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Posts Tagged ‘Wyeth’

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TODAY’S NEWS:

Very big news for Vertex75% of hepatitis C patients never treated before achieved a viral cure after receiving a 12-week course of the company’s experimental drug telaprevir plus the current standard of care, according to results from a phase III studymore

Genzyme’s Pompe remedy approved by FDA; meanwhile, more detail on their consent decree.

More on alleged Wyeth tactics to promote Rapamune off-label. If true, yuck! Gold-in Rule at work.

Connecticut passes new pharma ethics code.

Part 2 of my interview over at MessagingLab blog (by Karl Schmieder): Pharma, Social Media, and the FDA.

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Social Media in Pharma stuff today: An “Ultimate Guide to Facebook“, from our friends over at Pixels and Pills. And, reporting adverse events on social media. More? Sure – comparing how pharma companies are using social media currently (from @healthcarengage). Even more? OK, you asked for it – Social Media and Celebrities in pharma (from John Mack’s blog)

JUST FOR FUN

Examples of Lightning Photography. Stunningly beautiful.

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TODAY’S NEWS:

Watson gets FDA approval to start shipping generic Valtrex.

Novartis oral MS drug – FDA extends review another 3 months – Novartis will have to wait a bit longer in its bid to get the first oral treatment for multiple sclerosis on the market after regulators in the USA put back a review of Gilenia. The US Food and Drug Administration has extended by three months, to September, its review period for Gilenia (fingolimod), previously known as FTY720more

Genzyme: Big fine, big changes to get manufacturing back under control.

Another day, another whistleblower suit comes to light. This time, Wyeth and Rapamune promotion for unapproved uses.

Layoffs at Quintiles.

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The Three “I’s” of Tomorrow’s Successful Company. An important perspective from Dennis Urbaniak (VP U.S. Diabetes, Sanofi-Aventis). Titles, Budgets, and Staff are out – Ideas, Initiative, and Inspiration are in.

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50 Beautiful Examples of Architecture Photography.———-

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Pfizer buying Wyeth. Merck buying Schering-Plough. It’s pharma mega-merger season again.

I hate it.

“Market conditions” | “Complementary pipelines” | “Operational synergies” blah, blah, blah. I’ve heard all the explanations and rationalizations dozens of times before.

Analysts are looking at numbers. I’m looking at faces.

Every one of these mergers has a huge price tag that is rarely weighed in the balance. It’s called disruption.

  • Really good people end up losing their jobs, simply because they are re-labeled from “contributor” to “redundant”.
  • Creative and promising initiatives are stopped dead in their tracks, and often taken out back for burial.
  • Healthy corporate cultures are destroyed.
  • Productivity nosedives for month after month, as no-one knows what (if) their job will be in the future, and the inevitable jockeying and posturing takes over.
  • Agencies and service providers that served one (or both) companies are thrown into a tizzy and lose large volumes of work.
  • Any residual notion of corporate loyalty in our professional arena erodes further, with subsequent resentment and disenchantment.

I remember, with fondness, rubbing shoulders with the folks at Parke-Davis, at RPR, at HMR, at Pharmacia, at Aventis, at Wyeth, at Takeda. I remember bright and motivated people, imaginative programs, interesting corporate cultures, strong professional relationships. And I remember the disruption with every merger or buyout.

Yes, yes, I know that some mergers may actually pan out with an upside down the road (certainly not always, however!). And, some folks get a big payday out of these events. But sweep aside all those numbers, and if you’re involved in the industry, you see people. And pain. I hate these mergers.

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Enormous Bextra charge taken by Pfizer - If you’re going to take a $2.3 billion earnings hit over government investigations, you might as well announce it the same day everybody’s more interested in your $68 billion deal.

Amid the hullaballoo over Pfizer’s bid for Wyeth today, Pfizer announced its fourth-quarter earnings, which fell to $266 million from $2.72 billion a year earlier, due primarily to that enormous charge. It stems from an agreement in principle that Pfizer made with the U.S. Attorney in Massachusetts to resolve probes over alleged off-label marketing of now-withdrawn painkiller Bextra, plus “other open investigations,” the company said.

