China's ambitious $124-billion effort to provide basic health coverage for the vast majority of its 1.3 billion citizens by 2011 is a brimming opportunity for global pharmaceutical companies.
As growth in the US and European markets remains sluggish, many giant pharmaceutical companies are expanding their sales forces, distribution channels and research operations in China to tap into the country's robust drug market.
China's drug market is expected to grow about 22 percent annually over the next five years, said Mandy Chui, senior principal of (Intercontinental Marketing Services) IMS Health Inc.
Chui is the China expert at IMS Health, which provides market data on the pharmaceutical and healthcare industries.
"We see companies continuing to invest in China because the other markets are not growing," Chui said. "For companies, (China's growth) is certainly a good story to tell to Wall Street, right?"
With a huge and aging population, rapid urbanization and adoption of Western lifestyles that give rise to hypertension, obesity and other diseases, China is poised to become the world's third-biggest pharmaceutical market by 2013, up from its current No 5 spot, said Chui.
The $24.5-billion market is expected to swell to betweem $68 billion and $78 billion by 2013, Chui said, leaving it behind only the US and Japan.
"China is taking over from Germany and France," she said.
"It's like a big wake-up call. If they (big pharmaceutical companies) are not in there at this point in time, all of them are not going to grow," Chui said.
In the race to penetrate the Chinese market, she said European drug makers such as Bayer AG, AstraZeneca PLC and Sanofi-Aventis SA have taken the lead.
www.chinadaily.com.cn
Pharmaceutical Process Equipment
Saturday, 29 August 2009
Friday, 28 August 2009
P&G tops up coffers with £1.9bn pharma sale
Household giant Procter & Gamble has sold its pharmaceutical business to Irish healthcare group Warner Chilcott for £1.9bn.
The sale allows P&G, owner of brands including Vicks and Fairy Liquid, to focus on its core over-the-counter medicine and household cleaning ranges.
The prescription pharmaceutical division had annual sales of around $2.3bn but accounted less than 3% of P&G’s total turnover.
The deal is the largest in the sector so far this year and will triple the size of Warner Chilcott, which currently specialises in women’s healthcare.
www.thegrocer.co.uk
The sale allows P&G, owner of brands including Vicks and Fairy Liquid, to focus on its core over-the-counter medicine and household cleaning ranges.
The prescription pharmaceutical division had annual sales of around $2.3bn but accounted less than 3% of P&G’s total turnover.
The deal is the largest in the sector so far this year and will triple the size of Warner Chilcott, which currently specialises in women’s healthcare.
www.thegrocer.co.uk
Thursday, 27 August 2009
Warner Chilcott buys rival pharmaceutical firm for £3bn
A Pharmaceutical giant with strong links to Northern Ireland is buying a global pharmaceuticals business for £3.1bn.
Warner Chilcott’s acquisition of Proctor & Gamble’s branded pharmaceutical products and other businesses is expected to be complete by the end of this year.
US-founded Warner Chilcott was acquired in 2000 by Craigavon-based Galen Holdings, which took the name of its new acquisition and was Northern Ireland’s first billion dollar company.
Warner Chilcott was taken over by US private equity investors in 2004 but former Galen Holdings chairman Dr John King remains a non-executive director.
Galen Holdings was founded by Sir Allen McClay from Cookstown in 1968.
Sir Allen, one of Ireland’s richest men, stepped down from Galen in 2001, and a year later set up pharmaceutical and biotech company Almac in Craigavon. It now employs over 2,000 people in Craigavon, the US and other parts of the UK.
Also included in Warner Chilcott’s deal with P&G are its prescription drug product pipeline and manufacturing facilities in Puerto Rico and Germany.
Most of P&G’s 2,300 pharmaceutical staff are expected to transfer to Warner Chilcott, which already employs over 1,000 people worldwide including 120 people in the manufacture of women’s healthcare treatments in Larne, Co Antrim.
Roger Boissonneault, president and chief executive officer of Warner Chilcott and a former chief of Galen, said: “The acquisition of the P&G pharmaceutical brands and employee talent is a transformational, strategic move for us.
“The acquisition transforms Warner Chilcott into a global pharmaceutical company, expands our presence in women's healthcare, establishes us in the urology market in advance of the anticipated launch of our erectile dysfunction treatments, and adds gastroenterology therapies to our product portfolio.”
www.belfasttelegraph.co.uk
Warner Chilcott’s acquisition of Proctor & Gamble’s branded pharmaceutical products and other businesses is expected to be complete by the end of this year.
