Trouble with the Merck-Schering Plough Deal? Johnson & Johnson to Reclaim Marketing Rights to Remicade and Simponi

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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Simponi--A New Anti-TNF-alpha Monoclonal Antibody--Garners FDA Approval.

The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe rheumatoid arthritis , psoriatic arthritis, and ankylosing spondylitis. Unlike Enbrel, Remicade and Humira, other anti-TNF-alpha monoclonal antibody products—which require multiple monthly intravenous infusions—Simponi is injected under the skin and requires only a single monthly injection. 

Simponi is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Like other anti-TNF-alpha monoclonal antibody products, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.

I have no doubt that Simponi will provide much-needed relief to patients suffering from immune arthritis. However, I think that the marketing folks at J& J could have come up with a better name—it reminds me of Spumoni (the Italian ice cream) and The Simpsons television program. But, then again, the name is distinctive and easy to remember!

Until next time...

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

 

Are Biotech Drugs ALWAYS Better?

The buzz and promise of biotechnology is the likely cause of the buying frenzy that big pharma has been on lately. Word on the street is that biotechnology products are innovative, have a higher return on investment (ROI) and are generally perceived to be “better” than conventional small molecule drugs. I agree that biotechnology products are certainly innovative and the gargantuan ROIs are titillating. But, are biotechnology products always safer and more efficacious than extant small molecule drugs? According to a recent study–maybe not!

A study conducted at the Agency for Healthcare Research and Quality in the UK evaluated the effectiveness of 11 different drugs to treat rheumatoid arthritis (RA). They analyzed the results of clinical trials that enrolled at least 100 subjects that were conducted between 1980 and 2007. After analyzing 101 studies (50% of which were conducted by or on behalf of drug companies) they were unable to detect a significant difference in efficacy or safety of small molecule and biotechnology medications that are used to treat RA. The drugs that were analyzed included conventional corticosteroids, synthetic disease modifying anti-rheumatic drugs (DMARDS) such as hydroxychloroquine, leflunomide, methotrexate and sulfasalazine and a variety of biotechnology products including Orencia® (abatacept, Bristol Myers Squibb) Humira® (adalimumab, Abbott Laboratories) Kineret® (anakinra, Amgen), Enbrel® (etanercept), Remicade® (infliximab, Johnson & Johnson) and Rituxan® (rituximab, Genentech).

As is the case with all medications, there are substantial patient-to-patient variations in efficacy and side effect profiles and one drug may work better for patient than another– whether it is a protein-based biotechnology product or a small molecule drug. Generally speaking, biotechnology drugs focus on novel targets and may have unique mechanisms of action. That said it is not prudent to assume that new biotechnology drugs are inherently better than pre-existing small molecule treatments. The jury should remain out on any drug, biotechnology or otherwise, Phase IV clinical trials and exhaustive post marketing data are collected, analyzed and evaluated.

Until next time….