Here’s a list of compiled links providing information on Pristiq. These links include info from my blog and others.
Funny the writers decided to add that. A year ago, that clause would have never been considered yet alone thought of.
Pfizer isn’t doing badly; in fact, despite the credit crunch, they’ve been able to snag $22.5 billion in loans since they also have $26 billion cash on hand. The NYTimes also reports that this merger would be the biggest since AT&T and BellSouth merged back in March 2006. But of course, with mergers always come layoffs. And what a time to have layoffs. Pfizer today announced that they’ll be cutting 8,000 jobs.
But as I said in a previous post, Pfizer’s biggest challenge is get some pipeline products out to market soon since some of the patents on their big names (ie, Lipitor) are expiring soon. Don’t hold me to this but I think Wyeth has a bit more sitting in their pipeline, hence why the merger would make sense. But I hope Wyeth can produce a new blockbuster drug for Pfizer otherwise Pfizer’s really going to be hurting for money. Especially since Wyeth’s best-selling drug, Effexor, is now generic and Pristiq isn’t completely cutting it.
I just learned that Wyeth produces two major menopause drugs, Premarin and Prempro, that allegedly has produced hormones causing cancer in more than 5,000 women. This added up to a loss of 40 million users and $1 billion annually.
With Effexor going generic in 2 years and the introduction of Pristiq to the market, Wyeth hopes to lure some of those customers back and net an annual $2 billion. However, serious questions linger about Pristiq’s side effects in menopausal women.
Why did two women in the study group taking Pristiq have heart attacks
and three need procedures to repair clogged arteries compared with none
taking placebo? How can Wyeth assure long term safety when 604 of the
2,158 test subjects took Pristiq for only six months and 318 for a year
or more? And what about serious liver complications seen in the studies?
Martha Rosenberg, reporting on Pristiq’s use as a menopausal drug, culled comments from CafePharma’s message boards and found one thread rife with mixed comments on the new drug. From an Anonymous commenter:
I’m aware that my blog has taken a significantly dark turn. This may alienate some of my readers who seek happier, brighter topics. I don’t think my posts have been negative; on the contrary, I think they’ve been positive. Positive and educational.
Dr. Grohol interviewed Dr. Phil Ninan, Wyeth’s VP of Medical Affairs on Pristiq, its efficacy, and surrounding issues. It was quite an interesting interview (and long) but here are some highlights that I chose to comment on. I’ll be making some comments in between Dr. Ninan’s answers due to the extensive length. Some parts of the answers have been truncated.
According to a Decision Resources (DR) press release, Lexapro (escitalopram), a SSRI, “retains leadership among first-line therapies in the treatment of major depression” despite the fact that physicians have increasingly moved toward the use of SNRIs, eg, Effexor (venlafaxine). However, the reason why SSRIs still retain their first-line status is due to
SSRIs have been out on the market for much longer than SNRIs so it’s what physicians are more comfortable with. As far as I know, there currently aren’t any generic SNRIs in the U.S.
As a result, SNRIs are likely pricier.
DR’s survey of psychiatrists found that the majority believe SNRIs work better in treating clinical depression than SSRIs and about 44 percent believe they have fewer sexual side effects. PCPs were also included in this survey and it seems that the majority of them believed the opposite despite DR’s spin that a lot of PCPs are on board with psychiatrists. From personal experience, four SSRIs were prescribed to me before I was shifted to a SNRI.
In the up-and-coming SNRI department, DR forecasts a bright future for Pristiq (desvenlafaxine).
Physicians are expected to move patients from Effexor to Pristiq-a newly approved SNRI- over the next two years. … Pristiq will begin to replace Wyeth’s Effexor XR and Lilly’s Cymbalta, especially in
This is an interesting analysis from DR considering that psychiatrists, health insurers, and even some investors seem less than impressed with the slight advantages the “me-too” drug has over Effexor.
As patents expire on a variety of drugmakers’ moneymakers, pharma companies have gone to great lengths to structurally reinvent the successful drugs then tout the benefits that differ from their predecessors.
Case in point — Johnson & Johnson’s Invega. Invega is the successor to the popular antipsychotic drug, Risperdal, and competitor to AstraZeneca’s widely used antipsychotic Seroquel. Scott Hensley at The Wall Street Journal’s Health Blog (WSJ) reports that Risperdal is going generic in June. Gianna at Beyond Meds recently said it will not. According to the Dow Jones Newswires (DJN), these “junior” drugs face skepticism from health insurers and doctors. California-based Kaiser Permanente and Minneapolis-based UnitedHealth Group Inc. (UNH) are example of companies that have somewhat discouraged use of the drug. Kaiser doesn’t cover Invega at all, and members of UNH are required to pay higher copays for the brand name. The wire reports New York-based psychiatrist Jeffrey Lieberman wasn’t “buying it” the difference between Invega and Risperdal.
