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

Popularity: 3% [?]

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

Popularity: 8% [?]

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

Popularity: 2% [?]

Alzheimer’s disease is a bit like a murder mystery with numerous possible culprits and only a few vague clues. For years the prime suspect has been a protein fragment called beta-amyloid, which forms clumps inside the brains of dementia patients. Big drug companies since the 1990s have bet heavily on the concept that amyloid poisons brain cells and that blocking it will halt a patient’s devastating decline.

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But even as their drugs move into final human trials, the evidence implicating amyloid is starting to look a little shaky. An amyloid-lowering drug from Myriad Genetics did nothing in a giant trial. Wyeth and Elan’s amyloid-clearing antibody, called bapineuzumab, showed mixed results in a midstage human trial last year. It clearly helped only a subset of patients who lacked a certain gene mutation, and it had side effects such as fluid leakage in the brain.

Stranger yet, this summer researchers from the Mount Sinai School of Medicine in New York City examined an old allergy drug from Russia that recently showed promising results in Alzheimer’s victims. They wanted to know whether it lowered amyloid. To their surprise, it boosted short-term amyloid levels in animal and lab experiments, according to results reported at a big Alzheimer’s conference. Pfizer licensed comarketing rights for the Russian antihistamine from the biotech company Medivation in 2008 for $225 million plus milestone payments, and the companies are conducting large trials. Results are due next year.

All of this has some scientists wondering if they are targeting the wrong chemical. “People inside and outside the amyloid field are trying to think what are we doing wrong. Either we are treating the wrong thing or using the wrong drug or treating it in the wrong way,” says Mount Sinai’s Samuel Gandy, who led the research into the Russian drug and still thinks amyloid is involved. Adds Merck Vice President Richard Hargreaves: “There has been a sort of a narrow-minded approach to Alzheimer’s disease. Amyloid deposition is only one of the features.”

Some go much further. “I think amyloid is a complete nothing,” says University of Aberdeen (Scotland) researcher Claude Wischik. “One day someone has to write a book about how a whole field can get suckered into this for so long.”

Five million Americans suffer from Alzheimer’s disease, and the number will climb as baby boomers age. Existing drugs such as Aricept treat symptoms but don’t stop brain cell death.

While the bulk of research money remains focused on amyloid, some researchers are looking elsewhere. Merck is putting half of its Alzheimer’s research budget into drugs that don’t target amyloid. Harvard Medical School neuroscientist Jie Shen, who thinks amyloid is a mere accomplice, blames the disease on malfunctions in two proteins called presenilin. If her theory is correct, one class of antiamyloid drugs called gamma secretase inhibitors may make the disease worse.

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Some researchers are fingering cousins of amyloid as the killer. Amyloid is produced from a larger protein (amyloid precursor protein) that is chopped up into various fragments, including beta-amyloid. Until now the role of the others hasn’t gotten much attention.

Neuroscientist Marc Tessier-Lavigne, chief scientific officer at Roche’s Genentech division, has intriguing evidence implicating a fragment that binds to something on brain cells called death receptor six, which can trigger cells to die or shrivel and is named for its involvement in a natural self-destruct mechanism. High levels of death receptor six are found in the brain areas that die off in Alzheimer’s disease.

Could death receptor six be the murder weapon in Alzheimer’s? Maybe. Tessier-Lavigne’s evidence is indirect and doesn’t rule out a role for amyloid (which Roche also has drugs against). But unlike amyloid, his fragment provides a clear mechanism for brain-cell death, he says: “This mechanism we have described is very powerful at killing nerve cells.” Under his concept, Alzheimer’s disease results from brain-cell maintenance gone awry. Brain cells constantly prune excess nerve fibers during early development. This landscaping process may go haywire during Alzheimer’s and kill healthy cells, he says. Roche has made antibody drugs that block death receptor six and is testing them in mice with Alzheimer’s symptoms to see if they block memory loss.

Other drug researchers finger two other malfunctioning molecules linked to the disease. One is a protein called tau that makes up the neurofibrillary tangles found in the neurons of Alzheimer’s sufferers. Proponents argue that tangles correlate better with dementia than amyloid plaques do. Merck, TauRx Therapeutics (cofounded by Scotland’s Wischik) and Allon Therapeutics in Vancouver, B.C. are working on drugs that hit tau.

