PharmaGazette

Certican (Everolimus) Prolongs Advanced Kidney Cancer Survival

Wed, 23 Jul 2008 12:00:48 -0700

In a report published in the online edition of The Lancet Dr. Robert J. Motzer, from Sloan-Kettering Cancer Center in New York reported that treatment with everolimus improved the progression-free survival of patients with advanced kidney cancer who had not responded to other treatments.

The study involved 410 patients with kidney cancer that has metastasized to other parts of the body despite treatments with sunitab and/or sorfenib. Patients received either everolimus or a placebo once a day in addition to supportive care.

Everolimus, which has already been U.S. Food and Drug Administration approved as Certican, is indicated for the prevention of heart transplant rejection and if new approval is granted as a cancer drug, use of the agent would greatly expand.

The progression rate of the kidney cancer was found to be 37% in the everolimus group as compared to 65% in the placebo group with survival time being 4 months for patients receiving everolimus and 1.9 months for those receiving placebo.

Side effects of the drug included mouth sores, rash and fatigue were more common in the everolimus group but were found to be mild or moderate.

[Source: YahooNews]

Topamax (topiramate) May Cause Birth Defects

Wed, 23 Jul 2008 10:00:18 -0700

Only one month after Johnson & Johnson was required to put a black box warning on Regranex and a week after the U.S. Food and Drug Administration rejected a black box warning on epilepsy drugs, research has found that J&J's Topamax may increase the risk of birth defects.

The study, a small one of 203 patients, found a 14-fold increase in the risk of birth defects in patients taking the epilepsy drug Topamax. The risk was potentially even higher in patients that took Topamax with valproate (Depakote) or other epilepsy medications.

Due to the small size of the study, experts have stressed that more research is needed to confirm the possible birth defect link. Experts also stated that pregnant women who suffer from epilepsy should not stop taking there drug as the seizures without the medication can have an even greater damaging effect on the fetus. However patients taking the medication for the purpose of migraine relief and who are pregnant or contemplate getting pregnant are prompted to talk to the health care provider about a suitable alternative.

Epilepsy Drugs to get FDA Warning

Epilepsy Drugs LIkely to Avoid FDA Black Box Warning

Alcoholics’ Quality of Life Improves with Topiramate

[Source:FiercePharma]

Viagra Helps Depressed Women with Sexual Dysfunction

Tue, 22 Jul 2008 09:00:35 -0700

A recent study published in the Journal of American Medical Association found that the erectile dysfunction drug Viagra worked effectively at fighting sexual dysfunction in women taking antidepressants.

The study included 98 women whose depression was in remission but were still experiencing sexual problems such as pain during intercourse, lack of arousal and lack of interest. Over an 8 week period the women took a pill up to two hours prior to sex; half were given Viagra and the other half a placebo.

72% of the women taking the Viagra reported improvement while 73% of those on the placebo pill reported no improvement.

"By treating this bothersome treatment-associated adverse effect in patients who have been effectively treated for depression, but need to continue on their medication to avoid relapse or recurrence, patients can remain antidepressant-adherent, reduce the current high rates of premature medication discontinuation, and improve depression disease management outcomes," wrote lead author George Nurnberg of the University of New Mexico School of Medicine.

Currently Viagra is only U.S. Food and Drug Administration approved for use by men.

[Source:YahooNews]

Vytorin Study Disappointing

Tue, 22 Jul 2008 08:00:09 -0700

Results from a major European study found that Vytorin did not prevent worsening of heart valve disease nor did it lower the need for valve surgery.

Preliminary results of the study found that Merck & Co. and Schering-Plough's joint marketing venture of Vytorin showed no statistical difference between the drug and a placebo at lowering the risk of major cardiovascular event such as heart attack, stroke, surgery or death in patients with aortic stenosis. Other studies have also found no benefit to patients taking Vytorin which resulted in a media blitz by the manufacterers to attempt damage control.

