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Expert review from Thomson Reuters of the most promising drugs changing clinical phase, receiving approval and launched this quarter, based on the strategic data and insight of Thomson Reuters Pharma™, the world’s leading pharmaceutical competitive intelligence solution.

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THE ONES TO WATCHA PHARMA MATTERS REPORT.JULY-SEPTEMBER 2010

PHARMA MATTERS | THE ONES TO WATCH

* IMS Health

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PHARMA MATTERS | THE ONES TO WATCH

Strong demand for pharmaceuticals from emerging markets is causing analysts to predict sales increases of 5-7% for 2011 to US $880 billion, up from 4-5% in 2010. The forecast* shows ‘pharmerging’ countries including Brazil, India, Poland and Russia spearheading the growth with 15-17% increase in spending in 2011, as their governments spend more on drugs. In China, growth of 25-27% to more than US $50 billion is expected.

But this is masking constraints in developed nations, where the situation continues to be tough. While the US remains the largest market, its growth is forecasted at just 3-5%, and Canada and the five major European markets are expected to grow at an even smaller rate of 1-3%. This is partly due to governments and insurers seeking cheaper alternatives, but also because of the ‘patent cliff’ which sees a handful of huge sellers with sales of more than US $30 billion lose exclusivity in 2011.

But there is some light at the end of the tunnel with a range of new, innovative drugs expected to be launched next year as firms move away from areas where generics are available and into those that fulfil a variety of unmet patient needs. One third of new drugs launched in 2011 will be niche pharmaceuticals*, in areas such as melanoma and multiple sclerosis. For further analysis on the multiple sclerosis area, subscribe to our new Pharma Matters Report series ‘Spotlight On...’ which focuses on a different therapy area each quarter. View details of how to download this report on the back cover.

So could patients with unmet needs be the winners from the swathe of drug patent expiries hanging over the industry? It certainly looks that way from this edition of The Ones to Watch. For example, Novartis and Mitsubishi Tanabe have launched their multiple sclerosis drug Gilenya™, the first oral treatment for relapsing-remitting multiple sclerosis, while Onyx Pharmaceuticals’ multiple myeloma treatment, carfilzomib, is now in phase III trials.

And the larger markets are not being ignored either. Daiichi Sankyo’s hypertension drug, Tribenzor™, has the potential to help half the people on high blood pressure medication whose blood pressure is not reduced to within target parameters. And Boehringer Ingelheim’s antidiabetic medication BI-10773, now in phase III trials, could cater to the rapidly expanding market for Type 2 diabetes agents.

Let’s take a closer look at the five most promising drugs launched or receiving approval, and moving through each of the clinical phases, between July and September 2010.

PHARMA MATTERS | THE ONES TO WATCH

DiVERSE TREaTMEnT oPTionS, BUT PhaRMacEUTicaL inTERVEnTionS haVE faLLEn ShoRTTreatment of obesity is multifarious, with initial approaches based on improved diets and patients increasing levels of physical activity. While lifestyle changes are effective, many patients struggle to comply with challenging fitness and diet regimes. Maintaining the lifestyle that led to weight loss is an even greater challenge. Surgical procedures are becoming more popular and represent an effective treatment option for severely obese patients who have had no success with other interventions, but are associated with usual surgical risks, long-term digestive problems, and mineral and vitamin deficiencies. The holy grail of obesity treatment would be a simple pill that induces substantial (>10%) long-term weight loss.

Studies of the diverse mechanisms controlling weight regulation have brought to the table several pharmaceutical treatment options for obesity. Historical therapeutics were short term agents, to be used to ‘kick-start’ a weight loss regime. Redux (dexfenfluramine) was the only long-term treatment option until its withdrawal in 1997 due to reports of valvulopathy just a year after launching.

Safety issues and abuse potential have long plagued obesity drugs. Most of the early obesity drugs launched in the ‘50s and ‘60s were amphetamine derivatives, thus only approved for short term use.

