Daiichi Sankyo Quietly Grows While Other Pharmaceutical Firms Downsize

PARSIPPANY, N.J., Oct. 1 /PRNewswire/ -- Daiichi Sankyo, Inc. has been steadily expanding its New Jersey facilities and rapidly increasing its staffing since 2002 to support a growing pipeline of medications for cardiovascular disease, diabetes, oncology and infection. Daiichi Sankyo is one of the few pharmaceutical companies experiencing steady and sustained growth, in a market that has seen most of its larger competitors forced to downsize and consolidate operations.

Although not well known in the U. S., Daiichi Sankyo is heading toward mid-sized company status. "Over the next three years, we expect to achieve a 60 percent growth in sales," President and CEO Joseph P. Pieroni states. The company, which started its commercial operations in the U.S. about ten years ago, today revealed its plans for future growth and the impact it hopes to have in creating additional life sciences positions in New Jersey at a meeting with Congressman Rodney Frelinghuysen (N.J. - 11th District). The Congressman was visiting Daiichi Sankyo's U.S. headquarters to personally meet with the management and employees to discuss health care programs and the future of health care and the industry in the state.

"We applaud Congressman Frelinghuysen's conviction that all Americans should have access to affordable, high-quality health care," said Pieroni. "We are also grateful for his tireless efforts to ensure drug access for all our senior citizens through the Medicare Prescription Drug Bill. In addition, he supported doubling the research budget for the National Institutes of Health. Hopefully, we can demonstrate our appreciation by continuing to do what we do best: bring innovative medicines to the American public."

Pieroni explained that he was proud of the company's longstanding legacy of discovering leading cardiovascular and anti-infective products, but that, despite its presence in the U.S. for 46 years, most Americans do not recognize the company by name.

"That's because in the past our Japanese parent companies traditionally licensed our products to larger companies to market," explains Pieroni. "Sankyo discovered the statins, a lipid-lowering class of drugs which are now the mainstay of today's cholesterol reduction. Sankyo discovered the first statin, mevastatin, and co-discovered lovastatin with Merck, the first statin to be marketed. We also developed pravastatin sodium, which we licensed to Bristol-Myers Squibb. Daiichi discovered levofloxacin, an antibiotic for bacterial infections, which is marketed in the U.S. by Johnson & Johnson. Because these innovative and blockbuster products were out-licensed to large U.S. companies, Daiichi Sankyo is not exactly a household name in the U.S."

Sankyo and Daiichi merged in the U.S. in 2006 to form Daiichi Sankyo, Inc. and established its headquarters in Parsippany, N.J. From 2002 to 2007, the company's headquarters staff in Parsippany nearly doubled, its Edison, N.J.- based global Clinical Development staff more than doubled, and its national sales force grew by more than two and one-half times.

Daiichi Sankyo currently employs about 600 people in the state, including 300 at its Parsippany headquarters and 220 at the company's Clinical Development offices in Edison. Nationally, the company employs more than 2,000 people, with about 30 percent of its work force based in New Jersey.

The company develops and markets drugs in five therapeutic areas: cardiovascular, metabolic disease, oncology, immunology and anti-infectives.

The company expects that three anticipated product launches will continue to fuel its double-digit growth within the next two years. On September 26, 2007, the Food and Drug Administration approved the company's new anti- hypertensive drug, AZORTM (amlodipine and olmesartan medoxomil), a fixed-dose combination of the calcium channel blocker (CCB) amlodipine and the angiotensin receptor blocker (ARB) olmesartan medoxomil, or BENICAR(R). In the next several months, the company expects to launch a type 2 diabetes indication for its lipid-lowering drug, WelChol(R) (colesevalam hydrochloride). With FDA approval, WelChol will be the first LDL-lowering medication also indicated for improving glycemic control. And within two years, Daiichi Sankyo and its co-promotion partner Eli Lilly and Company hope to bring the anti-platelet agent prasugrel to market for patients with acute coronary syndrome.

Globally, Daiichi Sankyo currently ranks as one of the top twenty pharmaceutical companies, with sales last year exceeding $8 billion. As a company in existence for more than 100 years, Daiichi Sankyo is very well known in Japan-it is the country's second largest drug maker, ranking ahead of Astellas Pharma Inc. and Eisai Inc. whose sales are $7.5 and $4.6 billion, respectively.

"The legacy of Daiichi and Sankyo is more than a century of pharmaceutical experience in bringing important medical discoveries to market," Pieroni said. "We are continuing this tradition of solid R&D innovation and are confident that our company is well positioned as an emerging leader in cardiovascular care to excel in the challenging U.S. pharmaceutical marketplace-and in bringing more life sciences jobs to New Jersey."

Daiichi Sankyo Co., Ltd., , the U.S. organization's parent company, is traded on the Tokyo Stock Exchange.

