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AstraZeneca's Arthritis Drug Succeeds in Phase 3 Trial

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By Dan Carroll, The Motley Fool

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AstraZeneca‘s phase 3 study of the effectiveness and safety of developmental rheumatoid arthritis drug fostamatinib succeeded in meeting two primary endpoints. The OSKIRA-1 trial showed that fostamatinib increased ACR20 response rates in two different patient groups, according to a statement on the matter from the company. (ACR scores are used in measuring changes in rheumatoid arthritis symptoms.)

The drug also proved safe in the study, with patients tolerating fostamatinib about as well as they had in an earlier phase 2 study. Reported side effects were mild, including diarrhea, nausea, and hypertension.

Dr. Briggs W. Morrison, AstraZeneca’s chief medical officer and executive vice president of global medicine development, spoke about fostamatinib’s success in the statement, saying, “These top-line results provide important information on the efficacy and safety of fostamatinib and demonstrate that the compound has an effect on the signs and symptoms of rheumatoid arthritis.”

The success comes as the rheumatoid arthritis market heats up. Some of the leading treatments for the disease include best-selling immunology drugs such as AbbVie‘s Humira and Johnson & Johnson‘s Remicade, each of which made more than $6 billion for their companies last year.

The article AstraZeneca’s Arthritis Drug Succeeds in Phase 3 Trial originally appeared on Fool.com.

Fool contributor Dan Carroll has no position in any stocks mentioned. The Motley Fool recommends Johnson & Johnson and owns shares of Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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Business, Finance, Occupation & Industry

Is There a "First-Mover" Advantage in Biotech?

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By Keith Speights, The Motley Fool

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The early bird gets the worm. Business gurus might not use that old phrase, but many of them tout the principle behind it. They tell anyone who will listen that getting to market first provides significant advantages. Customers will gain familiarity with the first product on the market and be much less likely to switch to another product later. That’s what the gurus say, but is it true?

One biotech that certainly hopes they’re right is VIVUS . The company’s weight loss drug Qsymia gained FDA approval last July. VIVUS quickly moved to launch the drug, with Qsymia reaching the market in September.

However, Arena Pharmaceuticals is nipping at its heels. Arena’s Belviq actually gained FDA approval a few weeks earlier than Qsymia. The company hasn’t been able to launch the drug commercially, though, as it awaits scheduling by the Drug Enforcement Agency.

Will VIVUS be able to benefit from a first-mover advantage? Or is this concept really not applicable to biotech? 

Birds of a different feather
If history is a guide from a different area of biotech, VIVUS might be in for a challenge. Way back in 1998, Amgen‘s Enbrel became the first TNF inhibitor to receive FDA approval for treating rheumatoid arthritis. Regulatory approval for other indications followed over the next few years.

By any measure, Enbrel was a huge success. But another TNF inhibitor followed closely in its footsteps. Johnson & Johnson’s Remicade gained FDA approval for treating rheumatoid arthritis in 1999. The two drugs battled it out by themselves until 2002, when the FDA approved AbbVie’s Humira.

So, how well did Amgen’s first-mover advantage hold up? If we fast forward the clock to 2012, the sales for the three drugs tell the story. Amgen made $4.2 billion from Enbrel. Add to that figure another $3.7 billion from Pfizer‘s sales of Enbrel outside the U.S. That gives Enbrel a total of $7.9 billion in 2012 sales. 

Second-to-market Remicade trailed Enbrel with $6.1 billion in sales. AbbVie’s 2012 sales for Humira totaled $9.3 billion, making it the world’s top-selling drug. While Enbrel and Remicade also rank in the top five drugs in terms of worldwide sales, the laggard in getting to market became the leader.

One slippery worm
Of course, second or even third place isn’t all that bad, even for a first-mover, when sales are great for everyone. So far, though, VIVUS is finding that the market for weight loss drugs isn’t as easy to crack as it had hoped.

U.S. sales for Qsymia have been disappointing — only around $2 million in 2012. VIVUS also has faced challenges in gaining approval for reimbursement for the drug, although the company has made progress on that front.

Europe has proved to be even more difficult. The Committee for Medicinal Products for Human Use, or CHMP, rejected Qsymia (known in Europe as Qsiva) in October. VIVUS appealed the decision, but CHMP stood by its earlier negative decision. Another clinical trial focusing on cardiovascular …read more
Source: FULL ARTICLE at DailyFinance