DRUG DISEASE COMPANY

Tribenzor™ Hypertension Daiichi Sankyo

Daxas® Chronic obstructive pulmonary disease

Nycomed/Forest Laboratories

Silenor® Insomnia Somaxon Pharmaceuticals

Gilenya™ Multiple sclerosis Novartis/Mitsubishi Tanabe Pharma

Kynapid™ Recent onset atrial fibrillation

Cardiome Pharma/ Merck Sharp & Dohme

Table 1: THE FIVE MOST PROMISING DRUGS LAUNCHED OR RECEIVING APPROVAL

The first drug to hit the market in this edition of The Ones to Watch is tribenzor™, a new three-in-one oral medication from Daiichi Sankyo for the once-daily treatment of hypertension. The drug received approval in the US in July 2010.

More than half of hypertension patients on blood pressure lowering medication do not achieve the recommended blood pressure of <140/90 mm Hg (or <130/80 mm Hg for patients with diabetes, chronic renal disease or chronic cardiovascular disease). More than two-thirds need to take two or more medications to meet the goal.

Tribenzor combines olmesartan, an angiotensin II receptor antagonist; amlodipine, a calcium channel blocker; and the diuretic hydrochlorothiazide (HCTZ). Daiichi Sankyo hopes that combining the drugs will reduce the pill burden on the patient, as well as co-pays or prescription charges, and could lead to better patient compliance.

PHARMA MATTERS | THE ONES TO WATCH

Phase III trials showed that patients switching from three separate dual combination therapies to Tribenzor™ saw significant reductions in their blood pressure after eight weeks, with a higher proportion reaching their blood pressure goal.

Eighty million people worldwide have chronic obstructive pulmonary disease (COPD), according to the World Health Organization, and 5% of global deaths in 2005 were attributed to the disease. The treatment mainstays are bronchodilators, which relax the airway lining muscles, and corticosteroids, which reduce airway inflammation. Even with treatment, COPD is a chronic condition which worsens over time and patients experience exacerbations that require further steroid treatment and sometimes hospitalization.

Daxas®, an oral tablet phosphodiesterase (PDE) 4 inhibitor, has been developed by Nycomed, following its acquisition of ALTANA Pharma, and US licensee Forest Laboratories, to reduce exacerbations in COPD patients. It was launched as an add-on to bronchodilator treatment in Germany this September, after EU approval in July 2010.

Daxas® is a novel approach to COPD treatment, because it actually slows the decline of lung function rather than simply treating the symptoms. It works by relaxing the airway smooth muscle, as well as suppressing inflammatory cell activation and modulating pulmonary nerve activity.

Phase III trials showed that Daxas® can reduce exacerbations in patients regardless of whether they use a bronchodilator. Thomson Reuters Forecast anticipates global sales of US $388.1 million in 2014 (2% of the market).

Insomnia associated with sleep maintenance is common, but many sufferers are unwilling to take medication due to concerns about addiction. Silenor®, a low-dose oral formulation of the tricyclic antidepressant doxepin, is the first prescription medication for sleep maintenance that is non-addictive and has not been classed as a controlled substance by the US Drug Enforcement Administration. It was launched in the US in September 2010.

Silenor® was developed by Somaxon Pharmaceuticals under license from the Columbia-Presbyterian Medical Center. No withdrawal effects were observed during clinical testing, as well as no evidence of tolerance, amnesia or complex sleep behaviors such as sleep driving or sleep eating. Although the exact mechanism of action is unclear, Silenor® is known to block the effect of histamine, a neurotransmitter that promotes wakefulness. Existing sleep aids work by enhancing the effect of γ-aminobutyric acid (GABA), a sleep-promoting neurotransmitter. This enhancement is non-selective, leading to broad depression of the central nervous system and a risk of abuse.

Thomson Reuters Forecast predicts global sales of US $231.6 million (13% of the market) by 2014.

Two and a half million people around the world have multiple sclerosis, a progressive disease in which the immune system attacks the myelin sheaths of nerves and causes a loss of neuronal communication, leading to motor and vision problems. The most common form of multiple sclerosis is termed relapsing-remitting, in which symptoms appear and then recede for weeks, months or years. Current treatments involve frequent self-injection with drugs such as interferons.

