Dec. 5, 2014, 3:44 PM
- The FDA's Anti-Infective Drugs Advisory Committee voted as follows in its review of Cerexa's (ACT -0.7%) NDA for ceftazidime/avibactam:
- Question 1: 11 - 1 that CAZ-AVI NDA demonstrated substantial evidence of safety/efficacy in complicated intra-abdominal infections.
- Question 2: 9 - 3 that CAZ-AVI NDA demonstrated substantial evidence of safety/efficacy in complicated urinary tract infections.
- Question 3: 12 - 0 that CAZ-AVI NDA failed to show evidence of safety/efficacy in aerobic Gram-negative infections where patients had limited or no alternatives.
- Question 4: 11 - 1 that CAZ-AVI NDA failed to show evidence of safety/efficacy in aerobic Gram-negative infections when no adequate treatments are available.
- Previously: Ad Comm review approaches for Actavis anti-infective combo (Dec. 3, 2014)
- Related ticker: (AZN -0.3%)
Dec. 3, 2014, 1:46 PM
- The FDA's Anti-Infective Drugs Advisory Committee meets on Friday, December 5 to review the New Drug Application (NDA) submitted by Cerexa for the combination of ceftazidime/avibactam (CAZ-AVI) for the treatment of complicated intra-abdominal infections, complicated urinary tract infections and acute pyelonephritis. The NDA also includes a limited use indication for patients with aerobic Gram-negative infections with limited treatment options.
- The FDA designated CAZ-AVI a Qualified Infectious Disease Product (QIDP) in March 2013. Among the benefits of the tag is a five-year period of market exclusivity if approved.
- Cerexa was acquired by Forest Labs in 2006 for $480M. Forest was acquired by Actavis (ACT +0.5%) for $25B this year.
- Briefing doc and addendum
- Related ticker: (AZN +1.6%)
- Previously: AstraZeneca reports top-line results from Phase 3 antibiotic trials
Nov. 25, 2014, 2:42 AM
- After agreeing to buy Allergan (NYSE:AGN) this month for $66B, Actavis (NYSE:ACT) is now planning to announce a series of job cuts, Bloomberg reports.
- Actavis CEO Brent Saunders says there are overlaps in corporate functions, including human relations and finance, though he hasn’t yet quantified how many positions will be eliminated.
- Actavis is also planning to expand in China with generic and brand-name medicines and Allergan’s Botox.
Nov. 21, 2014, 1:51 AM
- Valeant Pharmaceuticals (NYSE:VRX) has slashed its stake in Allergan (NYSE:AGN) to 0.1% from 9.7%, three days after Actavis (NYSE:ACT) trumped its offer for the Botox maker.
- Pershing Square and Valeant have now sold all 2.2M Allergan in PS Fund 1, a shell fund that was set up by the two to act as a joint acquisition vehicle.
- VRX -0.8% AH
Nov. 18, 2014, 12:06 PM
- The U.S. Court of Appeals for the Federal Circuit rules in favor of generic firms, including Teva Pharmaceutical Industries (TEVA), in Roche's and Warner-Chilcott's (ACT +6.5%) patent infringement suit over Roche's branded osteoporosis med Actonel at a monthly dose of 150 mg (Warner licensed the product from Roche).
- From August 2008 to February 2011, Teva, Apotex, Mylan Pharmaceuticals (MYL +1.7%) and Sun Pharma all filed ANDAs to sell generic Actonel 150 mg tablets.
Nov. 17, 2014, 5:40 PM
Nov. 17, 2014, 12:22 PM
- It's doubtful that Pershing Square's Bill Ackman is disappointed that Valeant Pharmaceutical (VRX +0.3%) lost out to Actavis (ACT +1.9%) in a bid for Allergan (AGN +5.7%) considering the tidy $2.6B profit he'll bag on his 9.7% stake in the Botox maker.
- Pershing Square acquired 28.9M shares of AGN at $129.28 and will sell at $219. Doing the math: ($219 - 129.28) x 28.9M = $2.59B.
- The hedge fund will pay Valeant ~$389M as part of their profit-sharing agreement so its ultimate take will be ~$2.2B.
