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BioCentury Extra
As published Friday, April 24, 2015 6:14 PM PST


  • Biogen falls on Tecfidera miss

    Biogen Inc. (NASDAQ:BIIB) shed $28.57 to $401.71 on Friday, losing $6.7 billion of market cap, as investors digested disappointing sales of Tecfidera dimethyl fumarate. The multiple sclerosis (MS) drug posted 1Q15 revenues of $825 million, up from $506 million in 1Q14 but down 10% from $916 million in 4Q14. The 1Q15 consensus Tecfidera estimate was north of $930 million.

    Overall, Biogen reported 1Q15 revenues of $2.55 billion, up 20% from $2.13 billion in 1Q14 but shy of the $2.66 billion consensus estimate. EPS came in at $3.82, up 55% from $2.47 in 1Q14 but short of the consensus figure of $3.91.

    "Our commercial results were not as strong as we'd hoped," CEO George Scangos said on the company's earnings call.

    "Tecfidera had a more challenging quarter due to a number of issues, including an overall slowing of the MS market, the recent launch of Plegridy, the single PML case reported last year and some first quarter financial dynamics," he added.

    The European Commission approved Biogen's Plegridy peginterferon beta-1a last July to treat MS; FDA approved it a month later.

    "In markets where we have launched Plegridy, we believe the uptake of that product has also dampened Tecfidera patient growth by taking some interferon switches that could have gone to Tecfidera," Tony Kingsley, EVP of global commercial operations, said on the conference call. "But obviously for Biogen overall, this is a positive."

    CFO Paul Clancy said on the call that 1Q15 dynamics included 13 weeks of Tecfidera shipping compared to 14 weeks in 4Q14. He said the additional week of Tecfidera sales in 4Q14 represented about $50 million.

    Clancy reiterated that Biogen will give annual guidance and one update per year when the company announces 2Q earnings, and said Biogen continues to expect Tecfidera will be the largest contributor to its overall revenue growth. "If the U.S. trajectory does not improve, we may come in at the lower end of our previously provided revenue growth" of 14-16% for FY15, he said.

    On the pipeline front, analysts asked whether Biogen will wait to see Phase Ib titration data for its Alzheimer's disease (AD) antibody aducanumab before starting Phase III this year.

    "Our expectation is that we will begin the study prior to reporting out titration data," said EVP of R&D Douglas Williams. "I think we have a pretty good handle on the dosing parameters for the study and how we plan to handle that."

  • AZ licenses NKG2A inhibitor from Innate Pharma

    Innate Pharma SA (Euronext:IPH) gained EUR 4.38 (49%) to EUR 13.35 after the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) paid $250 million up front for rights to Innate's IPH 2201 to treat cancer.

    The deal gives AZ exclusive, global rights to co-develop and co-commercialize the mAb against killer cell lectin-like receptor subfamily C member 1 (KLRC1; CD159a; NKG2A) in combination with MEDI4736, its human IgG1 mAb targeting PD-L1. Innate will have the right to co-promote the combination in Europe, where the companies would share profits evenly.

    AZ intends to conduct Phase II trials of the combination to treat solid tumors, and will be responsible for any Phase III studies. Innate will continue to lead Phase II studies of IPH 2201 as monotherapy and in combination with approved therapies to treat a range of cancers, and would co-fund AZ's Phase III studies. AZ declined to say when the trials will start.

    Innate is eligible for a $100 million milestone payment before a planned Phase III trial of the combination begins and $925 million in additional regulatory and sales milestones, plus double-digit royalties.

    In February 2014, Innate regained worldwide development and commercialization rights to IPH 2201 from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) for EUR 2 million ($2.7 million) in cash and 600,000 Innate shares, plus EUR 20 million ($27 million) in milestones and single-digit tiered royalties. Novo had held rights to the candidate under a 2003 deal.

  • Celgene pays $450M to share MEDI4736 with AZ

    Celgene Corp. (NASDAQ:CELG) and the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) entered an exclusive collaboration agreement to develop AZ's MEDI4736, a human IgG1 mAb targeting PD-L1 to treat blood cancers.

