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%)
Sep. 15, 2014, 4:08 PM
- The Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet on Wednesday, September 17 to discuss the appropriate population for testosterone replacement therapy (TRT) and the potential for adverse cardiovascular outcomes associated with TRT.
- Briefing docs
- Related tickers: (ABBV +0.1%) (LLY -0.1%) (AUXL -2.9%) (TEVA -1.4%)
Sep. 11, 2014, 11:49 AM
- In a Phase 3b clinical study evaluating the incidence of injection-related adverse events, (TEVA +0.1%) finds that three-times-per-week injections of Copaxone 40 mg resulted in a 50% reduction in such events compared to daily injections of Copaxone 20 mg.
- The number of injections was reduced 57% (3 days vs. 7 days) and the number of injection-related adverse events was reduced 50%. The results certainly appear predictable.
Sep. 9, 2014, 2:55 AM
- The Federal Trade Commission has sued AbbVie (NYSE:ABBV) and other drug companies over delaying entry of generic competition for the company's blockbuster testosterone-replacement drug AndroGel.
- "We believe the defendants' anticompetitive conduct has forced consumers to overpay hundreds of millions of dollars for this medication," says FTC Chairwoman Edith Ramirez.
- The commission also sued Teva Pharmaceutical Industries (NYSE:TEVA) over allegations that AbbVie paid Teva to withdraw legal claims which could have led to a generic version of AndroGel.
Sep. 8, 2014, 10:34 AM
- In a Phase 3 clinical trial, Teva Pharmaceutical Industries' (TEVA -0.2%) product candidate for patients with uncontrolled moderate-to-severe asthma, the anti-IL-5 monoclonal antibody reslizumab, demonstrated significant improvements in lung function compared to placebo in patients with elevated eosinophils.
- Results from a second study in an asthma population not selected for elevated eosinophils, reslizumab demonstrated minimal improvements in asthma control.
- The data support the eosinophil threshold of 400/uL established for the reslizumab program.
Sep. 4, 2014, 10:36 AM
- Teva Pharmaceutical Industries (TEVA -0.2%) launches its generic equivalent to Bristol-Myers Squibb's (BMY +0.2%) Baraclude (entecavir) Tablets, 0.5 mg and 1 mg, in the U.S. Teva was first to file its ANDA so it has 180 days of marketing exclusivity before other generic makers' offerings are cleared for sale.
- According to IMS Health, Baraclude generated ~$330M in sales in the 12-month period ended June 2014.
Sep. 3, 2014, 9:16 AM
- The U.K. High Court rules in favor of Teva Pharmaceutical Industries (NYSE:TEVA) in its case challenging the validity of AstraZeneca's (NYSE:AZN) patent (EP 1,085,877) covering the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AZN's fixed dose formoterol/budesonide combination product, Symbicort.
- The Court agreed with Teva's position that AZN's SMART patent is obvious and rejected AZN's proposed amendments on the basis that they added matter.
- The ruling facilitates Teva's European launch of DuoResp Spiromax, its version of a formoterol/budesonide fixed dose combination product.
Sep. 2, 2014, 10:29 AM
- Teva Pharmaceutical Industries' (TEVA +0.3%) investigational anti-IL-5 inhibitor, reslizumab, achieves its primary endpoint of a reduction in the frequency of clinical asthma exacerbations (CAE) compared to placebo in two Phase 3 trials. Treatment with reslizumab reduced the frequency of CAE 50% and 60% in the studies (p value < 0.0001 for both). The results were highly statistically significant.
- Reslizumab is an investigational humanized monoclonal antibody against interleukin-5 (IL-5). IL-5 has been shown to play an important role in the maturation, growth and chemotaxis of inflammatory white blood cells called eosinophils that are implicated in a number of allergic diseases.
- The company expects to submit its regulatory applications in 1H 2015.
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