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Ancient Chinese cures translate into modern Western medicines

The Chem-TCM is the most comprehensive database of its kind and translates more than 12,000 chemicals from more than 300 Chinese herbs used in traditional Chinese medicine (TCM) into Western terminology.

“Future researchers will now be able to better understand the chemical basis of remedies that have been in use for thousands of years,” says David Barlow of King’s College London (KCL), who has helped to develop the database.

TCM chemicals are rarely used as raw materials to develop Western drugs because their complex nature makes the registration process difficult.

The database may also answer one of TCM’s regulatory challenges in the United Kingdom. An EU directive came into effect in the UK this May that makes it illegal for individual practitioners to sell TCM over the counter, except for varieties registered with the UK drug safety watchdog, the Medicines and Healthcare Products Agency.

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Vaccine for ovarian, breast cancer shows promise

(CBS) A new vaccine that targets ovarian and breast cancer has shown promise in early studies, giving scientists hope they may be closer to stopping the deadly diseases.

PICTURES: 25 breast cancer myths busted

Known as PANVAC, the vaccine triggers the immune system to attack tumor cells.

“With this vaccine, we can clearly generate immune responses that lead to clinical responses in some patients,” lead scientist Dr. James Gulley, director and deputy chief of the clinical trials group at the laboratory of tumor immunology and biology at the National Cancer Institute, said in a written statement.

For their research, published in the Nov. 8 issue of Clinical Cancer Research, scientists tested the vaccine on 26 patients, 12 of whom had breast cancer, 14 of whom ovarian. Most of the women had undergone prior chemotherapy treatment.

What did the scientists find? The vaccine caused women with breast cancer’s disease progression to stall for 2.5 months, and their median survival was 14 months. Four had stable disease, meaning the cancer didn’t grow nor shrink. Women with ovarian cancer reported a two month gap in disease progression, and survived for 15 months, and three had stable disease.

The cancer vaccine stalls cancer progression for only a couple of months? What’s the big deal?

“That time frame is not anything to write home about,” Gulley told WebMD. But he said that one of the women who had breast cancer currently shows evidence of cancer after undergoing the experimental vaccine – four years later.

“It gives us encouragement that we may be on to something here,” he said.

That 32-year-old woman was the youngest in the study, according to WebMD, but her cancer had spread to her liver and chest lymphnodes. At 18 months, there was no X-ray evidence of cancer. Gulley isn’t sure why her treatment was so successful, but the woman had only undergone chemotherapy once. That suggests her immune system might have been stronger than the other women’s.

But don’t expect the vaccine on the market anytime soon. This was only a small study, so more needs to be done.

Gulley said interest in a cancer vaccine is increasing among scientists, but said in the statement that “more studies in the appropriate patient populations are required” to ensure safety, and which patients would benefit most.

The National Cancer Institute has more on cancer vaccines in development.

Source: http://www.cbsnews.com/8301-504763_162-57321522-10391704/vaccine-for-ovarian-breast-cancer-shows-promise/

XXI Century Database of Traditional Chinese Medicine Released

October 18, 2011

A comprehensive database developed by King’s College London researchers that features the chemical components found in traditional Chinese medicines has been released to market this month, allowing researchers to explore age-old remedies in the search for tomorrow’s new drugs.

Provided under licence to Tim Tec LLC, a US-based life science supplier company, the ‘Chem-TCM’ database is the most comprehensive of its kind. Featuring over 12,000 chemicals found in plants used in Chinese medicine, the database provides a valuable research tool for the pharmaceutical and biotechnology industries, academic researchers, and the medical profession (including the complementary health sector).

Part-funded by Innovation China UK (ICUK), the database has been developed through collaboration between researchers in the Institute of Pharmaceutical Science at King’s, Dr David Barlow, Dr Thomas Ehrman and Professor Peter Hylands, and the Shanghai Institute of Materia Medica (SIMM).

To create the Chem-TCM database, the King’s researchers analysed patterns in the known and predicted biological activities of 12,000 chemicals from over 300 Chinese herbs in relation to their usage in traditional Chinese medicine. Their results reveal that many categories in Chinese medicine are translatable into Western terminology. Dr David Barlow said: ‘Traditional Chinese medicine has undergone a remarkable renaissance in recent years. However, the unique language used to describe categories of medicines has hindered effective understanding of one of the most developed and mature systems of alternative medicine in existence.

‘With the Chem-TCM database, future researchers will now be better able to understand the chemical basis of remedies that have been in use for thousands of years. This is likely to be of benefit both in the search for new drugs and, equally significantly, in understanding how Chinese medicine works.’

Chem-TCM features four major parts: chemical identification, botanical information, predicted activity against Western therapeutic targets, and estimated molecular activity according to traditional Chinese medicine categories.

Dr. Marat Niazoff, CEO of TimTec LLC, said: ‘This database is a comprehensive attempt to link Chinese and Western medicine on the molecular level. It is a great contribution to the further study of natural products and their pharmacological potential. The database gathers diverse structural material and a wealth of phytochemical information, opening new possibilities for virtual screening in particular.’ With over 15 years of experience in serving life-science R&D and established global customer base TimTec is well positioned to assume product development and distribution role. Chem-TCM commercial license is the protected adaptation of ChemDBsoft, TimTec chemical records and database managements software. TimTec welcomes this unique database product to its offerings.

Manyi Cristofoli, Director of ICUK, said: ‘I am pleased another ICUK-funded proof-of-concept project has now been commercialised in the pharmaceutical industry – this is a very good example of how academia and industry can successfully collaborate for innovation at a truly international level. The partnership with TimTec opens up a new global channel to jointly realise the wide potential in traditional Chinese medicine.’

King’s College London

King’s College London is one of the top 30 universities in the world (2011/12 QS international world rankings), and was The Sunday Times ‘University of the Year 2010/11′, and the fourth oldest in England. A research-led university based in the heart of London, King’s has nearly 23,500 students (of whom more than 9,000 are graduate students) from nearly 140 countries, and some 6,000 employees. King’s is in the second phase of a £1 billion redevelopment programme which is transforming its estate.

