.

Biopharma is the largest of the Healthcare businesses and operates in four franchises. During the year, new data on Rebif, Biopharma’s top-selling drug and leading multiple sclerosis (MS) therapy were presented at both the American Academy of Neurology’s (AAN) Annual Meeting in April 2016 and the Congress of the European Academy of Neurology (EAN) in May 2016.

In June 2016, the company reached a major regulatory milestone with the submission for registration of cladribine tablets to the European Medicines Agency (EMA). The company says that cladribine tablets, if approved, could lead to high and sustained efficacy through selective modulation of B and T cells resulting in lasting resolution of inflammation.

Erbitux (cetuximab) remains the second best-selling drug in the portfolio of the Biopharma business and is the company’s flagship product in oncology. In April 2016 Merck reached a major milestone regarding its expansion in growth markets with the positive results of the pivotal Chinese Phase III TAILOR study.

Also, through a strategic alliance with Pfizer, the company continued to make progress in the development and envisaged commercialization of avelumab, an investigational fully human anti-programmed death-ligand 1 (PD-L1) antibody.

The positive results from JAVELIN Merkel 200, the pivotal Phase II study in patients with metastatic Merkel cell carcinoma (MCC) treated with avelumab in second or subsequent lines of therapy, were presented at the American Society of Clinical Oncology (ASCO) 2016 annual meeting.

In terms of facility expansions, Merck KGaA continued to invest in its manufacturing network across the globe. In 2016, it completed the construction of a new facility in Nantong, China and expanded a plant in Rio de Janeiro, Brazil, as well.

The company also unveiled plans to invest more than €50 million in a new packaging center of excellence at its pharmaceutical manufacturing site in Darmstadt while also completing the expansion of its plant in Tres Cantos, Spain. In Aubonne, Switzerland, it pushed forward with the construction of a new packaging center there as well.

In the U.S., the company revealed plans for a new $115 million hub in Burlington, MA, that will serve as a major center of operations for the North American Life Science business. The new campus will also house an M Lab Collaboration Center.

Sales: 14 Billion

Headcount: 50,000
Revenues: $14,034 (+13%)
Net Income: $1,218 (-4%)
R&D: $1,867 (flat)

TOP SELLING DRUGS 

Drug Indication 2015 Sales (+/-%)
Rebif multiple sclerosis $1,964 -11%
Erbitux oncology $982 -2%
Gonal-f fertility $748 4%
Concor cardiovascular disease $506 9%
Glucophage type 2 diabetes $477 20%
Euthyrox hormone therapy $341 5%

Merck KGaA strengthened its drive to become a leading oncology company by taking full promotional responsibility for Erbitux (cetuximab) in Japan in 2015. The move ended the co-promotion agreement it had with Bristol-Myers Squibb. Merck KGaA said expanding its oncology presence in Japan is an important strategic step along achieving its long-term goal to become a leading global player in oncology and immune-oncology. The transfer of promotional responsibilities for Erbitux in Japan further increases the presence of the company in this strategic market, where it has already positioned Japan as its regional research and development hub for South East Asia.

Also during the year, Merck KGaA and Pfizer finalized an agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), the first ALK inhibitor approved in the U.S., Japan and the EU. The drug is supported by two positive global randomized trials in the first- and second-line ALK-positive advanced non-small cell lung cancer (NSCLC) treatment settings. Globally more than 8,000 patients have been treated with Xalkori, including those who received Xalkori in clinical trials. This co-promotion relationship is related to the announcement in November 2014 of a global strategic alliance between Merck KGaA and Pfizer to jointly develop and commercialize avelumab, an investigational anti-PD-L1 monoclonal antibody. The immuno-oncology alliance will also advance Pfizer’s PD-1 antibody.

By the end of 2015, the two companies had advanced clinical development program with two additional Phase III trials of avelumab. The Javelin Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum resistant/refractory ovarian cancer. The alliance also announced that the FDA provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer.

The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (bladder) cancer. The alliance has initiated six pivotal trials, reaching its goal for 2015, with additional trials expected to initiate in 2016.

Also on the regulatory front, Merck KGaA was granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. The compound, currently in Phase III trials, is being developed in collaboration with Threshold Pharmaceuticals.