The second is a bad version of a gene called apolipoprotein E. Discovered in 1993, the “bad” form, called APOE e4, can raise the risk of Alzheimer’s disease by a factor of ten for those with two bad copies, and it is involved in 50% to 60% of Alzheimer’s cases. Only 1% of Alzheimer’s sufferers have early-onset forms caused by inherited genes that boost amyloid production. (But two more common genes linked to amyloid were just identified.) “It seems perverse,” says Case Western Reserve researcher Mark Smith, an amyloid theory critic. “We have the major genetic determinant figured out, and few people are working on it.”

One of those few is Robert Mahley, president of the J. David Gladstone Institutes in San Francisco. He has shown that the APOE e4 gene produces a misshapen protein that can glom on to energy producing structures inside neurons called mitochondria and disrupt their function. This may make neurons more prone to damage over time, he says. In 2005 Mahley identified druglike chemicals that can restore the APOE e4 protein to a normal shape. He is collaborating with Merck to devise versions that could one day be tested in patients. One concept would be to treat people with the APOE e4 gene with such drugs in late middle age to prevent dementia from developing, much like cholesterol-lowering drugs are used to prevent heart attacks in those at risk. Still, he laments: “There hasn’t been a lot of attention paid to this. The field has been very myopic.”

Overall, 18 of the 41 drugs in efficacy trials for Alzheimer’s hit amyloid, says market researcher Datamonitor; most of the remaining drugs treat symptoms. The bets keep getting bigger. In July Johnson & Johnson agreed to a $1.5 billion deal to snag an 18.4% stake in Elan and a big share of the profits from bapineuzumab, now in final-stage trials. (The deal may be revised, as it breaches a pact Elan has with Biogen Idec.) Amyloid proponents say early trials were too small to give clear answers. “I think it is pivotal to the disease process,” says Elan Chief Scientific Officer Dale Schenk. “The genetic data in favor of amyloid is enormous.”

The imbalance worries Zaven Khachaturian, former head of Alzheimer’s research at the National Institutes of Health. He fears that if amyloid drugs fail “drug companies will walk away from Alzheimer’s disease as untreatable.” Roche’s Tessier-Lavigne is more optimistic. “It is a perplexing riddle right now,” he says. “In the next several years we will understand how it fits together.”

Alzheimer’s Whodunit

What is killing the brain cells of Alzheimer’s disease sufferers? There are more suspects than in an Agatha Christie murder mystery. Here are a few:

• Beta-amyloid Protein fragments that form plaques inside the brains of Alzheimer’s patients.
• Neurofibrillary tangles Another abnormality found in the brains of victims of Alzheimer’s upon autopsy.
• Apolipoprotein E e4 A common gene variant that markedly boosts Alzheimer’s disease risk.
• N-APP An amyloid cousin that hits a molecule on brain cells called death receptor six.
• Presenilin Two proteins that help neurons function properly and may go bad during Alzheimer’s, says Harvard’s Jie Shen.
• Mitochondria Energy-producing structures in cells that may weaken during Alzheimer’s. Medivation’s drug may protect them.

Source: Forbes.com

Popularity: 6% [?]

The National Institute for Health and Clinical Excellence issued a final appraisal determination Thursday which upheld an earlier decision by the agency to limit access to Pfizer’s and Eisai’s Aricept (donepezil), Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) on the NHS to patients with moderate forms of Alzheimer’s disease.

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NICE Chief Executive Andrew Dillon said that the decision was made after releasing for consultation “the executable version of the economic model used in this appraisal” and after the consideration of comments made by consultees. He explained that “although these comments resulted in minor changes to the model, our independent advisory committee concluded that these were not enough to make these treatments a cost-effective use of NHS resources in the mild stages of the disease.” A legal challenge by Pfizer and Eisai had resulted in a UK Court of Appeal ruling last year that NICE’s guidance process for the Alzheimer’s drugs was “procedurally unfair,” and the court suggested that the agency release details of its cost-effectiveness model.

The final appraisal also provides guidance for Lundbeck’s Ebixa (memantine), which NICE noted “is not recommended as a treatment option for patients with moderately severe to severe Alzheimer’s disease except as part of well-designed clinical studies.” The companies have until July 1 to appeal the appraisal.

