Sanofi, UCB in deal for immune-mediated diseases
Sanofi (Euronext:SAN; NYSE:SNY) and UCB Group (Euronext:UCB) partnered to jointly discover and develop oral small molecules targeting undisclosed pathways to treat immune-mediated diseases. The partners will use an approach developed by UCB to identify modulators of the pathway, for which the partners said biologics "have proven highly efficacious." UCB said the partners expect to identify a lead preclinical compound "shortly." UCB is eligible to receive more than EUR 100 million ($139 million) from Sanofi in an undisclosed upfront and milestone payments. The partners will split costs and profits evenly.
Chimerix, FDA agree on trial for brincidofovir
Late Tuesday, infectious disease company Chimerix Inc. (NASDAQ:CMRX) said it and FDA agreed on an open-label pilot trial to provide access to the biotech's brincidofovir (CMX001) to treat adenovirus infections in immunocompromised patients. Chimerix said it is also working with the agency on the design of a pivotal Phase III trial that would be a continuation of the open-label trial, which will enroll 20 patients. The first patient in the trial will be pediatric cancer patient Josh Hardy, who developed an adenovirus infection after a bone marrow transplant. An IV drug marketed for adenovirus infections led to kidney damage, and Hardy's doctors at St. Jude's Children's Research Hospital petitioned Chimerix for compassionate-use access to the company's oral brincidofovir.
Senators ask Sebelius to overturn Zohydro approval
Sen. Joe Manchin (D-W.Va.) became the second senator to call for HHS Secretary Kathleen Sebelius to overturn FDA's approval of Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX) because of the pain drug's "high potential for abuse." Last week, Sen. Charles Schumer (D-N.Y.) also sent a letter to Sebelius asking HHS to overturn Zohydro's approval. HHS said it will respond.
Nexavar as adjuvant misses in Phase III HCC trial
Bayer AG (Xetra:BAYN) and partner Onyx Pharmaceuticals Inc. said twice-daily oral Nexavar sorafenib as adjuvant treatment missed the primary endpoint of improving recurrence-free survival vs. placebo in the Phase III STORM trial to prevent recurrence of hepatocellular carcinoma (HCC). The double-blind, international trial enrolled about 1,100 HCC patients who had no detectable disease after surgical resection or local tumor ablation.
Zybrestat meets in Phase II ovarian cancer trial
OxiGene Inc. (NASDAQ:OXGN) said IV Zybrestat fosbretabulin plus Avastin bevacizumab every three weeks met the primary endpoint of improving progression-free survival (PFS) vs. Avastin alone in the Phase II GOG 186I trial to treat recurrent ovarian cancer (HR=0.685, p<0.05). The combination missed the secondary endpoint of improving objective response rate (ORR) vs. Avastin alone. The open-label, U.S. trial enrolled 107 patients with platinum-sensitive and -resistant recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. The Gynecologic Oncology Group (GOG) conducted the trial, which was sponsored by NIH's National Cancer Institute (NCI). OxiGene said it is evaluating next steps for the combination, but could not be reached for details.
Glycotope raises EUR 55 million
Glycotope GmbH (Berlin, Germany) raised EUR 55 million ($76.4 million) in a venture round from existing investors Jossa Arznei GmbH and Eckert Life Science Accelerator. Glycotope uses its glycosylation technologies to enhance the biological activity of both new and marketed therapeutic antibodies through the optimization of the proteins' glycosylation structures.
Lumena secures $45 million in series B
Lumena Pharmaceuticals Inc. (San Diego, Calif.) secured $45 million in a series B round led by new investor New Enterprise Associates. New investors Adage Capital Management and RA Capital Management also participated, along with existing investors Pappas Ventures; RiverVest Venture Partners; and Alta Partners. NEA's Ed Mathers will join Lumena's board.
Exosome Diagnostics raises $27 million in series B
Exosome Diagnostics Inc. (New York, N.Y.) raised $27 million in the initial close of a series B round co-led by new investors Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN); and Arcus Ventures. New investors Tiger Partners; CD Ventures; and Monashee Capital also participated, along with existing investors NGN Capital and Forbion Capital Partners. Exosome said it could raise up to $40 million in the round. Arcus' Steven Soignet will join Exosome's board.
TG Therapeutics raises $18.1 million
TG Therapeutics Inc. (NASDAQ:TGTX) raised $18.1 million through the sale of 2.7 million shares at $6.71 in a private placement to JPMorgan Asset Management's Global Healthcare Fund. Ladenburg Thalmann underwrote the offering. TG's ublituximab (TG-1101) is in an open-label Phase II trial to treat chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) in combination with Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and Johnson & Johnson (NYSE:JNJ). Ublituximab is a chimeric mAb against CD20.
Versartis amends IPO
Versartis Inc. (Redwood City, Calif.) amended its IPO on NASDAQ and now plans to sell 4.6 million shares at $16-$19. At the $17.50 midpoint, the company would raise $80.5 million and be valued at $382.5 million. Morgan Stanley; Citigroup; Cowen; and Canaccord are underwriters. Last month, Versartis raised $55 million in a series E round and filed to raise up to $80 million in the IPO (see BioCentury Extra, Feb. 18).
Liver company Vital revives IPO plans
Vital Therapies Inc. (San Diego, Calif.) revitalized plans for an IPO on NASDAQ. The company postponed its IPO in November, citing market conditions. On Tuesday, Vital filed an S-1A that no longer contains a share price or proposed number of shares. BofA Merrill Lynch; Credit Suisse; William Blair; and Canaccord are listed as underwriters.
POLITICS & POLICY
IMI launches GETREAL project
Europe's Innovative Medicines Initiative launched the GETREAL project to help companies generate real-world data for payers during the drug development process, along with the clinical data necessary for regulatory approval. Topics for the project include designing clinical trials that generate real-world effectiveness data and developing tools and methods that measure a drug's effectiveness during a trial in a way that reflects clinical practice. Other stakeholders -- including patient groups, health technology assessment (HTA) agencies and payers -- will also provide input and will be part of a network of "healthcare decision makers."
Controversial pediatric research bill goes to Obama
The U.S. Senate passed the Kids First Research Act (H.R. 2019), which would eliminate the options for taxpayers to fund presidential campaigns and party conventions and create a pediatric research fund managed by NIH's Common Fund. The bill authorizes $13 million per year through FY24 for the research fund. Some legislators and pediatric research advocates have expressed opposition to the bill, noting that the fund does little to offset sequestration and that the funds would still be subject to NIH's existing spending caps and would not provide the agency any additional funding beyond its authorized budget, instead diverting funds from other NIH programs.
ASCO projects rise in cancer care costs
The American Society of Clinical Oncology projected annual costs for cancer care in the U.S. will increase to more than $173 billion in 2020, up from $104 billion in 2006, in part due to the cost of new therapies. In an annual report on trends in cancer care in the U.S., ASCO said oncologists need to reduce the use of unnecessary or ineffective cancer treatments, tests and procedures. The group also said patients, payers and providers should work together on how to define and measure value in cancer care. The U.S. cancer care system will also be strained by an increase in the number of cancer patients coupled with fewer oncologists, according to the report.