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BioCentury Extra
As published Friday, July 24, 2015 6:12 PM PST

  • Biogen hammered after slashing guidance

    Biogen Inc. (NASDAQ:BIIB) sank $85.02 (22%) to $300.03, losing $20 billion in market cap Friday after it lowered its 2015 guidance for EPS and sales growth, primarily because the company expects sales of multiple sclerosis drug Tecfidera dimethyl fumarate to be slower than expected.

    The news dragged down biotech indices on Friday. The BioCentury 100 slipped 303.19 (4%) to 7,799.27, the NASDAQ Biotechnology Index was down 165.77 (4%) to 3,956.25, and the NYSE Arca Biotech Index lost 151.11 (3%) to 4,221.90.

    Biogen now expects overall revenue growth of 6-8% in 2015; in January, it had guided for 14-16%. It now expects non-GAAP EPS to be $15.50-$15.95 this year vs. its previous guidance of $16.60-$17.

    Global sales of Tecfidera in 2Q15 were $883.3 million, up 7% from $824.9 million in 1Q15 and 26% from $700.4 million in 2Q14. CEO George Scangos said on a conference call that the company "expected to see a reacceleration" in 2Q15, "but that did not happen to any appreciable extent" as the company continues to "work through the same commercial challenges" experienced in 1Q15.

    EVP of Global Commercial Operations Stuart Kingsley said on the call that Biogen had anticipated a higher rate of patients switching from injectable therapies to the oral Tecfidera as well as new starts, particularly in the U.S. and Germany. He also said a "safety event in late 2014" led to increased caution about switching to an oral therapy. FDA issued a warning last November that a patient receiving Tecfidera died from pneumonia after developing progressive multifocal leukoencephalopathy (PML) (see BioCentury, Oct. 27, 2014).

    Tecfidera had missed expectations last quarter as well; the company had blamed an overall slowing of the MS market, its recent launch of MS treatment Plegridy peginterferon beta-1a, the PML case and other financial dynamics (see BioCentury Extra, April 24).

    Also during the call, Biogen disclosed the trial design for the identical Phase III EMERGE and ENGAGE studies of aducanumab to treat Alzheimer's disease. Non-carriers of the apolipoprotein E (APOE) epsilon 4 variant will receive 6 mg/kg, 10 mg/kg or placebo, while APOE4 carriers will receive 3 mg/kg, 6 mg/kg or placebo. The primary endpoint of the trials, which will enroll 1,350 early AD patients each, will be Clinical Dementia Rating sum of boxes (CDR-SB). Biogen reported additional results from a Phase Ib study of aducanumab on Wednesday (see BioCentury Extra, July 22).

    Biogen also said Tysabri natalizumab missed the primary endpoint of change in infarct volume in a Phase II study to treat acute ischemic stroke; however, the company said it plans to continue development of Tysabri in the indication, citing results on other endpoints suggesting the drug had a beneficial effect on patient functional deficits.

    Biogen's 2Q15 non-GAAP diluted EPS was $4.22, up 21% from $3.49 in 2Q14 and beating the consensus estimate of $4.10. Its overall sales of $2.6 billion were up 7% over $2.4 billion in 2Q14, but were short of the $2.7 billion consensus estimate.

    For the week, Biogen lost $104.63 (26%), shedding $24.6 billion in market cap to $70.6 billion.

  • FDA approves Praluent

    FDA approved a BLA on Friday for PCSK9 inhibitor Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY). The human mAb against PCSK9 is the first approved in the U.S. to treat high cholesterol.

    The therapy is indicated as an adjunct to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease who require additional cholesterol lowering therapy. The sponsors had sought a broader indication that included patients with mixed dyslipidemia.

    Sanofi spokesperson Elizabeth Baxter told BioCentury Praluent would be available in the U.S. on Monday at a wholesale acquisition cost (WAC) of $40 per day, or $1,120 every 28 days. Both the 75 mg and 150 mg approved doses of Praluent are available in prefilled pens or syringes that patients self-administer every two weeks.

