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Today's Top Stories
1.
Covance's AZ lab closure to result in 130 lost jobs
2.
SNBL mending lab issues, tangling with animal welfare issues
3.
Quanticate looks to India to expand operations
4.
BASi trims lab costs to recoup losses from first half of 2012
5.
Home drug delivery considered a 'key initiative' for Marken
Editor's Corner:
Top 10 Best-selling Cancer Drugs in 2011
Also Noted: Spotlight On...
Patient recruitment should be a greater priority, drugmakers say in survey
Revenue at PDI falls 28%; Outsourcing improved in 2011, but not so much for manufacturing;
and much more...
More Fierce Life Sciences News:
1.
Pfizer's targeted drug knocks out child cancers in small study
2.
Former exec indicted, accused of selling adulterated devices
3.
Study links Z-Pak with risk of sudden death
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Top 10 Best-selling Cancer Drugs in 2011
Oncology drugs are hot. Scratch beneath the surface of most major drugmakers, and you'll find a host of them in various stages of development, as the upcoming American Society of Clinical Oncology meeting will attest. The usual reasons for growing drug demand apply: Rising healthcare spending in countries such as China; an expanding middle class better able to access healthcare in India and other emerging markets; and aging populations in big drug markets like the U.S. and Japan.
But cancer drugs have their own unique drivers. They treat deadly, frightening diseases, so patients demand them, even at nosebleed prices. Penny-pinching gatekeepers like the U.K.'s National Institute for Health and Clinical Excellence are more amenable to new drugs for patients with terminal illness, if not at pharma's asking price.
Many of the newer cancer drugs, recently approved and in development, are aimed at cancers with specific genetic variations, so the drugs can be targeted to patients who are most likely to benefit--and that likely benefit can command premium prices. Finally, biologic treatments for cancer don't face generic competition on schedule as traditional drugs do, so even older drugs such as Herceptin don't have to contend with low-cost knockoffs. U.S. provisions for biosimilar versions guarantee that will change--but it hasn't changed yet.
In fact, the three top-selling cancer drugs on our list--Rituxan, Avastin and Herceptin--were approved in 1997, 2004, and 1998, respectively. So, they've been long-term earners for their developer, Genentech, now Roche's ($RHHBY) U.S. unit. The newest drug on the list is Tarceva, another Genentech product, which won FDA approval in November 2004.
So, let's get down to the figures: These 10 treatments brought in U.S. sales last year ranging from $564 million to $3 billion, according to IMS Health numbers. Our Nesa Nourmohammadi gathered the data. You'll get the individual nitty-gritty in this report. It should be noted that the list of FDA approvals for each drug is not intended to represent the very precise indications on agency-approved labels. Click here to read the full report >> --Tracy Staton (email | Twitter)
Read more about: Alimta, Erbitux, Velcade
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Today's Top News
1.
Covance's AZ lab closure to result in 130 lost jobs
Covance ($CVD) will close its $100 million Chandler, AZ, laboratory by year's end, a Covance spokeswoman tells FierceCRO, meaning the loss of 130 jobs.
The CRO's decision to close the facility is due to dwindling demand for early development and toxicological work, said spokeswoman Melissa Thompson. Chandler employees are encouraged to apply for positions at other Covance sites, but the CRO says it will assist them with job transitions any way possible. As for projects at Chandler and the animals housed there for research purposes, they will be redirected to other Covance labs, Thompson added.
While Covance and its supporters are upset about the closure, others are rejoicing. Since opening the facility in 2009, Covance hasn't been welcomed by everybody in the region, as a story from The Arizona Republic details a controversial history, specifically when it comes to animal rights concerns and what some call unrealized jobs. As FierceBiotech reported three years ago, Covance expected to generate 500 jobs at the site, while the grass-roots organization Citizens Against Covance argues that it promised to bring upward of 2,000.
"When Covance moves out of the site where so much toxicity testing was performed, we wonder what will be left behind," said Jan McClellan, spokeswoman for Citizens Against Covance, to FierceCRO. "We do know they will be leaving behind their jobless employees which were supposed to be 2,000, but in reality are only 133."
