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Mylan gets provisional FDA greenlight for generic version of Lilly's blockbuster cancer drug Alimta

Mylan has scored a preliminary approval in the US from the FDA for its generic version of Eli Lilly’s blockbuster therapy Alimta (permetrexed) for the treatment of non-squamous non-small cell lung cancer (NSCLC) and mesothelioma.

This tentative approval means that Mylan will be cleared to market its product in the US, but only once Lilly’s patent on the originator medicine expires in the country. This means that Mylan will need to wait until May 2022, when the patent on low-cost generic competition is due to run out.  

NICE approves lung cancer and leukaemia treatments

The National Institute for Health and Care Excellence (NICE) has issued its approval of two drugs for routine use on the NHS: Pfizer’s leukaemia drug Bosulif (bosutinib) and Eli Lilly’s lung cancer treatment Alimta (pemetrexed). 

German Supreme Court grants Lilly appeal to block Alimta generics

Eli Lilly (NYSE: LLY) has announced that it has been granted an appeal by the German Federal Supreme Court, in its case against Actavis (now Allergan) relating to generic competition for Lilly’s vitamin regimen patent Alimta (pemetrexed disodium).

Lilly suffers damaging Alimta patent blow

Eli Lilly says it plans to appeal a UK High Court’s verdict that could imminently open its blockbuster lung cancer drug Alimta up to generic competition.

The court ruled on Friday that Actavis would not infringe the Alimta (pemetrexed disodium) patent by marketing pemetrexed trometamol in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution. 

Lilly defeats Teva in US court over Alimta patent

Eli Lilly has won a case in a US federal court, in a battle over Teva’s attempt to create a generic version of Lilly’s lung cancer treatment Alimta.

Teva brought the case to court in an attempt to challenge Lilly’s patent, protecting Alimta (pemtrexed) in combination with a vitamin regimen (folic acid and vitamin B12), which is used to negate the drug’s side effects.

UK Court weighs in on Lilly-Actavis Alimta case

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Actavis will be infringing Lilly’s patent if it were to produce generic versions of Alimta, the UK Court of Appeal has ruled.

Judges blocked a move by Actavis to market certain alternative salt forms of Alimta (pemetrexed disodium) in the UK before the patent's expires in June 2021.

Specifically, the Court of Appeal decided that if Actavis were to market a generic copy of the lung cancer drug, this “would constitute indirect infringement by supplying an essential means for putting the patented invention into effect”.

German court rules against Lilly in Alimta patent case

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A German court has ruled that Lilly’s patent for its lung cancer drug Alimta would not be infringed by generic competition when it expires later this year.

The court governed in favour of Actavis to develop a dipotassium salt form of Alimta (pemetrexed) – Lilly’s second-best selling drug last year, bringing in a total $2.7 billion in sales – to be marketed in Germany.

NICE rejects Alimta

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Eli Lilly is coming to terms with rejection by NICE after the cost watchdog said it would not recommend Alimta for the maintenance treatment of the commonest form of lung cancer.

In final draft guidance NICE says Alimta (pemetrexed) should not be used on the NHS for patients with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC).

Lilly was hoping that it would be used as maintenance in people whose disease has not progressed immediately following induction therapy with best-in-class chemotherapy pemetrexed and cisplatin.

Lilly to go ‘on offense’

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The loss of patent on antidepressant Cymbalta in the US last December was largely responsible for Eli Lilly & Co’s 2% dip in revenue to $5.8 billion during the fourth quarter of 2013, the company says.

US revenue slipped 6% to $3 billion as a result of generic competition for Cymbalta (sales of which fell 38% in Q4), although the $2.8 billion sales in the quarter outside the US represented a 1% increase.

Lilly suffers late-stage cancer blow

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Eli Lilly suffered a blow to its oncology programme when a new combination treatment failed to improve overall survival in lung cancer patients.

The Phase III POINTBREAK study put Lilly’s big-selling Alimta (pemetrexed dosdium) together with Roche’s own blockbuster Avastin (bevacizumab) to treat nonsquamous non-small cell lung cancer (NSCLC).

Alimta with cisplatin chemotherapy is a standard treatment for NSCLC, bringing in $2.5 billion in sales last year, and this trial was supposed to show how its reach could be expanded further.

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