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Roche Pharmaceuticals (RHHBY)

Stock

Roche Pharmaceuticals is a division of F. Hoffmann–La Roche, Ltd., a global health company headquartered in Basel, Switzerland. Known most famously for creating the world's first anti-depressant, Iproniazid, the entire company now boasts over 28.6 billion in total revenue in 2005, with 74,372 employees worldwide. It owns just over half of Genentech (an ownership percentage that allows it to include Genetech's revenue in Roche's own reporting), and Chugai Pharmaceuticals, of Japan.

Contents

[edit] Introduction

Roche, Inc. (NYSE:RHHBY) one of Europe’s largest pharmaceutical company that provides both innovative diagnostic and therapeutic products to the health care industry. Roche specializes in cancer and has provided blockbuster drugs such as Avastin, a colorectal specific drug, which maintained above a 17% growth in 2007 [1]. Roche has a very large pipeline providing pharmaceutical drugs and cutting edge diagnostic tests giving Roche a balance between risk and growth with 80% of their pipeline dedicated towards pharmaceutical drugs and the remaining 20% in diagnostic testing [1]. This type of diversity allowed sales to exceed 46 billion Swiss Francs through Roche key products including, Avastin, Mabthera, Herceptin [2].

The infrastructures of Roche lower risk by diversifying their products and placing new products when seasonal products run their cycle. For example Tamiflu is owned by Roche and was a huge revenue generating product in early 2000-2001 when the government stockpiled this drug [3]. However today in 2008, the supply has exceeded the demand and tamiflu have drastically been reduced. Roche can still maintain 30% of the market by re-launching seasonal drugs, like Tamiflu, as well as providing multiple cancer therapeutic and diagnostic products [4]. Roche has a decrease in regulatory, patent, and pricing risk [5].

Roche is a stable diverse company that has tackled one of the most challenging areas of disease, cancer. Cancer is one of the most sought out areas among all the pharmaceutical companies due to its huge potential in revenue generating profits. This provides a lot of competition for Roche, however, there is only a 22% risk for generic companies compared to the industry’s 42% within this sector [6]. Roche has large expansion products set for both Avastin and Mabthera, royalty income of 213 million, and partnerships- most notably Genetech, that has provided a large cash pile in 2007. This provides a tough quandary on what products to continue to research and develop and what other areas to explore.

[edit] History

Roche has a rich history dating back to the late 19th century. In 1896, Fritz Hoffmann formed F. Hoffman-La Roche & Company in Basel, Switzerland after himself and his wife [7]. The goal of the company was to provide novel and superior quality drugs to the entire world. Some of their first products included: Aiodin, a thyroid preparation, Airol, a wound anti-septic, Allonal, an analgesic sedative and hypnotic, pantopan, a remedy for pain, colic cough and anxiety [8]. Roche has always been involved in the most innovative and novel science starting in its earliest years with on the first compounds produced by synthetic chemistry, Sirolin. “This continued up and through 2003 when the company launched Fuzeon (enfuvirtide), the first in a new class of drugs (fusion inhibitors) that blocks HIV from fusing with a host cell” [9]. In 2005 Roche launched the first and only once a month oral treatment for osteoporosis [10]. The company established in the United States, first in New York City and relocating in 1929 to Nutley, N.J. where it still remains. Today Roche operates in more than 60 countries and employs more than 74,000 people.

[edit] Revenue Sources

Roche earnings grew 10% to 46.1 billion Swiss Francs larger due to an 80% growth in pharmaceutical sales (2.5). Oncology encompassed 20% and 50% within pharmaceutical sales. Roche saw a positive growth across their pipeline including 6% diagnostic, 22% operating profit and 16% R&D. In 2007 EPS growth was 17.3% driven by Avastin’s expansion contributing to 37% of the growth.

[edit] Business Update

Pharmaceutical In the first half of 2008 group sales increased by 10% in local currencies to 22 billion, this excludes seasonal Tamiflu and net income reached 5.7 billion Swiss francs. Pharmaceutical sales increased 9%, more than twice the global market average. Despite decreased sales in Tamiflu there was Double-digit growth of key products total sales shown by an increase of 3%. Avastin received accelerated approval for breast cancer in the United States and Actemra was approved and launched for rheumatoid arthritis in Japan, first market worldwide for this indication. Late-stage development projects on track: large phase III study with CETP inhibitor Dalcetrapib starts; phase III trials with GLP-1 analogue taspoglutide for type 2 diabetes to begin shortly.

Diagnostics Sales increased to 11%, with a growth and expansion within immunochemistry and DNA sequencing technology. Diabetes Care sales were up 2% for half-year, with accelerating growth in the second quarter.

[edit] Current Acquisition News

Roche acquired a 100% controlling interest in BioVeris Corporation (BIOV) for a reported 745 million Swiss Francs. This is a healthcare and biosecurity publicly owned US Company. Other notable acquisitions joining Roche’s diagnostic group was 454 Life Sciences which develops and commercializes novel instrumentation for high-throughput DNA sequencing purchased was 189 million Swiss francs.

