Business Report – Bloomberg Pfizer News

  

GoogleNews.com, BloombergNews.com, May 19, 2010  –  In a boost for San Francisco, Bayer HealthCare is expected to announce today that it will open a U.S. Innovation Center near the UCSF Mission Bay campus, filling the void that rival drugmaker Pfizer created last year when it canceled plans to make the city its hub for biotech discovery.
Bayer, a German pharmaceutical giant with a bio-manufacturing operation in Berkeley, will move 65 researchers into the building at 455 Mission Bay Blvd. S. that Pfizer left vacant last July after a merger caused the New York pharmaceutical company to rejigger its facilities.

City and UCSF officials say they’re thrilled to land another major drug company and Bayer officials say they’re eager to relocate their research team, now based in Richmond, to work amidst the academic and startup energy around UCSF.

Anchor tenant

“This is a real milestone for Mission Bay and for all our efforts to attract and grow biotech and life sciences companies to the city and region,” Mayor Gavin Newsom said in a statement. “We see Bayer as more than just another company. It’s an anchor and a catalyst for future activity and innovation.”

Regis Kelly, director of QB3, the UC-sponsored research and commercialization magnet at Mission Bay, said that while Bayer will take only half the space Pfizer would have used, the other half of the same building will soon be occupied by Nektar Therapeutics, a biotech firm that will be moving to San Francisco from San Carlos.

“Within about eight months of them (Pfizer) backing out, we filled out the space with two other companies,” Kelly said. He thinks the momentum is starting to favor Mission Bay as the economy improves and drug companies look for places to invest.

Bayer vice president of biologics research Terry Hermiston, who heads the company’s discovery center in Richmond and will run the newly christened U.S. Innovation Center when it opens later this year, said Mission Bay offered a perfect opportunity.

Potential collaborators

“We wanted to be where the cutting-edge research was being done and there was space available,” said Hermiston, adding that the decision followed some corporate soul-searching about where Bayer could find the richest pool of potential collaborators in fields like hematology, oncology, cardiology, women’s health and diagnostic imaging.

This is Bayer’s second big investment in the Bay Area in recent months. In September it decided to spend more than $100 million over the next four years to modernize a plant in Berkeley that employs 1,400 people making a blood coagulant for hemophiliacs.

In both instances, Bayer’s decision hinged in part on inducements from state and local officials, including Gov. Arnold Schwarzenegger, eager to disprove the notion that California won’t roll out the red carpet for industry.

In Mission Bay, Bayer will benefit from an enterprise zone designation that could result in five years’ worth of tax credits for some employees, as well as an exemption from San Francisco’s 1.5 percent payroll tax for 7 1/2 years.

Newsom spokesman Tony Winnicker said the city’s willingness to use all the means at its disposal to lure biotech firms to San Francisco are bearing fruit, with 56 companies now employing 2,750 people within the city’s borders – whereas in 2004 only one biotech firm had a San Francisco address.

Town and gown

Meanwhile, with 3,300 students and staff members circulating around the Mission Bay campus, UCSF Chancellor Susan Desmond-Hellmann recently asked some academic and industrial leaders to brainstorm about how to bring town and gown together to create the biotech community of which San Francisco has dreamed.

“Physical proximity is not enough,” said UCSF’s Kelly, adding that the hope is to create opportunities for the face-to-face interactions from which new collaborations can arise.

Read more about Pfizer……

 

Pfizer Global Manufacturing Announces Plans To Reconfigure Its Global Plant Network

Eight Sites Targeted for Exit; Reductions Recommended At Six Plants; Operations to Expand at Others

 

NEW YORK, N.Y., May 18 – Pfizer Global Manufacturing announced today plans to reconfigure its worldwide plant network to create a fully aligned manufacturing and supply organization from the

combined networks of Pfizer and Wyeth. This implementation of the first phase of Pfizer’s previously announced Plant Network Strategy includes recommendations to cease operations at eight manufacturing sites in Ireland, Puerto Rico, and the United States by the end of 2015, as well as to reduce operations at six other plants in Germany, Ireland, Puerto Rico, the United Kingdom, and the United States.

The planned reductions will increase manufacturing efficiency and lower costs by more effectively using resources and technology, improving plant processes, eliminating excess capacity, and better aligning production with market demand. These changes will result in a global reduction of approximately 6,000 jobs over the next several years. Product transfers will expand the roles of a number of plants in Pfizer’s manufacturing network. “The restructuring of our global plant network is critical to our efforts to remain competitive so that we can continue to meet patient needs and expand the access and affordability of our

medicines,” said Pfizer Global Manufacturing President Nat Ricciardi.

“Nevertheless, today’s announcement is very difficult to make because of its impact on our colleagues,” Mr. Ricciardi added. “We have a tremendous global workforce and some of the best manufacturing facilities in the industry. But we must continue to adjust to the fast-changing and extremely competitive

environment in which we operate. That means realigning our network and reducing our manufacturing capacity so that we can position Pfizer for the next phase of growth across biopharmaceuticals and our diversified business portfolio.”  The announcement is the culmination of an intense half-year evaluation of sites that manufacture aseptic (injectable), soliddose, and biotechnology medicines, as well as consumer healthcare products.

