Sanofi’s decision is not related to safety issues or deficiencies in the NDA, and resubmission is planned for 2015
Lixisenatide sales continue unaffected post approvals in the EU, Japan, Mexico and Australia
The LixiLan product, the investigational fixed-ratio combination of lixisenatide and Lantus®, remains on schedule to enter Phase III development in H1 2014
COPENHAGEN, Denmark I September 12, 2013 I Zealand Pharma (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs of Sanofi’s (EURONEXT: SAN and NYSE: SNY) decision, as announced earlier today, to withdraw the New Drug Application (NDA) for lixisenatide in the U.S. and resubmit in 2015 after completion of the ongoing ELIXA cardiovascular (CV) outcome study.
The NDA filed for lixisenatide was accepted for review by the U.S. Food and Drug Administration (FDA) in February 2013, including early interim results from the ELIXA study. The decision by Sanofi to withdraw the application follows discussions with the FDA regarding the authorities’ proposed process for the review of these interim data. It is Sanofi’s belief that potential public disclosure of interim data, even with safeguards, could potentially compromise the integrity of the entire ELIXA study of up to 6,000 patients, as it is still ongoing. The withdrawal of the NDA by Sanofi is thus not related to any safety issues or deficiencies in the NDA.
The ELIXA study continues as planned and has been fully enrolled. Sanofi expects complete study results to be available in early 2015, and based on this time frame has concluded that the most appropriate option is to supplement the FDA’s evaluation of lixisenatide based on the complete results of the ELIXA study rather than on interim data.
The investigational LixiLan combination product, the fixed-ratio combination of lixisenatide and Lantus®, is unaffected by the postponement of the U.S. NDA for lixisenatide and remains on schedule to commence Phase III development in the first half of 2014.
Sanofi are confident that existing data from the international GetGoal program, which involves more than 5,000 patients with type 2 diabetes, establish the current positive benefit-risk profile of lixisenatide.
“Sanofi’s decision to withdraw the application for lixisenatide in the US and resubmit in 2015 including full results from the important ELIXA CV safety study does not affect sales of the product outside of the U.S. Zealand has a solid cash position and we foresee continued commercial roll-out of Lyxumia in 2013 and 2014 in Europe, Japan and elsewhere, where approval has been granted. We note that the decision is voluntary and not a result of any FDA action nor related to safety concerns and we support Sanofi’s view that the integrity of the ongoing full ELIXA study should not be put at risk by making interim results publicly available,” said David Solomon, CEO and President of Zealand, and he continued; “Highly important is also to note that the timelines and Sanofi’s commitment to start Phase III studies with the LixiLan combination product are unaffected and reconfirmed.”
Financial guidance for 2013
Zealand’s expectations to receive revenues in 2013 from royalties on sales of lixisenatide (Lyxumia®) in regions where the product has been approved, including Europe, Japan, Mexico and Australia remain unchanged. As Sanofi has given no guidance on the expected sales of Lyxumia® and the timing of potential milestone payments from collaboration partners is uncertain, no more specific revenue guidance can be provided at this point in time.
Expectations of net operating expenses in 2013 at a range of DKK 210-240 (EUR 28-32) million are unaffected of Sanofi’s withdrawal and postponement of the NDA for lixisenatide in the U.S.
SOURCE: Zealand Pharma
Post Views: 185
Sanofi’s decision is not related to safety issues or deficiencies in the NDA, and resubmission is planned for 2015
Lixisenatide sales continue unaffected post approvals in the EU, Japan, Mexico and Australia
The LixiLan product, the investigational fixed-ratio combination of lixisenatide and Lantus®, remains on schedule to enter Phase III development in H1 2014
COPENHAGEN, Denmark I September 12, 2013 I Zealand Pharma (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs of Sanofi’s (EURONEXT: SAN and NYSE: SNY) decision, as announced earlier today, to withdraw the New Drug Application (NDA) for lixisenatide in the U.S. and resubmit in 2015 after completion of the ongoing ELIXA cardiovascular (CV) outcome study.
The NDA filed for lixisenatide was accepted for review by the U.S. Food and Drug Administration (FDA) in February 2013, including early interim results from the ELIXA study. The decision by Sanofi to withdraw the application follows discussions with the FDA regarding the authorities’ proposed process for the review of these interim data. It is Sanofi’s belief that potential public disclosure of interim data, even with safeguards, could potentially compromise the integrity of the entire ELIXA study of up to 6,000 patients, as it is still ongoing. The withdrawal of the NDA by Sanofi is thus not related to any safety issues or deficiencies in the NDA.
The ELIXA study continues as planned and has been fully enrolled. Sanofi expects complete study results to be available in early 2015, and based on this time frame has concluded that the most appropriate option is to supplement the FDA’s evaluation of lixisenatide based on the complete results of the ELIXA study rather than on interim data.
The investigational LixiLan combination product, the fixed-ratio combination of lixisenatide and Lantus®, is unaffected by the postponement of the U.S. NDA for lixisenatide and remains on schedule to commence Phase III development in the first half of 2014.
Sanofi are confident that existing data from the international GetGoal program, which involves more than 5,000 patients with type 2 diabetes, establish the current positive benefit-risk profile of lixisenatide.
“Sanofi’s decision to withdraw the application for lixisenatide in the US and resubmit in 2015 including full results from the important ELIXA CV safety study does not affect sales of the product outside of the U.S. Zealand has a solid cash position and we foresee continued commercial roll-out of Lyxumia in 2013 and 2014 in Europe, Japan and elsewhere, where approval has been granted. We note that the decision is voluntary and not a result of any FDA action nor related to safety concerns and we support Sanofi’s view that the integrity of the ongoing full ELIXA study should not be put at risk by making interim results publicly available,” said David Solomon, CEO and President of Zealand, and he continued; “Highly important is also to note that the timelines and Sanofi’s commitment to start Phase III studies with the LixiLan combination product are unaffected and reconfirmed.”
Financial guidance for 2013
Zealand’s expectations to receive revenues in 2013 from royalties on sales of lixisenatide (Lyxumia®) in regions where the product has been approved, including Europe, Japan, Mexico and Australia remain unchanged. As Sanofi has given no guidance on the expected sales of Lyxumia® and the timing of potential milestone payments from collaboration partners is uncertain, no more specific revenue guidance can be provided at this point in time.
Expectations of net operating expenses in 2013 at a range of DKK 210-240 (EUR 28-32) million are unaffected of Sanofi’s withdrawal and postponement of the NDA for lixisenatide in the U.S.
SOURCE: Zealand Pharma
Post Views: 185
