In Pursuit of the Elusive Drug — the Billion-Dollar Blockbuster

 NetworkNewsWire Editorial Coverage: Enormous amounts of money exchange hands in the big pharma space as companies merge and are acquired — all in search of the next blockbuster drug. While the discovery of a blockbuster drug, or a drug that generates more than $1 billion in sales per year, occurs rarely, the tremendous benefits of owning blockbuster therapeutics can mean tens of billions of dollars for a company during the patent-protected life of the drug. It makes sense, then, that pharmaceutical giants are in hot pursuit of what could be the next new drug — and the company that owns that drug. 180 Life Sciences Corp., a clinical-stage biotechnology company that has entered into a definitive merger agreement with KBL Merger Corp. (NASDAQ: KBLM) (KBL Merger Corp. Rights NASDAQ: KBLMR) (KBL Merger Corp. Warrant NASDAQ: KBLMW) (180 Profile), could be one of those companies. All four of the company’s founders have a background in developing therapeutics that were snatched up by larger pharmaceutical companies for billions. Certainly acquisitions is a common strategy for big players in the pharma sector. Alexion Pharmaceuticals Inc. (NASDAQ: ALXN) recently entered into a definitive merger agreement to acquire Portola, a commercial-stage biopharmaceutical company focused on life-threatening blood-related disorders. Gilead Sciences Inc. (NASDAQ: GILD) and Immunomedics just announced that they have entered into a definitive agreement as well; the agreement outlines Gilead intent to acquire Immunomedics, a leader in next-generation antibody-drug conjugate (ADC) technology. Eli Lilly and Company (NYSE: LLY) is also pursuing an acquisition target. Earlier this month the company announced plans to acquire Disarm Therapeutics, a move that expands the company’s R&D efforts in pain and neurodegeneration. And Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) also had an R&D objective — to develop curative cell-based treatments for type 1 diabetes — when it acquired Semma Therapeutics.

• Pharmaceutical giants are in hot pursuit of the next new drug — and the company that owns it.
• 180 Life Sciences founders have impressive streak of developing, selling large market drugs.
• KBLM, 180 Life Science have announced upcoming acquisition.
• Company’s first target is Dupuytren’s contracture, a defect that develops in the hands.

Blockbuster Potential

180 Life Sciences Corp. was started by four world-renowned scientists who share an entrepreneurial spirit. The four own the majority of the equity in 180 Life Sciences  and aren’t planning on selling any in the upcoming merger with KBL Merger Corp. (NASDAQ: KBLM), scheduled for completion by year end.

KBLM, the fourth Special Purpose Acquisition Company (SPAC) run by CEO Marlene Krauss, MD., raised $115 million with the end goal of identifying and merging with a company that offered a strong value proposition. An innovator and pioneer in SPACs, Krauss has invested more than $1 billion through three previous institutional venture capital funds, three prior SPACs and numerous IPOs. One of the first individuals to obtain both an MD degree and an MBA degree from Harvard, she is also one of only a few physicians to lead a SPAC. Krauss has a passion for healthcare and a talent for identifying innovative companies with blockbuster potential. Most recently, after eliminating dozens of other potential choices, Krauss and KBLM signed a definitive agreement to acquire 180 Life Sciences Corp.

The opportunity seems clear. The distinguished biomedical 180 Life Sciences pioneers were the first to successfully develop new anti-inflammatory drugs, such as the anti TNF biologics and the anti-integrin inhibitors, in the late ‘90’s. More than two decades later, these drugs are still on the market and generating billions of dollars annually in sales.

Company founders and co-chairs Marc Feldmann and Lawrence Steinman lead 180 Life Sciences drug-development efforts. Feldmann is recognized for his groundbreaking work in discovering and developing anti-TNF (tumor necrosis factor) therapy. The licensing of his patent to Centocor Biotech led to the development of Remicade and its acquisition for $4.9 billion by J & J. J & J wasn’t the only pharmaceutical giant to come calling; AbbVie also licensed Feldman’s patents for use with Humira, one of the best-selling drugs in the world.

