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BioCentury Extra
As published Wednesday, February 25, 2015 6:23 PM PST

  • FDA approves Avycaz for cUTIs and cIAI

    FDA approved an NDA for Avycaz ceftazidime/avibactam from Actavis plc (NYSE:ACT) to treat complicated urinary tract infections (cUTIs) and in combination with metronidazole to treat complicated intra-abdominal infections (cIAIs), both of which are caused by Gram-negative pathogens. FDA said the drug should be limited to patients who have few or no alternative treatment options. Actavis plans to launch Avycaz in the second quarter.

    The product is a combination of the third-generation cephalosporin ceftazidime and avibactam, which is a broad-spectrum beta lactamase (LACTB) inhibitor. Avycaz has Qualified Infectious Disease Product (QIDP) designation and was under Priority Review.

    FDA based its approval in part on existing data for ceftazidime, an approved drug, and in vitro data and animal models in which avibactam was tested. The agency said Avycaz was also studied in two Phase II trials that were "not designed with any formal hypotheses for inferential testing against the active comparators."

    Actavis and AstraZeneca plc (LSE:AZN; NYSE:AZN) are jointly developing Avycaz. Actavis has rights to commercialize it in North America; AZ has rights elsewhere. Actavis obtained the drug via its 2014 acquisition of Forest Laboratories Inc.

  • FDA delays meeting to discuss Remicade biosimilar

    FDA's Arthritis Advisory Committee postponed a meeting that had been scheduled for March 17 to discuss a BLA from Celltrion Inc. (KOSDAQ:068270) for CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). FDA said the postponement was "due to information requests pending" with Celltrion. The agency did not announce a new date.

    Celltrion said its application for CT-P13 is the first for a biosimilar mAb in the U.S. FDA will ask the committee to discuss use of the humanized mAb against tumor necrosis factor (TNF) alpha to treat rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis (see BioCentury Extra, Feb. 9).

    Last September, Celltrion and Hospira Inc. (NYSE:HSP) amended their 2009 partnership, giving Hospira exclusive rights to market the biosimilar in the U.S., Canada and other undisclosed territories (see BioCentury Extra, Feb. 23, 2014).

    In Europe, the companies have a co-exclusive agreement which allows Hospira and Celltrion each to market the biosimilar under their own brands. The European Commission approved CT-P13 in September 2013. This month, Hospira launched its biosimilar as Inflectra in 10 new European markets; Inflectra is now available in 24 European countries. On Tuesday, Celltrion launched its biosimilar as Remsima in 12 European countries (see BioCentury Extra, Feb. 24).

  • After cuts, Pfizer looks to gene therapy, immuno-oncology

    Pfizer Inc. (NYSE:PFE) said it will cut an undisclosed number of R&D jobs at its Cambridge, Mass., and Collegeville, Pa., facilities. Pfizer spokesperson Dean Mastrojohn declined to say which R&D areas would be cut. The company plans to reallocate resources to areas including immuno-oncology and gene therapy.

    In December 2014, Pfizer created a gene therapy unit within its rare disease research area and announced a deal with Spark Therapeutics Inc. (NASDAQ:ONCE) to develop gene therapies to treat hemophilia B (see BioCentury Extra, Dec. 8, 2014).

    Last summer, the pharma partnered with immuno-oncology company Cellectis S.A. (Euronext:ALCLS) to develop allogeneic chimeric antigen receptor (CAR) T cell therapies (see BioCentury, July 14, 2014).

  • G-BA backs J&J's Sylvant

    Germany's Federal Joint Committee (G-BA) concluded that Sylvant siltuximab from Johnson & Johnson (NYSE:JNJ) provides added benefit for patients with multicentric Castleman's disease (MCD) who are HIV-negative and human herpes virus 8 (HHV-8)-negative, the drug's approved indication.

    The committee said the extent of the drug's benefit could not be quantified. G-BA estimated that 130-1,460 patients could benefit from the chimeric mAb against IL-6.

    Sylvant has Orphan Drug status in the EU and the U.S. to treat MCD, a B cell proliferative disorder that affects groups of lymph nodes in different anatomical areas. Castleman's disease is not malignant but is chronically debilitating, and can be fatal because of systemic inflammation.

    The European Commission approved Sylvant in June 2014; FDA approved it in April 2014 (see BioCentury Extra, June 4, 2014).

  • Management tracks

    GTx Inc. (NASDAQ:GTXI) hired Robert Wills as executive chairman and chair of its board's Scientific & Development Committee, effective March 2. Wills is retiring as vice president, alliance manager at Johnson & Johnson (NYSE:JNJ), a position he had held since 2002. GTx Chairman J.R. Hyde will become the board's lead director.

    Epic Sciences Inc. (La Jolla, Calif.) hired Chris Bernard as Chief Commercial Officer. Bernard was SVP of sales and marketing at Metabolon Inc. (Durham, N.C.).

    Charles River Laboratories International Inc. (NYSE:CRL) said Corporate EVP and CFO Thomas Ackerman will retire in February 2016. David Smith, the company's corporate SVP of global discovery services, will succeed Ackerman.