    Last month, an FDA advisory committee voted in favor of approval for restricted hypercholesterolemia populations. The panel did not support approval for low-risk conditions such as mixed dyslipidemia, where statins are SOC. Panelists supported approval in HeFH based on LDL levels as a surrogate endpoint for CV benefit (see BioCentury, June 15).

    Also on Friday, EMA's CHMP recommended approval of an MAA for Praluent to treat patients with heterozygous familial and non-familial hypercholesterolemia or mixed dyslipidemia in combination with maximally-tolerated statins. CHMP also recommended Praluent alone or in combination with other lipid-lowering agents in statin-intolerant patients.

    On Tuesday, the EC approved Repatha evolocumab, a PSCK9 inhibitor from Amgen Inc. (NASDAQ:AMGN), in the same indications for which CHMP recommended Praluent. The EC also approved Repatha for patients with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies (see BioCentury Extra, July 21).

    Repatha is under FDA review, with an Aug. 27 PDUFA date. FDA accepted Amgen's BLA for Repatha in November 2014, but Sanofi and Regeneron used a Priority Review voucher in January to expedite Praluent's review (see BioCentury, June 1).

    Esperion Therapeutics Inc. (NASDAQ:ESPR) lost $19.85 (21%) to $75.91 on the news. Its ETC-1002 is a first-in-class AMP-activated protein kinase (AMPK) activator and ATP citrate lyase (ACL) inhibitor in Phase II testing to treat hypercholesterolemia as an add-on to statin treatment and in statin-intolerant patients.

    Regeneron lost $14.76 to $541.85 on Friday, while Amgen lost $5.51 to $158.59. Neither loss was as wide as the 4% decline in the NASDAQ Biotechnology Index.

  • CHMP backs GSK's malaria vaccine

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received a positive opinion from EMA's CHMP for its Mosquirix malaria vaccine in children aged 6 weeks to 17 months -- moving the product a step closer to becoming the first vaccine ever approved to prevent malaria. GSK expects the World Health Organization (WHO) to formulate a policy recommendation on use of the vaccine by YE15, after which GSK will submit an application to WHO for pre-qualification of the vaccine. Once pre-qualification is granted, GSK will apply for marketing authorization in countries in sub-Saharan Africa.

    Mosquirix (RTS, S) targets the circumsporozoite protein (CSP) sequence of Plasmodium falciparum and uses the AS01 adjuvant. AS01 contains the QS-21 Stimulon adjuvant from Agenus Inc. (NASDAQ:AGEN). Agenus, which said this would be the first approval of a product containing QS-21, will receive a milestone payment on approval and low single-digit royalties for 10 years. GSK developed the vaccine in partnership with the PATH Malaria Vaccine Initiative (MVI).

    Agenus dipped $0.39 to $8.56 on Friday.

  • AbbVie's Technivie approved for HCV

    FDA approved Technivie ombitasvir/paritaprevir/ritonavir from AbbVie Inc. (NYSE:ABBV) in combination with ribavirin to treat non-cirrhotic adults with chronic HCV genotype 4 infection. The regimen is the first interferon-free treatment for the indication in the U.S.

    AbbVie spokesperson Jackie Finley told BioCentury Technivie would be available nationwide in late August at a wholesale acquisition cost (WAC) of $76,653 for 12 weeks of treatment, the shortest approved treatment course.

    The regimen comprises tablets containing ombitasvir, an HCV NS5A protein inhibitor; paritaprevir, an HCV NS3/4A protease inhibitor; and ritonavir, an HIV protease inhibitor. All three are included in Viekira Pak, which also contains non-nucleoside HCV NS5B polymerase inhibitor dasabuvir; FDA approved that regimen last December with or without ribavirin to treat HCV genotype 1 infection in patients with and without compensated cirrhosis.

    An oral regimen of ombitasvir, paritaprevir and ritonavir is approved in the EU as Viekirax with ribavirin to treat chronic HCV genotype 4 infection. Another regimen including Viekirax and dasabuvir, known in the EU as Exviera, is approved in the EU with or without ribavirin to treat HCV genotype 1 in some patients.

