Tuesday, October 20, 2020

Banking on the Next Blockbuster Drug

 NetworkNewsWire Editorial Coverage: Pharmaceutical companies invest enormous amounts of time and money on the research and development of new drugs, typically years in the making and costing millions of dollars. Only occasionally is a new drug developed that’s approved and generates more than $1 billion per year in sales, a benchmark in the industry commonly called a “blockbuster.” Blockbusters are scarce, but the proverbial quest for blockbuster drugs continues unabated because of vast unmet medical needs and because blockbuster therapeutics can be worth tens of billions of dollars during their patent-protected lives. Little wonder that pharmaceutical giants often buy up promising new drugs, some even in their infancy, not just to fill their pipeline or mesh with current R&D projects but also to bank on a bonanza of prospective revenues that could exceed $100 billion. With so much at stake, it only makes sense to pay special attention to scientists who have previously developed and delivered these blockbusters. With this in mind, expectations are high for 180 Life Sciences Corp. (180 Profile) since the founders have significant expertise in developing new therapeutics that were sold to big pharma for billions. They are renowned for development of some of the largest-selling drugs to ever come to market. Now they aim to do it again with a pipeline of drug candidates in sequential stages of development that address large untapped markets. The founding scientists at 180 Life Sciences discovered the anti-TNF drug class that led to Remicade, the fourth all-time best-selling drug in the world. Presently owned by Johnson & Johnson (NYSE: JNJ)Remicade has exceeded $90 billion in total sales since approval. AbbVie Inc. (NYSE: ABBV) licensed the anti-TNF patents from these scientists for use with Humira, the second best-selling drug in the world, with lifetime sales of $137 billion. Amgen Inc. (NASDAQ: AMGN) owns the seventh best seller, Enbrel, that treats psoriasis and rheumatoid arthritis and has generated over $81 billion in lifetime sales. Novartis AG (NYSE: NVS) owns the world’s 12th best-selling drug, Diovan, which treats high blood pressure and heart failure and has over $60 billion in lifetime sales. Only a handful of every thousand drugs that start development ever make it to the final stages of clinical trials and, even then, not all of those are approved. However, the extremely low odds of success are worth the risks for big pharma when its realized how much revenue just one of these blockbuster drugs can rack up — they bank on it.

  • Big pharma consistently buys up blockbuster drugs for big revenues.
  • 180 Life Sciences founders have track record of success developing, selling large market drugs to big pharma.
  • 180 Life Science about to merge with KBLM, a $115 million SPAC.
  • Scientist founders targeting multi-billion-dollar markets, developing novel drug candidates across several platforms addressing large unmet medical needs.

Blockbuster Bankers and Scientists

180 Life Sciences Corp. was started by four world-renowned scientists and entrepreneurs who invested their own money to start the company. These scientists own the majority of the equity in 180 Life Sciences  and aren’t selling any in the pending merger with KBL Merger Corp. (NASDAQ: KBLM), slated to close before year end. KBL Merger Corp. (a blank-check company) is the fourth Special Purpose Acquisition Company (SPAC) run by CEO Marlene Krauss, MD.

KBLM raised $115 million with the goal of identifying and merging with a company with a strong value proposition. Krauss is an innovator and pioneer in SPACs and has invested more than $1 billion through three institutional venture capital funds, numerous IPOs and three prior SPACs. She is one of the first people to obtain both an MD and MBA degree from Harvard and one of the few physicians to lead a SPAC. Krauss has always had a passion for healthcare and innovative companies with blockbuster potential and, after eliminating dozens of other companies, signed a definitive agreement to acquire 180 Life Sciences Corp.

The preeminent biomedical pioneers of 180 Life Sciences were the first to successfully develop new anti-inflammatory drugs in the late ‘90’s, such as the anti TNF biologics and the anti-integrin inhibitors. These drugs are still on the market, consistently generating billions of dollars per year in sales. They have also  spawned a new class of therapeutics to treat inflammation.

Founders and co-chairs Marc Feldmann and Lawrence Steinman lead the drug-development programs of 180 Life Sciences. Feldmann performed 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 the acquisition by J&J for $4.9 billion. AbbVie also licensed his patents for use with Humira, now the second best-selling drug in the world.

Steinman’s work led to the development of Tysabri for treating multiple sclerosis and inflammatory bowel disease, which was sold to Biogen and currently generates approximately $2 billion in revenue. Steinman also founded Neurocrine Biosciences, which currently has a market capitalization of approximately $7.7 billion.