King’s has an outstanding reputation for providing world-class teaching and cutting-edge research. In the 2008 Research Assessment Exercise for British universities, 23 departments were ranked in the top quartile of British universities; over half of our academic staff work in departments that are in the top 10 per cent in the UK in their field and can thus be classed as world leading. The College is in the top seven UK universities for research earnings and has an overall annual income of nearly £450 million.

King’s has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar. It is the largest centre for the education of healthcare professionals in Europe; no university has more Medical Research Council Centres.

King’s College London and Guy’s and St Thomas’, King’s College Hospital and South London and Maudsley NHS Foundation Trusts are part of King’s Health Partners. King’s Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world’s leading research-led universities and three of London’s most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

The College is in the midst of a five-year, £500 million fundraising campaign – World questions|King’s answers – created to address some of the most pressing challenges facing humanity as quickly as feasible. The campaign’s three priority areas are neuroscience and mental health, leadership and society, and cancer. For more information, please visit www.kcl.ac.uk

TimTec

TimTec LLC is a privately held company located in Newark, Delaware, USA. It was founded in 1995 to begin its work in the areas of acquisition and distribution of synthetic organic and natural compounds, custom synthesis, scientific software and laboratory equipment to become a full service partner for drug discovery.

TimTec has developed strong in-house expertise in the design of screening products to offer a full line of libraries and compound sets of various specialisation for different assays. In addition, the company provides compound management, custom formatting and computational services.

www.chemtcm.com , www.timtec.net, or info@timtec.net


Innovation China UK

Funded by HEIF3 and BIS Global Partnership Fund, the Innovation China UK (ICUK) is a collaboration programme supporting joint innovation and knowledge transfer between the UK and China. Based at Queen Mary Innovation Limited – a wholly-owned subsidiary company of Queen Mary University of London, ICUK provides a full range of services to UK companies and HEIs seeking to develop and commercialise their research and technology in the Chinese market. www.icukonline.org

Body & Mind – HEALTH U.S. Doctor Cautious About HIV Vaccine

A New York City-based infectious disease specialist said a new vaccine developed by Spanish scientists, which could turn HIV into minor infection status, is reason to be cautiously optimistic.

Dr. Joseph Rahimian said Thursday news of an HIV vaccine is certainly exciting, but questions remain.

“An HIV vaccine has been the holy grail for infectious disease doctors for a very long time,” Rahimian said. “ There are a lot of people interested in creating one and obviously a lot of demand for it, so there would be a lot of excitement if this research is accurate.”

The vaccine, developed by scientists at the Spanish Superior Scientific Research Council (CSIC) in Madrid, works by training the immune system to detect HIV and learn how to combat the virus.

In a trial involving 30 healthy volunteers, scientists found that 90 percent of those who were given the MVA-B vaccine developed an immunity against the virus and 85 percent maintained this for a year.

Professor Mariano Esteban, from CSIC, said, “MVA-B vaccine has proven to be as powerful as any other vaccine currently being studied, or even more.”

He said the vaccine was like showing the body a picture of the HIV, “so that it is able to recognize it if it sees it again in the future.”

“If the virus enters the body and tries to develop in a cell, the immune system is ready to inactivate the virus and destroy the infected cell,” he added. Scientists hope that if bigger trials are successful, HIV would no longer cause AIDS and would be much less contagious.

‘”If this genetic cocktail passes Phase II and Phase III future clinic trials, and makes it into production, in the future HIV could be compared to herpes virus nowadays,” according to the study.

However, Rahimian said this study needs much more room to grow.

“The population that they used is very small, and they followed them out to one year. So one important question is how long does this last for? A vaccine that has to be given repeatedly every year is less exciting than a vaccine that can give long-term immunity,” he said.

On the other hand, Rahimian pointed out there are some vaccines given every year, which are successful, like the flu shot.

“I would say many people have tried to create vaccines, and it is a very difficult task, so any enthusiasm for a successful vaccine is guarded,” he said.

Source: http://www.foxnews.com/health/2011/09/29/new-vaccine-could-turn-hiv-into-minor-infection/

Critical Protein Discovery Could Help Prevent Lethal Ebola Virus

An international team of scientists has discovered a biochemical route used by the deadly Ebola virus to infect human cells.   Scientists say the discovery points the way to new drugs that could prevent or treat one of the world’s most lethal viral diseases.

The Ebola hemorrhagic virus, which got its name from the central African river near where the disease first emerged in 1976, kills an estimated 90 percent of the people and non-human primates it infects.

The disease causes very high fever, both internal and external bleeding, and has led to thousands of deaths in many sub-Saharan African countries, including Gabon, Sudan, the Ivory Coast and Uganda, since the first reported outbreak 35 years ago.

Although considered a rare disease, Ebola causes panic whenever there is an outbreak, in part because little is known about where the illness comes from or how it spreads.

Experts believe infected bats may be one source of these sporadic occurrences of Ebola, and the disease is then spread from person to person through tainted body fluids or blood.

To better understand the biology of Ebola, a team of researchers at Albert Einstein College of Medicine, Harvard Medical School, the Whitehead Institute at MIT and the U.S. Army Medical Research Institute of Infectious Diseases studied how the virus actually infects cells.

Kartik Chandran, a professor of microbiology and immunology at Albert Einstein, is a senior author of the study.

“The critical step that we were studying is what we call viral entry,” Chandran explained.  “And it’s basically the step that results in the virus getting into the cytoplasm where the [genetic] goodies are for making copies of itself.”

Researchers looked at normal cell proteins that the Ebola virus might be hijacking, in effect, to get inside and infect mammalian cells.  Investigators focused on one protein in particular – called Neimann-Pick C1  or NPC1.

Chandran says that in experiments with both human cells and in mice, the Ebola virus was unable to gain a toehold in cells that were missing the NPC1 protein.

“You couldn’t infect the cells with Ebola.  And there are also mice that, like the human[s], don’t have the protein and develop Neimann-Pick disease,” Chandran said.

The Neimann-Pick protein, which is embedded naturally in cell membranes, helps transport cholesterol throughout cells.  People who are born with a rare genetic defect and don’t make the protein eventually die of Neimann-Pick disease, in which fatty substances called lipids collect and clog various internal organs.

