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News For ACT;TEVA;ENDP;COV;ABT From The Last 14 Days
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March 5, 2015
11:30 EDTTEVATeva volatility at low end of range on tight price movement
Teva March call option implied volatility is at 22, April and June is at 20, September is at 21; compared to its 26-week average of 23, suggesting decreasing near term price movement.
08:31 EDTTEVAANI Pharmaceuticals acquires generic drug product from Teva
ANI Pharmaceuticals (ANIP) announced that it has acquired the approved abbreviated new drug application for Flecainide Acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva Pharmaceuticals (TEVA). According to IMS Health, the overall market for this product was approximately $39M in 2014. ANI has forty-seven generic drug products under development addressing a total annual market size of approximately $3B, based on data from IMS Health.
07:56 EDTENDPEndo coverage resumed with an Overweight at Morgan Stanley
Target $101.
March 4, 2015
17:50 EDTACTActavis confirms District Court ruling that Atelvia patents are invalid
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09:07 EDTENDPFDA making testosterone product makers change labeling
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March 3, 2015
07:58 EDTENDPEndo price target raised to $104 from $88 at Canaccord
Canaccord raised its price target on Endo to $104 from $88 following strong Q4 results. The firm cited strength in all business segments, potential for upside to guidance, and its recent sale of AMS, which gives it cash for acquisitions. Canaccord reiterated its Buy rating on Endo shares.
March 2, 2015
16:26 EDTENDPOn The Fly: Closing Wrap
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12:13 EDTENDPOn The Fly: Midday Wrap
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08:31 EDTACTActavis receives approval from Europcean Commission for Xydalba
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08:24 EDTTEVATeva announces sale of Sellersville, PA facility to G&W Laboratories
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07:20 EDTTEVACowen to hold a conference
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07:16 EDTENDPEndo to divest AMS men's and prostate health businesses to Boston Scientific
Endo International (ENDP) announced it has entered into a definitive agreement with Boston Scientific (BSX), under which Boston Scientific will acquire Endo's American Medical Systems' Men's and Prostate Health businesses for up to $1.65B, with $1.6B in cash payable at closing. Endo is also eligible to receive a potential milestone payment of $50M in cash conditioned on Boston Scientific achieving certain product revenue milestones in the Men's Health and Prostate Health businesses in 2016. In addition, Endo is currently evaluating strategic alternatives for the AMS Women's Health business. The transaction is expected to close in the third quarter of 2015, subject to customary conditions, including the expiration or termination of any applicable waiting periods under applicable competition laws. Endo will classify and report results of AMS as Discontinued Operations. FY15 Endo guidance will be provided on a continuing operations basis.
07:15 EDTENDPEndo sees FY15 adjusted EPS ex-AMS $4.35-$4.55, consensus $4.88
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07:11 EDTENDPEndo reports Q4 adjusted EPS $1.16, consensus $1.12
Reports Q4 revenue $799.96M, consensus $780.44M.
07:10 EDTENDPEndo to sell AMS urology portfolio to Boston Scientific for up to $1.65B
Boston Scientific (BSX) announced that it has entered into a definitive agreement with Endo International (ENDP) to acquire the American Medical Systems' urology portfolio, which includes the Men's Health and Prostate Health businesses, for $1.6B in up-front cash and a potential additional $50M milestone based on 2016 sales. The company expects to close the transaction in the third quarter of 2015, subject to customary closing conditions. Upon completion of the transaction, the AMS Men's Health and Prostate Health businesses will become part of Boston Scientific Urology and Women's Health. The acquisition encompasses the AMS product portfolio for treating urologic conditions, including benign prostatic hyperplasia, male stress urinary incontinence and erectile dysfunction. These technologies complement Boston Scientific's strong kidney stone, pelvic organ prolapse, female stress urinary incontinence and abnormal uterine bleeding treatment portfolios, and together, will provide customers with a comprehensive urology, urogynecology and gynecologic surgery portfolio. The AMS women's health business for treating pelvic organ prolapse and female stress urinary incontinence is not included in the transaction. The AMS Men's Health and Prostate Health businesses generated 2014 sales of approximately $400M and adjusted operating income of approximately $130M, excluding amortization and certain allocated expenses. GAAP operating income, including amortization and certain allocated expenses, was approximately $60M in 2014. The acquisition is expected to result in annual pre-tax synergies in excess of $50M by the end of 2018. On an adjusted basis, the transaction is expected to be breakeven to adjusted earnings per share in 2015, accretive by at least 3c in 2016, approximately 7c in 2017, and increasingly accretive thereafter. The transaction is expected to be less accretive, or dilutive, as the case may be, on a GAAP basis 2015 through 2017, due to amortization expense and transaction and integration costs. The acquisition is being structured as an asset purchase for tax purposes. Boston Scientific intends to finance the acquisition through a combination of existing and newly committed credit facilities.
