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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

uniQure partner prices gene therapy Glybera at EUR 1.1M

Chiesi Farmaceutici S.p.A (Parma, Italy) has filed a pricing dossier for Glybera alipogene tiparvovec with Germany's Federal Joint Committee (G-BA) that pegs the price of the gene therapy at over EUR 1 million. Chiesi has commercial rights to Glybera in Europe from uniQure N.V. (NASDAQ:QURE).

In the dossier, Chiesi seeks a retail price of EUR 53,000 ($65,625) per vial, or about EUR 1.1 million ($1.4 million) for a 62.5 kg patient who would require 21 vials.

Glybera is an adeno-associated virus (AAV) vector encoding the lipoprotein lipase (LPL) gene that was approved in Europe in 2012 to treat LPL deficiency in patients with recurring, acute pancreatitis, a rare disorder.

At the time of approval, uniQure said it planned to price the drug at EUR 250,000 ($322,625) per year of duration of clinical benefit, which was estimated at five years. The company also said it was considering a longer-term annuity pricing model, with an upfront payment followed by annual installments based on the duration of benefit.

However, under the subsequent 2013 deal, Chiesi is responsible for setting the price in Europe. Chiesi also has commercialization rights in Brazil, Mexico, Pakistan, Turkey, the Commonwealth of Independent States (CIS) and China. It did not reply to requests for comment in time for publication (see BioCentury, Sept. 2 , 2013).

uniQure shares jumped $2.32 (19%) to $14.82 on Friday. more >>

   COMPANY NEWS

CRL for daclatasvir sets back BMS's HCV program

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA issued a complete response letter for daclatasvir on Wednesday, requesting additional safety and efficacy data for the HCV drug in combination with other antiviral agents. BMS said its NDA for the selective HCV NS5A protein inhibitor focused on its combination with asunaprevir, an HCV NS3 protease inhibitor. Last month, BMS withdrew an NDA for asunaprevir and said it would no longer pursue approval of a combination of the two direct-acting antivirals (see BioCentury Extra, Oct. 7). more >>

   CLINICAL NEWS

Astellas: Data show fidaxomicin's efficacy, cost savings

Astellas Pharma Inc. (Tokyo:4503) said a pooled analysis showed that patients receiving fidaxomicin to treat Clostridium difficile infection (CDI) had reduced mortality, recurrence rates and healthcare costs compared with standard-of-care (SOC) vancomycin and metronidazole. more >>

   FINANCIAL NEWS

Genomics Ltd. raises L10.3 million

Sequencing analytics play and University of Oxford spin-out Genomics Ltd. (Oxford, U.K.) raised L10.3 million ($16.1 million) in its "first significant" round of funding, according to CEO John Colenutt. New investors Invesco Perpetual; Lansdowne Partners; Woodford Investment Management and the Wylie Family Trust participated in the untranched round alongside existing shareholders IP Group and the University of Oxford. more >>

Kite proposes $138M follow-on

Kite Pharma Inc. (NASDAQ:KITE) said it plans to raise up to $138 million in a follow-on underwritten by Jefferies; Credit Suisse; Cowen; and Stifel. Kite raised $146.6 million through the sale of 8.6 million shares at $17 in an IPO in June. more >>

S1 Biopharma amends IPO

S1 Biopharma Inc. (New York, N.Y.) amended its IPO on NASDAQ and plans to sell 1.75 million units at $12-$14. At $13, the company would raise $22.8 million and be valued at $105.7 million. Each unit comprises one share and one each of series A and series B warrants to purchase an additional share at the IPO price. The series A warrants expire in 2019 and the series B warrants expire in 2016. MLV and Northland Securities are underwriters. more >>

   POLITICS & POLICY

Singapore's A*STAR launches diagnostics hub

Singapore's Agency for Science, Technology and Research launched its Diagnostics Development (DxD) Hub to speed the development and approval of new diagnostics by connecting clinicians, researchers and entrepreneurs with industry professionals. more >>

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