Fri, Feb. 27, 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)
Fri, Feb. 27, 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.
Wed, Feb. 25, 1:43 PM
Wed, Feb. 25, 12:36 PM
- Citing good progress in obtaining clearances and approvals, GlaxoSmithKline (GSK +0.1%) expects to complete its three-part deal with Novartis (NVS -0.2%) sometime during the first week in March.
- The transaction, first announced in April of last year, consists of GSK buying NVS's vaccines business, the creation of a consumer healthcare joint venture between the two firms and the sale of GSK's marketed oncology portfolio to NVS, including related R&D and the rights to two AKT inhibitors in development.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (April 22, 2014)
Mon, Feb. 23, 3:55 PM
- The FDA approves Novartis' (NVS +0.3%) Farydak (panobinostat) for the treatment of patients with multiple myeloma (MM), the first histone deacetylase (HDAC) inhibitor cleared for this indication. It is intended for patients who have received two prior standard therapies, including bortezomib (Velcade) and an immunomodulatory agent. Farydak should be used in combination with bortezomib, a chemotherapy agent, and dexamethasone, a corticosteroid anti-inflammatory medicine.
- In November, the Oncologic Drugs Advisory Committee voted 5 - 2 that the benefits of panobinostat did not outweigh the risks. After the meeting, the company submitted additional data supporting the use of Farydak in MM patients who had received at least two prior standard therapies, including bortezomib and dexamethasone.
- Multiple myeloma afflicts ~22K Americans each year, with ~50% mortality rate within the first year of diagnosis.
- Previously: Ad Comm votes against panobinostat (Nov. 6, 2014)
- Previously: Priority review period for Novartis cancer drug extended (Nov. 25, 2014)
Mon, Feb. 23, 12:42 PM| Mon, Feb. 23, 12:42 PM | Comment!
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Fri, Feb. 13, 1:24 PM
- The FDA will review Novartis' (NVS -0.1%) New Drug Application (NDA) for LCZ696 under its Priority Review program, which shortens the total review clock from twelve months to eight. Approval could happen as early as August.
- The company has lofty expectations for LCZ696, an angiotensin receptor-neprilysin inhibitor (ARNI) for the treatment of heart failure with reduced ejection fraction. It projects peak sales of $5B.
- Previously: Novartis chief says new heart failure drug will be a winner (Oct. 28, 2014)
- Previously: Novartis heart drug study stopped early due to compelling efficacy (Aug. 11, 2014)
Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Thu, Feb. 5, 8:12 AM
- GlaxoSmithKline (NYSE:GSK) commences an offering of its entire stake of 4,471,202 shares (7.9%) of Danish biotech GenMab. The company is selling its position because it no longer considers it a core asset since it sold its oncology portfolio to Novartis (NYSE:NVS).
- The outcome of the divestment should be announced today.
Mon, Feb. 2, 6:46 AM
- The FDA approves Alcon's (NYSE:NVS) Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7% for the treatment of patients with ocular itching associated with allergic conjunctivitis. Pazeo, administered one drop per day, is effective for 24 hours post dose.
- It will be available by prescription in the U.S. in March, followed by Latin American and Asian markets through 2017.
Tue, Jan. 27, 7:13 AM
- Novartis (NYSE:NVS) Q4 results ($M): Revenues: 14,633 (-3.0%); Pharmaceuticals: 7,860 (-5.6%); Alcon: 2,703 (+1.8%); Sandoz: 2,512 (+4.2%); Vaccines: 494 (-24.6%); Consumer Health: 1,064 (+2.9%).
- COGS: 5,369 (+1.1%); R&D Expense: 2,753 (+2.1%); SG&A Expense: 3,676 (-23.0%); Net Income: 1,487 (-27.7%); EPS: 0.62 (-24.4%); CF Ops: 5,205 (+17.0%); Quick Assets: 13,862 (+50.3%).
- Gross Profit: 9,504 (-5.4%); COGS: 36.7% (+4.1%); Gross Margin: 64.9% (-0.2%); Operating Profit: 1,172 (-50.6%); Operating Earnings Yield: 8.0% (-49.1%); Net Earnings Yield: 10.2% (-25.5%).
- Key Product Sales: Gleevec/Glivec: 1,237 (+0.8%), Gilenya: 666 (+26.4%), Lucentis: 588 (-6.7%), Tasigna: 428 (+21.6%), Afinitor/Votubia: 426 (+18.0%), Sandostatin: 416 (0.0%).
- 2015 Guidance: Group Net Sales Growth: Mid-single digit; Core Group Operating Income Growth: High-single digit; Pharmaceuticals Growth: Mid-single digit; Alcon Growth: Mid-to-high single digit; Sandoz Growth: Mid-single digit.
Tue, Jan. 27, 6:09 AM
Mon, Jan. 26, 5:30 PM
Fri, Jan. 23, 4:34 PM
- The FDA approves Novartis' (NYSE:NVS) Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals ages 10 through 25.
- This approval, including Pfizer's clearance in October, covers the last remaining uncovered main serogroup of N. meningitidis bacteria that causes meningococcal disease: A, B, C, W and Y.
- Previously: Pfizer seeks regulatory approval for meningitis vaccine (June 17, 2014)
- Previously: Novartis submits BLA for vaccine (June 17, 2014)
Fri, Jan. 23, 9:26 AM
- Array BioPharma (NASDAQ:ARRY) acquires worldwide rights to Novartis' (NYSE:NVS) encorafenib, a BRAF inhibitor currently in Phase 3 development for the treatment of melanoma, contingent on the closing of the Novartis/Glaxo transaction that was announced last April.
- Under the terms of the agreement, Array will make a de minimus (minimal) payment to Novartis but no milestones or royalties will be paid by either party. Novartis will provide transitional regulatory, clinical development and manufacturing services. Specifically, it will conduct and fund the Phase 3 Columbus trial through the earlier of June 30, 2016 or the completion of the first visit from the last patient. Array will take responsibility for the trial at this point with Novartis reimbursing Array for out-of-pocket costs in addition to half of Array's full-time equivalent (labor) costs associated with completing the trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined period. For all studies transferred to Array, Novartis will reimburse Array under the same guidelines as it will for the Columbus trial.
- Array agrees to recruit a partner that has experience in global development and commercialization.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (April 22, 2014)
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