FDA accepts Sandoz's BLA for filgrastim biosimilar
Sandoz, a unit of Novartis AG (NYSE:NVS; SIX:NOVN), said FDA accepted a BLA for a biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGEN). Sandoz is the first company to announce FDA's acceptance of a biosimilar application.
EMA to review GSK's malaria vaccine
EMA accepted for review an MAA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for its RTS,S malaria vaccine -- moving the product closer to being the first vaccine approved to prevent malaria infection in infants and children. There are currently no approved vaccines for malaria. A positive EMA opinion on the MAA would be the basis for regulatory applications for RTS,S in countries in sub-Saharan Africa, which accounts for about 90% of annual malaria deaths. GSK said it does not expect a decision on the vaccine until next year. Pending EMA's decision, GSK said the World Health Organization also could issue an immunization policy recommendation for RTS,S by the end of 2015.
Bristol-Myers, Ono ink Asia immunotherapy deal
Bristol-Myers Squibb Co. (NYSE:BMY) and Ono Pharmaceutical Co. Ltd. (Tokyo:4528) partnered to jointly develop and commercialize multiple products, including Opdivo nivolumab and Yervoy ipilimumab, in Japan, South Korea and Taiwan. The deal also includes early stage BMS oncology compounds lirilumab (BMS-986015; IPH2102), urelumab (BMS-663513) and BMS-986016. The partners will jointly pursue development of monotherapy and combination regimens of the immunotherapies.
Gilead exec suggests lower cost for ledipasvir than Sovaldi
Comments by a Gilead Sciences Inc. (NASDAQ:GILD) executive during the company's 2Q14 earnings call suggest the company may not price HCV therapeutic ledipasvir (GS-5885) as high as Sovaldi sofosbuvir. EVP of Commercial Operations Paul Carter said Gilead hasn't finalized pricing for its fixed-dose combination of Sovaldi and ledipasvir, but that the company feels the "majority of the value" of the combination is in Sovaldi. The combination is under Priority Review at FDA with an Oct. 10 PDUFA date and is also under accelerated assessment in the EU.
Sarepta terminates CSO Krieg
Sarepta Therapeutics Inc. (NASDAQ:SRPT) disclosed in an SEC filing that Arthur Krieg was terminated as SVP and CSO on July 22. Krieg, co-founder and formerly CEO of RaNA Therapeutics Inc. (Cambridge, Mass.), joined Sarepta in January to run the company's drug discovery and early stage research programs. CEO Chris Garabedian declined to comment on Krieg's termination and said the company does not currently have a replacement. Garabedian did say Sarepta hopes that a future CSO "will have desires that align with fully utilizing the technologies available to our company."
Celgene tops Street estimates, raises guidance
Celgene Corp. (NASDAQ:CELG) reported 2Q14 earnings that beat the Street on Thursday and raised its full-year EPS and revenue guidance. The company reported 2Q14 adjusted diluted EPS of $0.90, beating by a penny the Street's $0.89 estimate and up from $0.76 in 2Q13. Total revenues in the quarter were $1.87 billion, above the Street's $1.85 billion estimate and up 17% from $1.6 billion in 2Q13.
Immune Design, Pfenex price IPOs
Cancer immunotherapy company Immune Design Corp. (NASDAQ:IMDZ) and biosimilar play Pfenex Inc. (NYSE:PFNX) priced their IPOs on Thursday. Immune Design raised $60 million through the sale of a bumped-up number of shares at the low end of its proposed range. Immune Design sold 5 million shares at $12, which values the company at $190.5 million. Last week, the company said it planned to sell 4.7 million shares at $12-$14. Jefferies; Leerink Partners; and Wells Fargo are underwriters.
Intersect raises $55 million in IPO
Intersect ENT Inc. (NASDAQ:XENT) was up $1.92 (17%) to $12.92 on its first day of trading Thursday after raising $55 million through the sale of 5 million shares at $11 in an IPO. The $11 price valued the drug-delivery device company at $247.5 million. Earlier this month, Intersect said it planned to sell 5 million shares at $11-$13. JPMorgan; Piper Jaffray; Leerink; and Wedbush were underwriters. Intersect markets the Propel and Propel mini mometasone furoate implants to treat chronic sinusitis. The products are bioabsorbable, steroid-eluting implants. In 1Q14, the company had revenues of $7.5 million and a three-month operating loss of $4.1 million.
Atox Bio closes $23 million in E round
Infectious disease play Atox Bio Inc. (Ness Ziona, Israel) raised an undisclosed amount in the first tranche of a $23 million series E round led by new investor SR One. New investors Lundbeckfond Ventures and OrbiMed Israel also participated. Atox's AB103 has completed a Phase II trial to treat necrotizing soft tissue infections. In 2H15, the company plans to start a pivotal trial of the short peptide that modulates CD28 in the indication. Atox was spun out of Hebrew University in 2003 by its Yissum Research and Development Co. Ltd. tech transfer arm.
Alexion reports 2Q14 earnings, EMA to review asfotase alfa
Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) reported 2Q14 earnings that beat the Street on Thursday and separately said EMA accepted and granted accelerated assessment to an MAA for asfotase alfa to treat hypophosphatasia (HPP). The company expects to complete a rolling BLA submission for the product -- a fusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP) and a bone-targeting peptide -- this fall. HPP is an inherited metabolic disease characterized by defective bone mineralization. An accelerated assessment shortens the review period to 150 days from 210.
Infectious disease play ContraFect amends IPO
ContraFect Corp. (Yonkers, N.Y.) again amended its IPO and now plans to sell 5.5 million units at $5-$6 on NASDAQ. At the $5.50 midpoint, the company would raise $30 million. Each unit comprises a share, a class A warrant to purchase a share at $4.80 and a class B warrant to purchase half a share, with each whole warrant exercisable at $4. Earlier this month, ContraFect said it planned to sell 3.6 million units at the same price range. The company filed to raise up to $23 million in the offering in April. Maxim Group is the underwriter.
Imaging play Lantheus sets IPO terms
Lantheus Holdings Inc. (North Billerica, Mass.) amended its planned IPO on NASDAQ and now plans to sell 9.3 million shares at $12-$15. At the $13.50 midpoint, the company would raise $125 million and be valued at $369.1 million. Lantheus filed to raise up to $125 million in the offering in June. Citigroup; Jefferies; RBC Capital Markets; Wells Fargo; and Baird are underwriters. Lantheus is the parent company of Lantheus Medical Imaging Inc., which develops, manufactures and markets diagnostic medical imaging agents and products. Lantheus had 2013 revenues of $283.7 million.
POLITICS & POLICY
CDC's Farrell resigns in wake of anthrax scare
The U.S. Centers for Disease Control and Prevention said Michael Farrell resigned as team lead for the Bioterror Rapid Response and Advanced Technology (BRRAT) Laboratory following an incident last month in which laboratory personnel were potentially, unintentionally exposed to viable anthrax. Farrell had held the position since 2009.
Crenezumab from the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY) missed the primary endpoint in the Phase II ABBY trial and missed a secondary endpoint in the Phase II BLAZE trial. The July 16 issue of BioCentury Extra mischaracterized the BLAZE results.