Novartis, GSK swapping assets
Novartis AG (NYSE:NVS; SIX:NOVN) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) announced multi-billion dollar deals that will see the pharmas sell assets to one another. Novartis will bolster its portfolio of marketed cancer drugs and GSK will bulk up its vaccine business. The pharmas also will create a JV focused on OTC. Novartis was up $1.10 to $86.56 on Tuesday, while GSK gained 81p to 1,640p in London and $2.18 to $55.30 in New York.
Pharma deals pump biotech, pharma indices
A slew of multi-billion pharma deals helped biotech and pharma indices post better gains than the broader markets on Tuesday. The BioCentury 100 index gained 4.1%, the NASDAQ Biotechnology index was up 3.2%, the NYSE Arca Biotechnology index gained 3% and the NYSE Arca Pharmaceutical index closed up 1.5%. The NASDAQ was up 1% on the day and the S&P and Dow Jones Industrial Average were both up 0.4%.
Sovaldi sales hit $2.3 billion in first full quarter
Gilead Sciences Inc. (NASDAQ:GILD) reported 1Q14 earnings late Tuesday, including $2.3 billion in sales of Sovaldi sofosbuvir in the HCV drug's first full quarter on the market. According to Deutsche Bank's Robyn Karnauskas, the Street was expecting $1 billion. Gilead said $2.1 billion of the sales were in the U.S., with the balance mostly in Germany and France. Gilead launched the drug in the U.S. in December and in Europe earlier this year.
Amgen misses Street
Amgen Inc. (NASDAQ:AMGN) reported 1Q14 adjusted diluted EPS of $1.87, missing by $0.07 the Street's estimate of $1.94 and down from $1.96 in 1Q13. First quarter revenues increased 7% to $4.5 billion, but missed the Street's $4.8 billion estimate. Amgen reiterated its 2014 revenue guidance of $19.2-$19.6 billion and adjusted EPS guidance of $7.90-$8.20. The Street was expecting full-year EPS of $8.16 on $19.6 billion in revenues.
Retinal disorder play Avalanche raises $55 million
Avalanche Biotechnologies Inc. (Menlo Park, Calif.) raised $55 million in a series B round from new investors Venrock; Deerfield; Adage Capital Management; Redmile Group; Rock Springs Capital; Sabby Capital; an undisclosed affiliate of Cowen; and two undisclosed healthcare funds. Undisclosed existing investors also participated. Cowen was placement agent for the round.
Cancer diagnostics play Guardant raises $30 million
Guardant Health Inc. (Redwood City, Calif.) raised $30 million in a series B round led by new investor Khosla Ventures. Existing investor Sequoia Capital and new investor Pejman Mar Ventures also participated. In February, Guardant launched its Guardant360 test, a non-invasive blood test that detects major classes of tumor genetic alterations to aid in treatment decisions. The test sequences cell-free DNA from tumors and is performed at Guardant's CLIA-certified lab. Khosla's Samir Kaul will join Guardant's board.
Principia secures $50 million in B round
Principia Biopharma Inc. (South San Francisco, Calif.) raised an undisclosed amount in the first tranche of a $50 million series B round led by new investor Sofinnova Ventures. Existing investors Morgenthaler Ventures; New Leaf Venture Partners; OrbiMed; SR One; and Mission Bay Capital also participated. Sofinnova's Srinivas Akkaraju joined Principia's board.
Sarepta planning $100 million follow-on
Sarepta Therapeutics Inc. (NASDAQ:SRPT) proposed late Tuesday to raise up to $100 million in a follow-on underwritten by BofA Merrill Lynch and Morgan Stanley. On Monday, Sarepta jumped $9.58 (39%) to $33.98 after the company said it plans to submit an NDA to FDA for eteplirsen (AVI-4658) to treat Duchenne muscular dystrophy (DMD) by year end. In November, the company fell after saying approval of eteplirsen could be delayed by at least two years (see BioCentury Extra, April 21).
