FDA approved Amjevita adalimumab-atto (ABP 501) from Amgen Inc. (NASDAQ:AMGN), a biosimilar of Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). The agency approved Amjevita for all indications Amgen had sought: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis and polyarticular juvenile idiopathic arthritis. It is the fourth biosimilar FDA has approved, and the first biosimilar of Humira.
Amgen did not respond to inquires about its launch plans. The biosimilar is under EMA review.
In a lawsuit filed last month, AbbVie alleged Amjevita infringes 10 Humira patents and sought an injunction preventing its launch. Amgen has said that it could launch the biosimilar as soon as 2017, while AbbVie has countered that its Humira patent portfolio is strong enough to keep Humira biosimilars off the U.S. market until 2022 (see BioCentury, July 25).
U.S. sales of Humira were $8.4 billion in 2015. The drug's $14 billion in total sales represented 61% of AbbVie's revenue in 2015. Adalimumab is a human mAb against tumor necrosis factor (TNF) alpha.
Amgen shed $0.82 to $174.80 on Friday. FDA announced the approval after market close.
The Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) submitted a BLA to FDA for sirukumab (CNTO 136) to treat moderately to severely active rheumatoid arthritis in adults who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
An MAA for the human IgG1 kappa mAb against interleukin-6 (IL-6) was submitted to EMA earlier this month (see BioCentury Extra, Sept. 12).
In December 2015, partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said sirukumab produced positive top-line results in three Phase III studies, but did not disclose details. It reported more detailed data from one of the studies in June (see BioCentury Extra, June 8).
Janssen and GSK partnered in 2011 to co-develop and co-commercialize sirukumab. GSK has exclusive rights to the compound in North, Central and South America, while Janssen retains rights elsewhere.
A BLA for competing IL-6 mAb sarilumab (REGN88) from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) is under review in the U.S. and EU. Its PDUFA date is Oct. 30.
Both sarilumab and sirukumab would compete with Actemra tocilizumab, a mAb against IL-6 receptor (CD126) marketed by the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY) and Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) to treat RA.
In draft guidance, the U.K.'s NICE recommended Epclusa sofosbuvir/velpatasvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat all genotypes of chronic HCV. The recommendation is contingent on Gilead providing the drug at an undisclosed discount.
NICE said Epclusa was cost-effective for all subgroups in all HCV genotypes at a threshold of L20,000 ($26,116) per quality-adjusted life year (QALY) gained, excluding patients with untreated HCV genotype 2 who do not have cirrhosis and who can receive interferon. Epclusa costs L38,980 ($50,900) for a 12-week course prior to the discount, according to the agency. Comments on the guidance are due Oct. 14.
The European Commission approved Epclusa in July. It is a fixed-dose combination of Gilead's HCV drug Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor; and velpatasvir (GS-5816), a pan-genotypic HCV NS5A protein inhibitor.
Earlier this month, NICE recommended HCV therapy Zepatier elbasvir/grazoprevir from Merck & Co. Inc. (NYSE:MRK) for certain populations of HCV patients. The committee also recommends three other HCV therapies (see BioCentury Extra, Sept. 8).
Zambon Co. S.p.A. (Milan, Italy), which develops CNS, respiratory and pain therapies, named Roberto Tascione CEO. He was president and CEO for Italy at Bristol-Myers Squibb Co. (NYSE:BMY).
Generics company Endo International plc (NASDAQ:ENDP; TSX:ENL) said Rajiv De Silva has resigned as president and CEO. Endo named Paul Campanelli as his successor in both roles. Campanelli was president of Endo's Par Pharmaceutical Holdings Inc. subsidiary.
The Lanthio Pharma B.V. subsidiary of MorphoSys AG (Xetra:MOR; Pink:MPSYF) hired Axel Mescheder as CMO. He was VP of medical and regulatory affairs for Europe at Medpace GmbH unit of Medpace Holdings Inc. (NASDAQ:MEDP).
Rare disease company Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) named Remi Menes chief commercial officer. He was general manager of Finland at AbbVie Inc. (NASDAQ:ABBV).
CNS and autoimmune company Alder BioPharmaceuticals Inc. (NASDAQ:ALDR) named Nancy Boman SVP of regulatory affairs and pharmacovigilance. Boman was SVP of clinical development and regulatory affairs at CTI BioPharma Corp. (NASDAQ:CTIC; Milan:CTIC).
