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Methylnaltrexone, an oral tablet for opioid-induced constipation (OIC) by Progenics, will soon undergo late stage clinical studies.

Progenics Pharmaceuticals, Inc plans to commence a phase 2b/3 clinical trial of a methylnaltrexone tablet in chronic-pain patients in the second half of 2010, the company said in a press release.

The study of the methylnaltrexone tablet was conducted in subjects with chronic, non-cancer pain receiving various opioid treatment regimens.

Study data suggest that oral methylnaltrexone is active and generally well tolerated.

Onset of action and the percentage of patients who had responded within four hours are consistent with that previously shown in clinical trials of subcutaneous methylnaltrexone.

“We believe that the activity demonstrated to date by the methylnaltrexone tablet shares the hallmarks of methylnaltrexone: both a prompt onset of action and a predictable response for a large percentage of patients,” stated Paul J. Maddon, M.D., Ph.D., founder, chief executive officer and chief science officer of Progenics.

The tablets to be used in Progenics’ planned phase 2b/3 trial were produced by Wyeth at Wyeth’s cost as provided for under the provisions of the termination of the collaboration between the two companies.

Opioids are considered to be effective analgesics for the management of moderate-to-severe pain, and one of the most common side effects of opioids is constipation.

Opioids provide pain relief by specifically interacting with mu-opioid receptors within the central nervous system (CNS) – the brain and spinal cord.

However, opioids also interact with mu-opioid receptors found outside the CNS, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating.

The tablet form of oral methylnaltrexone was developed by Progenics’ former collaboration partner Wyeth.

However, Progenics regained from Wyeth the rights to methylnaltrexone, including rights to this methylnaltrexone tablet at the time of Wyeth’s acquisition by Pfizer in October 2009.

The transfer of data and information to Progenics regarding Wyeth’s work on oral methylnaltrexone was recently completed and Progenics has now had the opportunity to review in detail information regarding the methylnaltrexone tablet which is being reported on today.

Methylnaltrexone selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects.

Because of its chemical structure, methylnaltrexone does not affect the opioid-mediated analgesic effects on the CNS.

Relistor (methylnaltrexone bromide), administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.

In April of 2008, the U.S. Food and Drug Administration approved Relistor subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

The use of Relistor beyond four months has not been studied. Relistor is now approved in over 40 countries, including the U.S., Canada, the European Union, Latin American countries and Australia. Other applications in additional countries are also pending.

Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products.

Progenic’s  Principal programs are directed toward supportive care, oncology and virology.

Relistor is now approved in over 40 countries, including the U.S., Canada, the European Union, Latin American countries and Australia.

Progenics is pursuing strategic alternatives for Relistor, including licensing, collaboration, strategic alliances and U.S. commercialization or co-promotion, following termination of its 2005 collaboration with Wyeth Pharmaceuticals, which is continuing manufacturing, sales, marketing, and certain development and regulatory activities for RELISTOR during the transition.

Ono Pharmaceutical Co., Ltd. has an exclusive license from Progenics for development and commercialization of subcutaneous Relistor in Japan. In oncology, the Company is conducting a phase 1 clinical trial of a human monoclonal antibody-drug conjugate (ADC) for the treatment of prostate cancer–a selectively targeted chemotherapeutic antibody directed against prostate-specific membrane antigen.

PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors.

Progenics is also conducting phase 1 clinical trials with vaccines designed to treat prostate cancer by stimulating an immune response to PSMA in immunized subjects.

Progenics is also developing novel multiplex PI3-Kinase inhibitors as a potential strategy to combat some of the most aggressive forms of cancer. In virology, Progenics is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody which binds to co-receptor CCR5 to inhibit human immunodeficiency virus (HIV) infection.

PRO 140 is currently in phase 2 clinical testing. The company’s hepatitis C virus discovery program seeks to identify novel inhibitors of HCV entry.

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Bayer Schering Pharma AG, Germany’s largest pharmaceutical company is planning to double its sales force in India as part of its strategy to make Asia an important market through making huge investments in the region, reports said.

Over 20% of Bayer’s healthcare division’s 2009 sales were generated from the Asia Pacific region.

Bayer Schering Pharma is currently one of the largest pharmaceuticals suppliers in China.

As of now, Bayer’s business in India is focused majorly on its CropScience pesticides unit. In the next 4-5 years time Bayer wants to be among the top 10 pharma groups in India by 2015.

