Recentin (cediranib) does not meet endpoint in study

8 March 2010 - Anglo-Swedish pharma major AstraZeneca (LON: AZN) (STO: AZN) said today its tablet cancer drug Recentin did not prove equal to injectable rival treatment Avastin by Swiss Roche AG (VTX: ROG) in a head-to-head Phase III trial.

The so-called Horizon III study did not meet the primary endpoint to prove non-inferiority of Recentin as a treatment for metastatic colorectal cancer (mCRC) in combination with chemotherapy.

Both Recentin (cediranib) and Avastin (bevacizumab) are designed to starve tumours by stopping them from building blood vessels, a process called anti-angiogenesis.

Crestor (rosuvastatin) is the first statin to receive FDA approval for primary prevention

Crestor (rosuvastatin) is the first statin to receive FDA approval for primary prevention of heart disease. According to MedPageToday, the indication is for the following:

The new indication would be for men 50 or older and women 60 or older who have fasting LDL of less than 130 mg/dL, a highly-sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke, or coronary heart disease risk.

The FDA has been discussing the results of a significant study called the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study. The results of the JUPITER study were published in the New England Journal of Medicine in November 2008 (and since it's now in the public domain, you can click here to read the full study). Considering that this is a paradigm shift regarding the use of statins, the FDA wanted plenty of time to go through the data before they approve a new indication.

The funny thing is that my wife and I were talking about primary prevention, normal lipid levels, hs-CRP, and primary prevention the other day. My cholesterol levels are fine, but what about my hs-CRP? Should I be on a statin? Any statin, or a specific statin?

Crestor (rosuvastatin) in marketed by AstraZeneca.

AstraZeneca to cut 8,000 jobs by 2014

The word "stability" doesn't seem to exist when we're talking about the world of pharmaceuticals. According to the Associated Press, AstraZeneca may be cutting 8,000 jobs by 2014.

There was a time when working for a pharmaceutical company seemed to be the "ideal" job for many working professionals. I wonder how those attitudes are changing during these difficult economic times.  Some physicians who wish to leave the world may be thinking about a career in the pharmaceutical industry, but how stable are such jobs?

FDA panel backs new use for AstraZeneca's Crestor

FDA panel backs new use for AstraZeneca's Crestor

12/15/2009, 5:56 p.m. EST

By MATTHEW PERRONE (AP)

GAITHERSBURG, Md. — Federal health advisers said Tuesday that expanded use of AstraZeneca's cholesterol pill Crestor can benefit patients with healthy cholesterol levels by preventing heart attack, stroke and death.
A Food and Drug Administration panel of experts voted 12-4 with one abstention that Crestor's benefits outweigh its risks in patients with normal cholesterol and no history of heart disease, setting the stage for a dramatic expansion of a drug that is already a blockbuster.
The FDA is not required to follow the group's advice, though it usually does. A decision is expected in the first quarter of next year.

(read more...)

AstraZeneca will Cover Co-pay for Medicare Part D

It's great to see how pharmaceutical companies are helping patients who are unable to afford their medications during these difficult economic times. We've seen many different patient assistance programs that have helped many people gain access to vital medications. AstraZeneca has made another step to help those on Medicare Part D. Here's a press release that was published today:

AstraZeneca Medicare Part D patient assistance program no longer requires co-pays

December 8, 2009 – Wilmington, DE – AstraZeneca (NYSE:AZN) announced today that patients enrolled in the company’s Medicare Part D prescription savings program will no longer pay co-pays for their medicines through the program.

Prescriptions also now will be mailed to patients’ homes or physician’s offices under the changes to the AZ&Me™ Prescription Savings program for people with Medicare Part D. The changes will take effect Jan. 1, 2010.

“These changes will better serve Medicare Part D enrollees by making it easier for them to access the medicines they need,” said Rich Fante, US President, AstraZeneca Pharmaceuticals LP. “This prescription savings program and these latest improvements reflect our ongoing commitment to patient health.”

Currently, patients enrolled in the program fill their AstraZeneca prescriptions at retail pharmacies and have a co-pay of between $15 and $25, depending on their qualifying income. The elimination of a co-pay will save approximately 30,000 patients enrolled in the program a total of $3 million each year.