Pfizer plans to discontinue manufacturing operations over the next 18 months to five years at three solid dose sites that manufacture tablets and capsules: Caguas in Puerto Rico; Loughbeg in Ireland; and Rouses Point, N.Y., in the United States. (Wyeth had previously announced in 2005 that it would exit and sell the

Rouses Point site.) The company also plans to phase out pharmaceutical solid-dose manufacturing at Guayama, Puerto Rico, and that site will expand its Consumer Healthcare operations.

Two aseptic facilities that make sterile injectable medicines are targeted for exit: Dublin, Ireland; and Carolina, Puerto Rico. Reductions are planned at two other solid-dose facilities: Illertissen, Germany and Newbridge, Ireland. While Pfizer’s biotechnology portfolio continues to grow significantly, the company also proposes changes at its sites that manufacture vaccines and large-molecule medicines to improve efficiencies, capitalize on process and productivity improvements and new technology, and to simplify the supply chain. Pfizer plans to exit operations in Shanbally, Ireland, as well as biotechnology manufacturing in Pearl River, N.Y., in the United States. Plants in Sanford, N.C., and Andover, Mass., in the United States and Havant, in the United Kingdom, also expect to see reductions.

Pfizer plans to cease production of consumer healthcare products at its plants in Richmond, Va., and Pearl River in the United States. The Pearl River site will remain Pfizer’s Center of Excellence for Vaccine Research and Development, as previously announced. Consumer Healthcare R&D also will continue in

Richmond. In both Pearl River and in Richmond, R&D jobs will be unaffected by the planned manufacturing exits.  The timing of specific exits will depend upon the complexity of operations, the amount of time required for product transfers, and other business requirements.

In an effort to preserve jobs and minimize the impact to communities, Pfizer will explore opportunities to divest plants in the event operations are discontinued. Success will depend upon a number of market factors, including present demand for pharmaceutical manufacturing facilities.

“We are keenly aware of the impact these types of changes have on employees and their families,” Mr. Ricciardi said. “We will provide support to our colleagues who lose their jobs so that their transition to new careers is as smooth as possible.” Pfizer’s solid-dose network will include plants in Freiburg,

Germany; Amboise, France; Vega Baja and Barceloneta, Puerto Rico; Ascoli, Italy; Newbridge, Ireland; and Illertissen, Germany. Plants in Puurs, Belgium; Perth, Australia; Catania, Italy; and Kalamazoo, Mich., in the United States will make up the aseptic network.

The biotechnology network will consist of sites in Grange Castle, Ireland; Strangnas, Sweden; Algete (Madrid), Spain; Havant, United Kingdom; and Andover, Mass. and Sanford, N.C., in the United States.

The Consumer Healthcare network will include plants in Guayama, Puerto Rico; Montreal, Canada; Albany, Ga., in the United States; Aprilia, Italy; Hsinchu, Taiwan; and Suzhou, China.

Evaluations of Pfizer’s Animal Health manufacturing sites are presently underway. Recommendations are expected by the end of June. Studies of the Nutrition and Emerging Markets plant networks will begin later this year.

Pfizer Global Manufacturing presently operates 78 plants internationally with a workforce of approximately 33,000 colleagues. It is one of the world’s preeminent biopharmaceutical supply organizations.

Recommended Site Exits:

  • • Caguas, Puerto Rico (solid-dose) • Carolina, Puerto Rico (aseptic)• Dublin, Ireland (aseptic)

    • Loughbeg, Ireland (solid-dose)

    • Shanbally, Ireland (biotechnology)

    • Rouses Point, N.Y. (solid-dose)

    • Richmond, Virginia (consumer healthcare manufacturing

    targeted for exit; R&D operations to remain in Richmond)

    • Pearl River, N.Y. (proposed exit of biotechnology and

    consumer healthcare manufacturing; vaccines and

    biotherapeutics vaccines R&D will remain active at this

    site)

    Recommended Plant Reductions:

    • Guayama, Puerto Rico (phase-out of pharmaceutical solid

    dose operations planned; volume increases in consumer

    healthcare)

    • Newbridge, Ireland (solid-dose)

    • Andover, Mass., U.S. (biotechnology)

    • Sanford, N.C., U.S. (biotechnology)

    • Havant, UK (biotechnology)

    • Illertissen, Germany (solid-dose)

    Pfizer, Washington University Announce Groundbreaking Collaboration

    May 19, 2010

    NEW YORK, May 17 /PRNewswire-FirstCall/ — In a first-of-a-kind collaboration between academia and industry, Pfizer Inc. (NYSE: PFE) will give scientists at Washington University School of Medicine in St. Louis unprecedented access to information regarding more than 500 pharmaceuticals and pharmaceutical candidates in a partnership that focuses on discovering new uses for existing compounds.

