CHMP backs Zydelig, Imbruvica
EMA's CHMP issued positive opinions for several drugs on Friday, including Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) and Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and partner Johnson & Johnson (NYSE:JNJ). The committee backed approval of Zydelig in combination with rituximab to treat chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy and as first-line therapy in patients with 17p deletion or tumor protein p53 (TP53; p53) mutation who are unsuitable for chemo immunotherapy. CHMP also backed the small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta as monotherapy to treat follicular lymphoma (FL) that is refractory to two prior lines of treatment. FL is a type of indolent non-Hodgkin's lymphoma (NHL).
Ocular, Innocoll take haircuts to get out IPO door
Ocular Therapeutix Inc. (NASDAQ:OCUL) and Innocoll GmbH (NASDAQ:INNL) priced IPOs on Friday. Ocular raised $65 million through the sale of 5 million shares at $13. The price values the company at $267.4 million. Earlier this month, the company amended the offering to sell 5 million shares at $14-$16. At the $15 midpoint, the company would have raised $75 million and been valued at $308.5 million. Morgan Stanley; Cowen; RBC Capital; and Oppenheimer are underwriters. Ocular's OTX-DP, a hydrogel-based punctum plug that delivers sustained- and tapered-release dexamethasone over one month, is in Phase III testing to treat pain and inflammation associated with cataract surgery. Data are expected in 1Q15.
Applied Genetic raises $30 million in follow-on
Rare ophthalmic disease company Applied Genetic Technologies Corp. (NASDAQ:AGTC) raised $30 million through the sale of 2 million shares at $15 in a follow-on underwritten by BMO Capital Markets; Stifel; Wedbush PacGrow; Cantor Fitzgerald; and Roth Capital Partners. Applied Genetic proposed the follow-on July 11, when its share price was $19.07.
Nexavar misses in Phase III breast cancer trial
Onyx Pharmaceuticals Inc. and Bayer AG (Xetra:BAYN) said Nexavar sorafenib plus capecitabine missed the primary endpoint of improving progression-free survival (PFS) vs. placebo plus capecitabine in the Phase III RESILIENCE trial to treat locally advanced or metastatic breast cancer. The double-blind, international trial enrolled 537 patients with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline is not indicated. The partners could not be reached for next steps for Nexavar in the indication.
POLITICS & POLICY
EU data protection regulations could hinder cancer research
The draft EU General Data Protection Regulation could make cancer research "unworkable" by adding a significant administrative burden, according to a position paper published by the European Society for Medical Oncology (ESMO) on Friday. In March, the European Parliament published its position on the proposed regulation, which would set the rules under which personal data are to be handled in the EU, including for health and research use.
NIH announces new Common Fund programs
NIH announced three new Common Fund programs focusing on emerging biotechnology research that could have a "transformative impact in five to 10 years." NIH told BioCentury it plans to spend $248 million on the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program, which will develop high resolution neural circuit maps and neural implants that can stimulate nerves.