US-founded Warner Chilcott was acquired in 2000 by Craigavon-based Galen Holdings, which took the name of its new acquisition and was Northern Ireland’s first billion dollar company.
Warner Chilcott was taken over by US private equity investors in 2004 but former Galen Holdings chairman Dr John King remains a non-executive director.
Galen Holdings was founded by Sir Allen McClay from Cookstown in 1968.
Sir Allen, one of Ireland’s richest men, stepped down from Galen in 2001, and a year later set up pharmaceutical and biotech company Almac in Craigavon. It now employs over 2,000 people in Craigavon, the US and other parts of the UK.
Also included in Warner Chilcott’s deal with P&G are its prescription drug product pipeline and manufacturing facilities in Puerto Rico and Germany.
Most of P&G’s 2,300 pharmaceutical staff are expected to transfer to Warner Chilcott, which already employs over 1,000 people worldwide including 120 people in the manufacture of women’s healthcare treatments in Larne, Co Antrim.
Roger Boissonneault, president and chief executive officer of Warner Chilcott and a former chief of Galen, said: “The acquisition of the P&G pharmaceutical brands and employee talent is a transformational, strategic move for us.
“The acquisition transforms Warner Chilcott into a global pharmaceutical company, expands our presence in women's healthcare, establishes us in the urology market in advance of the anticipated launch of our erectile dysfunction treatments, and adds gastroenterology therapies to our product portfolio.”
www.belfasttelegraph.co.uk
Wednesday, 26 August 2009
Pandemic (H1N1) 2009 influenza update
Source: Web
WireDate: 14-08-2009
London UK - GSK today issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed.
Dr.Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals, said “GSK is making good progress with the development of its pandemic vaccine. Enrolment into the first study has been completed and in total, GSK will conduct 16 clinical trials of its pandemic vaccine in over 9000 individuals vaacross Europe, Canada and the US. We continue to work closely with regulators and governments to assess and develop this vaccine.”
The first clinical trial, being conducted in Germany, will assess the use of the vaccine in healthy adults. Initial data is expected to be available for sharing with regulatory authorities in September.
Further trials of the Pandemic (H1N1) 2009 adjuvanted vaccine covering infants, children, adults and the elderly will commence over the coming weeks across Europe, Canada and the US. The clinical development programme, which has been designed in close partnership with regulatory authorities, will evaluate the immune response as well as tolerability and other safety aspects of the vaccine.
All the final data on the clinical development programme will be submitted to the regulators as soon as they are available and will be posted on GSK’s Clinical Study Register.
About the pandemic (H1N1) 2009 vaccine
The vaccine will comprise antigen of the recently isolated Pandemic (H1N1) 2009 influenza strain and also contain GSK’s proprietary adjuvant system AS03. In clinical studies using the bird flu influenza strain (H5N1), the adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The vaccine containing the adjuvant system therefore helps to substantially increase the number of vaccine doses that can be provided for mass vaccination.1 In addition, in clinical studies with the bird flu programme, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).2,3 Both the antigen sparing approach as well as the potential for additional protection against drifting strains are features for an impactful vaccine for use in a pandemic setting.
GSK has received regulatory approvals in the European Union and some Asian countries for its pre-pandemic and pandemic H5N1 vaccines, both of which contain the AS03 adjuvant. Currently, clinical trials in over 39,000 people have demonstrated that the AS03 adjuvant system used with an influenza vaccine has an acceptable safety and reactogenicity profile.
About the clinical trials
The first clinical trial, being conducted in Germany, has started this week and enrolment has been completed. The trial will assess the use of the vaccine given as 2 doses, 21 days apart in 128 healthy adults, aged between 18 and 60. Initial data is expected to be available for submission to regulatory authorities in September. Additional trials planned in the clinical development programme are expected to commence shortly and include 8 trials in healthy adults, 5 trials in children (including infants) and 2 trials in the elderly. Details of the clinical development programme will be posted to www.clinicaltrials.gov.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Cautionary statement regarding forward-looking statements�Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2008
1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580–89.
2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665
3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401.
WireDate: 14-08-2009
London UK - GSK today issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed.
