Thu, Jun. 2, 4:53 PM
- With the aim of informing doctors, Novartis (NYSE:NVS) inks a deal with Eisai (OTC:ESALF)(OTCPK:ESALY) to co-promote Lenvima (lenvatinib) capsules in the U.S. The FDA approved it last month, in combination with Afinitor (everolimus), for the treatment of patients with advanced renal cell carcinoma who have been previously treated with an anti-angiogenic therapy. It was first approved in February 2015 for treatment-resistant thyroid cancer.
- Under the terms of the agreement, the companies will promote the availability of the combination regimen to healthcare professionals nationwide and participate in certain joint medical education activities. Each company will continue to book sales of its respective product.
Thu, Jun. 2, 8:21 AM
- Buoyed by discussions with the FDA, GlaxoSmithKline (NYSE:GSK) plans to file its New Drug Application (NDA) seeking approval of its triple combination therapy for the treatment of chronic obstructive pulmonary disease (COPD) by the end of 2016 instead of H1 2018, as previously expected.
- The company's candidate, a combination of fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI), employs three different mechanisms of action to help open the airways of COPD patients, a more effective approach compared to current doublet therapies.
- Glaxo aims to maintain its lead in respiratory medicine, especially against AstraZeneca (NYSE:AZN) and Novartis (NYSE:NVS) who are developing their own "closed triple" combination products.
Tue, May 24, 4:47 PM
- PDL BioPharma (NASDAQ:PDLI), through an equity investment in privately held Noden Pharma DAC, acquires Novartis' (NYSE:NVS) anti-hypertension meds Tekturna (aliskiren) and Tekturna HCT (aliskiren and hydrochlorothiazide) tablets in the U.S. The products are marketed as Rasilez and Rasilez HCT in the rest of the world.
- Novartis, through an Asset Purchase Agreement with Noden, will receive an upfront payment of $110M, $89M on the first anniversary of the closing of the deal and up to $95M in milestones related to the achievement of sales targets and the date of the launch of a generic version of aliskiren.
- PDLI's investment in Noden will eventually reach 88%. It expects to make equity contributions of $107M in the first year of the transaction, including $75M at closing and an additional $32M on the one-year anniversary of the closing.
- Noden is expected to secure debt financing in conjunction with the PDLI investment. PDLI expects to invest no more than $145M, but it could potentially rise to $294M depending on the amount of debt raised by Noden. In other words, PDLI will make Novartis whole through additional equity investments in Noden if it cannot secure the expected amount of debt.
- PDLI will consolidate Noden' financials into its own, which are expected to be immediately accretive.
- The acquired products generated $154M in sales in 2015.
- Update: On July 6, PDL announced that the equity investment had closed.
Tue, May 24, 7:05 AM
- The FDA approves Holly Springs, NC-based Seqirus' FLUCELVAX QUADRIVALENT, the firs four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people at least four year old. The vaccine helps protect individuals against two influenza A and two B viruses for the current flu season.
- The traditional flu vaccine is trivalent, consisting of two influenza A viruses and one influenza B strain, although Sanofi's (NYSE:SNY) quadrivalent flu vaccine was approved by the FDA in December 2014 for use in adults.
- Each year, about 200K Americans are hospitalized due to flu complications.
- Seqirus was created in July 2015 when bioCSL and Novartis' (NYSE:NVS) influenza vaccines business combined, creating the second largest influenza vaccine company in the world. Novartis sold the business to Australian blood products firm CSL Ltd. in October 2014 for $275M.
- Related tickers: (NYSE:GSK)(NASDAQ:NVAX)(NASDAQ:SVA)(NYSEMKT:HEB)
Fri, May 20, 8:04 PM
- New global cardiology guidelines issued by three organizations may give a jump to a struggling heart-failure drug from Novartis (NVS +1.5%).
- Experts from the American College of Cardiology, the American Heart Association and the European Society of Cardiology have agreed that Novartis' Entresto should replace old ACE inhibitors and ARBs, in patients with adequate blood pressure and drug tolerance.
