November 9, 2010

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This week's sponsors:
Spotfire
World Congress

Editor’s corner:
Pharma's Top 10 Blockbuster Drugs

Today's Top Stories:
1. Reps question FDA oversight of P.R. plants
2. GAO says FDA bungled Lovenox-copy review
3. Growth in cancer-drug sales drops off sharply
4. Study: Fewer doctors report industry ties
5. Sanofi isn't the only Campath-sales skeptic

Spotlight:
Pricey Pradaxa aces cost-effectiveness study

Also Noted:
Merck withdraws bid for E.U. nod on Dulera; Crucell contamination cuts profits; Much more...

News From The Fierce Network:
1. It's time to halt product security decline
2. Top 10 List highlights medical innovation
3. Canadian 'alchemists' turn skin into blood



Webcast: Spotfire Clinical – Safety Data Visibility and Analytics for Risk Management in Drug Development
Tuesday, November 16th, 2010 @ 11:00 AM ET

Assessment of drug safety is a key aspect of drug development. However, safety data analysis has not been in focus until quite recently. In this talk, TIBCO Spotfire's Michael O'Connell will present some statistical and graphical analyses of safety data in an interactive visualization environment that enables detailed clinical review of sub-populations and patient-level data. Register today!


Editor's Corner

Pharma's Top 10 Blockbuster Drugs

By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn

Welcome to FiercePharma's look at the bestselling drugs of 2009. With the help of EvaluatePharma and PriceWaterhouse Coopers, we've identified a mix of old standbys and disease-altering biologics that make up this year's top 10 list. Some brands--such as Lipitor, Plavix, Advair--will be facing serious generic competition in the near future, while the harder-to-copy biologics are, for the time being, protected from copycats. In the coming years, EvaluatePharma predicts the top 10 list will be dominated by biologics as more small molecules go off-patent. Two top-selling mainstays, AstraZeneca's Nexium and Amgen's Epogen/Procrit, are absent from this year's list; Humira and Seroquel have taken their place. Click here to begin the slideshow ->

Sponsor:World Congress

Events

> Specialty Pharma Commercial Excellence Summit - November 15-16, 2010 - Boston, MA
> 7th Annual American Health Care Congress - December 7-8, 2010
> Hospital/Physician Alignment Leadership Summit - Dec 9-10, 2010 - Vienna, VA
> Pharmacovigilance and Risk Management 2011 - Jan 9 - 12, 2011 - Renaissance Hotel, Washington, DC
> New Paradigms to Fund & Manage Product Development for Biotech - January 13-14, 2011 - San Francisco, CA
> Social Media for Pharma Conference - January 13-14, 2011 - Washington, DC
> Drug Delivery Partnerships - January 26-28, 2011 - Miami, FL
> ePharma Summit 2011 – Register Early And Save - February 7 – 9, 2011 - New York, NY
> 18th International Molecular Med Tri-Con: A Life Changing Event - February 23-25, 2011
> 20th Annual Partnerships in Clinical Trials - Mar 30-Apr 1

Marketplace

> Brandjacking Index: Online Risks in Pharmaceutical Market
> Optimize your Media with our Animal Component Free Products and Supplements
> Are Your Digital Assets Where the Doctors Are?
> Improving the Effectiveness of Online Drug Distribution Through Web-Enhanced Portals
> Free White Paper: Social Media and Post-Marketing Drug Safety

Jobs

> Marketing Manager - Information Services - McKesson Corporation
> Manager of Marketing – Managed Distribution and Vaccines
> Senior Level Global Clinical Operations Role - Pharm-Olam International
> Pharmaceutical Company Compliance Officer - Clinical Data, Inc
> Chief Medical Officer
> Senior Clinical Research Associate
> Director of Marketing JD
> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

Today's Top Stories

1. Reps question FDA oversight of P.R. plants

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Does the FDA have a weak link? The House Committee on Oversight and Government Reform is asking the agency whether its office in Puerto Rico has been understaffed and under-performing, given recent drug-manufacturing problems found on the island.

Sent by Reps. Edolphus Towns and Darrell Issa, the letter points out the ongoing problems with drugs made at a Johnson & Johnson ($JNJ) plant that manufactured consumer drugs subject to a series of recalls. And it raises questions about serious manufacturing shortfalls at a GlaxoSmithKline ($GSK) plant; the company recently agreed to pay $750 million to settle claims involving substandard manufacturing there.