Program Details

Eligible patients can enroll in the AZ&Me™ Prescription Savings program for people with Medicare Part D at any time in the calendar year, but must meet program requirements in order to start utilizing the benefit.

The AZ&Me™ Prescription Savings program for people with Medicare Part D is one of three distinct prescription savings programs in the AZ&Me Prescription Savings Program suite. Other AZ&Me Prescription Savings Programs include a plan for individuals without insurance and one for healthcare facilities.

To learn if you qualify for the AZ&Me Prescription Savings Programs, please visit www.AZandMe.com or call 1-800-AZandMe. Program specialists are available Monday through Friday between the hours of 9:00 AM and 5:00 PM EST.

Other prescription savings programs are available regardless of which medications your doctors prescribe. To find out more about the more than 475 savings programs covering 2,500 medications, please visit www.pparx.org or call 1-888-4PPA-NOW (1-888-477-2669).

To learn more, visit AstraZeneca

FDA approves Onglyza (saxagliptin)

FDA approved Onglyza (saxagliptin) for type 2 diabetes. This is the 2nd DPP-IV inhibitor to be approved. The first DPP-IV was Januvia (sitagliptin).

Here's the FDA press release:

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

AstraZeneca Expands AZ&Me Prescription Savings Program

During these difficult economic times, any type of savings program is appreciated. AstraZeneca is expanding its prescription savings program by extending assistance to qualifying patients who have recently lost their jobs, had their incomes reduced, or experienced a change in marital status or family size.

"AstraZeneca is committed to helping patients get the medicines they need," said Rich Fante, US President, AstraZeneca Pharmaceuticals LP. "Our responsibility goes beyond developing medicines to also making them available to those who cannot afford them."

Here are the details of the AZ&Me(TM) Prescription Savings programs:

• AZ&Me(TM) Prescription Savings program for people without insurance: AstraZeneca provides AstraZeneca medicines at no cost to qualifying individuals without prescription drug coverage who make up to $30,000 per year and families of four who make up to $60,000 per year.
• AZ&Me(TM) Prescription Savings program for people with Medicare Part D: AstraZeneca provides low-cost AstraZeneca medicines for qualifying Medicare Part D patients who make up to $30,000 per year or couples who make up to $40,000 per year.
• AZ&Me(TM) Prescription Savings program for healthcare facilities: AstraZeneca provides AstraZeneca medicines at no cost to qualifying non-profit healthcare facilities, such as disproportionate share hospitals, community health centers and community free clinics. This program connects patients to the AstraZeneca medicines they need at the same time and place they receive their treatment.

Patients can learn more about the AZ&Me(TM) Prescription Savings program at www.azandme.com or by calling 1-800-AZandMe.

Targeting Angiogenesis in Cancer

Anti-angiogenesis drugs work by blocking the activity of vascular endothelial growth factor (VEGF) to prevent the growth of new capillaries into the tumor and thereby sustain tumor growth. They have significantly changed the landscape of oncology because of their effectiveness and their associated toxicities. There have been several new biologic agents that have been approved and more are coming down the pipeline. Here are a few agents that come to mind:

• Avastin (bevacizumab) is a monoclonal antibody that inhibits angiogenesis and it was approved in 2004. In fact, it was the first agent approved by the FDA to inhibit angiogenesis. Avastin targets vascular endothelial growth factor (VEGF).
• Cediranib (tentative trade name Recentin), also known as AZD2171, is a potent inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases.
• Vatalanib (PTK/ZK) is a small molecule tyrosine kinase inhibitor with broad specificity that targets all VEGF receptors (VEGFR), the platelet-derived growth factor receptor, and c-KIT.
• Sorafenib (Nexavar) is a multitargeted small molecule that inhibits VEGFR2, FLT3, PDGFR, and fibroblast growth factor receptor-1.
• The list goes on, but I'm going to stop here. This is a blog, not a medical review paper.

So why am I writing about these drugs? I'm curious: do you know who markets these drugs? Everyone probably knows Avastin (Genentech). What about Nexavar (Bayer/Onyx)? How about Recentin (AstraZeneca)? Vatalanib (Bayer Schering/Novartis).

