Teva Pharmaceutical: Bold Markets, Bold Moves
Jenks Jumps • 22 Comments
Jenks Jumps • 22 Comments
TEVA: Copaxone Patent Expiry Worries Are Overblown
Alpha Gen Capital • 10 Comments
Alpha Gen Capital • 10 Comments
Actavis Generics: A 2-Year Ticket To Insolvency?
Graham Osborn • 49 Comments
Graham Osborn • 49 Comments
Thu, Sep. 22, 8:53 AM
- Top-line data from a Phase 3 clinical trial, AIM-TD, assessing Teva Pharmaceutical Industries' (NASDAQ:TEVA) SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD) showed a statistically valid treatment benefit. The positive data follow successful results from an earlier Phase 3, ARM-TD, announced in June 2015. The company plans to file a New Drug Application (NDA) in the U.S. by year end.
- The primary endpoint was the reduction in involuntary movements versus placebo as measured by the Abnormal Involuntary Movement Scale (AIMS) from baseline to Week 12 for three fixed doses of SD-809 (12 mg, 24 mg and 36 mg tablets titrated for four weeks to the targeted randomized dose then maintained for eight weeks). Placebo tablets were administered twice daily for 12 weeks.
- At Week 12, the improvements in AIMS scores for 12 mg, 24 mg, 36 mg and placebo were -2.1, -3.2, -3.3 and -1.4, respectively. All were statistically significantly greater than placebo except the 12 mg dose. The 24 mg and 36 mg doses also demonstrated superiority to placebo as measured by the Clinical Global Impression of Change (CGI), an investigator-generated metric. Complete data will be presented at a future medical conference.
- SD-809 is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
- TD is a difficult-to-treat neurological disorder characterized by involuntary repetitive body movements. It commonly occurs in patients on long-term high-dose antipsychotic drugs.
- Previously: Teva's SD-809 successful in mid-stage study in movement disorder (June 16, 2015)
Wed, Sep. 21, 1:04 PM
- As previously reported, Bayer (OTCPK:BAYRY) aims to jettison its dermatology business in order to help fund its Monsanto buy. Although discussions are in the early phase, there appears to be plenty of interested parties. In addition to skincare-focused players like Allergan (NYSE:AGN), Almirall (OTC:LBTSF) and Nestle (OTCPK:NSRGY)(OTCPK:NSRGF), Teva Pharmaceutical Industries (NASDAQ:TEVA), Perrigo (NASDAQ:PRGO) and Sun Pharma (OTC:SMPQY) are also reportedly in the mix.
- On the institutional investor side, KKR (NYSE:KKR), Nordic Capital, Bain Capital, Blackstone Group (NYSE:BX) and Cinven may also be eyeing the unit which, analysts say, could fetch $1.1B.
- Previously: Bloomberg: Bayer eyes sale of $1.1B dermatology business (Sept. 8)
Tue, Sep. 20, 7:40 AM
- Teva Pharmaceutical Industries (NASDAQ:TEVA) and Regeneron Pharmaceuticals (NASDAQ:REGN) enter into a global agreement to develop and commercialize Regeneron's fasinumab, currently in Phase 3 for osteoarthritis pain and Phase 2 for chronic lower back pain.
- Under the terms of the deal, Regeneron will receive an upfront payment of $250M plus milestones and will equally share the global commercial value as well as the ~$1B R&D costs. It will lead global development and U.S. commercialization while splitting the U.S. profits 50/50. Outside of the U.S., exclusive of the territory (11 countries in Asia) covered in a previous collaboration between Regeneron and Mitsubishi, Teva will be responsible for development and commercialization and will pay Regeneron a specific purchase price for the product.
- Fasinumab is a fully human monoclonal antibody that targets Nerve Growth Factor (NGF), a protein that plays a key role in the regulation of pain signaling.
Mon, Sep. 19, 8:50 AM
- Top-line results from an exploratory dose-ranging Phase 2 clinical trial, PRIDE-HD, assessing Teva Pharmaceutical Industries' (NASDAQ:TEVA) pridopidine for the treatment of Huntington's disease (HD) failed to demonstrate an improvement in motor function compared to placebo at Week 26. The company says the culprit was an unexpectedly high placebo effect.
- Teva didn't give up, though. It says there was evidence of a symptomatic impact in a subpopulation of early-stage HD patients as evidenced by improvements in Total Motor Score (TMS) and dystonia (involuntary muscle movements) at Week 26 and Week 52. This discovery prompted the company to change the design of of PRIDE-HD to a 52-week study focused on pridopidine's impact on disease progression as measured by Total Functional Capacity (TFC). On this metric, pridopidine was successful at certain doses compared to placebo.
