Inova Top Ten Newsletter – November 2017

Last month’s partnering news was dominated by next-generation therapeutics. First, we have the FDA approval of Gilead/Kite’s CAR-T Therapy, called Yescarta. We have also seen progress in Spark Therapeutics’ landmark gene therapy for a rare form of blindness. It is expected to cost up to $1 million if it gets FDA approval in January. Nuclear medicine is also gaining traction in the field of oncology, as evidenced by Novartis acquisition of French biotech AAA for its pipeline of radiopharmaceuticals. Lastly, mRNA vaccines were also in the news, with Eli Lilly’s billion-dollar deal with CureVac. Having said that, we are expecting to see more innovative and breakthrough partnerships like these come to fruition in the near future. Read more below on the top November biopharma news:

1)Novartis to Buy French Cancer Specialist AAA for $3.9 Billion

Novartis recognizes that nuclear medicine is key to better cancer diagnosis and treatments, and so they have decided to purchase a French biotech that does just that to supplement its innovative oncology pipeline. Advanced Accelerator Applications (AAA) develops, markets and sells products for molecular nuclear medicine, such as those used in PET and SPECT imaging systems. With the $3.9 billion deal, Novartis will have access to AAA’s lead product in development, Lutathera, which is currently under regulatory review by the FDA and the EMA for rare gastroenteropancreatic neuroendocrine tumors, the likes of which killed Apple founder, Steve Jobs.

2) Sanofi’s key to bridging the gap between lab and real-world results?Behavioral science, it says

Sanofi is trying to leverage patient data in their clinical studies through a different kind of science – behavioral science. For the longest time, “hard-core” scientists like drug developers have distinguished themselves from their “softer” counterparts in the field of social science. But in this partnership with Sanofi and Evidation Health, as well as the improving analytic capabilities of big data and technology, we see the marriage of the two sciences work out.

3) We may soon have our first $1 million drug. Who will pay for it? And how?

This article from STAT News was inspired by the recent unanimous support from the FDA panel on Spark Therapeutics’ gene therapy on a hereditary form of blindness. The therapy will likely be approved sometime in January, with an anticipated enormous price tag. Analysts and insiders are expecting it to be valued around $1 million when it receives its expected FDA approval. How sustainable is this for both patients and payers?

4) Future of the Global Pharmaceutical Industry: A Torreya Report

This 97-page report by consulting firm, Torreya, presents a comprehensive overview of the global pharmaceutical industry’s evolution (what big pharma was like in the 20s), its current state, as well as the outlook for its future and the challenges it’s facing. Overall, the consulting company suggests that the industry is filled with growth opportunities and we are expecting to have more partnerships in the next year.

5) Gilead wins US approval for CAR-T cancer therapy

Gilead’s $11.9 billion acquisition of Kite Pharma bears fruit in the FDA approval of their CAR-T Therapy. To be marketed as Yescarta, Gilead’s CAR-T Therapy becomes the first CAR-T Therapy approved by the FDA for the treatment of adult patients with diffuse large-B cell lymphoma (DLBCL) as well as several other B-cell lymphoma types. In this regard, Yescarta will have a broader patient group compared to Novartis’ Kymriah, which was approved for a very limited indication, therefore giving it a relatively lower price tag than Novartis’ Kymriah.

6) Sanofi, J&J could join GlaxoSmithKline, Reckitt in $20B bidding war for Pfizer OTC

Pfizer has announced that they will launch an auction sometime in November for their OTC business so they can focus more on developing prescription drugs. Companies from both the pharma industry as well as in the consumer goods industry have expressed interest. From the pharma industry, we have big pharma companies GSK, Sanofi & J&J, and from the consumer goods industry, we have Reckitt, Nestle, and Procter & Gamble. Pfizer – whose consumer brands include famous painkiller Advil, lipbalm Chapstick, and multi-vitamins Centrum, expect to raise $20 billion from this sale due to the keen competition.

7) Eli Lilly to Pursue mRNA Cancer Vaccines with CureVac Pact

Eli Lilly, has just signed a $1.7B deal with German biotech, CureVac, to develop up to 5 messenger RNA (mRNA) cancer vaccines. CureVac develops synthetic versions of mRNA, which are molecules that carry genetic instructions to the part of the cell that produces proteins. The goal of mRNA drugs is to enable a cell to make therapeutic proteins. CureVac’s research in mRNA drugs encompasses diseases such as rabies, HIV, and influenza. The deal does not specify which cancers the partners will cover, leaving the selection of the drug target to the big pharma company.

8) What to Consider Before Partnering with a Young Tech Company

Partnering in the biopharma industry is not just all about the science and the technology. Nicole Mowad-Nassar talks about her experiences in partnering with young tech companies as Takeda’s Marketing head and how she learned from them. Now that Nicole is Takeda’s vice president and head of US business operations and external partnerships, she along with her team came up with a rubric that evaluates partners for 5 different criteria.

9) Amgen digs deeper in I/O with CytomX deal

Amgen and CytomX announce a $1.5 billion strategic collaboration to develop T-cell treatments for cancer. Currently, Amgen does not have immuno-oncology drugs in their pipeline. The collaboration orbits around CytomX’s Probody platform, which aims to deliver toxic drugs specifically to tumors rather than healthy cells. The California-based biotech has been striking deals with big pharma lately, just a few months ago, it has signed up a partnership with Bristol Myers Squibb worth $3.8 billion, as well as with Pfizer ($500M) and Abbvie ($635M).

10) Merck pays $760M to buy into KalVista drug for diabetic eye disease

Merck & Co. and KalVista has inked a partnership for an experimental treatment for a complication of diabetes (Diabetic Macular Edema) that can lead to blindness. KalVista has developed a technology called plasma kallikrein inhibition as well as an oral therapy, which would represent a ground-breaking advance for treatment of this indication. That is why this deal proves to be attractive for Merck & Co., which has a strong presence in diabetes – with 2 drugs already in the market, as well as another late-stage drug in partnership with Pfizer.

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