    (Logo:  http://photos.prnewswire.com/prnh/20100416/PFIZERLOGO )

    Under the five-year agreement announced today, Pfizer will provide $22.5 million to Washington University and give its scientists access to research data on a large array of Pfizer pharmaceutical candidates that are currently or were formerly in clinical testing.  

    Identifying new uses for existing compounds is known as indications discovery.  The potential for its success continues to grow, as scientists understand more fully disease mechanisms at the most basic molecular level and the influence of genetic variations on patients’ responses to medications.

    “There are two realities in drug discovery,” explains Don Frail, chief scientific officer of Pfizer’s Indications Discovery Unit. “The majority of candidates tested in development do not give the desired result, yet those drugs that do succeed typically have multiple uses.  By harnessing the scientific expertise at this leading academic medical center, the collaboration seeks to discover entirely new uses for these compounds in areas of high patient need that might otherwise be left undiscovered.”

    The partnership represents a new approach in academia-industry collaborations that has the potential to develop drug compounds more efficiently.  By sharing Pfizer’s data on existing compounds, researchers will not have to replicate extensive preclinical studies, thereby shaving years off the time it takes to evaluate new uses for existing drugs.

    The agreement builds on the long history of collaboration between the two organizations and brings together scientists from Pfizer and Washington University to jointly propose, design and carry out research on those compounds across a broad range of disease areas in which the University has internationally renowned scientific expertise, such as Alzheimer’s, cancer, diabetes and related metabolic disorders, and asthma and chronic obstructive pulmonary disease.

    “We are pleased to see our long-standing relationship with Pfizer evolve into this innovative model of partnership that has the potential to benefit the many patients whose medical needs can’t be met with existing drugs,” says Larry J. Shapiro, MD, executive vice chancellor and dean of Washington University School of Medicine.  “We look forward to the many discoveries that will emerge from this collaboration.”

    To encourage the exchange of ideas, Pfizer’s Indications Discovery Unit has developed an online portal through which certain Washington University investigators will have unprecedented access to information about Pfizer’s proprietary compounds, including extensive clinical and preclinical data.  The compounds have been extensively studied and their mechanisms of action are well-understood.  An advisory committee composed of scientists from both Washington University and Pfizer will evaluate proposals for new research that have been co-written by University and Pfizer researchers.

    To facilitate the collaboration, Pfizer’s Indications Discovery Unit is moving its laboratories from Chesterfield, Mo., in suburban St. Louis, to the Center of Research Technology and Entrepreneurial Exchange biosciences district (CORTEX), in the heart of St. Louis’ growing biotech corridor, adjacent to Washington University School of Medicine.

    The Washington University-Pfizer partnership has its roots in a research agreement the University signed in 1982 with a St. Louis-based predecessor to Pfizer.  The new agreement differs from other relationships in which pharmaceutical companies, even in collaborations with academic scientists, have not disclosed propriety information about drug compounds.

    “This is a tremendous opportunity for both partners,” says Jeffrey Gordon, MD, director of the University’s Center for Genome Sciences, who worked closely with Pfizer on the new agreement.  “It leverages the complementary strengths and interests of both Washington University and Pfizer. By creating this innovative new framework, academic and pharmaceutical researchers can collaborate in ways that are mutually advantageous for the University, Pfizer and society to meet the needs of patients.”

    Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

    Pfizer Inc.: Working together for a healthier world™

    At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life.  We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals.  Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products.  Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.  For more than 150 years, Pfizer has worked to make a difference for all who rely on us.  To learn more about our commitments, please visit us at www.pfizer.com.

    DISCLOSURE NOTICE: The information contained in this release is as of May 17, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about potential new uses for existing compounds that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications and supplemental drug applications for such new uses for existing compounds that may be filed for such compounds as well as their decisions regarding labeling and other matters that could affect their availability or commercial potential of such new uses for existing compounds; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

    SOURCE Pfizer Inc.

    Pfizer Enters Into Agreement With Ergonex Pharma To Acquire Investigational Treatment For Pulmonary Arterial Hypertension

    NEW YORK, N.Y., May 12 – Pfizer Inc. (NYSE: PFE) and Ergonex Pharma GmbH announced today that they have entered into an agreement under which Pfizer will acquire terguride, which is in development as a potential treatment for Pulmonary Arterial Hypertension (PAH). Under the terms of the agreement, Pfizer will support the completion of the ongoing Phase 2 trial for terguride and will have exclusive worldwide rights excluding Japan to commercialize terguride for the treatment of PAH. Ergonex will be eligible to receive milestone payments and royalties on the sales of terguride for PAH.

