OrthoPediatrics launches spine deformity device in U.S.

OrthoPediatrics (KIDS +0.6%) announces the U.S. commercial launch of the ApiFix Minimally Invasive Deformity Correction system for the treatment of progressive adolescent idiopathic (cause unknown) scoliosis (curvature of the spine).

The company secured the rights to the device via its acquisition of ApiFix in April.

https://seekingalpha.com/news/3581956-orthopediatrics-launches-spine-deformity-device-in-u-s

States go after generic drugmakers for alleged price-fixing

A coalition of 51 attorneys general in the U.S. has filed an antitrust complaint in federal court against 26 companies making generic dermatology drugs and 10 executives at these firms claiming wide-spread price-fixing, marketing allocating and bid-rigging related to over 80 different products.

Companies named in the complaint include Novartis (NVS -0.1%) unit Sandoz, Teva Pharmaceutical Industries (TEVA -3.8%), Pfizer’s (PFE -0.6%) Upjohn unit, Mylan (MYL -3.4%), Perrigo (PRGO -2.9%) and Taro Pharmaceutical Industries (TARO -1.7%).

Related tickers: Aclaris Therapeutics (ACRS -4.4%), Akorn (AKRX), Amphastar Pharmaceuticals (AMPH -2.2%), Amneal Pharmaceuticals (AMRX -8.0%), Bausch Health Companies (BHC -3.1%), Coherus Biosciences (CHRS -2.6%), Collegium Pharmaceutical (COLL -1.4%), Eagle Pharmaceuticals (EGRX -1.2%), Endo International (ENDP -5.1%), Lannett Company (LCI -4.4%), Mallinckrodt (MNK -5.0%), Dr. Reddy’s Laboratories (RDY -0.8%)

https://seekingalpha.com/news/3581977-states-go-after-generic-drugmakers-for-alleged-price-fixing

Three key studies of COVID-19 vaccines to launch in summer

The WSJ reports that the federal government (National Institutes of Health) plans to fund and conduct pivotal studies of three COVID-19 vaccine candidates starting this summer.

The large-scale trials will test Moderna’s (MRNA +3.8%) mRNA-1273 starting next month, Oxford University and AstraZeneca’s (AZN +2.2%) AZD1222 in August and Johnson & Johnson’s (JNJ +1.4%) Ad26.COV2-S in September. Each is projected to enroll ~30K people.

Pfizer (PFE -0.4%), which is not participating in the NIH testing program, together with collaboration partner BioNTech SE (BNTX -0.8%), plans to launch a Phase 3 study on its candidate, BNT162, as early as next month (four variants of the vaccine are currently being tested).

The feds may include additional large-scale studies of other vaccine candidates, such as those being developed by Sanofi (SNY +0.9%) and Merck (MRK -1.1%) according Dr. Larry Corey, a member of the committee advising NIH on the design of the trials.

https://seekingalpha.com/news/3581971-three-key-studies-of-covidminus-19-vaccines-to-launch-in-summer

Endo International under pressure on NY insurance fraud charges

Endo International (ENDP -12.5%) already under pressure from the large-scale antitrust complaint over alleged price-fixing among generic drugmakers, takes another shot related to its role in the opioid epidemic.

The New York State Department of Financial Services (DFS) has filed charges against the company accusing it of misrepresenting the safety and efficacy of its opioid pain medicines while minimizing the risk of addiction and other deleterious effects.

DFS claims that Endo made 18.4% of the opioids that were distributed in the state from 2006 – 2014.

The company faces penalties of $5,000 plus the amount of the fraudulent claim for each violation under one statute (each prescription considered a violation) and $5,000 per violation under another (also on a per-prescription basis).

A hearing is scheduled for October 26.

https://seekingalpha.com/news/3582055-endo-international-under-pressure-on-ny-insurance-fraud-charges

Lilly’s baricitinib shows sustained benefit in rheumatoid arthritis study

Eli Lilly (LLY +1.3%) announces positive long-term data from a study evaluating Olumiant (baricitinib) in patients with moderate-to-severe rheumatoid arthritis (RA) who were treated for three years. The results were virtually presented at EULAR.

52% of patients who failed to respond adequately to methotrexate who responded to Olumiant therapy by week 24 maintained their responses through week 148.

No new safety signals were reported from 3,770 patients treated with Olumiant for up to 8.4 years.

The FDA approved the JAK inhibitor for RA in June 2018.

https://seekingalpha.com/news/3582063-lillys-baricitinib-shows-sustained-benefit-in-rheumatoid-arthritis-study

Lilly’s COVID-19 treatment maybe available as soon as September

Eli Lilly (NYSE:LLY) Chief Scientific Officer Daniel Skovronsky says the company has human trials underway with two antibody therapies. If things go well in August and September – with folks under treatment not having to move into hospitalization – it could lead to emergency use authorization, he says.

“September, October, November is not unreasonable.”

Lilly also has a third antibody treatment under study that could soon move to human trials.

https://seekingalpha.com/news/3582085-lillys-covidminus-19-treatment-maybe-available-soon-september

AbbVie teams up with Genmab in cancer

AbbVie (NYSE:ABBV) and Genmab A/S (NASDAQ:GMAB) have signed a broad collaboration agreement to jointly develop and commercialize three of Genmab’s bispecific antibodies and enter into a discovery research collaboration for future antibody therapeutics for cancer.

The companies will partner to develop Genmab’s next-generation bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4.

Under discovery research collaboration, the companies will develop up to four additional differentiated next-generation antibody-based product candidates across solid tumors and hematological malignancies.

Both the companies will share commercial responsibilities in U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab will book net sales in U.S. and Japan and receive tiered royalties on remaining global sales.

For the discovery research partnership, Genmab will conduct Phase 1 studies for these programs.

Under the terms of the agreement, AbbVie will pay Genmab $750M in upfront payment with total potential milestone payments of up to $3.15B as well as tiered royalties between 22% and 26% on net sales for epcoritamab outside U.S. and Japan.

https://seekingalpha.com/news/3581807-abbvie-teams-up-genmab-in-cancer