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BioCentury Extra
As published Wednesday, July 27, 2016 5:48 PM PST


  • Lilly's Lechleiter retiring

    John Lechleiter intends to retire as president and CEO of Eli Lilly and Co. (NYSE:LLY), effective Dec. 31. David Ricks, SVP and president of Lilly Bio-Medicines, will succeed Lechleiter on Jan. 1, 2017.

    Lechleiter, who is also Lilly's chairman, will be non-executive chairman until May 31, 2017, when he will retire from Lilly's board. Ricks will join Lilly's board as he assumes the CEO role, and will become chairman on June 1, 2017.

    Lechleiter has been CEO since April 2008 and chairman since January 2009.

    Ricks has held his role at Lilly Bio-Medicines since January 2012. The unit leads the pharma's global marketing, and includes the therapeutic areas of Alzheimer's disease, urology, immunology, musculoskeletal disease and pain. Ricks joined Lilly in 1996 as a business development associate, and has held several roles on Lilly's commercial side. He was president and general manager of Lilly China in 2008-09.

    Lilly's recent launches include lung cancer therapy Portrazza necitumumab and psoriasis drug Taltz ixekizumab.

    Lilly added $1.31 to $83.40 on Wednesday.

  • Amgen again lifts 2016 guidance, tops consensus

    Amgen Inc. (NASDAQ:AMGN) reported 2Q16 financial results that beat estimates and again raised its full-year guidance. The company reported quarterly revenues of $5.69 billion, up from $5.37 billion in 2Q15 and beating the $5.58 billion consensus estimate. Non-GAAP EPS in the quarter was $2.84, up from $2.57 in 2Q15 and topping the $2.74 consensus.

    For the third time this year, Amgen raised its full-year guidance. It now expects 2016 non-GAAP EPS of $11.10-$11.40 on revenues of $22.5-$22.8 billion. In April, the company guided to non-GAAP EPS of $10.85-$11.20 on revenues of $22.2-$22.6 billion (see BioCentury Extra, April 28).

    Worldwide sales of PCSK9 inhibitor Repatha evolocumab were $27 million in 2Q16, up sequentially from $16 million in 1Q16. Amgen launched the cholesterol-lowering drug last September in the U.S. and Europe.

    Sales of leukemia drug Blincyto blinatumomab were $30 million, up slightly from $27 million in 1Q16. The bispecific T cell engager (BiTE) that binds to CD19 expressed on B cells and CD3 expressed on T cells has accelerated approval from FDA and conditional approval from the European Commission. Amgen launched Blincyto in the U.S. in December 2014. It received EU approval last November.

    Amgen rose $3.01 to $170.68 on Wednesday. The company released its financial results after market close.

  • Vertex stands by Orkambi, Kalydeco guidance

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) reported modest upticks in 2Q16 sales of cystic fibrosis drugs Orkambi ivacaftor/lumacaftor and Kalydeco ivacaftor.

    The biotech reported $245.5 million in global sales of Orkambi, narrowly missing the consensus estimate of $249 million. Orkambi sales were $223.1 million in 1Q16. The drug was launched in July 2015.

    Kalydeco sales were $180.2 million in 2Q16, up from $154.9 million in 2Q15 and beating the $174 million consensus. In 1Q16, Kalydeco sales were $170.5 million.

    On a conference call after market hours Wednesday, CFO Ian Smith said Vertex expects Orkambi growth to accelerate in 4Q16. FDA is reviewing an sNDA for Orkambi to treat CF in children ages six to 11 who are homozygous for the delta F508 mutation in the CF transmembrane conductance regulator (CFTR) gene. Vertex said approval would make an additional 2,400 patients eligible to receive the drug. The application's PDUFA date is Sept. 30.

    Vertex reiterated 2016 revenue guidance for the drugs. In April, the company guided for $1-$1.1 billion in 2016 Orkambi sales and $685-$705 million in Kalydeco sales (see BioCentury Extra, April 27).

    Chief Commercial Officer Stuart Arbuckle said Vertex does not expect significant EU revenue this year from Orkambi sales outside Germany due to ongoing reimbursement negotiations. He said sales growth in Germany has been slower than in the U.S. because of market fragmentation.

    Vertex reported non-GAAP EPS of $0.24 in 2Q16, beating the $0.21 consensus. The company posted a non-GAAP loss of $0.54 in 2Q15.

    Orkambi combines Kalydeco, a small molecule potentiator of CFTR, and lumacaftor, a small molecule CFTR corrector.

    Vertex released earnings after market close. It gained $1.03 to $96.01 on Wednesday and lost $2.01 to $94 in early after-hours trading.