    Terguride is an oral, potent antagonist of 5-HT2B and 5-HT2A (serotonin) receptors. Serotonin stimulates the proliferation of pulmonary artery smooth muscle cells, and induces fibrosis in the wall of pulmonary arteries. Together, this causes vascular remodeling and narrowing of the pulmonary arteries. These

    changes result in increased vascular resistance and PAH. Due to the potential anti-proliferative and anti-fibrotic activity of terguride, this potential medicine could offer the hope of achieving reversal of pulmonary artery vascular remodeling and attenuation of disease progression. Terguride has received orphan drug designation in both the United States and in the European Union for the treatment of PAH, a

    progressive, incurable disease that is estimated to affect 100,000 to 200,000 people in these regions. Terguride is also currently approved in Japan for the treatment of Hyperprolactinemia. “Pfizer’s unique business unit structure positions us to advance a broad portfolio of innovative research programs designed to lead to a diversity of products, including highly specialized ones in disease areas like PAH,” said Geno Germano, president, Pfizer Specialty Care Business Unit. “In the case of terguride, we are pleased that we can support its continued development given our commitment to advancing the science in PAH and to

    bringing new, potentially disease modifying treatments to patients.” Rudolf Reiter, Chief Executive Officer of Ergonex Pharma, said: “The serotonin hypothesis of PAH has been around for a long time.

    The clinical study of terguride in PAH is a challenging and demanding endeavor for us and we are excited about this agreement with Pfizer as it ensures continuity of development and advances our understanding of this pathway.”

    About Pulmonary Arterial Hypertension (PAH)

    PAH is characterized by high blood pressure and structural

    changes in the walls of the pulmonary arteries, the blood vessels

    that connect the right side of the heart to the lungs. In PAH,

    the pulmonary arteries become thickened and constricted, forcing

    the heart to work harder to pump blood through the lungs. Over

    -3-

    -moretime,

    the heart is unable to keep up, and blood flow and

    oxygenation become inadequate to meet the body’s demands. This

    can lead to breathlessness, fatigue, dizziness, fainting, edema,

    chest pain and the development of heart failure.

    Pfizer Inc: Working together for a healthier world™

    At Pfizer, we apply science and our global resources to improve

    health and well-being at every stage of life. We strive to set

    the standard for quality, safety and value in the discovery,

    development and manufacturing of medicines for people and

    animals. Our diversified global health care portfolio includes

    human and animal biologic and small molecule medicines and

    vaccines, as well as nutritional products and many of the world’s

    best-known consumer products. Every day, Pfizer colleagues work

    across developed and emerging markets to advance wellness,

    prevention, treatments and cures that challenge the most feared

    diseases of our time. Consistent with our responsibility as the

    world’s leading biopharmaceutical company, we also collaborate

    with health care providers, governments and local communities to

    support and expand access to reliable, affordable health care

    around the world. For more than 150 years, Pfizer has worked to

    make a difference for all who rely on us. To learn more about

    our commitments, please visit us at www.pfizer.com.

    About Ergonex

    ERGONEX Pharma is a pharmaceutical company focused on developing

    and commercializing well-tolerated and effective products for

    novel and typically underserved indications. This is being

    achieved by forging collaborations with commercial and academic

    partners with expertise in the field of interest and through

    outsourcing activities to service providers. Ergonex Pharma has

    received venture capital funding by High Tech Beteiligungen GmbH

    & Co. KG, Düsseldorf.

    -4-

    PFIZER DISCLOSURE NOTICE: The information contained in this

    release is as of May 12, 2010. Pfizer assumes no obligation to

    update forward-looking statements contained in this release as

    the result of new information or future events or developments.

    This release contains forward-looking information that involves

    substantial risks and uncertainties about an agreement between

    Pfizer and Ergonex Pharma and about a product candidate,

    terguride for the potential treatment of PAH, including its

    potential benefits. Such risks and uncertainties include, among

    other things, the uncertainties inherent in research and

    development; decisions by regulatory authorities regarding

    whether and when to approve any drug applications that may be

    filed for such product candidate, as well as their decisions

    regarding labeling and other matters that could affect the

    availability or commercial potential of such product candidate;

    and competitive developments.

     

    A further description of risks and uncertainties can be found in

    Pfizer’s Annual Report on Form 10-K for the fiscal year ended

    December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

    Pfizer R&D chief touts ‘golden age’ of drug discovery

    FierceBiotech.com, April/May 2010  –  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.

    Read more: http://www.fiercebiotech.com/story/pfizer-r-d-plots-golden-age-focus-asia/2010-04-07#ixzz0oJ14BdRi

     

     

    Pfizer to partner with MicuRx, Cumencor on TB drugs

     

    FierceBiotech.com, April/May 2010  –  Antibiotics developer MicuRx Pharmaceuticals and Cumencor Pharmaceuticals have entered a collaboration with Pfizer (NYSE: PFE) to discover novel therapeutic agents to treat multi-drug resistant tuberculosis. China-based Cumencor is applying MicuRx’s proprietary technology platform to discover and develop novel antibiotics for MDR-TB.

    Under the terms of the agreement, Pfizer will provide an upfront payment, funding for the discovery and preclinical development of novel antibiotics to treat MDR-TB, and payments linked to the development and commercialization of any antibiotics developed through the collaboration. All collaboration research will be conducted at the ZhangJiang High-Tech Park in Shanghai, China.

