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Nov. 24, 2015, 7:06 AM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Entresto (sacubitril/valsartan) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction.
- The data supporting approval was generated in the PARADIGM-HF study which showed patients receiving Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those receiving enalapril.
- An estimated 15M Europeans are affected by heart failure.
- Previously: European Ad Comm backs Novartis' Entresto for heart failure (Oct. 5)
Nov. 20, 2015, 5:34 PM
- A little under three months after the EU approved it, the FDA has approved the use of Novartis' (NYSE:NVS) Tafinlar and Mekinist "for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma."
- Novartis states the treatment is "the first targeted therapy combination demonstrating more than two years overall survival in patients with the most aggressive form of skin cancer." Over 5K patients have used the combo treatment in clinical trials since 2014. The FDA granted priority review for it in July.
- Novartis' Tafinlar/Mekinist revenue totaled $135M in Q3.
Nov. 18, 2015, 10:31 AM
- Thermo Fisher Scientific (TMO +0.4%) enters into a long-term agreement with Novartis (NVS +0.6%) and Pfizer (PFE +0.6%) to develop and commercialize a multi-marker, universal next-generation sequencing (NGS) oncology test that will serve as a companion diagnostic for non-small cell lung cancer (NSCLC). The collaboration has the potential to accelerate the development and registration on several new drugs targeting NSCLC.
- The test will be developed using Thermo's Ion PGM Dx system and Oncomine assays, based on the its Ion AmpliSeq technology which enables simultaneous sequencing of hundreds of genes with high reproducibility and rapid turnaround time.
- Financial terms are not disclosed.
Nov. 17, 2015, 1:00 PM
- AstraZeneca's (AZN +1.7%) Tagrisso (osimertinib), cleared by the FDA four days ago, will cost $12,750 for a month's supply. According to the company, the price is comparable to Pfizer's (PFE +0.4%) XALKORI (crizotinib) and Novartis' (NVS +1%) ZYKADIA (ceritinib).
- The company believes Tagrisso could be a blockbuster, generating peak sales of $3B per year.
Nov. 17, 2015, 7:06 AM
- Roche's (OTCQX:RHHBY) Genentech unit exercises its option to participate in the financial arrangements related to Novartis' (NYSE:NVS) rights under its ex-U.S. agreement with Ophthotech (NASDAQ:OPHT) for Fovista (pegpleranib) for the treatment of wet age-related macular degeneration (wet AMD). Roche's option originates from a pre-existing agreement with Novartis. Specific financial terms are not disclosed.
- Ophthotech's deal with Novartis, inked in May 2014, remains in effect. Ophthotech retains exclusive rights to Fovista in the U.S. while Novartis owns exclusive rights ex-U.S. Ophthotech has the potential to earn more than $1B in upfront and milestone payments during the course of the collaboration.
- Last month, patient recruitment was completed in a Phase 3 clinical trial assessing the combination of Fovista and Roche's Lucentis (ranibizumab) in wet AMD. Top line data should be available in Q4 2016.
- Previously: Ophthotech completes enrollment in second late-state study of Fovista in wet AMD (Oct. 26)
- Previously: Novartis acquires rights to ophthalmic drug (May 19, 2014)
- Previously: More on Novartis/Ophthotech commercialization deal (May 20, 2014)
Nov. 10, 2015, 9:00 AM
- The FDA approves Perrigo's (NYSE:PRGO) generic version of Upsher-Smith Labs' KlorCon (potassium chloride) extended-release tablets (600 mg and 750 mg) that are marketed by Sandoz Pharmaceuticals (NYSE:NVS). The product is indicated for the treatment of hypokalemia (low levels of potassium in the blood).
- The U.S. market for the both generic and branded offerings is ~$81M.
Nov. 5, 2015, 11:34 AM
- The European Medicines Agency (EMA) validates Bristol-Myers Squibb's (BMY +0.1%) type II variation application seeking approval for the use of Opdivo (nivolumab) for the treatment of adults with advanced renal cell carcinoma (RCC) after prior therapy. Validation confirms that the application is complete and the review process is underway.