Bayer aims tripling its workforce and a sixfold increase in sales in Vietnam by 2015.

The company also targets to become one of the top three pharmaceutical groups in South Korea by 2013 by increasing its staff by 20%.

Despite serious layoffs in the developed markets, an increasing number of  pharma multinational companies (MNC) from Europe and the US are planning to bolster their workforce in India. Big Pharma, which is incurring steady losses in the major markets, see the emerging pharma destinations like India as valuable hedges to offset their setbacks.

Of late, Becton, Dickinson and Company (BD), one of the world’s leading syringe suppliers, has announced its plans to add nearly 100 people its India team each year.

Becton Dickinson is proposing significant expansions in the manufacturing operations. The company is planning to transfer 10 manufacturing lines of IV catheter from Sweden to India.

The company has also plans to expand its marketing operations as well by adding more workforce, reports said quoting senior official from Becton.

Becton Dickinson has been operating in India since 1997. Currently India accounts for $100 million of its global annual income.

Becton’s Indian business had grown 20 per cent two years ago. It currently sells 80-90 per cent of the company’s global product portfolio in India, except for the high-end medical diagnostics.

Employment opportunities are worldwide, tough to come by right now. Unable to cope with the recession heat, drug giants may be drastically cutting down their staff everywhere else. But it is exactly the opposite what pharma MNCs are doing in India.

Pharma sector employment opportunities better as Aventis, GSK, Merck looking fill hundreds of jobs in field & marketing.

Aventis Pharma Ltd, the Indian arm of the French drug maker Sanofi-Aventis, which has been operating in India for several years, suddenly turned aggressive about the Indian market. Now they want to fill jobs and augment Indian sales force by 700-800 in the next couple of years.

Sanofi-Aventis will consider all possibilities including acquiring a local firm to consolidate its presence in the country to realize the goal of positioning itself in the top five league, he said.

GlaxoSmithKline (GSK) is another leading European pharma major looking to hire in India. The world’s second largest drug company plans to bolster its field force by employing at east 200 people. GSK India, which currently has 2,250-strong sales and marketing team, wants to enhance its field-force support in its vaccines, oncology and other speciality segments, the company said recently while announcing quarterly financial performance in India

GSK India’s net profit for the three months ended December 31, 2008 more than doubled over the net profit clocked in the corresponding period last year, due to Rs 119 crore exceptional items from the sale of shares and other income from investments, a one-time gain, a company spokesperson said.

For the year ended December 31, 2008, GSK Pharma posted a net profit of Rs 576 crore compared with a net profit of Rs 537 crore in the corresponding period of the previous year. It clocked a total income of Rs 1,708 crore for the year under review against Rs 1,621 crore in the corresponding period last year.

Recently, GSK Chief Executive, Mr Andrew Witty said that the company planned to cut medicine prices in poor countries and invest about 20 per cent of its profit from such markets into healthcare infrastructure.

Merck Sharpe & Dohme Pharmaceuticals (MSD), the Indian subsidiary of the world’s fifth largest drug firm Merck Inc, is another case in point of pharma MNCs looking at expansion and new job openings in India.

Merck, which exited in India markets decades ago fearing IP back lash due to an increasingly pro-generic regulatory climate, is now back in India with big plans.

MSD Pharmaceuticals wants to be one of the five top players in India by 2015 as it sees the IP environs improve following India’s adherence to Product Patent regime since the beginning of the year 2005.

Already in a hiring spree, MSD is looking to strengthen its marketing teams adequate to fulfil its requirements.

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Contraceptive pills used by women for birth-control could help them lead a longer life with lesser risk of major life-threatening conditions like heart disease and cancer, says a new study.

The study conducted in more than 46,000 women over a period of 40 years showed that contraceptive pills users were less likely to die of heart disease, cancer or a range of other medical ailments.

Prospective cohort study started in 1968 with mortality data supplied by participating general practitioners, National Health Service central registries, or both.

The study published in the British Medical Journal was organized through 1400 general practices throughout the United Kingdom.

A total of 46 112 women were observed for up to 39 years, resulting in 378 006 woman years of observation among never users of oral contraception and 819 175 among ever users.

The study found that 1747 deaths occurred in never users of oral contraception and 2864 in ever users.

Compared with never users, ever users of oral contraception had a significantly lower rate of death from any cause (adjusted relative risk 0.88, 95% confidence interval 0.82 to 0.93).

