Jazz Pharmaceuticals plc last year.) Shareholders did, however, vote in favor of a $200 million share buyback

Jazz Pharmaceuticals plc $120M Genentech Inc

Jazz Pharmaceuticals plc, of Dublin, Ireland, reported adjusted first-quarter net income of $84.4 million, or $1.37 per diluted share, compared to $51 .7 million, or 89 cents per diluted share, for the same period in 2012

Hours after reporting its first quarterly earnings as a commercial entity following FDA approval of Kynamro (mipomersen) in January and subsequent launch of the antisense drug, Isis Pharmaceuticals Inc. turned its attention to other candidates in its pipeline. The Carlsbad, Calif.-based company priced an underwritten public offering of 9 million shares of its common stock at $19 per share, seeking to raise $171 million from the offering, which is expected to close on or about May 14. Isis

Celgene's buy-in follows deals with Avanir Pharmaceuticals Inc., of Aliso Viego, Calif., and more recently with Jazz Pharmaceuticals plc, of Dublin, Ireland. (See BioWorld Today, March 1, 2012, and Feb. 28, 2013.) Deuterium, a heavy form of hydrogen for the discovery of which Harold Urey won the Nobel Prize in 1934, has garnered interest since, and "the existence of what are called deuterium-isotope effects has been recognized probably for over 50 years," Tung said

Jazz Pharmaceuticals plc $120M Genentech Inc

Jazz Pharmaceuticals plc (Dublin, Ireland) $120 Exclusive license agreement giving Jazz global rights to develop and commercialize deuterium-modified sodium oxbate compounds, including C-10323, aimed at narcolepsy Concert is slated to receive an undisclosed up-front payment plus $120 million in potential milestone payments as well as tiered royalties that could escalate into low double digits 2/28/13 ConfometRx (Palo Alto, Calif.) UCB SA (Brussels, Belgium) ND Research agreement to pursue the

10/9/12 10/30/12 $10 Periphagen bought Diamyd for $1 and 10% ownership, plus $10M in potential milestones Women's health business of Jazz Pharmaceuticals plc (Dublin, Ireland) Meda AB (Goteborg, Sweden) 10/17/12 10/17/12 $95 Meda purchased the business for $95M in cash NextWave Pharmaceuticals Inc. (Cupertino, Calif.) Pfizer Inc. (New York) 10/23/12 10/23/12 $680 Pfizer is buying NextWave for $255M, plus $425M in sales milestones OctoPlus NV (Leiden, the Netherlands) Dr. Reddy's Laboratories Ltd

struck another business development high note, inking an exclusive license agreement that provides Jazz Pharmaceuticals plc with global rights to develop and commercialize deuterium-modified sodium oxybate (D-SXB) compounds, including C-10323, aimed at narcolepsy

signed a license agreement that provides Jazz Pharmaceuticals plc with global rights to develop deuterium-modified sodium oxybate (D-SXB) compounds aimed at narcolepsy

struck another business development high note, inking an exclusive license agreement that provides Jazz Pharmaceuticals plc with global rights to develop and commercialize deuterium-modified sodium oxybate (D-SXB) compounds, including C-10323, aimed at narcolepsy

In 2008, a jury found Alfred Caronia guilty of promoting the narcolepsy drug Xyrem (sodium oxybate) for conditions not included in the label gained by Orphan Medical Inc. (acquired by Jazz Pharmaceuticals plc

Defendant Plaintiff Details/Decisions Date Abbott (Abbott Park, Ill.) U.S. federal and state authorities Abbott pled guilty and agreed to pay $1.5B as part of a settlement to resolve issues related to the big pharma's off-label promotion of Depakote; Abbott will pay $800M to resolve civil allegations, $700M for a criminal penalty and $100M to states to resolve consumer protection issues; Abbott was sentenced to a five-year term of probation 5/8/12; 10/4/12 AlCana Technologies Inc. (Vancouver

the study showed the product was safe, and that the first immunization increased anti-alphaGal IgG response compared with baseline 12/14/12 OncoMed Pharmaceuticals Inc. (Redwood City, Calif.) OMP-52M51 Targets the Notch1 receptor Hematologic cancers Began dosing in a Phase I trial 12/26/12 Jazz Pharmaceuticals plc (Dublin, Ireland) Erwinaze Asparaginase

Biotech Products Approved in 2013 | Biotech Products Approved 1982-2012 BIOTECH PRODUCTS 2013 Company Product Marketer Indication (U.S. Approval Date; Month/Day) Amgen Inc. Xgeva Amgen Inc. Giant tumor of the bone (6/14) Supernus Pharmaceuticals Inc. Trokendi XR Supernus Pharmaceuticals Inc. Epilepsy (6/11) Celgene Corp. Revlimid Celgene Corp. Mantle cell lymphoma (6/6) Flamel Technologies Inc. Bloxiverz Flamel Technologies Inc. To reverse effects of

January | February | March | April | May | June | June - 2013 Company Company Type/Product Area Terms/Details Algeta ASA Avipep Pty Ltd. Collaboration to evaluate a targeted thorium conjugate based on combining Algeta's thorium-227 alpha-pharmaceutical payload with a next-generation antibody fragment, known as an avibody, from Avipep that targets a number of solid tumor types Both companies will contribute financially to the collaboration, which is expected to last for up to

Jazz Pharmaceuticals plc, of Dublin, Ireland, said the FDA denied its citizen petition filed in July asserting that any abbreviated new drug appliation (aNDA) for a Xyrem (sodium oxybate oral solution) generic should include a proposal for a full risk evaluation and mitigation strategy, and sought that the FDA rescind any accepted aNDA for the narcolepsy drug that does not include such a proposal

Jazz Pharmaceuticals plc, of Dublin, Ireland, said the FDA denied its citizen petition filed in July asserting that any abbreviated new drug appliation (aNDA) for a Xyrem (sodium oxybate oral solution) generic should include a proposal for a full risk evaluation and mitigation strategy, and sought that the FDA rescind any accepted aNDA for the narcolepsy drug that does not include such a proposal