- read more from The Arizona Republic
Related Articles:
Covance readies new research center in Arizona
Covance sees early development losses, closes Arizona lab
Read more about: Arizona
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Catalent. More Products. Better Treatments. Reliably Supplied.
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2.
SNBL mending lab issues, tangling with animal welfare issues
Almost two years after receiving an FDA warning letter citing 9 violations at its Everett, WA, laboratory, SNBL USA announced that it remedied 7 of them. But while the U.S. subsidiary of Japanese CRO Shin Nippon Biomedical Laboratories is resolving its issues in one part of the world, it is caught up in an animal rights scandal in another.
Since receiving the FDA warning letter in August 2010, SNBL made numerous changes to the lab--the CRO tweaked its staff, provided additional training for all of its employees and enhanced programs to monitor equipment maintenance and calibration, according to a company release. And comply with the two remaining violations, SNBL will need to finalize several report amendments regarding specific assay issues on certain past studies, something it has already made "significant progress" on, it says. (The FDA's warning letter to SNBL, complete with a breakdown of the violations, can be found here.)
But as it corrects its mistakes stateside, SNBL is entangled in another controversy, this time in Israel. This month, the country's attorney general, Yehuda Weinstein, stopped a shipment of almost 100 macaque monkeys to SNBL in the U.S. He argued that the particular animals in this case didn't conform to national law when it comes to exporting creatures for medical purposes, according to The Jerusalem Post. Though SNBL declined to comment about the issue to Outsourcing-Pharma, it has made an investment to improve animal living conditions at the Everett lab, as the publication also reports.
- read the release from SNBL - learn more from Outsourcing-Pharma - here's additional info from The Jerusalem Post
Related Article: Animal rights group calls out MPI, USDA over monkey deaths
Read more about: SNBL USA, Israel
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3.
Quanticate looks to India to expand operations
U.S./U.K. CRO Quanticate announced this week that it would open a new office in Bangalore, India. It is a move that reinforces the CRO's commitment to work in the country, despite controversy surrounding India's clinical and pharma handlings.
Opening its first office in India comes as Quanticate hopes to grow in the region, Executive Vice President and Chief Commercial Officer Daniel Chapple explains in a statement. And as Chapple and PharmaTimes notes, the market will also allow customers to enjoy Quanticate's large-scale functional service provider (FSP) contracts, with FSP services being something that tickles the likes of Astellas Pharma, Eli Lilly ($LLY), Merck ($MRK) and Sanofi ($SNY).
The news comes at a time when the country's drug industry has been scrutinized at home and abroad. In March, an investigative piece on Indian CRO's by NBC's "Dateline" depicted two small CROs--Lambda Therapeutic Research and Synchron Research Services--as willing to conduct trials of a copy of Vioxx, a pain drug that led to the death of thousands, while compensating subjects only a fraction of what they would receive in the West. Adding to that was a parliamentary inquiry this month that revealed that India's health agency allowed 31 of 42 drugs approved between 2004 and 2010 onto the market without going through a clinical trial (though the drugs were already approved in the U.S.).
Still, Executive Vice President of Operations (Strategic Delivery) Karen Oooms maintains that Quanticate's work in India is more than just about saving money.
"Quanticate has been careful in its approach to using lower cost regions and does so for more than the purpose of achieving more attractive labor rates due to the importance and cost of gaining the data," she said in a statement. "The employees that are working in all our sites are not only highly experienced but also have a focus on teamwork to ensure that the high quality deliverables and communication that Quanticate has a reputation for is not impacted."
- read the release from Quanticate - learn more from PharmaTimes
Related Articles: India's drug regulator says it will clean up its act INC Research and Astellas expand alliance Reactions to poor practices, 'Dateline' special on CROs differ in India
Read more about: India
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4.
BASi trims lab costs to recoup losses from first half of 2012
The financial expectations Bioanalytical Systems ($BASI) executives had hoped for in the first half of fiscal 2012 were not met, according to its second-quarter results. With that, the Indiana CRO will have to reconfigure some of its lab operations in an effort to recoup losses.
