Branded drugs’ competition-free days numbered

Chemistry World's weekly round-up of money and molecules Posted by James under News , The Commercial Chemist

This week, we cover the first in a new class of contraceptive pill, the first signs of a clampdown on pay for delay deals, and further cuts to plants and personnel announced by BASF.

Authorities in the US and Europe are to look carefully at the tactics pharmaceutical firms use to delay competition from generic versions of their branded drugs. The European Commission is to increase its scrutiny of the industry following the publication of its final report on competition in the sector, while the US Department of Justice is hardening its line on ‘pay for delay’ deals.

Merck & Co. has signed an exclusive deal with Portola Pharmaceuticals to co-develop and commercialise an experimental anticlotting drug. Merck has paid an initial $50 million (£30.9 million) for a worldwide license for the drug, called betrixaban, with additional payments of up to $420 million due if agreed development, regulatory and commercialisation milestones are met. Portola will also receive royalties if the drug reaches the market. Betrixaban is an oral drug which blocks the action of the clotting protein factor Xa. It is currently in Phase II clinical trials for the prevention of strokes in patients with atrial fibrillation – an abnormal heart rhythm that affects approximately 7 million people in the US and Europe. The current treatment of choice for this condition is warfarin, but getting the dose right can be problematic and it can cause serious interactions with other drugs.

German chemical and pharmaceutical giant Bayer has filed for approval from the US Food and Drug Administration to sell its oral contraceptive containing a ‘natural’ form of oestrogen in America. This move comes a few weeks after the drug – sold under the tradename Qlaira – was launched in Europe. Qlaira is the first oral contraceptive to use estradiol valerate – which is quickly metabolised to the type of oestrogen naturally produced by female ovaries, estradiol. This is the first time that drug manufacturers have not used ethinylestradiol as the oestrogen component in a contraceptive pill. The progestin component, of which there are many different types, is dienogest. ‘We see a high interest in this new oral contraceptive by woman and gynaecologists,’ says Phil Smits, head of woman’s healthcare at Bayer.

BASF has announced plans to axe 3700 jobs by 2013 (most by the end of 2010), and left the future of 23 production sites in doubt following its acquisition of Swiss firm Ciba in April this year.

The announcement leaves a cloud hovering over 23 out of 55 former Ciba production sites with decisions regarding the possibility of their sale, closure or restructuring due to be announced by the end of the first quarter of 2010. The remaining 32 production plants will be restructured or brought in line with BASF’s existing network of sites. Thirty-six of 70 former Ciba research, sales and administration sites are also likely to be consolidated by the end of 2010.

Europe’s highest court has rejected an appeal on the interpretation of the Reach chemical regulations approach to polymers and monomers. The Reach regulations exempt polymers, but state that the monomers used to make the polymer must be registered (if they make up more than 2 per cent of the polymer and are made in quantities of more than 1 tonne per year) - even if the polymer is synthesised outside the EU and so the unreacted monomer does not enter the region. Several companies, including Germany’s C H Erbsloeh and UK-based Lake Chemicals and Minerals, had challenged the regulation, but the European Court of Justice declared regulation valid.

French industrial gas company Air Liquide has continued its expansion in the Middle East, buying 75 per cent of Saudi firm Al Khafrah for an undisclosed sum. The firm says the acquisition complements the Saudi activities of its Pure Helium business, which the French company bought last year.

France-based specialty chemicals company Rhodia has paid an undisclosed amount to acquire the EConcern group’s share in six pilot biogas production projects taking place in China and Vietnam. Rhodia say that they are anticipating a growth in the market for biogas – a mixture of methane and carbon dioxide that can be used to produce electricity and heat. ‘This new expertise is at the crossroads of our activities of chemist and our activities in the energy and carbon markets,’ says Philippe Rosier, president of Rhodia Energy Services.

The title will be just the title of the first story. It appears to be a weekly compilations of summaries. Links for each summary are at the source,

No, let’s hold them to the law. They use a lot of tricks to try to keep the money stream coming on drugs that are out of patent.

We no doubt will be hearing less and less about drugs that aren’t profitable to make coming onto the market. They’re the first to be cut given this little moronic move.

When the drug companies are no longer granted a patent period in which to recoup R&D expenses, it will no longer make economic sense to do R&D. This is an end run around the delay in implementing socialized medicine to end drug research and thus end, after a time of declining effectiveness of drugs in use, the availability of effective antibiotics to anyone. I guess this helps solve the "overpopulation" problem. Hussein and the Left are striving for ever shorter life expectancy. I wonder if they have thought it through to understand that their own class's life expectancy figures will drop along with those of the serfs?

5 posted on 07/10/2009 4:47:46 PM PDT by arthurus ("If you don't believe in shooting abortionists, don't shoot an abortionist." -Ann C.)

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