The users of contraceptives also had significantly lower rates of death from all cancers; large bowel/rectum, uterine body, and ovarian cancer; main gynaecological cancers combined; all circulatory disease; ischaemic heart disease; and all other diseases.

The never users of contraceptive had higher rates of violent deaths. No association between overall mortality and duration of oral contraceptive use was observed, although some disease specific relations were apparent.

An increased relative risk of death from any cause between ever users and never users was observed in women aged under 45 years who had stopped using oral contraceptives 5-9 years previously but not in those with more distant use.

The estimated absolute reduction in all cause mortality among ever users of oral contraception was 52 per 100 000 woman years.

The study concluded that oral contraception was not associated with an increased long term risk of death in this large UK cohort. But a net benefit was apparent.

The balance of risks and benefits, however, may vary globally, depending on patterns of oral contraception usage and background risk of disease.

The research was funded by contraceptive making companies Bayer AG, Pfizer Inc. and Johnson & Johnson besides the Royal College of General Practitioners, Medical Research Council, Imperial Cancer Research Fund, British Heart Foundation, Cruden Foundation.

What are oral contraceptives?

Oral contraceptive pills are also called birth-control pill or “pill” are used to control pregnancy.

Oral contraceptive pills pills normally contain e, is a birth control method that includes a combination of synthetic sex hormones oestrogen and progestogen.

Oral contraceptive pills pills can stop women from getting pregnant, if taken orally every day.

Oral contraceptive pills were first approved for contraceptive use in the United States in 1960.

Oral contraceptive pills are currently used by more than 100 million women worldwide and by almost 12 million women in the United States.

Some of the common brand names of oral contraceptive pills include Alesse, Apri, Aviane, Brevicon, Demulen, Desogen, Estrostep, Estrostep Fe, Genora, Jenest, Levlen, Levlite, Levora, Lo/Ovral, Loestrin, Loestrin Fe, Low-Ogestrel, Lybrel, Microgestin, Microgestin Fe, Mircette,  Modicon, Necon, Norinyl, Nordette, Nortrel, Ogestrel, Ortho-Cept, Ortho-Cyclen, Ortho-Novum,  Ortho Tri-Cyclen, Ovcon, Ovral, Seasonale, Seasonique, Tri-Levlen, Tri-Norinyl, Triphasil,
Trivora, Yasmin, Yaz, Zovia etc.

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A dendritic cell-based vaccination with cancer stem cells developed by ImmunoCellular has been found improving the survival rate of brain cancer -glioblastoma – patients.

ImmunoCellular’s experimental cancer stem cells vaccine demonstrated a statistically significant” survival benefit in a preclinical animal model of glioblastoma, the company announced in a press statement

In the preclinical studies, the rats were either immunized with cancer stem cells (CSCs) from a brain cancer tumour or the daughter cells (the bulk of the tumour), and results showed that those immunized with the CSCs had a median survival of 50 days compared to 29 days for daughter cells.

30 per cent of animals vaccinated against cancer stem cells also demonstrated long term survival as compared to animals vaccinated with the bulk of the tumour, all of which died.

“The data further validates our research indicating that targeting CSCs has the potential to be a highly effective method of treating various cancers,” stated Dr Manish Singh, president and CEO of ImmunoCellular Therapeutics.

The data also demonstrated increased Gamma-Interferon levels in animals treated with CSCs, indicating an increased immune response consistent with increase in survival further supporting the mechanism of action of this approach.

Dendritic cells are critical facilitators of a T cell response but are often not present in sufficient numbers and are often not aggressive enough against malignant tumors to permit an adequately potent immune response to fight cancer.

Dendritic cell therapy generally involves harvesting dendritic cells from a patient, then culturing and processing them in a laboratory to produce more numerous and effective dendritic cells. In the laboratory, the dendritic cells are cultured with specific tumor antigens to enable the dendritic cells to recognize cancer cells as targets for attack.

When the newly cultured dendritic cells are injected back into the patient, they seek out remaining tumor cells and signal the T cells to destroy them.

ImmunoCellular has recently completed phase-I trial of its lead cancer vaccination product candidate ICT-107.

ICT-107 is an active immunotherapy developed from studies conducted by ImmunoCellular Therapeutics, showed that targeting certain specific antigens that are highly expressed on cancer stem cells (CSCs) can lead to significant benefit in progression free survival as well as overall survival in glioblastoma patients.

The company is planning to initiate a multicenter Phase II study in the second half of 2010.