    “We are extremely pleased to join forces with Pfizer, a world-class pharmaceutical company that has developed numerous successful antibiotics to treat infectious disease worldwide,” says Zhengyu Yuan, president and CEO of MicuRx. “With the rapid increase of MDR-TB incidence in the emerging markets including China, we believe that it is critical to pursue development of new therapeutic options for patients suffering from this devastating disease around the world.”

    The agreement comes at the same time Pfizer announced it will conduct more research on Asian populations in coming years to design drugs for diseases prevalent in the region, such as cancers of the liver and head and neck,

    Read more: http://www.fiercebiotech.com/story/pfizer-partner-micurx-cumencor-tb-drugs/2010-04-08#ixzz0oJ07SFdT

    Did you read this about Pfizer back in June of 2008?………………..

 


Pfizer Eyes New Use For Stem Cells
 

Forbes.com, June 2008 – Big drug companies have largely stayed away from testing exotic stem-cell treatments. But now Pfizer is betting that a radical new adult stem-cell treatment may be able to stave off diabetes-induced retina damage, a leading cause of blindness.

In an unusual deal, the big drug maker is funding the creation of a biotech company in San Diego called EyeCyte, which will develop stem-cell treatments for eye diseases. The company is based on work by Scripps Research Institute ophthalmologist Martin Friedlander, who has pinpointed bone- and blood-marrow stems cells that, in animal experiments, have a remarkable ability to target and repair damaged blood vessels in the eye. Abnormal blood vessels are a key problem in both diabetic eye disease and macular degeneration.

In the future, patients with early signs of blood-vessel damage in the eye might go to the doctor in the morning and leave a blood sample. Adult stem cells would be isolated in the lab over the next few hours, and then the patient would come back in the afternoon and get an injection of his own purified stem cells into the eye. That single injection could stave off further blood-vessel damage for years, preserving eyesight that would otherwise be lost.

“It is unbelievable. These cells know where to go and they target the site of injury,” said Friedlander. In his lab, he has cured mice “10 times over” in work funded by the National Eye Institute. The big question, he said, is whether the treatment will help people.

Developing a complicated procedure to purify stem cells for human trials was difficult at Scripps, because academic settings and government grants support basic research, not the applied-process development required for such targeted research, and Friedlander didn’t want to go the typical venture-capital route. So instead, he approached Pfizer (nyse: PFEnews people ) about funding a company to commercialize the therapy. His timing was good, as Pfizer this April started a new regenerative-medicine unit devoted to therapies involving stem cells.

“Pfizer has put its flag in the ground that there is future in regenerative medicine,” said Corey Goodman, president of the company’s biotech unit. “The eye is a very good place to be starting–it is an isolated organ, and there is a huge need.”

The drug maker is putting in a modest $3 million to get the new company of the ground. But if the therapy looks promising in a couple of years, Pfizer has the right of first refusal to buy it outright. The concept is to combine “the entrepreneurial spirit of the start-up, but with the muscle and clout and access to resources of a pharmaceutical company,” said Goodman. It’s far from being a passive investment; Goodman says Pfizer’s top scientists will work with Friedlander and his team.

Goodman also says Pfizer would consider more deals like this in the future. The company has little to lose by trying new things. Its stock is in the dumps, and its main drug, Lipitor, will face patent expiration in 2011.

Few good treatments exist for diabetic retinopathy, in which blood vessels that bring oxygen to the retina grow abnormally, leading to leakage of fluid or blood cells. To solve the problem, doctors sometimes resort to the radical step of using lasers to kill retina cells responsible for peripheral vision in order to preserve enough oxygen for those engaged in central vision.

Far better would be a treatment that repaired the vessel damage and restored proper blood flow. The first focus for EyeCyte will devise an efficient procedure for isolating and purifying the stem cells, called “CD44 high.” Purified stem cells would be injected into a patient’s eyes, where they would mature into support cells that could jump-start healing.

The object is to have a stem-cell treatment ready for human trials within three years, said Mohammad A. El-Kalay, EyeCyte chief executive and a veteran of several cell-therapy companies. When he heard about the technology four years ago, he “got very excited” because it looked like there might be enough cells in one patient’s blood to treat the eyes without having to laboriously grow more cells in the lab.

“The goal is to intervene with these progenitor cells, stabilize the eye and prevent things from getting worse,” said Friedlander. If it works as well as he hopes, one stem-cell injection might prevent further damage for as long as a decade.

Friedlander’s stem-cell therapy could one day compete with drugs like Lucentis from Genentech (nyse: DNAnews people ). This drug is approved for macular degeneration and is in testing for diabetic eye disease. Novartis (nyse: NVSnews people ) also sells treatments for various eye diseases.

Besides Pfizer, one of the few big drug companies involved in cell therapy is Johnson & Johnson (nyse: JNJnews people ). It is an investor in the San Diego biotech company Novocell, which is developing stem-cell therapy to cure diabetes.

