Sen. Bernie Sanders (I-Vt.) said he would vote against confirming Robert Califf as FDA commissioner, citing the cardiologist's industry ties. In a statement, Sanders said Americans "need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person."
President Obama nominated Califf for commissioner last month. He has been deputy commissioner for medical products and tobacco since March. Califf took a leave of absence from his post as vice chancellor of clinical and translation research at Duke University School of Medicine to join FDA (see BioCentury, Feb. 2).
In June, data from CMS's physician payments database showed Califf had received consulting fees totaling $25,000 from five pharma companies in 2014. Califf divested equity in two biotechs prior to joining FDA (see BioCentury Extra, June 30).
Califf's confirmation will come before the Senate Health, Education, Labor and Pensions (HELP) Committee, of which Sanders is a member.
FDA approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat metastatic non-squamous non-small cell lung cancer (NSCLC) in patients who have progressed on or after platinum-based chemotherapy, well ahead of its Jan. 2, 2016, PDUFA date. The PD-1 inhibitor is already approved to treat metastatic squamous NSCLC.
The drug's label does not limit its use based on PD-L1 expression levels, although FDA said it appears that higher expression of PD-L1 "predicts those most likely to benefit" from Opdivo.
Last week, FDA granted accelerated approval to competing PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) to treat advanced squamous and non-squamous NSCLC in previously treated patients. Keytruda's label is limited to patients with PD-L1-positive tumors (see BioCentury Extra, Oct. 2).
In parallel with Opdivo's label expansion, FDA granted premarket approval to the PD-L1 IHC 28-8 pharmDx test, a companion diagnostic from the Dako A/S subsidiary of Agilent Technologies Inc. (NYSE:A).
Biogen Inc. (NASDAQ:BIIB) said EVP of Global Commercial Operations Tony Kingsley will leave the company. EVP of Pharmaceutical Operations and Technology John Cox will fill the position on an interim basis while the company searches for a replacement. Kingsley had held the position since 2011.
On July 24, Biogen lost $20 billion in market cap after it said it was lowering its 2015 guidance for EPS and sales growth, primarily due to slow sales of Tecfidera dimethyl fumarate. At the time, Kingsley said the company had anticipated more patients switching from injectable multiple sclerosis therapies to oral Tecfidera as well as new starts, primarily in the U.S. and Germany (see BioCentury Extra, July 24).
Biogen declined to comment on the personnel change.
Biogen fell $10.72 to $269.16 on Friday and ended the day 44% below its 52-week high of $480.18.
Immunomic Therapeutics Inc. (Hershey, Pa.) granted Astellas Pharma Inc. (Tokyo:4503) exclusive, worldwide rights to develop and commercialize candidates derived from its LAMP-vax platform to treat or prevent allergic diseases. Astellas gained an exclusive option to negotiate the license under a January deal.
Immunomic will receive $300 million up front plus 10% royalties on LAMP-vax products for allergic diseases. It will retain rights to LAMP-vax for other applications, including cancer immunotherapy.
Astellas will gain ARA-LAMP-vax, a preclinical vaccine candidate for peanut allergy.
In January, Astellas obtained exclusive, Japanese rights to ASP4070 (JRC2-LAMP-vax), a vaccine in Phase I to treat allergies induced by Japanese red cedar pollen. ASP4070 is a plasmid-based DNA vaccine containing the Cry J1 and Cry J2 plasmids that uses a lysosomal-associated membrane protein (LAMP) antigen targeting sequence to enhance immune response.
Roche (SIX:ROG; OTCQX:RHHBY) will acquire Adheron Therapeutics Inc. (Berkeley, Calif.), a developer of technology that disrupts cell adhesion via cell surface protein Cadherin 11 (Cad-11; CDH11). Adheron is investigating therapies for inflammatory and autoimmune disorders including rheumatoid arthritis and fibrotic diseases.
Adheron shareholders will receive $105 million up front and are eligible for $475 million in milestones. Adheron said it expects the deal to close "shortly."
Adheron's lead product is SDP051, a humanized mAb against Cad-11. In 2013, Adheron completed a Phase I study of the compound in healthy volunteers. CEO Hari Kumar told BioCentury the company believes SDP051 could be used in combination with tumor necrosis factor (TNF) alpha inhibitors to treat RA, and has potential to treat inflammatory bowel disease, liver and lung fibrosis, and cancer. Roche did not respond to inquiries.
Kumar said Adheron had raised less than $22 million since its founding in 2005. Its investors included Health Care Ventures; MedImmune Ventures; Partners Innovation Fund; Amgen Ventures; and SR One.
AstraZeneca plc (LSE:AZN; NYSE:AZN) temporarily suspended the Phase Ib TATTON trial and Phase III CAURAL trial of AZD9291 in combination with durvalumab (MEDI4736) to treat non-small cell lung cancer (NSCLC). Spokesperson Abigail Bozarth said the trials were halted due to reports of interstitial lung disease (ILD)-like events.
Bozarth said that in the TATTON trial, ILD-like events were reported in 6 of 23 previously treated patients and 5 of 10 treatment-naive patients that received AZD9291 plus durvalumab. No deaths as a result of ILD have been reported.
Patients enrolled in each trial will receive an updated consent form and may opt to continue treatment. AZ has not yet determined when it will resume patient enrollment in TATTON and CAURAL.
AZD9291 is under Priority Review by FDA to treat NSCLC. The oral irreversible inhibitor of EGFR-activating mutations and the T790M EGFR resistance mutations has Orphan Drug, Fast Track and breakthrough therapy designations.
Durvalumab, a human IgG1 mAb targeting PD-L1, is in Phase III testing for NSCLC.
Rival candidate rociletinib (AVL-301) from Clovis Oncology Inc. (NASDAQ:CLVS) is under Priority Review by FDA for previously-treated NSCLC patients with the EGFR T790M mutation. The small molecule that inhibits T790M EGFR mutation and the initial activating EGFR mutations has breakthrough designation from FDA. Clovis rose $3.62 to $93.60 on Friday.
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