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The Best Phase II Partnership Deal in History?

In 2011, Imbruvica (ibrutinib), a Pharmacyclics drug in Phase II trials, caught the eye of Peter Lebowitz, Johnson & Johnson's research director. Lebowitz convinced J&J's CSO Paul Stoffels and CEO Alex Gorsky to fly up to Sunnyvale to meet with Robert Duggan. Duggan had accumulated 13+ million shares in Pharmacyclics over the past six years and now served as company CEO. Back in 2006, Pharmacyclics had purchased a number of small molecule candidates from Celera, including the BTK inhibitor ibrutinib. Not all went well, and by 2008 it appeared Pharmacyclics was headed for biotech oblivion. However in 2011, Gorksy and team were so impressed with they saw in ibrutinib that J&J's Janssen Biotech division made a $150 million up-front payment and provided $825 million in development and regulatory milestones related to the drug. The companies would split development expenses 40/60 (Pharmacyclics/Janssen), and global profits and losses 50/50. Over the next thr...

Opdivo: The King of Combinations?

In 1901, J.S. Pughe published an illustration depicting John D. Rockefeller wearing a huge crown, standing on an oil storage tank labeled "Standard Oil" and glaring out at the world. The crown is decked with railroad cars, the names of railroad companies, oil tanks and wells, all topped by the mighty dollar sign. The piece is entitled: "The King of Combinations." In 2009, Bristol-Myers Squibb (BMS) paid $2.4 billion to acquire Medarex, a biotechnology company developing a promising treatment for melanoma. Four years earlier, Japanese pharmaceutical company Ono and Medarex had partnered to research and develop an antibody against the PD-1 receptor as a potential treatment for cancer. The compound they developed was named nivolumab and later branded as Opdivo. In 2011, BMS obtained exclusive worldwide rights to Opdivo except in Japan, Korea, and Taiwan, where Ono retained rights. And in 2014, the FDA granted accelerated approval to Opdivo to treat patients with ...

What do the top three selling drugs have in common?

In 2016, the three top selling drugs were Humira (about $16 billion), Harvoni (about $9 billion), and Rituxan (about $7.5 billion). Core indications targeted by these drugs are different (Humira = Hepatitis C; Harvoni = Rheumatoid Arthritis; Rituxan = Lymphoma). Basic technologies of these  drugs vary (Humira = monoclonal antibody; Harvoni = small molecule chemistry; Rituxan = monoclonal antibody). But a key element of the corporate development paths for these three drugs is the same. Rights to Humira, Harvoni and Ritxuan were acquired while in Phase III stage of development. In 2000, Abbott Laboratories announced it would pay $6.9 billion in cash for BASF. BASF's pharmaceutical businesses, headquartered in Germany, had products in the areas of pain relief and autoimmune disease. Knoll, a division of BASF, had developed monoclonal antibody technology with a Phase III rheumatoid arthritis candidate, D2E7. Two years later in 2002, D2E7 (now known as Humira) was approve...

Gilead beats its own clinical stage price record in buying Kite

In November 2011 Gilead Sciences purchased Pharmasset for $11.2 billion and gained a stronger foothold in the highly competitive hepatitis C therapeutics market. At the time, this acquisition was the highest price ever paid for a clinical-stage biotech company. Gilead was especially interested in Pharmasset’s lead candidate PSI7977, an oral uracil nucleotide analog that was in Phase III trials for hepatitis C. PSI7977 later became know as sofosbuvi, which was used in combination with ledipasvir to create Harvoni. Harvoni was approved by the FDA in 2014 and in 2016 enjoyed revenue of over $9 billion, the second highest selling drug. Sofosbuvi as a standalone drug known as Sovaldi generated $4 billion in 2016. (In 2017 sales of these two drugs were declining.) A few weeks ago on August 28, Gilead announced it planned to buy Kite Pharma, another clinical stage company. This time the price tag would be $11.9 billion. Kite is developing immunotherapy products using engine...