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BioCentury Extra
As published Monday, May 23, 2016 5:21 PM PST

  • Exelixis' Cabometyx meets in first-line RCC

    Exelixis Inc. (NASDAQ:EXEL) gained $0.44 to $7 on Monday after its Cabometyx cabozantinib met the primary endpoint in the Phase II CABOSUN study evaluating the drug as a first-line therapy for advanced intermediate- or poor-risk renal cell carcinoma.

    Cabometyx significantly improved progression-free survival (PFS) vs. Sutent sunitinib, which the company said is standard of care for first-line RCC. Exelixis plans to submit the data for presentation at a future medical conference.

    The company intends to discuss CABOSUN's data with regulators and determine next steps in the first-line indication. The open-label study enrolled 157 patients.

    In April, FDA approved Cabometyx as a second-line therapy for advanced RCC patients who have received prior anti-angiogenic therapy. An MAA for the drug as a second-line treatment for RCC is under review (see BioCentury Extra, April 25).

    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; HGFR; c-Met proto-oncogene). Exelixis also markets a capsule formulation as Cometriq in the U.S. and EU to treat medullary thyroid cancer (MTC).

    Ipsen Group (Euronext:IPN) has exclusive rights to develop and commercialize cabozantinib outside the U.S., Canada and Japan.

  • Arbor acquiring XenoPort

    Specialty pharma Arbor Pharmaceuticals Inc. (Atlanta, Ga.) is acquiring XenoPort Inc. (NASDAQ:XNPT) for $7.03 per share, or about $467 million. The deal will give Arbor rights to Horizant gabapentin enacarbil, which is approved in the U.S. to treat restless legs syndrome (RLS) and to manage postherpetic neuralgia. XenoPort reported $39.5 million in 2015 sales of the drug.

    The acquisition price is a 60% premium to XenoPort's close of $4.40 on Friday, before the deal was announced. It also is a slight premium to the biotech's close of $6.73 on Sept. 14, 2015, before XenoPort reported troubling adverse event data from a Phase II trial in which then-lead clinical candidate XP23829 met its primary endpoint (see BioCentury Extra, Sept. 15, 2015).

    In October, XenoPort restructured and said it would partner its pipeline candidates. In March, it granted Dr. Reddy's Laboratories Ltd. (NYSE:RDY) exclusive U.S. rights to the candidate to treat psoriasis (see BioCentury Extra, March 28).

    Arbor markets 20 approved products, primarily for the cardiovascular, hospital and pediatric markets. It employs 500 sales professionals among its 600 employees.

    Both companies' boards have approved the deal, which is expected to close next quarter.

    In Japan, Astellas Pharma Inc. (Tokyo:4503) markets Horizant as Regnite. The compound is a transported prodrug of gabapentin.

    XenoPort rose $2.48 (56%) to $6.88 on Monday.

  • FDA to review Samsung Bioepis' Remicade biosimilar

    Samsung Bioepis Co. Ltd. said FDA accepted its BLA for SB2, a biosimilar of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ).

    The BLA is the first submitted in the U.S. by Samsung Bioepis, a JV between Samsung Group (Seoul, South Korea) and Biogen Inc. (NASDAQ:BIIB). Merck & Co. Inc. (NYSE:MRK) has U.S. commercialization rights to SB2.

    Samsung Bioepis is seeking SB2's approval to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The company did not disclose the application's PDUFA date, and did not respond to inquiries.

    SB2 is approved in Korea as Renflexis, and is under review in Europe as Flixabi (see BioCentury Extra, Dec. 4, 2015).

    J&J reported $4.5 billion in U.S. sales of Remicade in 2015. Merck markets the chimeric mAb against tumor necrosis factor (TNF) alpha in Europe and other territories.

    On April 5, FDA approved Inflectra infliximab-dyyb, a Remicade biosimilar from Celltrion Inc. (KOSDAQ:068270). Pfizer Inc. (NYSE:PFE) has U.S. rights to Inflectra (see BioCentury Extra, April 5). When Inflectra was approved, J&J said its Remicade patents "remain valid and enforceable until September 2018," and that it does not expect biosimilar competition for Remicade in 2016.