Sales: 11.5 Billion

Headcount: 38,000
Revenues: $11,501 (+4%)
Net Income: $1,157 (-4%)
R&D: $1,704 (-13%)

TOP SELLING DRUGS  

Drug Indication 2014 Sales (+/-%)
Rebif multiple sclerosis $2,235 0%
Erbitux oncology $1,098 6%
Gonal-f fertility $763 9%
Concor cardiovascular disease $520 8%
Glucophage type 2 diabetes $459 -1%
Euthyrox hormone therapy $360 24%

Merck Serono, the biopharmaceuticals part of the larger Merck Group, recently entered an exclusive strategic collaboration and license agreement with Intrexon Corp. to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. With the deal, Merck Serono gains access to Intrexon’s suite of technologies to engineer T-cells. CAR-T therapies are designed to bind to a target and trigger an immunological attack against the cancer.

Intrexon will use its cell engineering techniques and RheoSwitch platform to develop products that empower the immune system in a regulated manner to overcome the current challenges of CAR-T therapy. Merck Serono has exclusive access to Intrexon’s suite of technologies to engineer T-cells with optimized and inducible gene expression.

Intrexon will be responsible for all platform and product developments until IND filing. Merck will select targets of interest to develop CAR-T products and will lead the IND filing and pre-IND interactions, clinical development and commercialization. Intrexon has the opportunity to explore targets independently, granting Merck opt-in rights during clinical development.

During the year, Merck Serono also entered a collaboration with Kadimastem, an Israeli biotechnology company, to provide drug screening for multiple sclerosis (MS) and potential other neurodegenerative diseases. Kadimastem will use its platform technology to screen compounds as potential new therapeutics. The drug screening will be performed with cells that Kadimastem produces for its own cell-therapy products. Kadimastem’s drug-screening platforms comprise human cells that can help predict the potential a drug will have to impact different cell types.

 

KING’S REPORTMerck Serono remains firmly situated in oncology, immune-oncology, fertility and neurodegenerative disease. Its pipeline of drugs shows that oncology is at the forefront of this. Although to be fair, much of the recent publicity has been around fertility. In May Merck Serono announced a collaboration with Austrian company Genea Biomedx committing to develop Assisted Reproductive Technologies (ART) in order to market and create IVF technologies. This resulted in CE Marking of two of the technologies Gavi and Geri in June. In the same month, this was followed with another announcement committing €1.2 million to the Grant for Fertility Innovation (GFI) guaranteeing to support six projects globally.

Within its cancer pipeline the company recently received fast-track designation by the FDA for its Phase III molecule Evofosfamide for advanced pancreatic cancer, which must have been seen as a God-send as its pipeline isn’t bursting with late stage trials of drugs heading to market.

Merck Serono as a whole hasn’t had the strongest start to 2015 although the financials suggest acquisitions and divestments account for this. Still facing the demise of Erbitux in 2016—although the patent doesn’t go until 2018—the company is hoping its pipeline is strong enough to support it alongside alliances in biomarker research into lupus (with Pfizer) and colorectal cancer (with Sysmex Inostics).

—Adele Graham-King

 

 

Sales: 15.3 Billion

Headcount: 38,000
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.

Sales: 8.2 Billion

Headcount: 39,000
Bio/Pharma Revenues: $8,234 (0%)
Total Revenues: $14,364 (0%)
Net Income: $729 (-14%)
R&D Budget: $1,526 (-11%)

Top Selling Drugs

Drug Indication $ (+/- %)
Rebif MS $2,434 3%
Erbitux oncology $1,140 -4%
Gonal-f female fertility $787 7%
Glucophage diabetes $514 7%
Concor group heart failure $489 -12%

Account for 65% of total pharma sales, up from 64% in 2011.

The hits keep coming for Merck Serono, and not in a good way. The company launched a restructuring plan in April 2012, after the failure of multiple sclerosis candidate cladribine. In September 2012, as part of the “Fit for 2018” efficiency program, MS announced plans to lay off 1,100 employees in Germany, from a starting point of 10,900 employees. The layoffs will come from early retirement and voluntary exits through 2015, with a promise of no forced firings in Germany until 2017.

