sales and marketing

Lawsuit claims Pfizer execs wanted to bury studies

John Carroll — Wed, 08 Oct 2008 11:49:14 -0400

A lawsuit against Pfizer is turning up some intensely embarrassing memos that show the marketing department's hands-on approach to new research studies that don't exactly bolster their sales pitch.

"We are not interested at all in having this paper published because it is negative!!" wrote Angela Crespo, Pfizer's senior marketing manager in 2002, about a new study of the company's blockbuster Neurontin. And Michael Rowbothan, then Neurontin's marketing team leader, wrote this in an email: "I think we can limit the potential downsides of the...study by delaying the publication for as long as possible."

In a statement to the Wall Street Journal, Pfizer said the company is "committed to the communication of medically or scientifically significant results of all studies, regardless of outcome."

- read the article in the Wall Street Journal

Developers look for rules to govern name game

John Carroll — Mon, 09 Jun 2008 11:59:11 -0400

The RPM Report focuses on a new effort to revise and improve the way the FDA approves proposed proprietary drug names. The agency kicks back about 40 percent of the brand names suggested by sponsors, creating a great deal of frustration with the process. The industry wants more predictability and more insight into what it needs to do to get an approval. But a new pilot program aimed at improving the process is instead raising fears that the name-game will only grow more complex.

- read the story from RPM Report

ALSO NOTED: ASCO already churning out news; Lilly, FDA ironing out Zyprexa shot problems; and much more...

Fri, 30 May 2008 06:59:50 -0400

> Today marks the start of the annual ASCO. Here's a round-up of some of the news coming out of the conference. ASCO report

> More from the Web-marketing frontier, where portals and blogs are passé: An Arizona entrepreneur is working up a site where cancer doctors and drugmakers can mix and mingle. Report

> Pharmacy records could soon become an open book in California. Yesterday, the state Senate passed a bill allowing pharmacies to sell patient info to third-party firms working for drugmakers. Report

> Eli Lilly says it's making progress with the FDA on approval of its long-acting, injectable form of Zyprexa. FDA report

And Finally... Solving the mystery of why type 1 diabetes is so prevalent in Finland could be the key to teasing out the causes of the disease. Report

Medivir could gain $430M from HCV collaboration

Tue, 20 May 2008 06:59:55 -0400

BioWorld examines a $430 million deal between Sweden's Medivir and Tibotec to develop new polymerase inhibitors. They'll jointly screen libraries for nucleoside analogues that show anti-HCV activity in vitro. And once a compound is identified, Tibotec will take over development and keep marketing rights outside of the Nordic countries. Medivir gets €5 million up front and up to €272 million in milestones if two products reach the market. Researchers for the two companies already have an HCV compound in development. BioWorld also notes that Anadys has a competing therapy being prepared for a Phase I trial that targets HCV viral replication.

- here's the release on the deal
- read the report from BioWorld

SPOTLIGHT: Novalar approval a small gain for big group

Tue, 13 May 2008 06:59:53 -0400

Novalar Pharmaceuticals may not have made drug history when the FDA approved their new therapy to speed the return of sensation after dental procedures, but the private biotech has some ambitious plans for marketing the drug. OraVerse goes on sale this fall at $12.50 a shot, promising to cut the amount of time spent drooling by about 75 to 85 minutes. Some people might call it trivial, but the experts say it addresses a real need. OraVerse release | Report

FDA staffers say that Eisai sedative appears safe

Mon, 05 May 2008 06:59:54 -0400

FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in general anesthetics. Eisai gained rights to fospropofol disodium with its acquisition of Minneapolis-based MGI Pharma. And an FDA expert committee is scheduled to meet on Wednesday to consider Eisai's application for marketing approval. The sedative is designed for use during a number of procedures, including colonoscopies. Researchers say the sedative has a safer profile than existing meds.

