Wednesday, December 19, 2018
G1 Therapeutics initiated at Raymond James
G1 Therapeutics initiated with a Strong Buy at Raymond James. Raymond James initiated G1 Therapeutics with a Strong Buy and a $66 price target.
https://thefly.com/landingPageNews.php?id=2839543
Spectrum says FDA did not grant BTD to poziotinib for treatment of NSCLC
Spectrum Pharmaceuticals, Inc. announced that based on a subset of data from MD Anderson’s ongoing Phase 2 study, the U.S. Food and Drug Administration did not grant Breakthrough Therapy Designation to poziotinib for the treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 20 mutations. The company’s overall development plan and timeline for a New Drug Application filing based on the first cohort of the ZENITH20 trial remains unchanged. Breakthrough Therapy Designation is one of several FDA programs designed to expedite the review of drugs to treat serious or life threatening conditions. Spectrum’s BTD application included data from 30 patients from the MD Anderson Phase 2 study who had failed platinum-based chemotherapy. The data demonstrated a confirmed objective response rate of 40% and median duration of response of 6.6 months. The safety profile in this subset was consistent with historical data published on poziotinib and other tyrosine kinase inhibitors. The historical objective response rates for mutation specific NSCLC patients range between 0% and 8% with tyrosine kinase inhibitors and for non-mutation specific NSCLC patients range between 0.8% and 22.9% with other treatments.
https://thefly.com/landingPageNews.php?id=2839513
Gilead bids $105M in cash to Scholar Rock for NASH pipeline deal
At last count Gilead $GILD had 3 clinical stage programs for NASH in the pipeline, topped by their Phase III work on selonsertib.
But that’s not enough.
Today the big biotech — which is getting a brain transplant in the executive suite as Roche’s Daniel O’Day heads for the helm — added a discovery program with Scholar Rock $SRRK on a slate of TGFβ inhibitors for fibrotic diseases, beefing up a portfolio of drugs that encompass NASH and diabetic kidney disease.
Gilead is paying $50 million in upfront cash to get the deal started, along with another $30 million bounty for equity plus $25 million for a near-term preclinical goal and $1.4 billion in milestones.
Gilead is paying $50 million in upfront cash to get the deal started, along with another $30 million bounty for equity plus $25 million for a near-term preclinical goal and $1.4 billion in milestones.
Gilead gets a shot at 3 programs: Inhibitors targeting activation of latent TGFβ1, inhibitors targeting activation of latent TGFβ1 localized to the extracellular matrix, and a third TGFβ program.
Gilead will be putting up Phase III data for selonsertib in the first half of next year in one of the most eagerly anticipated readouts for 2019. But ultimately the blockbuster indication is expected to need combo therapies to do the work needed, a field in which Gilead has demonstrated great expertise. Scholar Rock now gets to play a part in that drama as Intercept and others look to advance rival therapies.
Scholar Rock, meanwhile, gets to build its own portfolio of TGFβ1 drugs for oncology.
AC Immune, WuXi Biologics to Establish Exclusive Strategic Partnership
AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases and Wuxi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today announced the first steps of an exclusive strategic collaboration that covers biologics discovery, development and manufacturing.
AC Immune and WuXi Biologics have entered into a memorandum of understanding governing the terms of a preferred partnership allowing AC Immune to leverage WuXi Biologics’ capacities and capabilities in the manufacturing and supply of traditional and innovative New Biological Entities (NBE) against disorders of the central nervous system (CNS). Through this collaboration, AC Immune would have priority access to WuXi Biologics’ proprietary platforms, including the bispecific antibody platform WuXiBody(TM) and WuXiUP continuous manufacturing platform. In addition, WuXi Biologics would become a preferred partner of AC Immune for bioprocess development, as well as manufacturing for discovery, pre-clinical and clinical supply of AC Immune’s NBE pipeline.
Under the same agreement, the companies would explore the use of AC Immune’s platform to treat non-CNS diseases by identifying areas where AC Immune’s antibody discovery platform could generate superior novel candidates. In addition, WuXi Vaccines, the vaccine arm of WuXi Biologics, would explore enabling the application of AC Immune’s vaccine portfolio in China.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “I am very happy to work with WuXi Biologics and proud to form the basis for a partnership with such an esteemed partner in China. AC Immune aims to become a global leader in precision medicine of neurodegenerative diseases and in getting closer to develop a therapy against Alzheimer’s disease, in which China plays an important role.”