PHARMA MATTERS | THE ONES TO WATCH

gilenya™, from Novartis and Mitsubishi Tanabe Pharma, is the first oral treatment for relapsing-remitting multiple sclerosis and the first drug in the new class of sphingosine 1-phosphate receptor (S1PR) modulators. It was approved in the US and Russia in September 2010. Taken once daily, trials showed that it reduced the frequency of multiple sclerosis relapses by 52% after a year of treatment compared with Avonex®, a commonly prescribed treatment, as well as helping to slow disease progression. It is thought to work by retaining lymphocytes in the lymph nodes, thereby reducing the immune system’s attack on myelin sheaths. Thomson Reuters Forecast predicts worldwide sales of US $1372.3 million in 2014, equivalent to 9% of the market.

Our final treatment reaching the market is for atrial fibrillation (AF), the irregular ‘quivering’ of the heart’s atria rather than a coordinated contraction of the two chambers. Recent-onset atrial fibrillation – the first time AF has occurred or been detected - is common after heart surgery.

Kynapid™ is an intravenous formulation of the potassium channel blocker vernakalant for the rapid conversion of AF to a normal sinus rhythm in patients who have been experiencing AF for 7 days or less, and cardiac surgery patients who have been experiencing AF for 3 days or less.

Developed by Cardiome Pharma and Merck & Co (through its subsidiary Merck Sharp & Dohme), Kynapid™ was approved in the EU in September 2010 and launched the following month. It is the first product in a new class of drugs for cardioversion of AF to launch in this territory.

The phase III AVRO study compared Kynapid™ with intravenous antiarrhythmic amiodarone and found it to be significantly more effective and faster in promoting conversion to sinus rhythm in the first 90 minutes after administration. Sales of US $129 million (a 10% share of the market) by 2014 are predicted by Thomson Reuters Forecast.

DRUG DISEASE COMPANY

carfilzomib Multiple myeloma Onyx Pharmaceuticals

fostamatinib Rheumatoid arthritis AstraZeneca

GSK-1437173A Varicella zoster infection

GlaxoSmithKline

Zymafos™ Soft tissue sarcoma ZIOPHARM Oncology

BI-10773 Type 2 diabetes Boehringer Ingelheim

Table 2: THE FIVE MOST PROMISING DRUGS ENTERING PHASE III TRIALS

The blood cancer multiple myeloma cannot be cured and has a five-year survival rate of around 35%. Many patients relapse or experience resistance to treatment. New treatments and treatment combinations are needed to extend survival rates.

In July 2010, the phase III ASPIRE trial of the proteasome inhibitor carfilzomib in combination with the established chemotherapies Revlimid® and low-dose dexamethasone began in relapsed and treatment-resistant multiple myeloma patients.

Carfilzomib is an epoxomicin derivative and inhibits the ubiquitin-proteasome pathway, primarily the chymotryptic subunit of the 20S proteasome. The drug also has the potential to treat other hematological malignancies.

PHARMA MATTERS | THE ONES TO WATCH

Carfilzomib is being developed by Onyx Pharmaceuticals, following its acquisition of Proteolix, and under license from Yale University. Onyx says interim results of studies combining carfilzomib with Revlimid® and dexamethasone are positive, and carfilzomib alone has also proved successful in phase II trials. The drug is also being investigated for treatment of solid tumors.

AstraZeneca’s fostamatinib could prove useful in rheumatoid arthritis, another disease that has no cure. Current treatment is based on non-steroidal anti-inflammatory agents (NSAIDs), disease modifying anti-rheumatic drugs (DMARDs) and short-term corticosteroid use. But some patients stop responding to these treatments and need alternatives. Fostamatinib could meet this need, says AstraZeneca, which is developing fostamatinib under license from Rigel Pharmaceuticals.

The OSKIRA phase III trials for rheumatoid arthritis began in September 2010. Two 12-month placebo-controlled studies will assess oral fostamatinib in patients whose disease responds inadequately to DMARDs.

Fostamatinib is a pro-drug of the oral Syk kinase inhibitor R-406, which blocks the activity of mast cells, macrophages and B-cells. Preclinical studies of fostamatinib demonstrated a significant reduction in important inflammatory mediators such as TNF-α, IL-1, IL-6 and IL-18, leading to reduced inflammation and bone degradation in animal models of rheumatoid arthritis. In a phase II clinical trial, fostamatinib effectively improved American College of Rheumatology-defined response rates in patients with rheumatoid arthritis.

