This post will summarize highlights from biopharma conference calls - including Novartis, Roche, Baxter, and Sanofi - that are relevant either to Momenta Pharma MNTA specifically, or to the biosimilars space in general.
Novartis NVS reported $85m in generic LOVENOX (enoxaparin) sales in 4q-2012. There was no other discussion of this program, or their partnered generic version of Teva's COPAXONE.
Roche RHHBY earnings call: now predict earliest Rituxan biosimilars to launch in 2016 - delayed another year (once though 2013 was possible..)
Baxter BAX earnings call: no discussion, just the following update-
"And we continued to advance our partnership with Momenta Pharmaceuticals during the year, as we've now selected 3 biosimilars targeted for the treatment of oncology, autoimmune and other inflammatory disorders." (via SeekingAlpha)
Citi Healthcare webcast - MNTA programs not mentioned
"And we continued to advance our partnership with Momenta Pharmaceuticals during the year, as we've now selected 3 biosimilars targeted for the treatment of oncology, autoimmune and other inflammatory disorders." (via SeekingAlpha)
Citi Healthcare webcast - MNTA programs not mentioned
Sanofi SNY earnings call via SeekingAlpha.
"Can you make a comment on Lovenox in Europe, which is quite a big drug still for you. And we have new proposed guidelines that ... do not close anymore their doors to substitutable generic?
Yes, you're absolutely right. There is a guideline for biosimilars...we have been consulted in this process. We are overall, I would not say satisfied, but nearly satisfied with the outcome. The outcome is rigid, it's stringent as far as the definition of those products is concerned, we believe that it will not be easy for everyone to overcome those hurdles. Clinical trials are needed...we believe those guidelines are okay, and they are okay because they are safe for the patients. Independently, and I have said so over the years, I don't believe that the European market will be extremely sensitive to generics for Lovenox. The European market, for the last 20 years, has seen a multitude of low molecular weight heparins. The market situation is not at all comparable to the U.S. market. And let's not overlook that even in the U.S. market the penetration of generics has been relatively slow, very slow in special side of the hospital market where Lovenox even today controls about 50% in terms of volume."
From earnings press release:
"Sales of Lovenox in the fourth quarter were €441 million, down 13.1%, due to generic pressure in the U.S. where sales of the branded product declined 54.2% to €55 million. Sanofi commercializes an authorized generic of Lovenox in the U.S. (sales are booked in the Generics business). In Emerging Markets, sales of the product increased 5.0% to €149 million over the quarter.
Full-year sales of Lovenox reached €1,893 million (-12.0%), of which 83.1% (€1,574 million) was generated outside the U.S. (+5.5%). In Emerging Markets, full-year sales increased 11.6% to €615 million. Sales of Generics were €458 million, down 7.2% in the fourth quarter. In the U.S., sales decreased mainly reflecting lower sales of the authorized generic of Lovenox
"Can you make a comment on Lovenox in Europe, which is quite a big drug still for you. And we have new proposed guidelines that ... do not close anymore their doors to substitutable generic?
Yes, you're absolutely right. There is a guideline for biosimilars...we have been consulted in this process. We are overall, I would not say satisfied, but nearly satisfied with the outcome. The outcome is rigid, it's stringent as far as the definition of those products is concerned, we believe that it will not be easy for everyone to overcome those hurdles. Clinical trials are needed...we believe those guidelines are okay, and they are okay because they are safe for the patients. Independently, and I have said so over the years, I don't believe that the European market will be extremely sensitive to generics for Lovenox. The European market, for the last 20 years, has seen a multitude of low molecular weight heparins. The market situation is not at all comparable to the U.S. market. And let's not overlook that even in the U.S. market the penetration of generics has been relatively slow, very slow in special side of the hospital market where Lovenox even today controls about 50% in terms of volume."
From earnings press release:
"Sales of Lovenox in the fourth quarter were €441 million, down 13.1%, due to generic pressure in the U.S. where sales of the branded product declined 54.2% to €55 million. Sanofi commercializes an authorized generic of Lovenox in the U.S. (sales are booked in the Generics business). In Emerging Markets, sales of the product increased 5.0% to €149 million over the quarter.
Full-year sales of Lovenox reached €1,893 million (-12.0%), of which 83.1% (€1,574 million) was generated outside the U.S. (+5.5%). In Emerging Markets, full-year sales increased 11.6% to €615 million. Sales of Generics were €458 million, down 7.2% in the fourth quarter. In the U.S., sales decreased mainly reflecting lower sales of the authorized generic of Lovenox
RSS Feed