Dr.Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals, said “GSK is making good progress with the development of its pandemic vaccine. Enrolment into the first study has been completed and in total, GSK will conduct 16 clinical trials of its pandemic vaccine in over 9000 individuals vaacross Europe, Canada and the US. We continue to work closely with regulators and governments to assess and develop this vaccine.”
The first clinical trial, being conducted in Germany, will assess the use of the vaccine in healthy adults. Initial data is expected to be available for sharing with regulatory authorities in September.
Further trials of the Pandemic (H1N1) 2009 adjuvanted vaccine covering infants, children, adults and the elderly will commence over the coming weeks across Europe, Canada and the US. The clinical development programme, which has been designed in close partnership with regulatory authorities, will evaluate the immune response as well as tolerability and other safety aspects of the vaccine.
All the final data on the clinical development programme will be submitted to the regulators as soon as they are available and will be posted on GSK’s Clinical Study Register.
About the pandemic (H1N1) 2009 vaccine
The vaccine will comprise antigen of the recently isolated Pandemic (H1N1) 2009 influenza strain and also contain GSK’s proprietary adjuvant system AS03. In clinical studies using the bird flu influenza strain (H5N1), the adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The vaccine containing the adjuvant system therefore helps to substantially increase the number of vaccine doses that can be provided for mass vaccination.1 In addition, in clinical studies with the bird flu programme, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).2,3 Both the antigen sparing approach as well as the potential for additional protection against drifting strains are features for an impactful vaccine for use in a pandemic setting.
GSK has received regulatory approvals in the European Union and some Asian countries for its pre-pandemic and pandemic H5N1 vaccines, both of which contain the AS03 adjuvant. Currently, clinical trials in over 39,000 people have demonstrated that the AS03 adjuvant system used with an influenza vaccine has an acceptable safety and reactogenicity profile.
About the clinical trials
The first clinical trial, being conducted in Germany, has started this week and enrolment has been completed. The trial will assess the use of the vaccine given as 2 doses, 21 days apart in 128 healthy adults, aged between 18 and 60. Initial data is expected to be available for submission to regulatory authorities in September. Additional trials planned in the clinical development programme are expected to commence shortly and include 8 trials in healthy adults, 5 trials in children (including infants) and 2 trials in the elderly. Details of the clinical development programme will be posted to www.clinicaltrials.gov.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Cautionary statement regarding forward-looking statements�Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2008
1. Leroux-Roels et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370 (9587): 580–89.
2. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvant systemed Clade 1 rH5N1 Pandemic Influenza Vaccine PLoS ONE 3(2): e 1665. doi:10.1371/jounal.pone.0001665
3. Baras et al. Cross-protection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS ONE 2008; 3 (1): e1401.
Tuesday, 25 August 2009
'Pharma companies aren't profiteering'
Drug costs are regularly criticised as being too high - and the pharmaceutical industry attacked for not making them cheaper. But David Fisher, commercial director for the Association of the British Pharmaceutical Industry, says companies are unfairly attacked.
No one can fail to be moved by the experiences of cancer patients who are literally dying for the latest medicines.
My own father succumbed to cancer in 1993, and everyone who has been through that experience knows how patients and families are desperate for any help which will provide them with hope for the future.
But tough decisions have to be made - by the National Institute for Health and Clinical Excellence (the NHS drugs watchdog), NHS executives and patients and their families who wonder if they should use up their life savings paying for medicines which have been rejected by NICE.
Vilified
The pharmaceutical industry, the people who discover and make the medicines which can add precious months and years to the lives of terminally-ill cancer patients, face a different kind of angst.
They risk millions upon millions of pounds in order to find new medicines to treat people who are sick and dying and for whom there is currently no treatment.
The odds of success are almost "impossible".
If they are successful, the companies have to make enough money to recoup their investment and then fund increasingly expensive research and development in order to find the medicines of the future
In the process, they are often vilified as profiting from ill-health.
As an executive within the pharmaceutical industry, I want to stand up for my colleagues.
There is often concern about the price of medicines and their cost to the NHS in relation to the other calls on its £100 billion budget.
Department of Health figures show that 12% of total NHS expenditure goes on medicines, yet it sometimes feels like this is the area which gets all the attention.
We are fortunate in the UK, that the existence of a national health service allows us to "pool" or share our risk (or cost).