Chandran says the disease progresses over time. But to prevent or treat an Ebola infection, he thinks it might be possible to design a small molecule that interferes with production of the Neimann-Pick protein in cells temporarily — too briefly to cause problems with elevated cholesterol.

Chandran says such a compound would not have to totally block production of the NPC1 protein.

“You know the [Ebola] virus, it’s like ‘shock and awe.’  It’s like over within a week,” noted Chandran.   “I mean the virus grows very quickly and it kills off the very cells you need to mount your immune response.  If we could stop that from happening or slow it down enough, we might give the person a chance.”

Chandran says scientists have developed a candidate drug that could be used to treat or prevent an Ebola outbreak.  He says another hemorrhagic virus called Marburg uses a similar mechanism to infect cells and should also respond to a drug that blocks the Neimann-Pick protein.

Two articles by Chandran and colleagues on the biochemical keys involved in Ebola virus infections are published in the journal Nature.

Source: http://www.voanews.com/english/news/science-technology/Critical-Protein-Discovery-Could-Help-Prevent-Lethal-Ebola-Virus-128374013.html

Sanofi Pasteur to Evaluate Leukocare’s Stabilization Technology for Vaccines

    Sanofi Pasteur and Leukocare biotechnology inked a cooperation agreement through which Sanofi’s vaccines division will evaluate Leukocare’s Stabilizing and Protecting Solutions (SPS) platform for improving the shelf-life of certain vaccine formulations.

    Leukocare’s postcoating technology is designed to both stabilize biotherapeutic and diagnostic products and protect them against the otherwise damaging effects of terminal sterilization by irradiation or ethylene oxide. The firm says the platform can be used to help preserve the activity of biologics during processing for dry storage, and is applicable to lyophilization, air drying, spray drying or microcrystal powders.

    Leukocare specializes in technologies for biological functionalization of surfaces and for product stabilization. The firm offers collaborative research and development services that exploit its core technologies in the fields of biofunctional surface engineering, biopharmaceuticals, development and co-development of combination products, as well as related preclinical and clinical studies.

    The SPS technology has been tailored to specific product types. SPS-CP is designed for stabilizing and protecting combination products. SPS-BP is adapted specifically for the stabilization and protection of biopharmaceutical formulations and galenics. SPS-LT is designed to stabilize and protect diagnostic surface coating.

    In November 2010 Leukocare teamed up with sterilization services firm Sterigenics, for a collaboration that aims to combine the SPS platform with Sterigenics irradiation technologies and establish new sterilization procedures for biotherapeutics, including therapeutic antibodies.

    Source: http://genengnews.com/gen-news-highlights/sanofi-pasteur-to-evaluate-leukocare-s-stabilization-technology-for-vaccines/81245462/

Positive agreement received for approval of AXANUM (low-dose ASA/esomeprazole) in Europe

AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway. AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers.

Low-dose ASA (commonly known as aspirin) is recommended mainstay therapy for patients with high-risk for cardiovascular events. About one third of these patients are also at increased risk of stomach ulcer. Low-dose ASA further increases the risk for gastric ulcers and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems. The consequences of interrupting low-dose ASA treatment can be severe, increasing the risk of a heart attack or stroke as early as eight to 10 days later.

AXANUM is the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers. That means AXANUM has the potential to provide continuous CV protection in this patient population.

The EU decision took place under the decentralised procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.

Tony Zook, Executive Vice President of AstraZeneca’s Global Commercial Organisation said: “AstraZeneca has had some significant regulatory approvals this year, and we’re pleased with this positive agreement for AXANUM in Europe. We will now work with relevant health authorities to secure reimbursement decisions and get onto formularies to bring this medicine to patients as soon as possible.”

Source: http://www.europeanpharmaceuticalreview.com/8417/news/industry-news/positive-agreement-received-for-approval-of-axanum-low-dose-asaesomeprazole-in-europe/?utm_medium=email&utm_campaign=EPR+-+Newsletter+16+2011&utm_content=EPR+-+Newsletter+16+2011+CID_0d42f174df14efdb3a6804bfbf1f416a&utm_source=Email+marketing&utm_term=Positive+agreement+received+for+approval+of+AXANUM+low-dose+ASAesomeprazole+in+Europe

Daily pill can prevent HIV infection

The partners of people who have HIV can protect themselves from infection by taking a once-daily pill, two groundbreaking studies in Botswana, Kenya and Uganda have shown.

The discovery could bring work to combat Aids close to a “tipping point”, experts say. Attempts to promote condom use to protect against HIV in the hardest-hit parts of the world, and particularly Africa, have hit cultural barriers and had limited success.

But now it appears that men or women who know – or suspect – their partner has HIV could protect themselves, secretly if necessary. The larger study, involving 4,758 “discordant” couples (where one has HIV but the other has not) in Kenya and Uganda, led by the University of Washington’s International Clinical Research Centre, shows that those taking a single daily tablet of the Aids drug tenofovir had 62% fewer infections and those who took a pill combining tenofovir and emtricitabine had 73% fewer infections than those who took a placebo pill.

The drugs have few side-effects, which is important if they are to be given to healthy individuals. Both are made by Gilead, which has licensed their manufacture to generic companies in the developing world, allowing them to produce cheap copies – so this is a relatively inexpensive intervention.

“This study demonstrates that antiretrovirals are a highly potent and fundamental cornerstone for HIV prevention and should become an integral part of global efforts for HIV prevention,” said Dr Connie Celum, professor of global health and medicine at the university and principal investigator of the study, known as the Partners PrEP Study, which was funded by the Bill and Melinda Gates Foundation.

The second study in Botswana was conducted by the United States Centres for Disease Control. It followed 1,200 heterosexual men and women without HIV who received either a once-daily tenofovir/emtricitabine tablet or a placebo pill. The antiretroviral tablet reduced the risk of acquiring HIV infection by roughly 63% overall.

“This is a major scientific breakthrough which re-confirms the essential role that antiretroviral medicine has to play in the Aids response,” said Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/Aids (UNAids). “These studies could help us to reach the tipping point in the HIV epidemic.”