Two weeks after that announcement, MS announced that it was withdrawing an application to expand Erbitux’s label to cover non-small cell lung cancer. The drug failed in a gastric cancer trial in July 2012 and Serono R&D subsequently suffered failures from Stimuvax (NSCLC) in December 2012 and cilgenitide (glioblastoma) in February 2013. Also in February, Serono signed a pact with Opexa on a potential first-in-class treatment for MS currently in Phase IIb.

Merck Serono didn’t perform too badly in 2012, financially speaking. In Euros, revenues climbed 8%, driven by a 12% bump for MS treatment Rebif. But those gains were fueled by three price increases throughout the year. MS is such a competitive field that this strategy isn’t going to keep Merck Serono afloat too much longer.


Outsourcing News
In May 2013, Merck Serono signed a five-year clinical development deal with Quintiles. The CRO will serve as the sole primary provider of Merck Serono’s outsourced clinical development services for its global clinical programs, providing MS with “expanded global reach to implement development programs around the world,” according to a joint statement. MS will lead clinical strategy, while Quintiles will plan and execute trials, as well as contribute to MS’ future clinical trial design activities through optimized clinical trial design and execution strategies. Quintiles will also collaborate in strategic decision-making processes affecting the development of Merck Serono’s portfolio. To learn more about this pact, visit our Q&A with Quintiles execs Kathy Ford and Paula Brown Stafford at http://bit.ly/19dKoio

In December 2012, MS signed a deal for Neopharma to sell several MS medicines in the United Arab Emirates. Neopharma will manufacture hormone therapy Euthyrox and diabetes treatment Glucophage for the UAE market.

Sales: 8.2 Billion

Headcount: 32,800
Biopharma Revenues**: $7,338 (+20%/+12%*)
Royalty Revenues: $496 (+34%/+25%*)
Total Revenues: $11,120 (+15%/+7%*)
Net Income: $558 (-88%/-89%*)
R&D Budget**: $1,580 (+31%/+22%*)

* converted at avg. exch. rate / based on local currency (Euro)
** Pharma unit only

2008 Top Selling Drugs
Drug Indication Sales (+/-%)
Rebif MS $1,958 +17%
Erbitux oncology $831 +29%
Gonal-f female fertility $677 +14%
Concor group heart failure $637 +23%
Glucophage diabetes $427 +17%
Euthyrox thyroid $163 -13%
Raptiva psoriasis $137 +31%

Account for 66% of total biopharma sales, down from 67% in 2007.

PROFILE

In its annual report, Merck Serono refers to 2008 as the Year of Erbitux. Given that the drug gained three new approvals and sales increased 29% (20% in local currency), it’s no wonder! Merck Serono has non-North American rights to Erbitux (it shares rights in Japan with BMS and Lilly). In November 2008, MS began work on a $425 million expansion of the Merck Serono Biotech Center — including manufacturing facilities for Erbitux — in Corsier-sur-Vevey, Switzerland. Erbitux production is expected to start up in 2012, and the expanded area will add 120,000 liters of bioreactor capacity.

Unfortunately, one of MS’s up-and-comers had to be scratched from the lineup. In October 2008, the company reported that a patient taking Raptiva (chronic plaque psoriasis) developed PML (see Biogen Idec’s profile for more on that ailment). The case marked the third Raptiva user to come down with PML; the other two occurred in the U.S., where Genentech markets the drug. After a consultation with the EMEA, MS elected to pull Rapitva from the market, taking a $300 million writedown for production technology.

In better news, MS gained approval for Kuvan, a treatment for hyperphenylalaninemia (HPA) in phenylketonuria, in December 2008. MS has non-North America and non-Japan rights to the drug. The market for the drug isn’t huge — there are around 35,000 people with this condition in the entire European Union — but its benefits are apparently a godsend for people who suffer from HPA. Since Kuvan is an orphan drug, MS will receive 10 years of data exclusivity for it. U.S. development partner Biomarin got the drug on the U.S. market in December 2007 and posted sales of $47 million in 2008.

MS’s parent company, Merck KgA, could use another Year of Erbitux (and Rebif, its top seller, and Gonal-F, etc.). The company’s chemicals division got walloped during the financial crisis. MS is in a comfortable position with Rebif, Erbitux and Gonal-F as its troika. That Serono deal is still paying off.