Jim Edwards over at BNET explains how this settlement was both disclosed and “hidden.”

KV Pharmaceutical – major problems. KV Pharmaceutical (NYSE: KVa/KVb) has voluntarily suspended the manufacturing and shipping of all of its products, other than certain products that it distributes but does not manufacture. The suspension began on January 22, 2009.

Generic surge the major cause of drop in pharma sales forces? Sounds plausible, but where’s the data? Is this just a conclusion pulled out of thin air?

PLUS…blah blah blah Pfizer-Wyeth blah blah blah Wyeth-Pfizer… A lot of the coverage is endless repetition of not much. Here’s the take by some analysts, from the WSJ Health blog (a great source for pharma news, btw). And here’s a scary number – up to 25,000 job cuts?

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Impactiviti is a pharma consultancy focused on helping pharma/biotech/medical devices companies identify optimal vendors for training/marketing needs.

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Of course, the huge news this Monday morning…Pfizer buying Wyeth. This will dominate the headlines for days. Before the deal was announced, Jim Edwards did some analysis on potential downsides – interesting stuff. This also means that the Wyeth-Crucell discussions are scuttled. And who else may be making deals in the days ahead?

My take, fwiw – While lots of folks focus on the stock premium, the synergies of the product mix, the cost savings by chopping overlaps, etc., few talk about the incredible disruption that now occurs with both companies, as extraordinary amounts of time, attention, money, and other resources are expended coming up with merger plans and processes. There are the terrible work inefficiencies that occur every time one of these mega-mergers creeps forward, as initiatives are stalled, employees are paralyzed by angst as to their future roles, recruites swoop in and cherry-pick talent, etc. It gets really messy as entire organizations are unwound and PEOPLE are transitioned from clear productive direction to fear and uncertainty, over many months. It’s ugly. As a solutions-provider for many pharma clients over the years, I’ve seen this unpleasant process many times. My heart goes out to the folks at Wyeth, who now have to wrestle with loads of questions, and very few answers…

Here’s a list of the Top Ten (by $ value) pharma mergers in the past (a couple are “in process” currently).

The multiple sclerosis pill development race accelerates. Whatever the outcome of the 2-company race to market, these two experimental drugs promise to be a great win for patients. Merck KGaA pulled ahead of Novartis in the race to develop the first pill for multiple sclerosis on Friday, announcing it planned to submit its drug cladribine for approval in mid-2009.

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The Sales Force Shuffle, from Pharmaceutical Executive – The last week the pharma atmosphere was abuzz with news about sales force cuts, outsourcing, and overhauls. First, Schering-Plough announced that it had eliminated the 1,000 sales positions it said it would trim in April. This is being done as part of a new sales model called—internally—a productivity transformation program (PTP). The new model, to go into effect next month, will streamline the sales force to take a more customer-centric approach, including targeted and relevant physician calls and a relationship management–oriented business model…more

Alpharma to King: No. – In a filing with the Securities and Exchange Commission, Alpharma calls the $37-a-share offer was inadequate and continues to explore all strategic alternatives, including a possible sale to King or another party for a higher price…more

Lilly CEO to Boston: you’re scaring us away – The ink is barely dry on a new law governing how drugmakers can market to docs, but Lilly’s John Lechleiter isn’t wasting time trying to make lawmakers regret their decision. In remarks to the Associated Industries of Massachusetts Executive Forum, he claims the law will hamper innovation and force companies to reconsider expanding in Massachusetts, The Boston Business Journal reports…more

B-I goes to the shrink – The drugmaker has ended a contract with InVentiv, one of the players in the Rent-A-Rep business, which was promoting its troubled Micardis, an angiotensin receptor blocker, otherwise known as a blood pressure med…more

The needle or the drug? – Acupuncture works as well as Wyeth’s antidepressant to fight hot flashes and other menopausal symptoms caused by breast cancer treatment, and its benefits last longer without causing unwanted side effects, according to new research…more

Pfizer’s Pfuture – The big drugmaker is dramatically stepping up sales efforts in emerging markets, overhauling US business operations and slashing more costs ahead of the 2011 patent loss for cholesterol blockbuster Lipitor, the Associated Press informs us…more Plus, going after emerging markets for growth

Paxil damages sperm? – A group of 35 healthy men who were given Paxil over a five-week period had higher levels of sperm with damaged DNA, according to a report..more

Medicis to re-state numbers; stock plunges.

