Headquarters: Canonsburg, PA
Year Established: 1970
Revenues: $11,077 (+18%)
Specialty Segment: $5,630 (+10%)
Net Income: $480 (-43%)
R&D: $827 (+23%)
During 2016 the generic giant Mylan made two major acquisitions. First it boosted its over-the-counter (OTC) portfolio when it paid nearly $10 billion for Swedish drug maker Meda, adding a range of branded and generic pharmaceuticals. Meda’s key products include the allergy therapy Dymista (azelastine/fluticasone) and Elidel (pimecrolimus) for dermatitis and eczema. The deal reduces Mylan’s reliance on generic drugs with the addition of specialty brands that are less prone to pricing pressure and competition.
In another deal worth $1 billion, Mylan bought the non-sterile, topicals-focused specialty and generics business of Renaissance Acquisition Holdings, which nets Mylan a complementary portfolio of approximately 25 branded and generic topical products, a pipeline of approximately 25 products, and an established U.S. sales and marketing infrastructure targeting dermatologists. The business also brings Mylan an integrated manufacturing and development platform and a topicals-focused contract development and manufacturing organization.
The dermatology/topicals space has long been an area of focus for Mylan and one that it has targeted for expansion. Renaissance had approximately $370 million in 2015 revenues and has approximately 1,200 employees. The business’s commercial segment has a diversified portfolio of specialty brands and generic products in the dermatology space, as well as a pipeline of complex topical generics and brands in active development. Also, the acquisition includes two manufacturing sites with capabilities and capacity in creams, ointments, aerosols/foams, gels, suspensions, liquids and suppositories.
Mylan was also active on the biosimilar front during the year. In a deal worth up to $250 million, it entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals to develop and commercialize six of Momenta’s biosimilar candidates, including abatacept—Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia. The companies are jointly responsible for product development, and Mylan will lead worldwide commercialization. The collaboration builds on Mylan’s existing biologics and insulin analog partnership with Biocon, which includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogs (glargine, lispro and aspart). Five of these biosimilar programs have successfully completed Phase I trials, and four are in Phase III development. Mylan and Biocon submitted three biosimilar applications and one insulin application in the U.S. and EU in 2016.
On the new product front, Mylan made several generic advances during the year. Following FDA approval it launched Azacitidine injection, a generic of Celgene’s (CELG) Vidaza injection. It also launched Propafenone Hydrochloride extended-release capsules, the generic of GlaxoSmithKline’s Rythmol capsules. The company then launched Hydralazine Hydrochloride injections, a generic version of Novartis’s Apresoline injection.
Mylan currently has over 250 abbreviated new drug applications (or ANDAs) pending FDA approval. A few other recent launches include: Clindamycin Palmitate Hydrochloride, a generic version of Cleocin solution; Doxycycline Hyclate delayed-release tablets, a generic version of Doxteric; Armodafinil tablets, a generic version of Nuvigil; and Frovatriptan Succinate tablets, a generic version of Frova tablets. The FDA has also accepted its ANDA for Fluticasone propionate and Salmeterol, a generic version of GlaxoSmithKline’s Advair Diskus, with a GDUFA date of March 28, 2017.