This means that we can balance the high cost of some medicines, particularly those for rare diseases, against the lower cost for the majority of medicines.
'Significant hurdles'
It is the Department of Health's (DH) role to control prices, and this is done by what is known as the Pharmaceutical Price Regulation Scheme (PPRS).
In short, this limits the profit that pharmaceutical companies can make and the department has the ability to implement periodic price cuts.
The price of medicines in the UK has been reduced by 7% in 2005, a further 3.9% this year, and will decrease by a further 1.9% next year.
Each 1% reduction in the price of branded medicines saves the NHS roughly £80m per year.
Under this scheme companies are in theory free to set prices for some new medicines when they are first licensed, but NICE sets significant hurdles for prices.
Prices in the UK are amongst the lowest in Europe, and we spend far less on medicines than our European neighbours.
Revlimid, a treatment for bone marrow cancer, was a good example (and there are others) where manufacturers have shown flexibility in pricing in the UK, despite the fact that the same medicines are widely available to patients elsewhere in Europe and often at higher prices.
No-one is arguing that pharmaceutical companies should not demonstrate the value for money which their medicines deliver so that NHS can strike the right balance. That is perfectly proper.
But when it comes to considering the balance to be struck, we need to remember that recent price cuts have contributed billions to NHS savings, and in comparison to other countries where new medicines are often more readily available to patients, UK prices are low, total spend is low, and the cost per prescription is low and falling.
No one can fail to be moved by the experiences of cancer patients who are literally dying for the latest medicines.
My own father succumbed to cancer in 1993, and everyone who has been through that experience knows how patients and families are desperate for any help which will provide them with hope for the future.
But tough decisions have to be made - by the National Institute for Health and Clinical Excellence (the NHS drugs watchdog), NHS executives and patients and their families who wonder if they should use up their life savings paying for medicines which have been rejected by NICE.
Vilified
The pharmaceutical industry, the people who discover and make the medicines which can add precious months and years to the lives of terminally-ill cancer patients, face a different kind of angst.
They risk millions upon millions of pounds in order to find new medicines to treat people who are sick and dying and for whom there is currently no treatment.
The odds of success are almost "impossible".
If they are successful, the companies have to make enough money to recoup their investment and then fund increasingly expensive research and development in order to find the medicines of the future
In the process, they are often vilified as profiting from ill-health.
As an executive within the pharmaceutical industry, I want to stand up for my colleagues.
There is often concern about the price of medicines and their cost to the NHS in relation to the other calls on its £100 billion budget.
Department of Health figures show that 12% of total NHS expenditure goes on medicines, yet it sometimes feels like this is the area which gets all the attention.
We are fortunate in the UK, that the existence of a national health service allows us to "pool" or share our risk (or cost).
This means that we can balance the high cost of some medicines, particularly those for rare diseases, against the lower cost for the majority of medicines.
'Significant hurdles'
It is the Department of Health's (DH) role to control prices, and this is done by what is known as the Pharmaceutical Price Regulation Scheme (PPRS).
In short, this limits the profit that pharmaceutical companies can make and the department has the ability to implement periodic price cuts.
The price of medicines in the UK has been reduced by 7% in 2005, a further 3.9% this year, and will decrease by a further 1.9% next year.
Each 1% reduction in the price of branded medicines saves the NHS roughly £80m per year.
Under this scheme companies are in theory free to set prices for some new medicines when they are first licensed, but NICE sets significant hurdles for prices.
Prices in the UK are amongst the lowest in Europe, and we spend far less on medicines than our European neighbours.
Revlimid, a treatment for bone marrow cancer, was a good example (and there are others) where manufacturers have shown flexibility in pricing in the UK, despite the fact that the same medicines are widely available to patients elsewhere in Europe and often at higher prices.
No-one is arguing that pharmaceutical companies should not demonstrate the value for money which their medicines deliver so that NHS can strike the right balance. That is perfectly proper.
But when it comes to considering the balance to be struck, we need to remember that recent price cuts have contributed billions to NHS savings, and in comparison to other countries where new medicines are often more readily available to patients, UK prices are low, total spend is low, and the cost per prescription is low and falling.
Friday, 14 August 2009
Cadila to apply for swine flu vaccine clinical trials.
With an aim to launch vaccine for Influenza H1N1 A Virus (swine flu) in India, Cadila Pharmaceutical will seek the government's nod in two days for initiating clinical trials in this regard.
