EpiPen (epinephrine) / Viatris - LARVOL DELTA

Systemic Mastocytosis Treatment Options (Patient Power) - "Most of the time, for patients with non-advanced forms of SM, the goal of treatment is to mitigate symptoms, said Cem Akin, MD....Over-the-counter antihistamines, like Allegra, Zyrtec and Claritin, can help control itching, flushing, tachycardia, and headaches. Another class of antihistamines, called H2-blockers, can help with gastrointestinal symptoms, said Jason Gotlib, MD, MS....Over time, cytokines and other chemicals released by mast cells can lead to bone loss, which can cause osteoporosis. To prevent that from happening, physicians will sometimes prescribe bisphosphonates, particularly zoledronate (Reclast), Dr. Akin said."

Media quote

"$MSFT Tenth Circuit Embraces Sound Economics of Antitrust Law in Opinion Affirming District Court’s Grant of Summary Judgment to Defendant-Appellee Mylan in Sanofi’s EpiPen Monopolization Case https://t.co/uNfGJTuT3C" (@otcdynamics)

"My latest: EpiPen: Price-Gouging of Essential Medicine https://t.co/BEVXhIAb3h via @medscape #Mylan #Viatris #Manchin" (@DrJudyStone)

"$VTRS Mylan Wins Dismissal of Kansas EpiPen® Direct Purchaser Case https://t.co/NbjUHZ5tM3" (@stock_titan)

"Sanofi looks to take Mylan to court, again, over EpiPen antitrust allegations https://t.co/gxC6plpo4u" (@FiercePharma)

"13) Even worse, Mylan was also recently ***criminally charged*** by Department of Justice for outright fraudulent EpiPen billing, and fined $465 million by DOJ for its corrupt behavior in violating False Claims Act. https://t.co/KE90EdsQCf" (@DrEricDing)

"6) And we can’t let Mylan price gouge life saving drugs like EPIPEN’s, and hold parents hostage." (@DrEricDing)

"9) Even worse, Mylan was also recently ***criminally charged*** by Department of Justice for outright fraudulent EpiPen billing, and fined $465 million for its corruption. https://t.co/KE90EdsQCf" (@DrEricDing)

"$VTRS Mylan Wins Summary Judgment in EpiPen® Litigation Brought by Sanofi https://t.co/lz32HwaYX0" (@stock_titan)

Mylan’s US-labelled EpiPen 0.3 mg adrenaline auto-injectors now available in UK (Pharmacy Business) - "Pharmaceutical giant Mylan has released a batch of US-labelled auto-injectors in the UK to ensure patients have continuous access to Epipen 0.3 mg. The auto-injectors with the batch number 9FM766 have been approved by the UK regulator, Medicines and Health Regulatory Agency (MHRA)....The auto-injector device in this batch is exactly the same as the normal UK EpiPen in every way except for the information on the label on the device."

Commercial • Allergy • Immunology

Pharma Co. Must Mediate EpiPen Pricing Claims with Mylan (Law360) - "A retail and online pharmacy operator suing Mylan in Kansas federal court over an alleged scheme to inflate prices for the emergency allergy medication EpiPen has been ordered to mediate its antitrust claims."

Corporate lawsuit • Allergy • Immunology

Senate passes bill to allow police - firefighters to use EpiPens (Thumbnet.net) - "The Michigan Senate on Tuesday approved Senator Michael D. MacDonald's legislation to allow Michigan firefighters and police officers to carry and use EpiPens to treat life-threatening allergic reactions."

Corporate lawsuit • Allergy

Adamis Pharmaceuticals (ADMP) (Stocks Newswire) - "Shares of Adamis Pharmaceuticals (ADMP) were slipping 16.71% to $2.89 on substantial exchanging volume after adversary drug-producer Mylan (MYL) reported it would dispatch a non specific form of its serious hypersensitivity medicine EpiPen in the up and coming weeks....A week ago, Hatfield, AL-based Mylan was investigated for expanding the cost of its medication by more than 450% since 2004, achieving $600 for a two-pack. The organization later said it would lessen out-of-pocket expenses for EpiPens by offering a $300 investment funds card."

