Big Pharma Continues Jockeying for Position in India

Yesterday, Sanofi-aventis (S-A) agreed to acquire a controlling stake in Indian vaccine maker, Shantha Biotechnics, for an undisclosed amount. And, recently, Abbott announced a definitive agreement to acquire the nutrition businesses of Wockhardt Limited, Carol Info Services Limited, and certain Wockhardt subsidiaries and group companies for consideration totaling approximately US$130 million in cash.

While these two recent acquisitions don’t appear to be particularly noteworthy, they speak volumes about growing Indian influence in biologics and, perhaps more importantly, in biosimilars. India, long known for its expertise in generic drug development and its ability to work with US-based companies, has expanded beyond generic pharmaceuticals into generic biologics aka biosimilars. Biosimilars have been on the Indian market for over a decade and by all accounts several Indian companies, most notably BioCon, might be able to steal biosimilar market share in Asia from the likes of Sandoz, Merck and Teva—companies expected to be major players in the emerging biosimilar market.

Both Shantha and Wockhardt possess substantial experience in biosimilar development and commercialization. To that end, Sanofi-aventis has publicly announced its desire to get into biotechnology and Abbot must expand its biotechnology pipeline beyond Humira to remain competitive. These acquisitions likely represent Sanofi’s and Abbott’s attempt to gain a foothold in the emerging Asian markets. Also, it gives both companies access to lower cost biologics R&D and manufacturing capabilities.

It will be interesting to see how things unfold over the next year or so!

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!!!!!!!!!!!

 

Tysabri: A Drug Snatched from the "Jaws of Defeat"

You gotta give Biogen/IDEC and Elan credit for winning regulatory approval for a product that was previously pulled from the market because of serious and potentially life-threatening side effects. On Monday, the US Food and Drug Administration granted regulatory approval for Tysabri as a treatment for patients with severe Crohn’s disease who do not respond to more conventional biotechnology treatments like Humira (Abbott Laboratories) and Remicade (Johnson & Johnson). About 500,000 patients in the US suffer from Crohn’s disease (an autoimmune disease) and usually causes diarrhea, fever and severe intestinal inflammation and bleeding. Currently, there is no known cure for the disease.

As many of you may recall, Tysabri, a treatment for multiple sclerosis, was temporary pulled from the market in 2005 after three patients treated with the drug developed a rare and sometimes fatal nervous disorder called multifocal leukoencephalopathy (MFL). FDA allowed the drug back on to the market in 2006 but only under a restricted distribution program. Tysabri is used by more than 12,000 Americans with multiple sclerosis . Since its reintroduction, there have been no new reports of MFL or other serious side effects. Because of its past safety record, patients with Crohn’s disease who use the drug must also enroll in a distribution program similar to the one required for MS patients treated with Tysabri.

The approval of Tysabri for a new therapeutic indication may make Biogen/IDEC a more attractive  takeover candidate. As many of you may know, Biogen/IDEC put itself up for sale about 3 months ago and was unable to find a buyer.

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….