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  • Nov. 17, 2014, 7:19 AM
    • GCVRZ is up 135% to $1.20 in early premarket action after the FDA approved Lemtrada late on Friday. The deadline for a $1 payment with FDA approval has passed, so the next milestone would be for $2 if the drug exceeds $400M in worldwide sales over a four-quarter period.
    • The question: Is GCVRZ a better buy at $1.20 with approval in hand than at $0.50 without yet having approval?
    • GCVRZ forum
    • Previously: Genzyme's Lemtrada approved by the FDA
    • SNY -0.2% premarket
    | Nov. 17, 2014, 7:19 AM | 16 Comments
  • Nov. 14, 2014, 9:47 PM
    • Lemtrada was originally rejected by the FDA at the end of last year, but the Sanofi (NYSE:SNY) subsidiary resubmitted the application several months ago. With the FDA's action today, the U.S. joins pretty much the entirety of the rest of the globe in approving Lemtrada for treating relapsing forms of multiple sclerosis.
    • The contingent value rights on the drug (NASDAQ:GCVRZ) were trading at nearly $2 each before the FDA's rejection last year and closed today's session at $0.52. Monday should be interesting.
    • GCVRZ Forum
    | Nov. 14, 2014, 9:47 PM | 18 Comments
  • Oct. 7, 2014, 8:33 AM
    • Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
    • Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
    • Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
    • The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
    • F-1
    | Oct. 7, 2014, 8:33 AM
  • Sep. 11, 2014, 10:12 AM
    • Genzyme (NYSE:SNY) (NASDAQ:GCVRZpresents interim results from an extension study of Lemtrada (alemtuzumab) today at the European Committee for Research and Treatment in Multiple Sclerosis meeting in Boston.
    • Approximately 70% of patients treated with an annual course of Lemtrada at the start of the first study and 12 months later did not receive further treatment with Lemtrada in years 3 and 4.
    • Approximately 70% of the Lemtrada-treated patients demonstrated stable or improved disability scores for an additional two years beyond the two-year study period.
    • In year 4, the relapse rates for the patients who received Lemtrada in the two trials (CARE-MS 1 and CARE-MS II) were 14% and 24%, respectively. These were comparable to the annualized relapse rates for the Lemtrada cohorts in the pivotal trials.
    | Sep. 11, 2014, 10:12 AM | 2 Comments
  • Sep. 11, 2014, 7:46 AM
    • In an interview with Reuters, Genzyme's (NYSE:SNY) (NASDAQ:GCVRZ) chief of its multiple sclerosis franchise Bill Sibold says his firm intends to be a leader in the field via new products and acquisitions.
    • He is confident about the commercial success of Lemtrada (alemtuzumab) and Aubagio (teriflunomide). Analysts forecast Lemtrada's peak sales at $437M and Aubagio's at $1.2B.
    • Predictably, no word on acquisition targets, but he says that they are looking to acquire truly innovative products. "If the opportunity is the right opportunity, we'll evaluate it...We're well-resourced to execute our strategy."
    • The firm expects an FDA decision on its revised marketing app for Lemtrada in Q4. The agency rejected its initial application last December.
    | Sep. 11, 2014, 7:46 AM
  • May 30, 2014, 7:39 AM
    • Sanofi (SNY) reports that the FDA agrees to review Genzyme's resubmission of its Lemtrada application for the treatment of relapsing forms of multiple sclerosis. A six-month review window has been assigned. SNY expects FDA action in Q4.
    • The FDA sent Genzyme a CRL in December 2013 after reviewing its sBLA. It stated that the company failed to submit evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Apparently, the design of the completed Phase 3 active comparator studies was the problem.
    • Related ticker: (GCVRZ)
    | May 30, 2014, 7:39 AM
  • Apr. 7, 2014, 7:48 AM
    | Apr. 7, 2014, 7:48 AM | 1 Comment