Affordable Life-Saving Biologic Drugs

Our mission is to develop, market and sell more affordable, life-saving biologic drugs for cancer patients and patients with chronic diseases

 

Anew Biotechnology Inc.  will develop and commercialize a portfolio of affordable, life-saving biologic drugs that are critical in the treatment of cancer and other chronic diseases. Affordable life-saving biologic drugs.

Forward-ThinkingForward Thinking

Major biotech blockbuster drugs worth Billions of Dollars in annual revenue are coming off patent. Anew’s EPO and monoclonal antibody (Mab) products are low risk and high return, but early-stage higher-risk projects are being licensed and further developed as patented and proprietary new drugs.

OurStrategyOur Strategy

Key patents on the life-saving biologic drugs that created Amgen & Genentech have expired. Anew Biotechnology Inc. is preparing for Phase III and commercial launch of highly similar versions of these drugs in the U.S., Europe and emerging pharmaceutical markets around the world.

competitive-advantageOur Competitive Advantage

Anew’s strategic partner has invested $25-$50 million in the development of each highly similar biologic drug product. Anew acquires all of this data and experience for further development in the major drug markets – U.S., Europe, Japan, and Israel & other emerging markets. The programs are “Phase III ready” and the dossiers can be submitted to the emerging market countries immediately, without further development costs.

our-teamMeet Our Team

Anew Biotechnology, Inc management team is highly experienced in the oncology business. The Company has operations in the U.S. and Europe and is preparing to launch and generate revenue in Latin America from already-approved biologic drugs. Our international marketing team has marketed and sold oncology biopharmaceuticals in all major markets; the launch of Rituximab-Anew is a top priority.

Background

Biologics as New Drugs or as Biosimilars – Proving Equivalence as a true Biosimilar is a Risky Proposition.

Anew Biotechnology recognizes the pending patent expirations of the original blockbuster biotechnology products as a tremendous opportunity. However, there is still tremendous “risk” that several companies pursuing “biosimilars” will have to face – what if their product data, as judged by the regulatory authorities, is determined to be not “highly similar”? It is likely there will be small analytical differences in their protein compared to the Innovator’s product, and although small, they may be significant. What if a biosimilar biologic product is 18% more effective, or 15% less effective than the Innovator’s product? Will the regulators consider this result a clinically meaningful difference? What if one biosimilar product is better than another biosimilar product; will only one be approved? These are questions yet to be answered by the regulators and likely to be handled on a company-by-company and product-by-product basis.

So, after directing significant investor capital with millions of dollars in manufacturing infrastructure costs, and years of comparative analytical and clinical testing, there is a major risk and high potential to fail to prove that a “biosimilar” product is “highly similar” to the Innovator product. That risk translates to a risk of not being able to obtain market approval consistent with the law and FDA’s biosimilarity guidelines, which are very likely to evolve and change over time.

Anew Biotechnology intends to seek approval in markets including the US, Canada, Japan, Israel and Europe consistent with the concepts of section 351(a) of the US Public Health Service Act via the filing of a full Biological Licensing Application (BA), or section 505(b)(2) of the US Food, Drug, and Cosmetic Act via the filing of a New Drug Application (NDA). With the clinical and manufacturing data available to us via our partnership with Reliance Life Sciences (RLS), the Company will utilize the RLS dossier to apply as a “biosimilar” biotech product in the “emerging market” countries of Mexico and Latin America immediately after market approval in India. We assume a small confirmatory “in-country” study will be required for product approval in emerging market countries. Anew Biotechnology will distribute our follow-on biotech products in these countries utilizing corporate partnerships. With this strategic approach, we reduce the risk in the regulatory body’s interpretation of the comparative data and the “high similarity” conclusion proposed by companies developing “biosimilar” biotech drugs.


An Introduction to Biotechnology – Follow-On Biologics and Biosimilars

The pharmaceutical industry was spawned in the 1940’s with the introduction of sulfa drugs, penicillin, and morphine used during World War 2. The pharmaceutical industry blossomed in the 1950’s-1970s, and continues to grow at a high pace due to the development and introduction of synthetic, small molecules that were introduced to the American public as drugs for the treatment of many illnesses. Several of the first anti-cancer drugs were also a result of World War 2 in that the first alkylating agents were derivatives of a chemical warfare agent called “mustard gas”.

In the late 1970’s and throughout the 1980’s, a scientific and technical revolution occurred in the U.S. and abroad. Human genes were identified and spliced into the DNA of microorganisms and animal cells and this “living cell system” produced abundant amounts of the human protein as encoded by the human gene. This new technology, recombinant DNA technology (“rDNA”) and genetic engineering, ushered in the “biotechnology revolution” which has favorably affected people and healthcare around the world. Several companies were founded around this new biotechnology, and they included Amgen, Biogen, Genzyme and Genentech, to name a few. New, life-saving biologic drugs were introduced and have changed the lives of many.

Molecular MassSmall molecules such as aspirin are far less complex that biotech proteins such as erythropoietin or the monoclonal antibodies like rituximab. Pharmaceutical drugs are easier to make, less costly and remain a mainstay of therapeutics for the treatment of diseases of animals and mankind. Biotech-derived molecules are more complex, and a new series of regulations were created to deal with these complex biologic large molecules that were to be used as drugs.

