Sangamo And Biogen Tie Up, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

Sangamo Closes Gene Collaboration with Biogen

Sangamo Therapeutics (SGMO) reported that it has finalized its sale of stock to Biogen (BIIB), leading to the formal initiation of its global licensing collaboration with latter. The collaboration pertains to gene regulation therapies in neurology and their development and commercialization. These therapies are targeted towards ailments such as Parkinsons, Alzheimers, neurological and neuromuscular diseases.

Under the terms and conditions of the collaboration, Sangamo has received $225 million in funds and is entitled to receive further upfront license fee of $125 million. The latter payment will be due no later than May 8, 2020. Sanagmo also stands to earn up to $2.37 billion in different commercial, regulatory and development milestone payments. This sum includes up to $1.445 billion in first commercial sale and other sales related milestone payments and up to $925 million in pre-approval milestone payments. Apart from these payouts, Sangamo is also entitled to receive staggered high single-digit to sub-teen double-digit royalties on sales of products coming out of this collaboration.

Sangamo stated that the collaboration is a testimony to its commitment to grow by pooling resources with its peers for mutual benefit. Sandy Macrae, Sangamos CEO, said, "Importantly, with the addition of the upfront consideration from this agreement, we believe we have the balance sheet strength to execute on our wholly owned and partnered development programs through multiple important milestones, including the potential filing of the BLA for SB-525 for hemophilia A." Sangamo is mainly involved in developing gene therapies, gene regulation and genome editing.

The deal was initially announced in February 2020. Both the companies intend to leverage their unique expertise to come up with therapies for neurodegenerative diseases. Under this collaboration, Biogen has exclusive global rights to ST 501, ST 502 and one another undisclosed neuromuscular disease target. ST 501 is aimed at Alzheimers disease while ST-502 is designed to treat synucleinopathies including Parkinsons disease.

Biogen has a strong presence in neurological market. It is looking to file a Biologic License Application to the FDA with regard to its lead drug candidate Aducanumab. The company is working towards fortifying its product portfolio to include therapies for various neurological conditions including Alzheimers.

Under this collaboration, Sangamo will be responsible for carrying out initial research activities and the costs will be shared by both the companies. On the other hand, Biogen will have the exclusive rights to nominate up to nine additional undisclosed targets over a target selection period of five years. The therapies to be developed under this program will be the combination of proprietary CNS delivery vectors and ZFP-TFs targeting therapeutically relevant genes. Sangamo will also be entrusted with the responsibility of carrying out GMP manufacturing activities for the initial clinical trials for the first three products of the collaboration. Beyond these first three products, the GMP manufacturing responsibilities will fall on Biogen. Sangamo plans to leverage its in-house capacities for this purpose.

Apart from this deal, Sangamo has several other collaborations going on to harness its expertise in niche areas. Some of its most prominent collaborators are Pfizer (NYSE:PFE), Gilead Sciences (NASDAQ:GILD) and Sanofi (NASDAQ:SNY). This deal is expected to be highly accretive to the company should these partners succeed in achieving their targets. The main aim of this partnership is to work on gene regulation which allows the manipulation of how much of a gene is expressed.

AstraZeneca Plc (AZN) reported that the FDA has given its go ahead to the use of Koselugo, or selumetinib, to treat certain pediatric patients with neurofibromatosis type 1. The drug is approved specifically for patients who suffer from symptomatic and inoperable plexiform neurofibromas, the tumors which involve the nerve sheaths or the coating around nerve fibers. These tumors can grow anywhere in the body.

Selumetinib is now the first and only FDA approved treatment for NF1, which is a nervous system disorder which is generally diagnosed early in childhood. Genetic mutation is considered to be the major reason behind this disorder. While these tumors may be benign at the time, they may lead to other problems such as speech impediments, skeletal problems, disoloration spots on the skin and seizures. It is estimated that one in every 2,500 to 3,000 births experience this condition.

Selumetinib is a kinase inhibitor and works by blocking MEK, an enzyme mainly responsible for signaling pathways for cancerous cell growth. It is mainly designed for the patients whose tumors are inoperable or cant be removed without significant risk. The FDA decision has been supported by the data from a clinical trial conducted by the National Cancer Institute. The trial involved 50 patients given the drug candidate. 66 percent of the patients showed a 20 percent or greater reduction in their tumors. However, the patients showed a partial response to the drug implying that no patients had their tumors completely disappeared from their bodies.

Boston Scientific (BSX) suffered a blow as an appeals court ruled in favor of Nevro in a patent litigation. The decision reversed a lower courts ruling which favored Boston Scientifics contention that a patent is indefinite if it fails to inform about the scope of the invention with reasonable certainty. Nevro is based out of California and is engaged in the production of medical devices focusing on chronic pain treatments.

Boston Scientific and Nevro have a long history of patent disputes behind them. The company was first sued by Nevro in 2016 for infringement of its patents. The case led to Boston Scientific canceling its product launch. The company was also forced to modify its SCS system to ensure that no such patent infringement was done. Boston Scientific also decided to withdraw the launch plan for its high frequency product. However, in July 2018, a court decided that Boston Scientific is entitled to sell its Spectra WaveWriter systems without infringing any of Nevros patents. The decision was appealed by Nevro, culminating in the latest judgment.

The latest judgment found that a lower court committed an error in invalidating four Nevro patents covering high-frequency spinal cord stimulation. Nevros Senza spinal cord stimulation system is a non-pharmacologic neuromodulation platform and is designed to treat chronic pain. The appeals judge stated, We conclude the district court erred in holding indefinite the claims reciting the term configured to and we construe configured to to mean programmed to, However, there are still some legal issues between the companies which remain unresolved.

Boston Scientific has two cases pending against Nevro including the one alleging Nevro guilt of trade secrets theft. Nevro is involved in several other litigation with major companies such as Medtronic (NYSE:MDT) and Abbott (NYSE:ABT). However, the company has hailed the latest decision as a significant and overwhelming victory.

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Sangamo And Biogen Tie Up, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha