Biotechnology Companies Ramp up Funding as Deadly Diseases Come Into the Spotlight

NEW YORK, Feb. 27, 2019 /PRNewswire/ -- Biotechnology is rapidly and continually evolving each year with new innovative therapies and drugs. The companies within the industry are researching and developing new efficient ways to effectively treat their patients. Despite the advancements taking place in the biotech industry, the number of patients is constantly rising each year. Specifically, the incidences of chronic ailments such as diabetes and cancers are mainly propelling the overall industry growth. Along with advancements in therapies and drugs, biotechnology companies are also expanding healthcare access and growing their R&D expenses, which is expected to accelerate the market as well. According to data compiled by Global Market Insights, the global biotechnology market was valued at USD 399.4 Billion 2017 and is projected to witness a robust CAGR of 9.9% from 2018 to 2024. Algernon Pharmaceuticals Inc. (OTC: BTHCF) (CSE: AGN), Akebia Therapeutics, Inc. (NASDAQ: AKBA), Rockwell Medical, Inc. (NASDAQ: RMTI), Kadmon Holdings, Inc. (NYSE: KDMN), Conatus Pharmaceuticals Inc. (NASDAQ: CNAT)

Within the biotechnology marketplace, there are a vast number of companies involved in various sectors. However, the idiopathic pulmonary fibrosis (IPF) segment has come into the spotlight due to its deadly nature. IPF is a disease in which the lung tissues become thick and stiffens over time, which reduces the oxygen carrying capacity of the tissues. There are various drugs within the market to effectively treat patients suffering from IPF. And according to Allied Market Research, the IPF market was valued at USD 1.61 Billion in 2016 and is expected to reach USD 3.56 Billion by 2023, while growing at a CAGR of 11.9%. "The most common of the restrictive lung diseases, idiopathic pulmonary fibrosis (IPF) is a rare but deadly disease, affecting an estimated 6.8 to 42.7 per 100,000 people, with higher rates in those older than 65 years, and resulting in approximately 40,000 deaths annually in the United States," according to research conducted by Steven D. Nathan, Director of the Advanced Lung Disease Program Inova Fairfax Hospital, Jonathan H. Chung, Associate Professor of Radiology at The University of Chicago Medicine, and Marilyn K. Glassberg, Marilyn Glassberg, Professor of Medicine, Surgery, and Pediatrics at the University of Miami. "Education to community pulmonologists, radiologists, and primary care physicians, as well as the multidisciplinary team is important to increase knowledge related to recognition and diagnosis. Clinicians need to be aware of when to refer patients with potential IPF to specialty centers with pulmonologists, radiologists, and pathologists specialized in interstitial lung disease (ILD)."

Algernon Pharmaceuticals Inc. (OTCQB: BTHCF) (CSE: AGN) is also listed on the Canadian Securities Exchange under the ticker (CSE: AGN). Earlier this week the company announced breaking news that, "based on positive preliminary data from its first idiopathic pulmonary fibrosis (IPF) study, the Company has decided to conduct further research on compound NP-251.

Because fibrosis is a major underlying condition for many serious diseases, and as a result of the success of several Algernon compounds previously demonstrating anti-fibrotic activity in CKD and NASH, the Company screened a number of its lead compounds for IPF. Out of the 8 compounds screened by the Company during the early research phase, NP - 251 showed the most promise.

The research plan is to advance testing of NP-251 in a new in vivo animal study, directly against clinically relevant doses of both Pirfenidone and Nintedanib, the currently approved treatments for IPF.

'A successful IPF in vivo study for NP-251 would mean that Algernon could begin planning an additional phase II study for its fourth major global disease', said Christopher J. Moreau, CEO of Algernon Pharmaceuticals.' A potential new treatment for IPF could also mean an orphan drug designation, which could help expedite its availability to patients. We look forward to updating the market on our progress shortly.'

About IPF: Idiopathic pulmonary fibrosis is a type of chronic lung disease characterized by a progressive and irreversible decline in lung function and scarring (fibrosis) of the lungs. There is no cure for IPF and there are currently no procedures or medications that can remove the scarring from the lungs.

