Sat, Jan. 31, 12:35 PM
- The FDA approves Zogenix's (NASDAQ:ZGNX) Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek, a formulation technology that provides abuse-deterrent features without changing the release properties of hydrocodone.
- BeadTek incorporates pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents.
- The company intends to transition all Zohydro strengths to the BeadTek version in Q2. In H2, it expects to submit the results from its ongoing Human Abuse Liability Studies, which will further characterized the abuse-deterrent properties of the BeadTek formulation, to the FDA.
- Related tickers: (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NYSE:PFE)
Mon, Jan. 26, 10:20 AM| 1 Comment
Thu, Jan. 15, 7:22 AM
- In an effort to increase its focus on developing new drugs, privately-held Boehringer Ingelheim says that it is considering the sale of Roxane Labs, its U.S.-based generics unit. The company believes it makes more sense for a generics specialist to own the 1,300-employee business.
- The generics industry is fiercely competitive as the number of blockbuster drugs coming off patent has declined from its peak in 2012. The top players are (NYSE:TEVA), Sandoz (NYSE:NVS) and Actavis (NYSE:ACT).
- According to Bloomberg, Roxane could fetch as much as $2.4B. Morgan Stanley is advising.
Mon, Jan. 12, 9:34 AM
- The U.S. Federal Trade Commission grants early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in regard to Actavis' (ACT +1.2%) pending takeout of Allergan (AGN +1.9%). This satisfies one of the conditions for the transaction.
- The record date for determining eligible shareholders who will be entitled to vote on the deal is January 22.
Mon, Jan. 12, 8:56 AM
Thu, Jan. 8, 4:19 PM
- Adamas Pharmaceuticals (NASDAQ:ADMS) receives a $30M milestone payment from Actavis (NYSE:ACT) subsidiary Forest Laboratories for the FDA clearance of Namzaric (memantine hydrochloride/donepezil hydrochloride) for the treatment of moderate-to-severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
- Forest submitted the NDA in February 2014.
- Previously: FDA clears Adamas Alzheimer's drug (Dec. 24, 2014)
Dec. 24, 2014, 8:52 AM
- The FDA approves the New Drug Application (NDA) for Namzaric, a fixed dose combination of memantine HCl extended release and donepezil hydrochloride, for the treatment of moderate-to-severe dementia of the Alzheimer's type.
- Memantine is an NMDA receptor agonist which blocks the activity of the neurotransmitter glutamate. At normal levels, glutamate aids memory and learning but it the levels are excessive, it overstimulates and eventually kills nerve cells via excitotoxicity.
- Donepezil is a reversible acetylcholinesterase inhibitor. It inhibits the hydrolysis of acetylcholine which is a process associated with cognitive impairment.
- Namzaric was co-developed by Adamas Pharmaceutics (NASDAQ:ADMS) and Forest Laboratories (NYSE:ACT) under the terms of an agreement signed in November 2012.
- Adamas is due a $30M milestone payment from Forest for the approval.
- ADMS is up 19% premarket on moderate volume.
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. 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
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