Tarceva linked to liver damage - Genentech Inc and OSI Pharmaceuticals have alerted doctors about cases of liver damage among patients who took the cancer drug Tarceva in a post-approval study, U.S. regulators said on Tuesday…more

Takeda goes for diabetes combo – Takeda Pharmaceutical Co said on Wednesday it had applied for approval to market in the United States the SYR-322 and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes…more

An interesting analysis on adverse event reporting, and social media.

Is the war on cancer really winnable? A realistic and pessimistic analysis from Newsweek.

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A long and interesting article from NY Times magazine, about the process a doctor went through as a “recruit” to be a paid spokesperson for a drug company.

Excerpt:

    How many doctors speak for drug companies? We don’t know for sure, but one recent study indicates that at least 25 percent of all doctors in the United States receive drug money for lecturing to physicians or for helping to market drugs in other ways. This meant that I was about to join some 200,000 American physicians who are being paid by companies to promote their drugs. I felt quite flattered to have been recruited, and I assumed that the rep had picked me because of some special personal or professional quality…Regardless of how I preferred to think of myself (an educator, a psychiatrist, a consultant), I was now classified as one facet of a lunch helping to pitch a drug, a convincing sidekick to help the sales rep. Eventually, with an internal wince, I began to introduce myself as “Dr. Carlat, here for the Wyeth lunch.”

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From Forbes magazine, an article on the encouraging progress being made by pharma companies on the vaccine front:

A new golden age of vaccines is at hand, promising inoculations against malaria, meningitis and much more.

Vaccine researcher Ripley Ballou was an eager human guinea pig. As part of a six-man experiment at the Walter Reed Army Institute of Research in 1987, he had himself injected four times with a genetically engineered malaria vaccine. Then he taped to his arm a styrofoam cup. In it were five mosquitoes infected with malaria.

Ten days later Ballou got violently ill, with uncontrollable chills, profuse sweats and headaches that felt like “a 9-inch spike through my head,” he says. The experimental vaccine protected only one of the six volunteers in the trial. Even after drugs quelled the infection, Ballou felt run-down for weeks.

But that lone success provided inspiration for a far more potent malaria vaccine that 20 years later is finally set to go into giant clinical trials next year at GlaxoSmithkline, where Ballou now works. If successful, it could be the first vaccine for a scourge that has plagued mankind since ancient times. “This vaccine will have a huge impact,” predicts Jean Stephenne, chief of GlaxoSmithkline’s vaccine unit.

Glaxo’s malaria shot is at the forefront of a vaccine renaissance. The revolution in genomics and molecular biology has rescued a segment of the drug industry that for decades was viewed as a low-margin backwater beset by litigation and regulation. Drugmakers are producing vaccines that weren’t possible before–and getting a premium price for them. In diseases for which there is no private vaccine market, such as pandemic influenza, or for which cases are concentrated in poor countries, such as malaria and tuberculosis, governments and public-private partnerships have stepped in to subsidize development.

The resurgence couldn’t have come too soon. Mayo Clinic vaccine researcher Gregory Poland counts more than a dozen new diseases that have emerged in the last few decades: HIV, Lyme disease, West Nile virus, avian influenza. The vaccine boom, he says, “is shaking up the market.”

The $13 billion global vaccine business will grow 18% a year to $30 billion in 2011, predicts Lehman Brothers (nyse: LEH news people ), well above the 4.4% annual growth expected for the drug industry overall. Merck (nyse: MRK news people ) introduced three new vaccines last year, including Gardasil to ward off cervical cancer, while GlaxoSmithkline promises seven over the next five years, including a Gardasil competitor now awaiting approval from the Food & Drug Administration. AstraZeneca (nyse: AZN news people ) bought vaccinemaker MedImmune for $15.6 billion in June, while Pfizer (nyse: PFE news people ) last fall bought PowderMed, a British firm testing a needle-free inoculation. Sanofi-Aventis (nyse: SNY news people ) spent $150 million for a new plant that will double its flu shot production capacity in the United States to 100 million doses.