Source: FirstWord

Popularity: 5% [?]

Eisai indicated Thursday that it will start discussions with Pfizer about reviewing contract terms of the companies’ partnership for Aricept (donepezil) in light of Pfizer’s planned $68-billion acquisition of Wyeth. The Japanese drugmaker, which suggested last week that it would have the right to terminate the agreement once the merger is complete, expressed confidence about the Alzheimer’s disease treatment’s sales even without Pfizer’s contribution.

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Soichi Matsuno, the company’s deputy president of global pharmaceuticals, said that Eisai is working on plans to sell Aricept in markets where Pfizer is currently the sole promoter, and that “there’s no worry about Aricept sales in key countries such as Japan, the US, the UK, Germany and France because we have acquired skills through the joint promotion of more than 10 years.” Meanwhile, Pfizer stated that Eisai does not have legal grounds to terminate the agreement, adding it will oppose efforts to do so.

In related news, Eisai also reported financial results for the year ended March 31, during which Aricept sales climbed 4.4 percent to 303.8 billion Japanese yen ($3.2 billion), compared to the prior year. The company posted net income of 47.7 billion yen ($498.3 million), which was in line with consensus estimates, up from a prior-year period loss of 17 billion yen ($177.6 million). Overall revenue totalled 781.7 billion yen ($8.2 billion), compared with 734.3 billion yen ($7.7 billion) recorded for the year ended March 31, 2008.

Source: FirstWord

Popularity: 3% [?]

Japan’s drugmakers will sit out a wave of consolidation sweeping through the industry, focusing instead on integrating past acquisitions and smaller, bolt-on deals.

In recent weeks, Pfizer Inc has paid $68 billion for Wyeth, Swiss Roche Holding AG is paying $46.8 billion for the 44 percent it didn’t already own in U.S. biotech group Genentech Inc, and Merck & Co Inc agreed to buy Schering-Plough Corp for $41 billion.

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Japan’s top drugmakers, including Takeda Pharmaceutical Co, still have cash after $16 billion worth of overseas buys last year, and are aided by a strong yen, but are more likely to seek only minor acquisitions to plug gaps in their development pipelines than chase big deals just to build scale.

“Major Japanese drugmakers will continue buying ventures to supplement in-house efforts to improve their pipelines,” said Yasuhiro Nakazawa, a drug analyst at Mitsubishi UFJ Securities. “(But) they’re through with mergers for economies of scale.”

Analysts expect Japan’s drugmakers to seek out acquisitions or partnerships, mostly overseas, as they look to reduce their dependence on a mature home market and extend their global reach.

Attractive biotechnology ventures, which can strengthen a drugmaker’s pipeline, are mostly in the United States.

Last year, Takeda bought U.S. biotech firm Millennium Pharmaceuticals for $8.9 billion, while Eisai spent $3.9 billion on cancer specialist MGI Pharma.

Daiichi Sankyo grabbed a majority stake in Indian generic drug maker Ranbaxy Laboratories, which gets around a quarter of its sales in the U.S., for $4.6 billion.

Astellas Pharma, the only one of the top four not to have landed a major deal, withdrew a $1 billion hostile bid for CV Therapeutics on Monday after the U.S. biotechnology firm reached a deal with another suitor.

Astellas and Daiichi Sankyo were each created through mergers earlier this decade to ensure they had annual research and development budgets of at least $1 billion — a level thought to be necessary to compete amid rising safety standards and costs.

Eisai, with an R&D budget of around $1.5 billion, no longer sees the need for a big acquisition even as it braces for the 2010 expiration of Aricept, its blockbuster Alzheimer’s drug.

“I would not speak against a big pharma model, but in the coming era we have to focus on improving efficiency and productivity,” Eisai President Haruo Naito said last month. “I think we will only make small acquisitions here and there to take in technology and products.”

GROWING PAINS

Japan’s top three drugmakers — Takeda, Astellas and Daiichi Sankyo — have a healthy cash cushion and could take on debt to finance a big deal.

Takeda has 223 billion yen of cash and deposits after its all-cash Millennium deal. Astellas has 255 billion yen in cash and no borrowings. Daiichi Sankyo has 161 billion yen in cash.