- The groups also said Corlanor, from Amgen (AMGN +1%), may be beneficial when given on top of beta blockers for some heart failure patients.
- Despite a heavy buildup, first-quarter sales of Entresto were just $17M and Novartis sees only $200M in sales this year.
- Now read A New Realm Of Therapeutics Is Emerging: Johnson & Johnson And Novartis Are Key Players »
Tue, May 17, 12:01 PM
- With the aim of improving its execution and elevating the strategic importance of oncology to its growth plans, Novartis (NVS +0.2%) restructures its pharmaceuticals business, renamed as the Innovative Medicines Division.
- The division will operate as two business units: Novartis Pharmaceuticals and Novartis Oncology. EVP, North America Paul Hudson will head the former and Bruno Strigini, current head of Novartis Oncology will lead the latter. Both CEOs will report directly to Novartis chief Joe Jimenez and will join the executive committee on July 1.
- David Epstein, current Division Head and CEO, Novartis Pharmaceuticals, will leave the company.
Sun, May 15, 6:04 PM
- Under its Priority Review process, the FDA approves Eisai's (OTC:ESALF)(OTCPK:ESALY) Breakthrough Therapy-tagged Lenvima (lenvatinib), in combination with Novartis' (NYSE:NVS) Afinitor (everolimus), for the treatment of patients with advanced renal cell carcinoma who have been previously treated with an anti-angiogenic therapy.
- The data supporting the approval was generated in a Phase 2 clinical trial called Study 205. Patients receiving Lenvima plus Afinitor experienced a median increase in progression-free survival of over 165% (14.6 months versus 5.5 months) compared to those receiving Afinitor alone. The combination regimen also showed a 63% reduction in the risk of disease progression or death (hazard ratio: 0.37) compared to Afinitor as monotherapy. Other endpoints favoring the combination were objective response rate (37% versus 6%) and median overall survival (25.5 months versus 15.4 months).
- The most common treatment-emergent serious adverse events were renal failure (11%), dehydration (10%); anemia (6%), thrombocytopenia (low blood platelets) (5%), diarrhea (5%), vomiting (5%) and dyspnea (difficulty breathing) (5%).
- Lenvatinib is a receptor tyrosine kinase inhibitor that inhibits multiple VEGF (vascular endothelial growth factor) receptors which play key roles in the growth of cancer cells. Interfering with the receptors' activity slows the progression of cancer by restricting the blood supply to the tumors (antiangiogenesis).
- The FDA first approved Lenvima in February 2015 for treatment-resistant thyroid cancer.
Fri, May 6, 7:21 AM
- Results from a 10-subject clinical trial in China showed a 90% complete remission rate in patients with relapsed/refractory B lymphoblastic leukemia who were treated with CAR-T cell therapy developed by a company called Innovative Cellular Therapeutics (ICT), in collaboration with First Affiliated Hospital of Zehjiang University. The data were presented at the 2016 Haematogenic Immunity Summit in Hangzhou from April 22 - 24 by Professor Huang He.
- The trial was jointly conducted by the hospital and the company, with the company paying all patient expenses. A third-party clinical research organization monitored the study.
- All 10 subjects had late-stage disease and were expected to live only several months. Nine of the ten patients achieved complete remission (including eight who had minimal residual disease (MRD) who subsequently turned negative).
- In another trial in patients with relapsed/refractory acute lymphocytic leukemia conducted by the same two partners, 87% (n=20/23) who were treated with ICT's CAR-T therapy achieved complete remission. A study in lymphoma is next up.
- According to ICT, it joins Novartis (NYSE:NVS), Juno Therapeutics (NASDAQ:JUNO) and Kite Pharma (NASDAQ:KITE) as the only companies able to demonstrate this level of success with CAR-Ts. Maybe the elite company will motivate ICT to build a website to inform investors.
Tue, May 3, 6:34 PM
- Medivation (NASDAQ:MDVN) +3.9% AH following a Reuters report that Pfizer (NYSE:PFE) has approached the company to express interest in an acquisition, raising the possibility of a bid rivaling Sanofi's (NYSE:SNY) $9.3B offer by Sanofi.