A new adult and adolescent vaccine market will make up a big portion of that growth. Diseases such as antibiotic-resistant hospital infections and genital herpes have become hot targets. One company, VaxInnate, is testing a universal flu vaccine that would work against all strains and wouldn’t have to be taken every year. Ultimately, researchers envision shots to stave off chronic diseases such as cancer and atherosclerosis. One exception to the optimism is aids; a promising Merck vaccine failed in a recent study.

Modern vaccines date back to British doctor Edward Jenner’s 1796 work immunizing children using pus from cowpox blisters. Ensuing vaccines were nothing more than a dead or weakened strain of a pathogen such as polio, mumps or measles that trains the body to generate protective antibodies. By the 1980s vaccines had wiped out so many diseases, and vaccine prices had fallen so far, some companies gave up searching for new ones. Vaccines were also dogged by safety issues, including the swine flu vaccine fiasco of 1976, and by the dubious theory of a link between autism and the mercury once used in a vaccine preservative.

But in 2000 Wyeth scored a huge hit with Prevnar, the first vaccine for infants against pneumococcal bacteria, a common cause of pneumonia and ear infections. It uses a clever linking technology to hook together a diphtheria protein to sugars from the surface of seven pneumococcal strains. The resulting compound is easily spotted by the infant’s immune system. Pneumococcal infections in young kids plunged 77% after Prevnar’s debut. Sales should hit $2.5 billion this year, thanks in part to its premium $311 price for four doses. (An influenza shot costs only $15.) Wyeth is testing a second-generation version that covers six more strains.

The subsequent mapping of the genomes of many nasty pathogens has opened up wholly new approaches to vaccine discovery. In the late 1990s Novartis (nyse: NVS news people ) researchers decoded the genome of the Neisseria meningitidis B bacterium, which is responsible for one-third of cases of meningococcal meningitis. There are vaccines for other meningococcus strains, but a vaccine for the group B strains had been eluding microbiologists because their surface sugars are identical to human ones. After Novartis sorted through 2,000 proteins in the genomic database, it found five proteins that, when injected into laboratory mice, generated antibodies against at least 66 of 85 group B strains, according to a 2006 study. The vaccine is now in midstage human trials. Wyeth and Sanofi-Aventis have competing efforts.

Austria’s Intercell has spent the last several years gathering blood samples from patients who have survived staph infections to determine which antibodies they had in common. A vaccine based on its findings is now in early human trials at Intercell’s partner Merck.

Malaria is one of the toughest foes of all. The shifty parasite morphs into four different forms once inside the body and spends most of its time hiding inside cells where the immune system can’t get to it. It took Glaxo 20 years to make significant progress with the malaria vaccine that failed to protect Ripley Ballou. First Glaxo researcher Joe D. Cohen took the malaria surface protein used in Ballou’s vaccine and fused it to a protein from the hepatitis B virus, creating a harmless particle that looked like a virus to the immune system. That helped, but not enough. So Glaxo added adjuvants, substances that bolster immune response, including a bacterial wall extract and a detergentlike substance from the soapbark tree. In 1997 it hit the jackpot with an adjuvant combo that protected six of seven volunteers.

In a 2004 trial of 2,000 children in Mozambique the Glaxo vaccine slashed severe malaria cases by about half. Last month a smaller trial in infants (who are most vulnerable to malaria) found it prevented infection in 65%. Now Glaxo is gearing up to test it on 16,000 kids in seven African countries. One huge question is how long the protection will last. Glaxo has already spent $300 million on the vaccine and the Bill & Melinda Gates Foundation has kicked in another $108 million. Trial results could come in 2011. Glaxo is confident of success. It has revamped a giant factory in Belgium to produce tens of millions of doses.

Glaxo’s Stephenne hopes to sell huge quantities of malaria vaccine for a modest profit, while using its adjuvant components for more lucrative vaccines, such as one to prevent lung cancer recurrence. The cancer vaccine is now in final-stage trials.

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