Next up is gSK-1437173a, GlaxoSmithKline’s attenuated recombinant Varicella zoster virus vaccine for the prevention of shingles in the elderly. Varicella zoster is a herpes virus that causes chicken pox which can later return giving rise to shingles after sequestration in the nervous system, particularly in elderly people. There is no cure for shingles, which is characterized by pain in one area of the body followed by an itchy and painful rash.

Available treatments must be taken soon after the onset of symptoms for them to be effective and to avoid potentially serious complications such as postherpetic neuralgia, damage to nerves in the skin that can cause excruciating pain. In August 2010, two global phase III studies of GSK-1437173A, which contains Antigenics’ QS-21 adjuvant, began in adults over 70 years of age.

Soft tissue sarcomas (STSs) are cancers of tissues such as cartilage, muscle, fat, nerves, blood vessels and other connective tissues. No new therapies for sarcomas have been approved in the US for over 20 years and survival rates vary widely depending on the type of tissue involved and the stage of the cancer at diagnosis. Chemotherapy relies on the drugs doxorubicin and ifosfamide.

In July 2010, ZIOPHARM Oncology announced the initiation of phase III trials of its preactivated form of the alkylating agent ifosfamide, Zymafos™, in combination with doxorubicin, for the intravenous treatment of metastatic tumors. It is expected to overcome the resistance seen with ifosfamide and cyclophosphamide, two of the most commonly used DNA-alkylating drugs used to treat cancers, as well as some of the side effects of ifosfamide such as CNS and bladder toxicity.

PHARMA MATTERS | THE ONES TO WATCH

The PICASSO III study will assess progression-free survival in 424 sarcoma patients in North America, Europe, South America, Australia, Israel and Korea. Zymafos™, developed under license from Dekk-Tec, has Orphan Drug status for STS from the EU and the US with an oral formulation of the drug is being developed. Phase II trials found that the combination of palifosfamide and doxorubicin was more effective than doxorubicin alone.

Our final drug entering large-scale human testing is BI-10773, a sodium glucose transporter-2 (SGLT-2) inhibitor from Boehringer Ingelheim for the oral treatment of type 2 diabetes. Inhibitors of SGLT-2 interfere with glucose reabsorption in the proximal tubule of the kidney and therefore have the potential to treat hyperglycemia and obesity by increasing glucose loss through the urine. They are an emerging new class of anti-diabetic drug.

A phase III trial of BI-10773 began in Canada and Malaysia in July 2010, intended to test safety and efficacy in patients with type 2 diabetes and renal impairment. The company is also developing a fixed-dose combination of BI-10773 with another of its investigational antidiabetics, linagliptin; the combination is in phase I trials, which began in August 2010. Phase II trials combining BI-10773 with the antidiabetic metformin are also underway.

DRUG DISEASE COMPANY

XEN-402 Postherpetic neuralgia Xenon Pharmaceuticals

solithromycin Bacterial pneumonia Cempra

OGX-427 Prostate cancer OncoGenex Pharmaceuticals

claudiximab Gastroesophageal cancer

Ganymed

ACP-001 Growth hormone deficiency

Ascendis Pharma

Table 3: THE FIVE MOST PROMISING DRUGS ENTERING PHASE II TRIALS

The first product entering phase II trials in this edition of The Ones to Watch is an ointment for postherpetic neuralgia which, as mentioned above, is a common and serious consequence of shingles which can result in insomnia, fatigue depression, as well as pain. Xenon Pharmaceuticals is developing XeN-402, an analgesic and inhibitor of the Nav1.7 sodium channel. A phase II trial was initiated in patients with postherpetic neuralgia in August 2010.

People with mutant Nav1.7 cannot feel pain. By inhibiting Nav1.7 channels at the site of the neuralgia, XEN-402 should be a safe and effective treatment option, meeting a need only partly fulfilled by the complex and sometimes ineffective combination of anti-virals and analgesics that many patients currently take. Preclinical data for XEN-402 showed high efficiency as a painkiller alone and in combination with others, says Xenon. The company is also developing an oral formulation of XEN-402 as a general analgesic. Pfizer and Icagen’s product exploiting the same pathway has also just entered first-in-man studies.