Cadila Pharmaceutical Ltd (CPL) had set up a joint venture 'CPL Biologicals Pvt Ltd' with the US-based vaccine maker Novavax for manufacturing and developing a host of vaccines, including for swine flu, in India.
"The joint venture is going to file the application with the Drug Controller General of India (DCGI) in the next two days for phase-I clinical trials for swine flu vaccine,'' CPL Chairman and Managing Director, Mr I A Modi told PTI.
Modi expressed confidence that Cadila would be the first Indian pharma company to launch the swine flu vaccine in India by December. "If we get the permission of DCGI soon, then with the advanced technology available from our partner, (we) would be able to launch it in India by December this year,'' Mr Modi said.
With its existing facility, Cipla can produce up to one million doses of the vaccine per month, which can be scaled up to two million doses, Mr Modi said. "Novavax has already received permission for clinical trials from the US Federal Drug Administratio n and if we get it soon, we can simultaneously start the trials,'' he added. - PTI.
www.thehindubusinessline.com
Cadila Pharmaceutical Ltd (CPL) had set up a joint venture 'CPL Biologicals Pvt Ltd' with the US-based vaccine maker Novavax for manufacturing and developing a host of vaccines, including for swine flu, in India.
"The joint venture is going to file the application with the Drug Controller General of India (DCGI) in the next two days for phase-I clinical trials for swine flu vaccine,'' CPL Chairman and Managing Director, Mr I A Modi told PTI.
Modi expressed confidence that Cadila would be the first Indian pharma company to launch the swine flu vaccine in India by December. "If we get the permission of DCGI soon, then with the advanced technology available from our partner, (we) would be able to launch it in India by December this year,'' Mr Modi said.
With its existing facility, Cipla can produce up to one million doses of the vaccine per month, which can be scaled up to two million doses, Mr Modi said. "Novavax has already received permission for clinical trials from the US Federal Drug Administratio n and if we get it soon, we can simultaneously start the trials,'' he added. - PTI.
www.thehindubusinessline.com
Thursday, 13 August 2009
China admits its companies' involvement in fake drugs case
China has admitted that its pharmaceutical companies were involved in shipping fake drugs labeled 'Made In India' to Nigeria.
"The Chinese authorities have accepted this position (that its firms were involved in the case)," an official said.
"The Indian government took up the matter with the Nigerian authorities and on further probe, it was found that the drugs had actually originated in China and not in India," he added.
In June, Nigeria's drug regulatory authority National Agency for Food And Drug Administration And Control (NAFDAC) had reported about the detention of a large consignment of fake anti-malarial generic pharmaceuticals labeled 'Made in India' which were actually produced in China.
Following the incident, India took up the issue with China fearing that this could damage the reputation of the 12-billion-dollar Indian pharmaceutical industry in the global market.
www.ptinews.com
"The Chinese authorities have accepted this position (that its firms were involved in the case)," an official said.
"The Indian government took up the matter with the Nigerian authorities and on further probe, it was found that the drugs had actually originated in China and not in India," he added.
In June, Nigeria's drug regulatory authority National Agency for Food And Drug Administration And Control (NAFDAC) had reported about the detention of a large consignment of fake anti-malarial generic pharmaceuticals labeled 'Made in India' which were actually produced in China.
Following the incident, India took up the issue with China fearing that this could damage the reputation of the 12-billion-dollar Indian pharmaceutical industry in the global market.
www.ptinews.com
Wednesday, 12 August 2009
Javelin Pharmaceuticals Reports Ereska
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today described its initial review of top line results from a Phase III study of Ereska™ (intranasal ketamine 30mg). This randomized, multicenter, double-blind, 1:1 placebo-controlled study assessed the safety and analgesic efficacy of repeated doses of Ereska over 6 hours in 259 patients with acute moderate-to-severe pain following orthopedic surgery.
The predefined primary outcome measure for this trial was the summary of pain intensity differences over a 6 hour period after initial drug dosing (SPID-6). The baseline- and site-adjusted means (plus or minus standard errors) for SPID-6 were 78.2 ± 12.4 for the Ereska group and 47.9 ± 12.3 for the placebo group, yielding a borderline P-value of 0.053. (The standard for statistical significance in pivotal clinical trials is a P-value of 0.05 or less.) Having had only a brief period of time to review select data from the trial, our initial assessment is that a high degree of intersubject variability likely impacted the P-value of the primary endpoint. In addition, certain clinically relevant secondary endpoints that we have been able to review so far, including patient global evaluations, were statistically significant in favor of Ereska.
