While we wish everyone a Happy New Year and look forward for 2014, here's a quick relook into the key events that shaped 2013:
2013 would be looked upon as a year with a lot of changes in the Pharma Industry. The industry started to adapt itself to the newer regulations of GDUFA fees, Obamacare & its effects & the SCOTUS ruling on pay-for-delayed generic launches.
The Indian injectable facilities was in the spotlight as global pharma majors looked to grab manufacturing capacities here. While Mylan grabbed Strides’s Agila for about $2B, we had already witnessed other deals such as Hospira with Orchid & Otsuka with Claris.
Teva had a challenging year in 2013 with Copaxone patent loss, one of the highest among patent settlements for Protonix. Among the positives, Teva moved into the top 10 league as they chose to aggressively enter into Asia with JVs and acquisitions.
Among the M&As, Strides-Mylan deal for $2B and the Perrigo-Elan deal for $8B stood out among others.
We also bid farewell to Dr. Anji Reddy, one of the pioneers of the Indian Pharma industry and will always cherish his contributions due to which indian pharma is what it is today.
Lastly, the HIV treatment would now get a new direction with a key discovery on the way that the virus compromises human immune systems. We can now look forward to a newer set of drugs that may finally cure AIDS!!
Farewell 2013 & Happy New Year, 2014
Links to key events in 2013:
Jan – March 2013
USFDA’s GDUFA comes into full effect as drug companies around the world start paying the FDA for their services
Teva enters key Asian markets with an acquisition in Japan, JV in Korea, JV in India (with P&G for OTC) & and entry into China
Indian Injectable gets attention with several deals including Mylan-Strides; Hospira-Orchid & Otsuka-Claris
Mylan buys Strides’s injectables facility for $2B
Dr. Anji Reddy, pioneer of the Indian Pharma industry passes away
April – June 2013
Derma markets gets onto centre stage as Valeant buys Obagi. (Earlier, Novartis acquired Fougera; then Sun took Dusa; and now Perrigo snaps up Cobrek for $45 Million)
Its the 1st time that Teva, a non European company with a Generics focus is in the Global Top 10 League!!
Finally a NCE from Indian pharma -Cadila launches new diabetic drug, Saroglitazar. Expects to hit $1 Billion in sales
Teva & Sun Pharma pay $2.5 Billion as settlement for Protonix patent
US Supreme Court rules in favour of pay-for-delay cases
Teva loses patent challenge for its $4B drug, Copaxone to Sandoz & Mylan. But reaches a settlement with Mylan
Big M&A deal as Perrigo decides to buy Elan for $8 billion. Another Israeli giant seeks to grow big
Valeant buys out Baush & Lomb & restructures operations
June – December 2013
GDUFA Fees rise for 2014. FDA accounts for inflation related rise!!
Pay for delay cases under the new rules now start affecting generic players & innovatorsPay for delay cases under the new rules now start affecting generic players & innovators
New discoveries in HIV infection may now help discover a new approach to treat AIDS