    Celgene intends to evaluate MEDI4736 to treat non-Hodgkin's lymphoma (NHL), multiple myeloma (MM) and myelodysplastic syndromes (MDS), and plans to begin its first clinical study of the candidate next half. The partners said they plan to test MEDI4736 in combination with both companies' approved and investigational cancer therapies.

    Celgene will pay AZ $450 million up front and will fund 100% of R&D costs through 2016, plus 75% of R&D thereafter. Celgene will run clinical trials and be responsible for global commercialization. AstraZeneca will manufacture the mAb. If it is approved and marketed, AZ would initially pay Celgene a 70% royalty, which would taper to about 50% over four years.

    AZ said it expects the deal to close this quarter.

    On Thursday, AZ started a non-exclusive collaboration with Juno Therapeutics Inc. (NASDAQ:JUNO) to test MEDI4736 in combination with a Juno chimeric antigen receptor (CAR) T cell therapy directed against CD-19 (see BioCentury Extra, April 23).

    Celgene gained $2.62 to $118.71 on Friday.

  • ImmunoGen regains rights to DLBCL candidate

    ImmunoGen Inc. (NASDAQ:IMGN) said it regained rights to coltuximab ravtansine (SAR3419) from Sanofi (Euronext:SAN; NYSE:SNY). The humanized CD19 mAb linked to ImmunoGen's DM4 cytotoxic agent met the primary endpoint last year in a Phase II trial to treat diffuse large B cell lymphoma (DLBCL) (see BioCentury Extra, June 2, 2014).

    On the company's fiscal 3Q15 conference call, ImmunoGen executives said Sanofi's decision to return rights was a "portfolio decision" and cited the pharma's plans to downsize its oncology R&D division. Sanofi did not respond to inquiries. The companies partnered in 2003 to develop cancer antibodies (see BioCentury Extra, Feb. 11).

    ImmunoGen also is developing IMGN529, a CD37-targeting antibody linked to ImmunoGen's DM1 cytotoxic agent that is in Phase I testing for relapsed or refractory non-Hodgkin's lymphoma (NHL). The company plans to develop the compound for relapsed or refractory DLBCL and chronic lymphocytic leukemia (CLL) once a recommended Phase II dose is established.

    On the earnings call, President and CEO Daniel Junius said ImmunoGen may perform a head-to-head comparison of coltuximab ravtansine and IMGN529 to decide whether to advance both compounds.

    Immunogen also said it discontinued Phase I testing of IMGN289 due to safety concerns. The company had investigated the humanized mAb against EGFR linked to DMI1 to treat head and neck, lung and breast cancers.

    The company reported fiscal 3Q15 revenues of $11.4 million, up from $6.9 million in 3Q14. Most came from milestone and royalty payments, including $5 million from Novartis AG (NYSE:NVS; SIX:NOVN) upon the start of a Phase I trial of antibody-drug conjugate LOP628 to treat cKit-positive cancers and $5.1 million in royalties from Roche (SIX:ROG; OTCQX:RHHBY) on sales of Kadcyla ado-trastuzumab emtansine.

    ImmunoGen updated its revenue guidance for its FY15 ending June 30 to $85-$95 million, down from $100-$105 million, due to changes in expected timing of partner milestone events.

    ImmunoGen shed $0.29 to $9.96 on Friday.

  • FDA adds mCRC to Lilly's Cyramza label

    FDA approved an sBLA from Eli Lilly and Co. (NYSE:LLY) for Cyramza ramucirumab in combination with FOLFIRI chemotherapy to treat metastatic colorectal cancer patients who have progressed on first-line therapies containing bevacizumab, oxaliplatin and a fluoropyrimidine.

    The human IgG1 mAb VEGFR-2 antagonist is approved in the U.S. in combination with docetaxel to treat metastatic non-small cell lung cancer (NSCLC) after platinum-based chemotherapy, and as a monotherapy and in combination with paclitaxel for advanced stomach cancer and gastroesophageal junction adenocarcinoma after prior fluoropyrimidine- or platinum-containing chemotherapy (see BioCentury Extra, Dec. 12, 2014).