  • Witz among departing Sanofi execs

    Sanofi (Euronext:SAN; NYSE:SNY) said three executives will leave the company, including EVP of Diabetes and Cardiovascular Pascale Witz. Last year, Sanofi had named Witz to the post as part of a global reorganization (see BioCentury Extra, July 15, 2015).

    EVP of General Medicines and Emerging Markets Peter Guenter will take over the diabetes and cardiovascular unit, effective June 1. Olivier Charmeil, who is EVP of the company's Sanofi Pasteur vaccine unit, will take over Guenter's position. Sanofi Pasteur Head of Global Commercial Operations David Loew will become the unit's EVP and general manager.

    Sanofi also said EVP of External Affairs Suresh Kumar will leave the company.

    Carsten Hellmann, EVP of Sanofi's Merial animal health unit, will become president and CEO at ALK-Abello A/S (CSE:ALK-B) after Sanofi divests the unit to Boehringer Ingelheim GmbH (Ingelheim, Germany) (see BioCentury Extra, May 17).

  • FDA reviewers question Sanofi's iGlarLixi

    In briefing documents released ahead of an advisory committee meeting to discuss two Type II diabetes treatments from Sanofi (Euronext:SAN; NYSE:SNY), FDA reviewers again raised concerns about a combination therapy whose components include both a fixed-dose stand-alone product and a therapy that is titratable based on a patient's glycemic levels.

    On Wednesday, FDA's Endocrinologic and Metabolic Drugs Advisory Committee is to discuss NDAs from Sanofi for glucagon-like peptide-1 receptor (GLP-1R; GLP1R) agonist lixisenatide (ZP10) alone, and for a fixed-ratio combination of lixisenatide and the pharma's Lantus insulin glargine. In its own briefing document, Sanofi calls the combination product iGlarLixi.

    Lixisenatide is a fixed-dose standalone therapy, while Lantus is titratable.

    Reviewers were concerned about capped dosing of Lantus as a comparator for iGlarLixi in two Phase III studies, and whether the trials' titration algorithms could have biased their outcomes. Their concerns echoed those discussed in briefing documents released Friday for IDegLira insulin degludec/liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO), which combines a GLP-1 analog with a long-acting insulin analog (see BioCentury Extra, May 20).

    In Monday's briefing documents, reviewers questioned whether Sanofi's iGlarLixi studies are relevant to clinical practice and whether the observed treatment difference reflects an actual treatment difference.

    Reviewers also said Sanofi's proposed dose range for iGlarLixi allows for lixisenatide doses below those tested in lixisenatide's Phase III program. "It is unclear whether there is a benefit in the low dose range that balances the additional safety concerns from adding a second drug," wrote the reviewers.

    Most of FDA's questions for the committee focus on iGlarLixi. The agency will ask the panel to vote on whether data support the combination's approval to treat Type II diabetes. The committee also will discuss the benefits of starting iGlarLixi treatment in Type II diabetics who have previously received one or neither of its components alone, and any clinical concerns about a product that combines a titratable product with a product that has recommended effective doses.

    Sanofi markets lixisenatide outside the U.S. as Lyxumia. Sanofi withdrew an NDA in 2013 for lixisenatide, citing concerns regarding the potential public disclosure of interim data from its Phase IIIb ELIXA cardiovascular outcomes study. Last year, Sanofi said lixisenatide was non-inferior, but not superior, to placebo for CV safety (see BioCentury Extra, March 19, 2015).

    FDA asked the committee to discuss whether there are any safety of efficacy concerns with lixisenatide that could preclude its approval. In the briefing documents, reviewers said ELIXA data "do not raise concerns for increased cardiovascular risk or mortality with lixisenatide."

  • Darzalex gets conditional European approval

    The European Commission granted conditional approval to Darzalex daratumumab from Johnson & Johnson (NYSE:JNJ) to treat relapsed and refractory multiple myeloma (MM) in adults whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent.