The news follows hard on the heels of another very significant finding – that people with HIV who are taking combinations of antiretroviral drugs not only stay healthy themselves but are unlikely to infect their partner.

The two pieces of research give a massive boost to the cause of rolling out more Aids drugs and treating people at the earliest stage of their illness.

“Effective new HIV prevention tools are urgently needed, and these studies could have enormous impact in preventing heterosexual transmission,” said Dr Margaret Chan, WHO’s director general. “WHO will be working with countries to use the new findings to protect more men and women from HIV infection.”

Source: http://www.guardian.co.uk/world/2011/jul/14/hiv-daily-pill-breakthrough

Genentech to Appeal to F.D.A. for Breast Cancer Drug

Genentech this week will step up its efforts to keep the drug Avastin available as a treatment for breast cancer, urging the Food and Drug Administration to give it one more chance to prove the medicine works.

At a hearing on Tuesday and Wednesday in suburban Washington, Genentech will ask the F.D.A. to reconsider its proposal last December to revoke the approval of Avastin for breast cancer on the grounds that new studies did not confirm that the drug helped patients.

Genentech’s approach seems intended to broaden the terms under which Avastin can remain available. The company is arguing that even if the F.D.A. reaffirms that data do not support Avastin’s effectiveness, the approval should be retained while Genentech does one more clinical trial. Avastin has remained available for breast cancer pending the appeal process.

Avastin was put on the market under an accelerated program begun in the early 1990s that allows drugs for serious diseases to be approved with less than the usual amount of evidence, subject to further studies. Dozens of drugs have been approved this way, and in at least a couple of cases approvals have been withdrawn. But this is the first time the F.D.A. will hold a hearing to consider a company’s appeal.

The debate over Avastin has evoked passions on both sides among those involved in women’s health issues. Some patient advocates argue that the F.D.A. needs to revoke the approval to maintain the integrity of the accelerated process and to ensure that cancer patients receive drugs that work.

But some breast cancer patients are expected to testify at the hearing that the drug should be kept available because it helps some women, even if not all.

“It’s so depressing to think that a federal agency can make a decision that can potentially cause me to die,” said Crystal Hanna, 35, a mother of two from Parkersburg, W.Va., who said Avastin has kept her cancer under control for almost a year.

The public comments sent to the F.D.A. before the hearing at its campus outside Washington, overwhelmingly support retaining the approval. Many of them, using virtually identical language, cite the case of Ms. Hanna, who drafted a comment for friends that circulated widely on the Internet.

Even if approval as a breast cancer treatment is ultimately rescinded, Avastin will retain approval to treat lung, colon, kidney and brain cancers. So doctors will be able to use it “off label” to treat breast cancer. But insurers might no longer pay for it for that use, putting the drug, which can cost $88,000 a year, out of reach for many women.

The Avastin issue has become caught up in the politics of overhauling health care, with some critics saying the decision not to pay for it represents rationing and others saying that Medicare should not pay for a drug that does not work. The F.D.A. maintains that it is not permitted to consider costs.

The ultimate decision will be made by the F.D.A. commissioner, Dr. Margaret A. Hamburg, who appears to have some latitude. The rules say that the F.D.A. “may” revoke the approval of a drug, but does not have to.

“Even where F.D.A. determines that confirmatory trials do not establish clinical benefit, withdrawal is not required and instead should be based on the public health considerations that motivate the accelerated approval statute,” Genentech argues in a summary of its arguments filed before the hearing.

But the F.D.A.’s drug division views the company’s request as a stalling tactic. “How many bites of the apple do you get?” Dr. Richard Pazdur, the director of the agency’s oncology drug division, said in an interview at a cancer conference early this month.

The agency, in a summary of its arguments, says that because it has already determined that the benefits of Avastin do not outweigh the risks, retaining the approval while the new study is conducted “would not be in the interest of the public health and would jeopardize the integrity of the accelerated approval program.”

Genentech and its parent company, Roche, could lose as much as $1 billion in annual sales if the breast cancer approval were revoked. Already Avastin sales for treatment of breast cancer have started declining. The drug is the world’s best-selling cancer drug, with sales last year of roughly $7 billion.

The F.D.A. approved the drug for advanced breast cancer in February 2008, after one clinical trial showed that combining Avastin with another drug, paclitaxel, delayed the median time before tumors worsened by 5.5 months, compared with using paclitaxel alone. But the women who got Avastin did not live significantly longer than those who got only paclitaxel, which is also known by the brand name Taxol.

Subsequent trials, in which Avastin was combined with different chemotherapy drugs, showed a much smaller delay in tumor progression, ranging from less than 1 month to 2.9 months. And again there was no improvement in survival for those receiving Avastin.

Based on those results and on the fact that Avastin has some life-threatening side effects, including bowel perforation and hemorrhaging, the F.D.A.’s cancer drug advisory committee voted 12 to 1 last July that the approval for the treatment of breast cancer be revoked.

The hearing this week will be before the same committee, which will make recommendations to the F.D.A. commissioner. Of the six voting committee members expected to attend, five voted to revoke the approval last July. The sixth was not at that earlier meeting. Since the data have not changed, Genentech, in the summary of its arguments, concedes it is not likely to change the committee’s mind about the benefits of Avastin.

Instead it will argue that the drug with which Avastin is combined matters. Therefore, the company should be given a chance to do another trial in which Avastin is combined with paclitaxel, as in the original trial that led to the drug’s approval.

Source: http://www.nytimes.com/2011/06/27/health/27drug.html

Experimental Type 1 diabetes vaccine fails during second step of trial

The quest for a vaccine to stop Type 1 diabetes in its tracks has hit a roadblock.

An experimental drug failed in the second step of a three-phase trial on 145 American and Canadian patients who had just been diagnosed with the disease.

The vaccine is based on an enzyme that is targeted by a diabetes patient’s immune system.

Researchers hoped the vaccine would train the immune system to not attack the enzyme – a process that destroys the pancreas’ insulin-producing cells.

But according to a study published by the medical journal The Lancet on Monday, patients who got the vaccine experienced no difference in the progression of the disease.