Puerto Rican facilities were also involved in Pfizer's ($PFE) recent recalls of moldy-smelling Lipitor. Bristol-Myers Squibb ($BMS) has had ongoing problems at a facility in Manati, in-Pharma Technologist points out. And, according to Bloomberg, drug plants on the island failed their FDA inspections 64 percent of the time from 1999 to 2010--and 70 percent of the time since 2007.

So, the committee is asking for FDA documents, including a list of the Puerto Rican sites overseen by the agency, a list of its inspections performed over the past 10 years, and copies of warning letters issued for Puerto Rican facilities. "It appears that FDA's Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," Issa and Towns wrote. The FDA says it will respond when it receives the letter.

- see the New York Times coverage
- get more from Bloomberg
- see the in-Pharma Technologist story

Related Articles:
FDA needs to refocus plant inspections, GAO says
BMS aims for new inspection of troubled plant
FDA's new zeal attracts attention

Read more about: Puerto Rico, FDA
back to top


This week's sponsor is World Congress.

2. GAO says FDA bungled Lovenox-copy review

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

The U.S. government has just added its weight to the tug-of-war over generic versions of Lovenox. Momenta Pharmaceuticals ($MNTA) won the high-stakes race to sell its generic form of the Sanofi-Aventis ($SNY) blood thinner earlier this year, in partnership with the Novartis ($NVS) copycat drugs unit Sandoz. But that OK came only after conflict-of-interest accusations from other generics makers also seeking FDA approval for their Lovenox knock-offs.

As Amphastar Pharmaceuticals and Teva Pharmaceutical Industries ($TEVA) saw it, Momenta had a too-cozy relationship with CDER Chief Janet Woodcock in particular and the FDA in general. During the heparin scandal in 2008, Momenta pitched in on the investigation at no charge--at the same time the agency was considering its application to sell a Lovenox copycat. The agency investigated and recently announced that Woodcock had no financial conflicts in the generic-Lovenox review.

Now, however, Congress' watchdog group, the Government Accountability Office, says the agency's actions made it appear to show favoritism to Momenta, even if it really didn't. Momenta's free consulting work, coming at the same time as its application review, "ran the risk of undermining public confidence in the integrity of FDA's operations," the GAO says in a new report obtained by the Wall Street Journal.

Responding to GAO's report, the FDA told the Journal that it needed Momenta's help in identifying the source of heparin contamination that killed or seriously injured more than 100 people. But, the agency said, it should have considered the appearance of conflict--and should have done more to disclose the possibility.

- get the story from the WSJ
- see the Reuters news

Related Articles:
Lovenox copycat sucks market share from Sanofi
Amphastar sues FDA for 'vindictive' behavior
Judge unimpressed by Sanofi's Lovenox argument
Sanofi won't fall from Lovenox patent cliff
FDA's Woodcock draws conflicts-of-interest probe

Read more about: Momenta Pharmaceuticals, lovenox
back to top


3. Growth in cancer-drug sales drops off sharply

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

The cancer-drug gold rush has slowed. For the first nine months of this year, sales of oncology meds rose by only 3.5 percent, compared with 9 percent for all of 2009--and that was down from 14 percent in 2007 and 23 percent in 2006. And as IMS Health SVP Murray Aitken tells Reuters, this year's growth was driven mostly by price increases.

As Reuters points out, 2006 was when Roche launched Avastin, a revolutionary drug that targeted cancer in an entirely new way. Although drugmakers have plowed lots of investment into cancer-drug development, recent introductions have been variations on existing therapies rather than brand-new innovations. And as some targeted therapies go off patent, spawning generic competition--think Sanofi-Aventis' Eloxatin, which lost IP protection this year--those copycats are drawing off sales.

"This is an unprecedented slowdown," Aitken said at the Reuters Health Summit. But he went on to say that the slowdown can be reversed. "If we had another Avastin or Herceptin, it would quickly change direction," he said.

- read the Reuters story

Related Articles:
UnitedHealth targets cancer-drug payments
Avastin, Erbitux rack up data gains
Cancer docs judge drugs' cost-effectiveness
Cancer drugs rising to top of sales pyramid

Read more about: cancer drugs, Avastin
back to top


4. Study: Fewer doctors report industry ties

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

As public scrutiny of the financial ties between drugmakers and doctors has grown over the last few years, more physicians have backed away from gifts and payments from the pharma industry. That's the conclusion of a new report from the Mongan Institute for Health Policy, which found that 84 percent of docs accepted freebies, samples and speaking fees last year, compared with 94 percent in 2004.

