Showing 1 to 10 of 21 articles : Page 1 | 2 | 3 | Next
Influential consumer group files petition to get Avandia banned
Pharmatimes - 31 October 2008
The influential consumer group Public Citizen has called on US regulators to ban GlaxoSmithKline’s Avandia, claiming that the diabetes drug causes death from liver failure “and has many other life-threatening risks that far outweigh its benefits”.
Public Citizen says it has filed a petition with the US Food and Drug Administration to remove Avandia (rosiglitazone) from the market based on 14 cases of drug-induced liver failure, including 12 deaths. These cases were derived from the FDA Adverse Event Reporting System after what the group calls a “careful review of the agency’s MedWatch forms, which are submitted to the agency when adverse drug reactions are suspected”.
Public Citizen has previously encouraged diabetes sufferers to avoid taking Avandia because it says that the drug increases the risk of heart attack by approximately 40%, doubles the risk of heart failure and bone fractures and increases the risk of anaemia and vision loss from macular edema. The petition claims that there were 39 times more reports of the latter disease per million prescriptions filled for Avandia than for an older diabetes drug, glipizide.
The petition also notes representatives from the American Diabetes Association and the European Association for the Study of Diabetes have recently “unanimously advised” against using Avandia in Diabetes Care, the ADA’s journal. Avandia prescriptions have fallen sharply since a meta-analysis published in the New England Journal of Medicine in May 2007 connecting the drug with increased heart attack risk, but “approximately 10,000 prescriptions a day are still filled for this unacceptably dangerous drug”, Public Citizen says.
Sidney Wolfe, director of Public Citizen’s Health Research Group, said the “scientific consensus against Avandia is overwhelming,” and these latest findings “should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug”.
GSK is standing firmly behind Avandia and issued a statement saying that “we do not believe there is a connection between liver toxicity and this medicine”. Indeed the firm believes the drug has a favourable liver safety profile, a view backed by “an external panel of independent experts who review any reports of liver issues” and as recently as July “they continued to endorse a favorable hepatic safety profile”.
The company added that Avandia is a safe and effective medicine when used according to the label and data from long-term clinical trials, “which offer the most rigorous scientific measurement of safety and efficacy”, provide substantial evidence to back this up. Furthermore, GSK notes that Avandia is the only thiazolidinediones proven to sustain glycaemic control for up to five years. “In long-term clinical trials, the risk of cardiac ischemic events was similar between Avandia and other commonly used oral diabetes medicines”, the firm concluded.
Other sources:
www.citizen.org
www.gsk.com
GSK boosts HCV presence with Genelabs purchase
Pharmatimes - 30 October 2008
GlaxoSmithKline has once again hit the acquisition trail and is buying the USA’s Genelabs Technologies for $57 million.
The drugs giant is to pay $1.30 per share in cash to acquire Genelabs in a move that GSK says will strengthen its efforts “to develop and deliver novel therapies against the hepatitis C virus”. The price being offered is more than five times the closing price of $0.23 of Genelabs shares last night.
Zhi Hong, senior vice president of the Infectious Diseases Centre for Excellence in Drug Discovery at GSK, said that “Genelabs has demonstrated a strong track record in HCV drug discovery and identified numerous novel classes of inhibitors that target unprecedented mechanisms in the virus’s life cycle”.
GSK claimed that there is a high unmet need for new drugs to treat HCV infection. The current gold standard therapy comprises pegylated-alpha interferon plus ribavirin, but the efficacy rate of this combination is relatively low (approximately 50%) and both drugs are associated with significant side effects that lead to treatment discontinuation.
The firm noted that several new antiviral drugs targeting multiple virus and host targets are currently in development. Furthermore, “rapidly-emerging drug resistance suggest that combination therapies with multiple classes of drugs will be required to achieve sustained virological response”.
The deal fits in well with the strategy espoused by GSK chief executive Andrew Witty last week when the firm announced its third quarter results. He said that a major acquisition is highly unlikely and small-to-medium-sized deals will be the way forward, especially during the credit crunch.
Fred Driscoll, chief executive of Genelabs, was clearly pleased, saying that the transaction “provides our shareholders with certain value at a substantial premium to our stock price”. He added that “we have generated highly differentiated compounds with the potential to address unmet medical needs of people with the HCV infection” and linking up with GSK will help accelerate these treatments. The deal is expected to close in December.