- read the report in the Wall Street Journal

SPOTLIGHT: J&J chops jobs

Wed, 30 Apr 2008 06:59:53 -0400

With Procrit under siege, Johnson & Johnson wants to divert its promotional efforts elsewhere--a strategy that will lead to some 400 job cuts in its sales-and-marketing ranks. The company told employees it would consolidate sales-and-marketing operations of Ortho Biotech and Centocor and shave the payroll accordingly. Layoff report

U.S. R&D headcount tumbles in key categories

Wed, 09 Apr 2008 06:59:57 -0400

Pharmalot has been crunching the numbers for R&D jobs and concludes that the U.S. is seeing a considerable amount of shrinkage in the field. Looking at new numbers from PhRMA for 2006, R&D employment among its members dropped 3.9 percent. And there were a number of sizable reductions last year, with the axe expected to drop again over the course of 2008.

RPM concludes that the biggest cutbacks in R&D are occurring in the approval and post-marketing phases. The money spent on R&D in the U.S. continues to rise, but after an 11.3 percent hike in 2006 budgets rose only 2.7 percent to a still considerable $35.4 billion.

- read the report from Pharmalot
- see the PhRMA report (.pdf)

Related Articles:
Top 8 layoffs of 2007
The Top 15 R&D Budgets
Big Pharma's biotech shift means layoffs for chemists
Ranks of sales reps thinning

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:
Cell Therapeutics inks deal to buy cancer drug developer. Report
Cell Therapeutics inks deal for Xyotax. Report
Bayer Schering touts Zevalin study. Report
Cell Therapeutics makes bid to buy DOR. Report

HGS stock dives on drug safety concerns

Wed, 23 Jan 2008 06:59:57 -0500

Human Genome Sciences watched its stock take a dive this morning after an independent data monitoring committee noted lung-related side effects in patients receiving 1200-microgram injections of the hep C drug Albuferon every two weeks. Patients at that dosage level in the Phase III trial are being shifted to a 900-mcg injection every two weeks. HGS says it still expects to have late-stage data on the drug in the spring of 2009, with a marketing application to follow in late 2009. But that was no comfort to investors, who took a 22 percent bite out of its stock as Wall Street in general got off to another rocky start.

- see this release
- read the AP report for more

Related Articles:
HGS pockets $40M for Albuferon, preps Phase III. Report
HGS marks success of Albuferon in IIb. Report

ALSO NOTED: Cardiome awaits FDA decision; Congress to investigate Vytorin scandal; and much more...

Fri, 18 Jan 2008 06:59:50 -0500

> Cardiome is awaiting a critical FDA decision on its drug vernakalant. Report

> It seems that many black U.S. residents are less likely to participate in clinical studies, possibly due to distrust of physicians and fears that they might be harmed by participation, according to a study published in the journal Medicine. Report

> Amgen, you're being served. The New Jersey Attorney General has sent out a subpoena to the California company, asking for "a comprehensive array of documents and information" related to Enbrel sales and marketing. Report

> The deadline bell has rung. At final count, more than 50,000 Vioxx plaintiffs have registered for the $4.85 billion settlement. Report

> Congress is promising hearings on the Vytorin controversy. Report

And Finally... What's in a name? Drug-naming experts are charging hundreds of thousands for just the right combinations of vowels and consonants. Report

Positive data more likely to find its way to public

Thu, 17 Jan 2008 06:59:56 -0500

There's been a growing understanding in the drug development world that studies boasting of positive data on a drug tend to get published in the scientific literature with great fanfare; negative studies are often silently allowed to sink out from sight. Now a new report in the New England Journal of Medicine concludes how that trend has played out in the antidepressant field. Ninety-four percent of studies with positive drug data showed up in print, compared to 14 percent of the studies with negative or inconclusive results. And that has skewed the reported effectiveness of the drugs. If you combine the negative studies on antidepressants they were able to outperform placebos by only a modest amount, not the 60 percent in published trials that demonstrated a positive response.