Steinman also has leading drugs to his credit. His research led to the development of Tysabri for treating multiple sclerosis and inflammatory bowel disease. Tysabri, which currently generations an estimated $2 billion in revenue, was ultimately bought by Biogen. In addition, Steinman founded Neurocrine Biosciences, which currently has a market capitalization of approximately $7.7 billion.

As chief scientific officer at Centocor, 180 Life Sciences CEO James N. Woody, MD, was key in the discovery of Remicade, the first available anti-TNF blockbuster. Woody also previously founded Avidia and Proteolix, both of which Amgen has purchased. 180 Life Sciences chief scientific officer Jonathan Rothbard, MD, played a key role in establishing Amylin Pharmaceuticals, which was acquired for $7 billion by Bristol-Myers Squibb in 2012.

With such an impressive track record, these four scientists certainly deserve both respect and attention — from both inside and outside the industry. Life Sciences prominent group of leaders and their impressive backgrounds should open channels of opportunity for licensing, joint ventures or even buyouts.

Groundbreaking Study

In addition to its impressive leadership, 180 Life Sciences commands attention for its groundbreaking study into clinical programs designed to develop novel drugs that address separate areas of inflammation for which there are no effective therapies. 180 Life Sciences currently operates three synergistic programs that combine biotechnology and large-market therapeutics:

• The company’s primary platform is a novel program to treat fibrosis using anti-TNF, with its lead program in phase 2b/3 clinical trials for treatment of Dupuytren’s contracture, a debilitating disease that has no nonsurgical solutions.
• Inflammatory Pain (Preclinical): This program is focused on discovering novel compounds to treat chronic inflammatory pain.
• A7nAChR (Preclinical): Led by Lawrence Steinman and Jonathan Rothbard, MD. 180 Life Sciences is seeking to develop a treatment for ulcerative colitis in ex-smokers by targeting the a7nAChR, a nicotine receptor in the body and a central factor in the body’s method of controlling inflammation.

Targeting Dupuytren’s

It appears evident that the seasoned scientists at 180 Life Sciences are working toward another blockbuster. Their first target is Dupuytren’s contracture, a defect that typically develops in the hands and impacts the layer of tissue underneath the skin of the palm. The disease afflicts up to 12 million Americans in early or mild stages, with another 3 million who have at least one finger bent enough to have a procedure as well as an estimated 750,000 who suffer from more severe symptoms. Currently there are no treatments to stop Dupuytren’s from progressing, leaving surgery as the only viable treatment option.

With Dupuytren’s, knots and nodules form under the skin, creating a thick cord that pulls one or more fingers into a bent position. Humans are the only creatures that have hands that can grasp, hold, move and manipulate, and Dupuytren’s contracture destroys that ability, severely impacting an individual’s quality of life.

180 Life Sciences has commenced a special clinical therapy program designed to prevent Duptyren’s finger and hand contracture before it becomes severe and permanent or requires surgery. The phase 2b/3 human clinical trials evaluate both dosing requirements and efficacy in patients with the disease. 180 Life Sciences received a U.S. patent earlier this year for treatment of Dupuytren’s disease, along with several other patents. A successful treatment for Dupuytren’s might reach blockbuster status.

As clinical trials proceed on Dupuytren’s contracture, 180 Life Sciences continues to expand its robust IP portfolio across the company’s three major drug platforms in the areas of inflammation, fibrosis and pain. The company’s patent portfolio is made up of both its own IP and exclusive worldwide licenses with Oxford University Innovation Limited, the Kennedy Trust for Rheumatology Research University of Oxford, Stanford University and the Hebrew University. The patent portfolio covers 14 patent families with 42 patents issued and 32 pending in several significant jurisdictions around the world. Given the stature of the scientists and their impressive track record of success, it wouldn’t be surprising to see them develop another market moving therapeutic.

Big Pharma Acquisitions

Alexion Pharmaceuticals Inc.’s (NASDAQ: ALXN) announcement regarding its planned acquisition of Portola means ALXN will also acquire Andexxa (r), the first and only approved Factor Xa inhibitor reversal agent. The drugs has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding. According to the company, this acquisition will add near-term diversification to Alexion’s commercial portfolio and provide an opportunity for the company to apply its demonstrated global commercial excellence to create long-term value for patients and shareholders.

