Wed, Apr. 27, 11:13 AM
- Privately held Sunovion Pharmaceuticals announces successful results from two Phase 3 clinical trials, GOLDEN-3 and GOLDEN-4, assessing an inhalable mist formulation of SUN-101 (glycopyrrolate) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). Both studies (25 mcg and 50 mcg doses) met their primary endpoints of a statistically valid change from baseline to week 12 versus placebo in trough forced expiratory volume in one second (FEV1). Full results will be presented at future medical conferences.
- SUN-101 is a nebulized (mist) long-acting muscarinic antagonist (LAMA) delivered via an inhalation device called eFlow, developed by the German firm PARI.
- The company intends to file a New Drug Application (NDA) with the FDA this year. According to the company, SUN-101/eFlow, if approved, will be the first nebulized LAMA available for COPD patients, but AstraZeneca (AZN -0.9%) just received FDA approval of its LAMA/LABA offering, Bevespi Aerosphere.
- Related tickers: (GSK +1.7%)(MYL -1.5%)(NVS -0.2%)(TEVA -0.2%)(THRX)(AQXP -3.3%)
- Previously: AstraZeneca up 1.6% as FDA approves COPD treatment (April 25)
Fri, Apr. 8, 5:40 PM
Mon, Mar. 7, 6:41 PM
- Signing deals is often lucrative for executives, but squelching them can be as well. Perrigo (PRGO +2%) gave three executives bonuses for their roles in defending against a $26B hostile takeover by Mylan (MYL +3%).
- Perrigo CEO Joe Papa got additional restricted stock worth $1.5M in December along with a $500K cash bonus, tied to his “key contributions related to Mylan’s hostile takeover attempt” last year.
- CFO Judy Brown and General Counsel Todd Kingma each got stock awards of $375K and cash in the same amount, as well.
- Months of pursuit ended last year after Perrigo's board unanimously rejected Mylan's offer and only 40% of shareholders voted for the deal.
- Perrigo preliminary proxy statement
Tue, Mar. 1, 10:38 AM
- Citing major deficiencies, the FDA's rejects Teva Pharmaceutical Industries' (TEVA +0.1%) marketing application for a generic version of Mylan's (MYL +1.7%) EpiPen (epinephrine injection) for the treatment of allergic reactions. The time required for Teva to address the deficiencies and a new review cycle could boost Mylan's 2017 EPS by 20 cents says Evercore ISI analyst Umer Raffat.
- Analysts were projecting an erosion of $200M in EpiPen sales for next year for Mylan's specialty division. EpiPen is the unit's top seller.
- Teva now expects to launch its generic version in 2017 at the earliest.
Thu, Feb. 25, 8:10 AM
- The FDA approves Intellipharmaceutics' (NASDAQ:IPCI) abbreviated New Drug Application (ANDA) for levetiracetam extended-release tablets in 500 mg and 750 mg strengths for the treatment of partial onset seizures associated with epilepsy. The product is the generic equivalent of UCB's (OTCPK:UCBJF) Keppra XR.
- According to Symphony Health Solutions, the U.S. market for the 500 mg and 750 mg products is ~$170M. Mylan's (NASDAQ:MYL) generic version was cleared in December 2011.
- Shares are up 14% premarket but only on turnover of 225.
Mon, Feb. 22, 3:38 PM
Fri, Feb. 19, 12:50 PM
- The FDA accepts for review Mylan's (MYL +2.6%) abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline's (GSK +0.6%) Advair Diskus (fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder) for the treatment of asthma and maintenance treatment of chronic obstructive pulmonary disease (COPD). Its action date (GDUFA) is March 28, 2017.
- According to Glaxo's most recent earnings report, Advair (Diskus and HFA) sales in the U.S. last year were ₤1.865B ($2.664B), down 13%.
Fri, Feb. 12, 12:25 PM
- In its first pay-for-delay decision, the U.K.'s Competition and Markets Authority (CMA) dings GlaxoSmithKline (GSK +0.7%) for ₤37.6M ($54.4M) for its activities to delay generic competition to its antidepressant Seroxat (paroxetine) during the period 2001 - 2004.
- According to the Authority, the company paid more than ₤50M to certain firms to delay the launch of their versions, thereby depriving the National Health Service of significantly better pricing. When generics finally hit the market at the end of 2003, prices were 70% below branded Seroxat.
- Despite claims that it did nothing wrong, the company has agreed to the settlement in order to avoid costly litigation.