- The application for Opdivo's expanded label is based on data from the Phase 3 Checkmate-025 study which showed superior overall survival in patients with metastatic kidney cancer compared to Novartis' (NVS +0.4%) Afinitor (everolimus).
- The European Commission approved Opdivo for the treatment of advanced melanoma in June.
- Previously: Late-stage kidney cancer study comparing Bristol-Myers' Opdivo and Novartis' Afinitor stopped early after Opdivo shows superior overall survival (July 20)
- Previously: Bristol-Myers' Opdivo cleared in Europe (June 19)
Oct. 30, 2015, 10:21 AM
- Key points from this morning's call from Bill Ackman's Pershing Square Capital Management (PSCM) regarding Valeant Pharmaceuticals (VRX -4.2%). The notes start mid way in the presentation due to the inability to log on earlier.
- Example given of Novartis's (NVS) legal issue in 2013 with specialty pharmacies where it allegedly paid kickbacks to them to induce them to recommend its drugs. It only contracted with pharmacies that stated they could convert patients to Novartis drugs. Amount of payments tied to success of the conversions. This week, NVS agreed to pay $390M to settle all claims. It intends to continue using specialty pharmacies despite the alleged misconduct.
- PSCM aware of VRX's specialty pharmacy strategy at time of investment. Not aware of Philidor option until last week. VRX did not regard its $100M option premium as material. It did the deal to prevent Philidor from working with competitors. It didn't buy it outright because it was not comfortable with pharma laws in all 50 states and couldn't find an informed lawyer with expertise in the area.
- PSCM expects more negative press in the near term but feels VRX is resilient and will soldier on. Cites diversified portfolio. Consensus 2016 EPS view: $16.15 (+41%). If all Philidor business eliminated, the company is still cheap (~8x 2016 cash EPS). Long-term model shows stock could trade as high as ~$500 by 2019. Equates situation to American Express's salad oil scandal in 1963.
Oct. 30, 2015, 6:57 AM
- The FDA approves Novartis' (NYSE:NVS) dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or sudden symptoms of COPD.
- The commercial launch will commence in Q1.
- The FDA also approves Seebri Neohaler (glycopyrrolate) inhalation powder 15.6 mcg - one component of Utibron Neohaler - as a stand-alone monotherapy for the same COPD indication as Utibron. It will be commercially available in Q1 as well.
Oct. 27, 2015, 9:57 AM
- Novartis (NVS -2%) Q3 results: Revenues: $12,265M (-5.6%), Pharmaceuticals: $7,593M (-4.2%), Alcon: $2,346M (-12.0%), Sandoz: $2,326M (-3.1%); Operating Income: $2,234M (-18.4%); Net Income: $1,812M (-41.6%); EPS: $0.75 (-40.9%); Free Cash Flow: $2,788M (-11.0%).
- Growth Products: Gilenya: $696M; Tasigna: $416M; Afinitor: $414M; Tafinlar + Mekinist: $135M; Revolade: $117M; Jakavi: $103M; Cosentyx: $88M.
- 2015 Guidance: Group Net Sales Growth: mid single digit (unch); Core Group Operating Income Growth: high single digit (unch).
Oct. 27, 2015, 3:37 AM
- Novartis (NYSE:NVS) has agreed to pay $390M to resolve a lawsuit claiming the company paid kickbacks to increase sales of several prescription medicines including Myfortic, Exjade, Tasigna, Gleevec and TOBI.
- The settlement digs heavily into the drugmaker's third quarter profit. Today, Novartis reported that Q3 net income fell 42% to $1.81B (while core net income, which strips out one-time events such as settlements, fell 2% to $3.06B).
Oct. 26, 2015, 5:30 PM
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Oct. 23, 2015, 12:56 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Novartis' (NVS +1%) IL-17 inhibitor Cosentyx (secukinumab) for the treatment of psoriatic arthritis (PA) and ankylosing spondylitis (AS).