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc., (pronounced DIE - EECH -EE SANK- EE - O) headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899. The company is dedicated to the discovery, development and commercialization of innovative medicines that improve the lives of patients throughout the world.

The primary focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. The company is also pursuing the discovery of new medicines in the areas of glucose metabolic disorders, infectious diseases, cancer, bone and joint diseases, and immune disorders.

For more information, visit http://www.dsus.com/. About AZOR(TM)

AZOR was approved by the Food and Drug Administration (FDA) in September 2007 as a fixed combination of two antihypertensive drugs, the calcium channel blocker amlodipine and the angiotensin receptor blocker olmesartan medoxomil. AZOR is indicated for the treatment of hypertension, alone or with other antihypertensive agents. AZOR is not indicated for initial therapy of hypertension. AZOR is a convenient, once daily, single tablet combination of amlodipine, the number one prescribed calcium channel blocker (CCB) on the market, and olmesartan medoxomil. The combination of these two medications will give doctors a powerful new treatment option for patients with hypertension who need to reduce their blood pressure levels or who are uncontrolled on other medications.

In clinical trials, AZOR produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension. According to the pivotal registrational trial, AZOR 10/40 mg reduced systolic blood pressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0 mm Hg. These results were in comparison with mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo = 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, AZOR 10/40 mg resulted in a 53 percent greater reduction in the mean change of systolic blood pressure.

IMPORTANT SAFETY INFORMATION ABOUT AZOR USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

When pregnancy is detected, AZOR should be discontinued as soon as possible. See WARNINGS AND PRECAUTIONS, Fetal/Neonatal Morbidity and Mortality.

In volume- and/or salt-depleted patients, symptomatic hypotension due particularly to the olmesartan component may occur after initiation of treatment with AZOR. Treatment should start under close medical supervision.

Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy.

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with AZOR because of the olmesartan medoxomil component.

Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function, caution should be exercised when administering AZOR to patients with severe hepatic impairment.

The only adverse event that occurred in greater than 3% of patients treated with AZOR and more frequently than placebo was edema (22.2% vs 12.3%).

Please see full prescribing information for AZOR. About WelChol(R)

WelChol (colesevelam HCI) is indicated for LDL-C lowering and was approved by the U.S. Food and Drug Administration (FDA) for marketing in May 2000. WelChol is the top-selling branded drug in the bile acid sequestrants (BAS) class. WelChol is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, WelChol is not expected to have drug-drug interactions via the cytochrome P- 450 pathway. Systemic medications, which include statins, fibrates, and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.

WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa) when the response to diet and exercise has been inadequate. Liver- function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.

In clinical trials with patients with primary hypercholesterolemia, when WelChol was given alone in addition to a low-fat diet and exercise, it was shown to reduce LDL cholesterol by an average of 15% to 18%.

When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.8g provided up to an additional mean 16% (32 mg/dL) reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin.

WelChol is engineered for affinity and high capacity bile acid binding. It has been studied with our commonly prescribed statins -- Lipitor(R) (atorvastatin calcium), Zocor(R) (simvastatin), Pravachol(R)4 (pravastatin sodium) and Mevacor(R) (lovastatin). Additionally, WelChol has been studied with fenofibrate and had no significant effect on the bioavailability of fenofibrate. Like most prescription drugs, WelChol has not been studied in combination with all medications or supplements. Patients should always tell their doctor about all medications and supplements they are taking before starting any new therapy, including WelChol.

WelChol is not for everyone, especially those with bowel blockage. Caution should be exercised when treating patients who have trouble swallowing or severe stomach or intestinal problems. Side effects may include constipation, indigestion and gas. WelChol, either alone or in combination with a statin or fenofibrate, has not been shown to prevent heart disease or heart attacks.

WelChol is only indicated for the reduction of LDL-C either alone or in combination with a statin in patients with primary hypercholesterolemia. Additionally, WelChol has demonstrated beneficial effects on other lipid parameters such as HDL-C and APO-B. WelChol has also been studied in combination with fenofibrate in patients with mixed dyslipidemia (Fredrickson Type II B), and provided additional LDL-C reductions in these patients when added to a stable fenofibrate regimen. WelChol is not indicated for use in the treatment of mixed dyslipidemia or lipid parameters other than LDL-C.

For more information on WelChol, call 877-4-DSPROD (877-431-7763), or go to the WelChol web site at http://www.welchol.com/.

About prasugrel

Daiichi Sankyo Company, Limited , and Eli Lilly and Company are co-developing prasugrel, an investigational oral anti-platelet agent invented by Daiichi Sankyo and its Japanese research partner Ube Industries, as a potential treatment initially for patients with acute coronary syndrome undergoing PCI. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the adenosine diphosphate (ADP) receptor on the platelet surface. Anti-platelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and lead to heart attack or stroke.

For more information, please contact: Jason Ford Daiichi Sankyo, Inc. (973) 359-2634 jaford@dsus.com