The company’s “off the shelf” vaccine product candidate (ICT-121) targeting cancer stem cells for multiple cancer indications is targeted by ImmunoCellular to enter clinical trials for glioblastoma during the second half of 2010.

ICT-121 is a cancer stem cell vaccine that consists of a peptide to stimulate a cytotoxic T-lymphocyte (CTL) response to CD-133, which is generally overexpressed on the cancer stem cells.
It is designed as an off-the-shelf vaccine which may be applicable to multiple types of cancers overexpressing CD-133.

ImmunoCellular has entered into a research and license option deal with the Roche Group for one of the Company’s monoclonal antibody product candidates for the diagnosis and treatment of ovarian cancer and multiple myeloma, which provides for potential licensing and milestone payments of $32MM and royalties if the Roche Group exercises its option and commercializes this antibody technology for multiple indications.

ImmunoCellular is in pre-clinical development of another monoclonal antibody product candidate for the treatment of small cell lung cancer and pancreatic cancer, and is also evaluating its platform technology for monoclonal antibody discovery to target cancer stem cells.

ImmunoCellular Therapeutics is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers.

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Ciprofloxacin dry powder inhaler to treat cystic fibrosis caused by Pseudomonas aeruginosa has been given Orphan Drug designation in US, announced Bayer Healthcare.

Ciprofloxacin dry powder inhaler is an investigational drug–device combination that combines ciprofloxacin dry powder formulated using Novartis’ proprietary PulmoSphere technology with a delivery inhaler.

First-in-man studies with ciprofloxacin dry powder inhaler in cystic fibrisis patients showed that the drug reached high concentrations in the lung with very low systemic exposure following single and multiple dose administration.

Bayer is now conducting a multinational Phase II study evaluating safety and efficacy in cystic fibrisis patients.

The Orphan Drugs Act provides incentives to sponsors to develop products for rare diseases.  The first sponsor who obtains marketing approval for a designated orphan drug or biological product is granted US market exclusivity for a seven-year period, under legislation passed by the U.S. Congress in 1983.

Exclusivity begins on the date that the marketing application is approved by US FDA for the designated orphan drug and applies only to the indication for which the drug has been designated and approved.

“There continue to be significant unmet medical needs for people with cystic fibrosis,” stated Shannon Campbell, vice president and general manager, Oncology and General Medicine, Bayer HealthCare Pharmaceuticals.

Ciprofloxacin dry powder inhaler to treat cystic fibrisis has already been granted a similar designation by the European Medicines Agency.

An additional clinical study of ciprofloxacin dry powder inhaler not related to the orphan drug designation for cystic fibrosis is ongoing.

This study in patients with non-CF bronchiectasis is evaluating the safety and efficacy of ciprofloxacin dry powder inhaler with respect to overall bacterial load and clinical outcomes.

Cystic fibrosis is a life-threatening inherited disease affecting the lungs, pancreas, liver, and intestines.

Approximately 30,000 patients in the US are affected by cystic fibrisis. The median age of survival for patients in the US was 37.4 years in 2008, according to data compiled by the Cystic Fibrosis Foundation.

The major consequences of the disease are pancreatic insufficiency and reduced lung function. Lung disease accounts for about 90 percent of the mortality associated with cystic fibrisis.
Patients with cystic fibrosis have dehydrated, thickened respiratory secretions that are difficult to clear and provide an attractive environment for bacteria, thus increasing the risk of infection and inflammation.

Pulmonary infections in CF patients are a chronic problem and represent the leading cause of exacerbations and mortality.

P. aeruginosa is the leading pathogen in CF patients. The thick mucus in the lungs is ideally suited to bacteria, and individuals with CF are colonized and infected by bacteria from an early age; about 20 percent of children under 1 year of age and 80 percent of adult patients with CF have P. aeruginosa present in their sputum.

Chronic infection with P. aeruginosa is associated with an accelerated decline in pulmonary function, more frequent exacerbations, and increased mortality in patients with cystic fibrosis.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG.

Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.

In the U.S., Bayer HealthCare Pharmaceuticals comprises Women’s Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology and Oncology business units.

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Ayusrem, a herbal drug to treat H1N1 swine flu developed by two Indian scientists from Chennai, has been lauched for sales.

Ayusrem, prepared using the traditional approach of Indian classical medicine system Ayurveda has been found safe and effective, the researchers claimed.

The medicine contains 32 different herbal components.

