Celgene ‘stops Mylan entering market’
pharmafile | April 6, 2014 | News story | Sales and Marketing | Celgene, Mylan, Revlimid, myeloma
Generic manufacturer Mylan is suing Celgene in a spat over allowing copycat versions of existing cancer drugs – Revlimid and Thalomid – to market.
The two US firms are set for a legal showdown because Mylan believes Celgene is using federal legislation designed to promote the safety of these drugs in a bid to block other companies from producing their own generics.
Thalomid is a form of thalidomide, a drug made notorious for causing severe birth defects in the 1960s after being given to mothers for morning sickness – it was later taken off the market.
It has now been re-developed by Celgene as a medicine for multiple myeloma, while Revlimid (lenalidomide) has a similar licence for this type of cancer.
Revlimid is Celgene’s most valuable property, bringing in $4.3 billion last year – a rise of 14% on the drug’s revenue in 2012 – and providing the bulk of the company’s overall sales of $6.5 billion in 2013.
Thalomid is a much smaller deal, whose sales last year fell 19% to $245 million, but Celgene will be keen to protect its assets.
Reuters reports that Mylan’s lawsuit, filed in the US District Court in Newark, New Jersey, says Celgene is using federal limits on the distribution of Revlimid and Thalomid – designed to promote safety – to preclude competitors from getting hold of their own samples of the drugs.
This means it is not possible for generics makers to carry out the bioequivalence tests which are needed by law before new versions of the products can be brought to market, the lawsuit suggests.
A statement from Mylan said: “The effect of Celgene’s conduct is that no generic manufacturer, including Mylan, has been able to bring generic versions of Thalomid and/or Revlimid to market. Through its illegal actions, Celgene has foreclosed Mylan from even attempting to enter the market.”
The legal action is aimed at making Celgene sell Mylan Revlimid and Thalomid at market prices to allow bioequivalence testing to take place, Reuters says, plus forcing Celgene to pay compensation and damages for lost business to Mylan.
This is not the only legal action which Celgene faces over these two brands.
In February, one of Celgene’s former sales representatives accused her old company of promoting both drugs off-label and downplaying their safety risks.
The suit, filed in the US District Court for the Central District of California, also alleges that Celgene paid ‘kickbacks’ to doctors for prescribing the medicines.
Adam Hill
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