Tue, Feb. 17, 7:38 AM
- The U.S. District Court for the District of New Jersey rules that AstraZeneca's (NYSE:AZN) patent No. 7,524,834 (the '834 patent) protecting Pulmicort Respules is invalid. The patent, set to expire in 2018 and with pediatric exclusivity extending into 2019, will allow Actavis (NYSE:ACT) to release its generic version of the product. Teva Pharmaceutical Industries (NYSE:TEVA) has marketed a generic formulation for some time per a previous agreement with AstraZeneca.
- The court originally invalidated the '834 patent in April 2013 but the ruling was reversed and remanded in October 2013 by the U.S. Court of Appeals for the Federal Circuit.
- The company says the decision will not impact its 2015 guidance. Pulmicort generated $269M in sales in Q4 and $946M over the past 12 months. EVP, North America Paul Hudson says, "AstraZeneca strongly disagrees with the Court's decision. [The Company] has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. We are reviewing the decision and considering our legal options, including an appeal."
- Shares are down 1.5% premarket on light volume.
Fri, Feb. 13, 11:22 AM
- The FDA accepts for review Pfizer's (PFE -0.1%) New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- ALO-02 incorporates abuse-deterrent technology. The capsules contain pellets consisting of the opioid, oxycodone, surrounding sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, patients receive oxycodone in an extended release manner with no effect from the naltrexone. If the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released, counteracting the effects of oxycodone.
- Related tickers: (ZGNX +1.8%)(MNK +1.8%)(ACT +1.1%)(TEVA -0.6%)(ABBV +1%)(LCI -1%)(ALKS -3.7%)
Fri, Feb. 13, 9:45 AM
- Actavis (ACT -0.2%) sells its Aptalis subsidiary's Aptalis Pharmaceutical Technologies, known as Pharmatech, to private equity firm TPG for an undisclosed sum. The transaction is expected to close mid-year.
- Pharmatech is an oncology-focused contract research organization (CRO) and clinical trial site manager (SMO). Current President of Aptalis Pharmaceutical Technologies John Fraher will be CEO of the new standalone firm.
- Actavis COO Robert Stewart says, "Our decision to divest the Pharmatech business is consistent with our strategic commitment t build leadership positions in our core areas of strength. It will enable our industry-leading Global Operations team to sharpen their focus on supporting our existing global supply chain and on preparing for the expansion of our manufacturing network with the addition of the Allergan facilities following the close of the acquisition later this year."
Mon, Feb. 9, 5:49 PM
- Australia's Mayne Pharma (OTCPK:MAYNF) is buying the U.S. rights to the Doryx acne treatment from Actavis (NYSE:ACT) for $50M. The deal is expected to close by month's end.
- Actavis exec William Meury: "By agreeing to return the product to Mayne now, we receive value for the asset and, following a brief transition period, will enable our sales and marketing teams to focus their time and attention on supporting the expanded, industry-leading Dermatology portfolio that will be part of our combined company following the acquisition of Allergan later this year."
- Actavis is just a few days removed from announcing a deal to sell its North American respiratory business to AstraZeneca.
Fri, Feb. 6, 9:20 AM
- According to some observers, Pfizer's (NYSE:PFE) $17B takeout of Hospira (NYSE:HSP) is only a prelude to a bigger deal(s) considering that it was prepared to spend $120B for AstraZeneca (NYSE:AZN).
- According to Gabelli analyst Kevin Kedra, Actavis Plc (NYSE:ACT) is an attractive target, especially since nabbing Allergan (NYSE:AGN) and its fast-growing drug portfolio. A Pfizer takeover would be big enough to overcome the U.S. Treasury's stricter rules on inversions and lower its tax bill.
- John Boris of SunTrust Banks says GlaxoSmithKline (NYSE:GSK), AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY) and Mylan (NASDAQ:MYL) may be on the radar as well.
- Pfizer had $33B in cash at the end of September which it will use a portion of plus debt to pay for Hospira.
Fri, Feb. 6, 8:16 AM
- In an effort to sharpen its focus on its core therapeutic areas, Actavis (NYSE:ACT) divests its branded respiratory assets for the treatment of chronic obstructive pulmonary disease (COPD) in the U.S. and Canada to AstraZeneca (NYSE:AZN). Under the terms of the agreement, AZN will pay ACT $600M plus low single-digit royalties above a certain revenue threshold.
- AstraZeneca will own the development and commercial rights to Tudorza Pressiar (aclidinium bromide inhalation powder) and Daliresp (roflumilast). Sales for both products last year were $230M. AZN will also secure the development rights in the U.S. and Canada for LAS40464, which it sells in the E.U. under the brand name Duaklir Genuair.
- Actavis will receive an additional $100M from AstraZeneca on the basis of certain amendments to the firms' ongoing collaboration agreements.
- The transaction should close this quarter.
Thu, Feb. 5, 4:32 AM
- AstraZeneca (NYSE:AZN) reported a fourth-quarter loss this morning, but stressed that it was on track to return to growth by 2017.
- The company's fourth-quarter net loss came in at $321M, down 38% from $524M a year earlier, while sales for the last three months of the year fell 2% to $6.68B.
- Actavis (NYSE:ACT) also confirmed that AstraZeneca would buy its branded respiratory business in the U.S. and Canada for an initial $600M.
- ACT -1.7% premarket
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.
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