The FDA just gave Eisai a new weapon against generic competition for the company’s flagship Alzheimer’s therapy Aricept by approving a higher-dose form of the drug. And Eisai hopes the new version will keep generic copies from deeply slashing sales of its profitable drug.

The agency gave the nod to a 23-mg Aricept pill, which is meant to be taken once a day. Generic versions of the 10-milligram dose are on their way in November. According to recently released studies, patients using the higher dose got better results than those using the lower dose; patients with more advanced Alzheimer’s benefited most from the 23-mg pill, Bloomberg reports.

Eisai, which now partners with Pfizer on Aricept, one of the top patent expirations of 2010, has said it’s counting on new forms of Aricept, including this higher-dose version, to keep U.S. sales at half of the current $2 billion or so, once generic competition gathers steam. ”Aricept is a key earnings pillar,” Credit Suisse analyst Fumiyoshi Sakai, writes in a note to clients, and quoted by Bloomberg. “With the November 2010 patent expiration set to open the way for generic competition, Eisai had been keenly pursuing approval for a higher-dose formulation.”

Meanwhile, Eisai has been plotting a manufacturing move to India, aiming to lower production costs for Aricept so that it can cut prices to compete with generics makers. That way, as overall sales drop, it can still make profits off the drug.

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Eisai Co and Pfizer Inc said they won U.S. regulatory approval for a higher dose once-daily version of Aricept, a drug that treats Alzheimer’s disease.

Eisai, Japan’s No. 4 drugmaker, said in March it expected annual U.S. sales of the drug, its flagship product, to fall 60 percent to $800 million from $2 billion between 2011 and 2013 with the expiration of its patent for the drug looming.

The U.S. Federal Drug Administration approved a 23 mg tablet version of the drug, which treats moderate-to-severe Alzheimer’s. About 3.5 million Americans over the age of 65 suffer from the disease.

Source: Reuters

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Eisai and Pfizer rolled out a new set of clinical trial numbers on their long-acting version of Aricept (donepezil), with the experimental 23 milligram extended-release formulation besting the 10 milligram immediate-release drug that the Japanese company relies on for the lion’s share of its U.S. revenue.

In a study which enrolled 1,476 patients, researchers said that the once-daily 23 milligram therapy proved more effective in maintaining and improving brain function than the marketed drug, according to a report from Bloomberg. Eisai faces a July 24 PDUFA date on its FDA application for the long-acting form of Aricept. Data on a patch version of the drug will be submitted this month.

Eisai has a lot riding on these new formulations. Aricept, the world’s best-selling Alzheimer’s drug, provides the company with 60 percent of its U.S. revenue but loses patent protection in November, a milestone that will be followed by a rapid loss in sales. A host of new Alzheimer’s therapies are now being studied as developers attempt to do more than treat symptoms of the disease.

Aricept garnered $3.64 billion in sales during the last fiscal year, but Eisai says it expects sales to swiftly plunge by 50 percent once it loses patent protection. The Japanese pharma company says its long-acting version should earn $600 million a year once it reaches its peak.

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Eisai Co. plans to hire about 100 people for a research and development center in India that will give the Tokyo-based drugmaker its first laboratory in Asia outside Japan.

The facility, estimated to cost about $50 million, will be located in the eastern city of Visakhapatnam, Andhra Pradesh state, and employ about 20 scientists, said Kozo Akasaka, a spokesman for Eisai, in a telephone interview today. Plans to open an R&D center were reported June 26 in India’s Financial Express newspaper.

Eisai, which makes Aricept, the world’s best-selling Alzheimer’s disease treatment, aims to speed the development of medications for the Indian market as well as produce new ones for the global market, Akasaka said.

India’s domestic pharmaceutical industry, worth about $11 billion in the year ended March 2009, will expand to about $30 billion by 2020, accounting firm PricewaterhouseCoopers LLP said in an April report.

