Hepatology company Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) gained $25.93 (28%) to $120.22 on Friday after media reports again said the company was exploring a sale. The company declined to comment on the rumors.
On Dec. 15, 2015, Intercept rose 17% to $163.22 after reports said multiple companies were considering bids to acquire it (see BioCentury Extra, Dec. 15).
Intercept shares had since fallen 42% to close at $94.29 on Thursday, losing nearly $1.7 billion in market cap amid a broader biotech selloff. The company traded above $200 as recently as Nov. 11, 2015.
On Thursday, FDA said its Gastrointestinal Drugs Advisory Committee will meet April 7 to discuss an NDA for Intercept's obeticholic acid (OCA; DSP-1747) to treat primary biliary cholangitis (PBC). In September 2015, the company began the Phase III REGENERATE trial of OCA to treat non-alcoholic steatohepatitis (NASH) (see BioCentury Extra, Feb. 11).
The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) acquired European rights from Pfizer Inc. (NYSE:PFE) to PF-06438179, a biosimilar of autoimmune drug Remicade infliximab. Financial terms are undisclosed.
The European Commission required Pfizer to divest European rights to PF-06438179 as a condition for approving Pfizer's 2015 acquisition of Hospira Inc., which already markets a biosimilar of Remicade in Europe. Hospira has commercialization rights to its Remicade biosimilar, Inflectra (CT-P13),from Celltrion Inc. (KOSDAQ:068270) under a deal in which the companies commercialize Celltrion's biosimilars in parallel under separate brand names.
PF-06438179 is in the Phase III REFLECTIONS (B537-02) trial, which is evaluating the biosimilar vs. Remicade in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Pfizer retains rights to PF-06438179 outside of Europe. Sandoz spokesperson Sreejit Mohan declined to comment on when the companies expect data from REFLECTIONS, or when Sandoz expects to submit a European application for the biosimilar.
Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) market Remicade, a chimeric mAb against tumor necrosis factor (TNF) alpha.
Not-for-profit consortium GenomeAsia 100K said it plans to sequence 100,000 genomes in Asian countries to accelerate precision medicine applications for Asian patients.
MedGenome Inc. (San Francisco, Calif.) contributed $10 million to the initiative, while Illumina Inc. (NASDAQ:ILMN) and Macrogen Inc. (KOSDAQ:038290) are providing additional support. Illumina did not respond to an inquiry.
The initative intends to study patients in a total of 19 Asian countries, including 12 in South Asia. The project's scientific chairman, Nanyang Technological University Professor Stephan Schuster, told BioCentury the group initially will focus on India, Korea, Indonesia, Bangladesh, Malaysia and Japan.
GenomeAsia said the project will create reference genomes for all major Asian ethic groups. Genomic sequences will be combined with microbiome, clinical and phenotypic data to better understand healthy and diseased states in Asian populations.
Emerge Ventures CEO Mahesh Pratapneni will be the project's executive chairman. Jeong-Sun Seo, who is director of the Genomic Medicine Institute at Seoul National University and Macrogen's chairman, is its co-scientific chairman for North and East Asia.
FDA's Oncologic Drugs Advisory Committee will meet on April 12 to discuss an NDA from Clovis Oncology Inc. (NASDAQ:CLVS) for rociletinib (CO-1686) to treat non-small cell lung cancer (NSCLC) in patients who have the EGFR T790M mutation and have been previously treated with an EGFR-targeted therapy. Its PDUFA date is June 28.
Clovis amended rociletinib's NDA in November at FDA's request after the company said the rate of confirmed responses to rociletinib was lower than previously reported unconfirmed response rates that served as the original NDA's primary basis. In December, FDA extended the PDUFA date by three months (see BioCentury Extra, Nov. 16, 2015).
Clovis has exclusive, worldwide rights to develop and commercialize rociletinib from Celgene Corp. (NASDAQ:CELG). The small molecule inhibits the T790M EGFR mutation and the initial activating EGFR mutations.
Clovis gained $0.37 to $18.97 on Friday. The stock closed at $99.43 on Nov. 13, prior to the news it would amend the submission.
Indian pharmaceutical company Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) said it will wind down operations of its JV with Merck & Co. Inc. (NYSE:MRK) due to "changes in the strategic priorities of both the parent companies."
The companies partnered in 2011 to develop and commercialize new combinations and formulations of branded generics in emerging markets (see BioCentury Extra, April 11, 2011).
Last year, Simcere Pharmaceutical Group (Nanjing, China) took over management of SMSD (Shanghai) Ltd., its JV with Merck. SMSD was founded in 2011 to commercialize a combined portfolio of drugs from each company with a focus on faster-growing China cities (see BioCentury Extra, Feb. 6, 2015).
