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.
Nov. 3, 2014, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Oct. 30, 2014, 2:55 PM
- Teva Pharmaceutical Industries (TEVA +3.7%) Q3 results: Revenues: $5,058M (unch); Generic Medicine: $2,432M (-2.3%); Speciality Medicine: $2,176M (+5.1%); Gross Profit: $2,809M (+6.8%); Operating Income: $1,112M (+38.8%); Net Income: $876M (+23.2%); EPS: $1.02 (+21.4%); Quick Assets: $1,473M (+41.9%); CF Ops: $1,424M (+220.7%).
- Product sales: Copaxone: $1,107M (+5.2%), Treanda: $180M (-2.2%), ProAir: $111M (-0.9%), Women's Health: $137M (+2.2%).
- 2014 Guidance: Net revenues: $20B - 20.3B from $19.9B - 20.8B; Operating Income: $5.65B - 5.75B from $5.35B - 5.65B; EPS: $5.00 - 5.10 from $4.80 - 5.10.
Oct. 30, 2014, 7:07 AM| Comment!
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Oct. 17, 2014, 5:20 PM
- The FDA approves new labeling for Pfizer's (PFE +0.4%) Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules. The opioid analgesic is indicated for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- The new labeling describes Embeda's abuse deterrent properties, which are designed to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted. When crushed, the naltrexone blocks some of the euphoric effects of the morphine and can precipitate withdrawal in opioid-dependent persons.
- When swallowed intact, though, Embeda can still be abused/misused because the naltrexone will not substantially block the effects of the morphine. It is also unknown whether Embeda's abuse deterrent properties will reduce IV abuse.
- The FDA is requiring postmarketing studies to further assess the impact of the abuse-deterrent properties.
- Opioid-related tickers: (ZGNX +1.9%)(EGLT +0.2%)(ACUR +2.3%)(MNK +4.1%)(ABBV +0.9%)(TEVA -0.8%)(ALKS +2.7%)
Oct. 15, 2014, 4:13 AM
- The Supreme Court is due to hear oral arguments today over a patent for Teva's (NYSE:TEVA) top-selling multiple sclerosis drug Copaxone, which accounts for 50% of its profit.
- The patent was due to expire in September 2015, although in July 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid. Copaxone has no IP protection at the moment.
- Two consortia are developing generic versions of Copaxone, with one involving Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), and the other Mylan (NASDAQ:MYL) and Natco. The companies risk having to pay Teva hundreds of millions of dollars if they introduce Copaxone and then lose in the Supreme Court.
Oct. 13, 2014, 8:03 AM
- Lipocine's (NASDAQ:LPCN) oral testosterone replacement therapy candidate, LPCN1111, demonstrates positive top-line results in a 12-patient Phase 2a feasibility study in hypogonadal males.
- Study participants with serum total testosterone <300 ng/dL received a single dose of LPCN1111 (330 mg, 550 mg, 770 mg) followed by once-daily administration of 550 mg for 28 days (10 subjects) or once-daily administration of 770 mg for 28 days (eight subjects).
- The proportion of the 550 mg and 770 mg cohorts with 24-hour serum testosterone concentration within the normal range was 67% and 88%, respectively. The typical target for regulatory approval is 75%.
- A Phase 2b is expected to begin in Q1 2015.
- TRT-related tickers: (NASDAQ:RPRX) (NYSE:LLY) (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Oct. 9, 2014, 5:01 PM
- Alexza Pharmaceuticals (ALXA -0.5%) completes the initial stocking of Adasuve (loxapine) inhalation powder (Staccato loxapine) for the U.S. launch by commercial partner (TEVA -2.4%). It shipped 32,278 units in Q3 to complete the inventory build. Total Adasuve shipments to Teva to date have been 83,404 units.
- It does not expect to ship any additional product to Teva until Q1 2015.
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