Seeking Alpha
  • Friday, February 27, 2015

  • 7:14 PM
    • Shortly after CEO Keith Murphy suggested another capital raise is on the way to help his company grow its R&D investments, Organovo (NYSEMKT:ONVO) has filed to raise up to $190M via future stock, debt, and/or warrant offerings. (prospectus)
    • The 3D-printed tissue developer had $50M in cash at the end of 2014, and no debt. Shares have fallen to $5.67 AH.
    | 11 Comments
  • 5:35 PM
    • OPKO Health (NYSE:OPK): Q4 EPS of -$0.12 may not be comparable to consensus of -$0.06.
    • Revenue of $25.5M (+23.2% Y/Y) beats by $0.9M.
    • Press Release
    | Comment!
  • 3:26 PM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for Novartis' (NVS -0.4%) Zykadia (ceritinib) for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib (Pfizer's Xalkori). If approved, it will be the first treatment option for ALK+ NSCLC patients previously treated with crizotinib in the E.U.
    • NSCLC is the most common form of lung cancer, accounting for 85 - 90% of all cases worldwide. Of those, 2 - 7% are characterized by a rearrangement of the ALK gene, which increases the growth of cancer cells.
    • A final decision by the European Commission usually takes ~60 days.
    • The FDA approved Zykadia for ALK-positive NSCLC patients in April of last year.
    • Previously: FDA approves Novartis breakthrough therapy cancer drug (April 29, 2014)
    | Comment!
  • 1:56 PM
    • The FDA accepts under Priority Review Bristol-Myers Squibb's (BMY -0.4%) Biologics License Application (BLA) for the use of Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The PDUFA date is June 22.
    • The company stopped the Phase 3 trial early based on the recommendation of the independent Data Monitoring Committee after the study met its primary efficacy endpoint of superior overall survival compared to docetaxel.
    • Nivolumab is a human programmed death receptor -1 (PD-1) inhibitor currently currently approved for the treatment of metastatic melanoma.
    • Previously: Bristol-Myers stops cancer trial early after Opdivo meets efficacy endpoint (Jan. 11)
    | 1 Comment
  • 1:40 PM
    • Thinly-traded nano cap Nymox Pharmaceutical (NYMX +27%) jumps on a more than a 7x surge in volume on no news.
    • Shares collapsed in early November after the company reported the failure of two clinical trials assessing NX-1207 in benign prostate hyperplasia.
    • Previously: Nymox plummets after failure of BPH trials (Nov. 3, 2014)
    | Comment!
  • 1:28 PM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the use of Roche's (OTCQX:RHHBY +0.5%) Avastin (bevacizumab), in combination with standard chemotherapy, for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer. Cancer of the cervix strikes over 30K European women each year.
    • Avastin is currently approved in the E.U. for the treatment of breast, colorectal, non-small cell lung, kidney and ovarian cancers.
    • The U.S. FDA cleared Avastin for cervical cancer in August of last year.
    • Avastin is Roche's second best seller, generating $6.4B in sales last year.
    | Comment!
  • 1:10 PM
    • According Immunovaccine, there is no collaboration agreement with Gilead Sciences (GILD -1.2%). The press release published earlier today was apparently fraudulent. The company says it uses Marketwired for its PRs, not GlobeNewswire and says that the bogus PR contained no accurate information.
    • The post will be deleted from the SA site.
    | 7 Comments
  • 12:55 PM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion to update the therapeutic indication of Alexion Pharmaceuticals' (ALXN -1.4%) Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) for patients with high disease activity regardless of history of transfusion.
    • Alexion SVP Carsten Thiel, Ph.D., says, "The positive CHMP opinion is an important milestone as it underscores that complement-mediated hemolysis, not transfusions, is the key clinical indicator of the risk for devastating and life-threatening consequences in patients with PNH. We believe that, if approved by the European Commission, the updated EU label will better guide physicians in assessing and optimizing care for patients with this life-threatening and ultra-rare disorder." PNH is an ultra-rare blood disorder which results in the destruction of the patient's red blood cells (hemolysis).
    • CHMP also adopts a positive opinion to update Soliris' European label with additional data on the benefits of long-term treatment and the risks associated with the discontinuation of treatment in patients with atypical hemolytic uremic syndrome (aHUS). If approved, the label will specify that longer term treatment with Soliris is associated with an increase in the percentage of patients who experience clinically meaningful improvements. Based on treatment of more than 26 weeks, additional patients may achieve complete thrombotic microangiopathy (TMA) response and hematologic normalization. AHUS is an ultra-rare genetic disorder that causes the formation of blood clots in small blood vessels throughout the body.
    | Comment!
