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Both Pfizer and Johnson & Johnson have both received boosts this week in the battle to protect their patents on Lipitor and Topomax respectively. Pfizer has received a favorable opinion from the European Patent Office supporting the company's calcium salt patent covering Lipitor. Meanwhile a US district court has granted the request of J&J for a preliminary injunction against Mylan Laboratories, prohibiting the generic drug manufacturer from launching a copycat version of the drug Topomax. Vampire bats and jellyfish may not be everyone's favorite creatures, but they could offer new treatments to diseases. Quincy Bioscience has found that a compound from a protein found in jellyfish is neuro-protective and may be effective in treating neurodegenerative diseases, including Alzheimer's. Forest Laboratories and Paion AG are developing Desmoteplase, a genetically engineered model of a protein found in vampire bat saliva, although the study into its effects on acute ischemic stroke patients has been put on hold because of safety concerns about the drug. |
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SPONSOR'S MESSAGE |
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Positive economic growth, stabilizing political structures, growing patient populations and increasing direct foreign investment in the emerging markets of Brazil, Russia, India and China (BRIC) are creating significant opportunities for pharmaceutical companies to expand into these markets and maximize future revenue potential. This new report provides an in-depth insight into the competitive dynamics of the BRIC markets. |
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Schwarz: promising results for lacosamide Schwarz Pharma has announced positive second phase III trial results with epilepsy drug lacosamide. The impressive
top-line results for lacosamide as adjunctive treatment of epilepsy
could be important news for epilepsy specialist pharmaceutical company
UCB, which is negotiating a takeover of Schwarz. These results support
Datamonitor's opinion that UCB should continue to develop lacosamide
if its proposed acquisition of Schwarz is confirmed. Read
full article AstraZeneca: dropping another drug AstraZeneca has announced it no longer plans to develop NXY-059 for acute ischemic stroke. AstraZeneca has
dropped its stroke treatment NXY-059 after the drug failed to show
statistically significant reduction in stroke-related disability in
a recent study. The news is yet another high-profile setback for the
pharmaceutical company which has seen several drug failures recently
and, with other pipeline projects looking risky, there may be more
to come. Read
full article Novartis: Gleevec gains approval for five more indications The FDA has approved Novartis' targeted drug Gleevec, for five rare diseases simultaneously. Novartis' Gleevec
has now garnered simultaneous approval for the treatment of one solid
tumor and four rare blood disorders. However, given the relatively
small patient population groups within these diseases, expansion into
these indications is unlikely to significantly enhance Gleevec's sales.
Read
full article Altana: allergy drug faces obstacles despite approval Altana's nasal steroid spray Omnaris has been approved in the US for allergic rhinitis. Altana's Omnaris,
an intranasal corticosteroid based on ciclesonide, has been approved
in the US for the treatment of seasonal and perennial allergic rhinitis
in patients 12 years of age and older. However, given the major products
already on the market and the recent patent expiry of Flonase, Omnaris
is likely to have a limited impact on the field of allergic rhinitis
treatment. Read
full article |
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Pfizer: still biggest player in highly prized indication The success of neuropathic pain drug Neurontin earned Pfizer its reputation as the "neuropathic pain company" and the US pharmaceutical giant faced very little competition in a relatively untapped market for ten years. Neuropathic pain is now one of the most attractive indications in the pharmaceutical industry but Pfizer still dominates the market. With just five approved drugs on the market and millions of patients worldwide, neuropathic pain is one of the most attractive indications in the pharmaceutical industry. Estimated to be worth over $1.68 billion in 2005, the neuropathic pain market is forecast to grow to $5.5 billion by 2015, driven in the US by strong uptake of Pfizer's Lyrica (pregabalin), Eli Lilly's Cymbalta (duloxetine), and Endo's Lidoderm (lidocaine 5% patch). Indeed, the pipeline for new treatments is one of the most active in the central nervous system (CNS) arena, with more than 90 compounds in development. On 18 September 2006, Pfizer received approval from the European Agency for the Evaluation of Medicinal Products to add central neuropathic pain to the label of its new neuropathic pain and epilepsy drug, Lyrica (pregabalin), marking yet another key milestone for one of the industry's fastest growing brands. For almost a decade Pfizer has dominated the market with its anti-epileptic drug and Lyrica's predecessor, Neurontin (gabapentin), which has been used extensively off-label for a variety of neuropathic pain syndromes, such as painful diabetic neuropathy. Almost entirely as a result of the success of