- MDVN has not yet decided whether it should engage with PFE in negotiations and is in discussions with its financial and legal advisers, according to the report.
- MDVN last week rejected SNY's $52.50/share takeover proposal, and PFE, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have been speculated as potential suitors.
Fri, Apr. 29, 4:33 PM
- Cambridge, MA-based Intellia Therapeutics (Pending:NTLA) is set for its IPO of 5M shares at $16 - 18.
- The biotech firm develops therapeutics based on the much-hyped CRISPR/Cas9 gene editing system. Its in vivo pipeline includes programs for the treatment of transthyretin amyloidosis, alpha-1 antitrypsin deficiency, hepatitis B infection and inherited metabolism disorders. Its ex vivo programs include hematopoietic stem cells and CAR T cells, the latter the focus of a collaboration with Novartis (NYSE:NVS) that could generate as much as $230M in milestones. All programs are early stage.
- 2015 Financials ($M): Operating Expenses: 19.5 (+104.0%); Net Loss: (12.4) (-130.0%); Cash Burn: (1.8) (+24.1%).
- CRISPR/Cas9 competitor Editas Medicine (NASDAQ:EDIT) debuted in early February. Today's close was $33.05, up over 100% from the IPO price of $16.
- Previously: Leading gene editing firm Editas Medicine on deck for IPO (Jan. 25)
Fri, Apr. 29, 4:12 PM
- Medtronic (MDT -0.8%) initiated with Buy rating and $93 (18% upside) price target by SunTrust Robinson Humphrey.
- Celator Pharmaceuticals (CPXX +1.5%) initiated with Buy rating and $23 (53% upside) price target by Stifel Nicolaus.
- Caladrius Biosciences (CLBS -1%) upgraded to Buy from Neutral by H.C. Wainwright with a price target of $1.25 (81% upside).
- Insulet (PODD -0.6%) upgraded to Outperform from Market Perform by William Blair with a $40 (21% upside) price target.
- Alexion Pharmaceuticals (ALXN -2.3%) upgraded to Outperform from Market Perform by BMO Capital with a $168 (21% upside) price target.
- ResMed (RMD -1.2%) upgraded to Neutral from Underperform by Macquarie. Price target lowered to $57 (2% upside) from $65.
- Stryker (SYK -0.5%) upgraded to Buy from Neutral by Sterne Agee CRT with $130 (19% upside) price target.
- Jazz Pharmaceuticals (JAZZ -0.9%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target raised to $200 (32% upside) from $164.
- Rigel Pharmaceuticals (RIGL -1.7%) upgraded to Overweight from Neutral by JP Morgan with a $5 price target.
- Novartis (NVS -1.1%) upgraded to Equal Weight from Underweight by Barclays.
- Molina Healthcare (MOH -19.4%) downgraded to Neutral from Buy by UBS. Price target lowered to $54 (4% upside) from $76.
- St. Jude Medical (STJ -2%) downgraded to Neutral from Overweight by JP Morgan. Price target raised to $82.50 (9% upside) from $66.
- Stericycle (SRCL -21.5%) downgraded to Underperform from Sector Perform by RBC. Price target lowered to $96 (1% upside) from $119.
- Sarepta Therapeutics (SRPT +2.8%) downgraded to Underperform from Hold by Jefferies with a price target of $7 (51% downside risk). Downgraded to Underweight from Neutral by Piper Jaffray. Price target lowered to $6 (57% downside risk) from $15.
- Perrigo (PRGO +0.3%) downgraded to Neutral from Buy by BTIG Research. Priced target removed.
- Trovagene (TROV -3.6%) downgraded to Hold from Buy by Cantor Fitzgerald with a $6 (50% upside) price target.
- Community Health Systems (CYH -4.6%) downgraded to Underperform from Market Perform by Raymond James with a $19 (0% upside) price target.
Fri, Apr. 29, 3:09 PM
- Also mentioned alongside AZN and PFE as weighing bids for Medivation (MDVN +2.3%) is Novartis (NYSE:NVS), according to the report.