Other source:
www.gsk.com
Biogen, Elan shares fall as third Tysabri patient suffers brain infection
Pharmatimes - 30 October 2008
Biogen Idec and partner Elan Corp have suffered a slide in their respective share prices after a new case of progressive multifocal leukoencephalopathy in a multiple sclerosis patient being treated with Tysabri, was disclosed.
In a filing to the US Securities and Exchange Commission, Biogen said that the relevant regulatory agencies had been notified of a confirmed case of PML, a potentially deadly brain infection, in a patient suffering from MS in the USA who had been on Tysabri (natalizumab). The disclosure comes after Biogen and Elan reported in July that two cases of PML had emerged in Europe.
In the latest case, the filing reveals that the patient received 14 injections of Tysabri. The patient has a history of prior disease-modifying therapies including beta-interferons and Texa’s Copaxone (glatiramer acetate) and he/she had also been treated with methotrexate for a rheumatology condition. The individual is now under the care of their treating physician, Biogen said.
PML has played a major part in the history of Tysabri. These recent cases are the first to be recorded since the reintroduction of natalizumab in the USA and approval in Europe two years ago. Biogen and Elan had voluntarily withdrawn the drug a year earlier after three patients developed the brain infection.
Since reintroduction, sales of Tysabri have soared – by the end of September there were 35,500 patients using the drug worldwide and in the third quarter of this year, 3,700 new patients were added. It has also now available in the USA as a treatment for Crohn's disease and Biogen and Elan expect that 100,000 MS patients will be taking the drug by 2010.
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Biogen and Elan have a strict monitoring programme in place for the therapy and the reintroduction of Tysabri was based in part on the number of PML cases not exceeding the level acceptable to the US Food and Drug Administration (one in every 1,000). As only three cases have been reported, the treatment is well within that limit but the news has certainly spooked investors.
In after-hours trading last night, Biogen shares had fallen by as much as 15%, while this morning Elan stock has been hit. At 9.40 UK time, the Irish firm’s shares were down 18% to 4.80 euros.
Ian Hunter, an analyst at Goodbodys in Dublin, has issued a research note this morning saying “we believe that this new case should do little to projected numbers of patients on Tysabri, given that the considerable pull back in momentum after the first two cases…will have accounted for the majority of those patients and physicians wary enough of the PML risk” to consider not taking or prescribing the drug. However, the fact that this patient was on the drug for 13 months and the other two were on it for 14 and 17 months “may suggest that there is a timing issue and that it takes over a year on Tysabri for the interaction between drug and patient to lead to the development of PML”.
Other sources:
www.biogen-idec.com
www.elan.com
UCB boosted by US approval for epilepsy drug Vimpat
Pharmatimes - 30 October 2008
UCB’s stock has soared on the news that the Belgian firm’s epilepsy drug Vimpat has been given the green light by US regulators.
The US Food and Drug Administration has approved Vimpat (lacosamide) for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 and older. The approval is based on one Phase II and two Phase III trials of 1,300 people and before adding Vimpat, patients experienced a median baseline seizure frequency ranging from 10 to 17 seizures per month, despite being on one to three other antiepileptics; 45.2% of patients had previously tried seven or more AEDs to control their seizures.
In the studies, patients randomised to Vimpat had their seizures reduced by half and experienced reductions in median seizure frequency at rates that were significantly greater than those in placebo groups. In preclinical studies, Vimpat has been shown to bind to the collapsin response mediator protein-2, an important target that affects the way that nerves differentiate and grow. However, the precise nature of the interaction between the drug and CRMP-2 and between the latter and seizure control is not known.
Lead investigator Steven Chung at the Barrow Neurological Institute in Phoenix said that “Vimpat is unique because it works unlike any other antiepileptic drug that is currently available”. He added that it should be considered for patients who have uncontrolled seizures with their current treatment regimen, “no matter how many previous AEDS they've tried”.
Vimpat, which is approved in Europe and was recently launched in the UK and Germany, is seen as a vital element in plugging the gap in sales facing UCB from the loss of patent protection on the allergy drug Zyrtec (cetirizine) last year and the antiepileptic Keppra (levetiracetam) in the near future.
