Dec. 25, 2014, 12:41 PM
- Endo International plc (NASDAQ:ENDP) subsidiary Endo Pharmaceuticals and BioDelivery Sciences (NASDAQ:BDSI) submit a New Drug Application (NDA) to the FDA for Buprenorphine HCl Buccal Film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- The product uses BioDelivery's BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek) via a thin film that adheres to the cheek lining in less than five seconds and then completely dissolves.
- Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist which is different than full mu-opioid agonists like morphine. It is a Schedule III controlled substance which has a lower abuse potential than Schedule II drugs.
- Opioid-related tickers: (NASDAQ:ZGNX) (NYSE:PFE) (NASDAQ:EGLT) (NASDAQ:ACUR) (NYSE:MNK) (NYSE:ABBV) (NYSE:TEVA) (NASDAQ:ALKS)
Dec. 23, 2014, 8:43 AM
- The FDA approves Teva Pharmaceutical Industries' (NYSE:TEVA) Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. This will enable physicians to prescribe the product for either in-office or at-home use.
- Granix is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It has been commercially available in the U.S. since November 2013 and, until now, had to be administered by a healthcare professional.
- Teva plans to launch the new Granix syringe for self-administration in Q1.
Dec. 19, 2014, 9:26 AM
- The FDA approves Teva Pharmaceutical Industries' (NYSE:TEVA) QNASL (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis in children 4 - 11 years of age. It will be commercially available in February.
- The product's 80 mcg formulation is cleared for use in patients at least 12 years old.
Dec. 11, 2014, 7:45 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) provides its outlook for 2015 (versus most recent guidance for 2014):
- Net Revenues: $19.0B - 19.4B vs. $20B - 20.3B; Gross Profit: 59.5 - 61.5%; Operating Income: $5.7B - 5.9B vs. $5.65B - 5.75B; EPS: $5.00 - 5.30 vs. $5.00 - 5.10; CF Ops: $4.3B - 4.7B.
- Generics revenues: $9.1B - 9.5B; Generics Profit: $2.4B - 2.6B; Specialty revenues: 7.9B - 8.3B; Specialty profit: $4.1B - 4.4B.
- Copaxone: $3.5B - 3.7B; Azilect: $350M - 400M; Nuvigil: $300M - 330M; Treanda: $670M - 750M; ProAir family: $470M - 580M; Qvar family: $310M - 380M.
- Guidance assumes the entry of two generic competitors to Copaxone in the U.S. beginning in September. Earlier entry could reduce operating income by $30M - 50M per month. Generic Pulmicort will face additional generic competition in the first half which will decrease revenues $400M - 500M and decrease operating profit by $100M - 200M.
- Share buybacks should be $1.0B - 1.2B.
- Shares are off a fraction premarket on average volume.
Dec. 10, 2014, 9:48 AM
Dec. 10, 2014, 8:06 AM
- The Phase 3 study of Acorda Therapeutics' (NASDAQ:ACOR) CVT-301 for the treatment of OFF episodes in patients with Parkinson's disease (PD) is underway with the enrollment of the first patient. An OFF episode is a period of time during which PD symptoms such as tremor, muscle stiffness and slow movement reemerge despite taking PD medications.
- CVT-301 is a self-administered inhaled therapy that delivers a precise dose of levodopa through the lungs to return PD patients to an ON state.
- The multi-center, double-blind, randomized Phase 3 trial will enroll ~345 subjects across three treatment arms: 50 mg, 35 mg or placebo. The primary endpoint is improvement on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
- Acorda obtained the rights to CVT-301 via its acquisition of Civitas Therapeutics.
- Previously: Acorda to buy biopharma firm (Sept. 24, 2014)
- PD-OFF-related tickers: (OTCQX:CYNAF) (NASDAQ:NDRM) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRTA) (OTCQX:RHHBY)
Dec. 4, 2014, 11:44 AM
- Teva Pharmaceutical Industries (TEVA +0.6%) receives a Positive Assessment Report from the U.K. supporting a three-times-per-week dosing regimen of Copaxone (glatiramer acetate) 40 mg/ml for the treatment of patients with relapsing forms of multiple sclerosis. The positive outcome under the Decentralized Procedure also involved the Reference Member States Medicines and Healthcare Products Regulatory Agency and all Concerned Member States in Europe. The granting of national authorizations will occur shortly.
- Three-times-per-week Copaxone reduces the number injections by almost 60% compared to the once-daily 20 mg/ml formulation while maintaining its benefits.
- The FDA approved the 3x/week formulation in January.
