EMEA

EMEA issues host of decisions

Maureen Martino — Fri, 25 Jul 2008 10:54:29 -0400

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has been busy. The drug regulator released a host of decisions today, so here's the round-up:

The Committee for Medicinal Products in Human Use (CHMP) recommended approval of Bayer's blood-thinning pill Xarelto. The drugs, which Bayer hopes will generate €2 billion in sales, prevents thrombosis in patients bedridden after major orthopaedic surgery. Report
Sanofi-Aventis' Taxotere got shot down, as the agency recommended against using the drug to treat HER2 positive breast cancer. Report
The EMEA restricting the use of antibiotics based on moxifloxacin--marketed by Bayer under the name Avelox--because of the potential risk of liver damage, and also wants strengthened warnings. Report
A positive opinion was issued on marketing authorization for Ceplene for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia. Release
Novartis' osteoporosis drug Aclasta was recommended to treat the disease in men who are at increased risk of fractures. Release

GSK bird flu vaccine wins race for European OK

Mon, 19 May 2008 06:59:58 -0400

After investing about $2 billion in development efforts, GlaxoSmithKline has won European approval for the first bird flu vaccine that can be used either in advance of or in the early days of a human pandemic. Glaxo is clearly expecting to see orders for Prepandrix shoot up after regulators for the European Commission firmly placed the vaccine well in the lead in the heated race to develop an antidote designed to protect populations against H5N1. Switzerland has already ordered 8 million doses, enough to inoculate its entire population. And the U.S. has ordered 27.5 million doses.

"It's clear that some governments are more proactive than others," said Emmanuel Hanon, vice president of the Influenza Vaccine Franchise at Glaxo. "The policy is evolving, and I'm looking for some kind of alignment in terms of what governments are going to do. Governments are concerned by the real medical and economic threat of a pandemic."

Sanofi Aventis and Novartis are also in the race to gain approvals for a new vaccine, anxious to capture a market that may total about $1 billion a year.

- read the story from the International Herald Tribune

ALSO: South Korea, meanwhile, mobilized soldiers for a second time to help cull millions of poultry in the face of an outbreak of H5N1 in the country's bird population. Report

Pfizer rumored to be eyeing MediGene buyout

Wed, 14 May 2008 06:59:57 -0400

Rumors are swirling that Pfizer is looking to take over the German biotech MediGene. Shares of the smaller company leapt more than 12 percent today as reports of a possible deal hit the newswires. Neither company would comment on whether they've held talks, as reports suggest.

MediGene specializes in cancer, autoimmune disease and skin disease; its two marketed products are the prostate cancer treatment Eligard and a genital warts med Veregen. European approval for a skin drug, Oracea, is pending. In the pipeline: a pancreatic cancer drug, Endotag.

- see the story in Forbes
- check out the brief at Thomson Merger News

Developers: Politics behind slow approval process

Wed, 26 Mar 2008 07:59:57 -0400

Woodcock's defense, though, may seem particularly hard to accept at a slate of big pharma companies which have been able to win European approvals only to run straight into a roadblock at the U.S. agency. Galvus, Acomplia and Cervarix have all been OK'd by the European Medicines Agency, but are still languishing at the FDA. And Novartis says it may simply skip the U.S. market for Galvus if the feds raise the bar too high for the diabetes drug. The Wall Street Journal notes that a number of analysts believe the FDA faces a higher degree of public and political pressure during the approval process--precisely the kind of influences that Woodcock rejects as a significant factor.

"The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill," says James Shannon, Novartis' departing head of drug development. "I think it results in them taking decisions which are conservative."

- read the story in the Wall Street Journal

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Dry spell or parched desert for NME approvals? Report
Blogster sees lessons in FDA approvable letters. report

Canadian regulators forging new biosimilar pathway

Tue, 25 Mar 2008 07:59:55 -0400

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
- read the article on the EMEA's approvals in Motley Fool

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Debate over follow-ons focus on market exclusivity. Report
Budget has mandate for biogeneric approvals. Report
Insulin debate spurs push for generic biologics. Report
Waiting game continues for biogenerics. Report

Pharming shares sink after Rhucin gets thumbs down

Thu, 20 Mar 2008 07:59:57 -0400

There's new trouble for Pharming's Rhucin, an experimental treatment for hereditary angioedema. Pharming shares plunged after the company announced that the EMEA's Committee for Medicinal Products for Human Use is expected to refuse to approve Rhucin, saying that there is insufficient evidence of clinical benefits after repeated use and a possibility of immune system reactions. Pharming's shares were down about 27 percent after initially dropping by almost half.