    The human IgG1k against CD38 has accelerated approval from FDA to treat MM patients who have received at least three prior therapies, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

    Darzalex has met the primary progression-free survival (PFS) endpoint in two Phase III studies comparing it with marketed MM therapies (see BioCentury Extra, May 19).

    Janssen has exclusive, worldwide rights to Darzalex from Genmab A/S (CSE:GEN), which gained DKK75 to DKK1,205 on Monday.

  • Researchers hunting for immune checkpoint responders

    In a manuscript published in Nature, researchers said several variants of the PD-L1 gene are associated with increased PD-L1 expression and contribute to tumor cells' escape from immune surveillance across numerous cancers. The authors said cancer patients expressing the variants may show stronger responses to PD-L1 or PD-1 immunotherapy.

    Using whole-genome sequencing of patient samples and RNA sequencing data from the Cancer Genome Atlas (TCGA), the researchers identified several structural variations, including deletions, inversions, duplications and translocations, that disrupt the 3' untranslated region (UTR) of the PD-L1 gene and stabilize it, increasing PD-L1 expression. Disruption of the 3' UTR in T cells prevented tumor regression in mice treated with an immunostimulant, while an anti-PD-L1 antibody shrank tumors in mice expressing the variant.

    The authors studied 33 total cancer types from TCGA data sets. Among the study's 49 T cell leukemia or lymphoma patients, 13 had elevated PD-L1 expression paired with a 3' UTR variant. Four (8.3%) of 48 diffuse large B cell lymphoma (DLBCL) patients and nine (2.2%) of 415 of stomach adenocarcinoma patients showed elevated PD-L1 expression associated with a variant.

    In a separate manuscript published May 19 in Cancer Research, NCI scientists said cancer patients' total number of non-synonymous mutations (NsM) may predict their responses to immune checkpoint therapy. In a sample drawn from TCGA data, the researchers estimated that 16.2% of patients across 26 cancer types were likely to derive clinical benefit from immune checkpoint therapy, based on their NsM counts and historical data. The researchers said 30% of the study's bladder, colon, gastric and endometrial cancer patients had NsM counts associated with checkpoint inhibitor response.

  • OrbiMed closes second Israel fund

    OrbiMed closed its OrbiMed Israel Partners II fund at $307 million. The firm plans to invest the new fund in 20 Israeli healthcare companies across all stages of development.

    OrbiMed opened an office in Israel in 2010, and in 2012 had a final close for its first Israel fund at $222 million.

  • Coherus raises $63M in follow-on

    Coherus BioSciences Inc. (NASDAQ:CHRS) fell $1.38 to $18.12 on Monday after it raised $63 million through the sale of 3.5 million shares at $18 in a follow-on underwritten by Barclays. The company proposed and priced the offering Monday before market hours. Its shares had closed at $19.50 on Friday.

    Last week, the U.S. Patent Trial and Appeal Board instituted Coherus' inter partes review petition challenging a patent covering Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). Coherus' CHS-1420, a biosimilar of Humira, is in Phase III testing for psoriasis and rheumatoid arthritis (see BioCentury Extra, May 17).

  • CMS still reviewing comments on Part B model

    Media reports that CMS has delayed implementation of a proposed Medicare Part B drug payment model are incorrect, CMS spokesperson Aaron Albright told BioCentury Monday. "We have not announced a change in timing and we continue to review comments," he said.

    The reports are based on a misinterpretation of a White House Office of Management and Budget document that lists a March 2019 date for "final action" on the rule. The term reflects the final rule's statutory deadline, not the expected time of its issue, according to CMS.

  • inVentiv Health Consulting Summit Highlights Key Challenges and Best Practices for Medical Affairs Leaders

    inVentiv Health Consulting (formerly Campbell Alliance) brought together biopharma Medical Affairs (MA) leaders to share ideas at the fifth annual Medical Affairs Leadership Summit, a signature event capping a year-long cycle of collecting and analyzing data about MA leaders' most pressing issues. Downloadyour copy of the white paper now!

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