The vaccine was aimed at Type 1 diabetes, which used to be known as juvenile diabetes and affects less than 10% of people with the disease.

Most sufferers have what’s known as adult-onset or Type 2 diabetes.

New research shows vitamin D may ward off those at risk for Type 2 from actually developing the disease.

A study released over the weekend revealed that patients with the high levels of the vitamin were 25% less likely than those with the lowest amounts to get diabetes.

Scientists theorize that vitamin D may help the body produce more insulin or increase the body’s sensitivity to insulin.

Source: http://www.nydailynews.com/lifestyle/health/2011/06/27/2011-06-27_experimental_type_1_diabetes_vaccine_fails_during_second_step_of_trial.html?r=news/national

Kidney improvement sustained by Abbott drug-study

NEW YORK, June 24 (Reuters) – Diabetics with moderate to severe chronic kidney disease showed significant and sustained improvement in kidney function through 52 weeks of treatment with a novel drug being developed by Abbott Laboratories (ABT.N), according to data from a midstage clinical trial.

The oral drug, bardoxolone methyl, is the first medicine to demonstrate improvement in kidney function in patients with the deadly disease and could delay the need for expensive and inconvenient kidney dialysis, researchers said.

Current treatments, which are primarily blood pressure control medicines, have only been able to slow progression of chronic kidney disease.

“This is totally unique in my 20-plus years of treating patients with chronic kidney disease. There’s nothing out there that increases kidney function,” Dr. David Warnock, who presented the data at a European kidney meeting in Prague on Friday, said in a telephone interview.

“The important improvement we saw at the primary endpoint of week 24 is persisting and sustained throughout the entire 52 weeks of treatment,” Warnock added.

Bardoxolone showed statistically significant kidney improvement compared with placebo at all three doses tested — 150 milligrams, 75mg and 25mg — researchers said.

Based on the results of the 227-patient study, Abbott and its partner, privately-held Reata Pharmaceuticals, which discovered the drug, selected the 75mg dose for a recently initiated pivotal Phase III trial.

Bardoxolone is the first drug from a new class called antioxidant inflammatory modulators that work by suppressing inflammation, researchers said.

Patients in the midstage trial had Type 2 diabetes and moderate to severe chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) of 20 to 45. A person with normally functioning kidneys has an eGFR — a common measure of kidney function — of 100.

The Abbott drug raised eGFR by nearly 30 percent compared with placebo at the two higher doses. Those who got the 75 mg dose had an average eGFR improvement of 10.5, while 150mg patients saw a 9.5 eGFR improvement.

About 21 percent of placebo patients suffered a significant loss of kidney function (more than 25 percent) over the course of the 52 weeks, which is typical for the progressive disease, researchers said.

That compared with just 9 percent with significant kidney function loss for bardoxolone patients, meaning 91 percent experienced beneficial effects on kidney function, Warnock explained.

“What we have now today is a very promising data set that would suggest there is a possibility we can actually improve kidney function even in patients who have far advanced severe chronic kidney disease,” said Warnock, a professor of medicine in the division of nephrology at the University of Alabama in Birmingham.

“If this is confirmed as being clinically significant in terms of benefit to these patients, the prospects are very, very exciting,” he added.

The 1,600-subject Phase III trial will determine whether the new drug can delay progression to dialysis or cardiovascular death among very high risk kidney patients with diabetes.

The most common adverse side effect seen with bardoxolone methyl included muscle spasm, transient elevations in liver enzymes and nausea.

Most of the side effects seen in the first 24 weeks of treatment had moderated or subsided during the latter portion of the study, Warnock said.

“The adverse effect profile was something that we’re quite comfortable with, and we feel comfortable moving forward now with the definitive Phase III outcomes study,” he said.

An estimated 20 million Americans have chronic kidney disease; about 500,000 are on dialysis or in need of transplants, according to the National Kidney Foundation.

Diabetes is the most common cause of end stage renal disease, which progresses to a need for kidney dialysis and death.

“To keep patients off the dialysis machine will be a huge impact in terms of quality of life,” Warnock said.

In addition, end stage renal disease patients consume a huge portion of the Medicare budget compared to their numbers, he said.

“If we can keep people off dialysis, which costs about $75,000 a year, that would be just absolutely huge,” he said.

Results of the Phase II study presented in Prague are also being published in the New England Journal of Medicine. (Reporting by Bill Berkrot; editing by John Wallace)

Source: http://www.reuters.com/article/2011/06/24/abbott-kidney-idUSN1E75L0XM20110624

Pfizer’s Remoxy Fails to Win FDA Approval

WASHINGTON — The latest attempt at an abuse-resistant formulation of oxycodone (Remoxy) failed to win approval from the FDA, according to a statement from Pfizer.

Late Thursday, the company said it had received a complete response letter from the FDA, which described the reasons for the FDA’s decision.

The FDA had turned down an earlier version of the drug in 2008, but Pfizer’s King Pharmaceuticals re-submitted the new drug application in January.

Olivier Brandicourt, Pfizer president and general manager, said in the statement that the company was “working to understand and address the issues in the FDA Complete Response Letter. Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”

Pfizer was, however, successful with another abuse-resistant product — its short-acting oxycodone product, Oxecta, which was approved earlier in the week. An earlier formulation of that drug, too, had been turned down by an FDA advisory panel, but was okayed after the company removed the niacin from its recipe, which was meant to deter oral abuse.

The Oxecta only deters crushing, chewing, snorting, and injecting — not pill-popping.

Making drugs harder to abuse has been one key strategy for some companies in an attempt to control what the government has deemed an epidemic of prescription painkiller abuse.

Source: http://www.medpagetoday.com/PainManagement/PainManagement/27252

New Drug Effectively Treats Hepatitis C

WEDNESDAY, June 22 (HealthDay News) — The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease, two new studies show.

Click here to find out more!

The drug works not only in patients just starting treatment, but in those who failed earlier treatment, the research found.

The hepatitis C virus can lurk in the body for years, causing liver damage, cirrhosis and even liver failure.

