Thursday, December 20, 2018
Inovalon upgraded to Equal Weight from Underweight at Morgan Stanley
https://thefly.com/landingPageNews.php?id=2839685
UBS cuts Mednax target to $35 on ‘historically weak’ birth trends
Births declined 3.0% year-over-year in November across the four states that comprise UBS’s monthly birth tracker, Arizona, Colorado, North Carolina and Florida, analyst Whit Mayo tells investors in a research note. Birth trends remain “very weak” versus historical trends, Mayo writes in a note titled “UBS Birth Tracker: Trends Tracking at Historically Weak Levels.” The analyst believes his firm’s birth data supports his below consensus forecasts across 2019-2020 for Mednax. Mayo cut his price target for the shares to $35 from $37 and keeps a Sell rating on the name.
https://thefly.com/landingPageNews.php?id=2839691
Fennec initiates rolling NDA in the US for Pedmark
Fennec Pharmaceuticals has initiated a rolling New Drug Application for Pedmark, a formulation for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localized, non-metastatic, solid tumors, following a pre-submission meeting with the oncology division of the FDA. The company is targeting U.S. approval of Pedmark in 2H19. Pedmark has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations from the FDA. In Europe, Fennec intends to submit its Marketing Authorisation Application via the European Medicines Agency’s Paediatric-use marketing authorisation pathway next year.
https://thefly.com/landingPageNews.php?id=2839701
Feds toss 11 ‘white-coat’ kickback probes, questioning whistleblower motives
After digging into almost a dozen whistleblower complaints alleging pharma companies ran kickback schemes with nurse educators as the “payment”—so-called white-coat marketing—the government is backing out.
The National Healthcare Analysis Group and related organizations had sued Amgen, Biogen, EMD Serono, Teva, AstraZeneca, AbbVie, Otsuka, UCB, Bayer, Eli Lilly and Gilead, accusing the companies of using nurse educators as kickbacks to entice doctors to prescribe their meds.
But, after having investigated the claims for more than 1,500 hours, the government said in motions to dismiss that the allegations “lack sufficient merit to justify the cost of investigation and prosecution,” adding that further litigation would be “contrary to the public interest.”
In its motions, the government laid out some background around the National Healthcare Analysis Group and a series of shell companies formed to file the lawsuits.
NHCA, which claims to be a healthcare research company with “no particular bias” about the industry, in fact seeks profit from its lawsuits against drugmakers, the government says.
Its strategy, the government says, includes using public sources to compile a database of resumes to find “potential informants” for its lawsuits. With that info, it reached out to those professionals “under the guise of conducting a ‘qualitative research study’ of the pharmaceutical industry” and paid the participants.
With knowledge from those interviews, NHCA advanced “sweeping allegations of nationwide misconduct by thirty-eight different defendants.” The government said its own research found the allegations don’t merit further litigation.
Humana upgraded to Overweight from Neutral at JPMorgan
Humana upgraded to Overweight from Neutral at JPMorgan. JPMorgan analyst Gary Taylor upgraded to Overweight while lowering his price target for the shares to $333 from $354.
https://thefly.com/landingPageNews.php?id=2839665
Survey shows ‘solid fundamentals’ for Biogen MS franchise, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Biogen (BIIB) with a $400 price target after surveying 100 neurologists. The survey feedback shows “solid fundamentals” for the company’s multiple sclerosis portfolio, Raymond tells investors in a research note. He admits, however, that many investors are preoccupied with Tecfidera’s intellectual property situation. Nonetheless, neurologists reported meaningful share gains for Tecfidera and Tysabri this quarter, says the analyst. Raymond believes worries over the impact to Biogen’s multiple sclerosis franchise from Roche’s (RHHBY) Ocrevus launch “may be behind us.”
https://thefly.com/landingPageNews.php?id=2839671
Chi-Med amends License & Collaboration Agreement with Eli Lilly
Hutchison China MediTech (HCM) announces certain amendments to the 2013 License and Collaboration Agreement on fruquintinib with Lilly Shanghai an affiliate of Eli Lilly (LLY). The 2018 Amendment covers adjustments in the respective roles and responsibilities of Chi-Med and Lilly, in China, for the development and commercialization of fruquintinib in the areas of future life cycle planning and development, collaborations for co-development of fruquintinib with other third-party anti-cancer agents as well as promotion and distribution rights of fruquintinib. Under the terms of the 2013 Agreement, decision making on LCI development beyond the initial indications of third-line colorectal cancer, or CRC, third-line non-small cell lung cancer, or NSCLC, and second-line gastric cancer was controlled by Lilly. The majority of development costs for LCIs were to be paid by Lilly, with the minority by Chi-Med. The 2018 Amendment now gives Chi-Med all planning, execution and decision making responsibilities for LCI development on fruquintinib in China. Chi-Med will pay all of the costs associated with fruquintinib LCI development in China. In return for this investment of capital and resources, Lilly will pay Chi-Med a $20 million milestone upon approval of each fruquintinib LCI in China, for up to three LCIs, totaling up to $60 million in LCI approval milestone payments. Furthermore, upon the launch of the first LCI, the tiered royalty structure, payable by Lilly to Chi-Med on total molecule sales in China, has been raised from the range of 15-20% in the 2013 Agreement to a new level of 15-29% under the 2018 Amendment. Under the terms of the 2013 Agreement, Lilly held full commercialization rights to fruquintinib in China. The 2018 Amendment provides Chi-Med the right to promote fruquintinib in provinces that represent 30% of the sales of fruquintinib in China upon the occurrence of certain commercial milestones. The Chi-Med Territory will expand to provinces that represent 40% of the sales of fruquintinib in China subject to additional criteria being met. Lilly will pay Chi-Med a fee for service to conduct all promotional activities in the Chi-Med Territory. Lilly has provided consent, and freedom to operate, for Chi-Med to enter into joint development collaborations with certain third-party pharmaceutical companies to explore combination treatments of fruquintinib and various immunotherapy agents. The first such collaborations with Innovent Biologics and Genor Biopharma will explore the combination of fruquintinib and their respective programmed cell death protein-1 antibodies, sintilimab and genolimzumab, in several solid tumor settings.
https://thefly.com/landingPageNews.php?id=2839675
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