The past seven days have seen breakthroughs and heartbreaks for West Coast biotech companies. Mapp Biopharmaceutical of San Diego got promising preclinical news about its Ebola drug, then almost immediately got millions of dollars of federal funding to push it quickly into human trials. Up the coast near San Francisco, though, Exelixis’s flagship product returned such bad clinical news in prostate cancer that the biotech let go 70 percent of its staff.
There was a breakthrough therapy designation in San Diego: the FDA gave its coveted nod for expedited development and review to primavanserin, Acadia Pharmaceuticals’ treatment for Parkinson’s disease psychosis. And there was a breakup in Seattle: Bristol-Myers Squibb ended its development relationship with Alder Biopharmaceuticals. A lot more news has broken since our previous West Coast roundup. Let us, ahem, break it down for you.
—As our San Diego editor Bruce Bigelow reported Tuesday, the U.S. Department of Health and Human Services awarded a contract worth up to $42.3 million to help Mapp Biopharmaceutical speed the development of ZMapp, an experimental drug used to treat seven healthcare workers in West Africa, five of whom have survived so far. The contract, issued by the health agency’s Biomedical Advanced Research and Development authority, supports an accelerated development program for ZMapp, with a goal of winning FDA approval. The contract comes just days after Mapp scientists and others published a paper in Nature that showed ZMapp in preclinical testing protected all 18 monkeys given the drug after being infected with a strain of Ebola different than the one responsible for the current epidemic in West Africa. ZMapp has not yet been clinically tested in humans.
—The mysterious Calico has revealed its ambitions to at least one group of people. The biotech startup, backed by Google (NASDAQ: GOOG) and run by all-star management, said Wednesday it would partner with drug maker AbbVie (NYSE: ABBV) on treatments for age-related diseases such as neurodegeneration and cancer. The deal could ultimately include $1.5 billion in total cash coming from both parties and will help Calico build an R&D facility in the San Francisco Bay Area. Calico will begin hiring people “immediately,” it said. Each company will start by contributing $250 million, and another $500 million apiece could come later, although they didn’t say Wednesday what would trigger the additional cash. The companies said in a release that Calico will do the early research, discovery, and clinical work through Phase 2a before handing development duties off to AbbVie. Former Genentech CEO Art Levinson, who is running Calico, resigned from Roche’s board of directors less than 24 hours after the announcement. Levinson worked at Genentech for more than 20 years, starting out in 1980 as a research scientist before climbing through the ranks.
—Seattle-based VentiRx Pharmaceuticals has had a busy week. It announced Tuesday a new round of funding—amount undisclosed—from its venture backers and Celgene (NASDAQ: CELG), the Summit, NJ-based drug maker that holds an option to acquire VentiRx. The option stems from a 2012 deal in which Celgene paid $35 million upfront to provide support for VentiRx’s cancer immunotherapy motolimod in trials for ovarian and head-and-neck cancer. The drug is currently in Phase 2 trials in each indication. VentiRx also said Motolimod has received fast-track designation from the FDA in the ovarian cancer setting in combination with the chemotherapy doxorubicin. Xconomy reported recently that VentiRx CEO Rob Hershberg was tapped to run Celgene’s new Seattle “Immuno-Oncology Center of Excellence.” VentiRx reiterated this week that Hershberg will split his time between VentiRx and the Celgene center, and that Katie Fanning has been promoted from VP of business development and alliance management to chief operating officer. VentiRx also announced that motolimod will be tested in combination with other immunotherapy agents by two New York-based nonprofits, Ludwig Cancer Research and the Cancer Research Institute.
—Acadia Pharmaceuticals (NASDAQ: ACAD) of San Diego said the FDA gave “breakthrough therapy” designation to primavanserin (Nuplazid) for treating Parkinson’s disease psychosis. The company, which develops drugs for neurological and related central nervous system disorders, plans to submit a new drug application for primavanserin to the FDA near the end of this year.
—Exelixis (NASDAQ: EXEL) of South San Francisco, CA said Tuesday that its flagship product cabozantinib, approved to treat a form of thyroid cancer, failed in a Phase 3 trial in advanced prostate cancer. It’s a huge blow to the biotech; it said it would lay off 160 employees, or 70 percent of staff, and take a restructuring charge of $6 million to $8 million as it forges ahead with cabozantinib in trials for kidney and liver cancer. At market close Wednesday, Exelixis shares were $1.90 each, down 54 percent from their position just before the bad news.