However hopes are high that Vimpat could follow Keppra and become a blockbuster. The scientific community is also impressed with the compound according to its reaction to data presented at the European Congress on Epileptology in Berlin last month.
At the meeting in Germany, Elinor Ben-Menachem at the Institute for Clinical Neurosciences at the Sahlgrenska Academy in Gothenburg, Sweden, said that the pharmacokinetic profile of Vimpat is excellent. Lacosamide was completely absorbed in trials and can also be used with a wide range of other drugs patients may be taking for other conditions, such as metformin for diabetes, digoxin for herart failure and oral contraceptives.
Prof Menachem told PharmaTimes World News that the side effect profile of Vimpat is excellent and another advantage is that Vimpat will be available in three formulations – tablets, syrup and an intravenous injection. This is important especially in a hospital setting where patients in seizure need alternatives for administration.
Other source:
www.ucb-group.com
Recordati buys Turkey's Yeni Ilac for 48 million euros
Pharmatimes - 29 October 2008
Recordati has acquired Yeni Ilaç, a Turkish pharmaceutical company, and is paying 48 million euros as part of its strategy to expand in the emerging markets of central and eastern Europe.
Founded in 1927, Yeni Ilaç has a leading market position in the area of urology, the Italian drugmaker says, and is also engaged in contract manufacturing for other pharmaceutical companies. Headquartered near Istanbul, the company employs 300 staff, of which around 100 are reps.
Recordati says that Yeni Ilac “is very solid financially” and “sales have increased consistently over recent years”. For 2008, turnover is to be around 17 million euros and its operating profit margins are positive and in line with group margins.
The Turkish pharmaceutical market is the 13th biggest worldwide and “is in continuous expansion, with a growth rate of over 15% in recent years”, said the Milan-headquartered firm. It is already present in Turkey through licensing agreements with local companies and the acquisition “allows us to be present directly in a market with high growth rates, where, in addition, our products have already been present successfully for some time," said chief executive Giovanni Recordati,
He added that “we also intend to double the current field force of our new subsidiary” to adequately prepare for the launch of the new products, in particular its lercanidipine/enalapril combination for hypertension and pitavastatin, the cholosterol-lowerer developed by Japan’s Kowa that Recordati licensed the rights to earlier this week.
Other source:
www.recordati.com
Credit crunch hurting pharma and biotech R&D badly
Pharmatimes - 29 October 2008
The global financial crisis could lead to major delays in the discovery and production of many new drugs.
That was the key message that came out of a two-day conference hosted by the UK’s Economic and Social Research Council in London, where it was noted that investment into research for new treatments is now seriously at threat as former investors in drugmakers shy away as a result of the economic meltdown.
David Wield, director of the ESRC’s Edinburgh-based Innogen Centre, stated that "investing in biotech companies is now seen as risk-taking, and will not be for the timid. What will happen to investment in biotech research if finance cannot even be found for relatively everyday expenses which are increasingly becoming more of a struggle”?
He added that drug discovery “depends on long-term finance with high risk of failure – and lots of it”. Financing of biotechnology companies hit the $50 billion in 2007 and the vast majority only made profits for the very first time last year, amounting to $1 billion on revenues of $59 billion, Prof Wield claimed.
In addition to the impact on the basic research performed at biotechnology companies, the development of medicines by pharmaceutical companies has also been hit by the credit crunch, he argued. "Like many other sectors, the pharmaceutical industry has had tough times recently – there is seemingly no way to speed up and improve the drug discovery pipeline, and heavily increased R&D has not increased the number of new drugs”.
Prof Wield noted that as a result, big pharma has been laying off staff and closing down research units, “instead looking to biotechnology start-ups for new ideas".
Other source:
www.esrc.ac.uk
Did industry critics or parallel trade row halt EU pharma package?
Pharmatimes - 29 October 2008
Industry critics claim that a lobbying campaign against European Commission proposals to ease the current curbs on industry communication with consumers led to the postponement last week of the proposed European Union (EU) package of pharmaceutical legislation, but other sources says it was due to a rethink by legislators of stringent proposals concerning parallel trade, including a ban on repackaging.