“This is a significant advance in the treatment of hepatitis C,” said Dr. David Bernstein, chief of the division of gastroenterology, hepatology and nutrition at North Shore University Hospital in Manhasset, N.Y., who was not involved in either study.

“We know that if we can get rid of the hepatitis C, we can prevent the progression of [liver] disease,” he said. “This means we can prevent the progression of cirrhosis, we can prevent the development of cancer and also prevent the need for liver transplantation in a large number of people.”

Incivek (telaprevir) was approved by the U.S. Food and Drug Administration in May and is the second drug in a class of drugs called protease inhibitors to be approved to fight hepatitis C. The other drug, called Victrelis (boceprevir), was also approved in May.

The standard treatment for hepatitis C has been a combination of two drugs, pegylated-interferon and ribavirin, which are given for a year. If protease inhibitors such as Incivek are added to the mix, the “viral cure” rate improves and the treatment time is reduced to six months, researchers found.

Both reports were published in the June 23 online edition of the New England Journal of Medicine.

In one study, a Phase 3 trial known as ADVANCE, patients were randomly assigned to either a placebo or the treatment in a double-blind study, which means that neither the patients nor the researchers know who’s getting the drug and who’s getting a sham treatment. This type of study is considered the gold standard for clinical research.

In the ADVANCE trial, 1,088 patients with hepatitis C who had never been treated for the condition were randomly assigned to standard therapy for 48 weeks, or telaprevir combined with standard therapy for eight or for 12 weeks, followed by standard therapy alone for a total treatment time of either 24 or 48 weeks.

The researchers found that 79 percent of those receiving Incivek for the longest period (24 weeks) had a “sustained response,” which basically means their hepatitis C was contained. Among those receiving standard care, 44 percent had a sustained response, the researchers noted.

“We have entered a new era of therapy for hepatitis C, which enables us to cure many more patients than we could before,” said lead researcher Dr. Ira M. Jacobson, from Weill Cornell Medical College in New York City.

Incivek needs to be given along with pegylated-interferon and ribavirin, Jacobson said. The researchers learned early on that Incivek alone reduces the level of the virus, but later the virus can become resistant to the drug, he said.

For the second study, called the REALIZE trial, 663 patients with hepatitis C who had failed standard therapy were divided into three groups. One group received Incivek plus standard therapy, another group was started on pegylated-interferon and ribavirin and then had Incivek added. The third group received standard therapy alone.

Here, the researchers found up to an 88 percent sustained response in patients receiving Incivek, compared with a 24 percent sustained response in the standard treatment group.

“These drugs represent a real milestone in the treatment of this disease,” said lead researcher Dr. Stefan Zeuzem, a professor of medicine at J.W. Goethe University Hospital in Frankfurt, Germany.

“There were very limited treatment options in the past, but now many patients have excellent chances to be cured, even if they already have advanced disease,” he said.

Bernstein noted that in the past, these patients could only be treated with more of the standard therapy for a longer period and the “cure” rate was only 10 percent. “Now you can treat these patients for six months with cure rates approaching 90 percent,” he said. “You are really offering hope to a large number of patients.”

The side effects of the medications include skin rashes, anemia, fatigue, itching, nausea, diarrhea, vomiting and taste changes. Some side effects were serious enough to cause a few participants to drop out, according to the study.

Incivek, made by Vertex Pharmaceuticals Inc., is sold to wholesalers for $49,200 for a four-week course of treatment, said Vertex spokeswomen Nikki Levy.

While both Incivek and Victrelis are important breakthroughs in the treatment of hepatitis C, new drugs with even fewer side effects and perhaps shorter treatment times are in clinical trials, Bernstein said.

Hepatitis C affects almost 4 million Americans, most of whom don’t know they’re infected. Often there are no symptoms, but it is the leading cause of liver transplantation in the United States and is linked to as many as 12,000 deaths a year, the researchers say.

Source: http://health.usnews.com/health-news/family-health/digestive-disorders/articles/2011/06/23/new-drug-effectively-treats-hepatitis-c?PageNr=1

UPDATE 1-Pfizer stop-smoking pill raises heart risk-FDA

WASHINGTON, June 16 (Reuters) – Pfizer Inc’s (PFE.N) stop-smoking drug Chantix can lead to a small increase in cardiovascular problems such as heart attacks for patients who already have cardiovascular disease, U.S. drug regulators said on Thursday.

The Food and Drug Administration is changing the label for Chantix after reviewing the results of a clinical trial.

An independent randomized trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo showed that Chantix was effective in helping paients quit smoking for as long as one year.

However, patients who took the pill were also slightly more likely to have a heart attack or other adverse cardiovascular event versus patients on a placebo.

Many smokers who try to quit do so to prevent the risk of heart attacks, which may now be associated with Chantix.

“The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease,” the FDA said in a statement.

The FDA said it is also requiring Pfizer to evaluate the cardiovascular safety of Chantix by conducting a large, combined analysis of randomized, placebo-controlled trials.

Pfizer’s non-nicotine pill has already come under fire for psychiatric side effects, which have crimped global sales and prompted the FDA to issue a restrictive “black box” warning label for the drug.

Investors had high hopes for the drug — called Champix in Europe — when Pfizer first launched its smoking-cessation aid in 2006, but reports of serious side effects have prevented strong sales growth.

Annual sales are now about $800 million, making the pill a moderate-sized product for the world’s biggest drug maker.

Chantix has been associated with agitation, depression and suicidal thoughts, and, in clinical trials, linked with nightmares. Psychiatric symptoms have occurred in people without a history of mental illness and have worsened in people who already had mental illness.

Source: http://www.reuters.com/article/2011/06/16/drugs-fda-chantix-idUSN1618502520110616

FDA Okays New HIV Drug

WASHINGTON — The FDA has approved rilpivirine (Edurant) for the treatment of HIV patients who have not yet begun therapy.

The drug, a non-nucleoside reverse transcriptase inhibitor, is intended to be used as part of highly active anti-retroviral therapy (HAART) with at least two other medications, the agency said.

Rilpivirine, also known as TMC278, is to be taken once a day with food and offers another medication alternative for physicians and patients, the FDA said in a release.

