Thu, Oct. 20, 7:40 AM
- Theravance (NASDAQ:TBPH) and development partner Mylan N.V. (NASDAQ:MYL) report successful results from two replicate Phase 3 clinical trials assessing revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). Both studies met their primary endpoint of a statistically valid improvement versus placebo in trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment with each dose studied (88 mcg once daily and 175 mcg once daily).
- Both revefenacin doses were generally well-tolerated with comparable rates of adverse events (AEs) and serious adverse events to placebo. The most common AEs were exacerbations, cough, dyspnea (difficulty breathing) and headache.
- Complete results will be submitted for presentation at future scientific conferences.
- An ongoing Phase 3 safety study should be completed in 2017 followed by a New Drug Application (NDA) in the U.S. by year end.
- Revefenacin, a long-acting muscarinic antagonist (LAMA), is a once-daily nebulized bronchodilator.
- Theravance will host a conference call today at 8:00 am ET to discuss the results.
Mon, Oct. 10, 9:16 AM
Fri, Oct. 7, 5:36 PM
Fri, Oct. 7, 5:04 PM
- Mylan (NASDAQ:MYL) has spiked 9.4% after hours after coming to terms with government agencies in a $465M settlement connected to Medicaid rebate classifications for its EpiPen.
- The settlement -- regarding the question of whether EpiPen Auto-Injectors were properly classified as a non-innovator drug with Medicaid -- means Mylan admits to no wrongdoing.
- Mylan will take a pretax charge of about $465M accordingly, and cutting guidance: It now sees full-year (adjusted) EPS at $4.70-$4.90, down from a previous $4.85-$5.15, mainly due to changes in EpiPen access programs and the upcoming generic version.
- The company says it's still committed to at least $6.00 in EPS for 2018. It reports Q3 earnings after the bell Nov. 9.
Thu, Oct. 6, 2:40 AM
- U.S. government health plans spent more than $1B on Mylan's (NASDAQ:MYL) EpiPen between 2011 and 2015, but the company is accused of cheating taxpayers by underpaying rebates by hundreds of millions of dollars.
- Andy Slavitt, Acting Administrator at the Centers for Medicare and Medicaid, said Mylan wrongly classified the emergency epinephrine product as a generic, when it should have been classified as a brand-name product.
Fri, Sep. 30, 10:18 AM
- Mylan N.V. (MYL -0.8%) commences the U.S. commercial launch of its generic version of Watson's Fortamet (metformin HCl) Extended-Release Tablets, 500 mg and 1,000 mg for the adjunctive treatment, with diet and exercise, of adults with type 2 diabetes.
- According to IMS Health, the U.S. market is ~$770M.
Wed, Sep. 28, 3:42 PM
- The heat from the Feds is still on Mylan (MYL -2.8%) over its pricing for allergic reaction med EpiPen (epinephrine injection, USP). The U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) says the company has consistently misclassified the product as "generic" instead of "innovative" (branded) in order to minimize payments to Medicaid.
- Under Medicaid's rebate program, Mylan is paying 13% on the basis of the "generic" classification. If it were tagged a brand-name drug, the rebate would be 23.1% in addition to an inflation rebate that applies when the price of the drug is raised above the inflation rate, which the company has clearly done in this case. When Mylan acquired the product in 2007, it was selling for ~$100/two-pack. It now sells for $600.
- CMS spokesman Aaron Albright says, "CMS has, on multiple occasions, provided guidance to the industry and Mylan on the proper classification of drugs and has expressly advised Mylan that their classification of EpiPen for the purposes of the Medicaid Drug Rebate Program was incorrect. This incorrect classification has financial consequences for the amount that federal and state governments spend by reducing the amount of quarterly rebates Mylan owes for EpiPen."
- CMS adds that EpiPen was approved under a New Drug Application, has patent protection and has no FDA-approved therapeutic equivalents. This means that it meets the definition of a single-source (branded) drug, not multiple-source which applies to generics.
- Last week, the Senate Finance Committee asked the HHS Inspector General to investigate the issue.
- In a letter to the Justice Department, three U.S. Senators suggest that Mylan may be in violation of the False Claims Act and other statutes.
- Mylan counters that EpiPen was classified as a non-innovator long before it acquired the product. It says its classification as a non-innovator drug is consistent with longstanding written guidance from federal authorities.
- This year, the government adopted a new rule intended to clear up ambiguities in the current Medicaid rebate law. The company has until April 1, 2017 to submit an application requesting non-innovator status for its products.
Mon, Sep. 26, 12:52 PM
- In what Mylan (MYL -0.6%) CEO Heather Bresch would undoubtedly call a modest slip-up, the company's take on the sale of two-pack EpiPen is actually $160 instead of $100, the amount she told a congressional committee last week. The financial analysis she presented to lawmakers included a U.S. tax rate of 37.5% which, of course, understated net profit.
- The company's actual tax rate is ~17%, per its most recent 10-Q. Applying this rate to EpiPen's 2016 estimated operating profit of $671M, yields an after-tax profit of $557M, ~33% higher than the $419M stated in the analysis.
