How FDA and Oncology Industry are Making Joint Efforts to Utilize Accelerated Approval Pathways for Cancer Drugs

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, Nov. 26, 2019 /PRNewswire/ -- Worldwide, cancer drug sales bring in the most revenues for pharmaceutical companies. Worldwide cancer drug sales are already way ahead of those of other drugs and the revenue generated by them is expected to grow even larger by 2024. This is according to a report recently released by consultancy Evaluate, which analyses trends in the pharmaceutical sector, which also says that oncology drugs reached US$123.8 billion in sales in 2018, more than double that of the next item on the list, drugs treating diabetes with US$48.5 billion dollars in sales. By 2024, cancer drug sales are expected to almost double to US$236.6 billion dollars.  In 2018, the U.S. Food and Drug Administration (FDA) approved or added new indications to 47 drugs or biologics for oncology in 2018, and in 2019 20 such approvals in oncology have already been made as of July. The drug-development process that may ultimately result in FDA approval is long and requires many steps to ensure that the product is safe and effective.   Active biotech and pharma companies in the markets this week include Clovis Oncology, Inc. (NASDAQ: CLVS) , CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), The Medicines Company (NASDAQ: MDCO), Pfizer Inc. (NYSE: PFE).

Although there are different regulatory paths for different types of products, most oncology drugs follow a similar overarching drug development path. The traditional drug development pathway can take up to approximately 15 years, but efforts have been made by industry and the FDA to reduce this timeline.  The FDA has several tracks that it employs that can expedite the drug-approval process, which enables a drug to be reviewed by FDA more quickly than through the traditional approval pathway. These pathways include a fast-track designation, a breakthrough therapy designation, an accelerated approval pathway, and a priority review designation. All of these tracks are designed to reduce the development and/or FDA review period and are typically reserved for compounds that are thought to show promise in preclinical and/or early clinical testing.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS:  CNS Pharmaceuticals Entered $2.0 Million Dollar Sublicense Agreement with WPD Pharmaceuticals - CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, entered into a sublicense agreement with WPD Pharmaceuticals ("WPD"), a Polish corporation partially owned and controlled by Dr. Waldemar Priebe, the founder of the Company. The agreement grants WPD patent rights to research and develop, and manufacture or sell Berubicin in a limited territory comprised mainly of Eastern Europe and Central Asia. The Company is entitled to a 1% royalty on all commercial sales of Berubicin in these licensed territories.

As part of the agreement, WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin during the three year term of the agreement, which ends in August 2021. WPD plans to implement a multicenter pediatric Phase I clinical trial to determine maximum tolerated dose, and to determine the efficacy of Berubicin in Phase IB and II clinical trials in adults. WPD also plans to conduct preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as anticancer drugs.

"We were extremely excited to enter into an agreement with WPD and to further explore the potential of Berubicin as an anthracycline internationally," commented CEO of CNS, John M. Climaco. "Our agreement with WPD is truly a testament to our unrelenting commitment to pursuing treatments for glioblastoma around the world."   Read this and more news for CNSP at:  https://www.financialnewsmedia.com/news-cnsp/     

Other recent developments in the biotech industry include:

Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that the Italian Medicines Agency (AIFA) has approved rucaparib for reimbursement in Italy. Rucaparib will soon be available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.

Rucaparib is indicated for eligible patients regardless of BRCAstatus, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently confirmed that on November 23, 2019, it received an unsolicited, non-binding term sheet proposal submitted by two biopharmaceutical companies, to acquire all of the issued and outstanding shares of the Company for between $3.00 and $5.00 per share in cash.

After reviewing the proposal in consultation with its advisors, Sorrento's Board of Directors (the "Board") determined that the offer significantly undervalued Sorrento and was not in the best interest of the Company's stockholders. Accordingly, the Board unanimously rejected the proposal.

The Medicines Company (NASDAQ: MDCO) recently announced that it has entered into definitive agreement in which Novartis AG will acquire The Medicines Company for $85 per share in an all-cash transaction, implying a fully diluted equity value of $9.7 billion. The price represents a premium of approximately 45% to The Medicines Company's closing share price of $58.65 on November 18, 2019 (the last trading day prior to news reports of a potential transaction between The Medicines Company and Novartis AG). The transaction was unanimously approved by the Boards of Directors of both companies.

"Our company's singular, relentless focus and the unwavering commitment of our employees have led to this opportunity to unlock the intrinsic value of inclisiran for patients and to maximize value for our shareholders," said Mark Timney, Chief Executive Officer of The Medicines Company. "We are excited that millions of patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia will potentially benefit from this transformational therapy."

Pfizer Inc. (NYSE: PFE) recently announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira^® (adalimumab),¹for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.² For full details of indications please see the approved label.

"Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions," said Richard Blackburn, Global President, Pfizer Inflammation and Immunology. "Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients."

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