Update: Will Teva Lose Patent Protection For Copaxone After All?
- Teva announced Tuesday a favorable U.S. Supreme Court ruling over its patent for Copaxone, dealing a blow to various generic developers that are attempting to enter the MS space.
- I reiterate my bullish thesis on Teva.
- As expected, Teva continues to improve its prospects amid the enormous patent cliff. The favorable Supreme Court ruling corroborates this position.
- Recently, Teva has been authorized by the US Food Drug and Administration to introduce the generic counterpart of Diovan “Valsartan” tablets in the US market.
- The anticipated elevation in earnings is calculated to be $29 million. On a per share basis, the EPS is computed to go up by $0.03 in 2015.
- Apart from entering into the generic market of Diovan, Teva is also actively moving ahead to introduce generic version of two other antibiotics in the US market.
- The launch of generic equivalents of Pfizer’s Zyvox and USP’s Nafcillin is expected to uplift the EPS by $0.01 in the fiscal year 2015.
- The addition of generic medicines to its product portfolio will fortify the company’s business and stabilize its revenue generation sources which have continued to get affected by patent expiries.
Update: U.S. Launch Of Generic Diovan Improves Teva's Outlook
- On Tuesday, Teva announced the U.S. launch of generic Diovan.
- I reiterate my bull thesis on the company.
- As expected, Teva continues to improve its prospects amid the enormous patent cliff.
Teva Pharmaceutical Industries: Is It Time To Buy Or Sell?
- Shares of Teva are trading near 52-week highs.
- I believe it's difficult to determine the margin of safety at current price levels, as a myriad of factors could restrict Teva's growth (e.g., the patent cliff).
- A conservative options strategy mitigates these risks, while enhancing Teva's current yield.
- Copaxone’s sales are under serious threat as two of its generic versions made it to the market in September 2015.
- Teva’s Pulmicort, which treats asthma, is also expected to face generic competition in the future.
- Teva has successfully achieved FDA approval for the generic version of Pfizer’s Celebrex.
- The company has also successfully developed and launched Novartis’s Exforge HCT.
Generic EpiPen Could Give These 2 Stocks A Jolt Of Adrenaline
- Potential generic EpiPen launch date of June 22, 2015, assuming FDA approval.
- Analysis is provided using a comparable exclusive generic launch.
- It's unclear if another generic may enter before patents expire in 2025.
TEVA: Copaxone Patent Expiry Worries Are Overblown
- Copaxone worries are overblown and being compared to typical small molecule expiration's and not to biologics, which have higher retention rates behind patent expiry.
- The company has been preparing for Copazone's loss for years now diversifying its business mix with new acquisitions in the pharma space and growing biosimilar business.
- Management has been wringing out the expenses to grow operating margins and boost profitability.
- Growth has been tepid for Teva; in response, it had streamlined operations and has continued to increase R&D spend into core growth areas.
- I believe investors have already discounted shares of Teva, based on a generic rival competing with its drug Copaxone.
- Teva offers an attractive 2-to-1 reward-to-risk profile, even in the midst of potential major competition versus its key drug, Copaxone.
- Teva still offers an asymmetrical risk-reward opportunity.
- The company’s generic business showed significantly improved profitability.
- We continue to expect Teva to become either a target or a beneficiary from a merger-of-equals scenario.
- Teva is trying to recover the Copaxone sales loss due to patent expiration by introducing an improved version of Copaxone 40mg.
- Teva revealed positive data from the phase 3 study of its drug reslizumab for the treatment of moderate to severe asthma.
- Teva won its case against AstraZeneca in the UK High Court paving the way for the company to launch its DuoResp Spiromax inhaler in the UK.
- Recently Teva received 180-day marketing exclusivity in order to launch the generic version of Baracludes.
- Teva demonstrates how dependence on patented pharmaceuticals is a poor long-term business strategy.
- Sales of one such medication, Copaxone, are responsible for one fifth of Teva’s revenue.
- Teva is willing to do almost anything to preserve its Copaxone patent, which expired in May.
- Teva’s addiction to Copaxone revenue is now a threat to its future.
- Teva might be sacrificing long-term survival for short-term profits.
- Teva Pharmaceuticals has been in stagnation mode for several years.
- Its lead profit center, Copaxone, is under imminent threat from generics.
- Yet, it has turnaround characteristics, and Copaxone may turn out better than feared.
- Overall, I rate TEVA as a reasonable "buy" here to gain exposure to secular growth trends at a low valuation, with the possibility of a takeover if operations go poorly.
Teva Pharma: Underpriced And Misunderstood, Identifiable Catalyst
- Generics pharma giant Teva is a prime example of how the DCF can help the investor better exploit valuation mis-pricings.
- The long-term opportunity for lower-cost generics in an environment where governments across the globe are looking to cut expenses and become more efficient is just too great to pass up.
- The market is focusing too much on the patent expiration of Copaxone. The loss of exclusivity isn't a done deal, and shares have tremendous valuation upside with an identifiable catalyst.
