Tue, Aug. 25, 7:22 PM
- Eli Lilly (NYSE:LLY) says a U.S. federal court ruled that generic products proposed by a unit of Teva Pharmaceutical (NYSE:TEVA) would infringe a U.S. patent for LLY’s blockbuster cancer drug Alimta.
- The patent, which covers the administration of Alimta to patients with a vitamin regimen, provides intellectual property protection until May 2022, potentially preserving U.S. market exclusivity for Alimta until then, rather than allowing generic competition in 2017 when a separate patent expires.
- Teva had challenged a March 2014 ruling that upheld the validity of the vitamin regimen patent.
Wed, Aug. 12, 8:48 AM
- The FDA accepts for review Teva Pharmaceutical Industries' (NYSE:TEVA) New Drug Application (NDA) seeking approval of Orphan Drug-tagged deutetrabenazine (SD-809) for the treatment of chorea (involuntary movements) associated with Huntington's disease (HD), a rare and fatal inherited neurodegenerative disorder that affects ~20K Americans.
- Deutetrabenazine is an oral small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), a membrane protein that transports neurotransmitters such as dopamine and serotonin and is necessary for the vesicular release of the neurotransmitter GABA. Teva acquired ownership of the product candidate via its acquisition of Auspex Pharmaceuticals in May.
Mon, Aug. 3, 1:43 PM
- In a recent review of the Kronos Early Estrogen Prevention Study (KEEPS) trial, Dr. JoAnn Manson, investigator and co-author, discusses the therapeutic potential of estrogen for improving cognition and mood.
- The KEEPS study, published in PLOS Medicine last month, randomly assigned 693 women to one of the following three treatment groups: daily oral conjugated estrogen 0.45 mg with daily cyclical oral micronized progesterone 200 mg, estradiol patch (transdermal) 50 µg with cyclical micronized progesterone for 12 days a month, and placebo. Investigators assessed treatment groups for cognition and mood.
- After 4 years of treatment and follow-up, the study showed that the oral and transdermal estrogen did not provide statistically significant cognition benefits. In respect to mood, oral conjugated estrogen showed a favorable, but non-statistically significant effect on anxiety and depressive symptoms, whereas the transdermal estradiol had neutral effects.
- The results suggest that oral conjugated transdermal estrogen could possess a therapeutic benefit for women with mood symptoms. However, more research is required to assess the therapeutic benefit of estrogen for cognition. Dr. Manson stresses that cognitive outcomes are generally more correlative for younger, newly menopausal than for older women.
- This comes as micro cap Synthetic Biologics (SYN +1.9%) is expected to produce a top-line MRI readout for the Phase 2 study of Trimesta (oral estriol) in female multiple sclerosis patients suffering from cognitive dysfunction. A positive top-line readout would pave the way for continued advancement of the company's cognition program. The investigational drug is also being developed in a separate post-Phase 2 program in combination with Teva's (TEVA +1.1%) blockbuster MS drug Copaxone for the treatment of relapses in MS.
- There has never been an FDA-approved oral estriol drug for any indication. However, oral estriol has been used to treat post-menopausal symptoms for over 40 years throughout Europe and Asia. The market opportunity for Trimesta is likely significant, with more than 400,000 patients in the U.S. and 2.3 million worldwide. The majority of such patients are young adults aged 20-50. 70% of MS patients are women, and 50% of MS patients are affected by cognitive dysfunction. Annual worldwide sales of existing MS therapies exceed $14 billion, and none of them effectively address cognitive dysfunction.
- MS-related tickers: (BIIB +0.6%)
Mon, Aug. 3, 9:17 AM
- Pfizer (NYSE:PFE) acquires the exclusive U.S. commercialization rights to glatiramer acetate, a generic version of Teva's (NYSE:TEVA) blockbuster Copaxone, from Dutch drug firm Synthon. Under the terms of the agreement, Pfizer has exclusive rights in the U.S. for both dosage formulations (20 mg/ml and 40 mg/ml). Synthon will be responsible for the clinical development, manufacture and supply of glatiramer acetate. Financial terms are not disclosed.
