Dec. 16, 2014, 9:33 AM
- Actavis (ACT -0.5%) says CEO Brent Saunders and Executive Chairman Paul Bisaro will continue in their roles after its acquisition of Allergan closes. Under the new structure, Actavis exec C. David Nicholson will head branded pharmaceutical R&D reporting to Mr. Saunders. COO Robert Stewart will head generics and global operations, also reporting to Saunders.
- Global brand sales and marketing will be split into international brands, branded pharma and Allergan Pharma.
- No information is provided on who Allergan (AGN -0.5%) chief David Pyott will report to. If he stays, it would appear to be Saunders.
Dec. 12, 2014, 12:49 PM
- A federal judge in New York forces Actavis (ACT -0.9%) to defer its plan to discontinue the sale and distribution of Namenda IR. The company planned to kill the product several months ago, ahead of looming generic competition, in favor of the more expensive Namenda XR, which is patent protected until 2025.
- The NY Attorney General sued the company to prevent it from discontinuing the lower priced version. A hearing is scheduled for Monday to determine how long it must keep Namenda IR on the market. Actavis plans to appeal the decision.
- Whatever is decided will not have a material effect on Actavis' top or bottom lines. Analysts expect the Namenda franchise to generate $1.3B in the next three years with 95% of it coming from the XR formulation. According to the company, 40% of users have already converted to XR.
- Namenda (memantine HCl) is indicated for the treatment of moderate-to-severe dementia of the Alzheimer's type. The value proposition of the XR version is a simpler once-daily dosing schedule.
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. 22, 2014, 8:25 AM
- Harvard Business School's Bill George is troubled by the trend of activist investors shifting their wrath to some of America’s best companies, which he says may net nice profits in the short term but places the competitiveness of America’s great global companies at risk.
- An example is Amgen (NASDAQ:AMGN), whose stock has gained 185% in the past five years, but Dan Loeb still wants to split the company; George says this would destroy a productive innovator by taking away the cash it needs to develop new drugs and fuel growth.
- PepsiCo’s (NYSE:PEP) 52% increase in three years is double that of Coca-Cola, yet Nelson Peltz is agitating to split the company in two, as he did with Kraft - which has struggled, as has its Mondelez spinout.
- Peltz also is trying to break up DuPont (NYSE:DD) even though the stock has climbed 250% since Ellen Kullman became CEO in 2009; a disjointed conglomerate without a clear strategy, DuPont's stock had slipped 62% since 2000.
- Bill Ackman successfully partnered to put Allergan (NYSE:AGN) in play, which resulted in a sale, but George says the deal was unnecessary for a stock that had gained 2,400% since David E.I. Pyott became CEO in 1998.
- In each case, George says leaders were forced to focus on saving their companies instead of winning global competitive battles, creating great products and building new businesses.
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
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
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