Source: Bloomberg Businessweek

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The AARP says that manufacturer prices for brand-name prescription drugs commonly used by people on Medicare rose 9.7% for the year ending in March — the biggest annual jump since the group started tracking prices in 2002. The price of specialty drugs like biologics and injectables rose 9.2%. Generic drug prices, meantime, dropped 9.7%. (All this happened while general inflation hovered around 0.3%.)

The report found that all of the top 25 brand-name prescription drugs had higher prices in the last year. Here’s a list of the top 10, with manufacturer and percent change in manufacturer’s price:

1. Nexium – AstraZeneca – 7.4%
2. Plavix – Bristol-Myers Squibb – 10.5%
3. Prevacid – Takeda – 8.1%
4. Protonix – Wyeth – 9.3%
5. Lipitor (20mg) – Pfizer – 5.5%
6. Lipitor (10mg) – Pfizer – 5.5%
7. Aricept – Eisai – 13.9%
8. Fosamax – Merck – 6.7%
9. Norvasc — Pfizer — 5.0%
10. Advair — GlaxoSmithKline — 7.0%

Industry group PhRMA said in a statement that the report was “misleading” because it doesn’t account for “discounts and rebates generally negotiated between drug manufacturers and payers, which can significantly lower the cost of brand-name medicines, ultimately benefiting patients.” The group also said prescription drugs “represent a small and decreasing share of growth in overall health care costs in the U.S.”

This follows a report last month from pharmacy-benefit manager Express Scripts saying brand-name drugs registered a 9.1% price increase last year, with an 11.5% jump for specialty drugs. An Express Scripts exec told the WSJ then that the increases “were exacerbated by the health care reform debate.” Health-care overhaul legislation includes higher rebates manufacturers must pay to Medicaid. Drug makers disputed that notion, the WSJ reported.

Source: The Wall Street Journal

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There’s not enough evidence to suggest that medicines or dietary supplements prevent Alzheimer’s disease or cognitive decline, an independent committee of experts convened by the National Institutes of Health concluded today.

The three-day meeting of 15 experts took a critical look at the state of science surrounding the memory-robbing disease, which is now the sixth-leading cause of death in the U.S. The main conclusion: there’s not enough good research out there to show that any intervention prevents the disease.

Some factors that appear to be related to decreased risk of Alzheimer’s include “cognitive engagement” like training people in reasoning and memory, walking and a Mediterranean diet. But there’s no consistent evidence that multivitamins, gingko biloba or other supplements can do anything to stave off the disease.

The experts didn’t find evidence that Alzheimer’s drugs like Pfizer and Eisai’s Aricept and Forest’s Namenda, approved to treat memory loss and other symptoms of the disease, are also effective in slowing or preventing dementia.

The panel hopes that the results about what does and doesn’t work will reach doctors and patients to better inform decision-making. “People should know that so they can decide how they’re going to spend their money,” said Carl Bell, a panel member and a professor at the University of Illinois at Chicago.

Source: The Wall Street Journal

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Eisai has become the latest drugmaker to cut prices in an effort to push sales in emerging markets. On the heels of similar moves by GlaxoSmithKline and Sanofi-Aventis, the Japanese company is cutting prices on its Alzheimer’s remedy Aricept in at least six Asian countries.

The idea is to ratchet up demand by opening the door to less prosperous patients, says Eisai’s Yasushi Okada, who heads up operations in Asia, Oceania and the Middle East. “With the current prices, only a part of the wealthy people can afford to buy our products,” Okada tells Bloomberg. “I want to increase the patient accessibility of the medicines in Asia.”

Okada tells the news service that he expects growth in sales volume to outweigh the price cuts, delivering overall sales growth. And that’s the aim of GSK and Sanofi as well. GSK has announced major price cuts in emerging markets, with prices tiered according to the target population.

In some GSK markets, prices will be less than two-thirds of those in Europe; in the 50 poorest nations, they’ll be 25 percent of Western prices, Bloomberg points out. Meanwhile, Sanofi announced early this year that it would follow suit, cutting prices in Southeast Asia by as much as half.