In its acquisition of Immunomedics, Gilead Sciences Inc. (NASDAQ: GILD) will also acquire Trodelvy(tm) (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug Administration in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States sometime during Q4 2020 and is also planning to file for regulatory approval in Europe in the first half of 2021.

Eli Lilly and Company’s (NYSE: LLY) announcement this month that it is acquiring Disarm Therapeutics means the company will gain Disarm’s promising preclinical SARM1 programs for axonal degeneration. The strategic acquisition is designed to expand Lilly’s R&D efforts in pain and neurodegeneration.

A privately held biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration, Disarm has discovered novel, potent SARM1 inhibitors and is advancing them in preclinical development, with the goal of delivering breakthrough treatments to patients with peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis.

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) acquired Semma Therapeutics to further its goal of  developing effective treatments for Type 1 diabetes. A privately held biotech company, Semma Therapeutics is pioneering the use of stem cell-derived human islets as a potentially curative treatment for type 1 diabetes. More than 1 million people suffer from type 1 diabetes in the United States alone. Semma has made two major scientific advances: the ability to produce large quantities of functional human pancreatic beta cells that restore insulin secretion and ameliorate hypoglycemia in animal models and a novel device that encapsulates and protects these cells from the immune system, enabling durable implantation without the need for ongoing immunosuppressive therapy.

Acquisitions certainly seems like a common strategy in the world of big pharma and in the pursuit of the elusive blockbuster drug. The move rewards the dedicated efforts of smaller companies and provides valuable resources to elevate a potential drug to the next level.

For further information about 180 Life Sciences please visit 180 Life Sciences Corp. and check out the 180 Life Sciences Corporate Media Kit.

KBL Merger Corp. (NASDAQ: KBLM), KBL Merger Corp. Rights (NASDAQ: KBLMR), KBL Merger Corp. Warrant (NASDAQ: KBLMW), a Special Purpose Acquisition Corporation (SPAC) announced that, in connection with its previously detailed merger agreement with 180 Life Sciences, it consummated a bridge financing on June 29, 2020, and submitted its latest S4 filing with the SEC on August 28, 2020. It expects to close the business combination in Q4 of 2020. Following the merger, the company will be listed on the Nasdaq Capital Market under ticker symbol ATNF.

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Additional Information about the 180 Life Sciences Business Combination and Where to Find It

KBL Merger Corp. IV (“KBL”) has filed a registration statement on Form S-4, which includes a preliminary proxy statement/prospectus for KBL’s stockholders, with the Securities and Exchange Commission. KBL’s definitive proxy statement/prospectus will be mailed to KBL’s stockholders that do not opt to receive the document electronically. KBL and 180 Life Sciences urge investors, stockholders and other interested persons to read the preliminary proxy statement/prospectus, as well as other documents that will be filed with the SEC, because these documents will contain important information about the proposed business combination transaction. Such persons can also read KBL’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, for a description of the security holdings of its officers and directors and their respective interests as security holders in the consummation of the proposed business combination transaction. KBL’s definitive proxy statement/prospectus, which is included in the registration statement, will be mailed to stockholders of KBL as of a record date to be established. KBL’s stockholders will also be able to obtain a copy of such documents, without charge, by directing a request to: KBL Merger Corp. IV, 30 Park Place, Suite 45E, New York, NY 10007; e-mail: admin@kblvc.com  These documents can also be obtained, without charge, at the SEC’s web site (http://www.sec.gov)

Participants in Solicitation

KBL and its directors and executive officers may be deemed to be participants in the solicitation of proxies for the special meeting of KBL’s stockholders to be held to approve the proposed transactions in connection with the business combination with 180 Life Sciences. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of KBL’s stockholders in connection with the proposed business combination with 180 Life Sciences are set forth in the amended preliminary proxy statement/prospectus included in the registration statement that was filed with the SEC on August 28, 2020. You can find information about KBL’s executive officers and directors in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on April 7, 2020. You can obtain free copies of these documents from KBL using the contact information above.

Non-Solicitation

This communication is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination between KBL and 180 Life Sciences and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of KBL and 180 Life Sciences, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.