Wed, Feb. 18, 6:43 AM
Tue, Feb. 17, 10:06 PM
- Elite Pharmaceuticals (OTCQB:ELTP) plans to commence a Phase 3 study in late March evaluating its abuse-deterrent opioid product candidate, ELI-200. The company has submitted a study protocol to the FDA and expects to receive its comments by mid-March. Patient dosing should start shortly thereafter.
- The multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial will assess the safety and efficacy of abuse-deterrent ELI-200 for the treatment of adult patients with moderate-to-severe pain following surgery. The study will enroll ~150 patients and will take ~eight weeks to complete.
- Elite projects submitting a New Drug Application (NDA) in Q3 and achieving regulatory clearance by early 2016.
- The company's abuse-deterrent technology is a multi-particulate capsule that contains an opioid agonist in addition to the opioid antagonist, naltrexone. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the effects of the opioid. The technology is the firm's top priority, expected to add considerably to its modest revenues to date. Fiscal Q3's top line was only $1.4M.
- Related tickers: (NYSE:PFE) (NASDAQ:ACUR) (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Tue, Feb. 17, 5:35 PM
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Tue, Feb. 17, 8:40 AM
- The FDA accepts for review the New Drug Application (NDA) from privately-held Canton, MA-based Collegium Pharmaceuticals for Xtampza ER, its abuse-deterrent extended-release oxycodone formulation for the treatment of chronic pain.
- Its abuse-deterrent technology is called DETERx, which preserves the extended-release properties following common methods of tampering. It also avoids the use of antagonists (Pfizer's (NYSE:PFE) ALO-02 and Embeda) and aversive agents (Acura's (NASDAQ:ACUR) AVERSION), thereby minimizing the risks to legitimate patients.
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
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
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