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.
Oct. 8, 2014, 8:33 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) commences a rolling New Drug Application submission to the FDA for its acetaminophen-free hydrocodone bitartrate extended-release tablets designed with its proprietary technology that provides potential abuse-deterrent properties as allowed for Fast Track-designated products. The company expects to complete the submission by the end of 2014.
- Related ticker: (NASDAQ:ZGNX)
Oct. 7, 2014, 11:57 AM
- BC, Canada-based Xenon Pharmaceuticals (XENE) is set for its IPO of 4M shares at $10 -12.
- The clinical-stage biopharmaceutical firm discovers and develops differentiated therapeutics for orphan indications based on its Extreme Genetics platform. It focuses its discovery efforts on rare human diseases with extreme traits, including diseases caused by mutations in ion channels.
- The Extreme Genetics platform yielded the first gene therapy product approved in the EU, uniQure's (QURE +1.5%) Glybera (alipogene tiparvovec) for the treatment of adult patients with familial lipoprotein lipase deficiency.
- Its pharma partners include (TEVA -0.3%), Genentech (OTCQX:RHHBY -2.5%) and Merck (MRK -1.2%). Collaborations have generated over $140M in revenue to Xenon so far. Future milestone payments could potentially surpass $1B.
- The company's lead product is TV-45070 for the treatment of osteoarthritis of the knee. A 300-patient Phase 2b clinical trail run by Teva subsidiary Ivax International GmbH is underway.
- A second product candidate, GDC-0276, for the treatment of pain is being developed in collaboration with Genentech. A Phase 1 study commenced in September 2014.
- Osteoarthritis of the knee-related tickers: (AMPE +0.3%)(FLXN -4.6%)(ANIK -1.2%)(ZMH -0.7%)
Oct. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Oct. 6, 2014, 3:47 PM
Oct. 1, 2014, 10:37 AM
- Zogenix (ZGNX +4.3%) submits a supplemental New Drug Application to the FDA for an abuse deterrent version of Zohydro ER (hydrocodone bitartrate). The new capsule formulation contains additional inactive ingredients that make the product more difficult to abuse by injection and nasal insufflation (snorting).
- The company anticipates a target action date sometime in Q1 2015. If approved, the transition to the new formulation will occur in Q2.
- Related tickers: (MNK -1%)(ACT -2%)(TEVA -0.5%)(ABBV -0.9%)(LCI -4%)(ALKS -2.4%)(PFE -1.4%)
Sep. 24, 2014, 10:52 AM
- Lipocine's (LPCN +40.8%) oral testosterone replacement therapy candidate, LPCN 1021, achieves its primary efficacy endpoint in a Phase 3 clinical trial.
- The FDA guidelines for primary efficacy success stipulate a minimum of 75% of trial subjects on active treatment achieve a serum testosterone concentration within the normal range of 300-1140 ng/dL and the lower bound of the 95% CI (confidence interval) must be greater than 65%.
- In the Phase 3 study, 88% of LPCN 1021-treated patients achieved testosterone levels in the normal range with a lower bound CI of 82%.
- LPCN 1021's safety profile was acceptable as well. Three percent of the subjects reported a serious adverse event, though none were drug-related. All drug-related adverse events were mild or moderate. The safety extension phase of the trial is ongoing.
- One aspect of the value proposition of oral TRT therapy is the elimination of the risk of inadvertent testosterone transfer associated with transdermal gels (before the gel dries).
- Related tickers: (LLY +0.6%)(ABBV +1.1%)(RPRX +8.1%)(AUXL -0.2%)(TEVA +0.4%)
Sep. 18, 2014, 1:31 PM
- In a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee today, members vote 18-3 against approval for privately-held Clarus Therapeutics' oral testosterone Rextoro.
- The committees voted yesterday 20-1 in favor of revising who should be prescribe testosterone replacement therapies (TRT) and the need to conduct further studies to assess the cardiovascular risks. The revised population of patients appropriate for TRT will be much smaller as a result.
- Related tickers: (LLY +0.9%) (ABBV -0.5%) (RPRX -25.4%) (LPCN -25.3%) (AUXL -0.5%) (TEVA +0.3%)
Sep. 18, 2014, 7:40 AM
- In a joint meeting between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members vote 20-1 in favor of drug developers' need to further assess the cardiovascular risks of testosterone products. Sixteen voted that it should be studied only in certain situations.
- Members also voted 20-1 in favor of a revision of who should be prescribed the drugs. The panel says there is little evidence that testosterone replacement therapies (TRT) are effective for treating low levels of hormone caused by aging.
- Prescriptions for TRT products almost doubled from 2010 to 2013. About 20% of TRT patients do not have laboratory evidence that they need the therapy.
- Eli Lilly (NYSE:LLY) says that current evidence does not support a causal link between TRT and cardiovascular events. Based on the committee's statements, though, it will work with the FDA on how to communicate the cardiovascular risk to patients.
- The committees meet today to discuss Clarus Therapeutics' NDA for an oral testosterone.
- Related tickers: (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Sep. 16, 2014, 12:33 PM
- On Thursday, September 18, the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet to discuss privately-held Clarus Therapeutics' New Drug Application for Rextoro, an orally-available testosterone for patients with hypogonadism.
- Briefing docs
- Tomorrow, the two committees will jointly meet to discuss the appropriate population for testosterone therapy and the potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
- Related tickers: (ABBV +0.7%) (LLY +0.9%) (AUXL -1.6%) (TEVA +1.8%)
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