re :MNTA is working on a generic version of Lovenox.
Please Dew do some research before you post !
Synthetic heparin programme on track to deliver in 2008
Also GlaxoSmithKline (GSK) has released solid 4Q07 Arixtra sales results, with the
historical upward trend intact. Given that ACL is developing the only generic version
of GSK’s Arixtra (fondaparinux); we are focused on the level of sales recorded for
Arixtra. ACL also remains on track for approval of its generic fondaparinux around the
end CY08, depending on FDA review times. Further detail is contained overleaf.
Quarterly Arixtra results continue to trend upwards
GlaxoSmithKline (GSK) released its 4Q07 results on 8 February. Given that ACL is
developing the only generic version of GSK’s Arixtra (fondaparinux sodium), we are
focused on the level of sales recorded for Arixtra. The solid sales data reported
supports our positive outlook for ACL and we believe that the approvals for further
indications in the US and EU will further drive sales. The table below lists the recent
quarterly sale figures.
■ Following a flat 3Q07, it was pleasing to see Arixtra sales continue to grow in line
with historical trends to US$59m for the quarter and US$200m for CY07. We note
that in GSK’s quarterly presentation, the company identified Arixtra as a new
product opportunity, particularly with the ACS indication pending approval.
■ GSK received an approvable letter from the FDA in February 2007 for the use of
Arixtra in acute coronary syndrome (ACS) and submitted additional information to
the agency during the first quarter to support this. We are still awaiting approval
for this indication. We are not aware of any issues which are slowing this process
and take comfort from GSK’s mention of the ACS indication in its presentation
that this may well be around the corner. We think this approval will have a
positive impact on US sales of Arixtra.
■ In September 2007 GSK received the formal approval from the European
Medicines Agency (EMEA) for the once daily use of Arixtra for the treatment of
patients with ACS. We think this is a key driver of EU qoq growth.
■ ACL’s generic copy of Arixtra will be able to enter the EU market in 2012, when EU
market exclusivity expires. We also expect to see first sales in the US in 1HCY09,
following approval around the end of CY08, an important milestone for the
company.
