Pharmaceutical Executive Europe - November/December 2007 - (Page 19) Pharmaceutical Executive Europe Nov/Dec 2007 Special Report 19 acquisition of three companies at the end of March and beginning of April: it spent $155 million on buying high-throughput DNA sequencing specialist 454 Life Sciences from CuraGen, $56 million on the US-German antibody specialist Therapeutic Human Polyclonals, and $600 million on BioVeris, the American diagnostics company. The company has been less successful in its prolonged attempt to buy another US-based diagnostics outfit, Ventana Medical Systems, with a $3 billion hostile offer having been rejected as inadequate; at the time of writing, the bid is still on the table, the closure date having been revised. At the smaller end of the pharma business, Rottapharm (Italy) paid €600 million for Madaus Pharma (Germany). While Rottapharm is a traditional small molecule pharma company (whose lead product, IBS treatment dexloxiglumide, is in Phase III in Europe), Madaus’s forte is in drugs derived from plants. These include milk thistle derivative Legalon (used to treat liver disease), and Reparin, an anti-inflammatory from horse chestnut. The generics market has been busy on the takeover front, too. The biggest of these was undoubtedly the sale of Merck KGaA’s generics business to help fund the company’s move into biologics and its acquisition of Serono. The unit sparked a huge bidding war among some of the biggest players in the field, with interested parties reported to include two private equity firms, Iceland’s Actavis, Israel’s Teva, and the Indian companies Ranbaxy and Torrent. The battle was won in May by Mylan Laboratories (US); again, some have claimed that the €4.9 billion it paid was — being more than Mylan’s own market capitalisation — too high. The deal did, however, propel Mylan into the top-three companies in the global generics market, alongside Sandoz and Teva. signing up with XenoPort (US) on a gabapentin prodrug — which is in Phase II for restless legs syndrome and is also being investigated for neuropathic pain — and with Fabre-Kramer (US) on the selective serotonin agonist gepirone ER, currently under review by the FDA for major depressive disorder. GSK has extended both an R&D alliance with Ranbaxy (India) and its existing osteoarthritis deal with Galapagos (Belgium). Several other significant deals were announced this year. Roche is joining AZ in entering the world of RNAi, with a $1 billion deal with Alnylam (US); as part of this, Roche is acquiring Alnylam’s research site in Kulmbach, Germany. Oxford BioMedica will now co-develop its TroVax cancer vaccine with Sanofi-Aventis. Servier (France) and Vernalis (UK) have entered an oncology deal. Other antibody deals include MorphoSys (Germany) and Astellas (Japan), and newlyacquired Organon with Medarex (US). Two small European companies got a boost by signing alliances with US pharma major Wyeth — Elbion (Belgium) for schizophrenia, and Nautilus Biotech (France) for haemophilia treatments. Big Pharma has been continuing to fill its pipelines by in-licensing projects from biotechs and other small companies and gaining access to novel discovery techniques. New drugs The number of new drugs reaching the market continues to dwindle, and the truly big blockbusters are becoming fewer and further between. This year’s potential big sellers — Merck & Co’s Januvia (sitagliptin), and Galvus (vildagliptin) from Novartis — are both DPP-IV inhibitors to treat Type II diabetes. In the anti-infective field, Pfizer’s Celsentri (maraviroc) became the first CCR5 antagonist to be approved for the treatment of HIV infection. Another new anti-viral is Novartis’s Sebivo (telbivudine) for hepatitis B. GSK’s Altargo (retapamulin), indicated for the treatment of infected wounds and impetigo, also got the go-ahead. More drugs are in development for various forms of cancer than any other disease, and several more have gained approval in the past year. These include GSK’s Tyverb (lapatinib) for breast cancer, Celgene’s thalidomide derivative Revlimid (lenalidomide) for multiple myeloma, Novartis’s Tasignia (nilotinib) for patients with chronic myeloid leukaemia who cannot take Gleevec (imatinib), Wyeth’s Torisel (temsirolimus) for kidney cancer, and Zeltia’s Yondelis (trabectedin) to treat soft tissue sarcoma. Orphan drugs are growing; the number previously granted orphan status and now approved in Europe topped 40 this year. New on the market are Shire’s Elaprase (idursulfase), an enzyme replacement In-licensing, joint ventures, collaborations Big Pharma has been continuing to fill its pipelines by in-licensing projects from biotechs and other small companies and gaining access to novel discovery techniques. AstraZeneca has been particularly active in this field, to try and replace the numerous latestage failures it has had in the past couple of years. The company is moving into RNAi technology with a three-year deal with Silence Therapeutics, has licensed US company Regeneron’s VelocImmune mouse technology to discover monoclonal antibodies, and is collaborating with Argenta Discovery (UK) to look for potential new treatments for COPD. AZ has also linked up with Bristol-Myers Squibb to develop and commercialise two diabetes treatments, saxagliptin and dapagliflozin. GSK has also been busy, and is now working with Genmab (Denmark) on the monoclonal antibody ofatumumab, in development for chronic lymphocytic leukaemia, non-Hodgkin’s lymphoma and rheumatoid arthritis. It has also signed up with Targacept (US), formerly part of tobacco company RJ Reynolds, to develop drugs targeting neuronal nicotinic receptors in five therapeutic areas. GSK also added two late-stage compounds by
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