Vytorin is a combination of Merck's Zocor and Schering-Plough's Zetia and the study did find that the drug reduced cholesterol levels by 60% but results were no better than the previously established benefits of Zocor and other statins.

In March cardiologists recommended that doctors fall back to older, established treatments for high cholesterol. Schering-Plough reported that U.S. prescriptions for Vytorin and Zetia had both dropped by just over 25% in the period of January to June as compared to a 5% drop in total cholesterol drug sales.

[Source: YahooNews]

Teva Buys Barr Pharmaceuticals

Fri, 18 Jul 2008 11:00:18 -0700

The Isreali based Teva Pharmaceuticals has agreed to purchase Barr Pharmaceuticals, of New Jersey for approximately $7.5 billion and in addition will assume $1.5 billion in debt.

Both companies are manufacturers of generic drugs but with Teva facing a wave of patent infringement suits, the company is looking to expand upon its existing proprietary medications. Currently Teva has 300 generic drugs and 3 proprietary drugs (brands of its own). One for Multiple Sclerosis, one for Parkinson's and one for asthma. Barr Pharmaceuticals has a host of branded drugs, mostly in women's health products such as Plan B, an emergency contraceptive, Seasoniques, an oral contraceptive and Paragard, a long-term, non-hormonal contraceptive.

The deal is expected to close in late 2008 and the $7.5 billion purchase price values Barr at $69.44 per share which is a 48% premium over closing price on July 16. Friday's closing has Barr valued at $63.43 up $6.26 from the previous day's closing.

[Source: Forbes]

Interesting Articles for Week of July 18, 2008

Fri, 18 Jul 2008 10:00:44 -0700

It's been a slow week in terms of pharma news but I've been reading through a lot of health related articles that are interesting and what to share them with you. Check out some of the following, I think you will enjoy them!

Exercise Might Slow Brain Shrinkage in Alzheimer's Patients (HealthDay)
For Young Adults, Borderline High Blood Pressure a Threat (HealthDay)
Kids Should Work with Hands for Brains' Sake (Reuters Health)
Medical Visit Companions Boost Care Satisfaction (Reuters Health)
Not All Patient Adverse Events Recorded by Hospitals (Reuters Health)
Statins Show Little Benefit for Kids with Learning Disorder (HealthDay)
Stomach Germ May Protect Against Asthma (HealthDay)
No Evidence Breast Self-Exams Cut Cancer Deaths (HealthDay)
Premature Birth Linked to Some Unexpected Later Problems (HealthDay)
Researchers Find Link between Organ Transplants, Cancer (HealthDay)
Scientists Find Key Brain Circuits for Attention (Reuters Health)
Brain Scans Show Heightened Risk for Obsessive-Compulsive Disorder (HealthDay)
Cancer Survival Depends on Where You Live (HealthDay)
Dietary Fiber Cuts Risk of Pregnancy Complication (HealthDay)
FDA Reaches Settlement with California Hearing Device Maker (Food and Drug Administration)

Read on, you can never have too much info about what's going on in the world of health!

Combination Drug Therapy Improves Rhenumatoid Arthritis Remission

Fri, 18 Jul 2008 09:00:21 -0700

A new study at the University of Leeds and Leeds Teaching Hospitals Trust in the United Kingdom and recently published in The Lancet, found that patients with moderate to severe rheumatoid arthritis have benefited from a drug combination of Enbrel (etanercept) and methotrexate.

The study, funded by Wyeth manufacturer of Enbrel, found that combining the two drugs improved both remission and radiographic non-progression rates within 1 year when compared to treatment with methotrexate alone. Patients taking the drug combination were also found to stay employed.

The study consisted of 500 outpatients who had no been treated with methotrexate, a chemotherapy drug. Patients were randomly assigned either methotrexate plus 50 milligrams a week of Enbrel or methotrexate alone.

The study found that while only 28% of the patients receiving methotrexate alone went into remission, half of those receiving the combination therapy went into remission and 94% reported having a good/moderate response. the study also found that almost 25% of patients who were working at the start of the trial and were in the single drug group were forced to stop working while only 10% of the combination drug patients were required to stop.