That's not likely to be news to practitioners in the field. Antidepressants have long been notoriously unreliable. But it's, well, depressing, to see developers have been gaming the system with such indifference to the scientific pursuit of the truth. Could they have been more interested in making a marketing case for a drug? Need you ask?

- read the article in the New York Times

Related Articles:
Study: Antidepressant warnings work. Report
Top 10 drug warnings and recalls of 2007: Antidepressants

SPOTLIGHT: VCs back Caprotec

Mon, 14 Jan 2008 06:59:53 -0500

Berlin-based startup Caprotec Bioanalytics GmbH has rounded up $8.8 million in two rounds of financing from Creathor Venture, IBB Beteiligungsgesellschaft, ERP Startfonds and private investors for further development and marketing of its platform technology for analyzing complex protein mixtures. Release

WuXi buyout deal raises questions on scientists' pay scale

Tue, 08 Jan 2008 06:59:56 -0500

The average scientist on WuXi PharmaTech's Chinese payroll earns about $30,000 a year, roughly equivalent to 10 percent of what it costs to emply an American researcher with the same qualifications. Numbers like that make analysts salivate at the earnings potential of the publicly traded company, which has been renting out scientists to drug developers anxious to operate on a lean and mean R&D budget. WuXi recently moved to acquire the U.S. research and testing firm AppTec Laboratory Services, which may put some strain on the company's operating plan. I'd be willing to bet that scientists at AppTec--or anywhere else in the developed world, for that matter--aren't salivating over WuXi's pay scale.

- read the report in the Wall Street Journal

Related Articles:
China's WuXi buys Apptec for $151M. Report
Trend: Research (and marketing) heads to Asia. Report
Asian CRO gains $22M in second round. Report

SPOTLIGHT: Sepracor licenses epilepsy drug rights

Wed, 02 Jan 2008 06:59:53 -0500

Sepracor is shelling out $75 million up front to license the marketing rights for an experimental epilepsy drug from Portugal's Bial. Sepracor will pay up to $100 million more in developmental and regulatory milestones. Release

Endo touts successful Phase III in cancer pain

Mon, 17 Dec 2007 06:59:56 -0500

Endo Therapeutics' late-stage trial for Rapinyl, a cancer pain therapy, demonstrated that the therapy was highly effective, hitting all primary and secondary goals. The biotech said the trial was so successful--relieving cancer pain for a statistically significant group within 30 minutes--that it may go ahead with an application for marketing approval even as it recruits patients for another Phase III trial. The side effects of the drug were in line with other opioids. That's all good news for Orexo AB, which licensed the therapy to Endo.

"We remain confident that Rapinyl's quick dissolution and rapid absorption profile make it a potentially attractive treatment for breakthrough cancer pain," said David A. Lee, M.D., Ph.D., the company's CSO.

- check out the release for more info

Related Articles:
Endo plans for the future. Report
Endo, Vernalis get FDA rejection for Frova. Report
Endo shares up on positive painkiller data. Report

ALSO NOTED: Adventrx reports ANX-530 results; FDA to disclose financial ties; and much more...

Fri, 16 Nov 2007 06:59:50 -0500

> Adventrx Pharmaceuticals has announced positive results from its marketing-enabling clinical study of ANX-530 (vinorelbine emulsion). Release

> The FDA is planning to let some blue sky into its advisory committees. In an attempt to stifle conflicts of interest, the agency wants to tell the public about any advisory committee member's financial ties to the drug industry. Report

> Drug dosages, especially antibiotics, are often incorrect for obese patients. Release

> A Danish study found that patients using the Sanofi-Aventis' Acomplia almost doubled their risk for depression. Report

> It looks as if the big Vioxx settlement offers plaintiffs not just the carrot, but the stick, too. If one of an attorney's clients accepts the deal, then that lawyer has to recommend it to the rest of his or her Vioxx clients. The lawyer then has to fire any clients who hold out. Report