The idiopathic pulmonary fibrosis (IPF) market will rise substantially from just over $900 million in 2015 to $3.2 billion by 2025, representing an impressive compound annual growth rate (CAGR) of 13.6%. According to research and consulting firm GlobalData's latest report, such growth, which will occur across the seven major markets (7MM) of the USA, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the increased use of expensive therapies, the anticipated launches of two novel therapies, FibroGen's FG-3019 and Promedior's PRM-151, and a rise in diagnosed prevalent cases of the disease.

About Algernon Pharmaceuticals Inc.: Algernon Pharmaceuticals is a clinical stage pharmaceutical development company focused on advancing its lead compounds for of non–alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and inflammatory bowel disease (IBD)."

Akebia Therapeutics, Inc. (NASDAQ: AKBA) is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for patients with chronic kidney disease. Akebia Therapeutics, Inc. and Keryx Biopharmaceuticals, Inc. recently announced the successful completion of their previously announced merger. "We are very pleased to announce the completion of our merger with Keryx to create a fully integrated renal company that has the potential to set new standards of care for patients with kidney disease," said John P. Butler, President and Chief Executive Officer of Akebia. "With established renal development, manufacturing and commercial capabilities, strong cash position, a flexible balance sheet and experienced management team, our company is uniquely positioned to capitalize on the significant market opportunity by maximizing the growth of Auryxia® (ferric citrate) and build launch momentum for our Phase 3 product candidate, vadadustat, subject to approval by the U.S. Food and Drug Administration (FDA). On behalf of everyone at Akebia, we welcome Keryx and its talented team, and look forward to working together to achieve a seamless transition and to build value for all of our stakeholders."

Rockwell Medical, Inc. (NASDAQ: RMTI) is a biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD). Rockwell Medical, Inc. recently provided an update on the status of the Company's development of an intravenous formulation of the Company's proprietary drug Triferic®, which is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in adult hemodialysis patients with chronic kidney disease. The Company is in the process of preparing a New Drug Application for IV Triferic and anticipates that it will file the NDA in the fourth quarter of 2018, which would result in a Prescription Drug User Fee Act action date in late 2019. "Based on feedback from a pre-NDA meeting with the FDA, we believe that we have an NDA package, including bioequivalence data, that would enable the FDA to review and act on this application before the end of 2019," said Stuart Paul, Rockwell Medical President and Chief Executive Officer. "We are excited about our planned NDA submission as it represents an important milestone in this process. The entire Rockwell Medical team is dedicated to maximizing the opportunity with IV Triferic, which has great potential to help patients both in the U.S. and abroad."

Kadmon Holdings, Inc. (NYSE: KDMN) is a fully integrated biopharmaceutical company developing innovative product candidates for significant unmet medical needs. Kadmon Holdings, Inc. recently announced updated data from its ongoing Phase 2 clinical trial of KD025, its selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), in patients with previously treated chronic graft-versus-host disease (cGVHD). The updated results reaffirm data previously presented for KD025 in cGVHD, demonstrating favorable tolerability and robust and durable clinical activity, including in patients with multi-organ involvement. The data were presented today in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, CA. "KD025 continues to be well tolerated and show durable, clinically meaningful responses in cGVHD patients, including those with multiple organs involved and fibrotic manifestations of the disease," said Madan Jagasia, MD, MS, MMHC, Professor of Medicine, Vanderbilt University Medical Center; Co-Leader, Translational Research and Interventional Oncology; Chief Medical Officer, Vanderbilt-Ingram Cancer Center and study investigator. "In addition, new pharmacodynamics data further support the unique mechanism of action of KD025 and its ability to restore immune homeostasis in cGVHD patients."

Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) is a biotechnology company focused on the development of novel medicines to treat liver disease. Conatus Pharmaceuticals Inc. recently announced the completion of enrollment in ENCORE-LF, a Phase 2b clinical trial evaluating emricasan, the Company's first-in-class, orally-active pan-caspase inhibitor. "With screening in the ENCORE-LF clinical trial complete, we remain on track for clinical events as announced last quarter, with top-line results expected in mid-2019," said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. "We sincerely appreciate the participation of these advanced liver disease patients and their contributions to the development of emricasan to address a serious and largely unmet medical need."

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