—Another West Coast biotech saw its share price drop, but not for a discernible clinical failure. Alder Biopharmaceuticals (NASDAQ: ALDR) of Bothell, WA, said Monday that New York-based development partner Bristol-Myers Squibb (NYSE: BMY) was returning all rights to Alder’s clazakizumab, which showed promising Phase 2 data in 2013 as a rheumatoid arthritis treatment. A BMS spokesperson told Xconomy the decision was not based on any new data, but that “the projected profile” of the drug “did not meet [Bristol’s] criteria” to start a Phase 3 trial. Alder shares closed Wednesday at $14.52, down 14.5 percent.
—Roche CEO Severin Schwan got personally involved in his company’s final push to acquire Brisbane, CA-based InterMune (NASDAQ: ITMN) for $8.3 billion in a deal that was announced August 25. After InterMune rejected Roche’s $70-per-share offer, which was $13 more than any competing bid, Schwan called InterMune CEO Daniel Welch in mid-August with the final $74-per-share figure. For his stubbornness, Welch has earned a payout of nearly $36 million. More details are in a regulatory document InterMune filed August 29, which was reported the next day by the San Francisco Business Times.
—Danish diabetes specialist Novo Nordisk said Tuesday it was ending its inflammatory disorder R&D program, which means a loss of 63 jobs at its Seattle Inflammation Research Center, a company spokesman told Xconomy. The spokesman added, however, that Novo isn’t bolting Seattle altogether. Its research center will stay open, and the 63 positions being cut don’t constitute all of the jobs there. (He didn’t specify how many people staffed the site.) Novo will cut 400 employees total, with other job losses occurring in Denmark and China.
—San Diego-based Conatus Pharmaceuticals (NASDAQ: CNAT) said it began two mid-stage clinical trials for its lead investigational compound, emricasan. One trial will examine the drug in patients with liver cirrhosis; the second will evaluate the drug in cirrhosis patients with portal hypertension. The company said data from both trials are expected by the second half of 2015.
—San Diego’s Sophiris Bio (NASDAQ: SPHS) said it has completed enrollment in a late-stage trial for its lead drug candidate proaerolysin, a genetically-modified recombinant protein under development to treat enlarged prostates. In a statement, CEO Randy Woods said the pivotal trial is on schedule and a preliminary analysis should be done later this year. A complete data analysis would take another year. Sophiris has been developing proaerolysin as an alternative treatment to existing drug therapies that can lead to erectile dysfunction or cardiovascular side effects.
—Amgen (NASDAQ: AMGN) said this week it has submitted two drugs to European regulators for marketing approval. The first is talimogene laherparepvec, an immunotherapy that Amgen wants to sell as a treatment for metastatic melanoma. If approved, Amgen claims it would be the first oncolytic viral immunotherapy to reach the market. It would also provide at least some validation of Amgen’s billion-dollar acquisition of Woburn, MA-based BioVex in 2011. Amgen’s second submission this week is evolocumab, a monoclonal antibody that inhibits PCSK9 and could help people with high cholesterol clear the “bad” type of cholesterol, or LDL, from their blood.
—Edico Genome, founded in San Diego last year to accelerate the way genomic data gets processed, said it has sold its first Dragen Bio-IT processor to Sequenom (NASDAQ: SQNM), a San Diego company that provides prenatal diagnostics services. Edico says its technology can reduce the time required to analyze whole genome sequencing data from next-generation sequencers from 24 hours to 18 minutes. Edico and Sequenom recently completed a proof-of-concept study that compares results from the Dragen processor with Sequenom’s standard analysis software. Results will be presented at the American Society of Human Genetics annual meeting in October.
—San Diego’s Arena Pharmaceuticals (NASDAQ: ARNA) said the FDA has granted orphan drug status to APD811, a new drug candidate the company has been developing to treat pulmonary arterial hypertension. In a statement, senior vice president Craig Audent said that Arena aims to move APD811 into a mid-stage trial later this year. The orphan drug designation enables Arena to claim a variety of drug development incentives, like longer market exclusivity.
—BioLegend, a private San Diego company that provides antibodies and reagents for biomedical research, said it acquired Covance Antibody Services, a business operated by Dedham, MA-based Covance. Covance Antibody develops and manufactures antibodies and research reagents for neuroscience, immunopathology, cell biology, epitope tags, and immunohistochemistry detection. Financial terms were not disclosed.
Xconomy San Diego Editor Bruce V. Bigelow contributed to this report.