- The CMA also fined Generics UK (now part of Mylan (MYL -1%)) and its former parent Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) ₤5.8M and Actavis (AGN +0.1%) ₤1.5M as the successor to Alpharma.
Thu, Feb. 11, 9:13 AM
- Gainers: DDD +15%. AG +14%. FSM +13%. TRIP +12%. MUX +11%. AUY +11%. SBGL +11%. GFI +10%. AGI +10%. LC +10%. GG +10%. CDE +9%. EGO +9%. KGC +9%. HMY +9%. IAG +9%. EXPE +8%. ABX +8%. NEM +8%. SLW +8%. SSRI 8%. AU 7%. AEM 7%. HL 7%. NG 7%. CSCO 6%. SKX 5%.
- Losers: FLO -18%. INCY -15%. SFL -13%. MYL -13%. BTU -13%. ZNGA -13%. SNOW -11%. IFF -10%. ELMD -9%. AVP -8%. CS -7%. BCS -7%. SUNE -6%. CIG -5%. TWTR -6%.
Wed, Feb. 10, 5:40 PM
Wed, Feb. 10, 4:23 PM
- Mylan (NASDAQ:MYL): Q4 EPS of $1.22 misses by $0.05.
- Revenue of $2.5B (+20.2% Y/Y) misses by $200M.
- Shares -6.6%.
- Update: Shares are down 13% premarket on Thursday on robust volume.
Wed, Feb. 10, 4:22 PM
- Mylan N.V. (NASDAQ:MYL) acquires Solna, Sweden-based Meda Aktiebolag for $9.9B, including the assumption Meda debt. The cash-and-stock transaction values the Meda equity at $7.2B, with the cash portion at $5.7B.
- The deal will be immediately accretive to Mylan's earnings, adding $0.35 - 0.40 in 2017 and enabling the achievement of non-GAAP EPS of $6.00 a year earlier also in 2017.
- The combined company's 2015 sales were $11.8B with non-GAAP EBITDA of ~$3.8B generated by over 2,000 products sold in more than 165 markets worldwide. Meda's 2015 results were sales of $2.3B and non-GAAP EBITDA of $768M.
Tue, Feb. 9, 5:35 PM
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Tue, Jan. 12, 6:58 AM
- Mylan N.V. (NASDAQ:MYL) submits its Abbreviated New Drug Application (ANDA) to the FDA seeking clearance for a generic version of GlaxoSmithKline's (NYSE:GSK) COPD product Advair Diskus (fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder).
- The respiratory space is Glaxo's most important, accounting for 40% of its pharmaceutical sales through Q3 2015.
Fri, Jan. 8, 12:44 PM
- Momenta Pharmaceuticals (MNTA +3.3%) and Mylan (MYL -2.6%) subsidiary Mylan Ireland Ltd. enter into an exclusive global collaboration agreement to develop, manufacture and commercialize six of Momenta's biosimilar candidates, including M834, a biosimilar to Bristol-Myers Squibb's (BMY -1.6%) ORENCIA (abatacept).
- Under the terms of the deal, Momenta will receive an upfront payment of $45M. The companies will equally share costs and profits with Mylan funding part of its share of costs through six contingent early development milestone payments totaling up to $200M across all six candidates.
- Mylan will have an exclusive license to the products for all indications. In general, Momenta will be responsible for pre-clinical and early-stage clinical development, additional clinical development (Phase 3) of M834 and regulatory activities in the U.S. through approval. Mylan will be primarily responsible for late-stage development of the candidates, other than M834, regulatory activities ex-U.S. and post-approval regulatory activities in the U.S.
- Mylan will commercialize all products, but Momenta has the option to co-commercialize, in a supporting role, any U.S.-approved product.
Tue, Jan. 5, 11:31 AM
- Joining (TEVA -0.3%), Mylan (MYL +1.4%) launches its generic equivalent to Janssen's (JNJ +0.6%) contraceptive Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablets in the U.S. The branded product generates ~$490M in annual sales.
- Previously: Teva launches generic Ortho Tri-Cyclen Lo in U.S. (Jan. 5)
Mylan N.V., is a pharmaceutical company which develops, licenses, manufactures, markets and distributes generic, branded generic and specialty pharmaceutical products. It operates through two segments: Generic and Specialty. The Generic pharmaceutical business is conducted primarily in the U.S.... More
Industry: Drugs - Generic
Country: United States
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