Abbott: ABT-089 data for adult ADHD look promising

In two posters presented at the American Psychiatric Association annual meeting in Washington DC, Phase II data has demonstrated that once and twice-daily dosing of Abbott's ABT-089 is efficacious and safe in adults with ADHD. Furthermore, if it reaches the market, the drug's potential to decrease smoking behavior in adult patients is expected to give it a competitive edge over established brands.

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Abbott: Humira sales forecast increased

With Abbott's Humira (adalimumab) being reimbursed by 95% of managed care organizations three months after its US launch, the company has re-forecast the product's 2003 results. Abbott is under pressure to build US share rapidly, before the expected 2005 launch of Celltech/Pharmacia/Pfizer's rival rheumatoid arthritis drug CD870.

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Alexion: good news for new asthma approach

Alexion has demonstrated the efficacy of an inhaled monoclonal anti-C5 antibody to block airway hyper-responsiveness in preclinical models. This is clearly good news for what looks like an interesting and convenient new approach to treating those asthma patients who remain insufficiently controlled on existing drugs, although the drug candidate has a long way to go yet.

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Alkermes and Cephalon: Vivitrol's sales likely to be unaffected by FDA's warning

The FDA has warned of the risk of injection site reactions to Vivitrol, a once-monthly injection drug for the treatment of alcohol dependence. However, due to the considerable adverse health consequences related to alcohol dependence, along with the limited number of prescription drugs available, Datamonitor does not expect Vivitrol to experience a substantial downturn in sales.

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Alkermes/Eli Lilly: regulatory rumors temper insulin optimism

Alkermes' [ALKS] stock price has surged on the back of Lilly's [LLY] endorsement of the inhaled insulin project, as the latter seeks to keep up with close rivals Aventis [AVE] and Pfizer [PFE] and their inhaled insulin, Exubera. Yet reports of regulatory hurdles hindering the approval of Exubera means that Eli Lilly's move should be greeted with a certain amount of caution.

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Alkermes/Janssen: no FDA respite for Risperdal

Janssen's substantial slice of the lucrative antipsychotics market is under threat, even though the FDA may eventually approve injectable Risperdal if its makers provide more evidence of its safety. The agency has already approved an extended release formulation of Pfizer's Geodon, and this drug will now enjoy substantial first-to-market advantage.

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Alpharma: fight for blockbuster gabapentin heats up

Alpharma has received market exclusivity for the anticonvulsant gabapentin, which is currently protected under patent by Pfizer, using the brand name Neurontin. Alpharma is expected to wait for a court ruling on the validity of Pfizer's production patent before entering the market. That should allow time for Pfizer to launch its follow on product, pregabalin, thus protecting future revenues.

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Alza: a new focus on in-house development

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Alza: effective Concerta is hard to swallow

A new study shows that Alza's Concerta, which is already indicated in low doses for ADHD, can also treat severe ADHD in high doses. However, the news is unlikely to change Alza's strategy, since patients find Alza's pill uncomfortably large in its current highest dose, the company is likely to keep focusing on smaller doses.

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Andrx/Genpharm/Schwarz: three-way deal to hurt AstraZeneca

Following FDA approval of Schwarz's generic Prilosec, the company has allied with Andrx and Genpharm to market it. The deal, which combines Schwarz's court victory with Andrx/Genpharm's regulatory exclusivity, should bring significant revenue to all three. AstraZeneca, which made $4.5 billion from Prilosec in the US last year, is the only loser.

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