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.
Aug. 7, 2014, 11:28 AM
- Mylan (MYL -1.2%) Q2 results: Revenues: $1,837.3M (+8.0%); Gross Profit: $808.8M (+8.9%); Operating Expenses: $582.7M (+34.4%); Operating Income: $226.1M (-26.8%); Net Income: $125.2M (-29.5%); EPS: $0.32 (-30.4%); Quick Assets: $193.9M (-33.4%); CF Ops (1H): $448.0M (+63.5%).
- 2014 Guidance: Total revenues: $7.8B - 8.0B from $7.8B - 8.2B; gross margin: 51 - 53% (unch); EBITDA: $2.2B - 2.4B (unch); net income: $1.265B - 1.370B from $1.265B - 1.460B; non-GAAP EPS: $3.25 - 3.45 from $3.25 - 3.60; CF Ops: $1.2B- 1.4B (unch); CAPEX: $350M - 400M from $350M - 450M.
Aug. 7, 2014, 6:31 AM
Aug. 6, 2014, 5:30 PM
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Jul. 31, 2014, 7:27 AM
- Meda AB (OTC:MDABF) agrees to acquire Rottapharm Madaus for 21.2B kronor ($3.1B) adding consumer health products to its portfolio. The deal includes 15.3B kronor in cash, 30M Meda shares and another payment of 2.6B kronor in January 2017.
- The Rovati family, who owns 100% of Rottapharm, will own a 9% stake on Meda. Their company, founded in 1961, generated sales of 536M euros ($718M) in 2013.
- Earlier this year, Meda rejected a takeover bid from Mylan (NASDAQ:MYL).
Jul. 17, 2014, 8:28 AM
- The U.S. District for the District of New Jersey grants Mylan's (NASDAQ:MYL) motion for a permanent injunction against GlaxoSmithKline (NYSE:GSK) from supplying Paroxetine CR, the generic form of Glaxo's Paxil CR, to Apotex, which marketed the product. The Court also awards Mylan prejudgment interest and permits it to take an accounting so that it can determine the amount of additional damages it has suffered since September 30, 2013 as a result of Glaxo's ongoing breach. The Court denied all of GSK's post-trial motions.
- The Court awarded Mylan $106.7M in damages after a favorable jury verdict in March 2014. Mylan is the only firm with an FDA-approved generic version of Paxil.
Jul. 14, 2014, 7:03 AM
- Mylan (NASDAQ:MYL) acquires Abbott Labs' (NYSE:ABT) ex-U.S. specialty and branded generics business for $5.3B in an all-stock transaction. Abbott will receive 105M shares of MYL common stock representing a 21% ownership stake.
- The assets include a portfolio of more than 100 drugs that generate ~$1.9B in annual sales. The deal includes a sales force of ~2,000 representatives in more than 40 non-U.S. markets and two manufacturing facilities. The transaction will be immediately accretive to Mylan adding ~$0.25/share to diluted EPS the first year and increasing thereafter.
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.
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