the FDA is going to shut you down...this is from a wall street note:
"Concerns around the quality of Octapharma’s Octagam 5% liquid IVIG solution
have led a number of governments to quarantine product and require the
temporary withdrawal of Octagam from several European markets. Based on our
checks, Octagam is now off the market in Germany, Italy, France, and
Sweden. Other countries as well have taken note and issued advisories; the
US is considering additional action, which could occur as early as this week.
• Octapharma has by our estimates 11-12% of the global IVIG market,
including 7-8% in the US (see Tables 1-2). In Europe, the company offers two
liquid products: a 5% and more recently a 10% solution, both under the brand
name Octagam. In the US, the 5% solution has been on the market since May
2004, while the 10% is awaiting FDA approval. With Grifols receiving
approval earlier this month for its 10% product, Octapharma is the last of the
five legitimate US suppliers without a 10% solution.
• On August 20 Octapharma recalled 31 lots of Octagam from the US market on
concerns of a potential increased risk of thromboembolic events (9 reported
among 7 lots, another 24 lots withdrawn as a precaution). While Octapharma has
been surprisingly quiet since its Aug. 27 press release, reports have been
trickling out of a handful of countries of impacted lots, leading several European
governments to require a temporary withdrawal while Octapharma gets its arms
around the issue.
• A short withdrawal would have limited impact on the market, but a
protracted exit would certainly benefit the other players, starting with CSL
and Grifols, which have larger presences in Europe, and then followed by
Baxter and Talecris.
• Part of what makes this worth watching is that Octapharma has not one
but four manufacturing facilities: Vienna; Stockholm; Linholsheim, France;
and Springe, Germany. If this was an isolated manufacturing issue, one would
think it’s specific to one of the abovementioned facilities (most likely Vienna,
which does fill and finish) and not all Octagam product. That’s why the decision
by these governments to at least temporarily halt sales of Octagam out of any of
these facilities is so surprising and perhaps concerning. It suggests Octapharma
really doesn’t have its arms around this issue, or at least any answers at this
point. Expect to hear more on this in the coming days, and as we learn more
we’ll keep you updated."
"Concerns around the quality of Octapharma’s Octagam 5% liquid IVIG solution
have led a number of governments to quarantine product and require the
temporary withdrawal of Octagam from several European markets. Based on our
checks, Octagam is now off the market in Germany, Italy, France, and
Sweden. Other countries as well have taken note and issued advisories; the
US is considering additional action, which could occur as early as this week.
• Octapharma has by our estimates 11-12% of the global IVIG market,
including 7-8% in the US (see Tables 1-2). In Europe, the company offers two
liquid products: a 5% and more recently a 10% solution, both under the brand
name Octagam. In the US, the 5% solution has been on the market since May
2004, while the 10% is awaiting FDA approval. With Grifols receiving
approval earlier this month for its 10% product, Octapharma is the last of the
five legitimate US suppliers without a 10% solution.
• On August 20 Octapharma recalled 31 lots of Octagam from the US market on
concerns of a potential increased risk of thromboembolic events (9 reported
among 7 lots, another 24 lots withdrawn as a precaution). While Octapharma has
been surprisingly quiet since its Aug. 27 press release, reports have been
trickling out of a handful of countries of impacted lots, leading several European
governments to require a temporary withdrawal while Octapharma gets its arms
around the issue.
• A short withdrawal would have limited impact on the market, but a
protracted exit would certainly benefit the other players, starting with CSL
and Grifols, which have larger presences in Europe, and then followed by
Baxter and Talecris.
• Part of what makes this worth watching is that Octapharma has not one
but four manufacturing facilities: Vienna; Stockholm; Linholsheim, France;
and Springe, Germany. If this was an isolated manufacturing issue, one would
think it’s specific to one of the abovementioned facilities (most likely Vienna,
which does fill and finish) and not all Octagam product. That’s why the decision
by these governments to at least temporarily halt sales of Octagam out of any of
these facilities is so surprising and perhaps concerning. It suggests Octapharma
really doesn’t have its arms around this issue, or at least any answers at this
point. Expect to hear more on this in the coming days, and as we learn more
we’ll keep you updated."