[Source: WashingtonPost]

Pain Relief from "Liquid Marijuana" Oral Spray

Fri, 18 Jul 2008 08:00:29 -0700

Sativex is a mouth spray derived from marijuana plants. It is one part THC (Tetrahydrocannabinol), the main psychoactive substance found in a cannabis plant, and one part CBD (cannabidiol), the part of the plant that moderates the euphoria and seems to add a sedative effect.

GW Pharmaceuticals has begun late stage clinical trials on the buccal spray in both the U.S. and Europe. It was approved in Canada for the treatment of neuropathic pain in Multiple Sclerosis in 2005 and as an adjunctive analgesic treatment for peole with advanced cancer with moderate to severe pain.

According to GW Pharmaceuticals "Sativex is a pharmaceutical product standardized in composition, formulation, and dose...which has been, and continues to be, tested in properly controlled...studies," according to the company's website. "Crude herbal cannabis (marijuana) in any form...is none of those things."

The U.S. currently has two synthetic cannabinoid pills, Marinol and Cesamet, that are used in the treatment of chemotherapy-induced nausea and vomiting. Marinol is also indicated for the treatment of AIDS related appetite loss.

[Source: USAToday]

FDA Changes Drug Application Process

Mon, 14 Jul 2008 10:00:32 -0700

The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies.

Previously the FDA's Center for Drug Evaluation and Research (CDER) issued "approvable" or "non-approval" letters when a drug application was not approved. The new approval process will consist only of a "complete response" letter at the end of the review process to inform the drug company of the agency's decision.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."

The change in the application response process is not expected to affect the time it takes the FDA to review nor will it directly affect consumers. The changes become effective August 11, 2008.

Denosumab Prevents Osteoporosis in Trial

Mon, 14 Jul 2008 09:00:36 -0700

Amgen Inc. (NASDAQ:AMGN) announced that its experimental drug denosumab demonstrated that it can prevent bone loss in men that are being treated with prostate cancer drugs which can cause osteoporosis.

Results, based on a three-year Phase III study of over 1,400 men, found that denosumab increased bone mineral density at the lumbar spine and non-vertebral sites than a placebo. All men in the study had non-metastatic prostate cancer and were undergoing androgen deprivation therapy.

Amgen also stated that during the 36 months of the trial the men who received denosumab had have the incidence of new vertebral fractures than those receiving a placebo.

"This pivotal study in men with prostate cancer demonstrated once again that denosumab increases BMD consistently at all sites measured. We are also excited by the reduction in vertebral fractures, which permits the conclusion that the increased BMD seen in patients receiving denosumab is associated with improved bone strength," said Roger Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "We are encouraged by the potential benefit this may represent to prostate cancer patients undergoing ADT for whom bone loss and fractures are serious and under-recognized complications of cancer treatment."

[Source: Amgen]

Interesting Articles for Week of July 11, 2008

Fri, 11 Jul 2008 15:00:54 -0700

Check out some of the following articles. I think that they are not only interesting but also informative and worth your time.

Steroid Nasal Spray Eases Mild Sleep Apnea in Kids (Reuters Health)
Popular Antidepressants Linked To Gastrointestinal Bleeding (HealthDay)
Pregnancy Alone Not a Risk for Mental Health Problems (HealthDay)
Pregnancy Can Raise Risk of Heart Attack (Reuters Health)
Omega-3, Some Omega-6 Fatty Acids Boost Cardiovascular Health (HealthDay)
Pediatricians Recommend Cholesterol Drugs For Some Kids (HealthDay)
Treating Blood Pressure May Help Prevent Dementia (Reuters Health)
Drug Combo Taken Early Relieves Migraine (Reuters Health)
FDA Approves New Genetic Test for Patients with Breast Cancer (Food and Drug Administration)
Osteoporosis Drug Linked to Fractures (Reuters Health)
Osteoporosis Increased in Scleroderma Patients (Reuters Health)
Spray Dulls the Pain of Needles in Kids (Reuters Health)
FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs (HealthDay)
Melanoma Drug Boosts Recurrence-Free Survival (HealthDay)

Enjoy and Have a great weekend!