Rhucin has been a major headache for Pharming since the EMEA first denied approval last December, sending its stock into a downward spiral. The drug is manufactured in the milk of transgenic animals and has long been held up as a leading example of the potential of transgenic therapies. But Pharming isn't giving up. "European denial for the drug is not the end for Rhucin nor for Pharming," Chief Commercial Officer Rein Strijker told reporters. The company insists that additional data will convincingly make their case for Rhucin and win eventual approval.

- see Pharming's release
- check out the ABN story

Related Articles:
Pharming says it's closing in on Rhucin approval. Report
Pharming steps up marketing plans on Phase III data. Report
Regulators focusing on transgenic animals. Report
Pharming gets orphan status for transgenic therapy. Report

ALSO NOTED: U.K. calls for halt to HIV study; Cadence to raise $49.3M; and much more...

Fri, 15 Feb 2008 06:59:50 -0500

> The U.K.'s Medical Research Council has advised Indevus Pharmaceuticals to close the high-dose arm of it's Phase III HIV study. Release

> Cadence Pharmaceuticals is raising $49.3 million in a registered direct common stock offering. Release

> The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. Report

> Well, we didn't have to watch Alex Gorsky for long. According to the Wall Street Journal, when Novartis said that the U.S. pharma CEO was leaving, they left out the part about his returning to alma mater Johnson & Johnson. Report

> The FDA has approved a label change adding depression as a possible side effect of the cholesterol meds Vytorin and Zetia. Report

> Sanofi Pasteur has submitted the first vaccine delivered by an intradermal microinjection system for European approval. Report

> Despite spending a dramatically higher amount than before on treatments for spinal pain, Americans aren't getting great results, according to a new study. Report

> FierceHealthcare asks: Would a new agency curb pharma marketing misdeeds? Editorial

And Finally... Natural purple pigments found in fruits, vegetables and berries may help prevent obesity. Release

Cell Therapeutics reorganizes, scales back R&D

Thu, 31 Jan 2008 06:59:58 -0500

Cell Therapeutics is scaling back its research plans for Xyotax and pixantrone, cutting one group of staffers and beefing up on the sales side as it concentrates on marketing its recently-acquired Zevalin cancer therapy. The move--designed to reduce operating expenses by 35 percent--leaves 31 staffers out of jobs, reducing its headcount to 133 after it fills 13 sales and marketing posts. The biotech says that they are still on track to file for European approval of Xyotax and evaluate pivotal data for pizantrone.

"We believe the best way to maximize shareholder value now is to focus our resources on our marketed and late-stage products," said James Bianco, president and CEO. "It is with great disappointment that we must reduce head count elsewhere in order to meet these goals."

- see this release
- read the report from the Seattle Times

Related Articles:
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Cell Therapeutics inks deal for Xyotax. Report
Bayer Schering touts Zevalin study. Report
Cell Therapeutics makes bid to buy DOR. Report

EMEA shoots down UBC's Cimzia

Fri, 16 Nov 2007 06:59:55 -0500

It looks like UBC has struck out in the EU. The EMEA told the company that the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Cimzia, a treatment for Crohn's disease. The CHMP raised several issues that UBC plans to address in order to gain approval by mid-2008. The company said it will submit an appeal on the decision. UBC's shares plunged on the rejection. Back in March the FDA told UBC that it would need to conduct another trial of Cimzia, shocking investors and delaying the drug's U.S. approval by at least two years.

"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of Cimzia. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's disease," said Melanie Lee, Executive Vice President Research & Development of UCB.

- check out this release on the rejection

Related Articles:
FDA shocks UCB investors with Cimzia trial demand. Report
Late-stage Cimzia trial for RA hits endpoints. Report
UCB submits BLA for Cimzia. Report

Pharming raises $99M

Fri, 19 Oct 2007 06:59:55 -0400

Netherlands-based Pharming has raised $99 million (€70 million) through the issue of convertible bonds. The issue was managed by UBS Investment Bank. The company is also finalizing discussions for restructuring its financing agreement with Paul Capital Healthcare which Pharming entered into in February 2006. Pharming will repay Paul Capital EUR $13 million (€9 million) by the end of this year, with an additional $15 million (€11 million) to be paid in the first quarter of 2008.

