Opinion ID: 203426
Heading Depth: 2
Heading Rank: 2

Heading: Plaintiffs' Allegations of Misleading Statements

Text: We describe emblematic examples [12] of the alleged misleading statements and the plaintiffs' allegations that defendants knew at the time these statements were misleading. (1) A statement in a February 18, 2004 press release attributed to the defendants that: In previous clinical trials, the following adverse events occurred more commonly with natalizumab when compared to placebo: headache, nausea, abdominal pain, infection, urinary tract infection, pharyngitis and rash. Serious adverse events have included infrequent hypersensitivity-like reactions. CAC ¶¶ 164-165. (2) A statement, attributed to defendant Mullen, Biogen's Chief Executive Officer and President, during a March 2, 2004 conference call with analysts that: [13] Now, I want to focus really on the current state of the MS market, I know a lot of people are beginning to think about that very carefully after this announcement two weeks ago. In the US, there is approximately 400 to 450,000 MS patients of which 300 to 350,000 in the relapsing forms, we consider that the eligible market, that market is slightly over half penetrated. That's about 180,000 patients in the U.S. are on one of the interferons or Copaxone. There is more than 50,000 quitters, that number is hard to quantify but we think that's the right ballpark and there is about 10 to 15,000 new patients diagnosed annually. And when you think about the EU marketplace, you can pretty much just double all those numbers except the penetration is a little bit less. So there is huge, there is still a huge unmet need out there. [W]e do believe that this innovative therapy will offer hope to a large number of patients and the market will grow significantly in the U.S. and Europe. CAC ¶¶ 178, 180. (3) Defendant Adelman, the Executive Vice President of Development, made the following statement during the same March 2, 2004 conference call: We know that there are patients who have some degree of disease activity either as measured by relapse rate and/or MRI while they are on any of the current therapies, and that's why the clinical development program for this product includes not only a placebo-controlled trial as a standalone therapy, but includes study where we look at the efficacy of Antegren when added to patients already on interferon who still have some evidence of disease activity. So, I think it's going to be broadly applicable to the entire population of patients with MS who are or are not on therapy, who still have evidence of disease activity. CAC ¶ 181. (4) A statement, attributed to Mullen, in an April 30, 2004 earnings report that: We've had an excellent start to the year. Both revenue and earnings results are up strongly. The U.S. filing of ANTEGREN by mid-year is on track.... With access to two large scale manufacturing facilities on both coasts, the Company is well-positioned to fulfill ANTEGREN's blockbuster potential. CAC ¶¶ 199, 208. (5) A statement, attributed to defendant Rohn, the Chief Operating Officer, in a July 28, 2004 earnings report that: We are convinced of Antegren's blockbuster potential.... We believe the potential MS market over the next few years will grow to roughly $6 billion, up from $3.6 billion today, and we believe Antegren will not only expand the market but also capture a lion's share of the market. CAC ¶¶ 234, 235. (6) A statement, attributed to Adelman, during a July 28, 2004 conference call with analysts that: [T]here is no evidence that Antegren is associated with accelerated disease activation or relapse as we've seen with other potential targeted therapies to lymphocyte trafficking and you know, we have a huge safety database and these issues have not come up in conversation, you know, with any regulatory authority. CAC ¶¶ 237, 238. (7) A statement, attributed to Mullen, at a January 11, 2005 healthcare conference that AVONEX was the ideal combination product along with Tysabri, it's the only product that has proven efficacy along side in addition to Tysabri. CAC ¶ 297.