Next up is the only antibiotic in this edition. Solithromycin is an oral broad-spectrum antibacterial being developed by Cempra, under license from Optimer, for community-acquired bacterial pneumonia (CABP). A phase II trial comparing the safety and efficacy of oral solithromycin with levofloxacin in 150 patients with moderate-to-moderately severe CABP began in September 2010. Solithromycin is the lead candidate from the company’s series of fluoroketolide macrolides. An intravenous formulation of solithromycin is also in phase I testing.

PHARMA MATTERS | THE ONES TO WATCH

Pre-clinical tests showed that solithromycin has potent in vitro activity against respiratory pathogens such as pneumococci, including macrolide- and quinolone-resistant strains. A quarter of bacteria that cause pneumonia are resistant to existing macrolide and beta-lactam antibiotics. Solithromycin is the first fluoroketolide belonging to the macrolide class and is the first macrolide since azithromycin with the potential for both intravenous and oral administration. In addition to providing a new treatment option, solithromycin could reduce the length of stays in hospital, as patients receiving the intravenous formulation move on to the oral formulation, or eliminate the need altogether with less complex cases receiving the once-daily oral dosing at home.

The next two candidates entering phase II trials in this edition are both anticancer agents. The first is a potential treatment for advanced prostate cancer in men whose cancer has stopped responding to hormone treatment. These patients have only a few treatment options, and new agents are needed to slow disease progression.

In advanced prostate cancer that has become resistant to hormone therapy, the androgen receptor is often reactivated so many tumors remain sensitive to therapies directed at the receptor. ogX-427 is being developed by OncoGenex Pharmaceuticals, under license from the University of British Columbia, as a potential injectable treatment for this advanced cancer.

OGX-427 is an anti-sense oligonucleotide and the lead from a series of heat shock protein 27 (Hsp27) inhibitors with the potential to treat a range of cancers, including bladder cancer, and is the most advanced Hsp27 inhibitor currently in development. Hsp27 is a cell survival protein that is elevated in many cancers and associated with metastases, poor prognosis and resistance to radiation or chemotherapy.

In September 2010, a phase II trial began in chemotherapy-naive men with asymptomatic or minimally symptomatic prostate cancer. OGX-427 will be tested in combination with prednisone to assess whether it is more effective than prednisone alone. Preclinical studies show that OGX-427 significantly decreases levels of Hsp27, induces apoptosis in several human cancer cell lines, and is active alone as well as in combination with cytotoxic drugs including docetaxel.

Moving to gastroesophageal cancer, Ganymed began a phase II trial of intravenous claudiximab, a monoclonal antibody targeted to its proprietary oncological target claudin 18.2, in September 2010. The participants have advanced adenocarcinoma of the stomach or lower esophagus.

Claudin 18.2 is a cell surface antigen present in 70% of all gastric cancers, 50% of pancreatic cancers, 30% of esophageal cancers and 25% of non-small cell lung cancers. In pre-clinical cancer models claudiximab demonstrated potent activity against claudin 18.2-positive cells.

Current treatment for growth hormone deficiency involves daily injections of growth hormone. aCp-001 from Ascendis could cut this injection burden on patients by enabling weekly injections. A phase II trial of ACP-001 began in growth hormone-deficient adults in September 2010, after phase I results showed that a single dose of ACP-001 generated higher levels of the growth factor IGF-1 than the seven daily injections of an existing growth hormone formulation.

ACP-001 is a human growth hormone pro-drug that stimulates IGF-1 production, created using Ascendis’ proprietary TransCon pro-drug technology to allow the active drug to be released in a controlled manner. The pro-drug circulates with a PEG carrier in the plasma continuously for up to two weeks.

PHARMA MATTERS | THE ONES TO WATCH

DRUG DISEASE COMPANY

ALB-127158(a) Obesity Albany Molecular Research

BAN-2401 Alzheimer's disease Eisai

PAT-SM6 Melanoma Patrys

TRO-40303 Reperfusion injury Trophos

BP-100-1.01 Cancer Bio-Path

Table 4: THE FIVE MOST PROMISING DRUGS ENTERING PHASE I TRIALS

Our first candidate making the leap from the laboratory to the clinic is aLB-127158(a), an antagonist of oral melanin concentrating hormone (MCH-1) from Albany Molecular Research. In July 2010 Albany began a phase I trial of ALB-127158(a) as an anti-obesity drug.

