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BioCentury Extra
As published Friday, July 22, 2016 4:30 PM PST

  • Puma rises on neratinib survival data, NDA submission

    Puma Biotechnology Inc. (NYSE:PBYI) jumped $7 (20%) to $41.52 on Friday after the company disclosed interim five-year disease-free survival (DFS) data from the Phase III ExteNET trial of oral neratinib (PB272) and said it had submitted an NDA to FDA for the breast cancer therapy.

    On a conference call after market hours Thursday, President and CEO Alan Auerbach said the new ExteNET data seem to show a durable DFS benefit, countering a perception that the benefit "appeared to be contracting" over time. Puma conducted the analysis, which was neither pre-specified nor requested by FDA, to evaluate the durability of responses to neratinib.

    ExteNET is evaluating neratinib as an adjuvant treatment for HER2-positive early stage breast cancer previously treated with Herceptin trastuzumab. Puma previously said neratinib met the trial's primary DFS endpoint at two years vs. placebo, with two-year invasive DFS rates of 93.9% for neratinib and 91.6% for placebo. That represented a 33% reduction in risk of recurrence or death.

    The new analysis found that in 2,840 evaluable patients, five-year invasive DFS rates were 90.4% for neratinib and 87.9% for placebo, representing a 26% risk reduction (HR=0.74, p=0.017).

    Auerbach said older data from the study showed smaller absolute DFS benefits sequentially at two, three and four years. In the new analysis that included more patients, he said the absolute DFS benefit "appears to be consistent over time," with 2.2% at three years, 2.2% at four years and 2.5% at five years. The company plans to present full five-year DFS data next year.

    Also late Thursday, Puma said it submitted an NDA to FDA for neratinib. Puma had delayed the submission after FDA requested the company rewrite clinical sections (see BioCentury Extra, March 29).

    Both the NDA and an MAA that Puma submitted to EMA last month contain the five-year invasive DFS data.

    The company has exclusive, worldwide rights to neratinib from Pfizer Inc. (NYSE:PFE). It is an oral inhibitor of HER1, HER2 and HER4 kinases.

    Puma shares traded above $275 in 3Q14, a few weeks after it said neratinib met ExteNET's primary endpoint. Concerns about the candidate's side effects and the broader biotech selloff have contributed to its decline (see BioCentury Extra, July 22, 2014).

  • CHMP backs pair of RCC drugs

    On Friday, EMA's CHMP recommended approval of two drugs to treat advanced renal cell carcinoma in patients previously treated with a VEGF inhibitor. The committee recommended Kisplyx lenvatinib from Eisai Co. Ltd. (Tokyo:4523) in combination with Afinitor everolimus, and Cabometyx cabozantinib from Exelixis Inc. (NASDAQ:EXEL) as a monotherapy. Ipsen Group (Euronext:IPN) holds Cabometyx's rights outside the U.S., Canada and Japan.

    Kisplyx is an inhibitor of multiple VEGF receptor tyrosine kinases. Cabometyx is a tablet formulation of cabozantinib, a spectrum-selective kinase inhibitor of VEGF receptor 2 (VEGFR-2;KDR/Flk-1) and c-Met receptor tyrosine kinase (c-MET; MET; HGRF; c-Met proto-oncogene).

    Formulations of both drugs are approved in the U.S. and EU for thyroid cancer, and in the U.S. for second-line treatment of RCC. Kisplyx is also marketed as Lenvima. Exelixis markets a capsule form of cabozantinib as Cometriq for thyroid cancer.

    Exelixis added $0.09 to $8.68 on Friday. Ipsen rose EUR 0.23 to EUR 55.37.

  • CHMP recommendations include Truvada for PrEP

    EMA's CHMP backed approval of a host of drugs on Friday, and recommended expanding the label of HIV therapy Truvada emtricitabine/tenofovir disoproxil fumarate from Gilead Sciences Inc. (NASDAQ:GILD) to include pre-exposure prophylaxis (PrEP).

    The committee backed Truvada's use in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in adults at high risk. FDA approved Truvada for PrEP in 2012. It is a fixed-dose combination of the nucleoside analog reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir.

    The committee also recommended approval of Truberzi eluxadoline from Allergan plc (NYSE:AGN) to treat irritable bowel syndrome with diarrhea (IBS-D). Allergan markets the locally acting mu opioid receptor (MOR; OPRM1) agonist and delta opioid receptor antagonist in the U.S. as Viberzi for IBS-D.

    CHMP recommended Onivyde irinotecan (MM-398) in combination with 5-fluorouracil and leucovorin to treat metastatic pancreatic cancer. Shire plc (LSE:SHP; NASDAQ:SHPG) has rights to the drug from Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) outside the U.S. and Taiwan, where it already is approved. Merrimack has U.S. rights, and PharmaEngine Inc. (TPEx:4162) retains Taiwanese rights. Onivyde is a nanoparticle liposome formulation of irinotecan.

    On Friday, Shire rose 19p to 4,914p in London and added $0.03 to $193.49 on NASDAQ. Merrimack gained $0.14 to $5.50.

  • NICE recommends Lonsurf

    The U.K.'s NICE released final draft guidance recommending Lonsurf trifluridine/tipiracil from Servier (Neuilly-sur-Seine, France) to treat metastatic colorectal cancer in patients previously treated with or who are not candidates for some chemotherapies, anti-VEGF agents and anti-EGFR therapies.

    The recommendation is contingent on Servier providing Lonsurf at an undisclosed discount through a patient access scheme.

    The European Commission approved Lonsurf in April. Servier obtained EU rights to the drug from Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) in 2015 (see BioCentury Extra, June 15, 2015).

    Lonsurf is an oral combination of trifluridine (FTD), an antineoplastic nucleoside analog; and tipiracil, an inhibitor of the FTD-degrading enzyme thymidine phosphorylase. FDA approved it in September 2015.

  • FDA rejects Valeant's Vesneo

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) received an FDA complete response letter for Vesneo latanoprostene bunod to treat open-angle glaucoma or intraocular pressure. Nicox S.A. (Euronext:COX), which has co-promotion rights to the candidate, fell EUR 1.08 to EUR 11.58 on the news.

    Valeant said FDA's concerns arose following an inspection of a U.S. manufacturing facility and were not related to safety or efficacy. The company plans to meet with FDA to resolve the issue.

    In 2010, Nicox granted Bausch + Lomb Inc. exclusive, worldwide rights to the nitric oxide (NO)-donating prostaglandin F2-alpha analog. Valeant acquired Bausch + Lomb in 2013. Nicox exercised its co-promotion option in 2014.

  • Management tracks

    Boston Pharmaceuticals (Cambridge, Mass.) named Ian Sanderson CFO. He was CFO at Catabasis Pharmaceuticals Inc. (NASDAQ:CATB). Boston plans to in-license products that are in preclinical or early clinical testing, develop them through Phase II proof-of-concept, and then sell each asset back to its originator or out-license it to a third party.

    Bioinformatics company Molecular Health GmbH (Heidelberg, Germany) named Gerry Sheridan CFO and Les Paul CMO. Sheridan was CFO at Seno Medical Instruments (San Antonio, Texas) and Paul was a principal at Tradewind Life Science Advisors.

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