Teva Offers A Good Long-Term Investment Opportunity
Biotech Exposed To Summer 2014 Supreme Court Decision
Teva Pharmaceutical Shares Ready To Break Out In 2014
The NuPathe Contingent Value Right: Paying 25 Cents For A Dollar
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%)
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
May. 15, 2014, 3:51 PM
- Shares of Momenta Pharmaceuticals (MNTA +11.3%) are up on slightly higher volume in response to a federal judge's tossing of Teva's (TEVA -0.9%) lawsuit accusing the FDA of acting improperly by not demanding additional testing of generic forms of Copaxone before clearing them for marketing.
- Teva gets a "A" for effort in trying to stop competitors from selling their generic offerings especially since it is usually on the other side of the aisle. The U.S. Supreme Court has yet to rule on its patent infringement case vs Mylan and Sandoz.
Apr. 28, 2014, 9:11 AM
- Teva's (TEVA) and OncoGenex Pharmaceuticals's (OGXI) Custirsen treatment for prostate cancer has failed in a Phase III trial.
- When given with standard chemotherapy, the drug didn't improve the overall survival of patients with advanced castrate-resistant prostate cancer vs those who received just chemotherapy.
- OncoGenex's shares are -52%, while those of Teva are +0.25%. (PR)
Apr. 28, 2014, 7:55 AM
- Shares of OncoGenex (OGXI) are off 53% premarket on modest volume in response to its announcement that its Phase 3 clinical trial for custirsen failed to meet its primary endpoint of a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer.
- The SYNERGY trial compared the addition of custirsen to the standard first-line therapy of docetaxel/prednisone to docetaxel/prednisone alone.
- The company will hold an investors conference call this morning to discuss the matter.
- (TEVA +1.6%)
Mar. 31, 2014, 11:05 AM
- Shares of generic drug maker Momenta Pharmaceuticals (MNTA -11.4%) are down in early trading after the Supreme Court agrees to hear Teva's (TEVA +4.7%) appeal of a lower court's ruling invalidating its Copaxone patents.
- Without a reversal the product's exclusivity expires May 24.
Jan. 29, 2014, 4:57 AM
- Teva's (TEVA) shares are +2.7% in Tel Aviv after the FDA approved a 40 mg dose of the company's multiple sclerosis drug Copaxone that would be administered three times a week.
- Teva now plans to convert 57% of patients to the new regimen by the year-end from the daily dose of 20 mg.
- The longer-lasting regimen should help Teva cope with generic competition when Copaxone's patent protection expires in May. The higher-dosage version is protected until 2030. (PR)
Jan. 14, 2014, 3:37 PM
- Shares of Teva Pharmaceutical (TEVA +8.4%) are on their way to a solid session.
- The move higher is likely attributable to the reportedly upbeat tone struck at the JPMorgan Healthcare Conference, where the company presented today at 1:30 ET.
- According to chatter, the company says it is moving quickly with its new CEO.
- Also overheard during the presentation: The company is keeping the biosimilars business and remains interested in acquisitions.
- In other company news, TEVA says data published in the online scientific journal PLOS ONE suggests there are significant differences in biological and immunological effects between Copaxone and a purported generic." (PR)
Jan. 8, 2014, 12:46 PM
Jan. 8, 2014, 9:11 AM
Jan. 7, 2014, 9:58 AM
- BofA upgrades Perrigo (PRGO +1.2%) to Buy from Neutral. RBC starts the shares as a Top Pick, with a $187 price target.
- BofA upgrades Becton Dickinson (BDX +0.8%) to Neutral from Underperform.
- RBC upgrades Johnson & Johnson (JNJ +1.6%) to Outperform from Sector Perform. Price target is $104.
- Citi upgrades Varian Medical (VAR +1.6%) to Neutral from Sell.
- Roth starts ANI Pharma (ANIP +9.5%) at Buy. Price target is $27.
- RBC starts Teva (TEVA +0.1%) at Sector Perform. Price target is $39.
- RBC starts AcelRx (ACRX +2.5%) at Outperform. Price target is $15.
- RBC starts Mylan (MYL +2.3%) at Outperform. Price target is $50.
- RBC starts Allergan (AGN +1.3%) at Outperform. Price target is $131.
- RBC starts Impax Labs (IPXL +0.2%) at Sector Perform. Price target is $25.
Dec. 17, 2013, 12:17 PM
- Teva Pharmaceuticals (TEVA -0.1%) will be allowed to launch a generic version of Viagra on Dec. 11, 2017 (or earlier under certain circumstances) following a settlement of Pfizer's (PFE -0.1%) patent litigation case against the company. Teva will pay Pfizer a royalty for a license to produce the generic version. Other terms of the settlement are confidential.
- Press release
Dec. 16, 2013, 5:42 PM
Dec. 16, 2013, 12:46 PM
Dec. 16, 2013, 9:11 AM
Nov. 20, 2013, 3:15 PM
- Shares of Teva (TEVA +3.7%) are trading notably higher on the session.
- Helping the cause is Susquehanna, where analysts have upgraded the stock to Positive from Neutral.
- Price target is now $50 (from $43).
- Meanwhile, the rumor mill is alive with talk of a possible merger with either Mylan (MYL +0.8%) or Valeant (VRX +0.1%).
- "People are looking for the company to do something,” an S&P analyst quoted by Bloomberg says.
TEVA vs. ETF Alternatives
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