Pharming is on the verge of a major European approval for Rhucin, a transgenic therapy made from rabbit's milk that's designed to treat hereditary angioedema. An announcement is expected sometime in this quarter.

- see this release

Related Articles:
Pharming says it's closing in on Rhucin approval. Report
Pharming inks creative drug partnering pact. Report
Pharming wins fast track review, shares jump. Report
Pharming gets orphan status for transgenic therapy. Report

ALSO NOTED: Novartis teams up with MIT; EMEA approves Galvus; and much more...

Fri, 28 Sep 2007 06:59:50 -0400

> Novartis is teaming up with MIT to develop new ways to manufacture drugs. The company will give the university $65 million over 10 years to create a new research program. Report

> Galvus, a once-daily oral treatment for type 2 diabetes, has been approved by the EMEA. Release

> Celera has earned a clinical milestone payment of $2 million from Merck. The payment was triggered by Merck's advancement of odanacatib into a Phase III clinical trial as a potential treatment for osteoporosis. Release

> Scientists at the Institute for Neurodegenerative Disorders report that they have identified a drug that could potentially treat the cognitive disorders associated with schizophrenia. Report

> A new study concludes that two enzymes--SIRT3 and SIRT4--play a key role in mitochondria, regulating the aging process. Report

And Finally... Researchers at Texas A&M University are participating in developing a medicine that is worth sneezing about: a treatment for influenza that forms a jelly when sprayed into the nose. Release

ALSO NOTED: EU panel recommends Bayer, GSK drugs; Novacea names new CEO; and much more...

Fri, 21 Sep 2007 06:59:50 -0400

> An EMEA advisory panel has issued six positive opinions on marketing applications for new drugs, paving the way for EU marketing approval. Report

> Chutes & Ladders: Novacea has elected John P. Walker as CEO. He will continue to serve the Chairman of the company. Release

> Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases has won the Lasker Prize. Report

> Millipore is expanding on its reputation as a filtration supplier to scientific labs around the globe. Report

> Generics may be the bane of Big Pharma, but they're inflation-fighting ninjas. Over the last 12 months, prescription drug prices edged up by a measly 1 percent--the lowest rate of inflation in three decades. Report

> Pfizer is looking to set up its Japanese R&D operation, previously slated for shutdown, as an independent company--with the help of a few investors, of course. Report

And Finally... An ancient mechanism for coping with stresses also gives cancer a boost. Release

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

ALSO NOTED: GSK to commercialize Lunesta; second headline; and much more...

Tue, 11 Sep 2007 06:59:50 -0400

> GlaxoSmithKline has signed on to commercialize Sepracor's insomnia drug Lunesta, agreeing to pay $20 million up front and up to $155 million in total for milestones and licensing fees. Glaxo gains the rights to all countries except the US, Canada, Mexico and Japan. Glaxo is looking for European approval of the drug--dubbed Lunivia outside the U.S.--in the second half of next year. FiercePharma

> Arena Pharmaceuticals stock got a bump this morning when researchers found no sign of heart valve damage after six months of Phase III testing for its obesity drug Lorcaserin. Release

> Evotec has sold its Chemical Development Business to Aptuit for about $63 million in cash. Release

> As part of its overall restructuring, Pfizer will shut down its 53-year-old manufacturing facilities in Sandwich, England, shedding some 400 jobs in the process. FiercePharma

And Finally... According to new research from the Institute for Safe Medication Practices, the FDA received reports of 89,842 adverse events including 15,107 deaths in 2005, more than double the 1998 numbers of 34,966 reports and 5,519 deaths. Report

Pharming steps up marketing plans on Phase III data

Thu, 30 Aug 2007 06:59:58 -0400

Pharming says that its Phase III trial for Rhucin--a human protein developed to treat acute attacks of hereditary angieoedema--has hit its targets, opening the way to European and U.S. markets as the company pursues regulatory approvals on both sides of the Atlantic. With experts at the EMEA expected to give a thumb's up to Rhucin late this year, company officials reportedly believe that they are hot on the trial of a U.S. partnership deal that should include a substantial upfront payment. If all goes according to plan, Pharming tells the wire services, it will launch its therapy--derived from rabbit's milk--in Europe in the first half of '08. And FDA marketing application is expected later this year with an approval coming soon enough to launch in the U.S. soon after the therapy is introduced in Europe. Rhucin would be the second transgenic therapy to hit the market, and Pharming believes it has the potential to earn up to $820 million a year.

