Aug. 4, 2014, 5:30 PM
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Jul. 11, 2014, 7:48 PM
- Reuters reports that generic drug firm Mylan (MYL -1%) is in advanced negotiations with Abbott Laboratories (ABT +0.1%) to purchase a multibillion dollar portfolio of its established off-patent Europe-based drugs. The transaction is a tax inversion deal that will enable Mylan to redomicile in Switzerland.
- Mylan has been in the hunt for foreign assets since its failed attempt to buy Swedish drugmaker Meda AB earlier this year. Its two main competitors, (TEVA +0.9%) and Actavis (ACT +0.5%) are domiciled in lower tax countries.
- Abbott will use the proceeds of the sale, rumored to be as high as $5B, to invest in higher growth opportunities.
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)
Jun. 27, 2014, 10:48 AM
- Oxeo AB files a patent infringement suit in the District Court of Delaware against Actavis' (ACT +0.7%) ANDA for a generic version of Zubsolv (buprenorphine and naloxone). Zubsolv is protected by three patents that do not expire until at least 2019. Oxeo's action comes within the 45-day response window after receiving the Notice Letter from Actavis so there is an automatic statutory 30-month stay of an FDA decision on the ANDA.
Jun. 26, 2014, 7:11 AM
- Actavis (ACT) files an ANDA for a generic version of Acorda Therapeutics' (ACOR) MS drug Ampyra (dalfampridine) Extended Release Tablets, 10 mg. The company intends to vigorously defend its IP rights and will initiate a patent infringement lawsuit against ACT within the 45-day response period. This will trigger an automatic stay of a potential FDA decision for 30 months.
- Four of Ampyra's five patents are valid until at least 2025. It's Orphan Drug status extends until January 2017.
Jun. 25, 2014, 7:55 AM
- The U.S. District Court of New Jersey finds that Shire's (SHPG) patents protecting ADHD drug Vyvanse (lisdexamfetamine dimesylate) are both infringed and valid in a lawsuit against five would-be generic competitors. The patents are valid until 2023. In order to launch their competing offerings, the generic firms must overturn each of the 18 patent claims (from four Orange Book-listed patents) on appeal.
- The ANDA filers are Actavis (ACT), Amneal Pharmaceuticals, Mylan Pharmaceuticals (MYL), Roxane Labs and Sandoz (NVS).
Jun. 19, 2014, 8:46 AM
- The U.S. District Court for the District of Delaware finds that Actavis' (ACT) generic version of Novartis' (NVS) Exelon Patch (rivastigmine transdermal system) infringes on certain claims of NVS patents '031 and '023. ACT's ANDA for its generic offering is currently under FDA review. Actavis says that it is reviewing the court's decision and evaluating its options, including an appeal.
- The Exelon Patch is a treatment for mild-to-moderate dementia associated with Alzheimer's or Parkinson's disease.
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, 5:59 PM
- Vivus (VVUS +0.6%) files a lawsuit in the U.S. District Court for the District of New Jersey against Actavis' (ACT -1.1%) ANDA to market and sell a generic version of Qsymia.
- Since Vivus filed its suit within 45 days of the certification notice, the court will automatically issue a 30-month stay of the FDA's approval decision (the stay could be shorter if the court finds that the Qsymia patents are invalid, unenforceable or not infringed).
Jun. 11, 2014, 6:46 AM
- The U.S. Court of Appeals in Washington finds that two of Allergan''s (AGN) patents covering its eyelash drug Latisse are invalid. The patents cover ways to apply the drug to promote eyelash growth.
- Latisse is a variation of the company's glaucoma drug Lumigan. The company developed it after researchers noted that eyelash growth was a side effect of glaucoma treatments.
- The court threw out an order preventing Novartis' (NVS) Sandoz, Actavis (ACT) and Apotex from selling generic versions.
- Allergan expects Latisse to generate ~$110M is sales this year.
Jun. 10, 2014, 6:09 PM
- Actavis (ACT -0.4%) prices its $3.7B senior unsecured notes: $500M 1.3% senior unsecured notes due 2017, $500M 2.45% senior unsecured notes due 2019, $1.2B 3.85% senior unsecured notes due 2024 and $1.5B 4.85% senior unsecured notes due 2044.
- Shareholders did not have to wait for a regulatory filing after all.
Jun. 10, 2014, 12:20 PM
- Through its indirect subsidiary Actavis Funding SCS, Actavis (ACT -1.2%) privately offers three, five, ten and thirty-year senior unsecured notes. Net proceeds will be used to consummate the Forest Labs acquisition, to refinance Warner Chilcott's 7.75% senior notes due 2018, to pay related fees and expenses and for general corporate purposes.
- Shareholders will most assuredly have a keen interest in the prices and terms of the debt, but they will have to wait for the regulatory filings to find out.
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. 27, 2014, 4:52 PM
- Actavis (ACT +0.3%) files an ANDA for a generic version of AstraZeneca (AZN -0.3%) and Bristol-Myers Squibb's (BMY +0.2%) Onglyza (saxagliptin hydrochloride), a treatment for glycemic control in adults with type 2 diabetes.
- AZN filed suit against ACT on May 23, 2014 to prevent it from commercializing its generic version prior to the expiration of the '400 patent. The court instituted a stay of final FDA approval of the ANDA until January 31, 2017 or final resolution of the suit, whichever occurs sooner. ACT believes it is the first filer so it will be entitled to 180 days of generic market exclusivity upon regulatory clearance.
- According to IMS Health Data, U.S. Onglyza sales were ~$532M for the 12-month period ending February 28, 2014.
May. 15, 2014, 9:32 AM
- Actavis (ACT) and J&J (JNJ) unit Janseen Pharmaceuticals extend their supply and distribution agreement for Janssen's Concerta (methylphenidate hydrochloride extended-release tablets) to December 31, 2017. Janssen will continue to manufacture and supply all dosage strengths of the authorized generic product and Actavis will continue to market it in the U.S. and pay Janssen 50% of net sales.
- Under the terms of the contract, Actavis may pursue FDA clearance of its own ANDA for a generic version of the product and launch it at after 2017.
May. 15, 2014, 8:56 AM
- The English High Court has ruled that Actavis' (ACT) generic version of Eli Lilly's (LLY) blockbuster lung-cancer drug Alimta doesn't breach the latter company's dosage patents if Actavis sells certain alternative salt forms of the drug when its compound IP ends in 2015.
- The court granted corresponding declarations of non-infringement regarding patents on Alimta's vitamin dosage regimen in France, Italy and Spain.
- The U.K. court's ruling is contrast to the verdict of a regional court in Germany that backed Lilly on the IP. The U.S. company has other U.K. patents on the drug that are due to last till 2021.
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