Eiger, Celladon sign merger deal | Eli Lilly expands immuno-oncology partnership with Merck | Nasal formulation of naloxone approved as overdose treatment
November 20, 2015
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Eiger, Celladon sign merger deal
Eiger BioPharmaceuticals and Celladon agreed to merge into a single company, creating a combined firm with a diversified product portfolio that includes treatment candidates for hepatitis delta, lymphedema, pulmonary arterial hypertension and bariatric surgery-induced hyperinsulinemic hypoglycemia. The combined company, which will be called Eiger BioPharmaceuticals, has already received a $6 million investment from an investor syndicate and is eligible for an additional $33.5 million upon completion of the deal. Seeking Alpha (free registration) (11/19)
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Health Care & Policy
Eli Lilly expands immuno-oncology partnership with Merck
A late-stage trial will be conducted by Eli Lilly & Co. and Merck to evaluate the combination of Eli Lilly's Alimta, or pemetrexed, and Merck's Keytruda, or pembrolizumab, for use in non-small cell lung cancer patients as a first-line treatment. The trial broadens the ongoing immuno-oncology collaboration between the firms. Previously untreated NSCLC patients will be included in the trial, which will be funded by Merck. Seeking Alpha (free registration) (11/19)
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Nasal formulation of naloxone approved as overdose treatment
The FDA has approved a nasal spray version of Adapt Pharma's Narcan, or naloxone, for the reversal of opioid overdose. Adapt CEO Seamus Mulligan said the drug would be released in January and would be priced at $37.50 per unit for health departments, local schools and certain other buyers. Reuters (11/19)
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Multiple myeloma drug from Amgen gains marketing approval in Europe
Amgen obtained clearance from the European Commission to market Kyprolis, or carfilzomib, as a treatment for multiple myeloma patients who have been treated with at least one line of therapy. The drug is intended to be used along with lenalidomide and dexamethasone. The approval was backed by results from a late-stage trial, which showed that patients who took the three-drug regimen had median progression-free survival of 26.3 months, compared with 17.6 months for those who received only lenalidomide and dexamethasone. European Pharmaceutical Review (U.K.) (11/20)
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Bayer's prostate cancer drug gains NICE support
A final appraisal determination has been released by the National Institute for Health and Care Excellence endorsing the use of Bayer's Xofigo, or radium-223 dichloride, as a post-chemotherapy treatment for hormone-relapsed prostate cancer patients with symptomatic bone metastases who have no evidence of visceral metastases. Study data showed that the drug prolonged patients' median overall survival and delayed the occurrence of the first symptomatic skeletal event, compared with placebo. PharmaTimes (U.K.) (11/19)
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Rights to Cellectis blood cancer treatment acquired by Servier and Pfizer
Servier and Pfizer have obtained rights to CAR T cell technology developed by Cellectis to treat blood cancers. Servier acquired worldwide rights to UCART19, with Pfizer gaining marketing rights in the US. Early-stage clinical trials are being prepared for the therapy. Reuters (11/19)
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Mundipharma acquires rights to Spectrum's lymphoma drug
The rights to Spectrum Pharmaceuticals' lymphoma drug Zevalin, or ibritumomab tiuxetan, in the Middle East, Africa, Latin America and Asia-Pacific countries except China and India have been obtained by Mundipharma. In addition to an upfront payment of $15 million, Spectrum is eligible for $5 million in profits. Mundipharma will be responsible for Spectrum's operations in Japan. Seeking Alpha (free registration) (11/18)
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Company & Financial News
Axsome raises $51M in IPO
An initial public offering of 5.67 million shares has brought in $51 million for Axsome Therapeutics. The firm focuses on the development of treatments for pain and central nervous system conditions. Nasdaq.com/Renaissance Capital (11/19)
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Food & Agriculture
FDA approves biotech salmon for commercial sale
The FDA approved the commercial production and sale of biotech salmon developed by Massachusetts-based AquaBounty Technologies. The AquAdvantage salmon, which was created to grow faster than regular Atlantic salmon, is the first biotech farm animal cleared for sale in the US. BIO lauded the approval, saying that "animal biotechnology can improve livestock to require less feed, produce more protein, and reduce environmental impact, while also providing for enhanced animal health and welfare." The New York Times (free-article access for SmartBrief readers) (11/19), The Wall Street Journal (tiered subscription model) (11/19), Los Angeles Times (tiered subscription model) (11/19)
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Industrial & Environmental
Lawmakers call on Obama administration to maintain strong RFS
Four US House members have signed a letter urging President Barack Obama to reconsider the Environmental Protection Agency's proposed lower biofuel blending volume and to maintain a strong Renewable Fuel Standard program. "We hope you will keep in mind the need to reduce carbon pollution, and not expand it in the transportation sector in the days leading up to the President's historic efforts," the representatives said in the letter addressed to senior adviser Brian Deese. Rep. Nancy Pelosi, D-Calif.; Rep. Steny Hoyer, D-Md.; Rep. Collin Peterson, D-Minn.; and Rep. David Loebsack, D-Iowa, signed the letter. Reuters (11/19)
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News From BIO
FDA/Sponsor Interactions During Drug Development: Preliminary Data
BIO is conducting a first-of-its-kind survey on FDA/Sponsor Interactions During Drug Development. Earlier this year, BIO held an exclusive webinar to reveal the preliminary data from this survey. You can view select slides from the webinar. Survey participants have full data access -- you can sign up to receive exclusive insights from our upcoming spring data pull by visiting fdasurvey.bio.org. We have been able to glean some high-level insights from the preliminary data set presented during the webinar, but we need more participation for this survey to effect positive change at the FDA. In-depth company feedback will enable BIO to provide real-time information to the FDA and will inform BIO's policy priorities. Companies are encouraged to share their insights by signing up. If you have any questions, please contact Charles Crain.
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