- Previously: Teva rises after FDA OKs higher-dosage Copaxone (Jan. 29, 2014)
Dec. 4, 2014, 7:46 AM
- CTI BioPharma (NASDAQ:CTIC) receives a $15M milestone payment from Teva Pharmaceutical Industries (NYSE:TEVA) related to sales of the leukemia drug Trisenox (arsenic trioxide). CTI is eligible to receive up to an additional $80M in sales- and development-related milestones.
- Teva obtained the rights to the drug via its acquisition of Cephalon which acquired Trisenox from CTI.
Dec. 3, 2014, 7:36 AM
- AstraZeneca (NYSE:AZN) could be on the hook for substantial damages if it loses a trial in Boston involving Ranbaxy Laboratories Ltd. (OTC:RBXLY) (OTC:RBXZF) and their pay-to-delay agreement that blocked generic competition to Nexium. This is first such trial since the U.S. Supreme Court ruled that companies can be sued over these deals if the payments are large and unjustified.
- The suit challenges a 2008 settlement of a patent dispute between the two companies that postponed the entry of generic competition until this year. Plaintiffs argue that the $1B+ that Ranbaxy received violated antitrust law and was excessive for a patent case.
- Teva Pharmaceutical Industries (NYSE:TEVA) was also a defendant in the case but it reached a settlement with the plaintiffs after four weeks of testimony.
- If the plaintiffs win, there will be another trial to determine the amount of damages. A win, though, is far from certain because the drug buyers have failed to show that they were harmed by the deal. Two weeks into the trial, AstraZeneca filed a motion to throw out the claims on the basis that the plaintiffs' experts failed to offer evidence of what they regard as proper royalty rates for drugs, a stipulation made by the court for the trial to proceed. Judge William Young denied the motion without elaborating.
- Nexium generated almost $4B in sales last year.
Dec. 1, 2014, 4:00 PM
Dec. 1, 2014, 12:26 PM
- Teva Pharmaceutical Industries (TEVA) launches its generic equivalent to Novartis' (NVS -0.1%) high blood pressure med Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide) Tablets in the U.S.
- Teva was the first to file so it has marketing exclusivity against other generic firms for 180 days.
- Per IMS Health, Exforge HCT generates annual sales in the U.S. of ~$158M.
Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 20, 2014, 1:36 PM
- The FDA approves Purdue Pharma's Hysingla ER (hydrocodone bitartrate) for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
- Hysingla ER incorporates abuse-deterrent properties that make the tablet difficult to crush, break or dissolve and it forms a viscous hydrogel that makes it difficult to prepare for injection.
- The agency is requiring postmarketing studies of Hysingla ER to assess the effects of its abuse-deterrent properties on the risk of abuse and the consequences of that abuse in the community. Purdue is also required to make educational programs available to healthcare professionals on now to safely prescribe ER/LA opioid analgesics in addition to medication guides and patient counseling documents.
- Opioid-related tickers: (ZGNX -0.8%)(PFE +0.2%)(EGLT +4.5%)(ACUR)(MNK +0.9%)(ABBV)(TEVA -0.1%)(ALKS +1.5%)
Nov. 18, 2014, 12:06 PM
- The U.S. Court of Appeals for the Federal Circuit rules in favor of generic firms, including Teva Pharmaceutical Industries (TEVA), in Roche's and Warner-Chilcott's (ACT +6.5%) patent infringement suit over Roche's branded osteoporosis med Actonel at a monthly dose of 150 mg (Warner licensed the product from Roche).
- From August 2008 to February 2011, Teva, Apotex, Mylan Pharmaceuticals (MYL +1.7%) and Sun Pharma all filed ANDAs to sell generic Actonel 150 mg tablets.
Nov. 11, 2014, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Nov. 4, 2014, 10:23 AM
- Teva Pharmaceutical Industries (TEVA -0.6%) and Active Biotech (OTC:ATVBF) expand their clinical development of laquinimod with the initiation of a Phase 2 proof-of-concept clinical trial (ARPEGGIO) to evaluate the drug for the treatment of primary progressive multiple sclerosis (PPMS). The study will assess the efficacy of two doses (0.6 mg/day and 1.5 mg/day) versus placebo. The primary endpoint is brain atrophy as measured by percent brain volume change (PBVC) via MRI analysis from baseline to week 48. PPMS is characterized by worsening neurologic function without distinct relapses.
- Additionally, Teva has screened the first patient in another Phase 2 trial (LEGATO-HD) that will assess laquinimod for the treatment of Huntington's disease. The primary endpoint is the change from baseline after 12 months of treatment as measured by UHDRS-TMS.
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