- The data were presented yesterday at the 9th European Huntington Disease Network Plenary Meeting in The Hague. Complete results will be submitted for publication in a scientific journal.
- Teva intends to advance pridopidine into Phase 3 development.
- Pridopidine is a small molecule agonist of the Sigma 1 Receptor (S1R) which plays a key role in protecting neurons through the increased production of a protein called brain-derived neurotrophic factor (BDNF). Abnormally low levels of BDNF characterize HD, Parkinson's, Alzheimer's and ALS.
Thu, Sep. 15, 11:30 AM
- Teva Pharmaceutical Industries (TEVA +0.1%) commences the U.S. commercial launch of its generic version of Merck's (MRK +1.5%) antibiotic CUBICIN (daptomycin for injection) 500 mg. It is indicated for the treatment of complicated skin and skin structure infections caused by certain Gram-positive bacteria and bloodstream infections caused by Staphylococcus aureus.
- The U.S. market is ~$1.2B/year according to IMS.
Fri, Sep. 9, 6:51 PM
- Facing delays after its marketing application was rejected this year, Teva Pharmaceutical (TEVA -1.7%) now says it wants to get U.S. approval for a generic version of Mylan's (MYL -1.7%) EpiPen by late 2017 or early 2018.
- "We requested a meeting with the FDA," and didn't get a response, said Teva's Sigurdur Olafsson today; but with recent media attention to EpiPens, "the FDA has come back to us and we will have a meeting very, very quickly."
- With no strong competition, Mylan's product has about 94% market share. But a list price that has soared from less than $100 to more than $600 over the past nine years has sparked outrage.
- Mylan has said that it planned its own $300 generic version of the EpiPen.
- The recent "political noise" around the product may make the FDA more inclined to sign off on Teva's generic than before, Evercore ISI's Umer Raffat says, despite the fact that Teva is unlikely to make modifications to its autoinjector to remedy an FDA issue with dosing.
Fri, Sep. 9, 9:59 AM
- Eli Lilly (NYSE:LLY) upgraded to Overweight from Neutral by JPMorgan. Price target raised to $95 (20% upside) from $92.
- Ligand Pharmaceuticals (NASDAQ:LGND) upgraded to Hold from Sell by Deutsche Bank. Price target raised to $110 (2% downside risk) from $105.
- Gilead Sciences (NASDAQ:GILD) upgraded to Buy from Hold by Jefferies. Price target raised to $91 (16% upside). Morgan Stanley rates it Hold with a price target of $100 (27% upside).
- Teva Pharmaceutical Industries (NASDAQ:TEVA) upgraded to Outperform from Market Perform with a $66 price target by Oppenheimer.
- Novo Nordisk (NYSE:NVO) downgraded to Neutral from Overweight by JPMorgan.
- AbbVie (NYSE:ABBV) downgraded to Neutral from Overweight with a $73 (14% upside) price target by JPMorgan.
- Cepheid (NASDAQ:CPHD) downgraded to Neutral from Buy by BTIG Research.
- Tonix Pharmaceuticals (NASDAQ:TNXP) downgraded to Neutral from Buy by Roth Capital.
- Momenta Pharmaceuticals (NASDAQ:MNTA) downgraded to Sell from Hold with a $6 (48% downside risk) price target by Maxim Group.
- Biogen (NASDAQ:BIIB) downgraded to Hold from Buy with a $323 (7% upside) price target by Jefferies.
- Centene (NYSE:CNC) downgraded to Market Perform from Outperform with an $80 (19% upside) price target by Leerink Swann. Wedbush rates it Outperform with an $85 (26% upside) price target.
Fri, Sep. 9, 8:42 AM
- In a presentation today, Teva Pharmaceutical Industries (NASDAQ:TEVA) updated investors on its generics business now that the Actavis transaction has closed.
- The unit will generate $14 - 15B in sales this year (exclusive of OTC). 1,500 generics will be launched this year. Total global portfolio is 16,000 products sold in over 100 markets. Over 300 submissions (ANDAs) on file with FDA and over 2,000 globally. Achieved 43% of first-to-files in U.S. (25/58) in 2015, 48% (13/27) this year as of Sept. 7. Over 500 active development projects.
- Teva's global market share in 2015 was ~8%. Novartis' Sandoz second at 4.8% followed by Sanofi at 3.0% and Mylan at 2.8%.
- North America: Teva has 18% market share (#1 position). Mylan #2 at 10%, Sandoz #3 at 7%. Four customers account for 85% of the retail market. Teva submitted 65 new ANDAs in 2015.