Ereska was generally well tolerated in the trial. Of particular note, the incidences of psychological side effects were equal to or less than 3% in subjects given Ereska and were typically mild and transient.
The Company will thoroughly examine all aspects of this trial. In a recent interaction with the FDA, prior to the availability of this trial’s initial data, the Division offered to review the results of this study.
www.businesswire.com
The predefined primary outcome measure for this trial was the summary of pain intensity differences over a 6 hour period after initial drug dosing (SPID-6). The baseline- and site-adjusted means (plus or minus standard errors) for SPID-6 were 78.2 ± 12.4 for the Ereska group and 47.9 ± 12.3 for the placebo group, yielding a borderline P-value of 0.053. (The standard for statistical significance in pivotal clinical trials is a P-value of 0.05 or less.) Having had only a brief period of time to review select data from the trial, our initial assessment is that a high degree of intersubject variability likely impacted the P-value of the primary endpoint. In addition, certain clinically relevant secondary endpoints that we have been able to review so far, including patient global evaluations, were statistically significant in favor of Ereska.
Ereska was generally well tolerated in the trial. Of particular note, the incidences of psychological side effects were equal to or less than 3% in subjects given Ereska and were typically mild and transient.
The Company will thoroughly examine all aspects of this trial. In a recent interaction with the FDA, prior to the availability of this trial’s initial data, the Division offered to review the results of this study.
www.businesswire.com
Tuesday, 11 August 2009
Cumberland Pharmaceuticals raises $85M with IPO
Cumberland Pharmaceuticals Inc. raised $85 million in the company's initial public offering Monday.
The share price of $17 per share was below the Nashville-based company's earlier projections of $19 to $21 per share. Still, it was touted as the first IPO by a pharmaceutical company in almost two years.
The company's common stock is expected to begin trading on the NASDAQ Global Select Market Tuesday under the trading symbol "CPIX."
After paying expenses related to the offering, the company is expected to net about $75 million, which will be used for potential acquisitions, addition to the company's sales force and the launch of Caldoloran, an intravenous form of ibuprofen.
Caldolor's primary use will be for hospitalized patients who are unable to receive oral medication for pain relief and fever reduction. Company officials says the U.S. market for injectable pain relievers was about 679 million units in 2008.
The deal was underwritten by UBS Investment Bank, Jeffries & Co. and Wells Fargo Securities.
www.bizjournals.com
Saturday, 8 August 2009
Company targets China for overseas growth
Dundonald-based pharmaceutical manufacturing firm Sepha will be heading to China for the first time later this year as part of its bid to win new business in overseas markets.
The company, which makes inspection equipment to test the seals of pharmaceutical and medical device blister packs and other specialist products, has already shown its machines in Japan and Mexico this summer.
The firm will also be returning to India in the autumn.
The company currently employs 18 people and three executive directors and its customers already include some of the world’s biggest pharmaceutical companies.
Its turnover has increased 60% since management bought it out with the help of private equity firm Enterprise Equity in 2005, the company said.
Enterprise Equity is one of Northern Ireland’s longest established private equity businesses. It has invested over £27m in around 40 firms since its formation in 1987 in a broad spectrum of sectors. Other firms in its portfolio include Balcas, Kelsius and BCO Technologies. Sepha has made some headway in Japan with the help of an Invest NI-Enterprise Ireland service that offers on-the-ground translator services and helps develop sales leads.
www.belfasttelegraph.co.uk
The company, which makes inspection equipment to test the seals of pharmaceutical and medical device blister packs and other specialist products, has already shown its machines in Japan and Mexico this summer.
The firm will also be returning to India in the autumn.
The company currently employs 18 people and three executive directors and its customers already include some of the world’s biggest pharmaceutical companies.
Its turnover has increased 60% since management bought it out with the help of private equity firm Enterprise Equity in 2005, the company said.
Enterprise Equity is one of Northern Ireland’s longest established private equity businesses. It has invested over £27m in around 40 firms since its formation in 1987 in a broad spectrum of sectors. Other firms in its portfolio include Balcas, Kelsius and BCO Technologies. Sepha has made some headway in Japan with the help of an Invest NI-Enterprise Ireland service that offers on-the-ground translator services and helps develop sales leads.
www.belfasttelegraph.co.uk
Friday, 7 August 2009
Government refuses pharma factoring to control national deficit.
