L300M in new investments for Genomics England
U.K. Prime Minister David Cameron announced over L300 million ($509.4 million) in new investments for Genomics England Ltd. (London, U.K.), which is sequencing and analyzing the genomes of 100,000 NHS patients by 2017. The investments include about L162 million ($275.1 million) from Illumina Inc. (NASDAQ:ILMN), the partner for the sequencing element of the project. In turn, Genomics England will pay Illumina about L78 million ($132.4 million) for its services.
Biota's laninamivir octanoate misses in Phase II influenza
Biota Pharmaceuticals Inc. (NASDAQ:BOTA) said laninamivir octanoate delivered via TwinCaps dry-powder inhaler missed the primary endpoint of improving median time to alleviation of influenza symptoms vs. placebo in the intent-to-treat (ITT) population of the Phase II IGLOO trial to treat influenza infection. The double-blind trial enrolled 248 patients with PCR-confirmed influenza A or B infection. Median time to alleviation of influenza symptoms was 102.3 hours for the 40 mg laninamivir octanoate cohort (p=0.248) and 103.2 hours in the 80 mg cohort (p=0.776) vs. 104.1 hours for placebo.
NIH planning Phase I Ebola vaccine trial
NIH plans to start a Phase I trial in September to evaluate an Ebola virus vaccine, with data expected by January 2015. The plans come in the wake of a worsening outbreak of Ebola in West Africa. According to the World Health Organization, at least 729 deaths this year have been attributed to the virus, including 57 deaths reported July 24-27. NIH said it hopes to give the vaccine to health workers in affected African countries "as early as 2015" if it proves safe and effective. The vaccine -- a non-replicating chimpanzee adenovirus vector containing two Ebola genes -- was designed by researchers at the Vaccine Research Center at NIH's National Institute of Allergy and Infectious Diseases.
FDA approves Lumizyme for infantile Pompe's, says comparable to Myozyme
FDA expanded the label of Lumizyme alglucosidase alfa from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to include treatment of all patients with Pompe's disease. The agency also lifted a REMS that ensured the drug was used only in its previously approved population -- patients ages 8 and up who do not have evidence of cardiac hypertrophy. The product is recombinant human acid alpha glucosidase enzyme (rhGAA).
FDA approves Boehringer's Jardiance
FDA approved Jardiance empagliflozin from Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type II diabetes. The company said it plans to launch the sodium-glucose cotransporter 2 (SGLT2) inhibitor in the U.S. as soon as possible. Boehringer resubmitted an NDA for Jardiance in June after receiving a complete response letter for the product in March. According to Boehringer and partner Eli Lilly and Co. (NYSE:LLY), FDA had cited "previously observed deficiencies" at a manufacturing facility in the complete response. The European Commission approved Jardiance in May.
Kyowa submits application in Japan for antithrombin product
Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) submitted an application to Japan's Ministry of Health, Labor and Welfare (MHLW) for KW-3357 to treat thrombophilia due to congenital antithrombin deficiency and disseminated intravascular coagulation accompanied by a reduction in antithrombin. This is the first submission for the recombinant antithrombin.
Goolsbee steps down as Sarepta chair
Sarepta Therapeutics Inc. (NASDAQ:SRPT) said William Goolsbee stepped down as chairman but will remain a director. Director John Hodgman is serving as interim chair. Goolsbee has been a Sarepta director since October 2007 and became chair in June 2010. Hodgman -- EVP of finance and CFO of InterMune Inc. (NASDAQ:ITMN) -- has been on Sarepta's board since March 2004. Both Goolsbee and Hodgman are part of the board's audit and compensation committees. The only non-independent director on Sarepta's seven-member board is President and CEO Chris Garabedian.
Loxo raises $68.4 million in IPO
Loxo Oncology Inc. (NASDAQ:LOXO) raised $68.4 million through the sale of 5.3 million shares at $13 in a bumped-up IPO. The price values the company at $207.2 million. Last month, the company amended the offering to sell 4.4 million shares at $12-$14. At $13, the company would have raised $57 million and been valued at $195.8 million. Existing investor New Enterprise Associates purchased 230,769 shares for about $3 million in a concurrent private placement. Loxo's LOXO-101 is in Phase I testing to treat advanced solid tumors. Data are expected early next year. Loxo has exclusive, worldwide rights to the neurotrophic tyrosine kinase receptor 1 (NTRK1;TrkA) inhibitor from Array BioPharma Inc. (NASDAQ:ARRY). Cowen; Stifel; Oppenheimer; and JMP Securities are underwriters.
MacroCure raises $53.5 million in IPO
Israeli biotech regenerative medicine company MacroCure Ltd. (NASDAQ:MCUR) raised $53.5 million through the sale of 5.4 million shares at $10 in an IPO underwritten by Credit Suisse; Jefferies; Nomura; and Oppenheimer. The IPO priced valued MacroCure at $161.8 million. Last month, the company said it planned to sell 5.4 million shares at $13-$15.
Gen9 raises $25 million in undisclosed venture round
Synthetic biology company Gen9 Inc. (Cambridge, Mass.) raised $25 million from undisclosed investors in an undisclosed venture round. CEO Kevin Munnelly confirmed that the $25 million is in addition to a $21 million series C round raised from tool company Agilent Technologies Inc. (NYSE:A) in April 2013 (see BioCentury Extra, April, 24, 2013).
POLITICS & POLICY
Senators want HHS to release biosimilars guidance
Five Republican senators sent a letter to HHS Secretary Sylvia Burwell asking the agency to release an FDA draft guidance on biosimilar naming that is awaiting HHS clearance before it can be released for stakeholder comment. In the letter, the senators -- Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Mike Enzi (R-Wyo.), Orrin Hatch (R-Utah) and Pat Roberts (R-Kan.) -- also questioned whether FDA intends to approve the first biosimilar before policies on "key scientific questions" are released.
Brookings releases framework for compassionate use
The Engelberg Center for Health Care Reform at the Brookings Institution released a paper that lays out principles for compassionate access to experimental medicines. The paper outlines an industry-wide structure addressing how patients, healthcare providers, and FDA should navigate the process.
Pfizer and Roche join ADDPLAN DF consortium
Pfizer Inc. (NYSE:PFE) and Roche (SIX:ROG; OTCQX:RHHBY) joined the ADDPLAN DF consortium, which is seeking to develop new statistical methods for designing dose-finding trials. Aptiv Solutions (Reston, Va.), Eli Lilly and Co. (NYSE:LLY), Johnson & Johnson (NYSE:JNJ), and Novartis AG (NYSE:NVS; SIX:NOVN) formed the consortium to develop new statistical methods for the design of dose-finding trials. In February, the group said it would start by developing an adaptive version of existing multiple comparison procedure modeling (MCP-Mod) software for optimizing dose selection for Phase III testing (see BioCentury, Feb. 24).