- Previously: It's official: Actavis buys Allergan
Nov. 17, 2014, 10:13 AM
- Valeant Pharmaceuticals (VRX +0.7%) Chairman and CEO Michael Pearson says his firm cannot justify paying the $219 (or more) per share for Allergan that Actavis (ACT +3.6%) has committed, although his team will review the agreement to determine a course of action.
- He adds, "Our business is performing extremely well as evidenced by out third quarter results, our expected fourth quarter and our robust outlook for 2015. I am confident in our continued ability t generate exceptional shareholder value. We will remain focused on delivering strong organic results and evaluating acquisition opportunities as we always have: prudently, in a disciplined manner, and in the best interests of our shareholders."
- Previously: It's official: Actavis buys Allergan
Nov. 17, 2014, 9:26 AM
Nov. 16, 2014, 3:51 PM
- A deal could be announced as soon as Monday.
- Allergan (NYSE:AGN) is trying to fend off a hostile bid by Valeant (NYSE:VRX), which has offered AGN about $54B in cash and stock, and has said it was prepared to raise its offer to $200/share.
- Valeant, which has not been contacted by Allergan, would likely abandon its bid in the face of the Actavis (NYSE:ACT) deal.
- The deal could include a $2B breakup fee that would need to be paid by Valeant were it to try and outbid Actavis.
- Sources: Reuters, CNBC
Nov. 13, 2014, 9:44 AM
- The FDA accepts under Priority Review Actavis' (ACT +1.4%) Supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients ages 10 to 17.
- Saphris' current label is the the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, as monotherapy or as adjunctive therapy with either lithium or valproate.
- The PDUFA date has not been specified but should be in Q1 2015.
Nov. 12, 2014, 5:10 PM| Comment!
Nov. 12, 2014, 12:22 PM
- Allergan (AGN +0.7%) and Actavis (ACT -0.4%) are in advanced negotiations on a takeout bid for the Botox maker. According to people close to the matter, the price will be at least $200 per share or $60B. There remains a gap, though, in what Allergan is asking (~$210/share) and what Actavis wants to pay (~$200/share). Regardless, a deal seems likely in the next few weeks since the Valeant (VRX +0.9%)-instigated special shareholders meeting is December 18.
- The potential transaction will most likely include ACT stock with cash.
- Previously: Special shareholder meeting scheduled for Dec. 18
Nov. 11, 2014, 4:16 PM
- The presence of Pershing Square's Bill Ackman on the list of major investors in Zoetis (NYSE:ZTS) sends a clear signal that it may be an acquisition target by none other than Valeant Pharmaceuticals (NYSE:VRX). A deal is not out of the question in light of its diminishing prospects of acquiring Allergan (NYSE:AGN) since Actavis (NYSE:ACT) joined the mix.
- In after hours trading, VRX is up a fraction and ZTS is unchanged, both on higher-than-normal volume.
- Previously: Zoetis jumps 6% on report of Ackman stake
Nov. 5, 2014, 7:26 AM
- Actavis (NYSE:ACT) Q3 results ($M): Total Revenues: 3,683.1 (+83.0%), North America Brands: 1,619.3 (+999%), North America Generics and International: 1,613.2 (+5.6%), Anda Distribution: 423.2 (+37.8%); Gross Profit: 1,800.1 (+93.6%); Operating Expenses: 2,852.2 (+266.0%); Operating Loss: (1,052.1) (-799.1%); Net Loss: (1,042.8) (-999%); Quick Assets: 340.4 (+2.7%); CF Ops: 522.3 (+92.9%).
- 2H 2014 Guidance: Total revenues: ~$7.4B from ~$7B; non-GAAP R&D expense: ~$650M; non-GAAP SG&A expense: ~$1.7B; non-GAAP tax rate: ~16%; non-GAAP EPS: $6.60 - 6.70 from $6.25 - 6.50..
- 2014 Guidance: non-GAAP EPS: $13.51 - 13.61 from $13.02 - 13.32.
- 2015 Guidance (from last quarter): Total revenues: ~$15B; non-GAAP EBITDA: $5.958B - 6.364B; non-GAAP EPS: $15.60 - 16.80. Guidance will be updated in early 2015.
Nov. 5, 2014, 6:36 AM
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