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Scrip 100 Scrip's Analy S Is of the Pharmaceutical Indu S Tr Y's SCRIP 100 Scrip’ 100 SCRIP S ANALY S I S Melting…Melting… isis notnot aa novelty….novelty…. OF THE PHARMACEUTICAL INDU thethe environmentenvironment makesmakes thethe difference!difference! Alpex Pharma is an independent Swiss drug delivery company specialised in the Alpex Pharmadevelopment is an independentand manufacture Swiss of drugproprietary delivery solid company dosage specialized forms such inas theODT development and and manufactureEffervescent of Tabletsproprietary. The solidpredominant dosage focusforms for such Alpex as is Orallythe development Disintegrating Tablets, Buccal S Tabletsof and the Effervescent solid dosage Tablets. forms to The deliver predominant drugs directly focus intofor Alpex the oral is the cavity development in order of solid dosage TRy’ forms to deliver drugs directly into the oral cavity in order to potentially improve the bioavailability of S to potentially improve the bioavailability of drugs and at the same time, PERFORMANCE AND PRO drugs and at the same time, improve the patient compliance and convenience. improve the patient compliance and convenience. The company,The company, established established in 1985, in was 1985, managed has an effi from cient 1992 formulation by Elan Corporation development as Elanteam Pharma SA. It became independent in 2004. and a well experienced manufacturing site with an excellent cGMP track record. Alpex hasAlpex an productsefficient formulationare marketed development worldwide andteam has and a consistenta manufacturing pipe-line site with an excellent cGMP track record. of new formulations for the European and the US market. S PECT Alpex productsIts state-of-the-art are marketed facility worldwide is conveniently and has a located consistent in the pipe-line north of newLugano formulations for the European and the US market. S and houses two independent dedicated plants for manufacturing and packaging 2009 Its state-of-the-artpharmaceutical facility and is convenientlynutraceutical located products. in north of Lugano and houses two independent dedicated plants for pharmaceutical and nutraceutical products. For moreFor information, moreAlpex information, please Pharmacontact: please contact: Alpex Pharma SA Alpex PharmaVia Cantonale,Fast SA release – Via technologyCantonale from Switzerland CH-6805CH-6805 Mezzovico Mezzovico (Lugano), (Lugano) Switzerland Tel: +41Switzerland (0) 91 935 51 10 Fax: +41Tel: (0) COMPANY+41 91 (0)91935 51DESCRIPTION 935 20 51 10 r No stirring required for tablet disintegration; r Sugar-free formula; and Email: [email protected]:Alpex +41 Pharma(0)91 is935 a Swiss 51 drug20 delivery company specialising r Safe for diabetics. Website: www.alpex.comin the formulation, development, registration and production Email:of solid [email protected] dosage forms characterised by rapid release in water Granular in sachets containing moisture Website:or directly www.alpex.com in the oral cavity. Alpex Pharma collaborates with large and medium-sized companies for the distribution of its sensitive products products in various markets. Products can be formulated with the following claims: PRODUCTS/SERVICES r Administration at onset of symptoms; t Development capability – the company can carry out r Perceived faster onset; compatibility studies on actives and excipients, formula- r Patient hydration: 150-200 ml of water required; tion work including taste masking capability, analytical r Active ingredients (APIs) in suspension/solution; development and validation, scale-up, stability studies, r Potential faster adsorption; preparation of bio-batches, validation of manufacturing r Stirring required for tablet disintegration; batches – all in GMP-compliant environments. r Sugar-free formula; and r Safe for diabetics. t Manufacturing of solid dosage forms – products include orally disintegrating tablets (ODT), chewable Orally Disintegrating Tablets tablets, buccal tablets, effervescent tablets, effervescent Tablets formulated according to this pat- granular in sachets, granular in sachets and moisture- ented proprietary technology are able to dis- sensitive regular tablets. solve rapidly on contact with saliva releasing t Packaging of products – moisture-proof packaging such the drug from a highly soluble matrix. as aluminium-aluminium blisters, aluminium-aluminium Product features include: strips, aluminium-aluminium sachets, plastic tubes and r Sugar-free formula (safe for diabetics); plastic bottles with desiccant in the cap. r Highly hydrophilic matrix; PRODUCT CHARACTERISTICS r Highly soluble matrix; r Suitable for those who dislike swallowing tablets, Effervescent tablets and effervescent such as children and the elderly; granular in sachets r Ideal for acute