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Wednesday, August 22, 2018

Evotec and Novo Nordisk Ink Deal to Develop Drugs for Obesity and Diabetes


Months after partnering with Sanofi on infectious diseases, Germany-based Evotec has formed another significant partnership with Novo Nordisk. The two companies will combine their forces to develop treatments for diabetes, nonalcoholic steatohepatitis (NASH) and other diseases.
Evotec said it will apply its ligand-based drug discovery design program to select “safe and efficacious products” that can then be used to address diabetes and associated morbidities. When the preclinical candidates are selected, Danish drugmaker Novo Nordisk will use the German company’s INDiGo platform to take those preclinical candidates into the clinic.
Evotec Chief Operating Officer Mario Polywka said Novo Nordisk has a successful track record and proven leadership in developing treatments for diabetes and obesity.
“The integration of our industry-leading discovery and development platform with Novo Nordisk’s deep disease expertise will create a powerful combination that we hope will create a difference for patients with diabetes or obesity. We very much look forward to working with such an innovative partner,” Polywka said in a statement.
Marcus Schindler, head of global drug discovery at Novo Nordisk, touted Evotec’s work in small molecules. Schindler added that Novo is excited to work with Evotec on this endeavor.
“Novo Nordisk is confident that this will open up new possibilities in small molecule drug discovery and development targeting diabetes and obesity with the potential to make a difference for people living with these serious diseases,” Schindler said in a statement.
Novo has made some headway in its developmental efforts to treat diabetes and NASH. Earlier this week Novo reported that its diabetes drug Ozempic (semaglutide) hit the mark in a Phase II trial in the reduction of blood sugar levels and weight in adult patients with type 2 diabetes. Ozempic was approved by the FDA in December 2017 and was launched for commercialization in the U.S. in February as a treatment for type 2 diabetes. Also this week, Novo acquired Bristol, UK-based Ziylo and its glucose binding molecule platform, which will be used to develop glucose-responsive insulins.
In May the Danish company licensed an experimental chronic kidney disease (CKD) and diabetic kidney disease (DKD) treatment from San Diego-based Epigen Biosciences. The LPA1 receptor antagonist EPGN696 has shown preclinical efficacy in rodent models of kidney disease by targeting fibrosis, inflammation and growth factor responses.
Evotec has also made some strategic moves. In June the company signed off on the anti-infectives agreement with Sanofi. The French company licensed more than 10 infectious disease R&D assets, which include those in early-stage developmental programs, to Evotec in March. The German company plans to take the development lead using an open innovation platform at a facility in Lyons, France.
Evotec also has a long-running partnership with Celgene. The two companies inked a five-year neurodegeneration drug discovery and development deal in 2016.
Evotec did not disclose any financial details of the agreement with Novo Nordisk.

Mallinckrodt receives complete response letter from FDA for NDA of stannsoporfin

https://bit.ly/2BE5Xik

Sierra Oncology acquires drug candidate momelotinib from Gilead Sciences


Sierra Oncology (SRRA) announced it has acquired the drug candidate momelotinib from Gilead Sciences (GILD). Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control. Sierra will pay Gilead a $3M upfront fee for momelotinib and potential aggregate milestone payments of up to $195M, which are largely associated with commercial sales of the drug. Sierra will also pay Gilead royalties on any sales of momelotinib, which will be tiered based on commercial success and range from mid-teens to high-twenties. Sierra will assume all currently ongoing clinical studies with momelotinib following a transition period.

Medtronic price target raised to $104 from $95 at RBC Capital


RBC Capital analyst Glenn Novarro raised his price target on Medtronic to $104 and kept his Outperform rating, saying the company’s last 3 quarters have been more consistent while its growth rate is “approaching that of its faster growing peers”. The analyst states that there is room for more multiple expansion for Medtronic in spite of the stock’s 19% year-to-date rally, forecasting “beat-and-raise” results for the rest of FY19. Novarro raises his FY19 EPS view to $5.15 from $5.12 but also lowers his revenue view to $30.4B from $30.6B to reflect a $380M increase in expected FX headwinds from his prior estimate.

Neurocrine could rally $15 on positive Tourette’s data, says Jefferies


Jefferies analyst Biren Amin believes shares of Neurocrine Biosciences could rally $10-$15 on the year-end readout for the Phase IIb T-Force Gold study in pediatric Tourette’s syndrome. The analyst’s work indicates that a Yale Global Tic Severity Scale score reduction of 25%-30%, or seven-to-ten patients, over placebo would likely be considered clinically meaningful by doctors. Positive data within or above this range could see shares trade up by up to $15, while a near miss could send the stock down by $8-$10, Amin tells investors in a research note. He keeps a Buy rating on Neurocrine with a $131 price target.

Pfizer to host conference call


Analyst and Investor Call to review Tafamidis data presentation at European Society of Cardiology Congress 2018 will be held on August 27 at 9 am.  Weblink: https://www.webcaster4.com/Webcast/Page/748/27069

AbbVie decision suggests positive Argenx data, says Piper Jaffray


AbbVie’s (ABBV) decision to exercise an exclusive option to license Argenx’s (ARGX) anti-GARP antibody, ARGX-115, suggests positive preclinical data, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. The analyst looks for investigational new drug application filing plans this year. He reiterates an Overweight rating on shares of Argenx with a $130 price target.