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Gottlieb Announces Return to Private Sector Policy Development

April 8, 2019

On his last day as FDA commissioner, Scott Gottlieb announced he will return to the American Enterprise Institute to work on drug pricing in a part-time capacity.

Gottlieb, who last month announced he was resigning from the FDA to spend more time with his family, will put in six days a month as a resident fellow at the D.C.-based conservative think tank. It’s a familiar role for Gottlieb, who began serving as a resident fellow at AEI in 2002 before being appointed as the FDA’s commissioner in May 2017.

National Cancer Institute director Ned Sharpless will now serve as the acting commissioner of the FDA until the White House nominates a new candidate. No plans for a new nomination have been announced.

WCG Acquires Pain Med Developer Analgesic Solutions
The WIRB-Copernicus Group last week announced its acquisition of Analgesic Solutions, a pain medication developer and supporter of clinical trials for pain-indicated conditions.

The company advises research sponsors on protocol design and development, regulatory and FDA submissions, and signal-to-noise optimization.

Its Misuse, Abuse and Diversion Drug Event Reporting System (MADDERS) is the first standardized system for classifying and quantifying abuse-related events in clinical trials. With applications that extend beyond the field of pain management, MADDERS can be used in the trial of any drug that crosses the blood-brain barrier and therefore holds the potential for addiction.

CRO Giant Joins ACRP’s Workforce Development Project
Covance, one of the world’s largest CROs, has joined the Association of Clinical Research Professionals’ “Partners in Workforce Advancement” project, which aims to recruit the next generation of clinical trials leaders.

The CRO, which claims annual revenues above $2.5 billion, employs some 12,500 employees in 60 countries.

Cancer Research Investor Announces CAR T-Cell Trials for Solid Tumors
Stand Up to Cancer (SU2C) last week announced that it is funding two CAR T-cell therapy clinical trials it hopes will make headway in treating solid tumors.

CAR T-cell therapy has encountered multiple obstacles in dealing with solid tumors, such as identifying antigens to be targeted by the CAR T-cells, moving cells to tumors and keeping them there to attack cancerous cells, and dealing with the tumors’ immunosuppressive affects.

The collaboration between SU2C and the American Association of Cancer Research includes a Phase I clinical trial of regionally delivered CAR T-cells in treatment for malignant pleural disease, as well as a trial for the administration of HER2-CAR T-cells in patients with advanced sarcomas.

SU2C has invested more than $175 million in immuno-oncology research in the past 10 years.

Novartis’ Acquisition Will Add Anti-Inflammatory Programs to Arsenal
Novartis has reached a deal to acquire anti-inflammatory drug developer IFM Tre, an arrangement that will see one clinical and two preclinical anti-inflammatory programs added to the drug titan’s portfolio.

The two drugmakers reached a definitive agreement that includes an up-front $310 million payment from Novartis, in addition to a potential $1.265 billion in milestone payments.

The compounds Novartis is set to acquire include IFM-2427, a clinical-stage systemic antagonist for various chronic inflammatory disorders, such as atherosclerosis and NASH; a pre-clinical gut-directed molecule for treating inflammatory bowel disease; and a pre-clinical-stage CNS-penetrant molecule.

Ironwood Completes Cyclerion Spin-Off
Ironwood Pharmaceuticals has completed its $175 million spin-off of Cyclerion Therapeutics, which leaves the new entity with a portfolio of five orphan drugs and allows Ironwood to focus on gastrointestinal diseases.

Ironwood holds the rights to Linzess (linaclotide) for irritable bowel syndrome, which the company expects to bring in revenue of up to $390 million. Ironwood has two candidate drugs in development, one to treat persistent gastroesophageal reflux disease and the other to treat abdominal pain associated with irritable bowel syndrome.

BriaCell and Incyte Link Up for Breast Cancer Combo Therapy Collaboration
Clinical-stage biotech company BriaCell and global biopharmaceutical company Incyte have joined forces in a clinical trial collaboration in which they will work to select novel combinations for treating breast cancer.

The non-exclusive collaboration agreement focuses on the selection of novel combinations for treating advanced breast cancer, but also will involve a Phase I/IIa clinical trial of BriaCell’s Bria-IMT, a cell line that prods a patient’s immune system into treating tumor cells as foreign. The trial will use novel compounds selected by Incyte.

BriaCell is also developing Bria-OTS, a personalized immunotherapy for advanced breast cancer.

Chinese Regulators Approve Trials for Luye’s Eylea
Biosimilar Chinese regulators have approved Luye Pharma’s request to open clinical trials for its new antibody drug, the Shanghai-based company announced last week.

Luye’s LY09004 is a biosimilar to Regeneron’s blockbuster Eylea (aflibercept) injectable, indicated for a variety of eye problems, including age-related macular degeneration and diabetic retinopathy.

Eylea has been a top earner for Regeneron. The company reported $1.08 billion in sales in the fourth quarter of 2018, an increase of 11 percent over the previous year.

The approval comes less than three months after Luye announced an agreement with AstraZeneca to market lipid-busting Xeuzhikang capsules in China, the first time a global pharma company had been granted exclusive authorization to market a drug that had been developed by an independent Chinese company.