Government is refusing to accept factoring invoices of companies which supply the Government Health Procurement Services to control the national deficit, The Malta Business Weekly has learnt.
The issue that government is refusing to accept factored invoices was first highlighted a few weeks ago by The Malta Independent on Sunday. At the time, pharmaceutical importers were subsequently assured by government that it had agreed in principle to accept factoring for all pharmaceutical importers.
This newspaper is informed that various pharmaceutical importers have “sold” their invoices to HSBC Bank Malta in an attempt to ease their cash flow problems following a credit period of 150 days imposed by government. Moreover, payments by the Government Health Procurement Services entity, previously known as the Government Pharmaceutical Services, were until recently few and far between.
Following intense lobbying it is understood that HSBC accepted the 150 days credit period demanded by government instead of the maximum 120 days.
In the process, it is also believed that the bank wrote a couple of heavy worded letters to government, which however failed to elicit the expected response.
www2.maltabusinessweekly.com
The issue that government is refusing to accept factored invoices was first highlighted a few weeks ago by The Malta Independent on Sunday. At the time, pharmaceutical importers were subsequently assured by government that it had agreed in principle to accept factoring for all pharmaceutical importers.
This newspaper is informed that various pharmaceutical importers have “sold” their invoices to HSBC Bank Malta in an attempt to ease their cash flow problems following a credit period of 150 days imposed by government. Moreover, payments by the Government Health Procurement Services entity, previously known as the Government Pharmaceutical Services, were until recently few and far between.
Following intense lobbying it is understood that HSBC accepted the 150 days credit period demanded by government instead of the maximum 120 days.
In the process, it is also believed that the bank wrote a couple of heavy worded letters to government, which however failed to elicit the expected response.
www2.maltabusinessweekly.com
Thursday, 6 August 2009
Upbeat and optimistic future for the pharmaceutical industry
The future for limited companies and sole traders working in the UK's pharmaceutical industry is "upbeat" and "optimistic", an industry expert has claimed.
According to law firm Charles Russell, the level of international interest in the industry reveals that the UK is viewed as a "safe harbour" and offers plenty of opportunities for growth.
Tim Jenkins, partner leading the pharmacy transactions team at the law firm, said: "Clearly there will be an ongoing need for pharmacy as a professional service. It's a question of how it will be regulated going forwards, there have obviously been some changes.
"The biggest question is what will happen with control of entry. That's what's in the back of the minds of most operators. I don't see that that uncertainty is having an impact, because uncertainty has always been with us."
As long as the numbers of new businesses arriving on the market continues to increase then the pharmaceutical industry will continue to be buoyant, Mr Jenkins concluded.
Meanwhile, the Council of the Royal Pharmaceutical Society of Great Britain has announced a rise of 2.2 per cent in its fees for 2010.
www.brookson.co.uk
According to law firm Charles Russell, the level of international interest in the industry reveals that the UK is viewed as a "safe harbour" and offers plenty of opportunities for growth.
Tim Jenkins, partner leading the pharmacy transactions team at the law firm, said: "Clearly there will be an ongoing need for pharmacy as a professional service. It's a question of how it will be regulated going forwards, there have obviously been some changes.
"The biggest question is what will happen with control of entry. That's what's in the back of the minds of most operators. I don't see that that uncertainty is having an impact, because uncertainty has always been with us."
As long as the numbers of new businesses arriving on the market continues to increase then the pharmaceutical industry will continue to be buoyant, Mr Jenkins concluded.
Meanwhile, the Council of the Royal Pharmaceutical Society of Great Britain has announced a rise of 2.2 per cent in its fees for 2010.
www.brookson.co.uk
Wednesday, 5 August 2009
Another Top Ten Global Pharmaceutical and Medical Device Leader Selects Model N Revenue Management Suite
Model N, Inc., the leader in Revenue Management solutions, today announced that another global top ten pharmaceutical and medical device manufacturer has selected Model N's full Pharmaceutical and Medical Technology Commercial Revenue Management Suites. By selecting Model N, the manufacturer will align its business-critical pricing, contracting, and settlements processes across both its U.S. and international businesses.
