Business News
Biologics developers stand out from the gloomy UK biotech background
25/02/2008
Nick Hassell’s Tempus column in The Times discussed another bad week for Britain’s beleaguered band of biotech stocks. The FTSE techMARK Mediscience index – not the most precise proxy since it includes low-risk medical device makers such as Smith & Nephew – has fallen 26 per cent over the last 12 months, against a 5 per cent slide in the FTSE all-share. A tighter measure, Seymour Pierce’s UK Drug Discovery and Development index, which consists of 47 biotech stocks, underperformed the FTSE all-share by 36 per cent last year. The industry’s biggest problem is that it has conspicuously failed to produce any high-profile winners in recent years. But faced for the most part with drugs that have taken longer than expected to develop, or in some cases have failed altogether in late-stage trials, fund managers are now choosing to sit on their hands. The upshot is that the stock market is now left with two distinct categories of biotech stocks: those with cash and those without. Some have the benefit of already-approved drugs whose profits they can use to fund experimental treatments: Protherics ploughs cash from its CroFab rattlesnake bite remedy back into its portfolio of early-stage cancer, hypertension and septic shock medicines. Others have secured large slugs of cash by forging partnership deals with big pharma. Last year, Antisoma struck a deal with Novartis on its lead lung cancer drug that is potentially worth $890 million (£452 million). Elsewhere, Renovo tied up with Shire, while Oxford Biomedica and Acambis entered alliances with Sanofi-Aventis. There is also the odd company that has succeeded in raising fresh funds in the face of equity markets that otherwise appear shut: Ark Therapeutics, the cancer and vascular disease specialist, secured £35 million in November through a placing and open offer. One beneficial side-effect of the biotech gloom is that it has left a clutch of its well-funded constituents trading on lowly valuations. Conventional methods of measuring worth tend to be meaningless in biotech – balance sheets are of little use in capturing the potential of intellectual property – but those companies that might be considered oversold relative to their cash reserves include Antisoma, Ark, Oxford BioMedica, Renovo and Vectura.
---www.fd.com
Vernalis shake-up leaves it vulnerable to bid
21/02/2008
Vernalis became the latest takeover target in the biotechnology sector yesterday after it cut 60 per cent of its workforce, parted with its chief executive and put its American operations up for sale. Vernalis also said that it had settled a $56 million (£28.8 million) loan from Endo Pharmaceuticals, its partner, and would dispose of Apokyn, its Parkinson's disease drug. However, the refusal of the US Food and Drug Administration to license Frova, its painkiller, as a treatment for menstrual migraine meant that Vernalis missed out on about $40 million in payments from Endo, leaving its funding unclear.
---The Times
EUSA Pharma licensed anti-interleukin antibody to GSK
21/02/2008
EUSA Pharma, of Oxford, UK, said it has licensed OPR003, a human anti-interleukin-6 antibody discovered by Rochester, N.Y.-based Vaccinex Inc. to GlaxoSmithKline plc, of London. Under the terms, GSK will pay an undisclosed up-front license fee, development milestones and royalties on product sales. In exchange, the pharma firm gains worldwide rights to OP-R003 in rheumatoid arthritis and other indications. The drug was discovered using Vaccinex’s antibody discovery technology and licensed for co-development by EUSA. Vaccinex will share 50 percent of fees, payments and royalties.
-- www.bioworld.com
Stem Cell Sciences announced it is implementing a comprehensive restructuring programme
15/02/2008
Stem Cell Sciences announced it is implementing a comprehensive restructuring programme designed to improve financial, operational and growth performance, as well as provide a greater focus on its commercialisation efforts in the application of stem cell technologies. The program will involve the consolidation of commercial operations and all senior management into existing and expanded facilities in Cambridge, U.K. and the closure of facilities in Edinburgh. Operations in Melbourne, Australia will be streamlined, it said. It will now fully concentrate on advancing pioneering stem cell research. SCS said it's in the process of moving into expanded laboratory and administration facilities on the Babraham Research Campus in Cambridge. These new premises will become the operational headquarters from March 1, housing all administrative and operational functions as well as all senior management. The Cambridge site is already home to SCS' pharmaceutical services division.