The agency approved the drug on the basis of safety and effectiveness data from two phase III clinical trials with 1,368 adult participants who had not received prior HIV therapy, as well as an extension trial.

They were randomly assigned to treatment with rilpivirine or efavirenz (Sustiva), as well as other anti-HIV drugs.

In the two trials, the proportion of patients who were able to suppress their virus to undetectable levels was 84.3% for rilpivirine and 82.3% for efavirenz.

Those who started the trials with a high viral load and were assigned to rilpivirine were more likely to fail therapy than those who got efavirenz and the converse was true for those who started with a low level of virus, the researchers reported.

On the other hand, patients were more likely to drop out because of side effects if they were taking efavirenz, leading some observers to call the medication a trade-off.

Microneedle Drug Delivery Systems Moving Toward Commercialization by Converging with Existing Delivery Technologies

Evolutionary Design Enhancements Creating a Viable Path to the Market According to Greystone Research Associates

(Amherst, NH) – For the past decade a small group of device development companies, often supported by academic partners and national government technology transfer programs, have been attempting to commercialize drug delivery products based on arrays of microneedles. By creating channels in the stratum corneum, these devices were expected to deliver therapeutic drugs across the skin and into the dermal layers. While several product efforts focused on achieving a local anesthetic effect, the majority pursued a pharmacokinetic model that involved migration of the API via interstitial fluid to the vasculature to achieve systemic delivery.

After years of prototyping unique array designs, a several development programs have migrated toward improving the performance of existing delivery methods. While novel microneedle designs still exist, the evolving landscape can now be grouped into three main strategic approaches: (1) arrays mounted on the end of syringes to effect an injection with minimal discomfort; (2) stand-alone drug-containing devices (coated microneedles or microneedle reservoir patch) designed to be applied or attached to the skin directly; (3) two-step delivery systems that employ an array to create microchannels through the skin followed by a drug-containing patch designed to deliver the drug through the newly-formed microchannels.

Microneedle technology is attaining commercial viability at a time when drug developers are faced with new challenges as they assess ways to administer a new class of compounds with significant therapeutic potential. The commercialization of microneedle drug delivery devices such as the sanofi-aventis Intanza influenza vaccine, which is based on the Becton Dickinson Soluvia syringe-mounted microneedle array device, is a milestone in the transition of microneedle drug delivery from development to market place. Microneedle technology promises to impact health care by allowing the precise injection of therapeutic agents to prescribed locations below the skin.

A new research study, Microneedle Drug Delivery: Technology, Devices, Players, Markets and Prospects analyzes existing and emerging microneedle delivery products, product candidates and development programs, profiles market participants, and assesses key demand and technology factors influencing the commercial market and shaping growth in this sector.

More information is available at www.greystoneassociates.org .

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

Contact:

Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org

Source: Greystone Research Associates

Accessing Nuclear Receptors with ActiTarg-N

TimTec adds new targeted library to its ActiTarg Series. ActiTarg-N gathers 1040 nuclear receptors ligands analogs. Nuclear receptors are inside-cell proteins that regulate gene transcription and affect wide range of biological functions throughout organism normal and pathological development. These are the super-family of 48 structurally related transcription factors that can be regulated by small molecules. The search for the small molecule or its defining features is one of the priorities of contemporary life-science R&D.

TimTec uses “focused diversity” approach in designing the screening collection of nuclear receptor ligands analogs. Analogs compound pool started with about ninety “de-fragmented” known ligands. The following targets were primarily considered in the design: ER, estrogen receptor and estrogen related receptor; AR, androgen receptor; GRR, glucocorticoid receptor; RAR, retinoic acid receptor; THR, thyroid hormone receptor; VDR, vitamin D receptor; FXR, Farnesoid X Receptor; PPARa/y, Peroxisome proliferator-activated receptors; LXR, liver X receptor; CCR5, C-C chemokine receptor type 5; MRR, mineralocorticoid; PR, progesterone receptor; CAR, Constitutive androstane receptor.

TimTec stock was scanned to identify molecules with the same known ligands fragments, which re-assembled themselves in the new combinations of chemical possibilities. Additional computational manipulations drew in more compounds with overall structural similarity to known molecules. As a result ActiTarg-N presents desirable chemical diversity with the sharp focus on the target group.

Contact for more information and free consultation scheduling:

TimTec LLC
Harmony Business Park A-301
Newark DE 19711
Tel 302 292 8500
Fax 302 292 8520
info@timtec.net

Web: http://www.timtec.net/actitarg-n-nuclear-receptor-ligands.html

About TimTec

TimTec LLC is a privately held company located in Newark Delaware, USA. It was founded in 1995 and began its work in the areas of acquisition and distribution of synthetic organic and natural compounds, custom synthesis, and laboratory equipment to become a full service partner for drug discovery. TimTec has developed strong in-house expertise in the design of screening products to offer full line of libraries and compound sets of various specialization for different in capacity/size and purpose assays.

TimTec compound collections offer greater diversity since the company has balanced combination of in-house synthesis and outside sourcing. TimTec compounds are stored in dry form only and are freshly prepared in DMSO to orders. The company does compound management and custom formatting. Global customers include major pharmaceutical, biotech, agricultural, and educational organizations that use TimTec products and services for research and development programs.

http://www.timtec.net/

UPDATE 1-US panel says Optimer’s antibiotic effective

Optimer Pharmaceuticals Inc’s (OPTR.O) experimental antibiotic is safe and effective in treating a bacterial infection that causes diarrhea, a U.S. advisory panel said on Tuesday.

The advisory panel of 13 independent experts voted unanimously that the drug was effective but said there were concerns regarding the drug’s use in pregnant women and children.

However, the panel was divided on whether the oral drug, fidaxomicin, was also effective in lowering the risks of recurrence of infection-related diarrhea.

Last week, the U.S. Food and Drug Administration staff said the drug was effective in fighting an infection that causes a life-threatening diarrhea. [ID:nN01111028]

The FDA is expected to give its decision on the drug by May 30. A positive vote by the panel does not guarantee an approval, but the agency usually follows panel recommendations.

