Eli Lilly dishes out first milestone payment for Alzheimer's deal; ADC Therapeutics, Viela Bio set terms for IPO
→ With others shying away from the Alzheimer’s field after the many clinical implosions and disasters, Eli Lilly is still chugging along with its $2 billion deal with AC Immune — despite its share of BACE woes. AC Immune is set to receive its first milestone payment of CHF30 million, almost a year after the deal was inked. The company said that the payment “is a recognition of progress in the collaboration between the two companies and follows initiation in July 2019 of the Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer in development for treatment of Alzheimer’s disease (AD) and other neurodegenerative disorders.” A second milestone payment of the same amount is scheduled for Q1 of 2020.
→ After signing a pact with Freenome and closing a monster $303 million E round in the last few months, ADC Therapeutics set terms for its IPO on Monday. The Swiss company plans to offer 8.2 million shares at a price range of $23 to $26 to raise $200 million. Insiders intend to purchase $115 million worth of shares in the offering. At the midpoint of the proposed range, ADC would command a market value of $1.8 billion.
→ AstraZeneca spinout Viela Bio has closed in on the price range of its IPO, disclosing that it plans to offer 7.5 million shares between $19 and $21 each. At the top of the range, the biotech will bring in $157.5 million to bankroll the development and commercialization of its lead autoimmune drug, inebilizumab. The fully diluted market value (at the midpoint) could reach $1 billion.
→ Israeli-based Entera Bio has released positive data for its oral parathyroid hormone (PTH) drug Oral hPTH(1-34) from its Phase II study in patients with hypoparathyroidism. Having tested four times daily (QID) dosing in a previous study, the company wanted to also compare twice daily (BID) and three times daily (TID) regimens and dose strengths.
“The results showed that the largest changes in PD endpoints were found with QID dosing, with moderate changes in PD endpoints generally found with BID and TID dosing,” stated Professor Sofia Ish-Shalom, a principal investigator at the Endocrine Research Center at Lin Medical Center in Haifa, Israel. “In addition, the QID dosing decreased urine calcium over 24-hours, which indicates that it may be able to reduce urinary calcium in hypoparathyroid patients with hypercalciuria during long-term treatment.”
→ In June, teplizumab (PRV-031) — which was rejected by Eli Lilly 9 years ago, but picked up by Provention Bio — was shown to delay type 1 diabetes. Now, Provention announced that “based on written communications from the FDA and the FDA’s designation of PRV-031 as a breakthrough therapy, the Company believes that existing clinical and non-clinical data for PRV-031 will be sufficient to support a Biologics License Application (BLA) submission for PRV-031 in the fourth quarter of 2020 for the at-risk indication.” The New Jersey-based company expects to meet with the FDA in the fourth quarter of 2019 to discuss this expedited plan.