Neurontin, which at its peak generated $1.32 billion in disease-specific sales across the seven major markets, the neuropathic pain market has become one of the most sought-after indications in the pharmaceutical sector. Coupling several million patients with a strong demand for approved therapies, the growth prospects for a new drug in this market are very attractive. Neuropathic pain occurs when the nerves malfunction and send pain signals in spite of there being no bodily damage to trigger them. Neuropathic pain frequently presents itself in the limbs of advanced diabetes and HIV sufferers (peripheral neuropathic pain), lower back pain sufferers, and is a characteristic of shingles - also known as post herpetic neuralgia. The neuropathic pain company With Neurontin, Pfizer fashioned itself as the "neuropathic pain company", with established relationships with prescribing physicians and patients alike. The pharmaceutical giant has also enjoyed relatively little competition from other drug companies over the past ten years. However, the success of Neurontin did not come immediately. For the first three years after launch in 1993 as an adjunctive therapy for epilepsy, sales growth was modest as many neurologists regarded the drug as a relatively 'weak anticonvulsant' that was also quite expensive. It was not until the mid-1990s that studies demonstrated an application for neuropathic pain, which, at the time, was a relatively untapped patient group. The presentation of controlled trial data in journals and at medical conferences, in addition to the questioned promotional practices of Parke-Davis's sales representatives (for which Pfizer, which had since acquired Parke-Davis, had to pay a huge fine of $430 million in June 2004), signified the impressive rise in off-label Neurontin prescriptions for the neuropathic pain from 1997 onwards. In order to appease the FDA, Pfizer sought approval for post herpetic neuralgia in 2002. Succeeding Neurontin In October 2004, Alpharma and Teva launched generic gabapentin capsules despite the fact that Pfizer's motion for a preliminary injunction was still pending. In response, Greenstone Limited, a wholly owned subsidiary of Pfizer, also launched a generic version of Neurontin. This strategy, which is becoming increasingly popular among the big pharmaceutical firms, is helping to recapture some of the gabapentin market share and lessen the impact of rival generic incursion, which has been more severe in the US compared to the EU. However, the delay in getting Lyrica onto the market was a major setback for Pfizer. There was a 13-month gap between the launch of generic gabapentin in the US and the launch of Lyrica and this saw a huge drop in revenues - global sales of Neurontin fell by 82% to $236 million in 2005 and continued to fall in 2006. Pfizer had originally intended to switch physicians straight from Neurontin onto its follow-on product before generic incursion took place. In a sensible move to recapture share from generic gabapentin, Pfizer launched Lyrica at a competitive price point. Indeed, because of the less frequent daily dosing, long-term treatment with Lyrica may actually be cheaper than with generic gabapentin in the US. For companies looking to launch a reformulation of an older drug, this strategy is even more important amid the ever-increasing cost sensitivities in the pharmaceutical industry. As shown with Lyrica, such tactics have become commonplace in campaigns requiring rapid patient switching, particularly in instances where reformulations are poorly differentiated from their predecessors. Blockbuster by 2007 Despite the impact of generic gabapentin, Pfizer is doing a great job of playing catch-up in the market and the uptake of Lyrica has been strong to say the least. Total brand sales are expected to pip the billion dollar mark in 2007, just two years after launch, making it one of the most successful product launches in history. Unlike with Neurontin, Pfizer has been able to promote the use of Lyrica for neuropathic pain as soon as it launched. Given that neuropathic pain contributes the majority share of sales, it is unsurprising that the marketing emphasis is more on this indication than for its epilepsy labeling. This is exemplified by the Lyrica homepage, where the majority of text is dedicated to information relating to diabetic neuropathic pain and post herpetic neuralgia. When assessing the potential of Lyrica in the market, the huge marketing resource of Pfizer cannot be underestimated: Pfizer has the strongest and largest CNS portfolio in the industry, worth over $6.3 billion in 2005, which, despite some key patent expiries, is set to grow over the next 10 years, driven by success in the neuropathic pain and insomnia markets. The legacy of Pfizer in neuropathic pain has also laid the groundwork for other companies looking to enter the market. Pharmaceutical groups are now more confident to make neuropathic pain the primary indication for their drug candidates and this is reflected in the busy R&D pipeline in 2006. Additionally, the work Pfizer has done with regulatory bodies and clinical trial design has provided a clear route as to how to gain approval for neuropathic pain drugs. Moreover, through the marketing of its products and supporting clinical education seminars, Pfizer has helped to improve physician education and, to some extent, public awareness.
