Pharma news in brief

BMS hanging on for 2007 relief

Bristol-Myers Squibb's (BMS) performance so far this year has remained constant in the face of a plague of ongoing legal cases and several key patent expiries. Posting second quarter 2005 net sales of $4.9bn - worldwide pharmaceutical sales were up by just 1 per cent - the company blamed ìshort-term pressure on earningsî as a brake on its current and near-term future performance. However, BMS added that it is sticking to its strategy and expects to see its product portfolio and flexible cost structure ìstartî to deliver sustained sales and earnings growth from 2007. Marketing, selling and administrative costs increased by 6 per cent (to $1.3bn) during Q2 as the company continues to shift advertising and product promotion investments away from mature brands to focus on ìproducts expected to drive future growthî.

TKT buy will curb Shire's `05 performance

Shire Pharmaceuticals Group has reported a 32 per cent increase (to $424.6m; £239.5m) in revenues during the first half of 2005, following the official closure of the transaction to buy US biotech firm, Transkaryotic Therapies (TKT). The all-cash $1.6bn deal - at $37 per outstanding TKT share - was approved by shareholders in both companies on July 27. CEO Matt Emmens now expects total revenue growth for 2005 to hit the low double-digit range, as earnings from new product sales will ìincreasingly absorbî the high sales and marketing costs associated with four launches in the first half of the year. However, he warned that loss-making TKT, whose results now officially form part of the Shire Group's, will dilute the firm's overall financial performance: the total transaction costs could total more than $800m.

New medical malpractice legislation

New legislation has been approved in the US that seeks to put a $250,000 (£141,000) cap on the sums awarded in lawsuits relating to pain and suffering, in a bid to fix what America's House of Representatives referred to as a medical liability system that is ìbadly brokenî. The Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Bill aims to shape the country's legal protocols into a system that is fairer and more predictable, as well as protecting pharma companies from having to make huge payouts over safety issues (in cases such as Vioxx) for medicines that were approved by the Food and Drug Administration. Opposers of the Bill in the US believe that pharma firms should be held accountable, and the new laws would not limit economic damages or cover lost wages or medical expenses.

Celebrex label amended

Pharma leviathan Pfizer, which has held back from a full promotion of arthritis COX-2 inhibitor Celebrex, has now changed the drug's label to reflect the risks to takers of adverse cardiovascular events. With regard to marketing the medicine, sales of which nose-dived by 45 per cent (to $401m) in the second quarter of the year, the company said that it was waiting to understand the nature of the language to be used in the boxed warning requested by the Food and Drug Administration (FDA). The company has recommended that Celebrex be used ìat the lowest effective dose for the shortest durationî. On a more positive note for the firm, it also received approval from the FDA to market Celebrex for the relief of symptoms of ankylosing spondylitis, a form of arthritis that usually strikes patients between the ages of 17 and 35, often affecting the spine.

Marketing application fees hike

From October this year, there will be a 14 per cent premium to pay for any pharmaceutical company seeking marketing approval from US regulators, the Food and Drug Administration. The cost of a typical application for the FDA to review a drug, taking into account submitted clinical trial data, will be $767,400 (£432,679). There may also be additional ìestablishmentî fees of $264,000, as well as product fees, which could total $42,130 for each drug. The FDA's `user fee' programme purports to accelerate drug review times and quicken access to market for new medicines. However, detractors of the fees have pointed out that significant amounts of money involved could prejudice the agency's decisions, or affect the judgement of key officials. The FDA has denied this possibility.