Okada wouldn’t say just how much Eisai plans to cut the price tags on Aricept. In the coming quarters, however, we’ll be able to see how the cuts affect sales in those markets. For 2008, Aricept’s global revenues amounted to $3 billion; the company loses patent protection in the U.S. in November, so it stands to lose revenues here to generic competition. All the more reason to grow sales in emerging markets.

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FDA approved the first generic versions of Alzheimer drug Aricept (donepezil hydrochloride) orally disintegrating tablets. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer disease. The new generic tablets, manufactured by Mutual Pharmaceutical, have been approved in 5 mg and 10 mg strengths.

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In the U.S., Japan, and key markets in Europe, the product is co-promoted by Eisai and Pfizer. Pfizer reported $482 million in year-end revenue from Aricept for 2008 and $311 million for the first nine months of 2009.

Aricept was discovered and developed by Eisai and approved by the FDA in 1996. It is a once-a-day treatment for mild, moderate, and severe Alzheimer disease. Studies showed Aricept treats Alzheimer symptoms, slowing the loss of overall function and improving cognition.

Source: GEN News

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Takeda Pharmaceutical Co., maker of the world’s best-selling diabetes drug Actos, posted first-half profit that more than doubled on lower expenses, while cutting its revenue outlook because of weaker sales and the stronger yen.

Net income rose to 189.6 billion yen ($2.1 billion) in the six months to Sept. 30, from 71.8 billion yen a year earlier, when there was a one-time charge related to the takeover of Millennium Pharmaceuticals Inc., the Osaka, Japan-based company said today. That beat the 162.4 billion yen median of four analyst estimates compiled by Bloomberg. Sales fell 6.4 percent at Takeda, which generates almost half of its revenue overseas.

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Asia’s biggest drugmaker may open offices in Brazil, India and Russia to boost growth and seek further acquisitions after last year’s $8.9 billion purchase of Millennium, President Yasuchika Hasegawa said today. Takeda said sales in the year to March 31 will fall more than earlier forecast, after the yen’s 9.8 percent gain against the dollar in the six months to Sept. 30 cut overseas earnings.

“Scale is what matters the most for drugmakers and unless you’re within the world’s No. 10, you can hardly survive,” said Mitsushige Akino, who oversees $660 million of assets at Ichiyoshi Investment Management Co. in Tokyo. “I doubt if Takeda can compete with bigger rivals in the global arena.”

Takeda rose 3.4 percent to close at 3,650 yen in Tokyo trading. The stock has lost 21 percent this year, lagging behind the 4.1 percent advance by the benchmark Topix index.

Daiichi Sankyo Co. and Eisai Co., Japan’s third- and fourth-biggest drugmakers, today also posted higher earnings than analysts projected.

Expenses Decline

First-half earnings at Takeda were boosted by a 35 percent drop in sales and administrative expenses including research and development from a year earlier, when the drugmaker booked a 166.3 billion yen charge, mostly relating to the Millennium takeover.

“Takeda’s earnings only look good on the surface,” said Kenji Masuzoe, an analyst at Deutsche Bank AG in Tokyo. Sales of Takeda’s main products are inadequate, he said.

Takeda has set up more overseas sales offices including in Mexico and hired an external advisory board as part of efforts to counter an anticipated decline in revenue from its two best- selling products, Actos and Prevacid. Patent protection will expire next month for heartburn medication Prevacid, and in January 2011 for Actos.

“We have a dilemma in that we haven’t got a clear answer” for our future growth, Hasegawa said at a briefing in Tokyo. “We will continue to improve our business, cut costs and accelerate business development.”

Higher Profit

The Japanese drugmaker said net income will rise 20 percent to 280 billion yen in the year ending March 31, unchanged from its earlier projection. Analysts anticipated 272 billion yen, based on the median of three estimates compiled by Bloomberg in the past four weeks.

