European Commission

Pfizer tops the charts in global R&D spending

Mon, 08 Oct 2007 06:59:56 -0400

It hasn't had a lot to show for it so far, but Pfizer became the world's number one spender on research and development last year, grabbing the top spot from Ford. The list, assembled by the European Commission, looks at the top 50 research budgets on the planet. Biopharma companies ramped up spending big time last year, according to the EU, overtaking technology hardware and equipment makers. Much of that money was poured into programs designed to introduce a new generation of blockbusters as the current top products face a looming loss of patent protection. Merck, for example, increased R&D spending by 24 percent. Pfizer has been regularly held up to criticism that it has been notoriously ineffective in beefing up its pipeline--with the torcetrapib fiasco used as a prime example of its shortcomings. That helped lead the company to announce a major new initiative last week to launch a biotech center in South San Francisco that will be responsible for advancing critical new products--an announcement that left analysts buzzing for days.

- see the EU's press release
- check out the AP report for more info

Related Articles:
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Where's the ROI on drug R&D budgets? Report
Pfizer's future rests with biotech. Report
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Pfizer goes public with R&D pipeline. Report

SPOTLIGHT: Pfizer top R&D spender worldwide

Fri, 05 Oct 2007 06:59:53 -0400

Pfizer shelled out more on R&D last year than any other company in the world, and drugmakers in general have stepped up their research budgets, the European Commission says. Pfizer spent $8.18 billion, elbowing Ford out of the top slot. Johnson & Johnson came in third. Report

The trouble with Europe

Mon, 17 Sep 2007 06:59:59 -0400

It's always interesting to come to Europe and hear the latest about the Innovative Medicines Initiative, an attempt by the Europeans to develop a public-private approach to speed drug development. This is Europe's version of the Critical Path Initiative, and it has some real potential. As outlined by Jorgen Dirach, director of corporate research affairs at Novo Nordisk, at the 13th European Congress on Biotechnology, the IMI is hoping to fund new research efforts next year that will focus on new ways to speed more efficient clinical trials. One of the keys to making this new, collaborative approach work will be the development of a "virtual" research academy that is designed to accelerate academic research work by connecting researchers online. There's also €2 billion from the European Commission and private industry to prime the pump.

Europe has long been a hotbed of great science. Some of the leading institutes are at the top of their respective fields in drug research. The eager faces packing into one session on protein design are ample evidence of the keen interest in science here. And despite all the hype, Europe is still well ahead of Asia in terms of ongoing clinical trials. But there's always an air of concern here about the state of the industry, underscored by Dirach's comment that seven of 10 science students getting their PhDs in the U.S. have no plans to return to Europe. They'll stay in the U.S., going after well-paid jobs at some drug developers that are able to fund their work with money from some ambitious venture capital firms.

As long as the big money remains in the U.S., much of the science will as well. Nevertheless, great science will always earn the interest of developers--wherever it comes from. What ultimately ails Europe is the exact same set of problems that afflict American companies: The cost of research continues to multiply with no end in sight. I suspect that despite all the carefully worded support of public agencies on both sides of the Atlantic, that essential barrier will remain an ever-growing challenge. Regulatory groups are getting tougher about new approvals, not more lax. They have no great stake in lowering the barrier. As long as the bar remains high--as it should--reaching it will cost a fortune. The cost solution won't be found at the public level, but at private biotech companies that are leveraging investors' money into swifter development of biologics.

I will take issue with one off-hand comment of Dirach's. Referring to the cost of developing a drug, he said that "800 million dollars, or euros, it makes no difference." Anyone from the U.S. who had just purchased something in one of the Barcelona shops nearby would dispute that in a heartbeat. - John Carroll

In Europe, Sweden takes the lead

Fri, 17 Aug 2007 06:59:54 -0400

Despite being relatively new to the biotech field, Sweden's biotech industry is doing brisk business. The country has already attracted $46 million in venture capital this year and Swedish biotechs are responsible for some of the largest biotech IPOs in Europe this year. "Fledgling companies are attracting foreign and Scandinavian investors, striking lucrative deals with pharmaceutical giants, and outperforming many of their peers on European stock markets," notes BusinessWeek.

A recent report from the European Commission marked Sweden as having one of the most successful biotech sectors in the EU. Smart policies and good coordination between government departments contribute significantly to Sweden's ascent. The country also boasts strong academic institutions, a wealth of pharmaceutical talent and a unique approach to intellectual property.

