During 2016 the generic giant Mylan made two major ac- quisitions. 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 de-
velop 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 insu-
lin analog partnership with Biocon, which includes six biosimilar
programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab,
etanercept and filgrastim) and three insulin analogs (glargine, lis-
pro and aspart). Five of these biosimilar programs have success-
fully completed Phase I trials, and four are in Phase III develop-
ment. 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 ad-
vances during the year. Following FDA approval it launched
Azacitidine injection, a generic of Celgene’s (CELG) Vidaza in-
jection. It also launched Propafenone Hydrochloride extended-
release capsules, the generic of GlaxoSmithKline’s Rythmol cap-
sules. 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. CP
Dey, Mylan’s specialty business, focuses on respiratory, allergy and
psychiatric therapies. Its flagship product is EpiPen Auto-Injector,
which treats anaphylaxis; the product is the most prescribed auto-injector with over 90% market share in the U.S. and worldwide.
proposed biosimilar neutropenia
proposed biosimilar breast cancer
insulin glargine type 2 diabetes
EARLY RESEARCH PROJECTS
proposed biosimilar rheumatoid arthritis
DRUGS IN PHASE IIB AND BEYOND
revefenacin chronic obstructive pulmonary disease
Headquarters: Canonsburg, PA
YEAR ESTABLISHED 1970
REVENUES: $11,077 (+18%)
SPECIALTY SEGMENT: $5,630 (+10%)
NET INCOME: $480 (-43%)
R&D: $827 (+23%)