The drug aims to treat diarrhea caused by C. difficile infection (CDI,) a serious illness caused by infection of the lining of the colon. It afflicts more than 700,000 people each year in the United States, according to the company.

Late-stage trials of the drug had shown that it was as effective as the only FDA-approved drug for treating CDI — ViroPharma Inc’s (VPHM.O) Vancocin.

Optimer has a deal with Japan’s Astellas Pharma Inc (4503.T) on the drug. Astellas holds the rights to develop and sell the drug in Europe and parts of the Middle East and Africa.

Trading in the company’s shares was halted pending news of the panel’s decision.

Source: http://www.reuters.com/article/2011/04/05/optimerpharma-idUSN0515361620110405

Higher bleeding risk seen in J&J, Bayer clot drug

A blood clot preventer from Johnson & Johnson and Bayer caused a surprisingly high rate of bleeding in a trial of patients with acute illnesses, representing a significant setback for the drugmakers.

Bayer AG shares fell 3.6 percent in Frankfurt on Tuesday. J&J slid 0.6 percent on the New York Stock Exchange.

Industry analysts had predicted the trial of the drug rivaroxaban, if successful, would create a potential $2.8 billion annual market among the study’s population of patients who are susceptible to blood clots while hospitalized for illnesses such as cancer and pneumonia.

“This will surely impact the chances of admission of the drug and is a serious disappointment,” said Markus Huber, a senior trader at ETX Capital, adding that it could have financial repercussions for Bayer.

A lead investigator for earlier North American trials of rivaroxaban in patients getting knee replacements also took a pessimistic view of the new data.

“The data today would not be approvable …. Why approve something with no overall benefit” for patients like those in the trial, said Alexander Turpie, professor of medicine at McMaster University in Hamilton, Ontario.

Turpie and industry analysts said the results do not preclude other big opportunities for the drug, which is already sold in Europe by Bayer under the brand name Xarelto to prevent blood clots in patients undergoing hip and knee surgery.

The drugmakers are developing the pill to prevent stroke in patients with an irregular heartbeat called atrial fibrillation. Analysts see that market having the potential for $3 billion in annual sales.

“There is disappointment given the recent (Bayer) share price rally and expectations that this was going to start off a positive run of news flow,” said Emmanuel Papadakis at Collins Stewart in London. “But this is a small subset of Xarelto’s total market opportunities.”

Development of new blood clot preventers has been one of the hottest areas in cardiology. Several pharmaceutical companies are vying to come up with a drug of choice to displace decades-old warfarin and other medicines.

Potential rivals to rivaroxaban include apixaban by Pfizer Inc and Bristol-Myers Squibb, edoxaban from Japan’s Daiichi Sankyo and Pradaxa, already being sold by privately held Boehringer Ingelheim.

BLEEDING RISK

The 8,101-patient study released on Tuesday compared the bleeding risk and effectiveness of rivaroxaban with that of the standard injectable treatment enoxaparin in patients hospitalized for acute medical conditions, including heart failure, infectious disease and breathing difficulty.

Injections of enoxaparin, sold by Sanofi-Aventis under the brand name Lovenox, are typically given in the hospital, with treatment lasting no more than two weeks.

After 10 days of treatment in the study, rivaroxaban and enoxaparin were deemed equally effective in preventing dangerous blood clots in the extremities and in the lungs.

But patients taking the J&J drug had a significantly higher rate of bleeding at both 10 and 35 days, which researchers said was a surprising finding that negated the value of the drug for this patient population.

“We did not see a consistently positive benefit-risk balance with rivaroxaban use,” said lead researcher Alexander Cohen of King’s College Hospital in London.

Some 2.8 percent of patients taking rivaroxaban had clinically relevant bleeding at 10 days, compared with 1.2 percent of those receiving enoxaparin — a difference that was highly statistically significant.

At 35 days, 4.1 percent of the rivaroxaban group experienced bleeding, compared with 1.7 percent taking enoxaparin.

Peter DiBattiste, vice president of cardiovascular development for J&J, said the company will conduct additional analyses to see if rivaroxaban can be used more selectively in patients hospitalized with acute medical illness.

He noted the J&J/Bayer drug had similar bleeding risk to enoxaparin in a group of earlier studies involving patients undergoing orthopedic surgery.

Source: http://www.reuters.com/article/2011/04/05/us-heart-rivaroxaban-idUSTRE7343CV20110405

TimTec’s Contract Research Services

High Quality Organic Synthesis and Medicinal Chemistry Contract Research Services at an Outstanding Value

TimTec brings 15 years of expertise in organic chemistry design and supply for drug discovery closer to your supplemental bench-top requirements by launching The Organic Synthesis and Medicinal Chemistry Contract Research Services Division. TimTec scientists have a proven track record of providing high quality services and showing outstanding integrity to their clients.

TimTec remains flexible in delivering practical chemistry solutions molded to custom research requirements and budgets. All Contract Research Services are delivered with an emphasis on speed, real-time feedback, ongoing communication, superior compound quality, and the protection of our clients’ knowledge resources and interests. We are dedicated to providing these services at exceptionally competitive prices.

The Head of Contract Research Services has over 20 years of research experience in the US pharmaceutical industry as a hands-on medicinal chemist  and project Team Leader at large companies and smaller, start-up operations. We are keenly aware of all the intricate details and chemistry challenges that go into bench-top research before a qualified lead molecule emerges. Your TimTec contract research team consists of experienced, bench level scientists who have access to state of the art synthesis, analytical and quality control facilities.

TimTec Contract Research Services Start with:

  • Flexible Contracts

  • Program Management

  • State of the Art Facilities

  • Structure-Activity Relationship Evaluation

  • Lead Optimization

  • Property Optimization for ADME and PK

  • Metabolite Synthesis

  • Enabling Technologies – Parallel synthesis, multistep synthesis, analytical chemistry

  • Mg to Kg Capacity

  • Compound Distribution – Solid or solution, vials or plates

  • Patent Application Preparation Assistance

Supplemental Services and Products:

Custom Synthesis
Compound Acquisition
Weighting and Plating
HTS compounds and compound collections – ActiMol Line of products