The Association of the British Pharmaceutical Industry named Mike Thompson chief executive, effective March 1. Thompson was SVP of global commercial strategy and platforms at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Cepheid Inc. (NASDAQ:CPHD) promoted COO Warren Kocmond from EVP to president; he will remain COO. The diagnostics company also named Marc Haugen EVP of engineering and operations. He was group VP of worldwide operations and supply chain at Applied Materials Inc. (NASDAQ:AMAT).
Diagnostics company Asuragen Inc. (Austin, Texas) named Colin Hill SVP of commercial operations. Hill was VP of the platform business unit at Ortho Clinical Diagnostics (Raritan, N.J.).
Bamboo Therapeutics Inc. (Chapel Hill, N.C) raised $49.5 million in a series A round. Bamboo Co-Founder and CEO Sheila Mikhail declined to name any of the investors except CureDuchenne Ventures LLC, whose investment was announced last month. CureDuchenne told BioCentury it invested $1.5 million.
Bamboo has recombinant adeno-associated virus (rAAV) technology developed by Co-Founder, Chairman and CSO Jude Samulski, who is the director of the University of North Carolina Gene Therapy Center. Bamboo also has chimeric AAV, self-complementary and dual glycan receptor AAV technologies. According to Bamboo's website, the vectors have been engineered to improve delivery to some tissues while avoiding other tissues.
The company hopes to begin clinical studies in 1H17 of BMB-D001, a gene therapy to treat Duchenne muscular dystrophy (DMD). BMB-D001 delivers a shortened copy of the dystrophin gene.
Bamboo's most advanced vector, scAAV/JeT-GAN, is in an NIH-sponsored Phase I/II study to treat giant axonal neuropathy (GAN). The company also has preclinical candidates for Canavan disease and Friedreich's ataxia.
Shield Therapeutics plc (LSE:STX) raised L32.5 million ($47.1 million) through the sale of 21.7 million shares at 150p in an IPO on the London Stock Exchange. The company said its market capitalization will be L162.2 million ($234.8 million) upon its admission to LSE. Shield is expected to start trading by Feb. 26.
Additionally, for every 13 shares purchased in the IPO, investors will receive seven warrants exercisable for a share at 150p until June 30, 2017.
In December, EMA's CHMP recommended approval of Shield's Feraccru ferric maltol (ST10) to treat iron deficiency anemia in patients with inflammatory bowel disease (IBD). Shield expects European approval this quarter of the oral ferric iron non-covalently bound to three maltol molecules.
Shield proposed in September to raise up to L110 million ($159.4 million) in an IPO on LSE. It postponed the offering the following month, citing market conditions (see BioCentury, Sept. 21, 2015).
The biotech, previously based in Switzerland and known as Shield Therapeutics AG, is in the process of reorganizing under a U.K.-based holding company.
Apellis Pharmaceuticals Inc. (Crestwood, Ky.) raised $47.1 million in a series D round less than a week after it formally withdrew a proposed IPO on NASDAQ. Apellis is developing compounds that target complement 3 (C3) to treat autoimmune and inflammatory diseases, with two clinical-stage compstatin-derived small peptide C3 inhibitors.
New investors Cormorant Asset Management, Hillhouse Capital Group and venBio Global Strategic Fund co-led the round. Existing investors Morningside Venture Investments, AJU IB Investment and Epidarex Capital also participated.
Last October, Apellis filed for an IPO on NASDAQ. President and CEO Cedric Francois told BioCentury on Friday the company began to consider a private round after the biotech markets became turbulent.
The company expects data by summer 2017 from a Phase II trial of an intravitreal formulation of Apellis' APL-2 to treat geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD). A subcutaneous formulation of APL-2 is in Phase I testing to treat paroxysmal nocturnal hemoglobinuria (PNH) as a monotherapy and in combination with Soliris eculizumab, a mAb against C5 from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN). Data from those trials are expected in mid-2016.
Also mid-year, Apellis plans to start a Phase Ib trial of an inhaled formulation of the company's APL-1 to treat chronic obstructive pulmonary disease (COPD). It expects proof-of-concept (POC) data around YE17.
venBio's Robert Adelman and Cormorant's Bihua Chen joined Apellis' board.
Policy and advocacy organization FasterCures has published a report that surveys how patient groups are using registries, outlines best practices for their use, and points to their expanded roles.
Registries "inform natural history studies, assist clinical trial recruitment, facilitate safety monitoring, [and] allow patient participation in research," according to the report. It emphasizes the importance of treating patients who provide data to registries as partners who want to know how their data will be used and who want to receive outcomes data, and notes that some registries provide patients with information about how a participant's data compares to other participants'.
The report also states that foundation-led registries "are positioned to meet growing needs to collect real-world data about the patient experience." It suggests ways to expand registries' utility, including capturing data on patient preferences, healthcare costs, and adherence to care regimens.
BioCentury Extra will not publish Monday, Feb. 15, in observance of the Presidents' Day holiday in the U.S. BioCentury Extra will resume publishing Tuesday, Feb. 16.
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