Sales: 7.6 Billion

Headcount: 40,562
Pharma Revenues: $7,641 (3%/8%*)
Total Revenues: $12,337 (14%/20%*)
Net Income: $853 (62%/70%*)
R&D Budget**: $1,550 (-6%/-1%*)

* Converted at avg. exch. rate / based on reported currency (EUR)

** Pharma unit only

Top-Selling Drugs in 2010

Drug

Indication

$

(+/- %)

Rebif

MS

$2,215

3%

Erbitux

oncology

$1,089

12%

Gonal-f

female fertility

$669

-1%

Concor group

heart failure

$495

-10%

Glucophage

diabetes

$420

3%

Euthyrox

thyroid

$186

-2%

Account for 66% of total pharma sales, same as in 2009.

PROFILE

By today’s standards, Merck Serono had a pretty good year. In Euros (its reporting currency), the unit posted 8% revenue growth in 2010, driven by mainstays Rebif and Erbitux, the latter of which continued to expand its label in key markets. Revenues only grew 2% to $2.0 billion, due to extra stocking that took place in 1Q10 in the U.S.

Shortly before press time, Merck Serono threw in the towel on its highest-profile pipeline project: cladribine tablets (multiple sclerosis). The company experienced a big setback when CHMP gave a final negative opinion on the marketing application for cladribine in the EU, contending the drug’s risks outweigh its benefits. MS’ resubmitted NDA for cladribine also garnered a complete response letter from the FDA in March 2011. The CRL requested “an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies,” according to MS. In June 2011, Merck Serono decided that it wasn’t worth it to initiate further clinical trials to satisfy the FDA and EMA, and pulled the plug on the drug.

Merck Serono had big expectations for cladribine, projecting revenue growth of 5% to 10% in 2011, if cladribine was approved in the U.S. Without approval, growth would drop to 1% to 6% for the year, meaning they had expected around $300 million in first-year revenues from the drug. (The company did get approval for cladribine in a few markets — Russia and Australia — under the brand-name Movectro, but it will withdraw the product as part of its cancellation.)

MS also had a setback with safinamide, a Parkinson’s treatment that missed its primary endpoint in Phase III in November 2010. The company wrote down around $85 million in value for that dug.

That same month, MS got FDA approval for Egrifta, an injectable treatment for excess abdominal fat in HIV-infected patients with lipodystrophy. That drug was co-developed with Theratechnologies. In December 2010, MS and Sanofi began an oncology development pact to see if MS’ MEK inhibitor will work well in combination with some Sanofi candidates.

MS has a few prospects coming in its mid-to-late-stage pipeline, including cilengitide (glioblastoma), but without cladribine, the company will be depending on existing products for the next several years. Given that half its revenues come from Europe, where price pressures are mounting, that could be a problem.  —GYR

Previous Profile: Novo Nordisk // Next Profile: Baxter Bioscience

Sales: 7.5 Billion

Headcount: 33,062
Bio/pharma Revenues: $7,454 (+2%/+7%)
Royalty Revenues: $457 (-8%/-3)%)
Total Revenues: $10,804 (-3%/+3%)
Net Income: $526 (-6%/-1%)
R&D Budget: $1,678 (+6%/+12%)

Revenues converted at average exchange rate / based on reported currency (Euro)

2009 Top Selling Drugs
Drug Indication Sales (+/-%)
Rebif multiple sclerosis $2,1449 +9%
Erbitux oncology $972 +17%
Gonal-f female fertility $678 flat
Concor group heart failure $551 -14%
Glucophage diabetes $406 -5%
Euthyrox thyroid $173 -9%

Account for 66% of total bio/pharma sales, up from 64% in 2008.

 

PROFILE

“We don’t live on an island of the blessed, around which the rushing waters of the crisis flow,” wrote Dr. Karl Lurwig Kley, Merck KgA’s chairman, in what is surely the most lyrical prose in any shareholder letter in 2009.

Merck Serono weathered a tough year better than some of its competitors, and better than some other divisions of parent company Merck KgA. Pharma revs grew 7% in its reported currency (+2% after exchange rate), and MS treatment Rebif passed the $2 billion mark for annual sales, aided by Rebifsmart, a new electronic self-injection device not yet approved in the U.S.