- Specifically, the recommended indications are the treatment of active PA in adults either as monotherapy or in combination with methotrexate when the response to previous DMARD (disease-modifying anti-rheumatic drug) therapy has been inadequate and the treatment of adults with AS who have not responded adequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs).
- As the name implies, psoriatic arthritis is a form of arthritis that strikes some people with psoriasis. Ankylosing spondylitis is an inflammatory condition that causes the vertebrae in the spine to fuse together which results in a loss of flexibility and hunched-forward posture.
- A final decision by the European Commission usually takes ~60 days.
- Cosentyx was cleared in the EU and U.S. in January for the treatment of moderate-to-severe plaque psoriasis.
- Previously: Cosentyx cleared in Europe (Jan. 19)
- Previously: FDA clears Cosentyx (Jan. 21)
Oct. 22, 2015, 10:16 AM
- Exelixis (EXEL +1.5%) initiates the rolling submission of its New Drug Application (NDA) seeking clearance of Breakthrough Therapy-tagged cabozantinib for the second-line treatment of advanced renal cell carcinoma (RCC). The company expects to complete the filing before year end.
- The data supporting the application was generated in the Phase 3 METEOR study which showed treatment with cabozantinib reduced the risk of cancer progression or death by 42% versus Novartis' (NVS -0.3%) Afinitor (everolimus).
- Cabozantinib, branded as COMETRIQ, is currently cleared for the treatment of metastatic medullary thyroid cancer.
Oct. 12, 2015, 11:28 AM
- Novartis (NVS +0.2%) agrees to invest another $15M in Gamida Cell, a Jerusalem-based developer of stem cell therapies. The new investment, representing a 2.5% stake, will raise its total investment to $50M, or 17.5%. The deal could grow to $600M if Novartis exercises a buyout option that expires in 2016. It will invest an additional $10M if Gamida is successful in closing equity financing by the end of 2017.
- Gamida intends to use the funds to initiate a Phase 3 clinical trial evaluating NiCord in blood cancers in mid-2016.
- NiCord, an ex vivo expanded cell graft, is in development as an alternative to bone marrow transplant for patients who cannot find a donor with fully matched tissue. It utilizes the company's proprietary NAM platform technology to expand cells from umbilical cord blood.
Oct. 12, 2015, 8:00 AM
- Results from a randomized, double-blind, double-dummy Phase 4 study showed Amgen's (NASDAQ:AMGN) Prolia (denosumab) achieved greater gains in bone mineral density (BMD) than the intravenous biphosphonate zoledronic acid [Novartis' (NYSE:NVS) Zometa] in postmenopausal women with osteoporosis following treatment with oral biphosphonates. The data were presented at the American Society for Bone and Mineral Research Annual Meeting in Seattle.
- Biphosphonates [e.g. Merck's (NYSE:MRK) Fosamax (alendronate sodium)] are commonly used as first-line treatment for osteoporosis.
- The 12-month study enrolled 643 postmenopausal women with osteoporosis who had been taking oral biphosphonates for at least two years. They were randomized 1:1 to receive either subcutaneous denosumab 60 mg every six months plus intravenous placebo once yearly (n=321) or intravenous zoledronic acid 5 mg once yearly plus subcutaneous placebo every six moths (n=322).
- The primary endpoint was the change from baseline in lumbar spine BMD at month 12. The change in the denosumab arm was greater (+3.2%) than the zoledronic acid arm (+1.1%). The results were highly statistically significant (p<0.0001). The denosumab cohort also beat the zoledronic acid group in changes in BMD in the total hip, femoral neck and 1/3 radius.
- No new safety issues were identified. Both arms showed similar incidences of adverse events.
- Prolia, cleared by the FDA in June 2010, is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of men with osteoporosis at high risk of fracture and men/women who are at high risk of fracture receiving certain therapies.
- Prolia generated almost $1.2B in sales over the past four quarters.
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