180 Life Sciences CEO James N. Woody, MD, was instrumental in the discovery of Remicade, the first anti-TNF blockbuster, as chief scientific officer at Centocor. Woody previously founded Avidia and Proteolix, both of which were subsequently sold to Amgen. 180 Life Sciences chief scientific officer Jonathan Rothbard, MD, helped establish Amylin Pharmaceuticals, which was acquired by Bristol-Myers Squibb in 2012 for $7 billion.

Given such an incredible track record of blockbuster success, few other scientists command any greater respect or attention from big pharma. 180 Life Sciences prestigious group of leaders and their impressive backgrounds should open channels of opportunity for licensing, joint ventures or even buyouts.

Large Market Targets

180 Life Sciences is driving groundbreaking study into clinical programs, which are seeking to develop novel drugs that address separate areas of inflammation for which there are no effective therapies. 180 Life Sciences has three synergistic programs that operate at the intersection of 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.

Aiming for Another Blockbuster

The scientists at 180 Life Sciences are aiming for another blockbuster. Their first target is Dupuytren’s contracture, a deformity that usually develops in the hands and affects a layer of tissue that lies under the skin of the palm. The disease afflicts up to 12 million Americans in early or mild stages; another 3 million have at least one finger bent enough to have a procedure, and an estimated 750,000 suffer more severe symptoms. Currently there are no treatments to stop Dupuytren’s from getting worse, leaving surgery as the only viable option as the disease progresses.

Dupuytren’s causes knots and nodules to form under the skin, creating a thick cord that pulls one or more fingers into a permanently bent position. Hands are incredibly important in every aspect of life. No other creature in the world has hands that can grasp, hold, move and manipulate like human hands, and Dupuytren’s contracture destroys that ability, severely impacting quality of life.

180 Life Sciences has initiated a special clinical therapy program for preventing Duptyren’s finger and hand contracture before it becomes severe and permanent or requires surgery. The current phase 2b/3 human clinical trials are designed to evaluate both dosing requirements and efficacy in patients with the disease. 180 Life Sciences was granted a U.S. patent in June for treatment of Dupuytren’s disease, along with several other patents. A successful therapeutic for a large market such as Dupuytren’s could conceivably 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 important 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 Blockbusters

Johnson & Johnson (NYSE: JNJ) owns Remicade, the fourth all-time best-selling drug in the world, which has exceeded $90 billion in total sales since approval. JNJ acquired the drug in the purchase of Centocor Biotech for $4.9 billion in 1999. One of the world’s largest and most broadly based health care companies, JNJ recently completed its acquisition of Momenta Pharmaceuticals Inc., a company that discovers and develops novel therapies for immune-mediated diseases, in an all-cash transaction for approximately $6.5 billion.

AbbVie Inc. (NYSE: ABBV), a research-based global biopharmaceutical company, licensed the anti-TNF patents from the scientists at 180 Life Sciences for use with Humira, the second best-selling drug in the world, with lifetime sales of $137 billion. The company announced in May that it completed its acquisition of Allergan, which expands and diversifies AbbVie’s revenue base and complements existing leadership positions in immunology and hematologic oncology. Allergan provides new growth opportunities in neuroscience and a global aesthetics business, with leading brands including Botox and Juvederm.

Amgen Inc. (NASDAQ: AMGN) owns the seventh best-selling drug in the world, Enbrel, which treats psoriasis and rheumatoid arthritis and has generated more than $81 billion in lifetime sales. Amgen focuses on areas of high unmet medical need and leverages its expertise to find solutions that improve health outcomes and dramatically improve people’s lives. Last year Amgen acquired worldwide rights to Otezla for $13.4 billion in cash. Otezla is the only oral, nonbiologic treatment for psoriasis and psoriatic arthritis.

Novartis AG (NYSE: NVS) owns and markets the 12th best-selling drug, Diovan, which treats high blood pressure and heart failure. Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. In January, Novartis completed the acquisition of The Medicines Company in a $9.7 billion deal. The acquisition will add inclisiran, a potentially first-in-class treatment to lower cholesterol, to Novartis’ pipeline.

In candor, looking at the long list of acquisitions, it appears that all of big pharma clamors for control of blockbuster drugs. These industry leaders buy up potential big market therapeutics not only in an attempt to fill unmet medical needs but also out of the need for the big revenues that keep them going. An old real estate adage offers sage advice: If you want to make money in real estate, find out where everyone’s going, get there first and buy land. The same philosophy holds true when looking to make money in biotech companies: find out where big pharma is going, get there first and buy in cheap. All it takes is one blockbuster drug to rack up huge gains — smart companies are banking on it.

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.

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