- Earlier today, Medivation rejected Sanofi's (SNY -4.6%) $9.3B, or $52.50 per share offer, with one of Bloomberg's sources saying the company is looking for at least $65 per share. Sanofi has the capacity to go higher, say sources, but is naturally reluctant to overpay.
Wed, Apr. 27, 11:13 AM
- Privately held Sunovion Pharmaceuticals announces successful results from two Phase 3 clinical trials, GOLDEN-3 and GOLDEN-4, assessing an inhalable mist formulation of SUN-101 (glycopyrrolate) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). Both studies (25 mcg and 50 mcg doses) met their primary endpoints of a statistically valid change from baseline to week 12 versus placebo in trough forced expiratory volume in one second (FEV1). Full results will be presented at future medical conferences.
- SUN-101 is a nebulized (mist) long-acting muscarinic antagonist (LAMA) delivered via an inhalation device called eFlow, developed by the German firm PARI.
- The company intends to file a New Drug Application (NDA) with the FDA this year. According to the company, SUN-101/eFlow, if approved, will be the first nebulized LAMA available for COPD patients, but AstraZeneca (AZN -0.9%) just received FDA approval of its LAMA/LABA offering, Bevespi Aerosphere.
- Related tickers: (GSK +1.7%)(MYL -1.5%)(NVS -0.2%)(TEVA -0.2%)(THRX)(AQXP -3.3%)
- Previously: AstraZeneca up 1.6% as FDA approves COPD treatment (April 25)
Wed, Apr. 27, 8:40 AM
- The FDA grants three Breakthrough Therapy Designations (BTDs) for Novartis' (NYSE:NVS) Ilaris (canakinumab) for the treatment of three rare types of Periodic Fever Syndromes, inherited autoinflammatory disorders characterized by periodic fever frequently accompanied by joint pain and swelling, muscle pain and skin rashes. In extreme cases, the conditions can be life-threatening.
- The three conditions are: Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF) patients not adequately controlled with colchicine (gout medicine).
- The BTD tags were granted based on results from a Phase 3 umbrella study in the three disorders. The supplemental Biologic License Applications (sBLAs) are currently under review in the U.S.
- The FDA approved Ilaris in 2009 for the treatment of two subtypes of a rare autoinflammatory condition called Cryopyrin-Associated Periodic Syndromes. In 2013, it was approved for the treatment of a rare form of juvenile idiopathic arthritis.
- Canakinumab is a human monoclonal antibody that binds to the pro-inflammatory protein interleukin-1 beta.
- BTD status, designed to expedite the development and review of new promising therapies, provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the NDA.
Tue, Apr. 26, 8:04 AM
- Exelixis (NASDAQ:EXEL) is up 9% premarket on increased volume in response to its announcement that the FDA has approved lead cancer drug cabozantinib, branded as CABOMETYX, for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Market launch will commence in the next few weeks.
- The data supporting approval was generated in the Phase 3 METEOR study which showed treatment with CABOMETYX reduced the rate of cancer progression or death by 42% compared to everolimus [Novartis' (NYSE:NVS) Afinitor].
Thu, Apr. 21, 8:10 AM
- Novartis (NYSE:NVS) Q1 results ($M): Total Revenues: 11,600 (-2.8%); Pharmaceuticals: 7,729 (-2.9%); Alcon: 1,426 (-6.9%); Sandoz: 2,445 (+0.0%).
- Net Income: 2,011 (-84.5%); EPS: 0.84 (-84.2%); CF Ops: 1,542 (-18.7%).
- Oncology: 3,029 (+6.0%); Neuroscience: 847 (-6.5%); Ophthalmology: 1,370 (-13.3%); Immunology & Dermatology: 620 (+32.8%); Respiratory: 346 (+7.5%); Cardio-Metabolic: 303 (+3.8%); Established Medicines: 1,214 (-21.0%).
- 2016 Guidance: Sales and earnings in line with last year.
Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers... More
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