Published in the Archives of Internal Medicine, the survey shows that skeptical attitudes toward pharma-physician relationships--exemplified by new conflicts-of-interest policies at some medical schools and teaching hospitals--are having an effect on doctors' behavior, the lead author told Bloomberg. The biggest change: CME payments and junkets, which dropped to 18 percent from 35 percent. "The data clearly show that relationships have dropped dramatically," said Mongan director Eric Campbell. 

The study also found that doctors with industry relationships do tend to prescribe more brand-name drugs than those without such ties. Plus, U.S. regions with the lowest medical costs also have fewer gift-accepting doctors, the survey showed. "[W]hile the drug representatives tell the doctors that these gifts mean nothing," Campbell said, "studies show that accepting anything of value, even things of essentially no value, establishes a reciprocity between the person who gives the gift and the one who receives it."

PhRMA told the Los Angeles Times that many of the industry-doctor links are perfectly appropriate, such as drug samples. The industry association has slightly tightened its voluntary guidelines for relationships between physicians and pharma. And several Big Pharma companies have started disclosing their financial ties to physicians, including Eli Lilly, Merck and GlaxoSmithKline.

- read the Bloomberg coverage
- get more from Hospital Review
- see the Archives study abstract
- check out the LA Times piece

Related Articles:
Psychiatrists dominate doc-payment database
Doc-payment database details industry ties
Patients worry that pharma taints doctors' decisions
What if doctor dinners were illegal?

Read more about: Conflict of interest, Payments, doctors
back to top


5. Sanofi isn't the only Campath-sales skeptic

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Genzyme ($GENZ) and Sanofi-Aventis ($SNY) are once again trading barbs in their ongoing contest over Sanofi's hostile bid. But the most intriguing remarks about that potential deal today came from the sidelines.

First, the companies themselves: Sanofi released a letter urging Genzyme to abandon any defensive tactics suggested by management, including adopting a new poison-pill provision. "[I]n all fairness, you should allow your shareholders the opportunity to decide for themselves," CEO Chris Viehbacher wrote. Genzyme fired back with its own letter reiterating its contempt for Sanofi's $18.5 billion offer, once again saying that its sales-and-earnings forecasts show the company is worth much more.

But here's the rub, offered by Novartis. The Swiss drugmaker questions those very sales forecasts, predicated as they are on rosy projections for future sales of Genzyme's experimental multiple sclerosis drug Campath. Novartis just won FDA approval for Gilenya, an MS treatment that would compete with Campath, and its development chief says that drug will capture enough of the market to keep Campath sales below Genzyme's $3 billion target.

"$3 billion was probably realistic in May, but is it realistic now?" asks Trevor Mundel (as quoted by Reuters), saying that Gilenya will be the first-line drug, leaving Campath to compete for second-line status. "To the extent that we solved the first-line issue first, then space for Campath will close down."

Meanwhile, a key biotech investor says Genzyme has virtually no chance of remaining an independent company. Some 40 percent to 50 percent of the company's shares are now held by arbitragers, who are betting on a takeover. "Genzyme is history," Frederick Frank, vice chairman of Peter J. Solomon, said at Reuters' health conference. "It's only a question of when and at what price." 

- see the Genzyme release
- read the Bloomberg story
- get more from the Wall Street Journal
- check out the Reuters coverage
- find another take from Reuters

Related Articles:
Genzyme mulls Campath giveaway for cancer patients
Sanofi chief unswayed by Genzyme forecasts
What's the real fair price for Genzyme?
Novartis CEO 'fairly confident' Gilenya will top $1B
Novartis pill poised to rattle MS market

Read more about: multiple sclerosis, Gilenya, Novartis, Sanofi-Aventis
back to top


Also Noted

TODAY'S SPOTLIGHT... Pricey Pradaxa aces cost-effectiveness study

When is an $8-a-day drug a bargain compared with one that costs just a dollar? When the expensive drug is Boehringer Ingelheim's new blood thinner Pradaxa, according to a study by Stanford researchers. Report

@FiercePharma: J&J chief talks up plans for rehabbing image. Article | Follow @FiercePharma

> Merck has withdrawn its application for European regulatory approval of its asthma treatment Dulera, citing outstanding questions by regulators. Report

> Crucell swung to a third-quarter net loss after writing down its contaminated pediatric Quinvaxem vaccine inventory and said it now expects full-year revenues will be in line with 2009. Story

> A new consensus document from three medical groups says that the benefits of combining the clotbuster Plavix with acid-reducing meds such as Prilosec sometimes outweigh the potential risks. News

