Oct. 30, 2014, 4:36 PM
Oct. 28, 2014, 9:43 AM
- A U.S. District Court rules in favor of The Medicines Company (MDCO +12.7%) in its patent infringement suit against generic med firm Mylan (MYL +0.6%). The judge rules that Mylan's ANDA for a generic version of MDCO's Angiomax (bivalirudin) infringes on the latter's U.S. Patent No. 7,582,727, which is valid until 2028.
Oct. 22, 2014, 12:24 PM
- In response to the changes in the tax code related to inversions, Abbott (ABT -1.1%) and Mylan (MYL -2.5%) adjust the terms of their $5.3B all-stock deal. The pricing terms related to product manufacturing and supply have been changed in favor of New Mylan and the number of shares of stock to be issued to Abbott have been increased to 110M from 105M.
- Former shareholders of Mylan will own ~78% of New Mylan and Abbott and its affiliates will own ~22%. The transaction is expected to close in Q1 2015.
Oct. 15, 2014, 4:13 AM
- The Supreme Court is due to hear oral arguments today over a patent for Teva's (NYSE:TEVA) top-selling multiple sclerosis drug Copaxone, which accounts for 50% of its profit.
- The patent was due to expire in September 2015, although in July 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid. Copaxone has no IP protection at the moment.
- Two consortia are developing generic versions of Copaxone, with one involving Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), and the other Mylan (NASDAQ:MYL) and Natco. The companies risk having to pay Teva hundreds of millions of dollars if they introduce Copaxone and then lose in the Supreme Court.
Oct. 3, 2014, 9:10 AM
Oct. 3, 2014, 7:34 AM
- Citing a stronger-than-expected Q3, Mylan (NASDAQ:MYL) increases its Q3 and full-year guidance. For Q3, it now expects non-GAAP EPS to be $1.12 - 1.16 compared to its previous forecast of $0.90 - 0.95. The revised guidance includes $0.14 per share from an agreement with Strides Arcolab Limited. Myan recognized earnings for lost revenues in 2014 that arose from supply disruptions due to quality enhancement efforts initiated at certain Agila locations prior to Mylan's acquisition of Agila from Strides in 2013.
- Mylan ups its 2014 full-year non-GAAP EPS guidance to $3.44 - 3.54 from $3.25 - 3.45.
- The company will report Q3 results on October 30 after the close. The conference call will begin at 4:30 pm ET. Consensus view on revenue is $2.04B.
- Shares are up 4% premarket on light volume.
Sep. 23, 2014, 3:45 AM
- Under Treasury Secretary Jack Lew’s crackdown on inversions, the Treasury Department announced new tax rules late yesterday to deter U.S. companies from moving their domicile to countries with lower tax rates.
- The tax changes make it harder for companies to complete overseas mergers, and should they choose to invert, companies will face a hard time using the cash accumulated abroad.
- The new rules are effective immediately and apply to all deals that have not closed by yesterday.
- Related M&A: MDT, COV, SLXP, MYL, CQB, OTC:FYFFF,BKW, THI
Sep. 13, 2014, 1:53 PM
- The FDA grants tentative approval for Mylan's (NASDAQ:MYL) emtricitabine and tenofovir disoproxil fumarate combination tablets (200 mg/300 mg) co-packaged with nevirapine tablets (200 mg) for the treatment of patients with HIV-1. The product is cleared for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients at least 12 years old and weighing at least 38 kg.
- Tentative approval means that the product meets the quality, safety and efficacy standards for regulatory clearance, but is not eligible for marketing in the U.S. due to patent protections, although it clears the product for sale ex. U.S. under the PEPFAR program (President's Emergency Plan for AIDS Relief).
- The branded Emtricitabine/tenofovir (200 mg/300 mg) product is Gilead Sciences' (NASDAQ:GILD) Truvada. Nevirapine (200 mg) tablets are sold under the brand name Viramune by Boehringer Ingelheim.
Sep. 10, 2014, 7:42 AM
- Mylan (NASDAQ:MYL) acquires the U.S. rights to Arixtra (fondaparinux sodium) Injection and the authorized generic of Arixtra from Aspen Global Inc. Arixtra is indicated for the prophylaxis of deep vein thrombosis (DVT).
- Mylan is already selling Arixtra via an interim distribution agreement. Apotex is currently selling generic Arixtra but will transition it to Mylan by year end.
- Under the terms of the agreement, Mylan will pay Aspen $225M when the transaction is finalized. An additional $75M will be held in escrow pending the satisfaction of certain conditions. Aspen will supply Arixtra and its generic to Mylan.
- According to IMS Health, U.S. sales of branded Arixtra were $18.8M for the 12-month period ending June 30, 2014. Generic Arixtra sales were $95.3M over the same time frame.
