Key Developments: Mylan NV (MYL.O)

MYL.O on Nasdaq

4 Sep 2015
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Latest Key Developments (Source: Significant Developments)

Mylan NV Confirms the U.S. Patent and Trademark Office Institutes Inter Partes Review Proceeding against Third Copaxone 40 mg/mL Dosing Patent on All Claims
Wednesday, 2 Sep 2015 08:00am EDT 

Mylan NV:Says U.S. Patent and Trademark Office has instituted an inter partes review proceeding on all claims against a third Copaxone 40 mg/mL patent, U.S. Patent No. 8,969,302, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd.Says The patent relates to methods for the treatment of multiple sclerosis through the administration of at least three 40 mg/mL subcutaneous injections of glatiramer acetate per week.  Full Article

Mylan NV clarifies certain inaccuracies by third parties related to lowered acceptance condition to acquire Perrigo
Monday, 24 Aug 2015 02:00am EDT 

Mylan NV:Says clarified certain inaccuracies by third parties related to Mylan having lowered the acceptance condition in its offer to acquire Perrigo Company plc from not less than 80% of Perrigo ordinary shares to greater than 50% of Perrigo ordinary shares.  Full Article

Mylan NV raises FY 2015 EPS guidance
Thursday, 6 Aug 2015 07:00am EDT 

Mylan NV:Raises FY 2015 adjusted diluted EPS guidance range to $4.15 to $4.35.FY 2015 EPS of $4.12 - Thomson Reuters I/B/E/S.  Full Article

Mylan NV one of first to launch generic version of Namenda Tablets
Tuesday, 14 Jul 2015 07:30am EDT 

Mylan NV:Says U.S. launch of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, which is the generic version of Forest's Namenda Tablets.Mylan received final approval from U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for treatment of moderate to severe dementia of Alzheimer's type.Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, had U.S. sales of approximately $1.4 billion for the 12 months ending March 31, 2015, according to IMS Health.Mylan was one of first ANDA applicants to submit substantially complete ANDA with paragraph IV certification and has therefore been granted 180 days of shared generic drug marketing exclusivity.  Full Article

Mylan NV is Expanding Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presence of Particulate Matter - FDA
Sunday, 7 Jun 2015 08:00pm EDT 

Mylan NV:Says s is expanding its voluntary nationwide recall to the hospital/user level of select lots of the following injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples - FDA.Says Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.Says Intrathecal administration could result in a life threatening adverse event or result in permanent impairment of a body function.Says it has notifying its distributors and customers by letter and is arranging for return of all recalled products.Says Distributors, retailers, hospitals, clinics, and physicians that have these products which are being recalled should stop use and return to place of purchase.Says his recall is being conducted with the knowledge of the U.S. Food and Drug Administration.  Full Article

Mylan NV reaffirms FY 2018 EPS guidance
Tuesday, 5 May 2015 04:05pm EDT 

Mylan NV:Remains committed to target of at least $6.00 in adjusted diluted EPS in FY 2018.FY 2018 EPS of $5.60 - Thomson Reuters I/B/E/S.  Full Article

Mylan NV confirms patent challenge relating to Minivelle from Noven Pharmaceuticals and Hisamitsu Pharmaceutical
Tuesday, 5 May 2015 01:15pm EDT 

Mylan NV:Confirmed that it and its subsidiaries Mylan Pharmaceuticals Inc. and Mylan Technologies Inc. have been sued by Noven Pharmaceuticals Inc. and Hisamitsu Pharmaceutical Co., Inc., in connection with the filing of an Abbreviated New Drug Application (ANDA).with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP, 'Twice-Weekly' 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.This product is the generic version of Minivelle, which is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and the prevention of postmenopausal osteoporosis.The plaintiffs filed suit against the Mylan companies in the United States District Court in the District of Delaware.  Full Article

Mylan NV Board unanimously rejects unsolicited expression of interest from Teva Pharmaceutical Industries
Monday, 27 Apr 2015 09:20am EDT 

Mylan NV:Announced that its Board of Directors has unanimously rejected the unsolicited expression of interest from Teva Pharmaceutical Industries, Ltd. to acquire Mylan, which was announced by Teva on April 21.After a comprehensive review conducted in consultation with its financial and legal advisors, the Mylan Board concluded the approach did not meet any of the key criteria to depart from the company's standalone strategy, and consider engaging in discussions to sell the company.  Full Article

Perrigo Company PLC rejects Mylan unsolicited offer
Friday, 24 Apr 2015 12:09pm EDT 

Perrigo Company PLC:Announced its rejection of the unsolicited offer from Mylan NV to acquire all of the outstanding shares of Perrigo for $60.00 per share in cash and 2.2 Mylan ordinary shares for each ordinary Perrigo share.  Full Article

Teva Pharmaceutical Industries Ltd proposes to acquire Mylan
Tuesday, 21 Apr 2015 08:45am EDT 

Teva Pharmaceutical Industries Ltd:Proposes to acquire all of the outstanding shares of Mylan a transaction valued at $82.00 per Mylan share, with the consideration to be comprised of about 50 percent cash and 50 percent stock.Teva cash and stock proposal provides Mylan stockholders with a substantial premium and immediate cash value, as well as significant potential for future value creation through participation in a financially and commercially stronger company.Teva's proposal also provides Mylan stockholders with a more attractive alternative to Mylan's proposed acquisition of Perrigo Company plc as announced on April 8, 2015, as well as to Mylan on a standalone basis.Teva's proposal would provide Mylan stockholders with consideration representing 37.7 pct premium to the stock price of Mylan on April 7.Says April 07 which is the last day of trading prior to Mylan's press release regarding its unsolicited proposal for Perrigo 48.3 pct premium to unaffected stock price of Mylan on March 10, which is the last day of trading prior to widespread speculation of a transaction between Teva and Mylan.  Full Article

Largest Dutch pension fund exits Mylan over death penalty concerns

AMSTERDAM - The Dutch public employees' pension fund, the world's third largest, has sold all its shares in pharmaceuticals maker Mylan after it emerged that one of the company's products is in stock at a U.S. prison where death sentences are carried out.

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