With the new technology came new products and new regulations to control the study, use and commercialization of biotech products. The Public Health Service Act (PHS Act) was created and recombinant biologic products were reviewed and approved by the U.S. FDA for marketing under section 351(a) of the PHS Act. The regulations and requirements described in section 351(a) set forth the requirements for approval of such products under a Biologic License Application or BLA. The BLA has been used since the 1990’s for market approvals of biologics, vaccines, and cell derived products thereafter and this regulatory route is still utilized today for new biologic products. BLAs contain extensive manufacturing and quality control information, a dossier including animal and in vitro toxicology and carcinogenicity data, Phase I pharmacokinetics & pharmacodynamics (“PK/PD”) studies, Phase II efficacy and safety studies, and well-controlled, adequately powered, randomized Phase III clinical trials in patients with disease, usually evaluating “non-active” placebo versus the new biotech product. Many biotech products were proven highly effective versus placebo controls and the risk-benefit outcomes outweighed the clinical side effects observed with these groundbreaking, blockbuster, biotech drugs.

The new biotech products were “blockbusters” in that each new introduction provided billions of dollars of revenue each year to the biotech companies that patented the products and processes for making the biotech products. The companies strategically priced biotech products at the maximum allowable pricing to try to recoup their investment the U.S. remains the only country in the world with no price controls. Thus, biotech products still cost the consumer and/or insurance payers from $60,000 per year to $350,000 per year. Today, the novel antibody-based “immune-oncology” drugs cost the consumer around $150,000 for a year of therapy. Due to patent law, the founding biotech companies and current biotech companies have enjoyed a monopoly on these products for 20-30 years and have lobbied extensively to prevent legislation to prohibit product competition. However, patent expirations protecting these products and processes from competition are now poised for expiration. Patent expiration leads to the availability of highly similar, safe and effective biotech products that are more reasonably priced and more affordable for patients requiring treatment with such products.


Biosimilars versus Follow On Biologics via the BLA

Top 10 Selling Biologic's Patent Cliff

Biologic drugs continue to be approved via the BLA route. One solution is to clone and reproduce follow-on biologics (“FOBs”) using processes not covered by patent protection. Recent legislation passed by Congress in 2009 and regulatory guidance provided by FDA in 2015, has opened the door for potential market approval in the U.S. using an “abbreviated” regulatory pathway for “biosimilars” that does not follow the full requirements of section 351(a) and the BLA. The European Union legislation and European authorities passed regulatory guidance back in 2005 related to upcoming patent expirations in Europe for several recombinant biologic products including human growth hormone, erythropoietin and filgrastim (G-CSF). The safety and efficacy of biotech protein products made by companies other than the Innovator has been proven, and the sales price to the consumer of these products sold in Europe has come down.

Biologic Mimic

Although the U.S. has moved slowly to enact legislation, the FDA has recently moved to enact industry guidance to encourage the development of “biosimilars” into the U.S. market via the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”) that amends the PHS Act and other statutes to create an abbreviated licensure pathway in section 351(k) of the Act for biological products shown to be highly similar to or interchangeable with the Innovator’s FDA-licensed biological reference product. The BPCI Act states that a 351(k) application for a proposed biosimilar product must include information demonstrating biosimilarity based on data derived from, among other things, “analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.” Further to the Act, FDA issued guidance focusing specifically on therapeutic protein products and providing an overview of analytical factors to consider in demonstrating high similarity between a proposed product and the reference product.

As a result, in January 2015, the FDA approved the first biologic drug as a “biosimilar” protein – Sandoz’s filgrastim (recombinant human granulocyte colony stimulating factor or G-CSF). Following this approval, FDA issued further guidance in April and May 2015, describing the Agency’s current thinking on factors to consider when demonstrating that a proposed therapeutic protein product is highly similar to a reference protein product under section 351(k) of the PHS Act and providing recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) section of a marketing application for a proposed product submitted under section 351(k) of the PHS Act.

“Biosimilarity” is defined in section 351(i) of the PHS Act to mean that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (section 351(i)(2) of the PHS Act). Similar to a generic drug molecule, comparative analytical testing data provide the foundation for a development program for a proposed biosimilar product intended for submission under section 351(k) of the PHS Act. Although analytical tests can show similarity, having an observed clinically meaningful difference may not fit the definition of biosimilarity and prohibit market approval as a biosimilar.

The biologic products coming off patent are in high demand worldwide and may help to contain escalating healthcare costs and to treat patients who could otherwise not afford such therapies. Estimated to cost between 20-30% lower than the Innovator biologic, biosimilars and FOBs offer potential savings in excess of $300 billion by 2029. Governments, healthcare systems and payers are looking to the industry to develop these high-value, lower cost medicines. While several pharma-industry players such as Amgen, Sandoz, Pfizer/Hospira and Teva have the capabilities and know how to produce FOBs and biosimilars, smaller companies with novel business models and strategies like Anew Biotechnology are poised to introduce competition to the marketplace.

“With the current and upcoming biotech patent expirations – we are standing at the edge of the “Patent Cliff” with an array of blockbuster biologics that are important to mankind.”

Dr. Joseph Sinkule, Founder and CEO, Anew Biotechnology, Inc.

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