Synageva raises $211 million in follow-on
Synageva BioPharma Corp. (NASDAQ:GEVA) raised $211 million on Thursday through the sale of 2 million shares at $105.75 in the largest follow-on so far this year. The company proposed the offering late Tuesday, when its share price was $103.99. Goldman Sachs; JPMorgan; Morgan Stanley; Cowen; Canaccord; Baird; and Nomura Securities are underwriters.
Conditional EU approval for J&J's bedaquiline
The European Commission granted conditional approval to an MAA from Johnson & Johnson (NYSE:JNJ) for Sirturo bedaquiline to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults. The approval covers use of bedaquiline as part of a combination therapy when alternative treatments cannot be used due to resistance or intolerance. Bedaquiline also has accelerated approval from FDA for pulmonary MDR-TB as part of a combination therapy when other alternatives are not available (see BioCentury Extra, Jan. 2, 2013).
FDA approves Endo's Aveed
FDA approved a resubmitted NDA from Endo International plc (NASDAQ:ENDP; TSX:ENL) for Aveed testosterone to treat male hypogonadism. The company said it plans to launch the product in the U.S. this month. Aveed's label includes a boxed warning on the risk of serious pulmonary oil microembolism reactions and anaphylaxis. Aveed was approved with a REMS requiring prescriber education and certification as well as restricted product distribution. The REMS also includes elements to assure safe use (ETASU).
Zaffaroni passes away
Life science entrepreneur Alejandro Zaffaroni passed away on March 1 at the age of 91. Zaffaroni founded a number of companies, including Affymetrix Inc. (NASDAQ:AFFX); Alexza Pharmaceuticals Inc. (NASDAQ:ALXA); and Alza Corp., which Johnson & Johnson (NYSE:JNJ) acquired. The family requested that donations in Zaffaroni's memory be made to the Alejandro and Lida Zaffaroni Scholarship and Fellowship Program at Stanford University, the University of California, Berkeley Foundation and the Boys and Girls Clubs of the Peninsula.
Roche names Pao global head of oncology research
Roche (SIX:ROG; OTCQX:RHHBY) said William Pao will join its Pharma Research and Early Development (pRED) division as global head of the oncology disease and translational area, effective May 1. Pao is a professor of medicine at Vanderbilt University Medical Center. He also is director of the center's Division of Hematology/Oncology and Personalized Cancer Medicine unit.
Sequenom's Hixson retiring
Diagnostic company Sequenom Inc. (NASDAQ:SQNM) said Harry Hixson will retire as CEO, effective at the company's annual meeting on June 10. President and COO William Welch will succeed Hixson, who will continue to serve as Sequenom's chairman. Welch will be nominated to the board. Additionally, CFO Paul Maier will also retire, effective June 10. Carolyn Beaver, VP and chief accounting officer, will become CFO. Sequenom also said Dirk van den Boom, EVP of R&D and CSO, will be promoted to chief scientific and strategy officer.
Stallergenes names new CEO
Stallergenes S.A. (Euronext:GENP) reported 2013 financial results and named Christian Chavy as CEO, effective March 31. Chavy, a Stallergenes director and partner at healthcare investment fund Ares Life Science, will replace Roberto Gradnik. Before that, Chavy was in charge of global operations at Actelion Ltd. (SIX:ATLN). Stallergenes reported 2013 revenues of EUR 248.1 million ($341.8 million), up 4% from EUR 239.8 million ($330.4 million) in 2012. The company said it expects revenue growth in the low single-digit for 2014 and said it expects a decision from FDA by the end of the month on Oralair, which is under review to treat grass pollen-induced allergic rhinoconjunctivitis.
FDA reschedules serelaxin advisory committee
FDA rescheduled for March 27 a meeting of its Cardiovascular and Renal Drugs Advisory Committee to discuss a BLA from Novartis AG (NYSE:NVS; SIX:NOVN) for serelaxin (RLX030) to treat acute heart failure (AHF). The meeting was originally scheduled for Feb. 13, but was postponed due to weather. The recombinant human relaxin-H2 has FDA breakthrough therapy designation for the indication.