- see this BusinessWeek article

Related Article:
Tips for a successful biotech sector. Report

Chelsea wins European orphan status

Wed, 15 Aug 2007 06:59:55 -0400

European drug regulators granted orphan drug status to Chelsea Therapeutics' remedy for hypotension, Droxidopa, and recommended the same for Progen's experimental liver drug, known as PI-88. Designed to promote drugs that treat deadly and rare diseases, the E.U.'s orphan drug program offers marketing exclusivity for up to 10 years.

Chelsea's Droxidopa drug treats a particular sort of low blood pressure stemming from Parkinson's or from multiple-system atrophy. Its European orphan status covers both disorders and lasts for 10 years. It already has orphan-drug status in the U.S.

PI-88 treats primary liver cancer; its orphan designation won't be official until the European Commission officially adopts it, probably by the end of the third quarter.

- see the release
- read the report from the Charlotte Business Journal

Related Article:
FDA grants Droxidopa orphan drug status. Report

Tips for a successful biotech sector

Maureen Martino — Thu, 26 Jul 2007 08:27:12 -0400

A new report from the European Commission examines 27 EU countries (as well as non-members Switzerland, Norway, Iceland, Croatia and Turkey) to determine what factors foster a successful biotech industry. Public R&D spending, favorable political policies, publications and the number of patents granted were all taken into account in determining which countries have the healthiest biotechnology sectors.

The study found that countries focused on basic and applied research faired better than those focused primairly on commercialization. "Nations wishing to sustain or improve their commercial performance in biotechnology will not be successful if they focus their supporting activities only on functions of the innovation system which are directly related to commercialization," warns the report. In addition, size alone will not guarantee the industry's success, and pouring money into the sector will only garner limited results.

Countries could be grouped into three classes based on their biotech sector's performance, with Denmark, Finland, Sweden and Switzerland rising to the top of the heap. "Though they do not spend as much on biotechnology research as their larger neighbors, they more than make up for it with their smart policies and good coordination between government departments," explains Project Manager Bernhard Zechendorf of the European Commission's Research Directorate General. Austria, Belgium, France, Germany, Ireland, the Netherlands, the UK and Norway--many of which have large biotech industries--were in the second-best performing group of countries.

Bringing up the rear were Greece, Italy, Luxembourg, Portugal, and Spain, which the report cited as having below-average performance when compared to other nations. The fact that these countries were late to the biotech party has something to do with their sub-standard performance. For these countries that are still getting their footing, Zechendorf recommends that they pattern themselves after the most successful countries by making the most of limited budgets and developing expertise in niche areas.

- see the report for more

SPOTLIGHT: EMEA recommends Zeltia's Yondelis

Fri, 20 Jul 2007 06:59:53 -0400

The EMEA has recommended the European Commission approve Zeltia's drug Yondelis for the treatment of soft tissue sarcomas. The company's shares surged on the news. The recommendation comes almost four years after the EMEA rejected Zeltia's earlier submission. The company plans to begin selling the drug later this year. Report

Press Release: Positive Opinion For Type 2 Diabetes Treatment, JANUVIA

Maureen Martino — Fri, 26 Jan 2007 13:29:16 -0500

Positive Opinion For Type 2 Diabetes Treatment, JANUVIA - First In New Class Of Oral Treatments Known As DPP-4 Inhibitors, European Union

JANUVIA (sitagliptin), Merck, Sharp & Dohme's treatment for patients with type 2 diabetes, today received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) in Europe. The CHMP opinion recommends that JANUVIA be approved in the European Union for the treatment of type 2 diabetes. Following the conclusion of the CHMP review, the opinion for JANUVIA will be transmitted to the European Commission (EC). If the EC adopts the opinion, JANUVIA will be the first and only prescription medication in a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance the body's own ability to lower blood sugar (glucose) when it is elevated. The decision will be applicable to the 27 countries that are members of the European Union, including the United Kingdom, Germany, France, Italy and Spain. JANUVIA is currently approved in eleven countries including the United States and Mexico. Marketing authorization from the European Commission is expected in early April after the adoption of the opinion.

The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of comprehensive data supporting the efficacy and safety and tolerability profile of JANUVIA. The submission package consisted of studies involving approximately 4,000 patients with type 2 diabetes treated with JANUVIA.

JANUVIA has been investigated in patients with type 2 diabetes to improve glycaemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control. JANUVIA has also been studied as add on therapy with PPARγ agonists in patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (e.g. a thiazolidinedione) is appropriate. In addition, JANUVIA has been studied as monotherapy in many patients.

