Despite losing patent protection for the world’s bestselling drug next year, Pfizer (NYSE: PFE) R&D chief Martin Mackay says the company will be sitting pretty for years to come, thanks to its pipeline and the acquisition of Wyeth last year. “We’re in the golden age of drug discovery,” Mackay says in an interview, as quoted by Bloomberg. “We have a very replete pipeline in key areas such as cancer, Alzheimer’s disease, pain and inflammation.” The drug giant is also counting on treatments for infectious diseases.

Mackay adds that rather than trying to replace Lipitor’s $11.4 billion in annual drug sales with one mega-blockbuster, the company will rely on a variety of “smaller” blockbuster drugs to make up the difference. The R&D chief also notes that Pfizer won’t be wasting time on drugs that don’t show a lot of promise early in their development. “Flatliners are flatliners, and they kill us unless you find them really early,” Mackay tells Bloomberg. “In the next few years I think you’ll see less attrition, more survival of our compounds, and taking that attrition earlier.” In January, Pfizer cut about 100 drug development programs out of a pipeline swollen by the Wyeth merger. The bulk of the remaining 500 programs are focused on six key areas: oncology, pain, inflammation, Alzheimer’s disease, psychoses and diabetes. That left the developer with 30 oncology programs, 11 for inflammation, 10 for Alzheimer’s and eight for pain. Twenty-six of those drugs are in Phase III trials.

And with its sites firmly fixed on grabbing a chunk of the burgeoning Asian market, Pfizer added in a press briefing that it will use its clinical research unit in Singapore as a base for conducting trials for diseases prevalent in Asia. R&D will focus on illnesses such as liver and head and neck cancer, according to Reuters. “Prevalence rates for specific types of cancer are significantly higher (in Asia), for example gastric cancer, liver cancer, and head and neck cancer, probably due to factors such as diet, environment and genetics,” says Steve Yang, head of Pfizer’s R&D in Asia.

Source: FierceBiotech

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Fueled by windfall profits from swine flu vaccine sales, GlaxoSmithKline reported a big spike in revenue for the fourth quarter. But the extra money hasn’t stopped the pharma giant from sharpening its budget-cutting axe once again. Glaxo executives this morning outlined an additional 500 million pounds ($791.6 million) of budget cuts as it scales back on R&D.

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Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer’s, Parkinson’s and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator.

“We are allocating capital to areas where we can get the best return on investment,” the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company’s workforce that would amount to the “hundreds rather than thousands” in the U.K.

“In addition to our existing discovery effort, alternative opportunities need to be explored to make treatments available for rare diseases,” says Marc Dunoyer, GSK’s president of Asia Pacific and chairman of Japan, who will head the new rare diseases unit. “This complementary approach will combine our existing global expertise with specialist partners. Over time, this new unit has the potential to deliver multiple therapies responding to high medical needs of underserved populations of patients.”

Source: FierceBiotech

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EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform today announced poster presentations of preclinical data on EPX-102216 and EPX-105287, during the Keystone Symposia Neurobiology of Pain and Analgesia in Santa Fe, New Mexico.

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On February 23, 2009, Christine Kitsos, Ph.D., principal scientist, discovery biology at EPIX is scheduled to give a poster presentation entitled, “Attenuation of Inflammatory Pain by EPX-102216, a Novel CCR2 Antagonist.” CCR2 antagonists represent a novel mechanism of action for reducing the inflammatory response in several diseases by preventing macrophages (a type of inflammatory immune cell) from accumulating in body tissues. EPX-102216, wholly owned by EPIX, is a highly selective, oral CCR2 antagonist with an excellent safety profile that is being further developed for the treatment of pain. Dr. Kitsos will be presenting results that show dose-dependent efficacy in rodent models of chronic inflammatory and neuropathic pain.

On February 24, 2009, Dilara McCauley, Ph.D., director, discovery product leader at EPIX is scheduled to give a poster presentation entitled, “EPX-105287, a Highly Selective Metabotropic Glutamate 5 Receptor (mGluR5) Negative Allosteric Modulator, Reduces Writhing in Mice and Thermal Hyperalgesia in Rats.” EPX-105287, also wholly owned by EPIX, is a novel, potent, highly selective mGluR5 negative allosteric modulator that is being developed for the treatment of neuropathic (chronic) pain and L-Dopa induced dyskinesia (involuntary movement). Dr. McCauley will be presenting results of EPX-105287 displaying dose-dependent efficacy in acute visceral and chronic inflammatory rodent pain models.