- check out the release on Pharming's Phase III

Related Articles:
Regulators focusing on transgenic animals. Report
Pharming says it's closing in on Rhucin approval. Report
Pharming inks creative drug partnering pact. Report
Pharming wins fast track review, shares jump. Report
Pharming gets orphan status for transgenic therapy. Report

Pharming says it's closing in on Rhucin approval

Mon, 20 Aug 2007 06:59:57 -0400

Pharming says that the positive interim results it has received from a study of Rhucin is blazing the way to EMEA approval. The Amsterdam-based developer says it expects EMEA approval in the fourth quarter and should be able to launch the drug, which treats hereditary angioedema, in early '08. The company says it is also just weeks away from completing a U.S. study, and should be able to submit data from that trial for FDA approval. Pharming expects the therapy should garner up to €600 million a year in both the U.S. and Europe. The drug developer's shares jumped about 25 percent on the news.

- see Pharming's release
- and here's the report from ABC Money

Related Articles:
Pharming inks creative drug partnering pact. Report
Pharming wins fast track review, shares jump. Report
Pharming gets orphan status for transgenic therapy. Report

ALSO NOTED: Neuren buys Hamilton Pharma; Merck pulls out of MethyGene collaboration; Par licenses Zensana rights; and much more

Thu, 02 Aug 2007 06:59:50 -0400

> New Zealand's Neuren is acquiring Washington D.C.-based Hamilton Pharmaceuticals for $4.4 million in a deal that delivers the license for a drug called Motiva, a late-stage preclinical compound which is being developed for psychological and cognitive disorders. Release

> MethylGene is looking for a new partner for its beta-lactamase inhibitor program to overcome beta-lactamase mediated antibiotic resistance now that Merck has pulled out of a collaboration. Release

> Par Pharmaceutical says it will make a $5 million equity investment in Hana BioSciences in a deal to acquire the North American commercial rights to Zensana Oral Spray. Par also announced it has entered into an agreement with NovaDel Pharma to collaborate in the reformulation of Zensana. Release

> A new late-stage study of Pharmion's blood and bone marrow disorder drug Vidaza delivered positive data. Vidaza was approved in the U.S. three years ago and is now up for European approval. Release

> Advanced Cell Technology, a stem cell research company, has agreed to buy Mytogen for $5 million. Mytogen has successfully completed Phase I human clinical trials utilizing myoblast therapy safely in over forty patients. Release

> Genzyme says that a second Phase III trial of Mozobil for multiple myeloma hit primary and secondary endpoints. "The combined strength of these two trials--in which patients with two types of cancer achieved more rapid and effective mobilization of stem cells in preparation for transplant than patients treated with current therapies--will support Mozobil's regulatory approval, commercialization, and likely adoption as a standard of care in transplantation," Genzyme said in a release. Release

And Finally... Researchers conclude that the older you are, the less likely it is you'll laugh at the punch line. Report

Regulators focusing on transgenic animals

Mon, 30 Jul 2007 06:59:55 -0400

Genetically engineered animals are producing a range of therapies for human use, and The New York Times catches up on the action at companies like GTC Biotherapeutics in Massachusetts, Pharmathene and Pharming. Developing drugs in this field has been a slow and laborious task, and the FDA is now developing new guidelines to help govern how animals are used to produce therapies. Questions are also being asked about the ultimate fate of these animals. Should they be sold for food?

- read the article from The New York Times

Related Articles:
Transgenic chickens used to manufacture proteins. Report
GTC inks new transgenics collaboration deal. Report
EMEA rejects GTC's therapy from modified goats. Report
Pharming gets orphan status for transgenic therapy. Report

Samaritan posts strong Phase II HIV results

Fri, 20 Jul 2007 06:59:56 -0400

Las Vegas-based Samaritan Pharmaceuticals has announced positive Phase IIb data for its oral HIV entry inhibitor SP-01A. The therapy is being developed for HIV drug resistance and is designed to be used in conjunction with primary antiretroviral treatment. In the study, subjects taking SP-01A showed a reduction in the amount of viral infection in their blood, making it the third Phase II trial in which SP-01A has demonstrated its effectiveness. Samaritan said it will submit the data to the FDA and EMEA.

Dr. Greeson, CEO of Samaritan Pharmaceuticals stated, "We are very encouraged by these results. These results are not only positive for SP-01A as an adjunctive therapy; it also suggests to us that SP-01A might have potential alone as an entry inhibitor coupled with just one 'killer' antiretroviral drug."

- check out Samaritan's release for more

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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