  • CHMP backs Opdivo and Hetlioz, spurns Lympreva

    EMA's CHMP issued several recommendations on Friday, backing marketing authorization of candidates from Bristol-Myers Squibb Co. (NYSE:BMY) and Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) while declining to recommend one from Biovest International Inc. (Minneapolis, Minn.).

    CHMP recommended approval of BMS's Opdivo nivolumab as monotherapy to treat advanced melanoma. The committee has not yet issued a recommendation on Opdivo to treat non-small cell lung cancer (NSCLC); Opdivo is under EMA review for both indications. FDA approved the drug last month to treat metastatic squamous NSCLC, and in December 2014 to treat advanced melanoma. BMS has worldwide rights to the human IgG4 mAb against PD-1 from Ono Pharmaceutical Co. Ltd. (Tokyo:4528), excluding Japan, Korea and Taiwan, where Ono and BMS are partnered.

    CHMP also recommended approval of Vanda's Hetlioz tasimelteon, a melatonin MT1 and MT2 receptor agonist, to treat non-24-hour sleep-wake disorder in totally blind adults. EMA granted Orphan drug designation to Hetlioz in 2011; there are no approved treatments in the EU for the indication. FDA approved Hetlioz in January 2014 to treat the same disorder. Vanda has exclusive, worldwide rights to the drug from BMS.

    CHMP declined to recommend Biovest's Lympreva dasiprotimut-T to treat follicular non-Hodgkin's lymphoma (NHL). The committee called a study upon which Biovest based its MAA "inadequate... to establish the medicine's benefit," and said the treatment's effectiveness following induction treatment with anti-CD20 therapies was not demonstrated. CHMP also expressed concern about aspects of the manufacturing and quality control of Lympreva, an autologous vaccine containing tumor-specific idiotype proteins taken from an individual patient's lymphoma cells and conjugated to keyhole limpet hemocyanin (KLH).

  • Biocartis prices EUR 100M IPO

    Molecular diagnostics company Biocartis Group N.V. (Euronext:BCART) raised EUR 100 million ($107.8 million) through the sale of 8.7 million shares at EUR 11.50 in an IPO on Euronext Brussels. Underwriters were KBC Securities; Kempen; and Petercam. Biocartis said the offering was oversubscribed.

    The IPO price valued Biocartis at EUR 450.2 million ($485.3 million). The company expects its shares to begin trading Monday, April 27.

    Earlier this month, Biocartis said it planned to sell 8.7 million shares at EUR 10-EUR 11.50. At EUR 10.75, it would have raised EUR 93.5 million ($100.8 million) and been valued at EUR 420.8 million ($453.6 million).

    The IPO is the largest by a biotech on Euronext since Ipsen Group (Euronext:IPN; Pink:IPSEY) went public in 2005 (see BioCentury, April 20).

    Last year, Biocartis began selling its Idylla molecular diagnostics platform for cancer and infectious diseases.

  • Pfenex raises $40.5 million in follow-on

    Pfenex Inc. (NYSE-M:PFNX) raised $40.5 million through the sale of 2.6 million shares at $15.50 in a follow-on underwritten by Barclays; Evercore; and William Blair. Existing stockholders also sold 3.4 million shares in the offering. Pfenex proposed the offering before market open April 15, when its shares were worth $18.25. The stock lost $0.20 to $15.80 on Friday.

    Pfenex is conducting a Phase Ib/IIa trial of PF582, a biosimilar of Lucentis ranibizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Novartis AG (NYSE:NVS; SIX:NOVN), to treat wet age-related macular degeneration (AMD). It expects to begin a Phase III trial next year with partner Hospira Inc. (NYSE:HSP). In March, Pfenex began a Phase I trial of PF530, a biosimilar of Betaseron interferon (IFN) beta-1b from Bayer AG (Xetra:BAYN), to treat multiple sclerosis (MS).

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