But they would find it hard to convince investors of the merits of a big buy at a time when they are trying to squeeze value from past acquisitions and struggling to get drugs already in the pipeline to market.

They also face a global economic slowdown, rising development costs, tougher generic competition and sliding prices as the U.S. and other governments look to rein in medical costs.

Shares of Takeda, which expects its recurring profit to nearly halve in the year to end-March, hit a 10-year low on March 9 on worries that the replacement for Actos, its key diabetes drug, could be delayed in the United States.

“In line with industry trends, the efficiency of R&D at Takeda is falling. It has money, but I don’t see any more need for acquisitions,” said Kumi Miyauchi, sector analyst at Daiwa Institute of Research.

“It bought Millennium to expand its presence in the cancer drug market. However, because everyone is focused on this market, severe competition and thin margins may be waiting ahead for Takeda’s drugs in the pipeline. One thing it can do to cut costs is to narrow its therapeutic areas,” she said.

Daiichi Sankyo’s experience with Ranbaxy offers a cautionary tale about the risks of a large deal.

Daiichi Sankyo incurred a first-ever quarterly loss in October-December as its stake in Ranbaxy slumped by two-thirds on a scandal-led import ban on its products in the United States.

Astellas is the one major Japanese drugmaker seen needing an acquisition.

“Astellas is desperate (for new income sources). It’s up against the wall,” said Credit Suisse drug analyst Fumiyoshi Sakai.

Its Prograf transplant drug has lost U.S. patent protection, and its Flomax prostate drug, its second best-selling product, will lose exclusivity in the United States in October.

Astellas dropped plans to introduce a follow-up, Prograf MR, in the United States and a new antibiotic, Telavancin, in Europe, and it faces a fall in recurring profit as early as this year amid competition from generic drugmakers in some areas, such as transplant drugs.

“It still needs some kind of strategic investment, rather than just buying back its own shares to enhance shareholder returns. But it remains unclear what exactly the company can do to improve its outlook,” Daiwa’s Miyauchi said.

Astellas, which had hoped for synergy between its U.S. hospital franchise and CV’s products, including the Ranexa cardiovascular disease treatment, said it would continue looking for acquisitions and licensing deals. ($1=98.22 Yen) (Editing by Ian Geoghegan).

Source: Reuters

Popularity: 5% [?]

“Anavex believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s; seeking partners for early-stage compound, executives say”

Anavex Life Sciences (OTCBB: AVXL) believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s disease, and is currently seeking partners to develop an early-stage compound, according to Harvey Lalach, co-founder, president, chief financial officer and director.

Lead candidate ANAVEX 1-41 has a synergistic neuroprotective and anti-apoptotic effect in animal models that use amyloid (beta) 25-35 peptide to simulate the condition, according to results presented at the 2008 International Conference on Alzheimer’s Disease.

“If something comes across the table, we’ll address it,” Lalach said about potential partnerships. “The game plan would be to move one compound through Phase I in CNS. And if something comes to the table prior to that, we would seriously look at that.”

There has been “significant interest” from big pharma in both the company and its compounds, he noted, adding that there is a need for capital moving forward, as R&D to develop an Alzheimer’s candidate is very costly. “With additional capital, we can move other compounds into Phase I. We also have oncology compounds at various stages of development,” he said.

Companies developing late-stage candidates in Alzheimer’s include Eli Lilly (NYSE:LLY), Wyeth (NYSE:WYE), Pfizer (NYSE:PFE), GlaxoSmithKline (NYSE:GSK) and Bristol-Myers Squibb (NYSE:BMY). Avanex became publicly listed through a reverse takeover at the beginning of 2007, Lalach noted. The company was funded privately with approximately USD 15m in research capital. “It got to the point where the results were encouraging, and investors wanted to move this compound forward as soon as possible,” he said.

The company’s SIGMACEPTOR-N program involves the discovery and development of drug candidates targeting neurological and neurodegenerative diseases, such as Alzheimer’s, epilepsy and depression.

Sigma-1 receptors have been cloned and shown to be distinct from any known receptor class. In the central nervous system, they have been shown to be involved in the modulation of neurotransmitter receptor function, neurotransmitter release and response, as well as memory and learning processes, demonstrating potential neuroprotective and anti-amnesic properties.