EPX-102216 and EPX-105287 are both internally discovered and part of EPIX’s ongoing preclinical and discovery programs targeting G-Protein Coupled Receptors (GPCRs) and ion channels for the treatment of inflammatory diseases, pain and cystic fibrosis. Both molecules are wholly owned by EPIX Pharmaceuticals.

About EPIX

EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen and Cystic Fibrosis Foundation Therapeutics.

This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations regarding our drug development efforts and the timing and content of corporate presentations. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

Source: Business Wire

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Anavex Life Sciences Corp. (“ANAVEX”) (OTCBB), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer, was selected to present its latest results with ANAVEX 1-41 at Neuroscience 2008, the 38th annual meeting of the Society for Neuroscience, which took place November 15-19, 2008 in Washington, DC.

In a scientific poster abstract, ANAVEX detailed the outstanding neuroprotective potential of ANAVEX 1-41, evidenced by its ability to block the manifestation of the earliest toxic effects in a validated mouse model of Alzheimer’s disease. Currently in the late pre-clinical stage, ANAVEX 1-41 has shown synergistic potential for anti-amnesic and neuroprotective efficacy at extremely low doses. This is the first time these results have been attained by any pharmacological agent in an Alzheimer’s mouse model involving the injection of the amyloid-beta (25-35) peptide.

“We are excited by our ongoing progress in the development of ANAVEX 1-41 as it continues to demonstrate powerful neuroprotective action at extremely low doses with no toxicity,” said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. “In addition, we believe that our latest findings have relevance for ANAVEX 2-73, another lead Alzheimer’s compound, as 1-41 and 2-73 have a common origin and similarities in mechanism of action.”

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The earliest toxic effects of Alzheimer’s disease mouse models were measured by the expression of the caspase-12 marker. Caspase 12 is a recently discovered enzyme that indicates these early toxic effects. Non-transgenic Alzheimer’s mouse models are created by injecting amyloid-beta peptide (amyloid-beta 25-35) into mouse brains to bring on histological and biochemical changes, oxidative stress and learning deficits.

The neuroprotective potential of ANAVEX 1-41 is hypothesized to act by the compound’s ability to modulate sigma receptors which regulate calcium mobilization in neuronal cells. Calcium is regulated through the Inositol Triphosphate receptors “IP3R” and the sarcoendoplasmic reticulum “Ca2+/ATPase” pump.

The major effect of ANAVEX 1-41 occurs at the membrane of neuronal cells, in the endoplasmic reticulum (ER). The novel profile of ANAVEX 1-41, which is a mixed sigma-1, muscarinic and sodium-channel candidate drug, accounts for its ability to fight ER stress and thereby prevent apoptosis of the neuronal cells. This neuronal apoptosis is the prominent pathophysiological effect of brain degeneration in Alzheimer’s disease.

The neuroprotective effects of ANAVEX 1-41 were assessed in the hippocampus, the area of the brain that regulates learning, emotion and memory and which is highly implicated in Alzheimer’s disease. As recently discovered in pre-clinical testing, through its sigma-1 activity, ANAVEX 1-41 targets neuron structures (ER, mitochondria), as well as disturbed biochemical pathways and channels (UPR,IP3R,Bcl-2,apoptosis). Organizations involved in sigma receptor research, including ANAVEX, have determined that these are crucial factors in Alzheimer’s disease and in many other neurodegenerative diseases.

The company expects to complete pre-clinical trials on ANAVEX 1-41 in early 2009.

ANAVEX 1-41 and ANAVEX 2-73 share a common origin and related profile (congeners). ANAVEX is currently planning to prepare the Investigational New Drug (IND) (or IMPD) file to advance 2-73 to Phase 1 human clinical trials, which are expected to begin in 2009.