Dr Chris Chen, CEO of WuXi Biologics commented: “We are excited about finalizing this exclusive and comprehensive partnership and are pleased to enable AC Immune which has proven itself as a global leader in CNS diseases by partnering with Genentech and Lilly. Our comprehensive partnership would include discovery, development and manufacturing of multiple biologics and vaccine modalities including bispecific antibodies through our proprietary WuXiBody(TM) Platform. This platform coupled with WuXiUP tackles technical hurdles of conventional bispecific platforms and tremendously reduces the cost of making these biologics, which is critical for success of biologics in treating CNS disorders. We will continue to invest in developing next-generation globally leading technologies to enable global clients and transform biologics discovery, development and manufacturing. Together with global partners like AC Immune we are developing and manufacturing life-saving biologics to benefit patients around the world.”
Selloff in Allergan shares ‘overdone,’ says Raymond James
Raymond James analyst Elliot Wilbur notes that the French regulatory authority ANSM has issued a communique indicating that Allergan’s CE Mark for the company’s line of textured breast implants sold in various European countries will not be renewed based on input from GMED, the official French medical device certification body. Allergan can no longer sell textured breast implants in France and other affected European markets, and the company has ceased sales and commenced a recall of all existing supply, he adds. The analyst acknowledges that this is a “surprise but certainly not an unknown.” Further, Wilbur believes reaction is “overdone” and shares should be “aggressively accumulated” on the move. He reiterates an Outperform rating and $198 price target on the stock.
https://thefly.com/landingPageNews.php?id=2839471
Hikma To Join London’s Blue-Chip Index as Shire Exits
Hikma Pharmaceuticals will joint the FTSE 100 index, replacing Shire, FTSE Russell said Wednesday.
FTSE Russell attributed the swap to Shire’s takeover by Takeda Pharmaceutical. London-listed Hikma Pharmaceuticals was founded in Jordan, and manufactures generic medicines as well as in-licensed products.
Shares of the company are up 65% in the past 12 months. Demand of its injectable medicines was recently buoyed by a shortage in the U.S., and the company reported earnings that beat analyst expectations in its latest half-year report.
FTSE Russell said that changes to the index will be made effective from Dec. 24.
Altria nears Juul stake deal, valuing it at $38 billion
Marlboro cigarette maker Altria Group Inc is nearing an agreement to buy more than a third of Juul Labs Inc, valuing the e-cigarette startup at $38 billion, people familiar with the matter said on Wednesday.
The deal would value Juul at more than double the roughly $16 billion valuation it fetched in July in a private funding round, highlighting the San Francisco-based company’s explosive growth.
Juul’s vaping devices, which resemble a USB flash drive, have helped the company quickly become the market leader in the U.S. e-cigarette business, growing from 13.6 percent of the market in early 2017 to more than 75 percent last month, according to a Wells Fargo analysis of Nielsen retail data.
Altria will pay $12.8 billion in cash for a 35 percent stake in Juul, one of the sources said. The deal could be announced on Thursday or Friday, according to the sources. The Wall Street Journal first reported on the terms of the imminent deal.
Altria and Juul did not immediately respond to requests for comment.
Big tobacco companies have been investing in e-cigarettes as U.S. smoking rates decline, but those products have lost significant market share over the last year as Juul’s popularity has surged.
Altria said this month it would discontinue some of its e-cigarette brands, including all of MarkTen and Green Smoke e-vaper products, based on their financial performance and will take a related pre-tax charge of $200 million in the fourth quarter.
Altria has invested in e-cigarettes in recent years through its Nu Mark subsidiary, which sells devices such as the MarkTen in convenience stores and tobacco shops. In 2014, Altria acquired e-cigarette startup Green Smoke Inc for $110 million.
Altria’s products, however, have lost significant ground to e-cigarette maker Juul Labs Inc over the last year, as have e-cigarette brands from other major tobacco companies.
The Juul investment does not come without risks for Altria. Juul has faced heightened pressure from U.S. regulators as the growing popularity of flavored e-cigarettes among teenagers has sparked fears of a new generation of nicotine addicts.
Federal data released this month showed a 78 percent increase in high school students who reported using e-cigarettes in the last 30 days, compared with the prior year, coinciding with the rise in Juul’s popularity.
Also this month, Altria announced a $1.8 billion investment in Cronos Group Inc, which could give it up to 55-percent ownership of the Canadian cannabis producer.
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