conditions; and r Can be used to treat migraine, allergies including hay Effervescent products are characterised by a fever, diarrhoea, gastro-oesophageal reux disease, pain. chemical incompatibility between a source of CO2 (normally sodium bicarbonate) and an These products are also ideal for conditions in which organic acid (e.g. citric, tartaric or malic acid). swallowing is compromised, including: This is an autocatalytic reaction, catalysed r Emesis; by the presence of water and heat, which r Parkinson’s disease; and generates CO2 in solution: r Amyotrophic lateral sclerosis (ALS)/multiple sclerosis (MS). H2O Buccal tablets HCO - + H CO + H O 3 2 2 Tablets formulated according to this patented proprietary (heat) technology are able to dissolve in the oral cavity releasing the drug to be absorbed through the buccal The reaction is characterised by strict control of the residual mucosa. Product features include: amount of moisture present in the ambient and produced during the process, as well as on the nal dosage form. r Sugar-free formula (safe for diabetics); r Highly hydrophilic matrix; The advantages of an effervescent form can be r Highly soluble matrix; summarised as below: r Drugs can be adsorbed avoiding stomach degradation; r Administration at onset of symptoms; and r Perceived faster onset; r Ideal for acute conditions. r Patient hydration: 150-200 ml of water required; r Active ingredients (APIs) in suspension/solution (this can result in better absorption); CONTACT INFORMATION r Buffered solution because of presence of CO2; r Protection of gastric mucosa; Alpex Pharma SA Tel: +41 91 935 5110 r Potential faster adsorption; 6805 Mezzovico Email: [email protected] r Fizzy solution (taste improvement); Switzerland Web: www.alpex.com 16813 KENDLE Scrip PCT Nov08 FP AW.indd 1 14/10/08 14:30:34 Contents SALES & MARKETING 30 The latest buzz in sales force effectiveness How sales teams stand to gain from network intelligence and new web-based detailing approaches R&D 33 Innervation or enervation in pharma? Reports abound about pharma’s productivity crisis, but is the industry really in such a bad way? 38 40 Stem cells continue to excite Controversial and emotive, yet stem cell research Introduction is still capturing the imagination of the R&D All eyes on oncology community Industry’s most explored therapy area 5 witnesses both high-profile successes and Restructuring is the name 44 of the game in 2008 failures in 2008 Japanese approvals marked by high-need Given current turmoil in the financial markets, products should we be worried about a failure in the Initiatives aimed at bringing Japan’s therapeutic pharmaceutical sector? offerings more in line with other developed markets begin to bear fruit THE SCRIP 100 46 8 US NME approvals: cancer no longer Pfizer clings to top spot reigns supreme The US giant continues to reign, but competition Cancer and HIV therapies take a back seat to among the other heavyweights hots up constipation and hypertension in 2008 12 48 Life after M&A EU drug approvals roundup How two perfectly matched CROs merged to Generics and biosimilars join innovative drugs in form a global player the queue of products going through the EU’s centralised procedure BUSINESS 50 15 Empowerment through IT The next challenge for big pharma’s Pharma needs tools to track and report on clinical Mr Fix-it data and the IT community is evolving to respond Schering-Plough boss Fred Hassan mulls over the 18 to that US election and outlines his personable approach to doing business M&A: activity continues DRUG DELIVERY apace within pharma 23 Large buyouts capture the headlines while 53 Destination Moscow… Deals define drug delivery space in 2008 numerous smaller-scale transactions target Merck & Co’s head of global pharmaceuticals Dealmaking continues apace in the drug delivery Adam Schechter explains why he clocks up so biologics, generics and the speciality space with sector with players cashing in on new and many air miles the promise of business model diversification innovative technologies 25 2008 stock tracker: how robust is pharma? Scrip 100 sponsor Biopharmaceutical share prices held fast against extreme market volatility in 2008, but who were the winners and losers? 28 Sponsors How to spend it Pharma through the eyes of a global private equity player www.scripnews.com/supplements Scrip 100 3 Contents POLICY & REGULATION EMERGING MARKETS 60 92 89 US grapples with paying for pricey drugs Latin America: ripe for clinical research? What’s ruffling US seniors’ feathers? As the high-growth economies of Latin America become increasingly attractive, its largest markets are looking to align their regulatory systems with 63 those of the west Biosimilars regulation finds its feet Europe remains the only major market with
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