Europe

Pharma finds promise, peril in biotech revolution

John Carroll — Wed, 02 Jul 2008 09:44:37 -0400

The problem with the European pharmaceuticals industry--at least in part--is biotechnology. Or that's what the European Federation of Pharmaceutical Industries and Associations believes. The big trade association says that the slowdown in new drug approvals seen around the world can be directly linked to the biotech revolution, which has revealed a host of new drug targets while making the drug discovery process more complex and costly.

"The increasing information on the genetic basis of disease and the inherent diversity of human biology means that we are discovering new disease targets which push the boundaries of our knowledge and make the development of drugs difficult and costly," EFPIA added in a document quoted by BioWorld. The EFPIA prepared its arguments in response to critics who attribute the slowdown in drug discovery to antitrust activities.

"The biotechnology revolution has been just that, a revolution," said the EFPIA. "It has presented pharmaceutical companies with so many promising targets and opportunities for innovation that identifying the best candidates is costly and results in many blind alleys. Translating new discoveries into marketable products has taken the industry longer than expected."

- read the article from BioWorld

SPOTLIGHT: Big Pharma changes rules in emerging markets

Wed, 21 May 2008 06:59:53 -0400

Emerging markets are getting more and more attention these days, as drugmakers wake up to the fact that the coming growth areas on the globe aren't found in North America or Europe. And as the importance of countries such as India, China, and Brazil grows more evident to Big Pharma, so is the fact that the strategies that work in the super-industrialized world won't serve in countries where the middle class is just now growing by leaps and bounds. Report

European investors sour on biotech market

Tue, 13 May 2008 06:59:56 -0400

There's a loud drumbeat of warnings coming from Europe over the sour state of biotech investing. Zhining Xu, an analyst at Seymour Pierce, tells the Financial Times that 2007 was a "disaster for biotechnology in the U.K." Andrew Baker, chairman of the International Biotech Trust, calls the first half of 2008 "appalling." And in FierceBioResearcher, we feature the voice of Sir Chris Evans, one of Britain's pioneering biotech entrepreneurs, talking about the "perfect storm" that has smashed into the field, threatening the amount of research work that's being done on the continent.

The viral skepticism isn't restricted to Europe. Investors are noting an increasingly tough regulatory approach to approvals at the FDA, a string of late-stage drug failures and nervousness over the lengthy amount of time it will take to get new genetic therapies on the market.

Interestingly, biotech stocks have been beaten down so far that some of the pessimists are saying that there are grounds for optimism. In the investing world, what goes down must go up. Right?

- read the article in the Financial Times

ALSO: One bullish Danish expert says that Denmark's biotech companies have matured to the point where they are ripe for acquisition by Big Pharma. Report

Astellas faces new delay for Advagraf approval

Wed, 07 May 2008 06:59:54 -0400

Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised questions about the safety and efficacy of the drug for use in liver transplants. Last March the FDA issued an action letter regarding Advagraf for kidney transplants. The agency's action letters typically mean at least a six month delay before regulators will approve it.

Advagraf is already approved in Europe. Prograf earned $2 billion in sales last year.

- read the story in Yahoo News

UCB CEO plots strategy following Cimzia approval

Thu, 24 Apr 2008 06:59:58 -0400

Fresh off the FDA's approval of Cimzia for Crohn's disease, UCB chief executive Roch Doliveux forecast a swift regulatory success in Europe. Cimzia is one of the most closely watched late-stage drugs for arthritis, and Doliveux was clearly buoyed by the 20 percent jump in the value of UCB shares following yesterday's regulatory win. UCB's pegylated anti-TNFa therapy offers a new, easier form of administration than existing arthritis therapies and analysts have been bullish about its market potential.

The CEO also forecast a resolution of its manufacturing problems with Neupro, which was recalled in the U.S. after formulation problems were revealed. Cimzia, Vimpat, Neupro and Rikelta are all expected to add to the company's performance, says Doliveux, after which UCB plans a "breakthrough" phase.

