27 Mar 2012 - 29 Mar 2012, Barcelona
Eye For Pharma’s SFE & Commercial Excellence Europe 2012 Conference
Break internal and external approval barriers to your innovative digital projects by hearing case-studies with proven success from pharma's leading pioneers, the future plans of regulatory bodies from around the world and cutting-edge multi-channel strategies from pioneering thought-leaders. Learn why and how integrated digital campaigns realise the full potential of your marketing strategy. IMS will be sponsoring this event and exhibiting.
For more details and to register, click here.
Amgen entered into a $3.6bn merger agreement with Micromet, a German/US biotech with a Phase II antibody for haematological malignancies, while Bristol-Myers Squibb is to acquire Inhibitex for $2.5bn, to expand its presence in the hepatitis C market. Watson bought Strides Arcolab’s Australian and south-east Asian generics business, Ascent Pharmahealth.
Roche made a $44.50 per share offer for Illumina, valuing the DNA sequencing and diagnostics firm at $5.7bn; the bid was hostile, following a number of rebuffs from Illumina’s management. Two days later, Illumina adopted a shareholder rights plan, but after Roche commenced its tender offer the following day, Illumina’s board of directors said it would review the offer and postpone its 2011 financial results announcements. The tender offer will run until February 24th. Roche has also submitted four nominees for election to Illumina’s board at its annual meeting.
Valeant increased its hostile offer for ISTA from $6.50 to $7.50 per share, and told the ophthalmology specialist it might be willing to pay up to $8.50. ISTA said it would review the offer, but at the end of the month Valeant withdrew its bid due to lack of progress.
Spectrum expanded its interest in Zevalin, which it already markets in the US for non-Hodgkin’s lymphoma, and acquired ex-US (i.e. worldwide) rights to the intravenous product from Bayer. Shire acquired the US rights to Resolor, which it already sells in Europe for chronic constipation in women, from Johnson & Johnson, while Kyowa Hakko Kirin’s ProStrakan subsidiary licensed US rights to Rectiv, for pain associated with chronic anal fissure, to Aptalis. Actavis said it would "shake up" the global diabetes market via the formation of a joint venture with Bioton for the development of insulins, including analogue insulins.
Sanofi’s Genzyme subsidiary announced a global co-promotion agreement for Veracyte’s Afirma Thyroid FNA Analysis, which provides a personalised medicine solution for the improved diagnosis of thyroid nodules. Endo will develop and commercialise BioDelivery Sciences International’s BEMA buprenorphine for the treatment of chronic pain. Nuron Biotech licensed its HibTITER Haemophilus influenzae type B vaccine to Mitsubishi Tanabe for marketing in Japan, while Abbott will sell Apricus Biosciences’ topical erectile dysfunction product Vitaros in Canada.
GlaxoSmithKline exercised its option to licence ChemoCentryx’s CCX354 for rheumatoid arthritis. Biogen Idec and Isis formed a global collaboration for the latter’s antisense therapy for spinal muscular atrophy, ISIS-SMNRx, while LEO Pharma licensed in an oral psoriasis product from Virobay. SFJ Pharma will run a Phase III trial in Asia of Pfizer’s axitinib (Inlyta, see below) as an adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy. Sanofi and Third Rock Ventures launched Warp Drive Bio, a partnership aimed at transforming the discovery and development of natural product drugs. J&J began a cancer drug discovery alliance with Forma Therapeutics, Xenon will collaborate with Roche’s Genentech subsidiary on therapies and companion diagnostics for pain, and Ipsen began a research collaboration with Oncodesign focusing on LRRK2 kinase inhibitors as potential Parkinson’s disease treatments.
Takeda returned the European development and commercialisation rights to Durect’s Posidur, a post-operative pain relief depot, while Astellas terminated its agreement with Theravance for the sale of antibiotic Vibativ. Ipsen returned the rights to Santhera’s Parkinson’s product fipamezole and J&J ceased its OX-CLI and OX-ESI drug discovery collaboration, for asthma, COPD and other inflammatory diseases, with Orexo. Par and Talon ended their agreements with NovaDel for its ondansetron oral spray
Pfizer launched Oxecta, the oxycodone product featuring Acura’s Aversion technology (to discourage tampering), in the US. Lundbeck started the sale of ONFI in the US for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged 2+, and launched Sycrest in the UK for the management of moderate-to-severe manic episodes associated with bipolar I disorder.
