PharmaDeals Review Business Commentaries
Dr Fintan Walton, PharmaVentures’ CEO, provides monthly comment on topical biotechnology and pharmaceutical industry issues. Includes access to Fintan’s commentaries broadcast on PharmaTelevision.
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Post Exubera®: Can New Life be Breathed Back into Inhaled Insulin?
From issue 92 of the PharmaDeals Review (2008-02-01)
One of the biggest drug delivery stories of 2007 has been the flop of Pfizer’s Exubera®, the inhaled insulin product aimed at a multibillion dollar market. This article, adapted from a contribution to PharmaVentures’ Winter 2007/2008 Drug Delivery Report, looks back over what happened and what went wrong with the launch, examines what was wrong with the product itself, and assesses the repercussions of the failure – both the consequences of the flop for the companies involved (Pfizer and Nektar), and the regulatory aspects of new therapies. Finally, a number of upcoming inhaled insulin therapies – and their chances of success – are considered in the light of Exubera.
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Therapy Focus: Prostate Cancer
From issue 92 of the PharmaDeals Review (2008-02-01)
The year 2007 was busy for the US FDA, with high-profile Phase III failures, and debates over the use of various drugs, which have put its regulatory process under ever closer scrutiny. Much of this attention has recently been focused on the field of prostate cancer, following the FDA’s decision to issue an approvable letter for Dendreon’s Provenge® (sipuleucel-T), the withdrawal of the NDA for GPC Biotech’s satraplatin, and the suspension of Phase III trials of Novacea’s Asentar™ (calcitriol). This therapy focus looks at the impact of these problems, current treatment options, and the status of the prostate cancer pipeline – which looks strong, as there are 124 products in clinical trials.
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Astellas Builds Up Antibodies Pipeline
From issue 91 of the PharmaDeals Review (2008-01-01)
Biologics, in particular antibodies, are playing an increasingly important part in the R&D of big pharma, and it is to be expected that all of the major global players want in. The Japanese company Astellas Pharma is no exception: it announced a new mid-term management plan in October 2006, which included building new technological platforms for the development of antibody drugs. This move into biologics, along with other key changes, was designed to offset the difficulties anticipated by the company as a result of the patent expiries of two of its major products – the immunosuppressant Prograf® (tacrolimus), and Harnal® (tamsulosin), which is used to treat the functional symptoms associated with benign prostatic hyperplasia. Since then, Astellas been building up its R&D antibody capabilities and, on 26 November, its US subsidiary, Astellas US Holding, signed a definitive agreement to acquire antibody company Agensys for US$387 M upfront and US$150 M for the achievement of various milestones. This feature discusses the various ramifications of the deal.
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Eisai Takes Bold Step in MGI Acquisition
From issue 91 of the PharmaDeals Review (2008-01-01)
Change is afoot in the Japanese pharmaceutical industry. Long protected by regulatory guidelines that maintained its somewhat insular existence, the lowering of these barriers is forcing this industry to enter the global fray. The guidelines that were designed to prevent foreign companies entering the Japanese market were relaxed in 2006, and while there has been no major buyout of any of the big Japanese players yet, there is growing acquisition threat and increased competition from global pharmas. Further changes in the domestic market are also forcing shake-ups, and with many Japanese companies sitting on healthy cash reserves, deal making is on the cards. The acquisition of the US company, MGI PHARMA, by Eisai in December 2007 is symptomatic of these recent changes, and represents the largest ever overseas acquisition by a Japanese pharmaceutical company. Here we look at the rationale for the deal in the context of Eisai’s fifth mid-term strategic ‘Dramatic Leap Plan’.
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Big Pharma Strategies for Biologics Catch-Up
From issue 91 of the PharmaDeals Review (2008-01-01)
The healthcare industry is based on a history of small molecule therapeutics, but, today, the industry’s potential is considered by many to lie in biologics, although the majority of therapeutic drug sales are still for small molecules. Most of big pharma’s adoption of biological technologies can at best be described as ‘belated’. The exception may be Roche, which can be considered to be the forerunner of the movement. Thanks to its foresight in investing in Genentech in 1990, it now bears one of the industry’s most promising biologics pipelines. In this article, we take a look at the three companies that have the most ground to make up in the great biologics race – Pfizer, Novartis and AstraZeneca – and examine the deal making tactics that they are employing to play catch-up.
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