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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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Abbott Laboratories yesterday announced that it will buy Facet Biotech Corp. for about $450 million in cash. Facet, along with its development partner Biogen Idec, had planned on moving a potential monoclonal antibody (MAb) treatment for multiple sclerosis called daclizumab into late stage clinical development in the second quarter of this year. The company is also developing several different cancer treatments with other pharmaceutical partners.

Abbott’s purchase of Facet signals Abbott Laboratories’ ongoing commitment to biotechnology or protein-based drugs. The company launched Humira (a fully human MAb treatment for rheumatoid arthritis and other inflammatory diseases) several years ago and it has managed to glean market share from older competitor’s products including Remicade (Johnson & Johnson) and Enbrel (Amgen/Pfizer) to become a blockbuster drug. MAbs are viewed by many as the “drugs of the future.” At present, there are over 350 MAb-based products in various stages of discovery and clinical development.

Earlier in the year, Biogen Idec offered to purchase Facet for $17.50 per share. Company executives and shareholders rejected the offer citing that they thought it was too low. Abbott offered $27 per share which represented a 67 percent premium to Facet’s closing stock price of $16.21 on Tuesday.  Both companies’ boards of directors have already approved the deal which is expected to close some time in the second quarter. It is not clear how the purchase will affect Facet employees but expect to see layoffs and a mass exodus by company executives.

Look for more cash purchases of biotech firms by pharmaceutical companies as debt continues to accrue and venture money remains scarce and difficult to come by.

Until next time...

Good Luck and Good Job Hunting!!!

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Johnson & Johnson (JNJ) is trying to regain sole marketing rights to Remicade, its lucrative anti-TNF treatment for arthritis and psoriasis, because Schering Plough (SGP)—which has most of the marketing rights to the drug outside of the US—is being acquired by Merck. JNJ is seeking arbitration to determine whether or not Centocor, its subsidiary that manufactures Remicade and Simponi, can terminate a marketing agreement for the two drugs—based on terms stipulated in the original contract —if there is a “change of control” at SGP.

As you may recall, Merck was acutely aware of the terms of marketing agreement before it decided to purchase SGP and cleverly engineered the acquisition as a reverse merger— to prevent triggering provisions that could return Schering’s marketing rights for Remicade and Simponi to JNJ if their were leadership changes or a change of control at SGP. JNJ’s announcement contesting wasn’t unexpected after the Merck-Schering Plough deal was announced early last winter—sales of Remicade outside of the US topped $2.0 billion in last year. Simponi, Remicade’s highly touted successor (which recently received FDA approval), is also expected to reach blockbuster status after it reaches the market. 

The Merck-Schering deal left JNJ with few alternative or choices. The company could have counter offered to purchase SGP in its entirety or simply, as it did, invoke terms of the original agreement that would terminate SGP’s marketing rights if there was a “change of control” at the company. JNJ rightfully believes that a change of control will occur when Merck acquires SGP. According to a JNJ spokesperson “As its public statements make clear Merck is acquiring Schering Plough. The acquisition constitutes a change of control and trigger’s Centocor’s right to terminate.” It will be interesting to see how an arbitrator rules in the case.

While the loss of Remicade and Simponi isn’t likely to jeopardize the Merck-Schering Plough deal (according to Merck executives), it may affect the financial terms and overall benefit or upside of the acquisition. The expected completion of the deal is scheduled for the fourth quarter of this year.

Until next time...

Good Luck and Good Job Hunting!!!!

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Monoclonal antibodies (MAbs) directed against vascular endothelial growth factor (VEGF) receptors on cancer cells, have been found to slow the growth of a variety of cancers including colorectal, breast and lung.  While a number of blockbuster biotechnology products( based on these MAbs (Avastin by Genentech/Roche and Eribitux by Bristol-Myers Squibb/ImClone/Merck KGA) have been approved to treat a variety of different cancers their effectiveness as cancer treatments has been the subject of intense debate since their approvals.

Although numerous human clinical trials have shown that VEGF inhibitors slow the growth and development of tumors, they, as a class, don’t seem to significantly increase the survival time for most cancer patients. Further, Avastin and Erbitux are generally not used as stand alone treatments but are used in combination with more tradition anti-cancer chemotherapies. The high costs of these drugs, (Avastin’s worldwide sales hit $ 3.5 billion last year) and their variable effectiveness have caused many to question the usefulness of this class of drugs to treat cancer patients.

The well-publicized use of these drugs as cancer treatments coupled with anecdotal evidence about their effectiveness has put practicing oncologists between a rock and a hard place when it comes to treating patietns with cancer. In an article in Sunday’s New York Times one prominent oncologist said that depsite the controversy,  “I still use Avastin routinely. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” Others are more sanguine about VEGF inhibitors as cancer treatments “Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition. But we market them and give them to everybody.”  

Nevertheless, most oncologists find it difficult to withhold Avastin or Erbitux from cancer patients seeking hope. As one oncologist put it “ When I am not sitting in front of a patient, I think about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin, I think about the patient’s needs.” 

Regardless of their therapeutic value, the main issue with this class of anti-cancer drugs is cost. Avastin treatment costs patients about $4000-$9000 per month— Eribitux treatment is even more costly! While Medicare and most private insurers cover 80% of the cost, patients can be responsible for 20% or more of treatmetn costs.  As posited in the Times article “If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care.”

Are anti-VEGF drugs real cancer treatments or expensive red herrings? Clearly, the jury is still out on that one. That said, I think that only cancer patients can truly provide an accurate response to that question!

Until next time…

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

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