On September, 24th, 2008, Roche completed the acquisition of 100% of the issued and outstanding shares and warrants of ARIUS research. ARIUS is the developer of a proprietary antibody platform called FunctionFIRST(TM), which rapidly identifies and selects antibodies based on their functional ability to affect disease before progressing into clinical development [11].

Genetech rejects Roche’s offer of 43.7 billion dollar buyout for the remaining 44% of the company that Roche does not own. The board of Genetech unanimously voted against this offer claiming that it was too low.

[edit] Diseases

One of Roche's main goals is to provide the equipment necessary to prevent and diagnose diseases. Besides prescription drugs, the company company also focuses on the following areas:

  • Anemia
  • Inflammatory and autoimmune diseases
  • Central nervous system
  • Cardiovascular diseases
  • Infectious diseases
  • Metabolic disorders
  • Cancer
  • Transplantation
  • Virology

[edit] Roche Drugs

[edit] Cardiovascular Disease

Regulating cholesterol levels is a competitive area for most pharmaceutical companies. Two areas of interest are regultating high-density lipoprotein cholesterol (HDL), or ‘good’ cholesterol, and low-density lipoprotein cholesterol (LDL), 'bad cholesterol'. Studies have shown that low levels of 'good' cholesterol and high levels of 'bad' cholesterol increases your risk of developing cardiovascular disease. are associated with an increased risk of cardiovascular disease.

Roche developed and licensed R1658 (JTT-705), from Japan Tobacco, and is designed to raise levels of HDL by inhibiting cholesteryl ester transfer protein (CETP) activity. Based on promising phase II data, Roche has decided to move R1658 into phase III clinical trials.


[edit] Inflammatory and autoimmune diseases

Rheumatoid arthritis (RA) is a systemic autoimmune disease that is characterized by chronic inflammation, pain, and fatigue. The exact cause of RA is not known but it affects the mobility of joints within people of all ages. Mabthera/Rituxan is the first and only selective B cell therapy for the treatment of RA for those patients that have an inadequate or adverse response to tumor necrosis factor (TNF) inhibitors. This product has been launched in European, north and Latin America markets.

Actemra (tocilizumab) is the first human monoclonial antibody designed to block the effects of interleukin-6 (Il-6). This is a key protein involved in the inflammation of joints. In 2007 four phase III clinical trials so advantageous results and Roche filed marketing applications for Actemra in the US and EU in November 2007.

[edit] metabolic disorders

Diabetes [12] is a disease characterized by excess blood glucose due to a deficiency in insulin availability and/or resistance to its action. Type 2 diabetes accounts for 90% to 95% of all diabetes caes worldwide. The World health Organization estimates that the number of people with diabetes will double in the next 20 years to over 300 million. Several complications are common with diabetes such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness, are resulting in increasing disability, reduced life expectancy and enormous health cost for virtually every society [13].

Roche had positive results from a phase II clinical trial for its diabetic drug Taspoglutide. Taspoglutide is the first human once weekly glucagons-like peptide 1 (GLP-1) similar to the natural hormone GLP-1. This hormone plays a key role in blood sugar regulation. The drug has been well tolerated and could have a beneficial impact on obese people with type II diabetes. Based on these results Roche will move Taspoglutide into Phase III clinical trials [14].

osteoporosis [15] is a disease of bone that leads to an increased risk of fracture. It is characterized by a loss of bone mass that leads to weekness and susceptibility to fracture. Osteoporosis is defined by the World Health Organization (WHO) in women as a bone mineral density 2.5 standard deviations below peak bone mass. Osteoporosis affects millions of people worldwide, with one in three postmenopausal women and one in five men over the age of 50 affected. It may also develop in men and anyone in the presence of particular hormonal disorders and other chronic diseases or as a result of medications, specifically glucocorticoids, when the disease is called steroid- or glucocorticoid-induced osteoporosis (SIOP or GIOP) [16].

Bonviva/Boniva (ibandronic acid) is the first and only once-monthly oral bisphosphonate approved for the treatment of postmenopausal osteoporosis. Bonviva/Boniva continued to show strong growth even in a highly competitive market. The market share increased to over 15% in the US. Bonviva/Boniva has been shown to reduce the risk of bone fractures in susceptible individuals.

oncology Roche have first line therapies for many cancers including lymphocytic leukemia, non-Hodgkin’s lymphoma,prostate,lung,gastric,[17],and breast[18].

MabThera/Rituxan, Avastin, ‘and Tarceva are being evaluated in clinical trials studies as a potential first-line treatment for multiple different cancers. Avastin is being investigated for its role in colon, lung and HER2-negative breast cancer. A combination of 20 clinical trials is investigating the benefits of Tarceva in lung cancer including early-stage Non-small cell lung carcinoma (NSCLC) and other solid tumors.

Herceptin in advanced HER2-positive gastric cancer is moving forward as planned. Gastric cancer represents a significant unmet medical need; current data indicate that the HER2-positivity rate in advanced gastric cancer is comparable to that in breast cancer.

[edit] References

Roche 2007 Annual Report
Roche Half-year Report 2008
Roche 2007 business report

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