Tue, Mar. 10, 7:48 AM
- Ophthotech (NASDAQ:OPHT) earns a $50M enrollment milestone from commercial partner Novartis (NYSE:NVS) for reaching the second enrollment goal in its Phase 3 trial evaluating Fovista (anti-platelet-derived growth factor) in combination with anti-vascular endothelial growth factor (VEGF) therapy for the treatment of wet age-related macular degeneration (AMD).
- The company will record $40.6M of the payment as revenue in Q1. The remaining $9.4M will be deferred and recognized as revenue on a proportional basis through 2017.
- Under the terms of the license and commercialization agreement signed in May 2014, Novartis has exclusive rights to Fovista in all markets ex-U.S. while Ophthotech retains exclusive rights in the U.S. Potential payments to Ophthotech could reach over $1B, not including royalties on ex-U.S. net sales. The company expects Fovista to be the first anti-PDGF therapy approved for wet AMD.
- Previously: Ophthotech earns $50M milestone (Sept. 8, 2014)
- Previously: Novartis acquires rights to ophthalmic drug (May 19, 2014)
Tue, Mar. 10, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Fri, Mar. 6, 9:12 AM
- The FDA approves Sandoz's (NYSE:NVS) Zarxio, a biosimilar to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim), for the same indications as Neupogen.
- Zarxio is approved for the treatment of patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
- The placeholder nonproprietary name for Zarxio is "filgrastim-sndz."
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
- Related tickers: (NYSEMKT:PFNX) (NASDAQ:ESPR) (NYSE:HSP) (NASDAQ:CHRS)
Thu, Mar. 5, 8:06 AM
- Arrowhead Research (NASDAQ:ARWR) acquires Novartis' (NYSE:NVS) RNA interference (RNAi) R&D portfolio and associated assets, including certain patents and patent applications, an exclusive license to other patents and patent applications owned or controlled by Novartis, the assignment of a third party license and three preclinical product candidates.
- Specific assets include multiple patent families covering RNAi-trigger design rules and modifications that fall outside of competitors' patents which provides Arrowhead freedom to operate for any target or indication, the assignment of Novartis' license from Alnylam (NASDAQ:ALNY) that gives Arrowhead access to Alnylam IP, excluding delivery, covering 30 gene targets and three product candidates with varying amounts of preclinical data.
- Under the terms of the agreement, Arrowhead will pay $10M in cash (includes $7M paid previously) and $25M in ARWR stock within 30 days. Novartis is eligible to receive milestones and single-digit royalties on net sales.
- Arrowhead will host a conference call this morning at 8:30 am to discuss the deal.
Wed, Mar. 4, 11:39 PM
- Both boards have signed off on AbbVie's (NYSE:ABBV) $21B surprise acquisition of Pharmacyclics (NASDAQ:PCYC), announced a short while ago amid speculation that Johnson & Johnson (NYSE:JNJ) (or, earlier, Novartis (NYSE:NVS)) would be the one to acquire the cancer biotech.
- With the deal, AbbVie gets Pharmacyclics' blockbuster Imbruvica drug for hematologic malignancies -- which logged $548M in revenues in 2014 (Q4 earnings) and might go all the way to $5B/year. Imbruvica has received four indications in less than 15 months -- the latest being for Waldenström's Macroglobulinemia at the end of January.
- And with Imbruvica, AbbVie can lessen its reliance on its key drug Humira, an aging rheumatoid arthritis medication.
- The acquisition is expected to close in the middle of the year.
- Question: What happened to Pharmacyclics' Imbruvica partner JNJ on this deal?
- Previously: Pharmacyclics Q4 revenue up 135%, Imbruvica growing exponentially (Feb. 18 2015)
Mon, Mar. 2, 2:58 AM
- GlaxoSmithKline (NYSE:GSK) and Novartis (NYSE:NVS) have completed a series of asset swaps worth more than $20B that will reshape both drugmakers.
- Glaxo is forming a consumer health joint venture with Novartis, while at the same time buying the Swiss company's vaccines business and divesting its cancer drugs portfolio to Novartis.
- Following completion of the transactions, Glaxo plans to return £4B ($6.16B) to shareholders.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (Apr. 22 2014)
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| 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.
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