Thu, Sep. 22, 3:45 AM
- Mylan (NASDAQ:MYL) CEO Heather Bresch was accused of "disgusting greed" and of getting "filthy rich" by congressmen yesterday as she sought to defend her company's decision to hike the price of EpiPens by more than 500% in recent years.
- Bresch said that after rebates, marketing costs and other expenses, Mylan earns about $100 for a pair of EpiPens.
- She also emphasized that the company is planning a half-price version of the device, and it provides them for free to many schools.
Wed, Sep. 21, 3:07 AM
- Mylan (NASDAQ:MYL) CEO Heather Bresch is scheduled to testify today before the House Committee on Oversight and Government Reform.
- She will likely be grilled about EpiPen prices, which have increased to more than $600 for a two-pack from about $100 in less than a decade
- The hearing comes a day after West Virginia disclosed an investigation into whether Mylan violated antitrust laws or defrauded the state's Medicaid program.
Wed, Sep. 14, 1:51 AM
- The drugmaker buffeted by the furor over its hefty EpiPen price increases had the second-highest executive compensation among all U.S. drug and biotech firms over the past five years, paying its top five managers a total of $292.1M, according to a WSJ analysis.
- The big pay packages are unusual because of Mylan's (NASDAQ:MYL) relatively small size in the U.S. drug industry, where it is No. 11 by revenue and No. 16 by market capitalization.
Fri, Sep. 9, 6:51 PM
- Facing delays after its marketing application was rejected this year, Teva Pharmaceutical (TEVA -1.7%) now says it wants to get U.S. approval for a generic version of Mylan's (MYL -1.7%) EpiPen by late 2017 or early 2018.
- "We requested a meeting with the FDA," and didn't get a response, said Teva's Sigurdur Olafsson today; but with recent media attention to EpiPens, "the FDA has come back to us and we will have a meeting very, very quickly."
- With no strong competition, Mylan's product has about 94% market share. But a list price that has soared from less than $100 to more than $600 over the past nine years has sparked outrage.
- Mylan has said that it planned its own $300 generic version of the EpiPen.
- The recent "political noise" around the product may make the FDA more inclined to sign off on Teva's generic than before, Evercore ISI's Umer Raffat says, despite the fact that Teva is unlikely to make modifications to its autoinjector to remedy an FDA issue with dosing.
Thu, Sep. 8, 2:51 AM
- The U.S. Senate's permanent subcommittee on investigations will be the next to probe Mylan's (NASDAQ:MYL) pricing of the EpiPen, describing the review as a "preliminary inquiry."
- Despite heat over the allergy auto-injector's cost, EpiPen sales recorded a 32% increase in the first three weeks of August compared to the same period of 2015, according to data from Athenahealth.
Wed, Sep. 7, 2:19 AM
- New York has opened a probe into whether Mylan (NASDAQ:MYL) broke antitrust law under its EpiPen4Schools program, which gives many schools the devices for free, but may have barred institutions from buying rival products for a year.
- Meanwhile, new reports suggest Mylan pays no more than $30 per EpiPen, while some patients are forced to pay a little over $600 for a two-pack of the lifesaving medication.
Fri, Sep. 2, 1:19 PM
- In a factsheet just published on Presidential candidate Hillary Clinton's website, she outlines her plan to reign in rogue drug companies who aggressively increase the prices of their medicines.
- Her plan features three methods for containing runaway drug costs: make alternatives available and increase competition; enable emergency importation of safe treatments and fine drug firms for unjustified price increases.
- Her first action, as President, will be to create a dedicated group of representatives from Federal agencies that oversee health and safety and fair competition that will be charged with protecting consumers from "outlier" price increases. The group will establish criteria for determining if a price increase is justified for a long-available treatment and investigate and consider enforcement in certain situations.
- In cases where the level of competition is light, her plan will enable the emergency purchases of alternative versions and make them available to patients in need while encouraging competition from additional suppliers.
- She also calls for legislation to safely and securely import drugs from foreign nations whose regulatory regimes are as robust as the FDA, with the proviso of a "careful review" by the agency (more temporary than permanent).
- In cases where miscreant drug firms are fined, the funds will be used to support new programs to make lower-cost alternatives available and speed up approvals in order to beef up competition (specifics are not provided).
- In her broader plan to lower prescription drug costs for all Americans, she proposes a cap on out-of-pocket costs, additional funding to support the clearing of the FDA's backlog of generic drug applications, prohibit "pay for delay" deals (long overdue), a moratorium on direct-to-consumer advertising and allowing Medicare to negotiate drug and biologic prices.
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Thu, Sep. 1, 4:10 PM
- The USPTO's Patent Trial and Appeal Board (PTAB) has, again, ruled in Mylan's (NASDAQ:MYL) favor in its inter partes review of patents covering Teva Pharmaceutical Industries' (NASDAQ:TEVA) Copaxone (glatiramer acetate injection) 40mg/mL. It found that U.S. Patent No. 8,969,302 is unpatentable.
- On August 24, two other patents were invalidated.
- On August 15, the PTAB ruled that Mylan's petition against a fourth patent covering the 40 mg/mL formulation (U.S. Patent No. 9,155,776) was ineligible for post-grant review for procedural reasons.
- Previously: USPTO invalidates two Copaxone patents, ruling on third tomorrow (Aug. 24)