07:08 EDTENDPEndo to sell AMS urology portfolio to Boston Scientific for up to $1.65B
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07:08 EDTENDPBoston Scientific enters $1.65B agreement with Endo to acquire urology portfolio
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February 27, 2015
12:35 EDTABTMylan completes acquisition of assets from Abbott
Mylan N.V. and Mylan (MYL) announced the successful completion of the acquisition of Abbott Laboratories' (ABT) non-U.S. developed markets specialty and branded generics business. Under the previously announced terms of the transaction agreement, Abbott received 110M shares of Mylan N.V., resulting in former Mylan shareholders now owning approximately 78% of Mylan N.V. and Abbott now owning approximately 22% of Mylan N.V. Mylan Inc. and Abbott's non-U.S. developed markets specialty and branded generics business have been reorganized under Mylan N.V., a new public company organized in the Netherlands. Mylan N.V. will be led by the former Mylan Inc. executive team. The company will trade on Nasdaq under the ticker symbol MYL.
08:04 EDTACTActavis and Medicines360 announce FDA approval of LILETTA
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08:02 EDTACTFDA PDUFA Date for Actavis Nebivolol/Valsartan is February 27, 2015
February 26, 2015
07:33 EDTENDPQLT Inc. reports Q4 EPS 31c, consensus 14c
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February 25, 2015
17:26 EDTACTActavis' Avycaz for infections approved by FDA
Actavis' Avycaz has been approved by the FDA for the treatment of adult patients with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. AVYCAZ received a priority review based on Phase II data from the company's clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options. AVYCAZ will be available in Q2.
08:19 EDTACTActavis price target raised to $350 from $315 at Bernstein
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08:05 EDTTEVATeva says FDA accepts CEP-33237 NDA for review
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07:59 EDTACTActavis 13.2M share Secondary priced at $288.00
The deal size was lowered to $3.8B from $4.2B and but the convertible preferred was up-sized to $4.6B from $4.2B. JPMorgan, Mizuho, Wells Fargo and Morgan Stanley acted as joint book running managers for the offering.
February 24, 2015
16:27 EDTACTActavis confirms generic Uceris patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Budesonide Extended-release Tablets, 9 mg. Actavis' ANDA product is a generic version of Salix Pharmaceuticals' (SLXP) Uceris, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
14:31 EDTENDPBoston Scientific deal for Endo unit would be favorably received, says Needham
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12:40 EDTENDPBoston Scientific may strike deal for Endo AMS unit within weeks, Reuters says
Boston Scientific (BSX) is reportedly close to buying Endo International's (ENDP) AMS medical device unit which could be valued at roughly $2B, reports Reuters, citing people familiar with the matter. The sources said the companies want to finalize a deal "within a matter of weeks" but cautioned that talks are continuing and could still fail. Reference Link
12:14 EDTENDPEndo near deal to sell AMS device unit to Boston Scientific, Reuters says
09:02 EDTTEVATeva announces phase 2b study of TEV-48125 achieved endpoints
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February 23, 2015
15:04 EDTTEVATeva announces publication of data on Phase III trials of reslizumab
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12:53 EDTACT, ENDPAnalysts debate potential for competing Salix takeover bid
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09:02 EDTENDPAcceptance of NDA for Belbuca triggers $10M milestone payment to BDSI
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07:31 EDTENDPEndo, BioDelivery Sciences announce acceptance of NDA for Belbuca
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February 22, 2015
15:59 EDTENDPValeant to buy Salix for $10.1B, FT says
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February 20, 2015
09:17 EDTENDPEndo price target raised to $101 from $86 at Goldman
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08:46 EDTACTActavis receives final approval for generic version of Subutex
Actavis announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex. Actavis intends to begin shipping its product shortly. Subutex is indicated for the treatment of opioid dependence. For the 12 months ending December 31, 2014, Subutex had total U.S. sales of approximately $108M, according to IMS Health data.
08:21 EDTENDPSummer Street still feels Endo could acquire BioDelivery Sciences
Summer Street reiterated its belief that Endo (ENDP) could acquire BioDelivery Sciences (BDSI), its partner on multiple products. The firm says scripts for BioDelivery's Bunavail continue to trend in the right direction. It reiterates a Buy rating on the stock with a $25 price target.
08:07 EDTACTActavis price target raised to $340 from $310 at Argus
Argus increased its price target on Actavis as the firm believes that the company is generating strong growth. Argus is upbeat on the company's acquisition of Allergan and keeps a Buy rating on the shares.
08:04 EDTTEVATeva to present new respiratory data at AAAAI
Teva Pharmaceutical Industries announced that four company-sponsored abstracts will be presented at the 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology, or AAAAI, in Houston, Texas. Data to be presented include two replicate 52-week Phase III global studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with asthma and elevated blood eosinophils who were inadequately controlled on medium-to-high doses of inhaled corticosteroids with or without an additional controller. The data are scheduled for presentation on Monday, February 23 during an oral session titled “Asthma Therapy and Mechanisms.” Also to be presented are two Phase III studies of beclomethasone dipropionate 40mcg, which gained FDA approval in December 2014, and is now available for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years of age. In addition, a dose-response study evaluating the safety and efficacy of fluticasone/salmeterol multidose dry-powder inhaler in patients 12 years of age and older with persistent asthma will be presented.
07:08 EDTTEVA, ABTAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
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