Ayusrem preparation can prevent the spread of  a host of viral infections including swine flu, chikungunya, dengue and influenza.

Ayusrem can also address allergic diseases like asthma, rhinitis and treat  body pain, common cold and cold related symptoms.

Ayusrem has been tested effective in more than 2000 patients with various types of viral fever, reports said quoting researchers.

Dr Milton’s Lab in Pondicherry is manufacturing Ayusrem.

Maste Xhange Private Limited, Kuala Lumpur, Malaysia has inked an agreement with Ramoni Research Foundation (RRF)  for global marketing of the drug.

In January, South Korean scientists announced the development of KIOM-C, a combination of a dozen herbal extracts to treat H1N1 swine flu infection.

The Korea Institute of Oriental Medicine (KIOM), a state-run research institute announced researchers have successfully extracted materials commonly used in traditional herbal remedies that showed immediate results of recovery when injected to mice infected with the disease, the Korea Institute of Oriental Medicine (KIOM) said.

KIOM-C medicine has been developed by combining extracted materials from a dozen of common herbal substances, according to KIOM.

In December, Chinese media reported that Jin Hua Qing Gan Fang, a Chinese herbal remedy, is found effective in A/H1N1 swine flu patients.

Jin Hua Qing Gan Fang, also called “Jin Hua” is being hailed as the world’s first traditional Chinese medicine to treat the A/H1N1 swine flu by the Chinese news papers.

Clinical studies spanning seven months have come out with adequate scientific evidence that the Chinese herbal remedy Jin Hua Qing Gan Fangan can shorten patients’ fever period and improve their respiratory systems, reports said quoting medical experts from China.

Jin Hua Qing Gan Fangan has no adverse side-effects.

Above all, Jin Hua Qing Gan Fangan is also very cheap. The medication cost only about a quarter of the cost of Tamiflu -  the widely used anti-flu drug of Swiss drugmaker Roche Holding recommended by the World Health Organization (WHO) for the treatment of the A/H1N1 swine flu.

The clinical studies using Jin Hua Qing Gan Fangan lasted for almost five months and were conducted by experts from the China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences and Beijing University of Technology.

Chinese medical experts picked Jin Hua Qing Gan Fangan from among more than 100 classic anti-flu prescriptions based on traditional Chinese herbal medicine.

Jin Hua Qing Gan Fangan prescription had been adopted in many local traditional Chinese medicine hospitals.

Now backed by new clinical data, the Chinese health authorities are considering to develop Jin Hua Qing Gan Fangan further as an alternative to treat the A/H1N1 swine flu not only in China but to the whole world.

In November, a Chinese traditional medicine claiming to relieve all H1N1 swine flu symptom in two or three days, especially in children has been launched in China, reports said.

The Chinese traditional medicine called “No 2 Cold Medicine” is capable of curing the H1N1 swine flu in a single dose treatment in most of the cases, the maker of the medicine was quoted as saying in local press.

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CEM-101, an oral new generation macrolide antibiotic developed by Cempra Pharmaceuticals, will soon go on clinical studies to establish the drug’s efficacy as as intravenous formulation.

CEM-101 is a next-generation macrolide with potent activity against pneumococci, including macrolide- and quinolone-resistant strains. Bacterial pneumonia caused by multi-drug resistant pneumococci can result in clinical treatment failure and subsequent increases in healthcare costs.

Phase 1 clinical trials of its oral formulation of CEM-101 has shown good tolerability, Cempra said in a press statement.

Cempra is planning to submit an investigational new drug application (IND) to US FDA to begin a phase 1 study with the company’s intravenous formulation of CEM-101 in mid-2010.

A phase 2 trial with the oral formulation of CEM-101 is expected to begin in the second quarter of 2010 in patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP).

“CEM-101 has enormous potential because of its broad spectrum activity, including activity against resistant strains, its capacity to be administered both orally and intravenously and its unique pattern of ribosomal binding, which may limit the development of drug-resistant strains,” stated  J. Carl Craft, M.D., head of medical affairs, Cempra Pharmaceuticals, and a member of Cempra’s Scientific Advisory Board.

Cempra expects to start phase 2 studies in patients with moderate to moderately severe community-acquired bacterial pneumonia in the coming months, he said.

Cempra will present full details of the phase 1 studies at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on April 10 to 13 in Vienna, Austria.

