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BioCentury Extra
As published Friday, July 25, 2014 4:44 PM PST

  • 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).

    The CHMP recommendation for Zydelig comes on the heels of FDA approval of the drug to treat CLL and FL as well as small lymphocytic lymphoma (SLL), also a type of indolent NHL (see BioCentury Extra, July 23).

    CHMP also backed approval of Imbruvica to treat relapsed or refractory mantle cell lymphoma (MCL), CLL in patients who have received at least one prior therapy and as first-line therapy in patients with 17p deletion or TP53 mutation who are unsuitable for chemo immunotherapy. The Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 has accelerated approval in the U.S. to treat CLL and MCL in patients who have received more than one prior therapy.

    Gilead was off $0.70 to $89.84 on Friday. Pharmacyclics was up $0.32 to $104.82.

  • 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.

    Innocoll raised $58.5 million through the sale of 6.5 million ADSs at $9. The price values the company at $178.3 million. Earlier this month, the company amended the offering to sell 5.4 million ADSs at $13-$15. At the $14 midpoint, Innocoll would have raised $74.9 million and been valued at $261.3 million. One ordinary share represents 13.25 ADSs. Piper Jaffray; Stifel; and JMP Securities are underwriters. This half, Innocoll plans to start Phase III testing of XaraColl to treat postoperative pain and Cogenzia to treat diabetic foot infections. XaraColl is a biodegradable and fully bioresorbable collagen/bupivacaine matrix developed using the company's CollaRx drug delivery technology. Cogenzia is a topical bioresorbable collagen sponge with gentamicin sulfate.

    On their first days of trading Friday, Ocular was up $0.15 to $13.15, and Innocoll was unchanged at $9.

  • 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.

    Applied Genetic is developing gene therapies using viral vectors to deliver genes to patients with severe inherited Orphan diseases in ophthalmology. The company's most advanced lead compound is slated to enter a Phase I/II trial to treat X-linked retinoschisis (XLRS), with data expected in mid-2015. XLRS is caused by mutations in the retinoschisis X-linked juvenile 1 (RS1; XLRS1) gene.

    Applied Genetic -- which raised $57.5 million in an IPO through the sale of shares at $12 earlier this year -- was up $2.38 (15%) to $17.99 on Friday.

  • 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.

    Nexavar is approved for hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) in more than 100 countries. The inhibitor of CRAF (RAF1) and multiple receptor tyrosine kinases is also approved in the U.S., Japan and Canada to treat differentiated thyroid carcinoma. Bayer and Onyx, now part of Amgen Inc. (NASDAQ:AMGN), have a worldwide co-development agreement for Nexavar outside of Japan, where Bayer owns rights.

    Amgen was up $0.58 to $122.84 on Friday.

  • 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.

    ESMO said the Parliament's proposed wording requiring "explicit and specific patient consent" could have unintended consequences because it would require researchers to continuously ask patients to re-consent each time new research is planned using available data or tissue samples. ESMO recommends that the regulation instead allow patients to "donate" their data through a one-time consent process, which could then be withdrawn at any time. The EU adopted Clinical Trial Regulations in 2014 that also include a withdrawable one-time consent, ESMO said.

    "We are calling upon the European Union to assure that all forms of public health research will survive and be able to function within the safeguards that are in place, without adding the nearly impossible administrative burden of re-consenting each patient, every time, for every single project," said Paolo Casali, ESMO Public Policy committee chair and author of the ESMO position paper.

    The data protection regulation, which was introduced in 2012, is now awaiting a decision from the Council of the EU. The Parliament, Council and European Commission must negotiate and agree on the terms of the regulation.

  • 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.

    NIH said it does not yet have budgets for the other two programs: 4D Nucleome and Glycoscience. The 4D Nucleome will determine temporal and spatial importance of DNA nuclear organization and the role it plays in gene expression and cellular function. The Glycoscience program will develop resources to determine the importance of protein glycosylation.

    NIH has not determined how funds will be appropriated, but NIH's Common Fund program is designed to support collaborative research between NIH institutes or centers.

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