Invega is “basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school told Peter Loftus of Dow Jones Newswires.
The blog also quotes Daniel Carlat from the The Carlat Psychiatry Report.
Dan Carlat, a psychiatrist and a tough critic of Invega, wrote that J&J’s “marketing team apparently missed the fact that the word in the English language that sounds most like “Invega” is “inveigle,” meaning “to entice, lure, or ensnare by flattery or artful talk or inducements.’ ” He asked doctors: “Will you be doing your patients a favor by taking the plunge? Or will you simply be giving them the same wine in a fancier bottle?”
Even J&J’s Group Chairman of Pharmaceuticals, David Norton, admitted that Invega is a tough sell.
“We need to do a better job at drawing a differentiation in a difficult-to-treat population.”
So far, Invega sales have been incredibly disappointing compared to the Risperdal blockbuster.
Wyeth (antidepressant Effexor XR cum Pristiq) and Shire (ADHD drug Adderall XR cum Vyvanse) face the same uphill battle. Wyeth’s Effexor faces generic competition from Teva Pharmaceuticals despite efforts to halt generic sales of the drug and the patent on Shire’s Adderall is set to expire next year.
Hensley, in his analysis, raises a question in which the answer remains to be seen:
Cheap generics abound to treat a broad assortment of illnesses these days. What’s the point, the critics ask, of paying more for drugs that are at best only slight improvements over tried and true medicines available at bargain prices?
In an attempt to have the “me-too” drugs compete with its derivative, both Wyeth and Shire are slashing their prices, or as the DJN reported, “emphasizing improved dosing for the newer drugs.” Although Pristiq’s efficacy comes at higher doses, it’s being priced 20 percent lower than Effexor.
[Deutsche Bank pharmaceutical analyst Barbara Ryan] thinks the odds of
Pristiq’s success are slim because it appears to offer few benefits
beyond those of Effexor.
That remains to be seen. So far, a few patients have commented on my blog that Pristiq has already begun to help them. I haven’t seen any DTC ads for Pristiq so I can only assume that drug reps are doing a fine marketing job at selling the different benefits of the drug to doctors.
Vyvanse, on the other hand, is looking promising for Shire, already having 7 percent of U.S. ADHD drug prescriptions. Chief Executive Matthew Emmens says the drug is chemically different from Adderall (aren’t they all?) and has better pricing. Shire expects to beat Adderall’s 26 percent peak market share. Seems like a lofty goal to me.
As for Invega, J&J is currently seeking FDA approval to use the drug for bipolar disorder and not just treatment for schizophrenia. It is also l0oking to get approval for an injectable Invega XR.
(Invega logo from Janssen.com)
Wyeth Pharmaceuticals just can't seem to catch a break. The company is not only increasingly worried that it will lose a large chunk of its revenues to generic competition, it also faces the ongoing threat that its pipeline is starting to go dry. A further delay in the approval of its postmenopausal osteoporosis drug has become one more nail in the pharma company's coffin.
The drug, bazedoxifene, has had a hard time getting approval from the FDA since April 2007. The FDA is concerned about bazedoxifene's effects on causing myocardial infarctions or blood clots.
This is some pretty disheartening (to say the least) news considering that Effexor will soon be going generic and Pristiq has received some less-than-stellar reviews.
In previous posts, perhaps I’ve come off a little bit as “I hate Big Pharma.” I did. For a while.
I’m not in love with pharmaceutical companies either. I’ve quoted it before but “to whom much is given, much is required.” As a result of accumulating knowledge through reading and research, I know a whole lot more about pharmaceutical companies, the treatment options they put out there, and what lengths they go to get those treatments out there. Most of the things I read are negative. Much of what I’ve said is negative. Perhaps “ignorance is bliss.” My husband said this recently:
“The Internet is the great bitching ground. No one’s going to talk about how great medication is. Everyone’s going to go on and just bitch about side effects and bad experiences.”
I agree. “Effexor really helped me feel better today” doesn’t make for an interesting blog post. No one pays attention to medication when it’s working, however, everyone will complain if something is going wrong. The most “positive” drug comments I’ve seen are on my seemingly “negative” posts from people who are being helped by a drug.
Take, for instance, the following comment from Suffering:
BJ Harroun left this comment for me on one of my posts Pristiq's FDA Chances: Depression – Yea; Menopause – Nay:
I have just completed my first two weeks on Pristiq. I have suffered from MDD for 35 years. I cannot take Effexor because it increases my appetite. Pristiq has really helped me. I have taken everything and I think I have finally found something that works for me. Don't dismiss this drug because it is an Effexor metabolite.
I didn't expect to see much of a difference between Pristiq and Effexor in terms of side effects since I figure since they're from the same class (SNRI). But I'm glad that Pristiq seems to be helping BJ. It would behoove me to take a look at the PIs for Effexor and Pristiq and check out the clinical trial data and see how they shaped out differently. But there's only so much time for me during the day.