Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation, jcm@btobioinnovation.com

Editor’s Note

For the third time in three days, the US Senate has rejected the latest measure to repeal the Obama health care law and has decided to leave replacement for later. The bill failed 51-49, with Republican Senators John McCain, Lisa Murkowski, and Susan Collins voting against it.

Mergers, Acquisitions and Joint Ventures

Mitsubishi Tanabe acquires Israeli NeuroDerm for $1.1 billion which includes a phase 3 Parkinson treatment. Neu­ro­Derm’s biggest asset is a liq­uid for­mu­la­tion of lev­odopa/car­bidopa that could be con­tin­u­ously de­liv­ered via a wear­able pump. The drug could become an excellent fit well with Rad­i­cava, its recently US approved Amyotrophic Lateral Sclerosis drug. Neu­ro­Derm is also de­vel­op­ing apo­mor­phine, a mid-stage pro­gram for Parkin­son’s, and a trans­der­mal patch for CNS dis­eases and cog­ni­tive dis­or­ders.

Business

AstraZeneca enters a global oncology collaboration with Merck & Co to co-develop and co-commercialise Lynparza or alaparib, a PARP inhibitor. The companies will jointly develop and commercialize Lynparza as monotherapy and in combination with other medicines and will also partner to develop and commercialize AstraZeneca's MEK inhibitor selumetinib.They will also independently develop and commercialize Lynparza in combination with Imfinzi (durvalumab) and Keytruda (pembrolizumab), respectively. Under the terms of the agreement, the companies will share development and commercialization costs while gross profits will be equally shared. Merck & Co. gets half of the rights to Lynparza in an $8.5 billion deal, $1.6 billion up front and the remaining contingent on sales and regulatory milestones, plus potential licensing payments worth up to $750 million.

Eli Lilly licenses exclusive rights to Nektar’s NKTR-358, an early stage autoimmune drug for $400 million. NKTR-358, which was first dosed in a human in a Phase I study 4 months ago, was de­signed to ac­ti­vate reg­u­la­tory T cells by tar­get­ing IL-2, a mechanism which could put the im­mune sys­tem back on track in fix­ing au­toim­mune dis­eases. Under the terms of thed deal, Eli Lilly will make a $150 million upfront plus $250 million in milestones. Eli Lilly will pick up 75% of the Phase II de­vel­op­ment costs and Nek­tar will have the opt-in rights on this drug on an in­di­ca­tion-by-in­di­ca­tion basis.

Drugs at clinical stage

AstraZeneca reports that its open-label Phase 3 MYSTIC study assessing Imfinzi (durvalumab), in combination with tremelimumab, compared to platinum-based chemo in a first-line setting in patients with metastatic non-small cell lung cancer (NSCLC) failed to achieve its primary endpoint. Specifically, treatment with durvalumab and tremelimumab failed to demonstrate a statistically significant improvement in progression-free survival (PFS) compared to standard-of-care platinum chemo in NSCLC patients whose tumors express PD-L1 on at least 25% of their cancer cells. The company says durvalumab monotherapy would not have shown a treatment benefit over chemotherapy either, although this endpoint was not formally tested. Imfinzi continues to be evaluated in multiple monotherapy trials. The failure of the group's Mystic trial – its single most important event of 2017 – was summed up on a press call by its chief executive, Pascal Soriot, saying: "It's too early to conclude that Mystic is not positive."

Pfizer and Astellas stop the development of Xtandi, recently acquired through the Medivation acquisition, into breast cancer. Xtandi, which is already approved for treating prostate cancer generated more than $2.2 billion last year. Astellas has also been investigating the drug as a treatment for breast cancer as well as for liver cancer. In its recent pipeline update Astellas said that had discontinued the breast cancer program. The note, which affirms a disclosure first made in May, says the decision came after comprehensive discussions with Pfizer about a “competitive landscape change, need for further diagnostic development and new phase 2 data.”

Medical Devices and Diagnosis News.

Roche partners with Senseonics and TypeZero Technologies to develop and “artificial pancreas”. Under their original agreement, Senseonics and TypeZero would integrate glucose readings from Eversense with TypeZero’s inControl software to automatically adjust insulin delivery from a patient’s insulin pump. Now, Roche will bring its AccuChek Insight insulin pump to the system, Senseonics said in a statement. The system will be tested at three sites in Europe. “The promise of automated insulin delivery systems is the ability to automatically and sustainably maintain tight glucose control while avoiding hypoglycemia. With this partnership, we are one step closer to bringing this promise to market and to significantly improve the everyday challenges of people with diabetes,” said Senseonics CEO Tim Goodnow, in the statement.

Cost, Pricing and Market Access

Roche caught the market by surprise when it priced its new multiple sclerosis drug Ocrevus at a 25% discount to the competition. Roche’s gambit has surprised again, with Ocrevus winning immediate uptake and generating $200 million in its first quarter on the market. The drug not only outperformed analysts consensus by more than three times, it appears to have outperformed Roche’s because the drugmaker today said it has decided to raise its 2017 forecast."Particularly pleasing is the very successful launch of Ocrevus for the treatment of two forms of multiple sclerosis,” Roche CEO Severin Schwan said in a statement. “Based on our half-year performance, we raised the outlook for the full-year to midsingle-digit sales growth.” Roche has also bought itself some good will in the process. Express Scripts Chief Medical Officer Steve Miller, one of the most vocal critics of pharma’s practice of pushing pricing to the limits, recently pointed to Ocrevus’ price as one example suggesting pharma is beginning to compromise on prices.

Miscellaneous

People on the move

GlaxoSmithKline recruits Laurie Glimcher, a pioneering scientist to its Board.  Glimcher is the CEO of Dana-Farber, one of the most prestigious cancer research centers in the world. She is also a researcher who has devoted a considerable amount of lab time to immuno-oncology, a subject she helped cover during her 20 years on the board of Bristol-Myers Squibb, a post which she abruptly jumped out of a week ago with a note about her “retirement.”

David Meeker, the former chief of Sanofi-Genzyme, has another chairman’s role to fill at Trevi Therapeutics. Immedialtely after his retirement from Sanofi-Genzyme he was named chairman of Rhythm in April, following up with a board appointment at San Francisco-based MyoKardia.

Tessa Therapeutics, a Singapore based oncology-focused biotech, which recently partnered with the Parker Institute, announced the appointment of Jennifer Butler as chief commercial officer. She’s in charge of building the company’s US operations.

Bioevents

Nordic Life Science Days (NLS) 2017 on September 12-14 in Malmö-Copenhagen (Sweden and Denmark)

BIOPharm America on September 26-27 in Boston (USA)

BIO Latin America on October 26-28 in Sao Paulo (Brazil)

BIO Europe on November 6-8 in Berlin (Germany)

World Congress on Biomedical Engineering 2017 on November 9-11 in Xian (China)

BIOFIT on November 28-29 in Strasbourg (France)

http://btobioinnovation.com/events/pharma-biotech-events/

http://btobioinnovation.com/events/in-vitro-diagnostic-events/

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