Bacterial pneumonia is a serious infection, particularly in the elderly population. Macrolides have been a mainstay of treatment for this and other indications but drug resistance has increased to more than 25% of clinical isolates.

Doctors are looking for new and convenient alternatives and CEM-101 could be an important option, according to company officials.

CEM-101 is expected to be the first macrolide to have an intravenous formulation available in the U.S. since intravenous azithromycin was approved in 1997, a significant development that carves a path for studies in moderate to severe community-acquired bacterial pneumonia (CABP).

CEM-101 showed potent activity, in vitro and in vivo, against all important respiratory  pathogens, including pneumococci, as well as potent activity against a
broad spectrum of other serious pathogens including CA-MRSA, M. avium,         malaria, atypical bacteria such as legionella, mycoplasma,  chlamydophila, and against gonococci.

CEM-101 is generally 8 to 16 times  more potent than azithromycin and is active against organisms that have  become resistant to azithromycin.

Over 5 million patients  get  pneumonia in the United States is each year.

Cempra has licensed exclusive worldwide rights from Optimer Pharmaceuticals, Inc., except in the Association of Southeast Asian Nations (ASEAN) countries, to discover, develop and commercialize macrolides from a library of more than 500 compounds from Optimer’s OPopS drug discovery platform.

Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials.

The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders.

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Scivanta Cardiac Monitoring System (SCMS) can accurately measure cardiac performance, according to Scivanta Medical Corporation.

Clinical studies performed at Kaleida Health/Millard Fillmore Hospital in Buffalo, New York have established that Scivanta Cardiac Monitoring System is safe as well, Scivanta Medical said in a press release.

The clinical trial was designed to obtain data concerning the safety and efficacy of the Scivanta Cardiac Monitoring System by comparing mean left atrial pressure measurements obtained from the SCMS to left ventricular end-diastolic pressure readings measured in a simultaneous left heart catheterization procedure performed by a cardiologist in the cardiac catheterization unit.

These measurements of cardiac performance are used by physicians in the critical evaluation of a patient’s cardiac health.

Initial clinical trial showed that  the mean left atrial pressure for five patients, as determined by the SCMS, matched the left ventricular end-diastolic pressure, as determined by the left heart catheterization procedure, within 0.1mmHg to 0.5mmHg.

This translates into a maximum deviation of 3.3% for the SCMS data when compared to the left heart catheterization data.

These results for Scivanta Cardiac Monitoring System are considered by Scivanta to be highly accurate.  There were no adverse events reported during the course of the initial clinical trial.

“Scivanta has conducted an initial clinical trial using a new technique to gather sophisticated, difficult to obtain cardiac hemodynamic information.  If the planned subsequent studies confirm the reliability of this technique, physicians will have readily available information that will surely impact positively on the treatment of numerous cardiac and non cardiac patients,” stated Richard Berger, M.D., a professor of clinical cardiology at the University of Miami Miller School of Medicine and a fellow of the American College of Cardiology.

This information will be attainable with minimal risk due to the Scivanta Cardiac Monitoring System ’s relatively non invasive technique.

The Scivanta Cardiac Monitoring System is expected to provide the primary measurements of cardiac performance in a minimally invasive and cost-effective manner and is designed to be used outside of an intensive care setting.

Scivanta Medical Corporation is focused on acquiring and developing medical technologies and products.

Scivanta’s first product, the Scivanta Cardiac Monitoring System, formerly known as the Hickey Cardiac Monitoring System, is an innovative cardiac monitoring system that utilizes a two-balloon esophageal catheter to monitor cardiac performance.

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Fentanyl sublingual spray developed by Insys Therapeutics to treat breakthrough cancer pain has been found effective in clinical studies.

Insys Therapeutics has announced positive results from the pivotal phase III efficacy trial. All primary and secondary endpoints were achieved in the study.

Fentanyl sublingual spray is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutes  in a phase III breakthrough cancer pain trial using Fentanyl, the company said in a press release.

Given breakthrough cancer pain’s rapid onset and often peak intensity at three to five minutes, it is vital to provide patients with a faster onset of action.

“The sublingual spray demonstrated very rapid, effective pain relief. Patients began to experience meaningful pain relief within five minutes,” stated Dr. Richard Rauck, a principal investigator in the Phase III study observed.

An easy-to-use oral spray that can produce effective, potent and very rapid pain relief will be a tremendous advantage for our patients who experience moderate to severe cancer breakthrough pain, he added.