Epilepsy Drugs Likely to Avoid FDA Black Box Warning

Fri, 11 Jul 2008 11:00:09 -0700

In what was seen as a foregone conclusion in February 2008. a black box warning on epilepsy drugs is now far from reality.

The U.S. Food and Drug Administration advisory panel agreed that the drugs may increase the risk of suicide but felt the risk was not sufficient enough to merit a black box warning and risk patients avoiding the drug therapy.

The vote by the advisory panel stood at 14 against the warning, 4 in favor and 3 abstaining. However, the panel did recommend that a medication guide be sent to doctors detailing the possible suicide risk associated with the epilepsy medications.

The 11 drugs on the list to potentially have the warning bring a total of over $10 billion annually.

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

The narrow escape from black box warnings is not set in stone due to the fact that the FDA usually follows its panel's advice but is not required to.

Epilepsy Drugs to get FDA Warning

[Source:FiercePharma]

Fluroquinolone Antimicrobial Drugs Get Increased FDA Warning

Wed, 09 Jul 2008 12:00:33 -0700

The U.S Food and Drug Administration has notified the manufacturers of fluroquinolone antimicrobial drugs that a "boxed warning" in the label of the product is required to inform patients of the increased risk of tendonitis and tendon rupture.

Aside from the boxed warning the FDA also decided that manufactures provide a Medication Guide to patients warning of the possible side effects. The drugs already carry a warning of an increased risk of tendon ruptures but an increased number of adverse event reports prompted the increased visibility of that warning.

The class of antimicrobial drugs known as fluroquinolones, such as Cipro, have been approved to treat or prevent bacterial infections such as sinusitus, urinary tract infections, cystitis and lower respiratory tract infections.

The drugs involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research stated, "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."

[Source: FDA]

Happy Canada Day

Mon, 30 Jun 2008 18:00:29 -0700

Being a proud Canadian tomorrow is a big day for me. Yup, it's Canada's birthday.

There will be fireworks displays across the country and just about every little town and big city will be having festvities.

To my fellow Canadian readers:

To Canada:

Happy 141st Birthday

For those of you that don't know where Canada is here's a map ;)

Stock Market Fluctuations in Big Pharmas as of June 30, 2008

Mon, 30 Jun 2008 15:00:36 -0700

Company Name, Symbol, Share Price, Change

Abbott Laboratories' (NYSE:ABT) - $52.97 -0.03 (-0.06%)
AstraZeneca (NYSE:AZN) - $42.53 +0.78 (+1.87%)
Bristol-Myers Squibb (NYSE:BMY) - $20.53 +0.23 (+1.13%)
Eli Lilly & Co. (NYSE:LLY) - $46.16 +0.55 (+1.21%)
GlaxoSmithKline(NYSE:GSK) - $44.22 +0.24 (+0.55)
Merck & Co. (NYSE:MRK) - $37.69 +0.71 (+1.92%)
Novartis AG (NYSE:NVS) - $55.04 +1.62 (+3.03%)
Pfizer Inc. ( NYSE:PFE) - $17.47 +0.19 (+1.10%)

It was a good day for pharma stock with all stocks listed above recouping some losses with the exception of Abbott. However it has been a rough month for these stocks. When comparing price of these stocks from 30 days ago we see that all took a bit of a hit with one exception. AZN had the least decrease with only $1.16 loss followed by MRK with a loss of $1.27. Abbott took the biggest hit with a loss of $3.39 and BMX was a close second with a loss of $2.26.

Novartis was the only stock to increase in value in the last 30 days. It had a price of $52.53 as of May 30 and closed today at a price of $55.04. The stock had a volatile month as it had a low in the $50 range in mid month