- Synthon filed an ANDA with the FDA in November 2011 for the once-daily 20 mg/ml dose. It filed an ANDA for the 3x-per-week 40 mg/ml dose in early 2014.
Mon, Aug. 3, 8:30 AM
- To further its emphasis on personalized medicine, Teva Pharmaceutical Industries (TEVA -0.1%) establishes a 51% equity stake in privately-held Cambridge, MA-based Immuneering, a genomic analysis company that employs proprietary algorithms using genetic, genomic and proteomic data to generate biological insights that enhance the clinical and commercial success of medicines.
- The firms have been working together over the past several years in characterizing non-biological complex drugs in addition to genetic biomarkers and therapy-specific gene expression signatures. Teva has the right of first refusal in projects related to Immuneering's work in central nervous system disorders.
- The specific amount of Teva's investment is not disclosed.
Fri, Jul. 31, 1:40 PM
- Teva Pharmaceutical Industries (TEVA -0.3%) receives commitment letters from a group of major banks for loans totaling $33.75B, $27B under a senior unsecured Bridge Loan Credit Facility and $6.75B under an Equity Bridge Loan Credit Facility.
- Teva will use the funds to pay for its acquisition of Allergan's generic drugs business.
Thu, Jul. 30, 3:51 PM
- Teva Pharmaceutical Industries (TEVA -2.6%) resumed at Morgan Stanley with an Overweight rating and price target of $85 (23% upside).
- Depomed (DEPO -2.9%) downgraded to Sector Perform from Outperform by RBC Capital. Price target raised to $32 (3% upside) from $26.
- Immunomedics (IMMU -1.2%) downgraded to Hold from Buy by Jefferies. Price target lowered to $2 (4% downside risk) from $6.
Thu, Jul. 30, 7:33 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) Q2 results ($M): Total Revenues: 4,966 (-1.6%); Generic Medicines: 2,466 (-1.9%); Specialty Medicines: 2,090 (+3.1%); Other: 1,036 (+106.0%).
- Copaxone sales: 1,054 (+12.2%).
- Net Income: 539 (-27.7%); EPS: 0.63 (-27.6%); CF Ops: 1,480 (+40.6%).
- 2015 Guidance: Total Revenues: $19.0B - 19.4B (unch); Gross Margin: 60.0 - 62.5% from 59.5 - 61.5%; Non-GAAP EPS: $5.15 - 5.40 from $5.00 - 5.30.
- Shares are off a fraction premarket.
Thu, Jul. 30, 7:15 AM
Wed, Jul. 29, 12:52 PM
Wed, Jul. 29, 10:28 AM
- The FDA approves Ignyta's (RXDX -2.3%) Investigational New Drug (IND) application for RXDX-107, a nanoformulation of modified bendamustine, a nitrogen mustard used to treat certain blood cancers. The company intends to start a Phase 1/1b clinical trial promptly.
- RXDX-107, acquired from Teva Pharmaceutical Industries (TEVA +0.3%) in March, is a new chemical entity comprising an alkyl ester of bendamustine encapsulated in human serum albumin to form nanoparticles. Its value proposition is a longer half-life and improved tissue biodistribution compared to traditional bendamustine.
- Previously: Ignyta up 31% after hours on Teva oncology deal (March 17)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Mon, Jul. 27, 12:48 PM
Mon, Jul. 27, 9:14 AM
Mon, Jul. 27, 8:00 AM
Mon, Jul. 27, 7:09 AM
- Mylan (NASDAQ:MYL) drops 12% premarket on increased volume in response to Teva's (NYSE:TEVA) $40.5B deal for Allergan's (NYSE:AGN) generics business, dashing investors' hopes that it would pursue its hostile bid for Mylan.
- In a statement, Mylan reaffirms its interest in Perrigo. A vote on the combination by Mylan shareholders is expected to happen in the next few weeks.
TEVA vs. ETF Alternatives
Other News & PR