Orphan disease company Amryt Pharma plc (LSE:AMYT; ISE:AYP) named Mark Sumeray CMO. He was CMO at Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR).
All 20 patients receiving a six-week course of a triple-combination therapy from Johnson & Johnson (NYSE:JNJ) to treat HCV genotype 1 infection achieved an SVR12 in a Phase II study, according to J&J's partners Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) and Medivir AB (SSE:MVIR B). Data were presented at the European Association for the Study of the Liver (EASL) meeting in Paris.
The cohort, one of four in the study, received a combination including J&J's Olysio simeprevir and AL-335, plus Achillion's odalasvir (ACH-3102). J&J holds rights to Olysio from Medivir. It obtained AL-335 via its acquisition of Alios Biopharma Inc. in 2014, and received exclusive, worldwide rights to odalasvir in a May 2015 deal (see BioCentury, May 25, 2015).
The combo led to an SVR12 in 100% of patients in two other eight-week cohorts. A regimen with only AL-335 and odalasvir led to an SVR12 in 18 (90%) of 20 patients in the final cohort.
Olysio is an HCV NS3/4A protease complex inhibitor. AL-335 is a uridine-based nucleotide analog inhibitor of HCV NS5B polymerase. ACH-3102 is a second-generation HCV NS5A protein inhibitor. The combo's development program includes testing across all HCV genotypes.
Achillion gained $0.25 to $8.69 on Friday. Medivir added SEK4.25 to SEK64.75.
AbbVie Inc. (NYSE:ABBV) and partner Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) said an eight-week regimen of Viekirax ombitasvir/paritaprevir/ritonavir plus Exviera dasabuvir led to an SVR12 in 160 (98%) of 163 evaluable HCV patients in the Phase IIIb GARNET study to treat HCV genotype 1b infection, meeting the primary endpoint.
The partners said two patients experienced post-treatment relapse. One patient discontinued the study due to noncompliance.
GARNET evaluated treatment-naive, non-cirrhotic genotype 1b HCV patients. The results were presented on Friday at the European Association for the Study of the Liver (EASL) meeting in Paris.
The combo is approved in the EU to treat HCV genotype 1 infection. Viekirax includes tablets containing ombitasvir, an HCV NS5A protein inhibitor; paritaprevir, an HCV NS3/4A protease complex inhibitor; and ritonavir, an HIV protease inhibitor. Exviera is a non-nucleoside HCV NS5B polymerase inhibitor. It competes with single-tablet regimens including Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD), which is generally prescribed in 12-week courses.
Enanta is partnered with AbbVie for paritaprevir. It lost $0.21 to $26.39 on Friday. Gilead slipped $0.15 to $81.37.
Neurodegeneration company AC Immune S.A. (NASDAQ:ACIU) gained $4.66 (42%) to $15.66 on Friday in its first day of trading after raising $66 million in an IPO underwritten by Credit Suisse, Jefferies and Leerink (see BioCentury Extra, Sept. 22).
The listing price valued AC Immune at $609.4 million. It ended the day with a market cap of $867.5 million.
AC Immune's lead program is crenezumab (RG7412), a humanized mAb against beta amyloid to treat prodromal to mild Alzheimer's disease. Its partner, the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), began a Phase III study of the candidate in 1Q16.
FDA Commissioner Robert Califf named Rachel Sherman deputy commissioner for medical products and tobacco, effective immediately. The position had been vacant since Califf was confirmed in February as the agency's commissioner.
Sherman rejoined FDA last year as a senior official in the Office of the Commissioner. She had left the agency in 2014 to join consulting firm Greenleaf Health LLC (see BioCentury Extra, Oct. 15, 2015).
The U.S. Senate voted unanimously to extend the Rare Pediatric Disease Priority Review Voucher program until YE16 by passing an amended version of the Advancing Hope Act (S. 1878). The voucher program, designed to provide incentives to develop treatments for rare diseases, would sunset on Oct. 1 unless it is extended.
The National Organization for Rare Diseases (NORD) said the U.S. House of Representatives likely will vote on the amended bill next week.
According to a NORD statement, Sens. Lamar Alexander (R-Tenn.), Johnny Isakson (R-Ga.) and Bob Casey (D-Penn.) organized a compromise to extend the program. Prior to the amendment, the bill had included an extension of the program until September 2022.