The FDA granted expanded indications to Baxter's Tisseel, to include general haemostasis in surgery, and to UCB’s anticonvulsant Keppra, which can now be used in children as young as one month old with partial onset seizures. The EC endorsed the CHMP’s positive opinion of J&J and Furiex’s Priligy, clearing the way for it to be approved across the EU for the treatment of premature ejaculation.
New drugs approved by the FDA included: Bydureon, Amylin and Alkermes’ once-weekly treatment for Type 2 diabetes (based on the same compound as twice-daily Byetta); Boehringer Ingelheim and Lilly’s Jentadueto, which combines Tradjenta with metformin, also for Type 2 diabetes; Curis and Roche/Genentech’s Erivedge, the first therapy for advanced basal cell carcinoma; Pfizer’s Inlyta, for the second-line treatment of advanced renal cell carcinoma; Kalydeco from Vertex, the first medicine to treat the underlying cause of cystic fibrosis (in patients aged 6+ and who have at least one copy of the G551D mutation in the CFTR gene); and LEO Pharma’s Picato, a topical gel for actinic keratoses. Astellas and XenoPort’s Regnite was cleared in Japan for the treatment of moderate-to-severe restless legs syndrome.
AstraZeneca and BMS’ closely watched SGLT2 inhibitor for Type 2 diabetes, dapagliflozin, received a Complete Response letter from the FDA, which indicated that additional clinical trials may be necessary. Watson and Columbia’s progesterone vaginal gel 8% was not recommended for the reduction of risk of preterm birth in women with short uterine cervical length by an agency advisory committee. In Europe, the CHMP issued a negative opinion on Allos and Mundipharma’s Folotyn as a second-line therapy for peripheral T-cell lymphoma.
Novartis’ Consumer Health unit recalled a number of products, including Excedrin and Bufferin, in the US because of the potential of foreign or broken tablets in the packs; the manufacturing problem also led to supply issues for Endo’s Opana ER and certain other analgesics.
Medivation and Pfizer announced further disappointing trial results for dimebon in Alzheimer’s disease and announced that they would be discontinuing its development for all indications and terminating their collaboration.
Teva announced that President and CEO Shlomo Yanai would be retiring in May; he will be succeeded by Jeremy Levin, a former alliance executive at BMS.
Both the EMA and FDA approved Sanofi/Genzyme’s Framingham manufacturing plant, allowing production of Fabry disease therapy Fabrazyme to recommence. Thirteen major manufacturers began an alliance with the WHO and non-profit organisations to provide free treatments for neglected tropical diseases.
Following its acquisition of Nycomed, Takeda said it would be consolidating its R&D sites, changing to a more diverse portfolio focused on new products, and laying off approximately 2,800 employees (2,100 in Europe and 700 in the US); the plan is expected to reduce income by ¥35bn in the financial year to March 2012. Novartis is cutting 2,000 jobs in the US linked to the patent expiry of top-seller Diovan this September and will take a $900m charge related to reduced sales expectations for newer antihypertensive Tekturna/Rasilez. It announced an agreement to resolve the US class action litigation regarding unpaid over-time by sales representatives, providing up to $99m to be shared amongst eligible class members.
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Pricing & Reimbursement News
USA: Publication of draft priorities and agenda for comparative effectiveness research
The Patient-Centered Outcomes Research Institute (PCORI), established under the 2010 healthcare reforms to co-ordinate comparative effectiveness research (CER) nationally, has published its draft research priorities and research agenda, and invited feedback from stakeholders (including drug manufacturers).
Japan: Korosho announces planned price cuts due to market expansion
The Ministry of Health, Labour and Welfare (Korosho) has confirmed that 16 active ingredients will be subject to re-pricing due to expansion in market size at the next National Health Insurance (NHI) reimbursement price revision, scheduled to take effect on 1 April 2012.
Spain: Andalucía publishes first retail sector drug tenders
The autonomous community (CA) of Andalucía has published its first retail sector drug tenders, covering 55 presentations (17 off-patent active ingredients
Germany: IQWiG finds no additional therapeutic benefit for Halaven in breast cancer
An early benefit assessment conducted by the Institute for Quality and Efficiency in Healthcare (IQWiG) has concluded that the additional therapeutic benefit over comparators of Eisai’s breast cancer treatment Halaven (eribulin) is "not proven".
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