- Europe: Teva has leadership position with 14% market share. Top three positions in 26 countries. 272 projects in pipeline. 65 dossiers completed in 2015.
- Growth markets (worldwide exclusive of North America, Western Europe and Scandinavia) will be key. Asia to have 2/3 of the global middle class by 2030. #3 market share in Russia, 1,000 sales reps promoting ~300 products. 14 regulatory submissions in 2015. #3 in Japan, JV with Takeda inked in April, Portfolio of 775 products promoted by 350 sales reps. 17 regulatory filings in 2015.
Tue, Sep. 6, 11:53 AM
- August monthly performance was: 0%
- 52-week performance vs. the S&P 500 is: -17%
- No dividends were paid in August
- Top 10 Holdings as of 6/30/2016: RELX PLC (OTC:RLXXF): 2.98184%, Sky PLC (OTCQX:BSYBF): 2.94851%, British American Tobacco PLC (OTCPK:BTAFF): 2.66638%, Teva Pharmaceutical Industries Ltd ADR (TEVA): 2.50786%, WPP PLC (OTCPK:WPPGF): 2.36147%, Taiwan Semiconductor Manufacturing Co Ltd (2330): 2.35528%, CGI Group Inc A (GIB): 2.31975%, Roche Holding AG Dividend Right Cert. (OTCPK:RHHVF): 2.27147%, Broadcom Ltd (AVGO): 2.25054%, Deutsche Boerse AG (OTCPK:DBOEF): 2.18513%
Fri, Sep. 2, 1:19 PM
- In a factsheet just published on Presidential candidate Hillary Clinton's website, she outlines her plan to reign in rogue drug companies who aggressively increase the prices of their medicines.
- Her plan features three methods for containing runaway drug costs: make alternatives available and increase competition; enable emergency importation of safe treatments and fine drug firms for unjustified price increases.
- Her first action, as President, will be to create a dedicated group of representatives from Federal agencies that oversee health and safety and fair competition that will be charged with protecting consumers from "outlier" price increases. The group will establish criteria for determining if a price increase is justified for a long-available treatment and investigate and consider enforcement in certain situations.
- In cases where the level of competition is light, her plan will enable the emergency purchases of alternative versions and make them available to patients in need while encouraging competition from additional suppliers.
- She also calls for legislation to safely and securely import drugs from foreign nations whose regulatory regimes are as robust as the FDA, with the proviso of a "careful review" by the agency (more temporary than permanent).
- In cases where miscreant drug firms are fined, the funds will be used to support new programs to make lower-cost alternatives available and speed up approvals in order to beef up competition (specifics are not provided).
- In her broader plan to lower prescription drug costs for all Americans, she proposes a cap on out-of-pocket costs, additional funding to support the clearing of the FDA's backlog of generic drug applications, prohibit "pay for delay" deals (long overdue), a moratorium on direct-to-consumer advertising and allowing Medicare to negotiate drug and biologic prices.
- Representative tickers: (NASDAQ:IBB)(NASDAQ:AMGN)(NASDAQ:BIIB)(NASDAQ:GILD)(NASDAQ:CELG)(NYSE:BMY)(NYSE:ABT)(NYSE:MRK)(NYSE:PFE)(NASDAQ:MYL)(NYSE:VRX)(NASDAQ:TEVA)(NASDAQ:PRGO)(NYSE:AGN)
Thu, Sep. 1, 4:10 PM
- The USPTO's Patent Trial and Appeal Board (PTAB) has, again, ruled in Mylan's (NASDAQ:MYL) favor in its inter partes review of patents covering Teva Pharmaceutical Industries' (NASDAQ:TEVA) Copaxone (glatiramer acetate injection) 40mg/mL. It found that U.S. Patent No. 8,969,302 is unpatentable.
- On August 24, two other patents were invalidated.
- On August 15, the PTAB ruled that Mylan's petition against a fourth patent covering the 40 mg/mL formulation (U.S. Patent No. 9,155,776) was ineligible for post-grant review for procedural reasons.
- Previously: USPTO invalidates two Copaxone patents, ruling on third tomorrow (Aug. 24)
Mon, Aug. 29, 9:42 AM
- Top-line data from a Phase 3 study evaluating Amgen's (AMGN) Prolia (denosumab) compared to risedronate [Teva Pharmaceuticals' (TEVA -0.8%) ACTONEL] in patients with glucocorticoid-induced osteoporosis met all primary and secondary endpoints at Month 12. Patients receiving Prolia experienced greater gains in bone mineral density at the lumbar spine and total hip versus those treated with risedronate (4.4% vs. 2.3% at the lumbar spine and 2.1% vs. 0.6% at the total hip). The results also favored Prolia over risedronate in patients just starting glucocorticoid therapy (3.8% vs. 0.8% at the lumbar spine and 1.7% vs . 0.2% at the total hip).
