Making progress

 

PASADENA, Calif.—The beginning of August saw Arrowhead Pharmaceuticals Inc. report that it had earned a $10-million milestone payment from Amgen following the administration of the first dose of AMG 890, formerly referred to as ARO-LPA, in a clinical study. Amgen is evaluating AMG 890 in a Phase 1 clinical study designed to assess its safety in volunteers with elevated levels of lipoprotein (a), or Lp(a). Emerging research has shown that elevated levels of Lp(a) are strongly associated with cardiovascular disease. AMG 890 is an RNAi therapeutic designed to lower Lp(a) for the treatment of cardiovascular disease.

 

“Amgen has extensive expertise in developing and commercializing innovative cardiovascular medicines, and we view our collaboration as further validation of the potential for Arrowhead’s proprietary Targeted RNAi Molecule, or TRiM, technology platform to generate compelling product candidates,” said Dr. Chris Anzalone, president and CEO of Arrowhead. “Importantly, AMG 890 represents the third drug candidate enabled by TRiM to enter clinical development this year, following ARO-AAT and ARO-HBV.”

 

Under the terms of the two cardiovascular agreements announced in September 2016, Arrowhead is eligible to receive up to $617 million in option payments, and development, regulatory and sales milestone payments. Arrowhead is further eligible to receive up to low double-digit royalties for sales of products under the AMG 890 agreement and single-digit royalties for sales of products against an undisclosed target.

 

 

CAMBRIDGE, U.K.—F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies (mAb²), announced recently that FS118 has successfully reached its first clinical milestone. FS118 is a first-in-class antagonist mAb² which simultaneously targets the LAG-3 and PD-L1 immuno-suppressive pathways and which has the potential to overcome tumor resistance and restore the natural anticancer immune response. In May, FS118 entered into a Phase 1 study in patients with advanced malignancies that have progressed on PD-1/PD-L1 therapy.

 

“Achieving this clinical milestone is a significant step in our alliance with Merck,” noted John Haurum, CEO of F-star. “FS118 is uniquely positioned as a first-in-class treatment for cancer patients. We are pleased with the progress being made and look forward to advancing our next mAb² molecules into the clinic.”

 

Under the collaboration, which was announced in June 2017, Merck has an exclusive option to acquire FS118 and a further four early-stage immuno-oncology bispecific antibody programs which are under discovery and development by F-star. Further payments are contingent on option exercise and achievement of clinical and commercial milestones, with a potential total deal value reaching over €1 billion.

 

 

PAOLI, Pa. & SHANXI, China—May 30 saw Sedor Pharmaceuticals LLC and Xi’an Xintong Pharmaceutical Research Co. Ltd. announce that Xintong has provided Sedor with a milestone payment pursuant to the license agreement that grants Xintong exclusive rights within the People’s Republic of China (PRC) for Sedor’s lead program, Captisol-enabled (CE) Fosphenytoin. This milestone payment is the result of Sedor submitting an New Drug Application with the U.S. Food and Drug Administration (FDA) seeking approval of IM/IV CE-Fosphenytoin for the treatment of patients that are at risk for status epilepticus seizures or to prevent/control status epilepticus seizures that occur during or following neurosurgery or neurologic trauma.

 

Xintong secured the exclusive right to develop and commercialize Sedor’s CE-Fosphenytoin within the PRC in June 2017. Under the terms of the agreement, Xintong is responsible for all costs related to the development and commercialization of IM/IV CE-Fosphenytoin in the PRC.

 

Status epilepticus are single epileptic seizures lasting more than five minutes, or two or more seizures within a five-minute period. Importantly, status epilepticus seizures can create irreversible neurologic damage or death if not treated in a short time window.

 

“We are very pleased to be partnering with Sedor in the PRC on its lead program, CE-Fosphenytoin. Sedor executives have three decades of expertise with biologics and pharmaceuticals, and a track record of success in bringing development-stage programs through the approval and commercialization process in order to benefit patients and providers,” noted Zhang Dengke, CEO of Xintong. “We look forward to working with Sedor to secure the regulatory approvals that are needed to make IM/IV CE-Fosphenytoin available in the PRC.”

 

 

SOUTH SAN FRANCISCO, Calif.—Portola Pharmaceuticals Inc. recently announced that the company had received a $100-million milestone payment from HealthCare Royalty Partners (HCR) following the FDA approval of Andexxa [coagulation Factor Xa (recombinant), inactivated-zhzo] on May 3.

 

In February 2017, Portola entered into a $150-million royalty agreement with HCR in exchange for a tiered, mid-single-digit royalty based on worldwide sales of Andexxa. Portola received $50 million at closing, with an additional $100-million payment contingent upon the FDA approval of Andexxa. The agreement is subject to a maximum total royalty payment of 195 percent of the $150 million funded by HCR, at which time the royalty obligation will expire.

 

“Our partnership with HCR provides us with non-dilutive capital to fund the further development and commercialization of Andexxa,” said Bill Lis, CEO of Portola. “We appreciate HCR’s support during this pivotal time in the company’s evolution and their recognition of the lifesaving potential of Andexxa as a reversal agent for Factor Xa inhibitor-related bleeding.”

 

 

BALLERUP, Denmark—Saniona, a biotech company pursuing ion-channel research, recently announced that Boehringer Ingelheim has selected the first candidate for preclinical and clinical development under the companies' collaboration in schizophrenia. Saniona will receive a research milestone of €4 million as a result of the candidate selection by Boehringer Ingelheim.

 

The partners entered into a drug discovery and development collaboration in 2016. The collaboration focuses on research of new small-molecule therapeutics that could be capable of restoring brain network activity in patients with schizophrenia.

 

Saniona may receive up to €90 million in milestone payments, including an upfront payment of €5 million that was paid upon signing of the agreement. The milestone payments include up to €50 million upon the achievement of certain research, development and regulatory milestones and up to €35 million in commercial milestones. In addition, Saniona is entitled to tiered royalties on net sales of any potential products commercialized by Boehringer Ingelheim as a result of this collaboration. Following the above milestone payment of €4 million, Saniona will have received a total of €9 million under the collaboration.