It's exciting to see advances in cancer therapy, but in the spirit of recent healthcare reform discussions, I must ask, "who gets to decide how much (in terms of dollars) therapy a cancer patient should receive?" These biologic agents are very expensive and many patients are having tremendous difficulty paying for them. At what point does it make sense to deny coverage for therapy simply because it's too expensive? Never? I'm glad to I don't work in a managed care organization because these are some of the ethical issues that must get discussed on both an individual and a population level.

New cancer drug has few side effects

There's an interesting article in the New England Journal of Medicine (NEJM) that talks about a novel new cancer agent called olaparib. In a phase 1 study, this drug was found to have few adverse effects (compared to conventional chemo) and displays antitumor activity in certain tumors. Here's the brief conclusion: Olaparib has few of the adverse effects of conventional chemotherapy, inhibits PARP, and has antitumor activity in cancer associated with the BRCA1 or BRCA2 mutation.

Technology Review has a nice article on this titled, "New Drug Kills Cancer with Few Side Effects." Sounds simple, doesn't it?

Compare that to the NEJM title: "Inhibition of Poly(ADP-Ribose) Polymerase in Tumors from BRCA Mutation Carriers." Did you catch all that? What's PARP?

Did you learn about PARP in medical school? The inhibition of poly(adenosine diphosphate [ADP]–ribose) polymerase (PARP) is a potential therapeutic strategy for the treatment of cancers with specific DNA-repair defects, including those arising in carriers of a BRCA1 or BRCA2 mutation. Olaparib (AZD2281) is an orally acting PARP inhibitor.

As cancer therapy becomes more tailored in our evolving world of personalized medicine, it's exciting to see all this research that combines molecular biology, genomics, and targeted therapies. Advances in medical technology and drug development are leading to innovative treatments in the world of oncology.

Olaparib (AZD2281), previously known as KU-0059436, began to be manufactured by AstraZeneca after the company acquired KuDOS Pharmaceuticals.

FDA: Labeling Change for Leukotriene Modifiers

Leukotriene modifiers (also known as Leukotriene Receptor Antagonists) are common asthma drugs that have been rarely linked to something called Churg-Strauss syndrome (good trivia fact). The FDA has requested that certain drug manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

• Singulair is manufactured by Merck.
• Accolate is manufactured by AstraZeneca
• Zyflo is manufactured by Cornerstone Therapeutics, Inc.
  

What is it about certain medications? Can we be certain that these are all drug-induced effects? If clinical studies are not designed to look for such findings, can we be confident that post-marketing data can be interpreted properly? Do these drugs really cause mood changes? Or, are these simply associations that have no causality? Pretty soon, every single prescription drug out there will have some type of black box warning about mood changes and possible suicidal behavior. Once that happens, everyone will be ignoring these warnings.

Will Roche have the first PPAR agonist?

The Wall Street Journal (WSJ): "Roche Diabetes Drug in Late-Stage Test"

Will Roche be the first with a dual PPAR agonists? Thiazolidinediones (TZDs) like Avandia (rosiglitazone) and Actos (pioglitazone) bind to peroxisome proliferator-activated receptors (PPARs). Several new thiazolidinediones are being investigated as "dual PPAR agonists." One such compound is aleglitazar (made by Roche). My gut tells me that they won't be marketed as TZDs. "Dual PPAR Agonist" sounds better, doesn't it?

A few years ago, AstraZeneca stopped R&D on a similar drug, Galida (tesaglitazar), while Bristol-Myers Squibb (BMS) stopped work on a drug called Pargluva (muraglitazar). TZDs just haven't had much luck, have they? Remember Rezulin (troglitazone)? It was the first TZD and it got pulled from the market because of liver problems.

Symbicort is now FDA approved for COPD

The FDA has approved the use of Symbicort (budesonide/formoterol) for the treatment of COPD. Symbicort is a combination inhaler that was originally approved for the treatment of asthma and is manufactured by AstraZeneca. Like many other new drugs, it has been available in Europe for a while now.