> Takeda is launching new ads touting its star diabetes drug today, saying, "If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke." If you think it sounds like it's aimed at GlaxoSmithKline's Avandia, you're right. Report

> Yesterday on the Senate floor, Senator Charles Grassley (R-IA) said that he wants any would-be pharma whistleblowers to call his office. Report

And Finally... Iceland's DeCODE Genetics has launch deCODEme, a service that lets individuals get a detailed look at their own genome. Release

ALS sees strong data in Phase III antibiotic trial

Thu, 15 Nov 2007 06:59:54 -0500

Advanced Life Sciences is touting data from a recent trial of its antibiotic cethromycin. The therapy produced positive data that it can fight pneumonuia effectively and safely and demonstrated an ability to combat the MRSA superbug as well. ALS officials told the Chicago Tribune that the data was good enough to pursue FDA approval. In the trial, cethromycin essentially matched the efficacy of a standard of care in fighting community-acquired pneumonia. Flavin added that the company planned an NDA next year with marketing to commence in 2009.

"We are very excited to have met all of our endpoints in Trial CL-05, and we are pleased to have successfully completed the clinical development program of cethromycin. The results attained in this trial, along with the positive results achieved in Trial CL-06 reported in June of this year, will form the core of our New Drug Application submission and positions us well with prospective commercial partners," said Dr. Michael Flavin, chairman and CEO of Advanced Life Sciences.

- see the release for more
- here's the report from the Chicago Tribune

Related Articles:
Advanced Life Sciences raises $36M. Report
Clues shed light on fighting lethal MRSA strain. Report

ALSO NOTED: Novartis plots $700M biotech plant; Genzyme wins marketing approval; Glenmark, Forest to pursue Phase II; and much

Mon, 29 Oct 2007 07:59:50 -0400

> Novartis will plow $700 million into a new cell-culturing facility in Singapore. The plant will boost the drug maker's capacity for biotech drugs, delivering products for commercial distribution and for clinical development. Report

> Genzyme has won FDA marketing approval for Epicel, a therapy for severe burns. Release

> Researchers at Glenmark Pharmaceuticals and Forest Laboratories have been given a partial favorable response for an additional mid-stage study of GRC 3886 for asthma and COPD. Report

> Warburg Pincus has wrapped its $3.67 billion buyout of Bausch & Lomb. Release

> Shares of Dusa Pharmaceuticals surged this morning on the news that it had settled a patent dispute with River's Edge Pharmaceuticals regarding Nicomide. Report

> Look for a crackdown on direct-to-consumer ads if John Edwards is elected in 2008. Report

> You win some, you lose some. Bayer is abandoning plans to launch a bigger dose of its multiple sclerosis treatment Betaferon. Report

> Outgoing GlaxoSmithKline CEO Jean-Paul Garnier is shouldering the heavy load of layoffs and restructuring to give his successor Andrew Witty a clean slate when he takes over next May, the Times of London is reporting. Report

And Finally... Scientists from Bangor University have found a 400-year-old clam, the oldest living animal known to science. Report

HTG lands $10M in third round

Wed, 24 Oct 2007 06:59:55 -0400

High Throughput Genomics, an Arizona-based provider of microplate-based gene expression assay technology and services, has raised $10 million in its third round of financing. Merck's investment arm led the round. Also contributing were Solstice Capital, Valley Ventures and Arcturus Capital. HTG is hoping to develop a universal molecular biology-based tool set to improve the drug discovery process.

"Adoption of HTG's technology continues to rise, and we have diversified our portfolio of products and services including a strategic focus on academic collaborations, to best meet the evolving needs of our clients. With this new financing, HTG will be able to scale our sales and marketing activities to our growth," said E. William Radany, Ph.D., Chief Executive Officer, HTG.

- see this release
- read this Arizona Star report for more