“The lead compound comes from the sigma receptor platform, which is a proprietary platform technology that generates molecules based on sigma ligands and receptors,” Lalach said. There is interest from large pharma, as the platform has a potential to create multiple compounds across a variety of different disease indications, he said. George Kalkanis, Anavex’s co-founder and vice-president for strategic planning, said to the surprise of the Alzheimer’s community, it turns out that the current market leader, Pfizer’s Aricept, also affects sigma ligand. Pre-clinical experiments in mice showed that Anavex’s drug can attain all these synergistic receptors, he noted.

“We don’t care if the neuronal toxicities are coming from amyloid or not,” he said. “It turns out that diluting or reducing amyloid beta protein is not a means of treating Alzheimer’s disease.”

The failure of Neurochem and Myriad Genetics’ Alzheimer’s candidates – which worked to reduce or prevent amyloid build-up – is proof of the fact that targeting the amyloid pathway may be wrong, said Kalkanis. Alzheimer’s is due to oxidative stress, and amyloid beta may be a result of oxidative stress, he noted. The oxidative stress pathway may also activate other undesirable effects. The amyloid plaques can come initially as a defense, which is why they accumulate in the brain, he said.

Anavex plans to conduct a single dose-ascending study, which will include 40 volunteers in Europe. A multiple ascending dose study will include 24 volunteers, according to Kalkanis. “These studies will be able to establish the profile of the drug.”

The company is open to any prospects, said Lalach. “Our strategic initiative is to raise some money from investors and advance our first compound to the end of Phase I and beginning of Phase II trials,” he added. “We don’t exclude any proposals for partnership.”

The company recently appointed Dr Mark Smith – a leading researcher who is executive director of the American Aging Association and editor-in-chief of the Journal of Alzheimer’s Disease – to its scientific advisory board. “We’re in the process of upscaling synthesis of the compound, and selecting the right contract research organization,” Lalach said. Anavex has a market cap of USD 50m.

Source: Pharmawire

Popularity: 5% [?]

In an interview with the Chicago Tribune, Pfizer CEO Jeffrey Kindler said that in the future, the company will focus more on treating unmet medical conditions with biotechnology, and will concentrate less on blockbuster drugs. He stated that “the dependence on a couple of large blockbuster products is not a good model…Having a diverse business portfolio is very prudent.”

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Pfizer, which agreed last month to acquire Wyeth for $68 billion, is focusing on biotechnology-derived vaccines and therapies for diseases such as cancer and Alzheimer’s, rather than on drugs for cholesterol, depression and hypertension. Kindler noted that “if Pfizer of the past was best known for a few very large blockbuster drugs, then the new Pfizer is vastly more diversified.” The CEO also remarked that Wyeth’s technologies are as good as those of rival biotechnology companies Amgen and Genentech, if not better.

The executive suggested that Wyeth’s platform for treating Alzheimer’s disease in different ways will be a benefit to Pfizer, which already markets the drug Aricept (donepezil) for the condition. Kindler commented that “when you come to something like Alzheimer’s, it becomes more of an effort to try different things to succeed.”

Source: FirstWord

Popularity: 8% [?]

A look at Pfizer Inc.’s pharmaceutical sales last year suggests one major reason for its offer to buy Wyeth Pharmaceuticals for $68 billion: sagging revenues from its current drug offerings.

Last year’s overall pharmaceutical sales were off $250 million, or about 1 percent, from the year before, according to Pfizer’s unaudited year-end report. Wyeth, on the other hand, reported an increase in revenues of about 2 percent, or more than $400 million.

Still, both drug companies face a near-term problem with expiring patents on some of their leading compounds.

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For Pfizer, the elephant in the room is Lipitor, the leading medicine in the world, which will be subject to generic competition in 2011, taking a huge bite out of sales numbers that totaled $12.4 billion last year, or more than a quarter of the company’s revenues. Pfizer acquired Lipitor when it bought out Warner-Lambert for $90 billion nine years ago.

”It’s the world’s biggest drug ever,” said health care analyst Les Funtleyder of Miller Tabak & Co. in New York. “No one drug is going to replace it.”

