Key drug launches for 2011
pharmafile | January 20, 2011 | Feature | Sales and Marketing | Benlysta, Cladribine, Movectro, Pradaxa, Xarelto, axitinib, boceprevir, crizotinib, telaprevir
This year is expected to see new treatments for hepatitis C, multiple sclerosis and lupus among those that could reach the market.
InPharm takes a look at some of the stand-out contenders and details their prospects.
Hepatitis C
Merck’s new oral hepatitis C drug boceprevir has been give fast-track reviews from both the FDA and the EMA after the regulators decided it marked a major advance in treatment.
This could see the drug launched in both the US and European market by July.
A rival treatment from Johnson & Johnson is also in the offing. The company’s oral hepatitis C drug telaprevir has been fast-tracked by the EMA and is expected to reach the European market at the same time as its rival.
Boceprevir has been forecast by industry analysts at EvaulatePharma to make around $800 a year by 2016, but impressive phase III results for telaprevir have seen some financial analysts predict peak sales J&J’s drug of over $3 billion.
Multiple Sclerosis
Merck Serono’s oral multiple sclerosis drug Movectro (cladribine) was rejected by key European regulatory advisors in September and again in January as they believed its benefits failed to outweigh its risks.
In February Merck decided to pull European licence application given the CHMP decisions, but still has the opportunity to resubmit the drug in the future.
It has, however, been approved in both Australia and Russia and is still under FDA review, though this was delayed when the US regulator asked for more information on the drug.
Movectro could still make it to the US market by the second quarter, but it has already lost first-to-market advantage to Novartis’ rival oral MS drug Gileyna, which was approved by the FDA in September and is to reach forecast peak year sales of over $2.5 billion.
Lupus
GlaxoSmithKline and Human Genome Science’s and lupus drug Benlysta was given priority review by the FDA in August and could be approved for launch by March, but the drug will have to stand up to extended post-marketing data requirements if it is to be a success.
The priority review reflects Benlysta’s potential to be a major advance in the disease area and could be the first new lupus drug on the market for over 50 years.
Because of this, analysts predict the drug to be a blockbuster, with EvaluatePharma projecting annual sales of over $2.7 billion from 2016.
Oncology
Pfizer initiated a ‘rolling’ fast-track submission for its new oral ALK non-small cell lung cancer (NSCLC) drug crizotinib that could see it on the market by late 2011.
The rolling submission, which is available to medicines that have received fast-track designation, allows completed portions of their new drug application to be submitted and reviewed by the FDA on an ongoing basis
ALK, or an anaplastic lymphoma kinase mutation, is believed to be a key driver in tumour development in NSCLC patients.
This will be the first ALK-targeted drug and will follow a similar mechanism of action as AstraZeneca’s NSCLC drug Iressa by targeting a particular mutation that causes tumour growth.
Pfizer also plans to submit two other investigational oncology compounds to European and US regulators in 2011.
Axitinib is an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3 that treats metastatic renal cell carcinoma, and bosutinib is an oral dual SRC and ABL kinase inhibitor for the treatment of chronic myeloid leukaemia.
Both could see early 2012 launch dates as Pfizer gears up to run a personalised cancer healthcare awareness initiative later this year.
Anticoagulants
Bayer is looking to expand its anticoagulant Xarelto’s indications to add stroke prevention in patients with atrial fibrillation, the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism.
The drug was first approved in 2008 to prevent venous blood clots in patients undergoing elective hip or knee replacement surgery, but these new indications will greatly expand its reach and revenue potential.
Xarelto (rivaroxaban), which won the prestigious Prix Galien awards in October for the most innovative pharmaceutical, is part of a new batch of anticoagulants looking to replace the 65-year old drug warfarin.
Warfarin has a high number of side effects and other contenders hoping to offer an alternative treatment option include Pfizer/Bristol-Myers Squibb’s apixaban and Boehringer Ingelheim’s Pradaxa.
Pradaxa stole a march over its rivals in October when it received approval from the FDA for stroke risk reduction in patients with non-valvular atrial fibrillation.
Ben Adams
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