Emmanuel E. Baetge

Novocell

Disease: Type 1 diabetes

Cell: Embryonic stem cells

Approach: Converting embryonic stem cells into insulin-producing cells that could be injected into patients to replace ones the disease has killed off.

Stanford Institute for Stem Cell and Regenerative Medicine/OncoMed Pharmaceuticals

Disease: Cancer

Cell: Cancer stem cells

Approach: Cancer stem cells that drive tumor growth. Killing these stem cells may make a malignant tumor become benign, and OncoMed is inventing drugs to do just that.

Hematologist/Oncologist

Children’s Hospital Boston/Harvard Stem Cell Institute

Cell: Embryonic stem cells/induced pluripotent cells

Disease: Genetic blood diseases

Approach: Use stem cells to fix a variety of single-gene blood disorders that can only be treated now with immune-system suppressing drugs or bone marrow transplants.

Courtesy George Daley

Molecular and Cellular Biology

Stowers Medical Institute/Harvard Stem Cell Institute

Cell: Embryonic stem cell/induced pluripotent cell

Disease: Numerous, including amyloid lateral sclerosis

Approach: Eggan’s research focuses on understanding what makes embryonic cells able to turn into other types of cells. He’s also been involved with efforts to use those cells to test for disease.

© AP Photo/Chitose Suzuki

Cardiff University

Cell: Mouse embryonic stem cell

Disease: Numerous

Evans started the whole stem cell revolution by isolating embryonic stem cells in mice in 1981. In 2007 he was awarded the Nobel Prize for his work.

Courtesy Cardiff University

Pharmacologist/psychiatrist

Center for Neurobiology and Behavior

Columbia University/BrainCells

Cell: Neural stem cell

Disease: Depression

Hen showed that antidepressants like Prozac boost growth of new neurons in the brain. BrainCells, which he co-founded, hopes to devise safer antidepressants that do a better job at boosting neuron growth than existing drugs.

Courtesy René Hen

University of California, Irvine/California Stem Cell Inc.

Disease: Amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) and spinal muscular atrophy

Cell: Embryonic stem cells

Approach: Converting embryonic stem cells into motor neurons that could be used to hunt for new ALS drugs, or to treat spinal muscular atrophy.

© DAMIAN DOVARGANES/AP

Harvard University

Cell: Embryonic stem cells

Disease: Type 1 diabetes

Approach: Inspired by his children, who have diabetes, he has become one of the leading lights in embryonic stem cell research and a leading advocate for the importance of the cells.

© Justin Ide/Harvard University

Embryologist; created first human embryonic stem cells

University of Wisconsin School of Medicine/Cellular Dynamics International

Cell: Embryonic stem cell, induced pluripotent cell

Disease: Drug toxicity, basic research

Approach: His company, Cellular Dynamics, is using embryonic stem cells to make heart cells for drug toxicity testing. Thomson’s lab is exploring the basic science of what makes embryonic and adult cells different.

© James Schnepf for Forbes

Neurobiologist

Rutgers University

Cell: Umbilical cord stem cell

Disease: Spinal cord injury

Young is working with Pfizer and Stemcyte to do a large trial of umbilical cord cells and drugs to treat spinal-cord injury patients in China.

Courtesy The Marine Biological Laboratory

Stem Cells and Regenerative Medicine

Burnham Institute for Medical Research

Disease: Tay-Sachs

Cells: Neural stem cells/embryonic stem cells

Approach: Both types of stem cells increase the lifespan of mice with a Tay-Sachs-like disease, and a human trial in kids with this fatal brain disorder could begin next year.

Courtesy Evan Snyder

Sanford-Burnham Medical Research Institute

The Sanford-Burnham Medical Research Institute is a non-profit medical research institute with two locations in La Jolla, California and Lake Nona, Florida. The more than 750 scientists at Sanford-Burnham are focused on revealing the fundamental molecular causes of various diseases, with research including topics such as, cancer, neuroscience, stem cell research, diabetes and obesity.

Research at Sanford-Burnham is supported by funding from National Institutes of Health, National Cancer Institute, and Juvenile Diabetes Research Foundation among others, and partnerships with pharmaceutical companies such as Johnson & Johnson Pharmaceutical Research and Development.[1] In 2008, Burnham was awarded a $97.9 million grant by NIH to establish a high-throughput screening screening center.

History

William (Bill) H. Fishman, M.D., Ph.D., and his wife Lillian Fishman, M.Ed., left Boston, Massachusetts, to found an independent research institution dedicated to the then-new concept of oncodevelopment in 1976.

The Fishmans, who had then retired from Tufts University School of Medicine, moved across the country and established the La Jolla Cancer Research Foundation in San Diego, California to conduct biomedical research. The institute was established in 1976 as the La Jolla Cancer Research Foundation, and was renamed the Burnham Institute for Medical Research in 1996 for businessman Malin Burnham, after he joined with an anonymous donor to give $10 million. In 2007, T. Denny Sanford gave the institute $20 million through his Sanford Health, allowing it to create the Sanford Children’s Health Research Center, which has sites in Sioux Falls and La Jolla, CA, the latter within the campus of Sanford-Burnham. In 2010, the institute re branded to its current name following a $50 million pledge of support from Sanford.

