The FDA approves Teva Pharmaceutical Industries' (NASDAQ:TEVA) VANTRELA ER (hydrocodone bitartrate) extended-release tablets for the management of pain. The product was formulated with its proprietary abuse-deterrent technology. The company says the abuse-deterrent characteristics should reduce, but not totally prevent oral, intranasal and intravenous abuse of the drug when the tablets are manipulated.
Eli Lilly (LLY +2.6%) perks up on increased volume in response to a positive ruling from a federal appeals court upholding a district court ruling that generic products proposed by Teva Pharmaceutical Industries (TEVA -0.6%) would infringe on its vitamin regimen patent related to cancer med Alimta (pemetrexed).
Leerink's Seamus Fernandez says the decision "removes an overhang" and supports the company's 2017 financial outlook.
Last week, Teva Pharmaceutical Industries (NASDAQ:TEVA) cut its 2017 sales guidance by $1B. The new range is $23.8B - 24.5B compared to $25.2B - 26.2B that was released in July 2016. The downward revision was due to much lower new product sales in 2016 ($140M) than expected ($600M) that will carry over into this year.
At JPM17, CEO Erez Vigodman explained the situation and promised "to do everything in our power to make sure that something like that does not happen again."
There has been some fallout with analyts. Wells Fargo and Maxim Group recently downgraded the stock to Neutral, but four other shops that recently updated coverage rate it a Buy. Price targets range from $36 - 80.
Top 10 Holdings as of 9/30/2016: RELX PLC (OTC:RLXXF): 3.02784%, Sky PLC (OTCQX:BSYBF): 2.97002%, Taiwan Semiconductor Manufacturing Co Ltd (2330): 2.69423%, SAP SE (OTCPK:SAPGF): 2.57985%, CGI Group Inc A (GIB): 2.55274%, Publicis Groupe SA (OTCQX:PGPEF): 2.48737%, CK Hutchison Holdings Ltd (OTCPK:CKHUF): 2.48635%, Broadcom Ltd (AVGO): 2.46497%, WPP PLC (OTCPK:WPPGF): 2.42404%, Teva Pharmaceutical Industries Ltd ADR (TEVA): 2.26637%
Teva Pharmaceutical Industries (TEVA +1.7%) reaches a settlement with the U.S. Department of Justice and SEC over alleged violations of the Foreign Corrupt Practices Act (FCPA) related to past conduct in Ukraine, Russia and Mexico.
The resolution includes a guilty plea by its Russian subsidiary, a deferred prosecution agreement, the implementation of a temporary independent compliance monitor and the payment of $519M.
The inquiry, which began in 2012, involved improper payments by then-employees, all since dismissed from the company. None of the issues involved Teva's U.S. operations.
Antares Pharma (ATRS +5.7%) announces that Teva Pharmaceutical Industries (TEVA +0.5%) has completed the decentralized procedure registration process in Europe for its generic teriparatide injection product for the treatment of osteoporosis in women and men (sold under the brand name Forteo by Eli Lilly (LLY +0.8%)). Teva's U.S. marketing application is currently under review.
Antares will manufacture and supply the multidose pen that Teva will use with the product.
Attorney Generals from 20 states have filed a civil complaint against Teva Pharmaceutical Industries (TEVA +0.4%), Mylan N.V. (MYL +0.4%) and four smaller firms accusing them of price-fixing. Apparently, additional charges are on the way reports the NYT.
The complaint alleges that the companies conspired to artificially inflate prices of an antibiotic and a diabetes drug through informal gatherings, personal calls and text messages.
Teva counters by saying, "We have not found evidence that would give rise to any civil or criminal liability." Mylan adds that it knew of "no evidence that Mylan participated in price-fixing."
The drugs in question are doxycycline hyclate and glyburide. According to a congressional report, the price of the antibiotic skyrocketed from $20/500-pill bottle in 2013 to $1,849 in April 2014.
The other four firms are Heritage Pharmaceuticals, Aurobindo Pharma, Citron Pharma and Mayne Pharma.
The complaint singles out two former executives at Heritage who allegedly contacted competitors to make pricing deals prior to entering the market with their own offerings.
An appeals court has affirmed a New Jersey district court's ruling that Actavis (NASDAQ:TEVA) infringed on two patents covering Supernus Pharmaceuticals' (NASDAQ:SUPN) epilepsy med Oxtellar XR and that all three patents (including the two infringed upon) covering Oxtellar XR are valid.
The healthcare sector - particularly pharmaceuticals and biotechs - had a rough session on Wednesday after the president-elect promised to bring down drug prices.
Sporting sizable gains yesterday afternoon and again this session, the sector has recovered all of Wednesday's slide and more.
Up 1.15% today, the XLV has joined the broader market in the green for the week, as has the IBB. The SPDR S&P Pharmaceuticals ETF (XPH +1.5%) is having the best day of all, but remains marginally lower on the week.
Swedish biotech Orexo AB intends to appeal a decision from a Delaware district court that its U.S. Patent No. 8,940,330 (expires in September 2032) is invalid. The decision was rendered in a patent infringement case regarding Actavis' (NASDAQ:TEVA) generic Zubsolv (buprenorphine and naloxone). The court found that Orexo's U.S. Patent No. 8,454,996 (expires in September 2019) was valid.
Two other U.S. patents, Nos. 9,259,421 and 9,439,900, covering Zubsolv were not addressed in the decision. They are currently the focus of separate litigations against Actavis.
Teva Pharmaceutical Industries (NASDAQ:TEVA) slumps 4% premarket on average volume in apparent reaction to the news that the head of the company's global generics unit, Siggi Olafsson plans to retire at the end of Q1 2017.
Bank of America regards the news as "incrementally negative" while Citigroup says the change will likely "further dampen near-term sentiment."
Successor Dipankar Bhattacharjee, no doubt, believes he will convince the market otherwise.
Teva Pharmaceutical Industries (NASDAQ:TEVA) reports that that European regulators have approved a change to the label of COPAXONE (glatiramer acetate injection), specifically removing the pregnancy contraindication.
The company says the decision was based on a comprehensive review of the available prospective pregnancy cases with known outcome and confirmed exposure to COPAXONE in addition to a supporting analysis from its in-house database which captured over 8K pregnancies over 20+ years.