Commercial • Stock price • Allergy

Pfizer, Mylan can't quickly appeal EpiPen RICO class cert (Law360) - "EpiPen manufacturer Pfizer and distributor Mylan cannot immediately appeal a Kansas federal judge's certification of a nationwide class under the Racketeer Influenced and Corrupt Organizations Act in multidistrict litigation over the price of the emergency allergy treatment..."

Corporate lawsuit • Allergy

Edited transcript of ATRS earnings conference call or presentation (Yahoo Finance) - "According to Symphony prescription data, 206,000 prescriptions were filled with Teva's generic EpiPen in the first quarter, representing a 43% share of the EpiPen market….Overall EpiPen market declined in the first quarter versus the fourth quarter, Teva's share in the EpiPen market increased 7%, while their total prescriptions increased almost 13% sequentially during the same period…in the first quarter this year, the overall EpiPen market grew 8% versus the same period last year….Royalty revenue was $4.2 million for the first quarter of 2020…The net increase in royalty revenue for the 3-month period was a result of an overall increase of $1.9 million in royalties received from Teva on their net sales of epinephrine..."

Commercial • Allergy • Immunology

Mylan pushes for mediation in EpiPen antitrust suit (Law360) - “Mylan has urged a Kansas federal judge to compel a pharmacy operator to mediate its proposed class action over the price of emergency allergy medication EpiPen, saying the company is bound by a contract that requires it to enter mediation before filing a suit.”

Corporate lawsuit • Allergy • Immunology

District of Kansas confirms plaintiffs cannot expand scope of EpiPen MDL litigation via motion to transfer and consolidate (JD Supra) - "A Kansas District Court recently reinforced that cases alleging claims outside the Judicial Panel on Multidistrict Litigation (JPML) Transfer Order cannot be employed to broaden the scope of the MDL litigation. In reaching that conclusion, the court denied a motion to consolidate a new class-plaintiffs’ lawsuit with a mature multidistrict litigation (MDL)."

Corporate lawsuit • Allergy • Immunology

EpiPen buyers lost bid to depose ex-Teva CEO in MDL (Law360) - Subscription required.

Corporate lawsuit • Allergy • Immunology

"Is @GileadSciences gonna be the next Mylan epipen, and BANG US for $10,000 a dose @POTUS @KellyannePolls" (@LarryLaFata)

Judge keeps EpiPen expiration date suit out of MDL (Law360) - “A Kansas federal judge on Monday refused to roll claims that Mylan and Pfizer manipulated EpiPen expiration dates into multidistrict litigation over an alleged scheme to inflate prices for the life-saving allergy medication.”

Corporate lawsuit • Allergy • Immunology

EU approves merger of Pfizer off-patent unit and Mylan (Medical Xpress) - "The European Commission on Wednesday authorised a merger of US drug giant Pfizer's off-patent business unit with the pharmaceutical company Mylan to create a global powerhouse for lower-cost medicines. The merger between Pfizer's Upjohn unit, based in China, and Netherlands-based Mylan will create a new company selling popular products such Viagra, the anti-cholesterol drug Lipitor and the anti-allergy injector EpiPen."

M&A • Allergy • Immunology

FDA approves first generic version of EpiPen (FDA) - "The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths."

NDA

Mylan investors get cert. in EpiPen securities fraud action (Law360) - "A New York federal judge granted certification Monday to a class of thousands of Mylan NV investors who say the pharmaceutical giant committed securities fraud by misleading them about how it was allegedly overcharging Medicaid for EpiPen purchases and engaging in other anti-competitive conduct."

Corporate lawsuit

"Look into Heather Bresch, CEO of the generic producer Mylan, making over $20 million annually, responsible for the infamous EpiPen price-gouging debacle and DAUGHTER of Joe Manchin (Democrat in name only) and their connection to #Hydroxycloroquine." (@rfsullivan)

Pricing

Drugmakers Mylan, Pfizer delay merger due to coronavirus outbreak (Reuters) - "Drugmaker Mylan NV’s (MYL.O) merger with Pfizer Inc’s (PFE.N) off-patent branded drug unit, Upjohn, will now close in the second half of this year…blaming the coronavirus pandemic for the delay…..The merger, which will bring…Lipitor from Pfizer under one umbrella with Mylan’s EpiPen…"

M&A