The center originally focused on oncodevelopment, the study of developmental biology in conjunction with oncology as a means to better understand cancer.

Research

Sanford-Burnham was founded with the primary focus on cancer research. The institute employees more than 1,000 people, of which 750 are scientists. The scientists who work at Sanford-Burnham include biologists, chemists, biophysicists, engineers, and computer scientists. Sanford-Burnham ranks consistently among the world’s top 25 organizations for its research impact, according to Thomson Scientific data. It also ranks among the top four research institutes in the United States in National Institutes of Health grant funding.

The institute now conducts a broad array of medical research activities and is home to five centers:

In 2006, Sanford-Burnham established a center for bionanotechnology research at the University of California, Santa Barbara.

The Vascular Mapping Center, led by medical researcher Dr. Erkki Ruoslahti, is focused on discovering peptides that target cancer cells and developing methods to deliver therapeutic agents to those cells.

Stem cell research

Sanford-Burnham is one of four institutes that have joined together to carry out stem cell research in a partnership renamed for T. Denny Sanford after he donated $30 million to the effort in 2008. The Sanford Consortium for Regenerative Medicine in December 2009 broke ground on a $126 million research facility following more than a year of financing delays wrought by California’s budget problems.

Sanford Health-MeritCare is a non-profit, integrated health care delivery system. It was formed on 2 November 2009 with the merger of Sanford Health, based out of Sioux Falls, South Dakota, and MeritCare Health System, based out of Fargo, North Dakota[5]. It is composed of hospitals, clinics, long-term care, managed care, licensed practitioners, a health plan, a foundation, a clinical research center and seven basic research centers. The organization is based in Sioux Falls with additional corporate offices in Fargo. Its geographical reach covers over 60,000 square miles (160,000 km2) in Iowa, Minnesota, Nebraska, North Dakota, Oklahoma, and South Dakota.

History

In 1996 the Sioux Valley Health Care System was established with the Sioux Valley Hospital in Sioux Falls as its centerpiece. On 3 February 2007, its name was changed to Sanford Health to commemorate a $400 million gift from businessman and philanthropist T. Denny Sanford[6]. Then on 2 November 2009 Sanford merged with MeritCare to form the current health system, Sanford Health-MeritCare.[5]

Sanford Health

Sanford Health is the southern region of the overall health system. The region includes over 350 physicians at over 150 facilities across South Dakota and the surrounding states. Sanford Health’s organizational structure consists of two compartments: the Health Services compartment, which includes all areas of patient care operations; and the Development and Research compartment, which includes all non-patient care activities. The system is presently composed of five divisions: Sanford USD Medical Center, the region’s largest tertiary medical center and the system’s flagship medical center; Sanford Clinic, a multi-specialty group of over 350 physicians; Sanford Health Plan, a non-traditional, non-gatekeeper HMO and the second largest health care payer in South Dakota; Sanford Health Foundation, the system’s fundraising arm; and Sanford Health Network, which includes all regional hospitals, clinics, long-term care and congregate facilities, assisted-living facilities, home health providers, and home medical equipment entities in the states of South Dakota, Minnesota, Iowa, and Nebraska.

MeritCare

MeritCare is the northern region of the overall health system. It is the largest healthcare provider in the state of North Dakota. MeritCare’s service area spans 250 miles west to east; from Jamestown, ND to Bemidji, MN. It is known for regional excellence in a number of medical specialties offered at Roger Maris Cancer Center, Heart Center and Children’s Hospital. MeritCare’s Heart Center has been named a 100 Top Heart Hospital nine times, one of only five in the nation to receive this distinction.

MeritCare offers two Fargo hospitals that include a total of 583 beds, 20 Fargo-Moorhead and West Fargo locations and nearly 30 satellite clinics spanning eastern North Dakota and northwestern Minnesota. MeritCare has been designated as a “Level II” trauma center.

BloombergNews.com, May 18, 2010, by Nicole Ostrow  –  Scientists said they learned more about why falling asleep in front of a switched-on television may make it harder to wake up in the morning, a finding that may help doctors develop therapies for sleep disorders.

Researchers had thought the human sleep-wake cycle was affected by blue light, which is detected by a photoreceptor system in the eye that suppresses melatonin, a hormone that helps induce drowsiness. A study published today in the journal Science Translational Medicine showed that different eye cells, cone photoreceptors used for color vision — and most responsive to green light — also influence circadian patterns.

The findings may help doctors develop better light-based therapies for sleep disorders, seasonal affective disorder and dementia, as well as ways to help night-shifts workers combat sleepiness, the study authors wrote.

“We can use light, in a way like caffeine, in a sleepiness countermeasure,” said Steven Lockley, an author of the research and an associate neuroscientist at Brigham & Women’s Hospital in Boston, in a telephone interview yesterday.