  • Merck ending allergy tablet deal with ALK-Abello

    ALK-Abello A/S(CSE:ALK-B) fell DKK206 (18%) to DKK968 on Wednesday after it said Merck & Co. Inc. (NYSE:MRK) will return North American rights to the biotech's sublingual allergy immunotherapy (SLIT) tablets. ALK-Abello said Merck, which has the rights under a 2007 deal, based its decision on a strategic review of its priorities.

    After a transition period, ALK-Abello will regain rights to SLIT tablets against grass, ragweed and house dust mite (HDM) allergies. The company and Merck market Grazax/Grastek to treat grass pollen-induced allergic rhinitis, and Ragwitek for ragweed-pollen induced allergic rhinitis. FDA is reviewing a BLA from Merck for MK-8237, the HDM SLIT tablet, to treat HDM-induced allergic rhinitis, with a PDUFA date in 2017. ALK-Abello said it will take a greater role in HDM SLIT's registration process as it continues.

    ALK-Abello plans to reassess its approach to the North American market, and may seek other partners or market the SLIT products on its own.

    ALK-Abello said the deal termination will have no effect on its 2016 outlook. The company expects to report 1H16 financial results on Aug. 16. It announced the Merck news on Tuesday after market hours.

  • GSK picks up asthma candidate from J&J

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it obtained exclusive, worldwide rights to CNTO 7160 from the Janssen Sciences Ireland UC unit of Johnson & Johnson (NYSE:JNJ). The mAb against IL-33 receptor is in a Phase I trial to treat asthma and atopic dermatitis.

    Janssen is eligible for L175 million ($229.7 million) in upfront and milestone payments, plus tiered royalties. GSK is to take over development and commercialization after the Phase I study is complete.

    J&J spokesperson Brian Kenney told BioCentury that the company is deprioritizing pulmonary R&D within its immunotherapy business, and is working to partner pulmonary candidates. Kenney declined to give a timeline for the Phase I study.

    GSK, which holds rights in all indications, said CNTO 7160 "could be applicable to a broad spectrum of severe asthmatic populations." Spokesperson Mary Anne Rhyne declined to disclose details on the company's development plans for the candidate.

  • Cytokinetics, Astellas add ALS to existing deal

    Cytokinetics Inc. (NASDAQ:CYTK) and Astellas Pharma Inc. (Tokyo:4503) expanded their skeletal muscle activator collaboration to add a focus on amyotrophic lateral sclerosis and extend through 2017 their joint program to research and discover next-generation skeletal muscle compounds.

    Cytokinetics granted Astellas an option to license certain territorial rights to tirasemtiv(formerly CK-2017357), a fast skeletal muscle troponin activator that is in the Phase III VITALITY-ALS study to treat ALS. The deal includes tirasemtiv's rights outside North America, Europe and other territories where Cytokinetics will retain rights.

    The companies also now intend to develop CK-2127107 and other next-generation fast skeletal muscle troponin activators for ALS. CK-2127107 is in a Phase II study to treat spinal muscular atrophy (SMA).

    Cytokinetics is to receive $65 million up front from Astellas and is eligible for more than $100 million in payments associated with the exercise of the option and milestones. The companies each would be eligible for double-digit royalties on sales in the partners' territories.

    Cytokinetics also will receive about $30 million in R&D funding through 2017 for CK-2127107, which will help support a Phase II ALS study of the compound and the extension through 2017 of the discovery deal.

    The companies partnered in 2013 to develop and commercialize skeletal muscle activators to treat diseases and conditions with muscle weakness. In 2014, the partners expanded the deal into neuromuscular indications (see BioCentury Extra, Dec. 23, 2014).

    Cytokinetics rose $0.47 to $10.36 on Wednesday.

  • LabCorp acquiring Sequenom

    Diagnostics company Laboratory Corp. of America Holdings (NYSE:LH) is acquiring Sequenom Inc. (NASDAQ:SQNM) for $2.40 per share, or about $371 million including Sequenom's net debt. The price is a 182% premium to Sequenom's close of $0.85 on Tuesday, before the deal was announced.

    Sequenom's market cap peaked above $4 billion shortly after its IPO in 2000, during the biotech bubble.

    Last month, the U.S. Supreme Court declined to review a lower court's decision that had invalidated Sequenom's patent covering prenatal diagnosis with nucleic acid analysis, as used in the company's MaterniT21 Plus laboratory-developed test. On June 27, Sequenom shares fell 16% on the news (see BioCentury Extra, June 27).

    The companies expect the deal to close by YE16. Sequenom gained $1.50 (176%) to $2.35 on Wednesday.

  • NICE recommends Opdivo-Yervoy combo

    In final guidance released Wednesday, the U.K.'s NICE recommended Opdivo nivolumab in combination with Yervoy ipilimumab to treat advanced melanoma. NICE said it completed its appraisal 24 working days after the combo received marketing authorization, making the appraisal its fastest ever in cancer.

    The recommendation is contingent on a discounted patient access scheme for Yervoy.