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Bristol-Myers
falling profits caused by generic competition US court protects
Pfizer's Lipitor patent Qiagen acquires
Genaco Biomedical Products J&J granted
generic injunction against Mylan |
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FDA
rejects Replidyne antibiotic FDA extends
review period for Genasense GSK wins approval
for extended release heart drug Health Canada
grants priority review for Lucentis |
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Curry
spice may help arthritis Jellyfish protein
could treat Alzheimer's AstraZeneca
stroke drug fails study Vampire bat
stroke trial halted over safety concerns |
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Crucell and
Aeras start TB vaccine trial Sapphire licenses
cancer drug for Asian market Millennium,
Ortho Biotech enter US co-promotion for Velcade ViroPharma
and Wyeth commence phase II hepatitis study |
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SPONSOR'S MESSAGE |
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The Diabetes Market Outlook to 2011
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drugs makers: Teva tops the list The global generics market is dominated by Israeli-based Teva and Novartis' Sandoz division, which generated $5.3 billion and $4.7 billion, respectively, in sales in 2005. Both Teva and Sandoz are truly global companies, with sales being derived from North America, Europe and, increasingly, emerging markets in Asia. Recent large acquisitions made by both companies - Teva's acquisition of Ivax and Sandoz's Eon and Hexal buys - have also helped diversify the companies' geographic reach while solidifying their positions as market leaders. However, the generics market is rapidly evolving, with traditionally local or regional players becoming ever more important. Watson is expected to cement its position in the US market with the pending acquisition of Andrx, while Barr could expand its geographic scope to Europe through the possible acquisition of Pliva. Significantly, Indian manufacturers are also becoming more influential in the global generics market, with companies such as Ranbaxy mounting aggressive patent challenges and many players, including Dr Reddy's, Wockhardt and Ranbaxy, participating in the wave of consolidation by buying European companies. Indeed, the wave of consolidation that has swept through the generics market recent is unlikely to end anytime soon. The table below
ranks the top 5 generics firms by sales value in 2005.
Related Research: Global Generics Guide: Part 2 - Benchmarking country markets and strategic issues |
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Cambrex is to sell its biopharma and bioproducts businesses for $460 million to Swiss chemicals group Lonza. Upon completion of the transaction of its biotech businesses, Cambrex said that it will concentrate on deploying its resources to maximize the potential of its human health business through reducing overheads by approximately $8 million per year. This will be an attempt to offset the reduction in size and complexity of the Cambrex business. The company also recently announced the sale of its subsidiaries based in Ireland and Belgium. Assuming financing can be arranged on favorable terms, Cambrex expects the special dividend to be approximately $13.50 to $14.50 per share. The agreement is a positive step for Lonza and could help the company sell more advanced drug products to pharmaceutical companies. Combined 2005 sales from the biotech businesses accounted for 42% of the Cambrex's total sales of $452 million. Under the terms of the agreement with Lonza, Cambrex may consider superior acquisition proposals, subject to a customary break-up fee. Key Facts Cambrex Corporation Tel: 1 201 804
3000 www.cambrex.com
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Transplantation:
a growing but problematic market Colorectal
cancer: Amgen's pipeline drug set to overtake Erbitux Big Pharma:
turning to reformulation Schizophrenia:
generics influx set to damage revenues |
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Boehringer
Ingelheim: PharmaVitae Profile The
Cancer Market Outlook to 2011 Pipeline/Commercial
Insight: Molecular Targeted Cancer Therapies - More drugs on the market,
more targets in the pipeline Stakeholder
Insight: Atrial Fibrillation - Limited efficacy and poor safety lead
to bleak outlook The
Specialty Pharma Market Outlook: Key players, new company growth models
and emerging opportunities Mergers,
acquisitions and licensing to continue drive industry growth Pipeline
Insight: Bipolar Disorder - New treatments for bipolar depression
set to drive near-term growth |
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