In a clinical study, JANUVIA plus metformin, compared to treatment of a sulfonylurea (SU) plus metformin, showed comparable glucose lowering efficacy. In this study patients taking JANUVIA plus metformin lost weight (-1.5 kg) compared to patients taking glipizide plus metformin who gained weight gain (+1.1 kg). Hypoglycaemia (when blood sugar becomes too low) was more common in patients treated with glipizide plus metformin (32 percent) compared to patients treated with JANUVIA plus metformin (4.9 percent). In the overall phase III clinical programme the incidence of hypoglycaemia in patients taking JANUVIA was similar to patients taking placebo (1.2 percent, JANUVIA vs. 0.9 percent, placebo). In clinical trials of up to 2 years in duration, patients have received treatment with JANUVIA alone or in combination with metformin, a sulfonylurea (with or without metformin) or a PPARγ agent. In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8 percent with JANUVIA and 1.5 percent with other treatments. No adverse reactions considered as drug- related were reported in patients treated with JANUVIA occurring in excess (> 0.2 % and difference > 1 patient) of that in patients treated with control. Reported adverse events included nausea (common), somnolence, upper abdominal pain, diarrhoea and hypoglycaemia (uncommon).* JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

About JANUVIA

JANUVIA (sitagliptin) is an oral, once daily, potent and highly selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose. DPP-4 inhibitors enhance the body's own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.

Expanding Clinical Trial Program for JANUVIA

MSD's clinical development program for JANUVIA is robust and continues to expand with 43 studies completed or under way, and four more studies set to begin this year. There are about 6,700 patients in the Company's clinical studies with about 4,700 of these patients being treated with JANUVIA. Additionally, about 1,100 patients have been treated with JANUVIA for more than a year.

About Merck

Merck & Co., Inc., which operates in many countries as MSD (Merck Sharp & Dohme), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forwarding-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.

GSK wins EMEA approval for pandemic vaccine

Thu, 14 Dec 2006 19:01:37 -0500

The European Medicines Agency has given GlaxoSmithKline a thumb's up for Daronrix, its pandemic flu vaccine. The European Commission will now take up the issue. Glaxo's victory at the EMEA followed an extraordinarily swift development process, with clinical trials beginning in April. The drug developer filed what's called a mock-up dossier on the vaccine, asking for approval against one strain of the H5N1 virus. In the event of a potential pandemic, Glaxo would adapt the vaccine to work against the pandemic strain without having to go back to regulators to ask for approval again.

- see this GSK press release
- read the report on the vaccine from MarketWatch

Related Articles:
HHS awards H5N1 contracts. Report
Switzerland to stockpile GSK's bird flu vaccine. Report

EC approves Thelin as FDA continues discussion

Thu, 10 Aug 2006 20:01:38 -0400

The European Commission has approved Encysive's Thelin for pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. The move came after the FDA decided it would need to see additional data on the drug before it could be approved. The FDA issued a second approvable letter for Thelin in late July, which Encysive officials say contained one outstanding issue. That raised analysts' concerns that Thelin would not be approved prior to the arrival of Myogen's ambrisentan. There has been some speculation that the FDA may be concerned with the way patients would respond to a combination of Thelin and warfarin, a standard therapy.

- see the release on Thelin for more information

MabThera wins European approval for RA, lymphoma

Mon, 10 Jul 2006 20:01:38 -0400

The European Commission has given the green light to Roche to start marketing MabThera to patients with severe rheumatoid arthritis, a key step in clearing the way to blockbuster status in a disease category that includes 21 million patients worldwide. The Europeans also approved MabThera for some forms of lymphoma. The FDA gave MabThera--Rituxan--its approval for RA earlier this year. MabThera works by targeting B cells that play a role in the disease process. Roche believes the therapy has great potential for RA patients who do not respond to other drugs.

- here's the Business Day report on MabThera

SPOTLIGHT: Europeans OK Kaletra tablets

Sun, 02 Jul 2006 20:01:33 -0400

The European Commission has given marketing approval to the tablet form of the HIV drug Kaletra. The new formulation does not require refrigeration and allows patients to take it with or without food, which should make it more effective in developing countries. Report

Encysive shares surge on regulatory opinion

Thu, 01 Jun 2006 20:01:38 -0400

The EMEA also bolstered Encysive, sending its stock up 44 percent, with a recommendation in favor of the high blood pressure medicine Thelin. Thelin is Encysive's lead drug candidate. Just days ago, Encysive responded to the FDA's appovable letter from earlier this year, which had sent shudders through the ranks of analysts worried the agency might demand another trial of Thelin.

"The CHMP's positive opinion will now be considered by the European Commission, which is expected to issue a final decision regarding marketing approval for Thelin within approximately 90 days," Encysive noted. "Under the EMEA's centralized licensing procedure, if approved, Encysive would be granted marketing authorization for Thelin in all 25 member states of the European Union."