Patient advocacy group the Picker Institute and consumer organisation Which? have claimed that groups who believe that the draft directive on patient information “could have undermined the EU-wide ban on the advertising of prescription medicines” had raised sufficient questions for it to be impossible to achieve the consensus required before the law could go on to the European Parliament and the Council of Ministers.
Angela Coulter, chief executive of the Picker Institute, pointed out that no groundwork has yet been done in Brussels on the separation of objective, non-promotional information from advertising. There is no consensus on this at the policy or legal levels, and in practice the distinction could be unworkable, she added.
Meantime, a ban on repackaging was first mooted in a Commission public consultation earlier this year, after Guenter Verheugen, the Commissioner for Enterprise and Industry, told Parliament that the initial findings of a study into drug distribution had shown that parallel imports pose a “considerable” risk for patient safety for “numerous” reasons. The consultation pointed to the potential dangers for patients when packs are opened for repackaging and changed for relabeling purposes and proposed that repackaging should be banned.
Moreover, earlier this month a report conducted for the Commission by independent consultancy Europe Economics called for new legislation to outlaw repackaging and relabeling and concluded that parallel trade presents no benefits to patient safety, only disadvantages.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the report, and pointed out that making repackaging illegal was not about a ban on parallel trade. However, the European Association of Euro-Pharmaceutical Companies (EAEPC), which represents the parallel importers, said in a statement to Pharma Times that the report was “short on robust and empirical evidence to support its conclusions” and was “categorically not a reliable base for good policy-making.”
Then, just ahead of the publication of the legislative package, which was scheduled for October 21, the Commission let it be known that it did not intend to ban repackaging or indeed make any changes to the regulations covering parallel imports. The proposals put forward by Commissioner Verheugen were considered by Brussels to be too punitive on the parallel traders who are, as spokesmen pointed out, conducting a legal activity, and the Commission does not intend to change this, they said.
While no new date has been given for publication of a revamped legislative package, the anticounterfeiting proposals will not include proposals to ban either repackaging or relabeling, said the spokesmen.
However, cracking down on the trade in counterfeits is still a priority for Commissioner Verheugen, and on October 22 he told Parliament that the Commission will draw up new regulations to ensure a medicine is traceable throughout its entire lifespan, right from the source of its active ingredients. “The technical solutions required to ensure traceability of medicines already exist,” he said.
Other sources:
www.ec.europa.eu/enterprise
www.europe-economics.com
www.efpia.org
www.eaepc.org
www.pickereurope.org
Shareholders take Lilly and ImClone to court over merger
Pharmatimes - 28 October 2008
Eli Lilly’s $6.5 billion proposed acquisition of ImClone BioSystems has upset a group of the latter’s shareholders which have filed a lawsuit against the firms.
The Massachusetts Public Pension Forum and several individual shareholders are looking to block the deal and the lawsuit alleges that ImClone's board breached fiduciary duties to investors by agreeing to the takeover. It also claims that the board neglected to provide investors with material information so they could make an informed decision about whether to tender their shares.
The suit is seeking class action status on behalf of all ImClone stockholders and an injunction preventing the acquisition from proceeding until investors are given more information.
The lawsuit was disclosed in regulatory filings from both Lilly and ImClone which noted that a court hearing is scheduled for tomorrow. The drugmakers stated that the complaint was without merit and they are ready to vigorously defend themselves.
Lilly recently outbid Bristol-Myers Squibb to acquire ImClone.
Recordati gets rights to new statin from Kowa
Pharmatimes - 28 October 2008
Recordati has signed an agreement with Japan's Kowa Co giving the Italian drugmaker marketing rights to the cholesterol drug pitavastatin.
The deal covers France, Spain, Portugal, Greece, Ireland, Cyprus, Turkey, Russia and the Commonwealth of Independent States, as well as Italy. Pitavastatin was submitted by Kowa at the end of August in the seven European Union countries covered by the agreement and Recordati will seek approval in the remaining countries.
The Milan-headquartered firm said that in clinical trials involving more than 1,600 patients, it has been shown that pitavastatin is more effective than other statins, “since its affinity for the HMG-CoA enzyme is stronger”. It added that the high bioavailability and long half-life of the drug “ensure the prolonged effect of the statin and support the rationale for a once-daily dosing”.
Pitavastatin is already available in Japan and Korea, and has already reached a 10% market share. Launches in the territories covered by the agreement is expected to take place from the second half of 2010.