> Chinese officials said their country's biopharmaceutical industry needs to tighten quality control measures and maintain its own standards to overcome barriers in overseas markets as well as secure an emerging domestic market. Article

> Pfizer's Wyeth unit beat back a challenge from generic drug makers against the patent on the extended-release form of its antidepressant Effexor in Australia. Report

> King Pharmaceuticals' third-quarter profit slid 7.7 percent, but revenue fell less than analysts had expected it would. Story

> Treating patients more intensively with statin drugs to safely lower cholesterol can lead to even greater reductions in the risk of heart attacks and strokes than giving standard doses, scientists say. Item

Biotech News

 @FierceBiotech: Dear Henri: Sanofi chief advises Genzyme against defensive moves. Report | Follow @FierceBiotech

 @JohnCFierce: Skin into blood, without the stem cell step? Story | Follow @JohnCFierce

> Bavarian Nordic spotlights hopes for big cancer vax pact. Story

> Arena touts new obesity data as it campaigns for quick OK. Article 

> Will Moody's downgrade spur Lilly to rethink its strategy? News

Biotech Reasearch News

> After three centuries, quinine no longer best for malaria. News

> Finding the X-Factor in Chronic Fatigue Syndrome. Story

> Research grants harder to win. Article 

> Next big drug discovery made possible by video games. Report

Manufacturing News

> Package test technology turns pacifist. News 

> Ops, QA staff escape Genzyme's job cuts. Item

> Merck's shingles vax bulk supply to rise slowly. Report 

> Celanese debuts controlled-release excipients. Story 

> Legacy facilities are getting tough to unload. Item

And Finally... The U.S. healthcare system will reap at least $70 billion in savings over the next four years as brand-name medicines become available as lower-cost generics, a top drug industry expert said. Report

Events

> Specialty Pharma Commercial Excellence Summit - November 15-16, 2010 - Boston, MA

The first event of its kind focused on the Specialty market will provide a platform where big pharma can learn from specialty and visa versa. Hear case studies from Genzyme, Amgen, Roche and take part in a mock managed market and hospital P&T committee. See the full speaker line up & agenda click here.

> 7th Annual American Health Care Congress - December 7-8, 2010

This event is an intensive, two-day educational and networking forum, designed for senior health care executives from all industry sectors to address critical implementation challenges post-reform. Register and save $200! To register, contact us at 800-767-9499 with code BYG327!

> Hospital/Physician Alignment Leadership Summit - Dec 9-10, 2010 - Vienna, VA

Learn about the different types of alignment strategies - contracting, integration and service line - and the culture, legal and reimbursement implications that must be considered under each alignment approach. Register or learn more at www.worldcongress.com/HPA.

> Pharmacovigilance and Risk Management 2011 - Jan 9 - 12, 2011 - Renaissance Hotel, Washington, DC

Clinical trial safety and postmarketing pharmacovigilance is more critical than ever in the development and evaluation of the safe use of marketed medical products. This comprehensive three-day program will discuss the current complexities and controversies in pharmacovigilance and risk management. Learn more.

> New Paradigms to Fund & Manage Product Development for Biotech - January 13-14, 2011 - San Francisco, CA

The only event addressing alternative sources to fund product development together with the impact of an effective Biomarker & Comparative Effectiveness strategy to increase success rates. Fierce readers use code FBNP to receive 20% discount.

> Social Media for Pharma Conference - January 13-14, 2011 - Washington, DC

Hear from your peers first hand on how the new FDA guidance will mandate your social media strategies. Gauge how to integrate social media strategies into your current practices. By attending this conference you will learn how to boost product exposure, generate market research, build relationships and increase sales and overall business in the long term.

For more information or to receive a discounted rate, please email Michele Westergaard at Michelew@marcusevansch.com

 

> Drug Delivery Partnerships - January 26-28, 2011 - Miami, FL

For 15 years, Drug Delivery Partnerships has brought together companies at the forefront of innovative science, formulation and delivery. Learn more at www.drugdelivery.com

> ePharma Summit 2011 – Register Early And Save - February 7 – 9, 2011 - New York, NY

Now in its 10th year, the ePharma Summit is going to be bigger than ever. Get insight on new trends and opportunities in digital marketing with unparalleled access to leading industry innovators. The 2010 event was sold out. Don't miss this special event. Register using the code XP1606FIERCE and save 10% off your registration.

> 18th International Molecular Med Tri-Con: A Life Changing Event - February 23-25, 2011

The one scientific event for cutting-edge research, trends and analysis. Attend 12 concurrent programs within 5 scientific channels over 3 days:DIAGNOSTICS, DRUG DISCOVERY & DEVELOPMENT, INFORMATICS, BIOLOGICS, CANCER. Register by November 19 to SAVE!