A copy of the poster abstract, titled “The neuroprotective action of ligands acting at the sigma-1 chaperone protein involves regulation of the expression of IP3 receptor subtypes and SerCa pumps,” can be viewed on the company’s web site at http://www.anavex.com/sfn08.html. The authors are Vanessa Villard, Fanny Malhaire-Ferreux, Francois Monnet, Alexandre Vamvakides and Tangui Maurice.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer’s, epilepsy and depression. The company’s proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.

ANAVEX’s SIGMACEPTOR(TM)-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. ANAVEX 1-41 and ANAVEX 2-73 modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compounds have performed extremely well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of the company’s new alternative approach to the disease.

ANAVEX SIGMACEPTOR(TM)-C program involves the development of novel and original drug candidates targeting cancer. The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Source: Anavex Life Sciences Corp.

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NEW YORK – Pfizer Inc. will abandon early stage research on heart drugs as part of a strategy to sharpen its focus on ailments such as cancer, Alzheimer’s disease, and diabetes where the chances of a bigger profit are greatest.

The New York company, the world’s largest drug maker, is in a rush to find new medicines for when the cholesterol pill Lipitor loses patent protection in 2011. Lipitor had $12.7 billion in sales last year, one-quarter of Pfizer’s revenue.

As part of its shift, the company will sell or share rights to at least 11 medicines in early testing for diseases the company no longer believes profitable enough, said Martin Mackay, the head of research and development. That includes treatments for heart failure, high cholesterol, and obesity. Besides Alzheimer’s, cancer, and diabetes, the company will pursue remedies for inflammatory diseases, pain, and schizophrenia.

“These are the disease areas with a higher medical need where the science is really breaking,” Mackay said in a telephone interview yesterday. “From an opportunistic point of view, we see greater opportunity to fight cancer and Alzheimer’s and diabetes.”

Pfizer’s research budget of about $7.2 billion is unlikely to change next year, he said. The intensified focus won’t affect drugs in the last of three stages of testing needed for US approval.

Chief executive Jeffrey Kindler said in a March 5 interview that Pfizer would focus on medicines for cancer, pain, Alzheimer’s disease, and diabetes.

Pfizer rose 79 cents to $18.44 in New York Stock Exchange composite trading. The shares have dropped 19 percent this year.

By ending heart disease research, Pfizer abandons an area of medicine that propelled its rise. Pfizer acquired Lipitor from Warner Lambert Co. in 2000, when the drug had less than $1 billion in annual sales, and transformed it into the best-selling pill in history. Lipitor sales have slumped since 2006, when generic copies of a similar drug, Merck & Co.’s Zocor, were introduced.

Products for cancer and pain are typically more profitable because drug makers can charge a higher price, and there’s less competition.

Pfizer said yesterday the number of projects in final human tests has increased 50 percent since March, faster than it projected, to 25. The only new compound added was the drug CP-751871, which is being tested against lung cancer. The other added projects are for new uses of drugs already in late-stage testing or on the market.

The restructuring won’t result in laboratories closing and will shift many research employees to other areas, the company said. Mackay said he didn’t know how many jobs would be cut.

Source: Boston.com

Popularity: 5% [?]

A September 25, 2008 memo by Martin Mackay, Pfizer’s (PFE) president for Global Research and Development, confirms that Pfizer will not develop any more drugs that target cholesterol as the culprit in causing heart disease. In fact, Pfizer will exit drug development for cardiovascular disease altogether.

Pfizer’s exit from statin development indicates the cholesterol craze has reached the end of its cycle trend. Profits have declined as more statins go off patent, and patients switch to much cheaper generics, or forgo statins altogether in order to take “essential” medications.

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This means that high cholesterol as an indicator of heart disease was nothing more than a marketing strategy for big pharma to make a ton of money and should be viewed like any other product trend. Bone health and frailty (osteoporosis) is another trend Pfizer is exiting for the same reasons.

Pfizer’s “higher priority areas” for drug development are Alzheimer’s disease, diabetes, inflammation/immunology, oncology, pain, and psychoses (schizophrenia). Medicines for pain and inflammation could be big blockbusters if they have the ability to target the specific area needing treatment rather than affecting the entire body.

