Ligand reports planned acquisition of Pfenex

Ligand Pharmaceuticals Inc. (LGND) announced that it has inked a definitive agreement with Pfenex Inc. (PFNX) for acquiring the latter. The companies expect the transaction to be closed in the fourth quarter of 2020, subject to required regulatory approvals. Ligand is expected to provide a detailed outlook for the Pfenex business after the closure of the transaction.

The terms of the agreement states that Ligand will come up with a tender offer to acquire all the outstanding shares of Pfenex Inc. The stock of the latter has been priced at $12 apiece, totaling to $438 million in cash upfront. The shares have been valued at 57 percent premium to their closing price on August 10, 2020. Ligand will also be responsible for the payment of $2 per share, or $78 million, to Pfenex shareholders as a Contingent Value Right. The CVRs will be actionable if a predefined regulatory milestone is achieved by December 31, 2021.

Pfenex is a development and licensing biotechnology company. The company widely uses its proprietary Pfenex Expression Technology® for developing therapies. This technology is ideal for complex, large-scale protein production which is not amenable to traditional production techniques. The company uses this technology for in-house purposes and has also out-licensed it.

Ligand has presented a strong case for this acquisition. The company expects that it will be able to draw benefits from Pfenex’s protein expression technology. Further, the company believes that the acquisition will be accretive in terms of profitability and cash flows beginning in 2021. Pfenex also has various collaborations with major pharma companies, such as Jazz Pharmaceuticals (JAZZ), Merck (MRK) and Serum Institute of India. These collaborations will also help Ligand in boosting its portfolio.

The company will also use Pfenex’s process development operations located in San Diego with top-notch engineering capabilities and scalable equipment. John Higgins, Chief Executive Officer of Ligand, said, “Pfenex is an ideal strategic, business and cultural fit with Ligand. The acquisition holds potential to have a significantly positive scientific and financial impact on our business in the short and long term, similar to how our Captisol and OmniAb acquisitions have played out.”

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Ligand also provided financial outlook for the transaction. While the transaction will be mildly dilutive to 2020 adjusted diluted EPS, it will offer $0.10-0.30 of adjusted diluted EPS accretion in 2021. It will also offer significant annual adjusted diluted EPS accretion thereafter. It is estimated that the accretion will be $0.60-0.80 in 2022 and $1.25-1.50 in 2023.

Teriparatide injection is a lead product of Pfenex. It is a therapeutic equivalent candidate to Forteo® and was previously known as PF708 and Bonsity™. Pfenex has 88 employees, 24 U.S. patents, 16 active partnerships and 10 products available for partnering.

Ligand is a biopharmaceutical company and is focused on developing or acquiring technologies which aid pharmaceutical companies in developing their products. It mainly collaborates with other pharma companies for leveraging the processes and drawing synergies. The company’s OmniAb® technology platform is a patent-protected transgenic animal platform and is used for discovering fully human mono- and bispecific therapeutic antibodies.

Precigen ActoBio reports positive data from Type 1 diabetes study

Precigen, Inc. (PGEN) announced positive top line results for the Phase 1b monotherapy portion of the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics™. The company stated that the results demonstrated that the drug candidate was able to meet the primary endpoint of safety and tolerability for treating early-onset type 1 diabetes.

The Phase 1b trial is an open-label portion of the study. It is designed to assess the safety and tolerability of AG019 administered as a single dose and repeated daily doses as a monotherapy in adult and adolescent patients. Pieter Rottiers, PhD, CEO of Precigen ActoBio, said, “These preliminary data for the Phase 1b monotherapy portion of the study are very promising. In particular, the encouraging trend we are seeing in C-peptide levels indicates potential treatment-related disease modification over time.” Precigen ActoBio is a wholly owned subsidiary of Precigen Inc.

The study met its primary endpoint demonstrating safety and tolerability. None of the patients had to discontinue treatment, and no serious or severe TEAEs were reported in treatment cohort. Eight-week treatment with the drug candidate was found to be safe and well-tolerated in daily dosages up to 6 x 1011 CFU in adult and adolescent patients suffering from T1D.

The safety profile of the drug candidate was further bolstered when there was no evidence for systemic exposure of bacteria and proteins (hPINS/hIL-10) in the circulation. The analysis of fecal samples confirmed gastrointestinal exposure of AG019 in most treated patients. The data collected from the preliminary analysis carried out by the Immune Tolerance Network showed that there was increase in the frequency of islet-specific Tregs expressing inhibitory receptors for patients three months after the start of the treatment.

Arrowhead initiates RNAi-based cystic fibrosis study

Arrowhead Pharmaceuticals Inc. (ARWR) announced the dosing of its first patient in its AROENaC1001 trial. The trial aims to test ARO-ENaC for treating patients suffering from cystic fibrosis. The company has used its proprietary Targeted RNAi Molecule (TRiM™) platform for developing this drug candidate. It is also the company’s first inhaled RNAi candidate aimed at pulmonary epithelium.

AROENaC1001 is a Phase 1/2 dose-escalating study. It is designed to assess the safety, tolerability, and pharmacokinetic effects of ARO-ENaC. The trial has enrolled up to 24 normal healthy participants. It will also assess the safety, tolerability, and efficacy in up to 30 patients with CF.

Exploratory objectives pertaining CF patients will include assessment of the impact of the drug candidate on changes in lung clearance index and forced expiratory volume. Javier San Martin, M.D., chief medical officer at Arrowhead, said, “We believe ENaC, or epithelial sodium channel, is a target with great potential for many CF patients that may not be eligible for existing therapies due to their specific genotypes, commonly called class I patients, and for those that have an inadequate response to therapy.”

ARO-ENaC works by reducing activity of the epithelial sodium channel alpha subunit in the airways of the lung. In patients suffering from CF, elevated ENaC activity is caused by dysfunction of the cystic fibrosis transmembrane conductance regulator. So far, the development of inhaled small molecule ENaC inhibitors has been marred by various factors, including short duration of action in the lung and on-target renal toxicity.

Arrowhead is mainly engaged in the development of various treatments using gene silencing techniques. It also uses RNAi mechanism, which regulates the expression of a specific gene and thereby impacts the production of a specific protein.

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