    Bristol-Myers Squibb Co. (NYSE:BMY) markets both drugs. Opdivo, a human IgG4 against PD-1, is approved in the EU as monotherapy to treat locally advanced melanoma, and to treat squamous non-small cell lung cancer (NSCLC) and renal cell carcinoma. Yervoy, a human mAb against CTLA-4 (CD152), is also approved as monotherapy in the EU to treat advanced melanoma.

    NICE previously recommended both treatments as monotherapies for advanced melanoma.

  • TauRx's LMTX fails in Phase III AD study

    TauRx Pharmaceuticals Ltd. (Singapore) said LMTX (TRx0237) missed the co-primary endpoints in the Phase III TRx-237-015 trial as an add-on therapy to treat mild to moderate Alzheimer's disease. The candidate did not lead to significant improvements from baseline vs. control in ADCS-Activities of Daily Living (ADCS-ADL23) and 11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11) scores.

    TauRx said there was also no significant difference between the groups on the level of brain atrophy as determined by lateral ventricular volume, the trial's principal secondary endpoint. The 891-patient trial studied 75 and 125 mg twice-daily oral LMTX for 15 months.

    TauRx said a prespecified analysis showed significant differences between the groups on the two co-primary endpoints in a subgroup of patients who received LMTX as monotherapy. The company said it could not explain the reason for those results. About 15% of the study's patients were receiving LMTX as monotherapy.

    The TRx-237-015 data were presented at Alzheimer's Association International Conference in Toronto.

    TauRx said an initial analysis of data from TRx-237-005, its second Phase III study of LMTX in AD patients, "confirms the findings" and supports the potential of LMTX as a monotherapy. The two studies have the same co-primary endpoints, though TauRx said it modified TRx-237-005's statistical analysis plan after observing the monotherapy findings in the TRx-237-015 study.

    The company plans to present TRx-237-005 data in 4Q16, and said it will discuss the results with regulatory authorities to determine next steps.

    LMTX is a second-generation tau aggregation inhibitor.

  • Kadmon sinks in first trading day

    Kadmon Holdings Inc. (NYSE:KDMN) fell $2.30 (19%) to $9.70 in its first day of trading Wednesday. The company raised $75 million by pricing its IPO at $12 after market close Tuesday (see BioCentury Extra, July 27).

    Kadmon is developing compounds for autoimmune disorders, fibrotic diseases and cancer. It priced the offering below the proposed $16-$20 range.

  • FDA user fees dropping in FY17

    FDA unveiled FY17 user fee rates for drugs and biosimilars that will be lower than those the agency set for FY16.

    The fee for drug applications containing clinical data will be $2.04 million in FY17, compared to $2.37 million in FY16. The new fee for applications that do not require clinical data, and for supplemental applications requiring clinical data, will be $1.02 million, down from $1.19 million in FY16.

    The newly announced rates for biosimilar applications are the same as for drug applications. For biosimilars, FDA will charge an annual development fee of $203,810 (10% of the PDUFA fee) in FY17 for sponsors that have filed an IND but not a marketing application, down from $237,420 in FY16.

    The FY17 fees take effect on Oct. 1.

    Industry and FDA have agreed to restructure PDUFA fees as part of the PDUFA VI agreement goals letter released this month. Individuals involved in the negotiations told BioCentury earlier this month that annual user fee growth is expected to slow to 2-4% while PDUFA VI is in effect from FY18-FY22, from about 11% in FY16 (see BioCentury Extra, July 15).

  • BIO, PhRMA lay out principles for off-label communications

    In a set of joint principles, BIO and PhRMA emphasized that companies should be able to communicate "truthful, non-misleading" information outside of an FDA-approved label to insurance providers, PBMs and government healthcare programs as they consider reimbursement decisions.

    According to the principles, a company should be able to describe to payers its pipeline, the status of FDA applications, the anticipated uses of products, relevant clinical trial data, pharmacoeconomic information and applicable treatment guidelines. A company should be able to discuss analyses of real-world data derived from "sound and well-described" research methods, the principles said.

    Communications should be tailored to the sophistication of the intended audience, and should provide "scientific substantiation" for information not included in FDA-approved labeling, the document said. A company should provide details on the design and implementation of studies that generated data, including patient populations and statistical analysis plan. BIO and PhRMA also said that when applicable, companies should inform healthcare professionals that other research led to different results.

  • Eighth annual study offers prospective view of dealmaking landscape for the year ahead

    The inVentiv Health Consulting (formerly Campbell Alliance) Dealmakers' Intentions Study is the only forward-looking measure of dealmaking activity in the biopharma industry. Now in its eighth year, the study provides insight into what will likely drive the industry's partnering and M&A efforts moving forward--the results of which were released at last month's BIO International Convention. Download your copy of the full white paper now.


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