Erbitux, which Merck Serono sells outside the U.S., nearly reached $1 billion in 2009 sales, and is sure to pass that milestone in 2010 as the company adds more indications in Europe — but not non-small cell lung cancer (NSCLC), an indication the EU nixed in July 2009 — and develops the Japanese market. Unfortunately, the rest of its major products were flat or down for the year. We covered the company’s decision to withdraw psoriasis drug Raptiva from the market in last year’s report (it happened in February 2009), but a pair of new drugs also faced regulatory problems in the past 12 months.

In November 2009, the FDA sent a “refuse to file” letter to Merck Serono for its NDA of cladribine tablets for MS. Neither the agency nor the company revealed the contents of that letter (neither party is obliged to), and the NDA was resubmitted in June 2010. The seven-month delay hurts, as it will likely leave Novartis’ new competitor, Gilenia, with a head start. An advisory panel recommended approval of Gilenia in June 2010.

Merck Serono also had to suspend clinical trials of its cancer vaccine, Stimuvax, in March 2010. A patient in Phase II developed encephalitis, forcing recruitment for Phase III trials to be held up. The FDA cleared Merck and partner Oncothyreon to proceed with a trial against NSCLC, but kept a hold on trials against breast cancer and multiple myeloma.

In addition to getting its development pipeline back on track in the west, Merck Serono also took steps to expand its R&D capabilities in the east. In November 2009, the company announced plans to build a global R&d center in Beijing, investing more than $200 million and adding 200 staffers in the next four years. The biomarker-focused center will lead drug development in Asia for both local and global trials.

It’s not an island of the blessed, but Merck Serono has some growth prospects ahead.

 

 

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Sales: 9.7 Billion

Headcount: 30,968
Biopharma Revenues**: $6,111 (+39/27%)
*Total Revenues: $9,673 (+23/12%*)
Net Income: $4,825 (+284/252%)
*R&D Budget***: $1,205 (+104/87%*)

* Change based on local currency (Euro)
** Included ethical and generic sales in 2006, ethical only in 2007
*** Pharma unit only

Top Selling Drugs
Drug Indication Sales (+/-%)
Rebif MS $1,670 +15%
Erbitux oncology $644 +52%
Concor group heart failure $520 +19%
Gonal-f female fertility $595 +10%
Glucophage diabetes $365 +17%
Serostim growth deficiency $223 +7%
Euthyrox thyroid $171 +32%

Account for 69% of total pharma sales, down from 80% in 2006.

 

PROFILE

At a time when several of the industry’s big guns are bulking up on generics, Merck KgA went in the opposite direction last year. In October 2007, the company closed on the $7.0 billion divestiture of its generics unit to Mylan. That unit had sales of $2.6 billion and more than 4,000 employees in 2006.

Why the exit? To help pay down its September 2006 purchase of Serono, a $13.3 billion move that established Merck Serono and created a new player on our Top Biopharmas list. The new MS makes more than half its revenues from bio-drugs, and focuses its pipeline on oncology, neurologic diseases, fertility, endocrinology, cardiometabolic care.

The acquisition made the new MS a biopharma player, but it also opened the U.S. market to Merck, which saw sales in that region grow 237% in 2007.

MS doesn’t have U.S. rights to its #2 seller, cancer treatment Erbitux, but that hasn’t slowed growth of the MAb that once led to Martha Stewart’s imprisonment. MS’s sales of the drug were up 52% in 2007 and 33% in 1Q08, outpacing the performance of lead drug Rebif, which posted increases of 15% and 11% in those timeframes. In June 2008, MS applied to expand Erbitux’s label in the EU after strong trial results.

In October 2007, MS signed an agreement with co-developers ImClone and Bristol-Myers Squibb to jointly market Erbitux in Japan, pending approval there. Merck will receive 50% of profits (and/or pay for half the losses), while the partners will each get 25%. In June 2008, MS signed a pact with BMS to market, sell and distribute 30 of Bristol’s products in Latin America.

Serono was considered a consolation prize for Merck KgA after it struck out in its attempt at buying Schering AG. Bayer was declared the winner in that battle, but it looks like Merck Serono made out pretty well for losing.

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