After an extensive evaluation by the customer of competitive solutions, including incumbent contracting and ERP solutions, the manufacturer decided Model N was best suited to handle its growing commercial business requirements and to complement its legacy SAP ERP implementation.
Key Selection Factors
-Model N is the only vendor that possesses the experience, technology, and domain expertise required to meet the unique business needs of both the pharmaceutical and medical technology industries.
-Model N's integrated Revenue Management Suite, proven in production with major Life Science companies, offers a dramatic advantage over risky, first-generation competitive solutions.
-The comprehensive capabilities of Model N's fifth-generation platform meet the majority of the manufacturer's needs out of the box and deliver significant usability advantages.
-Model N's expertise and experience integrating with SAP and other legacy /incumbent systems demonstrated that the project would leverage and complement existing investments.
www.prweb.com
After an extensive evaluation by the customer of competitive solutions, including incumbent contracting and ERP solutions, the manufacturer decided Model N was best suited to handle its growing commercial business requirements and to complement its legacy SAP ERP implementation.
Key Selection Factors
-Model N is the only vendor that possesses the experience, technology, and domain expertise required to meet the unique business needs of both the pharmaceutical and medical technology industries.
-Model N's integrated Revenue Management Suite, proven in production with major Life Science companies, offers a dramatic advantage over risky, first-generation competitive solutions.
-The comprehensive capabilities of Model N's fifth-generation platform meet the majority of the manufacturer's needs out of the box and deliver significant usability advantages.
-Model N's expertise and experience integrating with SAP and other legacy /incumbent systems demonstrated that the project would leverage and complement existing investments.
www.prweb.com
Tuesday, 4 August 2009
U.S. Pharmaceutical Distribution Examined in New URCH Report.
Today, URCH Publishing launches a comprehensive new report covering the distribution of medicines in the United States. “Pharmaceutical Distribution in the US - Current and Future Perspectives” shows how the US pharmaceutical wholesale sector has witnessed a rapid wave of consolidation to reach its current concentrated form dominated by three major full-line companies, namely Cardinal Health Inc., McKesson Corporation and AmerisourceBergen Corporation. Known collectively as the ‘Big Three’, these companies now account for between 90% and 95% of revenue within the sector.
Over 100 buyouts have taken place since 1980, and at least 57 have occurred over the past decade, but despite their dominance of the market the Big Three continue to look for further acquisitions, and market conditions favour a trend towards further consolidation, notes the report. However, the dominance of the Big Three has persuaded the Federal Trade Commission to re-examine their activities. Although there is no evidence of any gross violations, there is the potential for the market to be distorted as a result of the activities of these companies.
www.businesswire.com
Over 100 buyouts have taken place since 1980, and at least 57 have occurred over the past decade, but despite their dominance of the market the Big Three continue to look for further acquisitions, and market conditions favour a trend towards further consolidation, notes the report. However, the dominance of the Big Three has persuaded the Federal Trade Commission to re-examine their activities. Although there is no evidence of any gross violations, there is the potential for the market to be distorted as a result of the activities of these companies.
www.businesswire.com
Saturday, 1 August 2009
Pharmaceutical giants in Stevenage gives antivirals to all staff.
PHARMACEUTICAL giants GlaxoSmithKline (GSK), which has a base in Stevenage, has issued all its UK employees and their families with the antiviral drug to swine flu "in case of need".
Tamiflu has been given to workers as a precautionary measure to fight the H1N1 virus.
A spokesman for the company said: "GSK has invoked its own internal pandemic preparedness plan, to ensure continuity of supply of all its critical medicines and vaccines."
At the end of May, GSK started production of a swine flu vaccine and has so far received orders for 195 million doses.
First supplies will be available from September.
It also expects to increase annual production of Relenza - which can both treat and help prevent flu - from 60 million to 190 million by the end of the year.
www.thecomet.net
Tamiflu has been given to workers as a precautionary measure to fight the H1N1 virus.
A spokesman for the company said: "GSK has invoked its own internal pandemic preparedness plan, to ensure continuity of supply of all its critical medicines and vaccines."
At the end of May, GSK started production of a swine flu vaccine and has so far received orders for 195 million doses.
First supplies will be available from September.
It also expects to increase annual production of Relenza - which can both treat and help prevent flu - from 60 million to 190 million by the end of the year.
www.thecomet.net
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