    Turing Pharmaceuticals AG (New York, N.Y.), a newco launched by former Retrophin Inc. (NASDAQ:RTRX) CEO Martin Shkreli, hired Michael Harrison as CFO; Nancy Retzlaff as CCO; and Howard Dorfman as SVP, general counsel. Harrison was Retrophin's corporate comptroller. Retzlaff is VP of global marketing/commercial at Mesoblast Ltd. (ASX:MSB; Pink:MBLTY). Dorfman was VP, general counsel at Ferring Pharmaceuticals A/S (Saint-Prex, Switzerland). Shkreli is Turing's executive chairman.

  • Funding roundup: Actavis, Xencor, Curis, Celldex, AMAG

    Actavis plc (NYSE:ACT), Xencor Inc. (NASDAQ:XNCR), Curis Inc. (NASDAQ:CRIS), Celldex Therapeutics Inc. (NASDAQ:CLDX) and AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) raised more than $8.9 billion in follow-on offerings on Wednesday.

    Actavis raised $8.4 billion through simultaneous offerings of ordinary and convertible preferred shares. The specialty pharma raised $3.8 billion through the sale of 13.2 million ordinary shares at $288 and $4.6 billion through the sale of 4.6 million shares of 5.5% mandatory convertible preferred shares at $1,000. JPMorgan; Mizuho; Wells Fargo; Morgan Stanley; Barclays; and Citigroup were underwriters. Actavis proposed the offerings premarket on Feb. 19, when its shares were valued at $284. The stock gained $1.29 to $290.40 on Wednesday. Actavis is acquiring Allergan Inc. (NYSE:AGN) (see BioCentury Extra, Nov. 17, 2014).

    Antibody play Xencor raised $106.9 million through the sale of 7.5 million shares at $14.25. Leerink; Wedbush PacGrow; and Oppenheimer were underwriters. Xencor proposed the offering after market close on Monday, when its shares closed at $15.32. Xencor picked up $0.59 to $15.10 on Wednesday.

    Cancer company Curis raised $60 million through the sale of 21.8 million shares at $2.75. Cowen; RBC Capital Markets; Baird; and Roth Capital Partners were underwriters. The company proposed its offering after market on Tuesday; the stock gained $0.36 (13%) to $3.16 on Wednesday.

    Antibody and vaccine developer Celldex raised $174 million through the sale of 7.3 million shares at $24. Jefferies; Leerink; Guggenheim Securities; Oppenheimer; Brean Capital; Cantor Fitzgerald; and Roth Capital Partners were underwriters. Celldex proposed the offering Tuesday after market close; the stock lost $0.50 to $24.96 on Wednesday.

    Hematology company AMAG raised $175 million through the sale of 4 million shares at $44. JPMorgan; Deutsche Bank; Cowen; and Baird were underwriters. AMAG proposed the offering on Tuesday after market close; AMAG gained $0.89 to $45.07 on Wednesday.

  • Uptake of Orexigen's Contrave outpaces rivals

    Orexigen Therapeutics Inc. (NASDAQ:OREX) said net U.S. sales of weight-loss drug Contrave naltrexone/bupropion were $6.5 million in 4Q14, its first quarter on the market.

    Partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) launched the fixed-dose combination of naltrexone sustained release (SR) and bupropion SR on Oct. 20. FDA approved Contrave in September as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with co-morbidities (see BioCentury Extra, Sept. 10, 2014).

    Contrave's uptake in the U.S. was stronger than uptake of competing obesity drugs' in their first full quarters on the market. In 4Q12, Vivus Inc. (NASDAQ:VVUS) reported net revenues of $2 million for Qsymia, a low-dose combination of phentermine and topiramate. Belviq lorcaserin from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) and Eisai Co. Ltd. (Tokyo:4523), a serotonin (5-HT2C) receptor agonist, had net sales of $5.4 million in 3Q13.

    Qsymia net sales were $12.7 million in 4Q14, while Belviq's were $16.8 million in 3Q14. Arena will report 4Q14 sales Monday, March 2.

    FDA also approved Saxenda liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) in December 2014 to treat obesity (see BioCentury Extra, Dec. 23, 2014).

    Orexigen gained $0.03 to $5.85 on Wednesday.

  • Permanent R&D tax credit bill reintroduced in Senate

    Sens. Tom Carper (D-Del.) and Pat Toomey (R-Pa.) reintroduced a bill that would increase and make permanent the alternative simplified R&D tax credit. The bill would increase the tax credit to 25% from the 14% credit that expired last year and enable CROs to claim a portion of the credit. Carper introduced a similar bill last July (see BioCentury Extra, July 31, 2014).

    The bill is known as the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation, or COMPETE Act.

  • Market Entry Strategy and Planning with Campbell Alliance

    Find a commercialization partner, or go it alone? This decision involves not only strategic questions regarding a company's identity and core competencies, but also multiple value drivers that are easy to overlook. This article examines how a value-based approach can help companies position themselves to ensure their business plans contribute to a product's success and an improved return on investment. Download your copy now!

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