Sep. 8, 2014, 1:33 PM
- The U.S. District Court for the District of Maryland rules that sales of generic versions of Hospira's (HSP -2.1%) proprietary sedative, Precedex (dexmedetomidine HCL injection), may proceed. The Court initially granted the company's motion for a temporary restraining order against the FDA, Mylan (MYL +2.1%) and Par Sterile Products against the introduction of generic formulations. Hospira has filed an appeal of the decision and a motion for injunction pending appeal before the U.S. Court of Appeals for the Fourth Circuit. Not known for waiting, Mylan restarts the launch of its generic version.
- Despite the adverse ruling, Hospira reaffirms its 2014 EPS guidance of $2.30 - 2.50.
- Precedex generated ~$440M in revenues in 2013. The company previously stated that the encroachment of generic Precedex competitors may force it to lay off sales personnel.
Aug. 30, 2014, 12:05 PM
- In the largest study of its kind ever done, Novartis' (NYSE:NVS) investigational heart failure drug candidate, LCZ696, demonstrated superiority over the ACE-inhibitor enalapril on several key endpoints.
- LCZ696 reduced the risk of death from cardiovascular disease by 20%, reduced heart failure hospitalizations by 21% and reduced the risk of all-cause mortality by 16%. All the results were highly statistically significant.
- The twice-daily tablet acts to enhance the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system. Current therapies act only to block the harmful effects.
- Novartis intends to submit its NDA to the FDA by the end of 2014 and its MAA to the EC in early 2015.
- Related tickers: (NYSE:VRX) (NYSE:TEVA) (NASDAQ:MYL) (NYSE:TARO) (NYSE:RDY)
Aug. 28, 2014, 11:53 AM
- The FDA accepts Mylan's (MYL -0.2%) ANDA for a 3x/week Glatiramer Acetate Injection 40 mg/mL which is a generic version of Teva's (TEVA -0.3%) Copaxone 40 mg/mL indicated for the treatment of patients with relapsing multiple sclerosis. Mylan believes it is one of the first companies to make the filing so it expects to be eligible for 180 days' market exclusivity (although this is based on the "first to file").
- According to IMS Health, Copaxone generated ~$412M in U.S. sales over the 12-month period ending June 30, 2014.
Aug. 25, 2014, 10:18 AM
- The FDA approves Iroko Pharmaceuticals' Zorvolex (diclofenac) for the management of osteoarthritis pain. The agency cleared the NSAID for the treatment of mild-to-moderate pain in adults in October 2013.
- Related tickers: (PFE +0.1%) (MRK +0.9%) (OTCPK:BAYZF) (OTCPK:BAYRY +1.2%) (OTCQX:RHHBY +0.6%) (TEVA -0.5%) (MYL +0.8%) (PRGO -0.1%) (GSK +0.8%)
Aug. 22, 2014, 8:07 AM
- Mylan (NASDAQ:MYL) begins shipping its potassium chloride extended release tablets (8 mEq (600 mg) and 10 mEq (750 mg)), generic versions of Upsher-Smith's Klor-Con, for the treatment of patients with hypokalemia, with or without metabolic alkalosis, digitalis intoxication and hypokalemic familial periodic paralysis.
- According to IMS Health, the U.S. market is ~$135M.
Aug. 20, 2014, 1:22 PM
- A federal judge issues a temporary restraining order against the FDA's decision to allow the sale of generic versions of Hospira's (HSP +1.4%) sedative Precedex (dexmedetomidine HCL injection) In its lawsuit filed yesterday, Hospira claims that the agency violated its own rules by allowing generic firms to launch competing products as long as the labeling omitted information about the drug's uses (intensive care unit sedation) covered by Hospira's patent.
- In his order, Judge Jarrod Hazel says that Hospira would likely win its suit because the FDA's decision as "at odds with relevant authority" and "tantamount to a change of the rules."
- Generic firm Sandoz (NVS +0.3%) intervened on Hospira's behalf because the ruling would deprive it of the six-month exclusivity it negotiated in its patent infringement settlement with Hospira in December.
- Related ticker: (MYL +2.8%)
Aug. 19, 2014, 4:12 PM
- After the FDA approved its ANDA yesterday, Mylan (MYL +1.3%) launches dexmedetomidine hydrochoride injection, 100 mcg (base)/mL, the therapeutic equivalent of Hospira's (HSP -2.8%) Precedex. The U.S. market is ~$156M.
- Mylan has 295 ANDAs pending FDA approval representing ~$105B in sales while 43 are potential first-to-file opportunities.
MYL vs. ETF Alternatives
Other News & PR