Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Mon, Apr. 27, 3:42 PM
- Teva Pharmaceutical Industries (TEVA -4.3%) is allegedly scheduled to meet with institutional holders of Mylan (MYL -5.5%) this week in an effort to clarify the valuation necessary to close the deal. Some observers think a revised bid will be in the $85 - 95 range. Teva's first offer, which Mylan rejected, was $82.
Tue, Apr. 21, 8:48 AM
- 50% stock and 50% cash
- The proposal gives Mylan (NASDAQ:MYL) shareholders a 37.7% premium to the stock price of Mylan on April 7, 2015, the last day of trading prior to Mylan's press release regarding its unsolicited proposal for Perrigo (NYSE:PRGO), and a 48.3% premium to the unaffected stock price of Mylan on March 10, 2015, which is the last day of trading prior to widespread speculation of a transaction between Teva (NYSE:TEVA) and Mylan.
- Expected to be significantly accretive to Teva non-GAAP EPS, starting in the mid-teens in year 1 and approaching 30% by year 3.
- Teva/Mylan product offerings would create a combined pipeline of over 400 pending ANDAs and over 80 first-to-files in the U.S.
- MYL +9.3% premarket to $74.40. TEVA +2.8% premarket.
- Source: Press Release
- Previously: Bloomberg: Teva offer for Mylan could come today (Apr. 21)
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20)
- Related: Why Does Mylan Want To Buy Perrigo? (Apr. 9)
Tue, Apr. 21, 6:17 AM
- Teva (NYSE:TEVA) could make an unsolicited offer for rival Mylan (NASDAQ:MYL) as soon as today, Bloomberg reports, in what could be the drug industry's largest takeover attempt this year. Mylan has a market value of $33.3B.
- Teva has been working with Barclays on the approach and has contacted other banks about financing a potential deal.
- On Friday, Mylan said it's not interested in a sale and doesn't expect a potential combination to clear antitrust hurdles.
- TEVA +3.9%; MYL +12% premarket
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20 2015)
- Previously: Teva reportedly weighing bid for Mylan; shares jump (Apr. 17 2015)
Fri, Apr. 17, 2:30 PM
- The WSJ and Bloomberg report Teva (TEVA +3.4%) is weighing a bid to acquire fellow generic drug giant Mylan (MYL +5.5%), while adding no decision has been made yet. Shaes of both companies have spiked higher.
- Bloomberg's sources state Teva "hasn't made a formal approach yet," though Mylan is aware of Teva's interest. Many analysts have long expected Teva to go after Mylan, given many perceived top and bottom-line synergies. Teva is currently worth $66.2B, and Mylan $34.3B.
- Perrigo (PRGO -2.8%), which Mylan announced a $28.9B ($205/share) bid for last week, has moved lower on the news.
Mon, Mar. 30, 7:18 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) acquires Auspex Pharmaceuticals (NASDAQ:ASPX) for $101 per share ($3.2B) in an all-cash transaction. The deal will enhance Teva's revenue and earnings growth profile as well as strengthen its central nervous system franchise.
- Auspex's lead product candidate is SD-809, a small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), that is designed to regulate the levels of dopamine in the brain. It is being investigated for the treatment of various movement disorders.
- Shares are up 42% premarket on average volume.
- Previously: Auspex Pharma completes enrollment in tardive dyskinesia trial (Feb. 3)
- Previously: Auspex chorea treatment candidate successful in Phase 3, shares jump (Dec. 17, 2014)
- Previously: Auspex candidate for TS tagged an Orphan Drug (Jan. 14)
Thu, Feb. 5, 3:23 PM
- The resignation of prominent healthcare investor/entrepreneur Dr. Phillip Frost, M.D., from Teva Pharmaceutical Industries' (TEVA +1.8%) Board of Directors prompts aggressive buying from speculators who think a potential deal is afoot with Opko Health (OPK +4.6%). Teva is up on 50% higher volume while Opko's turnover is 3x average.
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
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