Avexa: apricitabine shelving demonstrates obstacles for new HIV drugs in FDC-dominated market

Melbourne-based biotech Avexa has announced the closure of its lead HIV program for apricitabine after failing to attract a licensing partner for the Phase III drug. In the increasingly competitive HIV market, once-daily cross-class fixed-dose combinations (FDCs) will drive future growth, dwarfing the commercial opportunity for single nucleoside reverse transcriptase inhibitors like apricitabine.

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Basilea: FDA issues approvable letter for ceftobiprole

Basilea has received an approvable letter from the FDA for its new drug, ceftobiprole. Against the backdrop of investigations into the safety of Ketek, and considering the scrutiny Telavancin has endured, the letter is yet another indication of the FDA's more rigorous and defensive approach to the drug approval process.

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Battle for HIV drug market share getting fiercer

The HIV market, worth $9.3 billion in 2007, is expected to grow to $15.1 billion by 2017, driven by the increasing prevalence of HIV worldwide and the longer life expectancy of patients receiving treatment. Despite this growth, the competition is getting tougher across all antiretroviral drug classes, which may cause some of the big players in the HIV market to opt out or be squeezed out.

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Biovest/Accentia's BiovaxID revives hope for therapeutic cancer vaccines

Biovest, a subsidiary of Accentia, has announced positive data from a pivotal trial of BiovaxID in lymphoma, and the vaccine now stands a good chance of becoming the first therapeutic cancer vaccine to gain approval in the seven major markets. However, despite this breakthrough, a number of economical and logistical issues could prevent the vaccine from achieving significant market penetration.

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Boehringer Ingelheim: Mirapex once-daily development on-track but commercial potential unclear

Recently released data show that the Mirapex once-daily formulation was superior to placebo in early Parkinson's disease patients, and comparable with the thrice-daily version of the drug. With generic versions of Mirapex expected in early 2010, the development of this reformulation may be too late to prevent significant revenue loss for Boehringer Ingelheim.

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Brazilian patent threat poses challenge to big pharma

Relying on its reputation as a world leader in HIV/AIDS drug pricing negotiations, Brazil is threatening to disregard patents unless Abbott Laboratories, Gilead Sciences and Merck & Co. allow it to produce generic versions of their four leading AIDS drugs. Datamonitor's Mar Ferrero investigates the likely ramifications of such a move...

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Breaking Merck patent may drive investment away from Brazil

Brazil's government will bypass Merck's patent on HIV drug Sustiva in order to manufacture this best-selling NNRTI as a lower-priced generic. Although this will increase therapy-access for many HIV/AIDS patients, it will intensify concerns over parallel imports into Western markets, according to Datamonitor's HIV analyst Lisette Oversteegen.

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Breakthrough pain market: high unmet need set to drive growth

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Bristol-Myers Squibb: arthritis antibody bolsters pipeline but competition will limit impact

Bristol-Myers Squibb has signed a licensing agreement with Alder Pharmaceuticals for its anti-IL-6 rheumatoid arthritis candidate, ALD518. Prior to the deal, Bristol-Myers Squibb's pipeline was thin, with only two late-stage agents in this indication. However, if approved, ALD518 will face significant competition from Actemra as well as more promising pipeline agents that may limit its impact.

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Can biologic drugs tackle antibiotic resistance?

Antibody-based products present a novel approach to the treatment and prevention of infections, as an alternative to conventional antibiotics. Several companies are developing such agents for a range of indications, but their cost, complex manufacturing methods and mode of administration are restrictive. A high unmet need and well defined target groups are key to commercial success in this market.

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