> 20th Annual Partnerships in Clinical Trials - Mar 30-Apr 1

Celebrate 20 years in clinical development excellence at the #1 event in clinical operations and outsourcing. Partnerships is the industry's annual meeting place for clinical trial executives to meet with nearly 2,000 peers and over 200 solution providers to meet your trial needs. Click here

Marketplace

> Brandjacking Index: Online Risks in Pharmaceutical Market

Read this report which measures how pervasive brand-based attacks are in the pharmaceutical market.

> Optimize your Media with our Animal Component Free Products and Supplements

The Biotech market relies on Sheffield Bio-Science for cell culture optimization products like HyPep™ UltraPep™, Hy-Soy™ and rAlbumin. Every day we expand our capabilities to meet the changing needs of the cell nutrition market. Learn about the newest animal component-free (ACF) products we've developed at our state-of-the-art Center for Cell Culture Technology. Visit www.sheffieldbioscience.com or call 800.833.8308

> Are Your Digital Assets Where the Doctors Are?

Create an opportunity for HCP's to discover and connect with your brand by establishing a reliable Information Destination TM and persistent 'on-demand' presence within our vibrant professional web community. Click Here to Learn More.

> Improving the Effectiveness of Online Drug Distribution Through Web-Enhanced Portals

Every year, hospitals and clinics spend billions on drug and medical supply orders, many still placing orders using inefficient methods, like phone fax, and EDI. Pharmaceutical companies need to ensure their ability to handle orders quickly and efficiently, making an online system a vital sales channel. Read more.

> Free White Paper: Social Media and Post-Marketing Drug Safety

Facebook, Twitter, Linkedin, blogging - learn how emerging Internet technology can promote transparency and health literacy in pharmacovigilance. With impending FDA guidance on the recommended use of social media, the time to join the conversation is now. Click here to download the free white paper.

Jobs

> Marketing Manager - Information Services - McKesson Corporation

This opportunity is for a seasoned marketing leader in McKesson Specialty Care Solutions, a division of McKesson Corporation that serves manufacturers of specialty pharmaceuticals including oncology and supportive care products. We are building a new marketing team in South San Francisco, CA to support the strong growth that our business is experiencing. Learn more.

> Manager of Marketing – Managed Distribution and Vaccines

This opportunity is for a seasoned marketing leader in McKesson Specialty Care Solutions, a division of McKesson Corporation that serves manufacturers of specialty pharmaceuticals including oncology and supportive care products. Responsible for development and implementation of the overall marketing strategy for McKesson Specialty Care Solutions' managed distribution and vaccines distribution businesses, targeting the pharmaceutical manufacturer customer segment. Learn more.

> Senior Level Global Clinical Operations Role - Pharm-Olam International

A newly created opening for a senior level Global Clinical Operations role. This role will be responsible for the oversight of all clinical trial activities from inception to finish for all global clinical trials. The position would be based at POI's global headquarters in Houston. Learn More

> Pharmaceutical Company Compliance Officer - Clinical Data, Inc

This person will plan, develop and execute the company compliance program. Reporting to the Chief Legal Officer, this newly created position will be based in the company's Newton, Massachusetts headquarters, and will require regular travel to our facilities in New Haven, Connecticut and Charlottesville, Virginia. Learn More

> Chief Medical Officer

This position is responsible for providing medical direction, management and review of clinical trials and product development. Specific tasks include development of a clinical development program plan for new drug candidates, clinical protocol development, medical monitoring of clinical trials and analysis of study data and preparation of trial reports. Learn more.

> Senior Clinical Research Associate

Travel to and monitor Sponsor studies at sites within the U.S. Responsible for the management of assigned clinical study sites. Ensures the regulatory and scientific integrity of studiesEvaluates, monitors, and documents all study information. Learn more.

> Director of Marketing JD

The Director of Marketing will develop, implement and manage brand plan strategies and tactics for the anticipated launch of a First in Class Drug, for the treatment of depression. Monitor, analyze and interpret latest trends in the market; communicate insights and recommendations to team members. Learn more. develop and implement brand plan strategies and tactics for the anticipated launch of a First in Class Drug, for the treatment of depression. Learn more.

> Need a job? Need to hire? Visit FiercePharma and Biotech Jobs

50+ new jobs just posted. Employers now post to the web site free. Find the perfect job or post your openings at FiercePharma Jobs.


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