Many patients may not be able to take other currently available drugs due to difficulty in swallowing, nausea or other gastrointestinal problems.

Breakthrough cancer pain is a common, debilitating feature of chronic pain, seen in approximately 75% of patients with cancer. It is a severe pain flare-up that “breaks through” the relief provided by around-the-clock analgesics.

Unlike persistent cancer pain, breakthrough cancer pain is generally rapid in onset and can last a couple hours with the average episode averaging thirty minutes. Patients with cancer may experience between two and seven episodes of breakthrough cancer pain a day.

It is estimated that over a half-million people in the U.S. with cancer suffer from breakthrough pain, however, only about 25,000 receive a treatment approved for the condition.

Fentanyl SL spray single unit dose device is formulated with the opioid narcotic fentanyl for delivery to the oral mucosa.

Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain.

Insys Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative products that address chemotherapy-induced nausea and vomiting (CINV), pain management and other central nervous system disorders.

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AstraZeneca has entered into a license and supply agreement with  Indian firm Torrent Pharmaceuticals Ltd tol supply 18 generic products to nine emerging markets.

As per the deal Torrent will supply a portfolio of generic medicines to AstraZeneca for which the Indian company already has licenses in a range of countries.

AstraZeneca will brand Torrent generics and sell them in many of its emerging markets, using its marketing force.

Initially, AstraZeneca will purchase from Torrent the licenses and market authorizations for 18 products in nine countries.

The AstraZeneca-Torrent agreement allows the flexibility to add further products and new countries, the Anglo-Swedish company said in a press statement.

Financial terms were not disclosed.

Torrent will manufacture the medicines as per AstraZeneca’s quality and process standards.

“ Working in partnership with Torrent will extend the range of branded medicines we can offer to patients in emerging markets, where we see continuing opportunities for our business to grow,” stated Tony Zook, head of AstraZeneca’s global commercial organisation.

AstraZeneca has chosen Torrent because of their complementary product portfolio and proven ability to manufacture to AstraZeneca’s high quality standards, he added.

In January, Pfizer reached a similar collaboration with India’s Strides Arcolab on the supply of 40 generic products.

Under the new collaboration Pfizer will commercialize Stride’s off-patent sterile injectable and oral products in the United States through its Established Products Business Unit.

These finished dosage form products will be licensed and supplied by Strides and Onco Laboratories Limited and Onco Therapies Limited, two joint ventures between Strides and Aspen, South Africa, in which each has a 50% ownership interest.

The first of the products commercialized under Pfizer-Strides collaboration is expected to be launched in 2010.Pfizer’s deal with Strides Arcolab follows two similar alliances last year with Aurobindo and Claris LifeSciences of India.

In May, Pfizer, the world’s largest drug maker, acquired rights to 55 generic  pills and 20 injectables for more than 70 emerging and developed markets through new deals.

Pfizer Inc, also entered into a licensing pact with Indian generic injectables producer Claris Lifesciences besides expanding it present alliance with Aurobindo.

Pfizer has expanded the existing collaboration with the Hyderabad, South India-based Aurobindo Pharma Ltd reached earlier this year to sell 60 off-patent drugs. Meanwhile Pfizer’s agreement with Claris Lifesciences Ltd is to market 15 off-patent injectable drugs.

In February, Indoco Remedies Ltd., a Mumbai-based generic company, announced a technology licensing agreement to produce generics with   Watson Pharmaceuticals, Inc.

Under the agreement Indoco will develop and manufacture a number of sterile products to Watson for the United States market.

In June 2009, the British drug giant GlaxoSmithKline plc has sealed an agreement with India’s Dr. Reddy’s Laboratories Ltd to develop and market over 100 branded generic products across a number of emerging markets, excluding India.

The British drug giant GlaxoSmithKline plc has sealed an agreement with India’s Dr. Reddy’s Laboratories Ltd to develop and market over 100 branded generic products across a number of emerging markets, excluding India.

Under the terms of the agreement, GSK will gain exclusive access to Dr. Reddy’s portfolio and future pipeline of more than 100 branded pharmaceuticals in therapeutic segments such as cardiovascular, diabetes, oncology, gastroenterology and pain management.

The emerging markets are forecast to contribute around 70 per cent of pharmaceutical industry growth in the next five years, and branded generics represent approximately 50 per cent by value in these emerging markets.  AstraZeneca believes it can capitalise on this opportunity and over time plans to broaden its portfolio beyond these initial 18 products.

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