- see UCB release on the approval
- read the AFX report

Introgen gets positive Phase III Advexin data

Tue, 15 Apr 2008 06:59:56 -0400

Introgen Therapeutics announced that a preliminary analysis of a late-stage trial of Advexin confirmed their mid-stage efficacy data for patients with recurrent head and neck cancer. And researchers added that a biomarker for the gene target is predictive for identifying patients likely to respond to the therapy. Austin-based Introgen says it will file for approval in U.S. and Europe this quarter.

"Advexin provides therapeutic benefit by restoring p53 tumor suppressor function which is blocked in the majority of head and neck cancers," said Robert E. Sobol, senior vice president, medical and scientific affairs.

- check out the release
- read the report from BioWorld

Related Articles:
Introgen reports biomarker link to new therapy. Introgen report
Introgen touts cancer data. Introgen report

Biopharma execs sign on to tout UK's R&D work

Mon, 07 Apr 2008 06:59:56 -0400

A high-profile crew of biopharma execs are signing on to help promote the life sciences industry in the UK. Chris Brinsmead, president of AstraZeneca U.K., will chair a 12-man strategy group for UK Trade & Investment to scout overseas markets for the U.K.'s life sciences industry while recruiting overseas investors. The life sciences industry is one of five sectors getting some muscular promotional support. And with the largest pipeline for new products in Europe, the country feels it has plenty to boast about.

"The UK is Europe's top location for research and development and a global hub for scientific research, but retaining this position in the face of growing competition from abroad is a significant challenge," Lord Digby Jones, the UK's trade minister, told The Times.

- read the report from The Times

Related Articles:
Market volatility spurs M&A talks at UK biotechs. Report
U.K. to require more disclosure of drug trial data. Report
U.K. researchers driven out by tough regulations. Report
GSK looks abroad for more scientists as U.K. shortage grows. Report

BioCon buys stake in German pharma company

Fri, 15 Feb 2008 06:59:56 -0500

Fulfilling an earlier promise to acquire a company, Bangalor-based BioCon has spent €30 million to purchased a 70 percent stake in German pharmaceutical company AxiCorp. The deal will allow BioCon to market its injectable insulin, Insugen, in Europe; it will be followed by other generics, biosimilars and biologics.

In January BioCon indicated that it was exploring ways to promote its products in North America and Europe, and planning to spin off its clinical research group. According to Biocon's release, this marks the first of several acquisitions Biocon has planned following the sale of its enzymes business last year. "We are very focused on becoming a key player in insulin globally," said a BioCon spokesperson. "We can deliver through a combination of Biocon's low cost manufacturing and AxiCorp's low cost distribution."

- here's the release
- and check out this Economic Times report

Related Articles:
Biocon CEO plans acquisition, spin-off. Report
Biocon plots new deals after sale of enzymes business. Report
India focuses on biosimilars. Report

Penwest shares dive as pain drug flunks endpoint

Mon, 04 Feb 2008 06:59:55 -0500

Penwest Pharmaceuticals says that a Phase IIa for nalbuphine ER, an extended release pain drug, failed to hit a primary goal. But researchers say that the drug performed well enough on its secondary endpoints to warrant advancement into Phase IIb trials later this year.

Investors didn't share the company's sunny disposition, though. Penwest shares dived 20 percent after investors learned that the drug failed to reduce pain intensity as intended. Currently available by injection, Penwest is testing an oral form of the drug. And the company says it is also pursuing talks to partner the drug in Europe.

- see the release from Penwest
- read the AP report

Related Articles:
Endo, Penwest boosted by new Opana approval. Report
Pain drug prescriptions skyrocket. Report
Biolex pockets $30M for drug discovery work. Report

Biocon CEO plans acquisition, spin-off

Thu, 17 Jan 2008 06:59:55 -0500

Biocon chief Kiran Mazumdar-Shaw says the Indian drug developer is close to completing a multimillion-dollar acquisition to push its products in North American and Europe and plans to spin off its clinical research group--Syngene--into a separately listed company. Shaw added that the spin-off should be completed this year.

"We believe Syngene has attained critical mass that can be leveraged to deliver a strong growth trajectory," says Shaw. "As one of Asia's largest and most profitable contract research companies, Syngene's public float can deliver superior shareholder value."

- read the article in the Hindustan Times

Related Articles:
Biocon plots new deals after sale of enzymes business. Report
India focuses on biosimilars. Report