  • 12:20 PM
    • According the the World Health Organization (WHO), a recommendation from the Strategy Advisory Group of Experts (SAGE), an independent advisory body, to commence the widespread introduction of an Ebola vaccine won't happen until at least August due to the timing of results from clinical trials.
    • Liberia is currently testing vaccine candidates from GlaxoSmithKline and Merck-NewLink. Sierra Leone and Guinea will announce their plans soon.
    • The steep decline in Ebola cases will make it more difficult to prove the efficacy of the experimental vaccines so some of the testing may have to be moved to Sierra Leone, according to the U.S. National Institutes of Health.
    • More than 23,500 cases of Ebola have been reported in the three African countries, with more than 9,500 fatalities. Only 99 new confirmed cases were reported for last week.
    • (GSK -0.6%)(MRK -0.5%)(NLNK +1.2%)(GILD -0.8%)
    | 1 Comment
  • 11:57 AM
    • In addition to missing Q4 revenue estimates (while posting in-line EPS), Allscripts (NASDAQ:MDRX) has guided for 2015 revenue of $1.43B-$1.46B, below a $1.47B consensus. EPS guidance of $0.42-$0.50 is in-line with a $0.46 consensus.
    • Also: Q4 bookings fell 11% Y/Y to $244M, a bigger drop than Q3's 5%. The healthcare hardware/software provider states "a decline in client demand for patient portal solutions" offset "double-digit growth in ambulatory solutions, managed IT services, and international sales." SaaS bookings made up 48% of total bookings vs. 44% a year ago.
    • System sales (drives future services revenue) fell 22% Y/Y to $21.6M, and professional services 17% to $50.5M. Maintenance revenue fell 2% to $118M, and transaction processing/other grew 6% to $150.8M.
    • Boosting EPS: Operating expenses fell 9% Y/Y thanks to "initiatives to decrease corporate SG&A expenses, streamline business functions, and leverage prior investments in [R&D]." Gross margin fell 50 bps to 43.9%.
    • Shares are close to a 52-week low of $11.00.
    • Q4 results, PR
    | Comment!
  • 11:56 AM
    • By order of the Japanese Ministry of Health, Labor and Welfare, Novartis' (NVS -0.3%) Japanese unit will suspend its operations for 15 days in March (5th - 19th) as punishment for not reporting side effects from its products in a timely fashion. The ministry stated that the company failed to report 3,264 cases of side effects pertaining to 26 drugs within the time frame specified by law.
    • Novartis Japan has accepted the punishment and apologized to patients and doctors for "causing trouble and worry." It also said that it bolstered employee education to ensure that safety reports are submitted correctly.
    • This is the first time the ministry has issued a suspension for failure to report side effects.
    | Comment!
  • 11:19 AM
    • The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Otsuka Pharmaceutical Co.'s (OTCPK:OTSKF) (OTCPK:OTSKY) Orphan Drug-designated Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD).
    • ADPKD is a chronic and progressive genetic disorder characterized by the growth of numerous cysts in both kidneys. The progressive expansion of the cysts slowly replaces the normal mass of the kidneys, reducing their function and leading to failure. It affects ~200K Europeans.
    • In a Phase 3 trial, patients treated with tolvaptan showed a 49% reduction in the annual increase total kidney volume versus placebo and a reduction in the decline in kidney function by 30% compared to placebo.
    • A final decision from the European Commission usually takes ~60 days. If approved, Jinarc will have a 10-year period of market exclusivity in the E.U. for this indication.
    | Comment!
  • 10:48 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion to extend the marketing authorization for Amgen's (AMGN -0.6%) Vectibix (panitumumab) to include combination with the chemotherapy regimen FOLFIRI as first-line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC), which constitutes ~50% of mCRC patients.
    • Vectibix is currently cleared Europe for the treatment of adult patients with wild-type RAS mCRC as first-line treatment in combination with the chemo regimen FOLFOX; as second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) and as monotherapy after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
    • A final decision from the European Commission usually takes ~60 days.
    • Vectibix generated $505M in sales last year.
    | Comment!
  • 10:28 AM
    • The FDA approves Allergan's (AGN +0.1%) Natrelle Inspira round gel-filled smooth breast implant. The product has a higher fill ratio which provides an additional shaping option for women undergoing reconstruction, augmentation or revision surgery.
    • Allergan acquired the breast implant business via its buyout of Inamed in 2005.
    | Comment!