Valeant makes bid to merge with Allergan
Allergan Inc. (NYSE:AGN) gained $21.65 (15%) to $163.65 on Tuesday after Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) made public an unsolicited offer to merge with Allergan in a cash and stock deal that would value Allergan at about $47 billion based on 307.6 million shares outstanding as of Feb. 20. Under Valeant's proposal, Allergan shareholders would receive $48.30 in cash and 0.83 Valeant shares for each share held, which values Allergan at about $152.89 per share based on Valeant's close of $126.01 in New York on Monday, before the offer was made public.
Biocad's rituximab biosimilar approved in Russia
Biocad (St. Petersburg, Russia) said the Russian Ministry of Health approved the company's AcellBia (BCD-20), a biosimilar of autoimmune and cancer drug rituximab. Biocad said AcellBia is the first mAb biosimilar to be approved in Russia. The company could not be reached for details. Biogen Idec Inc. (NASDAQ:BIIB) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) co-market rituximab as Rituxan in the U.S. Roche markets the chimeric mAb against CD20 antigen as MabThera elsewhere.
NICE rebuffs Kadcyla
The U.K.'s NICE issued draft guidance recommending against the use of Kadcyla trastuzumab emtansine from Roche (SIX:ROG; OTCQX:RHHBY) to treat HER2-positive, unresectable, locally advanced or metastatic breast cancer in patients previously treated with the pharma's Herceptin trastuzumab and a taxane -- Kadcyla's approved indication in the EU. The committee said the most plausible incremental cost-effectiveness ratio (ICER) for Kadcyla compared to Tyverb lapatinib plus Roche's Xeloda capecitabine was L185,000 ($311,022) per quality-adjusted life year (QALY) gained, above the limit normally considered cost-effective. Roche did not submit a patient access scheme. Comments are due May 19. Kadcyla is a humanized mAb against HER2 linked to a DM1 cytotoxic agent from ImmunoGen Inc. (NASDAQ:IMGN).
AbbVie submits NDA for all-oral HCV regimen
AbbVie Inc. (NYSE:ABBV) submitted an NDA to FDA for its all-oral regimen comprising ABT-450 plus the company's Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype 1 infection. The regimen has breakthrough therapy designation from FDA. AbbVie plans to submit an MAA to EMA for the regimen in early May.
Advisory committee rebuffs MoxDuo IR
FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 14-0 against approval of MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) to treat moderate to severe acute pain. The panel also voted unanimously that the company did not provide evidence that MoxDuo IR is safer than its individual components at comparable doses. MoxDuo IR, an immediate-release combination of oxycodone and morphine, has a May 25 PDUFA date (see BioCentury Extra, April 18).
POLITICS & POLICY
FDA to hold meeting on opioid postmarketing requirements
FDA is holding a public meeting on May 19-20 to obtain stakeholder input on the design and conduct of postmarketing requirements for extended-release and long-acting opioids. In September, FDA announced classwide labeling changes and new postmarketing study requirements to assess abuse and other risks. The agency is holding the meeting to obtain input on the studies for manufacturers of extended-release and long-acting opioids, who are required to submit final protocols for the new postmarketing requirements by August. The new postmarketing requirements include at least one study to quantitatively estimate the risks of misuse, abuse, addiction, overdose and death, as well as a trial to evaluate the risk of developing hyperalgesia, or increased sensitivity to pain (see BioCentury Extra, Sept. 10, 2013).
FDA finalizes guidance on Orphan mAb sameness
FDA published final guidance on how the agency determines the sameness of mAbs under the Orphan Drug Act. The final guidance now explicitly states that FDA "does not intend to apply the considerations discussed in this guidance to determinations under the [Biologics Price Competition and Innovation] Act."
Blum leaving CMS
CMS Administrator Marilyn Tavenner announced in an internal memo that Jonathan Blum, principal deputy administrator, is departing the agency May 16. CMS declined to disclose details on his next steps or successor. Blum joined CMS in 2009 and became principal deputy administrator in August. Prior to that, he served as deputy administrator and director of CMS's Center for Medicare.