Yet Lipitor isn’t the only problem for Pfizer: Analysts project that about half of the company’s drug sales would dry up because of patent expirations if the company’s research and development operation, headquartered in New London, doesn’t find replacements in the next five years.

Wyeth also has its drug-development issues, with two top compounds facing patent expirations: depression medication Effexor in 2010 and heartburn drug Protonix in 2011. Meanwhile, a promising new Alzheimer’s vaccine that Wyeth has been developing with Elan Pharmaceuticals has been slowed by unexpected results from a clinical trial, and the FDA last year denied two of the company’s other drug candidates.

”R&D is not linear,” said Funtleyder. “More money does not necessarily equal more drugs. There are those eureka moments. It’s cyclical.”

The cycle has been running against major pharmaceutical companies for some time now, and Pfizer has become a poster child for those who believe major R&D investments don’t necessarily guarantee a better drug pipeline. An article on Forbes.com Tuesday, typical of the skepticism regarding the Wyeth deal, noted that in the past decade “Pfizer has launched only one medicine with annual sales surpassing $1 billion, despite plowing more than $60 billion into research and development.”

Indeed, even Pfizer’s one blockbuster drug, Lyrica, traces its roots to Warner-Lambert. Other Pfizer best-sellers include arthritis treatment Celebrex, overactive bladder medication Detrol and cancer compound Sutent, all of which came out of the purchase of Pharmacia in 2003.

Sutent, Detrol, Celebrex and Lyrica are all performing relatively well for Pfizer – particularly the pain medication Lyrica, which showed a sales increase of more than 40 percent last year, launching it into the No. 2 position among the company’s top sellers.

But several other drugs counted on to help shoulder the burden of Lipitor’s loss showed weakness, and Pfizer’s older pharmaceutical pipeline is beginning to show cracks.

”Pfizer is in the most desperate state of anyone in the industry in terms of patent expirations,” Standard & Poor’s analyst Herman Saftlas told Business Week magazine.

As an example, blood pressure medication Norvasc, which once accounted for 10 percent of Pfizer’s bottom line, lost a quarter of its sales last year compared to the year before after facing generic competition for the first time in 2007. And cancer compound Camptosar, which went off patent last year, saw 42 percent of its sales dry up last year.

Other negative performers last year included Chantix, the once-ballyhooed anti-smoking drug that lost its luster in the United States after it was tied to concerns about suicidal thoughts; pain medication Neurontin, which got bad press when Pfizer was accused of suppressing studies showing the drug didn’t help with diabetic nerve pain; and Diflucan, an older anti-fungal drug whose patents expired some time ago.

Pfizer also lost more than $250 million in sales with the patent expiration of Zyrtec, an allergy medication.

On the plus side, psychiatric medication Geodon and antibiotic Zyvox reached $1 billion in sales last year, while erectile dysfunction pill Viagra, still going strong after 10 years on the market, neared the $2 billion mark. But Pfizer’s biggest rising star, on a percentage basis, was cancer drug Sutent, which finished with nearly $850 million in sales, 46 percent more than last year.

Pfizer will need more compounds like Sutent, a chemotherapy drug expected to gain more traction with an aging population of baby boomers. But analysts said there appear to be few if any blockbusters in Pfizer’s pipeline to make a dent in the loss of Lipitor – a situation that caused Forbes.com to headline an article on the Wyeth deal “Big Pharma’s Death Spiral.”

”It’s not necessarily a death spiral, but you have to have new drugs,” said analyst Funtleyder.

Pfizer seems to be staking its biggest hopes on Alzheimer’s disease medicines, including bapineuzumab, which Wyeth has partnered with Elan Pharmaceuticals on and is currently in late-stage trials. It’s unclear, however, whether the partnership will continue once Pfizer takes over Wyeth.

Pfizer has its own Alzheimer’s pipeline, but its current top medication, Aricept, loses patent protection at the end of next year. Pfizer had five Alzheimer’s drugs in development, but its acquisition of Wyeth would triple that total.

”If Wyeth delivers on Alzheimer’s, it will be all worthwhile,” said Funtleyder. “Who knows? Maybe drug development will go into an up cycle, and it will be good to be big.”

Source: TheDay.com

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