  • 9:59 AM
    • Biogen Idec (BIIB -0.5%) and collaboration partner Swedish Orphan Biovitrum AB announce positive top-line results from a Phase 3 trial evaluating Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) in children under age 12 with severe hemophilia B.
    • Medical professionals recommend prophylactic treatment in children with severe hemophilia in order to manage and/or prevent bleeding episodes, but frequent administration schedules can be burdensome for patients and caregivers. Alprolix is administered once every 7 - 10 days for routine prophylaxis (prevention).
    • In the study, children treated with Alprolix experienced an overall median annualized bleeding rate (ABR) of 1.97, while the median ABR for spontaneous joint bleeds was zero. About one third of the participants had no bleeding episodes at all. Overall, 91.7% of bleeding episodes were controlled by one or two infusions of Alprolix. None of the patients produced inhibitors (antibodies) to Alprolix in the study, which was the most significant potential complication of treatment.
    • The European Medicines Agency requires the inclusion of pediatric study data in the initial Marketing Authorization Application (MAA) for a new hemophilia treatment. Interim data were used in the U.S. New Drug Application (NDA).
    • Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body. The FDA cleared it in March of last year. It generated $25.3M and $40.3M in sales for Biogen in Q3 and Q4, respectively.
    • Related tickers: (BAX +0.3%)(OPK -0.8%)(SGMO -1.9%)(ALNY -1.9%)(ONCE +3%)(PFE -0.2%)(SHPG -1.6%)
    | 4 Comments
  • 9:31 AM
    • Isis Pharmaceuticals (NASDAQ:ISIS): Q4 EPS of $0.25 may not be comparable to consensus of $0.02.
    • Revenue of $84.9M (+100.9% Y/Y) beats by $10.32M.
    • Press Release
    | Comment!
  • 9:23 AM
    • The European Medicines Agency (EMA) accepts Amgen's (NASDAQ:AMGN) Marketing Authorization Application (MAA) seeking approval for the use of Kyprolis (carfilzomib) for the treatment of patients with relapsed multiple myeloma (MM) who have received at least one prior therapy. The EMA will review the MAA under its accelerated assessment protocol.
    • Approximately 90K Europeans are living with MM. There are ~40K new cases diagnosed each year and ~24K deaths.
    • Kyprolis, a proteasome inhibitor, was cleared by the FDA in July 2012. It generated $331M in sales for Amgen in 2014.
    | Comment!
  • 9:01 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) amend their long -standing collaboration agreement to transition the sole responsibility for the development and commercialization of Zaltrap (ziv-aflibercept) Injection for Intravenous Infusion for cancer indications worldwide to Sanofi.
    • Sanofi will now bear all development and commercialization costs and will reimburse Regeneron for its costs related to such activities. It will also pay Regeneron 15 - 30% of aggregate net sales of Zaltrap each year. Regeneron will no longer be required to reimburse Sanofi for 50% of the development expenses pertaining to Zaltrap per the original agreement.
    • Zaltrap generated €69M in sales for Sanofi last year. Regeneron booked a total of $541.3M in 2014 from its overall collaboration with Sanofi.
    | 2 Comments
  • 8:28 AM
    • Two Phase 3 studies show that Gilead Sciences' (NASDAQ:GILD) investigational single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naive adults was statistically non-inferior (no worse than) to Gilead's Stribild (elvitegravir 150 gm/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablets) with significantly better renal and bone laboratory parameters. TAF is a novel nucleotide reverse transcriptase inhibitor with high antiviral efficacy at a dose 10x lower than Gilead's Viread (tenofovir disoproxil fumarate).
    • In a combined analysis, 92.4% of patients receiving the single tablet TAF regimen (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg), or E/C/F/TAF, achieved HIV RNA levels less than 50 copies/mL compared to 90.4% for those taking Stribild. The rates of virologic success were similar across patient subgroups.
    • Patients receiving E/C/F/TAF showed less stress to the medicine than the Stribild cohort based on laboratory parameters of kidney, bone and plasma lipid levels. There were statistically significant differences in glomerular filtration rate (test of kidney function) from baseline and bone mineral density loss both favoring E/C/F/TAF. Patients on the TAF regimen also demonstrated higher plasma lipid levels.
    • Gilead filed a New Drug Application (NDA) with the FDA on November 5, 2014 seeking clearance for E/C/F/TAF. The PDUFA date is November 5 of this year.
    • Investigators presented the data at the 22nd Conference on Retroviruses and Opportunistic Infections in Seattle.
    | 17 Comments
  • 8:11 AM
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