- Adverse events and serious adverse events were similar across treatment groups. The study remains double-blinded and will continue for an additional 12 months.
- The analysis of data is ongoing. The results will be submitted for publication and presentation at a future medical conference.
- Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk of fracture and men with osteoporosis at high risk of fracture. The European label also includes the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fracture.
- Amgen reacquired the rights to Prolia and two other drugs in 48 ex-U.S. countries from GlaxoSmithKline (GSK +0.1%) in December 2015.
- Previously: Amgen regains rights to three drugs from Glaxo (Dec. 14, 2015)
Wed, Aug. 24, 4:39 PM
- The USPTO's Patent Trial and Appeal Board (PTAB) invalidates two patents covering Teva Pharmaceutical Industries' (NASDAQ:TEVA) top selling MS drug Copaxone (glatiramer acetate injection). The Board is reviewing a total of three patents being challenged by generic drug makers. A decision on the third is due tomorrow.
- The patents in question pertain to the administration 40 mg of the drug three times per week. Teva has transitioned ~80% of its Copaxone customers to the higher dose to stay ahead of generic competition at the original 20 mg dose.
- Analysts say the encroachment of generic versions could erode $3.2B in sales by 2019.
- Despite the favorable ruling, generic firms usually wait until the U.S. Court of Appeals for the Federal Circuit rules before entering the market, a tollgate that appears to be quite far in the distance since the district court case won't begin until next month with a ruling in early 2017.
- TEVA is up a fraction after hours.
- Update: Teva confirms that the PTAB invalidated the '250 and '413 patents. The company says it will defend four patents ('250, '413, '302 and '776) in district court next month and will appeal an adverse decision. All patents remain valid and enforceable as well as a fifth patent ('874) that was recently issued.
- Update: On September 1, Mylan reported that the USPTO ruled that a third patent (U.S. Patent No. 8,969,302) was unpatentable.
Tue, Aug. 23, 4:32 PM
- Mylan N.V. (NASDAQ:MYL) is the latest pharma firm to be in the crosshairs of the government over aggressive price hikes. Shares were off 5% today on triple normal volume in response to the news that Iowa Senator Chuck Grassley has officially requested an explanation from management why it has increased the price of its EpiPen (epinephrine injection). Since acquiring the auto-injector in 2007, the company has jacked the price up almost 400%. The product is used to treat allergic reactions in an emergency setting.
- The company's behavior with EpiPen pricing could be construed as a profit-grabbing strategy ahead of generic competition which could capture as much as $200M of EpiPen's sales say analysts. Product pricing will most certainly fall when generic alternatives are available.
- Teva Pharmaceutical Industries (NYSE:TEVA) hit a bump in the road earlier this year with its generic version of EpiPen when the FDA rejected its marketing application. It now expects to launch its product in 2017 at the earliest.
- Previously: Teva's generic EpiPen pain is Mylan's gain (March 1)
Thu, Aug. 18, 6:54 AM
- As expected, the European Commission approves Teva Pharmaceutical Industries' (NYSE:TEVA) CINQAERO (reslizumab) as add-on therapy in adults patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
- Reslizumab, a humanized monoclonal antibody that binds to interleukin-5, is administered via IV infusion every four weeks. It reduces severe asthma attacks by reducing the levels of blood eosinophils, a type of white blood cell that creates inflammation related to allergies and asthma.
- The product will be commercially available in the coming months. It is marketed under the brand name CINQAIR in the U.S. and Canada.
- Previously: European Ad Comm backs Teva's Cinqaero for severe treatment-resistant asthma (June 24)
Thu, Aug. 4, 10:03 AM
- Teva Pharmaceutical (TEVA +0.6%) Q2 results: Revenues: $5,038M (+1.4%); R&D Expense: $375M (-2.8%); SG&A: $1,263M (+6.6%); Operating Income: $361M (-45.5%); Net Income: $254M (-52.9%); EPS: $0.20 (-68.3%); Non-GAAP EPS: $1.25 (-12.6%); Quick Assets: $6,984M (+0.5%); CF Ops: $963M (-34.9%).
- 2016 Guidance: Revenues: $22.0B - 22.5B; Non-GAAP EPS: $5.20 - 5.40; CF Ops: $5.7B - 6.1B.