Studies comparing ALB-127158(a) with the weight-loss drug sibutramine in diet-induced obese mice over 28 days showed that ALB-127158(a) reduced food intake and resulted in up to 18% weight loss, which was more effective than sibutramine. In addition, the food intake reduction and weight loss were sustained over the period of study, rather than exhibiting the rebound associated with sibutramine.

Small molecule MCH-1 antagonists represent a promising new approach to tackling obesity. MCH-1 is known to stimulate feeding in animal models and increases glucose, insulin and leptin levels, mimicking the human metabolic syndrome. The WHO predicts that by 2015, approximately 2.3 billion adults will be overweight and more than 700 million will be obese. Increasing rates of obesity are a particular problem in emerging economies.

Another condition expected to increase in the coming years is Alzheimer’s disease, which affects around 26 million people worldwide and is expected to quadruple by 2050. There is no cure for Alzheimer’s disease and while some drugs can slow progression of the disease, they do so only in some people and have only modest or temporary effects.

Eisai, under license and using proprietary technology from Bioarctic Neuroscience, is developing BaN-2401, a humanized monoclonal antibody for the potential treatment of Alzheimer’s disease. A phase I trial in 80 Alzheimer’s patients with mild to moderate forms of the disease began in September 2010.

BAN-2401 selectively binds, neutralizes and eliminates the soluble amyloid protofibrils which are thought to cause Alzheimer’s disease. If successful, it could halt the progression of the disease.

Staying with monoclonal antibodies, Patrys, following its acquisition of Acceptys’ and OncoMab’s cancer pipelines, is developing the fully human monoclonal immunoglobulin M (IgM) antibody pat-Sm6 as an anti-cancer drug. A phase I trial for melanoma began in July 2010.

Current treatments for melanoma are largely ineffective and the five-year survival rate is just 16%. It is a very serious global medical problem, with an expected doubling of incidence every 15 years.

PAT-SM6 binds Hsp protein Grp78, which is over-expressed on the surface of cancer cells and plays a role in the aggressiveness and spread of the disease. It is not found on the surface of healthy cells. By binding to Grp78, PAT-SM6 mediates the import of toxic LDL into the cancer cells and initiates apoptosis. Studies in mice have shown that PAT-SM6 halves the number of cancers that spread from the colon to the liver compared with the control.

PHARMA MATTERS | THE ONES TO WATCH

Patrys hopes PAT-SM6’s completely human nature will provide benefits over other potential antibody-based treatments that claim to be fully human, but contain non-human carbohydrates. The company anticipates that PAT-SM6 will be less likely to be rejected and will more easily recruit other components of the immune system against cancer cells. The drug could also be a treatment for pancreatic and gastric cancer.

Cardiac reperfusion injury, caused by damaging inflammation to the heart tissues upon re-entry of blood after ischemia during surgery, is a common side effect of the 1.6 million reperfusion surgeries carried out each year. There is no prevention or treatment.

To meet some of this need, Trophos is developing tro-40303 for the potential intravenous treatment of ischemia-related reperfusion injury. A phase I study began in September 2010. TRO-40303 is a mitochondrial pore modulator which is associated with reducing damage to cardiomyocytes. Pre-clinical studies showed that TRO-40303 halved the size of myocardial infarct in mouse and rat models of cardiac ischemia-reperfusion injury.

Next up is Bio-Path’s anticancer drug Bp-100-1.01, an anti-sense drug that targets the adaptor protein Grb-2 thought to be essential for the growth of cells made cancerous by the presence of the mutated Philadelphia chromosome. Novartis’s Gleevec® limits the growth of Philadelphia chromosome-positive cells but some people develop resistance to the drug, so novel treatments are needed. BP-100-1.01 has been shown to inhibit the growth of human chronic myelogenous leukemia (CML) cells in animal models.

BP-100-1.01 is delivered using the University of Texas MD Anderson Cancer Center’s neutral lipid-based liposome technology. A phase I trial for Philadelphia-chromosome acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS) began in the US in July 2010. The drug also has potential against colon and breast cancer.

Progress in using anti-sense therapeutics has been hindered by the lack of a suitable delivery method to ensure a high uptake by target cells without associated toxicity. Studies of the MD Anderson liposomal technology have shown a ten- to thirty-fold increase in uptake of antisense and siRNA drugs compared to other delivery methods.

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