At this point in time, pharmaceutical stocks should be viewed like a utility company. In the next few years, the real leaps in health care will not emanate from a drug company’s R&D lab but instead come from the physics department. Think magnetism, light waves, sound waves, and other forces.

*All of Pfizer’s patents related to Lipitor expire in 2011.

Source: Seeking Alpha

Popularity: 4% [?]

BRUSSELS – Belgian pharma group UCB (UCB.BR) said on Monday that U.S. health authorities had approved epilepsy drug Keppra XR and that it would go on sale just before its mother drug loses patent protection.

UCB said Keppra XR, the once-daily extended release tablet version of its blockbuster Keppra, had been cleared as an add-on treatment for partial onset seizures of people aged 16 years or older.

The company expects it to be available in U.S. pharmacies at the end of September. UCB hopes that it will win over epilepsy patients who typically take drugs at least twice a day. Read the full story

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Pfizer and GlaxoSmithKline—the number one and two drug companies by pharmaceutical sales—are reshaping their R&D organizations, with job cuts likely.

Pfizer’s biannual drug pipeline update highlighted candidates in Phase III development, most of which are in its high-priority research areas of oncology, pain, inflammation, diabetes, schizophrenia, and Alzheimer’s disease.

Separately, Martin Mackay, president of Pfizer global R&D, told managers in an internal memo that Pfizer is ending research in anemia, bone health, obesity, gastrointestinal disease, and some cardiovascular diseases. “We are investing in the most promising disease areas, where there is strong unmet medical need, favorable markets, and an opportunity to advance medical science,” Mackay said. Read the full story

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Pfizer is making headlines this week for improving its pipeline, but is it really? While it announced it is ditching the heart disease medication research in favor of working towards advancements in other key clinical areas, some doubt the promise of the pipeline. The company is also backing out of bone health and anemia research, along with several other research areas.

Recently, Pfizer had to withdraw an FDA filing for the antibiotic dalbavancin when it failed to demonstrate sufficient evidence for the efficacy of the drug, although it is taking the antibiotic back into clinical trial. However, the company says it has increased its late-stage pipeline from 16 to 25 projects in the last six months and that it will continue to make advancements with medications aimed at treating cancer, diabetes, immunology, inflammation, pain, schizophrenia and Alzheimer disease. Pfizer shares rose 4.5 percent following the announcements.

The company announced its decision to back out of cardiac and other markets at nearly the same time it announced the improved pipeline, but some in the investment world wonder if shareholders are getting enough R&D bang for their Pfizer bucks–especially since some of the medications in Phase III trials are old drugs looking for a new raison d’être.

As an aside, all this change leaves us wondering if Carl Icahn will announce today that Pfizer is Imclone’s secret bidder.

Source: FiercePharma

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Even as Pfizer is bailing out of drug research for heart disease, the company’s late-stage pipeline has increased to 25 projects from 16 in the past six months.

The new figures come from Pfizer’s regular six-month pipeline update and on the same day as news of its departure from new cardiovascular research.

Overall, the company moved 31 clinical programs to the next stage of development. Pfizer said it made the most progress in six areas: pain, Alzheimer’s, diabetes, inflammation, schizophrenia and cancer.

The company killed 13 other projects across a range of therapeutic areas, and as previously announced, has withdrawn its FDA filing on the antibiotic dalbavancin, acquired with much fanfare three years ago, in order to run an additional clinical trial.

The pipeline update didn’t reflect Pfizer’s decision to stop internal drug development in cardiovascular drugs and other areas. Martin Mackay, the head of R&D, told the Health Blog that the company will decide on a case-by-case basis exactly which compounds in these areas will be terminated — the ones in phase III won’t be touched. Then, in a departure from past Pfizer form, the company may partner with other companies to bring the compounds to market. “Outlicensing will very much come to the fore,” Mackay told the Health Blog.

The pipeline progress wasn’t enough to cheer some shareholders. “I’m not sure that investors are getting their money’s worth for Pfizer’s R&D spending,” said Mike Krensavage, whose money-management firm Krensavage Partners holds Pfizer shares. As explained to the Health Blog, Pfizer spent $3.8 billion on R&D in the first six months of the year, but only one internally developed new chemical entity moved into phase III testing during that time.

Source: The Wall Street Journal

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