- read the article from TheStreet.com
- and here's more on the analysts and the FDA

EMEA staff supports generic biotech treatment

Thu, 26 Jan 2006 19:01:39 -0500

Regulators at the European Medicines Agency have issued a positive opinion for a generic biotech product, laying the stage for what may become the first approval for a generic biotech treatment. The move is being closely watched in the global biotech industry. U.S. biotech companies have fought for years against any move to permit generic biotech drugs, saying that the manufacturing process is too complex to permit knockoffs. But Europe has been moving steadily toward a new regime that will green-flag so-called biosimilars, which may well put pressure on the FDA to follow suit.

"The positive CHMP opinion for Omnitrope is an important step on the way to make this medicine available for patients who need it," said Dr. Andreas Rummelt, CEO Sandoz. "Omnitrope will contribute to cost savings in the healthcare systems and we are confident that the European Commission will now grant marketing authorization."

- read this report for more information

UCB granted orphan drug status by FDA

Tue, 08 Nov 2005 19:01:36 -0500

Brussels-based UCB has announced that the FDA has granted orphan drug status to brivaracetam for the treatment of symptomatic myoclonus, a disease characterized by jerking, involuntary movements of the arms and legs, which is sometimes a symptom of various epileptic disorders. The European Commission also granted brivaracetam orphan status earlier this year.

- read this press release for more

FEATURE: Europe plans a biotech push

Thu, 20 Oct 2005 20:01:32 -0400

Biotechnology is driving innovation in medicines, agriculture and industry, and the European Commission is anxious to position the continent to make sure it gets a share of the economic development action the industry is likely to create along the way.

The European Commission's in-house research facility, the Joint Research Centre (JRC), is launching a study on the social, economic and environmental consequences and challenges presented by biotechnology. The Commission plans to draw on the study to update its Biotechnology Strategy of 2002 as it prepares for the Spring European Council 2007. And the EU is making it clear that biotech--with its educated, well-paid work force, concentration on cures and environmentally-friendly R&D activities--will figure prominently in its plans to promote sensible economic growth.

"This Commission has made biotechnology a high political priority," said Commission Vice-President Günter Verheugen responsible for enterprise and industry policy. "If used properly, it has the potential to become a driving force in our knowledge-based economy."

And Europe has a lot to gain economically as well.

The EU biotech industry, having approximately the same number of companies as in the US sector, employs nearly half as many people, spends one-third as much on R&D, raises three or four times less venture capital and has access to four times less debt finance, says the EU. Nevertheless, the US industry generates only roughly twice the revenues of the EU sectors.

The main financing obstacle for EU biotech companies, says the Commission, seems to occur after a few years in the business cycle. At the moment at which companies should take off, many of them appear to run out of money. "Therefore it is important for European business to exploit the potential of biotechnology while addressing ethical and social concerns in close cooperation with third countries. This initiative aims at supporting research, competitiveness and innovation while safeguarding intellectual property in an increased electronic information network."

Another related document, the third Biotech report, outlines what needs to be done by the Commission and other EU institutions. It identifies which groups need to deliver on the aims set out in the Commission's strategy of 2002, which consists of policy orientations and a 30-point action plan.

For instance, these actions aim at:

developing skills (by identifying education and training needs, linking education, industry and career guidance, staff exchanges, etc.)
supporting research
getting the EU intellectual property system in force; the cost of protecting intellectual property is four times higher in Europe than in the US
networking all the various stakeholders working in biotechnology (technology platforms, web portal, EuroBioClusterSouth regional network)
building on recommendations to the Commission from the Competitiveness in Biotechnology Advisory Group composed of representatives from industry and entrepreneurial academics.

John Carroll is editor of FierceBiotech.

ALSO NOTED: GW Pharma must mount new trials; Elan shares surge on Tysabri strategy; and much more...

Thu, 09 Jun 2005 20:00:50 -0400

> GW Pharma confirmed reports that regulators will require the company to mount new clinical trials to confirm the safety of its cannabis-based Sativex. Story

> Shares of Elan and Biogen Idec surged late Thursday after the New England Journal fo Medicine quoted doctors for Biogen discussing strategies to return Tysabri to the market while protecting patients from a possible brain infection. Story

> The European Commission has approved Schering-Plough's Temodal for first-line use for the treatment of newly diagnosed glioblastoma multiforme, the most common and aggressive form of primary brain cancer. Release

> The FDA has extended its review of Insmed's Somatokine for three months, until October 3. Release

And Finally... Drug makers believe a proposed new law on patents could make life harder for the industry. Story