---www.fd.com
Syntaxin makes appointment
12/02/2008
Syntaxin, a UK biopharmaceutical company developing biologic drugs that control cell secretion, has appointed Dr Richard Jones chief medical officer and Dr Nicola Thompson head of cell biology. Dr Jones has more than 25 years' pharmaceutical industry experience, having most recently served as senior vice-president of experimental medicine, clinical and regulatory affairs at Aspreva Pharmaceuticals. He also held senior development roles at Johnson & Johnson and Roche. Dr Thompson previously worked at GlaxoSmithKline as head of allergic mechanism and target discovery.
--www.scrip-news.com
FDA accepts Cimzia BLA
06/02/2008
UCB S.A. said the Food and Drug Administration will review the company's biologics license application for Cimzia for the treatment of active rheumatoid arthritis. The pharmaceutical company said the application is based on data that includes three Phase III trials. In addition, UCB is preparing to submit a marketing authorization application to the European Medicines Agency for Cimzia. The company plans to file the application in the first half of 2008.
--www.fd.com
Eden develops biomanufacturing process for iQur
12/02/2008
Eden Biodesign Ltd., of Liverpool, UK, reached an agreement with iQur Ltd., of Southampton, UK, a liver disease specialist, to develop iQur's, tandem core vaccine for hepatitis A and B. Eden will develop a biomanufacturing process and carry out GMP manufacture for clinical trials. iQur said its vaccine platform, based on the HBV core protein, can carry antigens for both hepatitis A and B simultaneously. The construct is highly immunogenic, which should increase vaccine efficiency and reduce the current need for booster vaccinations. The concept could be applied to vaccines against other diseases and cancer.
--www.fd.com
ReNeuron granted FDA review meeting on Phase I trial
01/02/2008
ReNeuron Group plc, of Guildford, UK, said it was granted a Type A regulatory review meeting with the FDA to try and steer round the issues that are blocking progress of the company's application to start a Phase I trial of ReN001, its fetal stem cell therapy for stroke. ReNeuron announced on Jan. 3 that the IND remained on clinical hold. The Type A meeting will be held Feb. 14.
--www.fd.com
GE Healthcare to acquire Whatman for £363m
05/02/2008
Today’s nationals covers new that GE Healthcare, the UK-based subsidiary of General Electric, has agreed to buy Whatman, the filtration products maker, for £363m ($716m) cash. The FT’s Salamander Davoudi writes that GE will pay 270p a share, a premium of 12 per cent over the company’s closing price on Friday. The proposed deal remains subject to shareholder approval and is expected to close in the second quarter of 2008.
--www.fd.com
MedImmune submitted licence application to FDA for Motavizumab
04/02/2008
The Times’ ‘Need to Know’ column notes that AstraZeneca’s MedImmune biologics division has submitted a licence application to the US Food and Drug Administration for Motavizumab, an investigational antibody derived from recombinant DNA technology. The company expects the submission to result in the division’s first new medicine since it was acquired in June.
--www.fd.com
Novartis warned by US regulators on investigation of contamination
04/02/2008
In a warning letter, the received Food and Drug Administration's Center for Biologics Evaluation and Research cited failures in keeping to manufacturing standards that hark back to those that plagued Chiron (now owned by Novartis) and forced the company to withdraw a big-selling flu vaccine from the market in 2005. Through its acquisition of Chiron for $2.3bn in 2005, Novartis also now owns the Speke facility on Merseyside in the UK, which was at the centre of the flu vaccine problems. Other contamination events have also been seen (Medeva vaccines polio vaccine in 2000), but this was long before Novartis acquired the site.
--www.in-pharmatechnologist.com
Cobra manufactures TNFerade for GenVec
25/01/2008
Cobra Biomanufacturing announced that it has entered into a manufacturing development agreement with GenVec, Inc. for TNFerade(TM), GenVec's lead product candidate. The company said that the agreement will cover technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots that will be produced at Cobra's facility in Oxford, United Kingdom
--www.fd.com