  • 3SBio acquires Zhejiang Wansheng

    3SBio Inc. (HKSE:1530) will acquire Zhejiang Wansheng Pharmaceutical Co. Ltd. (Hangzhou, China) for RMB528 million ($85.1 million).

    Zhejiang Wansheng markets oncology, diabetes and hypertension products. 3SBio said the acquisition would allow the company to expand into diabetes and dermatology markets.

    3SBio derives most of its revenue from hematology products EPIAO, a human recombinant erythropoietin (EPO) to treat anemia associated with chemotherapy or chronic kidney disease (CKD), and TPIAO, a recombinant human thrombopoietin (TPO) to treat chemotherapy-induced thrombocytopenia and idiopathic thrombocytopenic purpura (ITP).

    Last month, 3SBio raised HK$4.4 billion ($569.2 million) in an IPO. 3SBio was traded on NASDAQ from 2007-13, when Chairman and CEO Jing Lou and CPEChina Fund, a unit of CITIC Private Equity, took the company private (see BioCentury Extra, June 10).

    3SBio shed HK$0.06 to HK$9.49 on Friday.

  • Management tracks

    Gene therapy play Avalanche Biotechnologies Inc. (NASDAQ:AAVL) said Thomas Chalberg resigned as president, CEO and a director. EVP of Business Operations Hans Hull will be interim CEO.

    Oncology play Mologen AG (Xetra:MGN) named Mariola Soehngen CEO, effective Nov. 1. Soehngen will remain CMO at Paion AG (Xetra:PA8) through Oct. 31.

    Novo Nordisk A/S (CSE:NCO; NYSE:NVO) promoted Brian Hilberdink to president of Novo Nordisk Canada. Hilberdink was VP of diabetes marketing and market access in Canada.

  • Exelixis raises $135M in follow-on

    Exelixis Inc. raised $135 million through the sale of 25 million shares at $5.40 in a follow-on underwritten by Cowen; William Blair; and Stifel. The company proposed to sell 20 million shares after market on Tuesday, when its stock closed at $6.05. Exelixis shed $0.29 to $5.59 on Friday.

    On Monday, Exelixis said the Phase III METEOR trial of Cometriq cabozantinib vs. everolimus in metastatic renal cell carcinoma (RCC) met its primary endpoint, showing a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients (see BioCentury Extra, July 20).

  • Docs decry high cost of cancer drugs

    More than 100 oncologists said that the high price of cancer drugs is negatively affecting the care of patients and called on patients to form a grassroots organization to advocate for more rational drug prices.

    The comments were published online Thursday in the Mayo Clinic Proceedings in which the oncologists noted that 10-20% of patients don't adhere to or even take their prescribed medications because of the cost.

    The oncologists also recommended the creation of a postmarket review mechanism to propose a "fair price" for new drugs based on the value of the therapy to patients and the healthcare system. The group made six additional recommendations: Medicare should be allowed to negotiate drug prices; the Patient-Centered Outcomes Research Institute (PCORI) and similar organizations should be allowed to include a drug's price in their assessment of a treatment's value; importation of cancer drugs should be permitted; new legislation should be enacted to prevent branded drug companies from delaying generic drug entry via pay-for-delay deals; the patent system should be reformed to allow generics to be available sooner; and groups like the American Society of Clinical Oncology (ASCO) should be encouraged to consider the overall value of drugs and treatments in formulating treatment guidelines.

    Last month, ASCO unveiled its Cancer Value Framework, which considers a drug's clinical benefit and toxicity to determine the value of a drug relative to its price (see BioCentury, July 20).

    Additionally, at least one PBM, Express Scripts Holding Co. (NASDAQ:ESRX), has said that it will use new tools like the ASCO framework and the Drug Abacus from Memorial Sloan Kettering Cancer Center to determine the value cancer drugs provide for the PBM's pilot of an indication-based pricing model (see BioCentury, July 20).

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