At least 40 million people in the U.S. each year suffer from chronic sleep problems, according to the National Sleep Foundation, based in Washington. The visible portion of the light spectrum contains wavelengths that appear as different colors, including green and blue. Light that appears to be white is actually a mixture of colors. TV sets, computer screens, lamps and other light sources can affect sleep.

The study, led by Joshua Gooley, an assistant professor at the Duke-NUS Graduate Medical School in Singapore, involved 52 people, ages 18 to 30, who were placed in rooms with no time cues such as windows, clocks, television or the Internet.

Awake 50 Hours

After being kept awake for 50 hours, the participants were allowed to sleep for eight hours and were wakened in the evening and exposed to more than six hours of either green or blue light. The timing helped to shift the body’s internal clock.

The researchers found that blue light is an effective way to stimulate the sleep-wake rhythm responses, especially under bright light. Green light is equally able to activate such reactions and works best when people are exposed to dim light, the study showed.

“If the light is very dim or the light duration is short, then green light is just as good or maybe even better at resetting our clock or affecting our hormone levels,” said Lockley, who is also an assistant professor of medicine at Harvard Medical School in Boston.

Medscape.com, May 19, 2010, by Yael Waknine — The US Food and Drug Administration (FDA) has approved a combination hormonal contraceptive tablet containing estradiol valerate and dienogest (Natazia; Bayer HealthCare Pharmaceuticals).

The product offers 4 progestin/estrogen dosing combinations during each 28-day cycle and is the first “4-phasic” oral contraceptive to be marketed in the United States. It also is the first contraceptive to contain the bioidentical synthetic estrogen estradiol valerate, rather than ethinyl estradiol.

“Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives,” said Scott Monroe, MD, director of the FDA’s Division of Reproductive and Urologic Products, in an agency news release. “The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”

FDA approval was based on data from 2 multicenter, open-label, single-arm phase 3 studies in which 1867 women with a body mass index of 30 kg/m2 or less underwent nearly 30,000 treatment cycles in North America and Europe.

The Pearl Index (PI) was the primary measure for assessing contraceptive reliability, based on FDA criteria for pregnancies that occur in women aged 18 to 35 years during cycles 1 to 13, including pregnancies at 7 days posttreatment.

Results from the North America trial (3969 exposure cycles) and European trial (11,275 exposure cycles) showed contraceptive failure rates at 1 year of 0.016 (5 pregnancies; PI, 1.64) and 0.010 (9 pregnancies; PI, 1.04), respectively, which are similar to those of other hormonal contraceptives containing 20 μg ethinyl estradiol.

Adverse events most commonly (≥2%) reported with estradiol valerate/dienogest use included headache, including migraines (13.2%); metrorrhagia and irregular menstruation (8.0%); breast pain, discomfort, or tenderness (6.6%); nausea/vomiting (6.5%); acne (3.9%); and weight gain (2.8%).

As with other oral contraceptives, the safety labeling for estradiol valerate/dienogest strongly advises that women not smoke because of an increased risk for serious cardiovascular events that increases with age and number of cigarettes, particularly for those older than 35 years.

Estradiol valerate/dienogest contraceptive tablets (marketed as Qlaira) previously were approved for use in the European Union and are also being studied for the treatment of excessive, prolonged, and frequent menstrual bleeding.

Harvard Medical School, May 18, 2010  –  Studies attest that strength training, as well as aerobic exercise, can help you manage and sometimes prevent conditions as varied as heart disease, diabetes, arthritis, and osteoporosis. It can also protect vitality, make everyday tasks more manageable, and help you maintain a healthy weight.

If you’ve never lifted weights in your life — and many people haven’t — why should you start now? The answer is simple: Muscle tissue, bone density, and strength all dwindle over the years. So, too, does muscle power. These changes open the door to accidents and injuries that can compromise your ability to lead an independent, active life. Strength training is the most effective way to slow and possibly reverse much of this decline.

Having smaller, weaker muscles doesn’t just change the way people look or move. Muscle loss affects the body in many ways. Strong muscles pluck oxygen and nutrients from the blood much more efficiently than weak ones. That means any activity requires less cardiac work and puts less strain on your heart. Strong muscles are better at sopping up sugar in the blood and helping the body stay sensitive to insulin (which helps cells remove sugar from the blood). In these ways, strong muscles can help keep blood sugar levels in check, which in turn helps prevent or control type 2 diabetes and is good for the heart. Strong muscles also enhance weight control.

On the other hand, weak muscles hasten the loss of independence as everyday activities — such as walking, cleaning, shopping, and even dressing — become more difficult. They also make it harder to balance your body properly when moving or even standing still, or to catch yourself if you trip. The loss of power compounds this. Perhaps it’s not so surprising that, by age 65, one in three people reports falls. Because bones also weaken over time, one out of every 20 of these falls ends in fracture, usually of the hip, wrist, or leg. The good news is that the risk of these problems can be reduced by an exercise and fitness routine that includes strength training.