Chief executive Giovanni Recordati said the agreement with Kowa represents an important opportunity to extend the company’s presence in the cardiovascular area, “and in particular to be present in a significant way in the market for anti-cholesterol treatments, the most important therapeutic class in the global pharmaceutical market”. He noted that the statins sector in the eight largest of the 21 countries covered by the agreement was worth 2.8 billion euros in 2007.
This is expected to grow further in the future, he added, particularly in emerging markets such as Turkey, Russia and the CIS countries. “Pitavastatin is an innovative drug with an improved clinical profile over the statins currently in use which will allow us to reach interesting market shares in a very competitive drug class”, Mr Recordati concluded.
Other source:
www.recordati.com
Expensive new diabetes drugs may not be worth the money
Pharmatimes - 28 October 2008
The annual cost of diabetes drugs in the USA have nearly doubled to $12.5 billion between 2001 and 2007, raising questions about whether this actually translates into improved care.
That is the concern expressed in a study by researchers at Stanford University and the University of Chicago and published in the Archives of Internal Medicine. Randall Stafford, senior author of the study, noted that “this near-doubling of diabetes costs may partly reflect better care, but we need to step back and examine the value of newer and more costly medications that may be overused”.
A major problem, according to Caleb Alexander, the study's first author, is that approval by the US Food and Drug Administration does not require that a treatment be compared against alternative medicines – it only has to be safe to use and better than a placebo. Nor, he noted, does a company have to demonstrate that a drug's effectiveness justifies its price.
New drugs such as Merck & Co’s dipeptidyl peptidase-4 inhibitor Januvia (sitagliptin) and Amylin/Eli Lilly’s glucagon-like peptide-1 analogue Byetta (exenatide), priced at $160 and $210 per prescription respectively, cost eight to 11 times more than older, generic drugs such as metformin or glipizide. They are marketed with claims of greater convenience and better control of blood sugar levels, and physicians have increasingly used them as alternatives to injected insulin, Dr Alexander said, noting that insulin use has dropped from 38% of treatment visits in 1994 to 28% in 2007.
However Dr Stanford claims that “just because a drug is new or exploits a new mechanism does not mean that it adds clinically to treating particular diseases," he said. "And even if a new drug does have a benefit, it's important to consider whether that benefit is in proportion to the increased cost of new therapies." The study also found that patients are increasingly being prescribed more than one medication. In 1994, 82% of patients were prescribed only one drug and last year only 47% were.
In a second AoIM article, a meta-analysis carried out by Elizabeth Selvin and colleagues at the Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that metformin may be associated with a lower risk of death from cardiovascular disease. No associations were found between other diabetes drugs and beneficial or harmful cardiovascular effects, but that was in part because of insufficient data, the authors noted.
Most trials too short to spot adverse events
The meta-analysis, taken from 40 clinical trials published on or before January 2006, noted that “there have been few trials of oral diabetes therapies that have lasted longer than six months and that reporting of adverse events for cardiovascular disease is poor".
In an accompanying editorial, David Nathan, of Massachusetts General Hospital in Boston, wrote that “the current approach to assessing the relatively rare but clinically important adverse effects of diabetes management is unsatisfactory". He noted that the “vagaries of meta-analyses make them unreliable. On the other hand, increasing the size and duration of controlled clinical trials to provide adequate statistical power to detect relatively infrequent events would potentially bankrupt the pharmaceutical industry that supports most of the trials and delay the development of new drugs".
Therefore, new approaches are needed to ensure the safety of drugs without slowing development, Dr Nathan said. He suggests “the phased introduction of new medications with uniform, standardised collection of adverse outcome data [which] might identify relatively rare complications before the drugs are used by millions”.
The use of clinical databases may also provide an early alert regarding adverse outcomes, he concluded. In the meantime, “there are well-established and safe treatments that, if used aggressively, can improve the long-term health of patients with type 2 diabetes."
Other source:
archinte.ama-assn.org
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http://www.business.scotsman.com/latest.cfm?id=2300181
http://pharmiweb.com
http://www.pharmatimes.com/newsonline/
http://www.ukbusinesspark.co.uk/
http://www.biotext.co.uk/
http://www.bionow.co.uk
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