Friday, January 18, 2019
Allscripts upgraded to Overweight from Sector Weight at KeyBanc
KeyBanc analyst Donald Hooker upgraded Allscripts to Overweight with a $15 price target following the company’s divestiture of Netsmart. In a research note to investors, Hooker says he sees material upside in the company’s share price if Allscripts can show any acceleration of growth in 2019 or 2020.
https://thefly.com/landingPageNews.php?id=2850913
SunTrust Robinson Humphrey Assumes La Jolla Pharma (LJPC) at Buy
SunTrust Robinson Humphrey analyst Joon Lee assumes coverage on La Jolla Pharma (NASDAQ: LJPC) with a Buy rating
Lilly stops promoting cancer drug after shock trial failure
Shares in Eli Lilly were down in early trading after the US drugmaker said its cancer drug Lartruvo failed to meet main survival goals in a late stage trial, prompting the company to stop promoting the already-marketed medicine.
Lartruvo (olaratumab) is already approved in the US for advanced soft tissue sarcoma – but only from data from a smaller trial under the FDA’s accelerated approval scheme for badly-needed drugs.
The company needed the data from the ANNOUNCE study to confirm that it worked in a larger group of patients.
Unfortunately the expected results did not materialise: Lilly said Lartuvo in combination with chemotherapy had missed survival endpoints in the trial using chemotherapy alone as a comparator, in patients with advanced or metastatic soft tissue sarcoma.
Lilly needed the drug to improve overall survival in the fully study population and in a group of patients with leiomyosarcoma for the trial to be considered a success.
But initial results show there was no difference in survival between the study arms for either population.
There were however no new safety signals identified and the safety profile was comparable between treatment arms.
Lilly said that as ANNOUNCE did not confirm clinical benefit, it is working with the FDA and other regulators including the European Medicines Agency to decide “appropriate next steps” for Lartruvo.
Lartruvo in combination with doxorubicin previously showed an overall survival benefit in STS in a 133-patient, US-only, randomised phase 2 trial, which led to accelerated approval by the FDA in 2016 and a conditional marketing authorisation by the European Medicines Agency.
While these discussions are ongoing, patients receiving the drug may still receive it if they are experiencing a clinical benefit, in consultation with their doctor.
However Lilly will cease promoting Lartruvo, which generated sales of $77 million in Q3.
Lilly expects to incur a charge in the first quarter of 2019 as a result. The exact amount of the charge has not yet been determined, but is estimated to be in the range of $70 million to $90 million before tax, or around $0.10 per share after tax.
Lilly forecast this to have an impact of approximately $0.17 per share on Lilly’s full-year 2019 earnings per share guidance.
Lartruvo is also being studied in an ongoing global, randomised, double-blind, placebo-controlled Phase 2 trial in advanced STS in combination with gemcitabine and docetaxel.
The company will provide a further update in upcoming Q4 and full year results, as well as further information about its recent acquisition of cancer drugs firm Loxo.
Thursday, January 17, 2019
Accelerate Diagnostics prelim 2018 fourth quarter and full-year financials
Accelerate Diagnostics, Inc. (NASDAQ: AXDX), announced preliminary financial results for the quarter ending December 31, 2018. The company reported a 127.2% increase in U.S.instruments placed under commercial contract during the fourth quarter, and full-year revenue of $5.7 million, an increase of 35.7% from the prior year (see also Accelerate Diagnostics Inc.).
Regeneron to Study Efficacy, Safety of Dupilumab in Pediatric Peanut Allergy
Newly launched clinical trial, NCT03793608, has the following summary description: “The primary objective of the study is to assess whether dupilumab as compared to placebo improves peanut protein tolerability, defined as an increase in the proportion of patients who safely pass a double-blind placebo controlled food challenge (DBPCFC) at week 24. The secondary objectives are: – To determine whether dupilumab treatment compared to placebo improves peanut tolerability, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC – To evaluate the safety and tolerability of dupilumab treatment compared to placebo in peanut allergic patients – To evaluate the effects of treatment (dupilumab vs placebo) on the levels of peanut-specific Immunoglobulin E (IgE) – To evaluate the treatment effect of dupilumab vs. placebo on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations – To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time”
Bavarian Nordic $44M Fed Option for Smallpox Vax to be Exercised
Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA) have exercised another option under the ongoing contract for freeze-dried MVA-BN® smallpox vaccine.
The option, valued at USD 44 million, will cover qualification of the new fill-finish facility, currently being established at the Company’s manufacturing site in Denmark, as well as transfer and validation of the freeze-drying process. The majority of this contract option is expected to be revenue recognised in 2019 and 2020.
This is the second option exercised under the contract. In 2017, BARDA exercised an option of USD 37 million to cover development costs associated with the Phase 3 study required for the eventual approval of the freeze-dried MVA-BN smallpox vaccine. This Phase 3 will be initiated in the first half of 2019.
“We are well underway in the establishment of our new fill-finish facility, which will not only unlock the full value of our smallpox vaccine contracts with the U.S. Government, but will also strengthen the commercial foundation of our company in the future as we become a fully-fledged vaccine manufacturer. The option awarded today will support the final stages of bringing the facility into operations, and we look forward to continuing our successful partnership with BARDA in the development and production of biological countermeasures to protect the U.S. population, ” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
Sun Pharma hit on report of fresh allegations by whistleblower
Shares of India’s Sun Pharmaceutical Industries Ltd slumped over 13 percent on Friday to near six-year low, after a media report of a complaint by a whistleblower raised fresh concerns on the drugmaker’s corporate governance.
The complaint, sent to the capital market regulator Securities and Exchange Board of India (SEBI), is the second in over a month, according to the report by Moneylife magazine.
The whistleblower complaint alleges that an Indian pharmaceutical manufacturer Aditya Medisales Ltd had transactions with Suraksha Realty, controlled by Sun Pharma’s co-promoter, Sudhir Valia, the report stated.
The transactions took place between 2014 and 2017, and were worth over 58 billion rupees ($814.65 million), it added.
A whistleblower had approached SEBI late last year with a document alleging various irregularities by Sun Pharma, its promoter Dilip Shanghvi and others.
Sun Pharma did not immediately respond to a Reuters request seeking comment.
Shares of the country’s largest drugmaker by market value recorded their biggest intra-day percentage drop since May 29, 2017.
Over 31.4 million shares changed hands as of 0453 GMT, around 2.7 times Sun’s 30-day trading volume average of 11.7 million shares.
Earlier this month, Sun Pharma had recalled muscle relaxtant vecuronium bromide for injection due to the presence of glass.
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