Biotech slides, broader markets even
The BioCentury 100 Index lost 166.21 points, or 2.8%, to 5,714.16 on Thursday, while the broader markets remain relatively flat. The BC100 is a price-weighted index of top U.S.-listed biotechs by market cap. The days big decliners included Gilead Sciences Inc. (NASDAQ:GILD), which fell $2.95 (4%) to $79.92 on the day, and Celgene Corp. (NASDAQ:CELG), which closed off $6.63 (4%) to $156.61.
Sangamo jumps on HIV gene therapy data
Gene therapy play Sangamo BioSciences Inc. (NASDAQ:SGMO) jumped $3.35 (17%) to $22.96 on Thursday following the release of data from two trials evaluating the company's SB-728-T (formerly CCR5-ZFN) to treat HIV. Researchers at the University of Pennsylvania published data in the New England Journal of Medicine showing one patient who received a single infusion of SB-728-T had HIV RNA rise and then fall back down to undetectable levels during interruption of treatment with highly active anti-retroviral therapy (HAART). All patients in the Phase I trial had undetectable HIV RNA levels at the start of the 12-week interruption of HAART. The other three patients also completing the interruption saw HIV RNA levels increase, peaking at weeks 6-8 and then fall again. In all four patients, the average reduction in HIV RNA was 1.2 log from peak levels during the treatment interruption (p=0.07).
Boehringer reports data for faldaprevir in HCV/HIV patients
Boehringer Ingelheim GmbH (Ingelheim, Germany) reported data on Thursday from a Phase III trial evaluating faldaprevir (BI 201335) in patients with HCV genotype 1 infection co-infected with HIV and also said FDA accepted for review an NDA for the oral HCV NS3/4A protease inhibitor. In the 308-patient Phase III STARTVerso 4 trial, once-daily oral faldaprevir in combination with pegylated interferon and ribavirin led to an HCV sustained virologic response (SVR) 12 weeks after the end of treatment in 71% of patients who received 120 mg faldaprevir for 24 weeks (n=123) and 72% of patients who received 240 mg faldaprevir for 12 or 24 weeks (n=185).
POLITICS & POLICY
FDA holding workshop on sequencing to identify microbes
FDA is holding a public workshop on April 1 to obtain input on the use of high throughput sequencing devices to diagnose infectious diseases, including the detection of antimicrobial resistance markers. The agency is seeking stakeholder input on the clinical applications of the devices, including specific applications where high throughput sequencing could be used for diagnosis; and ways to validate device performance, including developing and adapting standards for the sequencing process.
USPTO updates guidance to determine eligibility of claims
The U.S. Patent and Trademark Office issued updated guidance to patent examiners on determining whether product claims that involve natural phenomena and natural products are patent eligible. The updated guidance notes these claims are patent eligible only if they are "significantly different" from what exists in nature. The guidance provides a list of factors that "weigh toward eligibility," including elements or steps that "impose meaningful limits on claim scope" or "add a feature that is more than well-understood, purely conventional or routine in the relevant field." The updated guidance also provides several examples for patent examiners, including when methods or process patent claims would be appropriate.
EMA, FDA extend Quality by Design pilot program
EMA and FDA agreed to extend by two years a pilot program for parallel assessment of Quality by Design (QbD) components of NDAs and MAAs. QbD is an approach using statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines to ensure quality. One of the goals of the approach is to identify, explain and manage all sources of variability affecting a process. The EMA and FDA pilot program is intended to prevent the regulatory agencies from applying QbD standards inconsistently. The agencies reviewed one application for an undisclosed product from Pfizer Inc. (NYSE:PFE) and "several" scientific advice requests under the original three-year pilot program, which has run since April 2011.