Full-year revenue will probably decline 3.8 percent to 1.48 trillion yen, less than the previously estimated 1.5 trillion yen, because of the yen’s appreciation, the company said.

The U.S. currency averaged 93.6 yen and the euro 133.8 yen in the three months ended Sept. 30, compared with 107.5 yen and 161.9 yen a year earlier, according to data compiled by Bloomberg. A stronger yen reduces the value of overseas sales when repatriated.

Aricept Demand

First-half net income at Eisai increased 7.7 percent to 30.9 billion yen on cost savings and demand in Japan for Aricept, the world’s best-selling drug for Alzheimer’s disease. Analysts anticipated 28.2 billion yen, according to Bloomberg data. Sales slipped 1 percent to 395 billion yen.

Sales in Japan of Aricept, which faces competition from generic drugs when its patent protection expires in November next year, climbed 20 percent to 45.8 billion yen, helping to counter a decline in other regions including Europe.

The company has at least three drugs in the second or last of three trial phases typically required for regulatory review.

Eisai said today its experimental breast cancer treatment E7389, or eribulin, met goals set in Phase III trials. The company said it plans to apply for marketing approval in the U.S., Europe and Japan by March 31.

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Tokyo-based Eisai maintained its July forecasts for net income to rise 32 percent to 63 billion yen in the year ending March 31 and sales to climb 4.9 percent to 820 billion yen.

Higher Development Costs

Daiichi Sankyo said first-half profit fell 45 percent to 18.7 billion yen because of higher development costs and tax charges. That’s better than analysts’ expectations of 12.4 billion yen, according to Bloomberg data. Sales rose 16 percent to 471 billion yen.

Tokyo-based Daiichi Sankyo maintained its full-year forecasts and said the company will review the outlook after its 64 percent-owned unit Ranbaxy Laboratories Ltd. reports earnings for the quarter ended Dec. 31. The Japanese company consolidates earnings at Gurgaon, India-based Ranbaxy, the nation’s biggest drugmaker, with a quarter’s lag.

Daiichi Sankyo expects to turn to a net income of 40 billion yen for the year ending March 31, while sales may rise 14 percent to 960 billion yen.

Eisai shares gained 0.9 percent to 3,250 yen and Daiichi Sankyo’s stock fell 1.4 percent to 1,788 yen today.

Takeda said today it’s assuming an average rate of 90 yen to the dollar and 135 yen to the euro for its forecasts, compared with 95 yen and 120 yen expected in July. Daiichi Sankyo projects the U.S. currency will trade at 90 yen and the euro 130 yen, compared with 95 yen and 120 yen. Eisai kept its predictions for the dollar to be at 95 yen and the euro 125 yen.

Astellas Pharma Inc., Japan’s second-largest drugmaker, is scheduled to report earnings on Nov. 5.

Source: Bloomberg.com

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Call it a win-win deal. Pfizer and Eisai have restructured their Aricept partnership and entered a new co-promotion deal on Lyrica. The deals ward off a court battle over the Alzheimer’s treatment Aricept. As you know, Pfizer’s impending merger with Wyeth prompted Eisai’s chief executive to threaten a legal tussle over the terms of their 1994 partnership.

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Here’s the skinny: Pfizer and Eisai will continue to co-market Aricept in the U.S., Japan, and some European markets, but Eisai will get the Japanese rights in 2012. Pfizer will have exclusive Aricept rights in other markets till 2022. On Lyrica, the two companies are pledging to co-promote the pain and epilepsy drug in Japan till 2022–provide it, in fact, gains approval there as requested.

Eisai said it expects the arrangements to boost revenues and profits beginning in the fiscal year ended March 2011, Reuters reports. Pfizer chief Jeff Kindler said in a statement that the company “look[s] forward to forging a new alliance with Eisai … with our co-promotion of Lyrica in Japan.” We’ll have to wait and see if Japanese regulators cooperate and approve the drug.

Source: FiercePharma

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