Jul. 3, 2014, 8:28 AM
- In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
- Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
- One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
- Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
Jul. 2, 2014, 1:19 PM
- The FDA grants tentative approval to Eagle Pharmaceuticals' (EGRX -0.5%) NDA for a ready-to-dilute concentrate version of bendamustine hydrochloride for the treatment of Indolent B-cell non-Hodgkin lymphoma. The product is currently marketed as a lyophilized powder requiring reconstitution and dilution.
- The approval is termed "tentative" because of the company's ongoing patent litigation with (TEVA +2.1%) and the resolution or expiry of certain Orphan Drug exclusivities held by Teva.
Jul. 2, 2014, 7:54 AM
- Zogenix (ZGNX) plans to submit an sNDA by October 2014 for a next-generation version of Zohydro (hydrocodone bitartrate) Extended-Release Capsules that incorporates unspecified abuse deterrent technology designed to make it more difficult to abuse via injection or snorting. If approved, the new formulation will be available in early 2015.
- The company has also selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The product will incorporate abuse deterrent technology that maintains the extended-release properties of Zohydro when the tablet is crushed or chewed. This minimizes one on the ways that opioids are abused. It will have additional features that addresses abuse by injection or nasal administration. Zogenix plans to submit an NDA in H1 2016.
- Related tickers: (TEVA) (ABBV) (ALKS) (MNK)
Jun. 24, 2014, 3:45 PM
- (TEVA -0.9%) unit Cephalon wins its suit involving certain drug wholesalers who sued the company over its "pay for delay" agreements with generic competitors. Philadelphia District Court judge Mitchell Goldberg tossed the claims that Cephalon conspired with generics makers to delay cheaper versions of the sleep disorder drug Provigil saying that an overall conspiracy to improperly put off generic competition "cannot be established."
Jun. 20, 2014, 9:41 AM
- Teva Pharmaceutical Industries (TEVA +0.4%) settles its litigation against Perrigo Pharmaceutical Co. and Catalent Pharma Solutions LLC regarding four patents for Teva's ProAir HFA (albuterol sulfate) Inhalation Aerosol product. Under the terms of the settlement, Teva will provide a license to both firms to sell limited quantities of Perrigo's generic version beginning December 19, 2016 and ending June 2018. Afterward, no limits will apply.
Jun. 18, 2014, 9:20 AM| Comment!
Jun. 17, 2014, 9:33 AM
- Teva Pharmaceutical Industries (TEVA) settles its patent infringement suit regarding patent no. 7,132,570 for Nuvigil (armodafinil) tablets. It grants licenses to sell generic versions to Sandoz, Actavis (ACT), Lupin, and Apotex 180 days after first filer Mylan (MYL).
- Actavis will be able to launch generic 100 mg and 200 mg dosages in June 2016. The others may launch the same dosages 180 days later. Mylan may launch generic versions of 50 mg, 150 mg and 250 mg dosages beginning in June 2016.
Jun. 12, 2014, 4:29 PM
- The U.S. Court of Appeals for the Federal Circuit upholds a district court ruling invalidating Bristol-Myers Squibb's (BMY -0.2%) patent no. 5,206,244 for Baraclude (entecavir).
- Teva's (TEVA -0.3%) ANDA for a generic version has received tentative approval by the FDA. The commercial launch will commence after the agency issues its final approval.
- According to IMS Health, Baraclude's U.S. sales were ~$314M in the 12-month period ending in March.
Jun. 9, 2014, 8:36 AM| Comment!
Jun. 5, 2014, 10:36 AM
- The European Medicines Agency (EMA) reinstates the GMP certificate for India's generic drug maker Ranbaxy Laboratories' Toansa manufacturing site after the company implements corrective measures. The EMA suspended the GMP certificate in January after an on-site FDA inspection discovered significant deficiencies. An EMA inspection team concluded that there was no evidence that any drugs in the EU market containing Toansa-made ingredients were of unacceptable quality or presented a risk to patients.
- Related generic drug tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
Jun. 3, 2014, 10:47 AM
- Teva Pharmaceutical Industries (TEVA -0.7%) acquires Labrys Biologics for as much as $825M ($200M upfront and up to $625M in milestone payments). Labrys's lead product is LBR-101, an anti-CGRP mAb for the prevention of chronic and high frequency episodic migraines. Peak sales of the product could hit $2B - 3B. It is currently in a Phase 2b clinical trial.
Jun. 2, 2014, 1:30 PM
- Mylan (MYL) and Pfizer (PFE +0.5%) settle their suit regarding MYL's ANDA for a generic version of Celebrex (celecoxib). Under the terms of the agreement, MYL may begin selling its version at the earliest market formation but not later than December 2014. No other terms are disclosed.
- MYL has appealed the recent ruling by the U.S. District Court for the Northern District of West Virginia affirming rival Teva's (TEVA +2.7%) 180-day exclusivity as the "first filer."
Jun. 2, 2014, 10:44 AM
- Effective June 1, Teva Pharmaceutical Industries (TEVA +2%) will operate as two commercial business units: Global Specialty Medicines (GSM) and Global Generic Medicines (GGM). GSM will be led by Dr. Rob Koremans and GGM by Sigurdur Olafsson.
- Newly-formed Corporate Development, Strategy and Innovation Group will focus on short and long-term value creation including emerging market initiatives. A leader has not yet been appointed.
- Newly-formed Corporate Marketing Excellence and Communications Group will execute all marketing, brand management, company communications and corporate social responsibility initiatives. It will be led by Iris Beck-Codner.
- Executive committee reduced from 15 to 9 members.
- Eric Drape promoted to Group EVP, Global Head of Quality. EVP and CFO Eyal Desheh leads the corporate efficiency program and will jointly manage Investor Relations with President and CEO Erez Vigodman.
May. 30, 2014, 4:35 PM
- Actavis (ACT -0.8%) and Cephalon (TEVA -0.4%) settle their patent suit over generic Nuvigil (armodafinil). CEPH grants ACT a license to sell the 100 mg and 200 mg tablets beginning June 1, 2016 and the 50 mg, 150 mg and 250 mg dosages 180 days later.
- According to IHS Health Data, Nuvigil generated $437M in U.S. sales in the 12-month period ending February 28, 2014.
May. 30, 2014, 4:03 PM| Comment!
May. 30, 2014, 9:28 AM
- The U.S. District Court for the Northern District of West Virginia denies a motion by Mylan (MYL) and affirms the FDA's decision recognizing Teva's (TEVA) 180-day "first-to-file" exclusivity for generic Celebrex 100, 200 and 400 mg capsules.
- Teva and Celebrex maker Pfizer (PFE) reached a settlement on April 17 regarding Teva's generic version which it plans to launch in December of this year. According to IMS, the branded product generated $2.2B in U.S. sales in 2013.
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