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It was only a matter of time before some company decided to attempt to commercialize a generic version of a therapeutic monoclonal antibody (MAb). The main barrier to entry to the biosimilar MAb market was the patent expiry dates for the first generation of therapeutic MAbs (most were commercialized in the early 1990s and have patent protection until 2018 or longer). The recent health-care overhaul law signed by President Barack Obama earlier this year permits U.S. regulators to approve biosimilar versions of branded biologic drugs and paves the way for commercialization of biosimilar MAbs (and other biologics) in the US.

This past Monday Teva Pharmaceuticals, the world’s largest generic prescription drug manufacturer, announced its plans to commercialize a generic version of Rituxan (rituximab), Roche’s blockbuster MAb used to treat rheumatoid arthritis, leukemia and certain forms of non-Hodgkin lymphoma. Rituxan has patent protection in the U.S. until 2018 and in the rest of the world through 2013. According to the announcement, Teva joined worked with the biomanufacturing giant Lonza to produce sufficient quantities of generic Rituxan for clinical development.

Earlier this month Teva began recruiting patients with rheumatoid arthritis for a clinical trial comparing its biosimilar copy, TL011, with the Roche drug, sold outside the U.S. as MabThera. Teva and Lonza are focusing on monoclonal antibodies, and aim to gain regulatory approval for their first product by the end of 2014 said a Lonza spokesman.

Rituxan generated $5.24 billion in sales last year. Indian generic-drug maker Dr. Reddy’s Laboratories Ltd. began selling a new version of Rituxan in India in 2007 which had $4.2 million in sales in 2009. Interestingly, the size of the biosimilar MAb market is predicted to be much larger than that for therapeutic proteins like Epogen, Neupogen, Avonex and other therapeutically-active proteins.

What will be the next branded MAb-based product to succumb to the biosimilar encroachment? Only time will tell.....

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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The New York Times reported today that Genentech’s blockbuster cancer treatment, Avastin, failed to show a significant effect on preventing the recurrence of colon cancer, limiting its utility as an adjunct treatment to treat primary colorectal cancer. While Avastin is already a best-selling cancer treatment, success in this closely watched and highly visible clinical trial could have paved the way to a new uses of the drug, potentially increasing sales by billions of dollars a year.

Avastin had sales of $2.7 billion in the United States alone last year. But it is currently approved only for late-stage colon, breast and lung cancers. For those indications, patient’s lives have been prolonged for up to a few months. The new trial was designed to determine whether or not Avastin could be used earlier in the course of the disease, right after surgery to remove the tumor. The hope of such so-called adjuvant therapy is to prevent the cancer from coming back at all, effectively curing the patient.

While the Avastin failure will have little or no effect on Genentech’s financial outlook, it does call into question whether or not Roche paid too much last month to buy the 44 percent of Genentech it did not already own. Roche has long insisted that its desire to own all of Genentech did not hinge on the results of this trial. And yet, the trial appeared to play a major role in Roche’s months-long negotiations with Genentech.  It appeared that Roche, which had started those discussions last summer, wanted to complete the deal before results of the Avastin trial were announced — on the assumption that a successful trial would have sent Genentech’s stock soaring, possibly putting the takeover price it offered out of reach.  A failed trial, on the other hand, could have pushed down the value of Genentech’s stock. So it now looks as if Roche could have paid less had the results of the Avastin trial come out before it completed the deal.

Art Levinson, Genentech’s former CEO who played hardball with Roche over the course of negotiations, needs to be recognized for his outstanding business acumen. He and other Genentech executives convinced Roche that Avastin sales could quadruple, to $10 billion, by 2015 if the drug could be used for early-stage colon, lung and breast cancers. This possibility induced Roche to raise its bid for Genentech’s outstanding shares from $86.50 to $95 per share. Although Dr. Levinson wasn’t able to fend off Roche’s takeover and is no longer Genetech's CEO, he is likely “laughing all the way to the bank” as the expression goes. And, who said that PhDs aren’t any good at business?

Roche shares were down more than 10 percent on Wednesday, closing at $29.54.

Until next time...

Good Luck and Good Job Hunting!!!!!

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There has been some confusion surrounding the reporting of results from the Enhance Trial. As you know, the results from this study showed that the cholesterol-lowering drug Vytorin—a combination of Zetia and Zocor (a statin) —was no better than a generic version of Zocor by itself at controlling atherosclerosis.

In the Enhance clinical trial, 720 patients were treated with Vytorin or a generic version of Zocor and the amount of plaque that accumulated in the arteries of both groups was assessed by blood vessel imaging. Because Vytorin lowers LDL-cholesterol more than Zocor alone, both Schering –Plough and Merck (the companies that sponsored the trial) expected the patients who took Vytorin to have less growth of plaque in their arteries than those who took generic Zocor alone. As we all now know, this was not the case. In fact, there are some data which suggests that Vytorin treatment may actually enhance or promote plaque deposition and growth.

Since arterial plaque is closely associated with heart attack and stroke, the results from the Enhance trial led some to suggest that Vytorin doesn’t work any better than Zocor at preventing heart attack or stroke. While this may prove to be the case, there are currently no data to substantiate or refute this assertion. Those data will be generated in planned outcome trials that will measure the incidence of heart attack and stroke in patients taking Vytorin or Zocor. Merck and Schering-Plough began enrolling patients for these studies in 2006 and don’t expect any results before 2012. This may be too little, too late.

Merck and Schering have come under fire for not releasing the results from the Enhance trial in a timely fashion. A Congressional committee investigating the Vytorin controversy alleges that Merck and Schering Plough executives knew about the results of the Enhance studies at least two years before they released the data. The companies repeatedly delayed releasing the results of the trial, however, saying publicly that many of the images of the arteries were unclear and might need to be re-examined. Both companies have also have been criticized for delaying the initiation of the planned outcomes trials.

Shares of Merck and Schering-Plough plummeted yesterday following Sunday’s announcement at the American College of Cardiology meeting in Chicago.

Until next time….

Good Luck and Good Job Hunting (avoid NJ)!!!!!!!!!

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