Overall revenue fizzled 12% over the first half that ended March 31 compared with a year earlier, which led to BASi deciding to close its McMinnville, OR, lab before the end of this month. Consolidating the services there into BASi's facility in West Lafayette, IN, will lead to a charge of $450,000 in the current quarter, CFO and Vice President of Finance Jacqueline Lemke said in the financial report.
But laboratory consolidation and cutbacks don't end there. BASi will reduce operating costs at its labs in West Lafayette and Evansville, IN, over the next few months, while continuing to monitor its U.K. lab in Warwickshire to make a determination of where to go with it. And just like Covance ($CVD) and Charles River Laboratories ($CRL) experienced this year, demand for services in toxicology lagged, though BASi saw some slight improvement in requests for work in the sector, President and CEO Tony Chilton maintains in a statement.
If the chips fall into place and BASi plays its cards right, the changes over the next few months could save $4.5 million annually, according to the CRO.
- read the financial report
Related Article:
Covance sees early development losses, closes Arizona lab
Read more about: BASi
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5.
Home drug delivery considered a 'key initiative' for Marken
Why go to the clinical trial, when you could bring the trial home to you? Offering a home delivery service for clinical subjects is a concept supply chain service provider Marken is looking at possibly using, as an Outsourcing-Pharma story shows.
The notion isn't unusual, as pharma giant Pfizer ($PFE) has tried remote trial testing, an experiment that had its ups and downs. What Marken envisions is shipping pharmaceuticals directly to the homes of the subjects, rather than bringing the subjects to sites. It's a service that Marken has already toyed with through a limited number of trials in some countries, Senior Vice President of Commercial Operations Ariette van Strien tells Outsourcing-Pharma.
"We cannot commit to a final timeline as each country will have its specific legal and regulatory requirements, but it is a key initiative for Marken," said van Strien, as quoted by Outsourcing-Pharma.
While remote testing can raise questions, it could help take the growing company to new heights. As Marken evolves through its recent acquisition of LabCorp's sampling kit sector, as well as the launch of new sites and online inventory and diagnostics tools, offering this new service can set it apart not only from its contemporaries, but another group of possible competitors: global shipping giants, like World Courier, UPS, DHL and FedEx, all of which have made investments in trial logistics, the article highlights.
- get more from Outsourcing-Pharma
Related Articles:
Frustrated Pfizer seeks Euro recruitment contractor for 'virtual' trial
Pfizer looks to electronics to streamline trials
Read more about: clinical trials
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Also Noted
SPOTLIGHT ON...
Patient recruitment should be a greater priority, drugmakers say in survey
As CROs and clinical outsourcing grow, it seems that subject recruitment and participation in clinical trials are lagging, as the American Association of Cancer Research (AACR) has shown. A survey conducted by market research firm Industry Standard Research shows that nearly 90% of surveyed drugmakers would prefer reaching patient recruitment goals at least 10% faster over cutting Phase II or Phase III trial costs 20%, as Ed Silverman details in his blog Pharmalot. As Silverman further explains, dissatisfaction in the field may explain why many pharma companies and drugmakers are taking the initiative to handle the recruitment process themselves, rather than bestowing that duty on CROs. Blog
@NesaNFierce: Clinical and pharma controversy in India hasn't scared off Quanticate. Article | Follow @NesaNFierce
> Outsourcing experienced a recovery in 2011, but contract manufacturing still has a way to go. More
> Revenue fell 28% at PDI, something the CSO attributes to the expiration of some contract sales deals. Article
> Amdescope, a CRO from Finland, announced that it would offer the PlexPress' TRAC (transcript analysis with the aid of affinity capture) platform for high-throughput gene expression analysis, as part of its in vitro drug interaction and preclinical ADME-Tox services. News
> Industry leaders gathered at the Avoca Group's Quality Summit this month in New Jersey, where they discussed how to ensure high-quality, outsourced clinical research. Story
> Research: Special Report: Cancer Immunotherapy Production: Overcoming Obstacles to Profitability
Preventative vaccines have changed the face of infectious disease, even leading to the near eradication of polio. Now therapeutic vaccines are looking to change the treatment of cancer and other diseases. The science is exciting and the results are positive. But the challenges of manufacturing cancer vaccines could risk making this an impractical solution to an already complex problem. Download the report today.
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