Counterfeit Avastin circulating in the United States

Please spread the word. We have counterfeit Avastin circulating in the United States. Pictures of the counterfeit version of Avastin are shown below:

Roche Warns of Alien Counterfeit Cancer Drug in US

From Associated Press (February 15, 2012)


WASHINGTON -- The maker of the best-selling cancer drug, Avastin, is warning doctors and patients about counterfeit vials of the product distributed in the U.S. but made abroad.

Roche's Genentech unit says the fake products do not contain the key ingredient in Avastin, which is used to treat cancers of the colon, lung, kidney and brain.

A spokeswoman said the counterfeit drug has been distributed to health care facilities in the U.S., although it is unclear how many products are in circulation or where they may be concentrated. The company is working with the U.S. Food and Drug Administration to track down the counterfeit vials and analyze their contents.

"We're still analyzing what it is; we know it doesn't contain the active ingredient in Avastin," said Genentech spokeswoman Charlotte Arnold.

Arnold said the company was alerted to the problem by foreign health regulators and believes the counterfeits were imported, although she could not specify a country of origin.

FDA approves Rituxan (rituximab) to treat Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA)

FDA approves Rituxan to treat two rare disorders

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

DNA Electronics Partners with Roche to Develop Semiconductor Based Sequencing System

Collaboration to focus on development of a low-cost, high-throughput, long read, high density DNA sequencing system.

London, United Kingdom, Nov 01, 2010 - DNA Electronics, a fabless semiconductor provider of solutions for real-time DNA and RNA analysis, announced today that it has entered a partnership with 454 Life Sciences, a Roche Company. The collaboration will focus on the development of a low-cost, high-throughput, long read, high density DNA sequencing system. As part of the agreement, DNA Electronics has signed a non-exclusive licence to provide relevant IP from its proprietary semiconductor technology portfolio to Roche. This technology which enables sensitive detection of nucleotide incorporation during sequencing will build on 454 Life Sciences’ current pyrosequencing-based platform. The collaboration leverages DNA Electronics’ unique knowledge of semiconductor design and expertise in pH-mediated detection of nucleotide insertions with 454 Life Sciences’ long read sequencing chemistry to produce a seamless evolution from optical detection to low-cost, highly scalable electrochemical detection.

Roche Social Media Principles

Roche has recently published their "Social Media Principles." Did you know that Roche also has a Social Media Advisory Board?

In short, they describe their principles in two different sections:

• 7 Rules for PERSONAL online activities Speaking “about” Roche
• 7 Rules for PROFESSIONAL online activities Speaking “on behalf of” Roche

Most of this reflects common sense (if you're familiar with social media). You can read the policies here:
http://www.roche.com/social_media_guidelines.pdf

Antibody-drug conjugates (ADCs)

What do you know about antibody-drug conjugates (ADCs)? I don't recall learning about them in medical school. You probably haven't either. However, I'm sure that most oncologists have heard of ADCs.

Genentech (now a member of the Roche Group), is researching ADCs because this therapeutic option may have the potential to treat cancer and improve patients’ lives. I'm now quoting from a commerical website (www.ResearchADCs.com):

An ADC is a unique combination of a precise and targeted monoclonal antibody, a stable linker, and a potent cytotoxic and is designed to more selectively kill cancer cells while minimizing effects on normal tissue.

Will research surrounding ADCs lead to a cure for cancer? I think that most experts will agree that the future of cancer therapy will significantly revolve around targeted biologic agents and small molecules. If you're thinking about a research career, it's probably a good time to be a molecular biologist who also has extensive knowledge about nanotechnology. 

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.

FDA approves Actemra (tocilizumab) for rheumatoid arthritis

The FDA has approved Actemra (tocilizumab) for rheumatoid arthritis.

The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.

Read the full FDA Press Release here.

Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.

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.

Chemotherapy in Older Women with Early Breast Cancer

There aren't that many clinical studies that include older women with early breast cancer. Plus, older women are more likely to be treated with lower doses of chemotherapy than younger women. So, it becomes difficult to know how they should be treated if they present with early breast cancer.

Fortunately, the NEJM has an interesting article about the use of "Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer." Here's the conclusion: Standard adjuvant chemotherapy is superior to capecitabine in patients with early-stage breast cancer who are 65 years of age or older. In this study, standard chemotherapy was either cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide plus doxorubicin. Capecitabine is marketed by Roche under the trade name Xeloda.

So what does all this mean? Here are some of the highlights from the discussion section of the article:

The authors note that "the choice of chemotherapeutic agents, dose, schedule, and dose modification should be based on the treatment plans in published reports." There are significant toxicities associated with certain chemotherapy agents and many older patients are unable to tolerate such regimens.

The authors also write that "patients in this trial had an excellent performance status and no major organ dysfunction. The toxicity of these regimens in vulnerable or frail patients is probably greater than the toxicity observed in the patients in this study, and they should be administered with caution or not at all in such patients."

Avastin in Early-Stage Colon Cancer Misses Primary Endpoint of DFS

Does Avastin plus chemotherapy improve outcomes in patients with early-stage colon cancer? These types of questions are difficult to answer because the answer depends on what you're measuring as your main outcome. Survival? Disease-free progression? Quality of life? The world of oncology is a complex one with many different measurable outcomes.

The National Surgical Adjuvant Breast and Bowel Project (NSABP) C-08 study did not meet its primary endpoint (which was improved disease-free survival or DFS) with adjuvant use of bevacizumab (Avastin) plus chemotherapy in patients with early-stage colon cancer. Avastin (or bevacizumab) is made by Genentech, Inc. (which is to be acquired by Roche). Who can keep up with all these mergers and acquisitions in the pharma/biotech world?