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. 11, 2014, 7:23 AM
- Sun Pharmaceutical Industries voluntarily recalls 41,127 bottles of antidepressant venlafaxine hydrochoride in the U.S. because the pills do not meet dissolution specifications. The recall is classified as Class II which means that the use of the drug may cause temporary or medically reversible adverse health consequences.
- Pfizer (PFE) recalled 104,000 bottles of the same drug several months ago after a pharmacist noticed that one of the bottles contained a heart medication. It sells in the U.S. under the brand name Effexor XR.
- Sun is also recalling 200 vials of the chemo drug gemcitabine in the U.S. due to a lack of assurance of sterility.
- Related tickers: (TEVA) (RDY) (MYL) (MNK) (PRGO)
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. 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. 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. 9, 2014, 12:34 PM
- Mylan (MYL -0.2%) launches carboplatin injection, 50 mg/5 ml as a treatment in combination with other chemotherapeutic agents for ovarian cancer. It is a generic version of Bristol-Myers Squibb's (BMY -1.3%) Paraplatin Injection. The company plans to launch three additional dosages in the near future.
- According to IMS Health, carboplatin injection generated ~$30M in U.S. sales in the 12 months ending March 31, 2014.
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. 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."
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.
May. 29, 2014, 7:55 AM
- Mylan (MYL) launches its generic version of Glaxo's (GSK) Malarone Tablets (atovaquone & proguanil hydrochloride 62.5 mg/25 mg and 250 mg/100 mg) for the prophylaxis and treatment of P. falciparum malaria. According to IMS Health, Malarone generated ~$89M in U.S. sales for the 12-month period ending March 31, 2014.
- Mylan has 299 other ANDAs pending FDA approval.
May. 15, 2014, 8:16 AM
- Teva (TEVA) has lost a case in which it tried to persuade a court to delay the release of generic forms of Copaxone by saying that more testing was needed for these versions of the multiple-sclerosis drug.
- A 20-milligram dosage of Copaxone is due to lose its patent protection on May 24, after which Mylan (MYL) and Novartis (NVS) unit Sandoz can start selling cheaper forms of the treatment.
- Teva hopes to switch patients to a longer-lasting 40-milligram regimen, which is protected until 2015.
May. 1, 2014, 8:46 AM
May. 1, 2014, 7:15 AM
Apr. 29, 2014, 10:09 AM
- Wockhardt plays down reports that Mylan (MYL) and Pfizer (PFE) are in discussions with the Indian generic drug-maker about acquiring some of its assets.
- Mylan was reported to be in negotiations to buy Wockhardt's India business, which could fetch over $1B, as the latter company is looking to focus on foreign markets.
Apr. 29, 2014, 7:35 AM
- Taking exception to the FDA's decision to award exclusive rights to Teva Pharmaceutical Industries (TEVA) to sell a generic version of Pfizer's (PFE) Celebrex, Actavis (ACT) sues the regulator. The company's action follows Mylan's (MYL) suit filed on Friday.
- The company believes the agency acted improperly when it awarded exclusivity to Teva despite a ruling from the U.S. Court of Appeals for the Federal Circuit that resulted in the expiration of that entitlement.
- The Celebrex patent will expire in May. Teva plans to launch its generic version in December.
- Celebrex generated almost $3B in sales in 2013 according to Pfizer.
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