MRK Combination Trial With Generex Biotechnology A37 Cancer Vaccine Signals Enormous Potential Windfall For GNBT Shareholders
Oct. 10, 2019 3:14 PM ET|About: Generex Biotechnology Corp. (GNBT), Includes: MRK
14 Deals over $173 Billion in Big Pharma acquisitions for first half 2019 dominated by cancer drugs. Average deal was $12.3 Billion.
Generex A37 Breast Cancer Vaccine attracted Merck because it demonstrates high efficacy with low adverse side effects against many common cancers.
Began enrollment of A37 Combination Phase II trial with Merck blockbuster Keytruda for Breast Cancer.
Upfront license payments for AE37 by Shenzhen BioScien Pharmaceuticals for Prostate Cancer in China, Taiwan, Hong Kong and Macau.
Plans underway for the spin-out of A37 to GNBT shareholders could lead to windfall profits for Generex shareholders.
9-month 2019 revenues increased 2,800 times versus same 2018 period and expected to soar from here.
Upcoming 1 for 1 dividend ONLY to float shareholders.
Recently retired 20,375,900 shares.
Upcoming Nasdaq up-list announced.
One key factor driving the current growing wave of biopharma acquisitions is the diminishing return on investment generated by traditional in-house R&D. In December 2018, Deloitte’s Center for Health Solutions issued a report concluding that the projected ROI fell to 1.9% last year from 3.7% in 2017, and from 10.1% in 2010, the first year Deloitte began its annual study of the topic. The decline, according to Deloitte, reflects the rising average cost to develop and win marketing approval for new treatments.
Diminishing ROI has compelled drug developers facing loss of exclusivity for marketed drugs to expand portfolios and replenish their pipelines through M&A. The following table outlines 10 of the top acquisitions in the first half of 2019.
Rank
Company
10.
Brammer Bio
Acquired by: Thermo Fisher ScientificPrice: Approximately $1.7 billionDeal status: Completed May 1. Thermo Fisher increased its presence in gene therapy with the viral vector contract development and manufacturing organization (CDMO) through the deal, announced March 24. Brammer’s chief operations officer before the deal—Christopher K. Murphy, now vp and general manager of viral vector services in Thermo Fisher Scientific’s Pharma Services Group—told GEN in June that Thermo Fisher will complete $100 million in Brammer Bio capital expansion projects designed to satisfy growing demand for gene therapies for clinical and commercial use.
9.
Peloton Therapeutics
Acquired by: Merck & Co.Price: Up to $2.2 billionDeal status: Expected to close in the third quarter. Merck aims to expand its cancer pipeline through the deal, announced May 21. Merck plans through a subsidiary to acquire all outstanding shares of Peloton in exchange for $1.05 billion cash upfront. Merck has also agreed to pay Peloton shareholders up to $1.15 billion tied to achieving regulatory and sales milestones.
8.
Spark Therapeutics
Acquired by: RochePrice: $4.8 billionDeal status: On June 10, Roche extended again its tender offer for shares of Spark Therapeutics, after both companies received a request from the U.S. Federal Trade Commission (FTC) for additional information in connection with the agency’s review of the acquisition, announced February 25. Spark shareholders now have until July 31 to tender their shares. Roche acknowledged that on June 7, shareholders representing just approximately 21.1% of Spark’s outstanding Shares had been validly tendered and received. At least 50% of Spark shares are required for completion of the deal.
7.
Tesaro
Acquired by: GlaxoSmithKline (GSK)Price: Approximately $5.1 billionDeal status: Completed January 22. GSK said the acquisition, announced December 3, 2018, was intended to “significantly” accelerate the development of its pipeline and commercial capability in oncology with Tesaro’s marketed once-daily oral poly ADP ribose polymerase (PARP) inhibitor Zejula™ (niraparib), under study for several additional cancer indications. GSK also cited Tesaro’s pipeline of additional oncology candidates, including antibodies directed against PD-1, TIM-3, and LAG-3 targets. Tesaro was among “10 Takeover Targets” included in GEN’s A-Lists published in February 2018 and again in September 2018.
6.
Loxo Oncology
Acquired by: Eli LIllyPrice: Approximately $8 billionDeal status: Completed February 15. Eli Lilly jolted this year’s J.P. Morgan 37th Healthcare Conference in San Francisco when it announced the deal January 7. Lilly signaled it was serious about catching up in cancer drug development by becoming a top-tier precision oncology company, Brad Loncar, CEO of Loncar Investments, who tracks developments in cancer immunotherapy and the broader biopharma industry, told GEN.
5.
Array BioPharma
Acquired by: PfizerPrice: Approximately $11.4 billionDeal status: Announced June 17, the planned acquisition reflects Pfizer’s intent to expand its oncology presence and pipeline. Array’s combination of Braftovi® (encorafenib) and Mektovi®(binimetinib) is approved for BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma, and is now being investigated in the Phase III BEACON trial (NCT02928224) in patients with BRAF–mutant metastatic colorectal cancer—one of 30+ clinical trials across several solid tumor indications. The boards of Pfizer and Array have approved the acquisition, which is expected to be completed in the second half of this year.
4.
GE BioPharma (BioPharma business of GE Life Sciences)
Acquired by: DanaherPrice: Approximately $21.4 billionDeal status: Announced February 25, the deal is designed to enhance Danaher’s bioprocessing offerings and pay down GE’s debt. Danaher president and CEO Thomas P. Joyce, Jr., said in the company’s first-quarter earnings press release on April 18 that his company continues to expect the deal to close in the fourth quarter of this year.
3.
Shire
Acquired by: Takeda PharmaceuticalPrice: £46 billion ($58.6 billion)Deal status: Completed January 7. Takeda president and CEO Christophe Weber trumpeted the deal as accelerating “our transformation journey to deliver highly-innovative medicines to patients around the world with expanded scale and geographical footprint.” Three weeks later, on January 28, Tokyo-based Takeda announced it was selling its former headquarters site in Osaka among non-core assets, in order to reduce debt that ballooned to ¥5.4 trillion ($50.3 billion). In May, Weber ratcheted up projected annual savings to $2 billion by the end of 2021, up from $1.4 billion.
2.
Allergan
Acquired by: AbbViePrice: $63 billionDeal status: Announced June 25, the acquisition would create a $48 billion biopharma giant, based on 2019 revenues, by strengthening AbbVie’s topline with the up-to-$15.425 billion projected this year by Allergan. The deal, set to close in “early 2020,” comes as AbbVie is three years away from losing U.S. market exclusivity for its longtime top-selling drug Humira® (adalimumab), which topped GEN’s A-List of the Top 15 Best-Selling Drugs of 2018.
1.
Celgene
Acquired by: Bristol-Myers Squibb (BMS)Value: Approximately $74 billionDeal status: BMS acknowledged June 24 that its acquisition of Celgene will take longer to close than initially anticipated, stating that it now expects to complete the purchase “at the end of 2019 or the beginning of 2020,” rather than during the third quarter as predicted when the deal was announced on January 3. The extra time became necessary when BMS agreed to divest itself of the psoriasis drug Otezla® (apremilast) to address “concerns” raised by the U.S. Federal Trade Commission (FTC) about the blockbuster deal. Shareholders of both companies have approved the acquisition, designed to create a powerhouse in immunology and inflammation, cardiovascular disease, and oncology.
Generex Biotechnology Corp. (GNBT: OTC) shares have been in a strong uptrend and steadily climbing during the short time since Joe Moscoto took over the helm of the company. Since then, the company has amassed an almost unbelievable number of acquisitions and LOI’s where each one has multi-blockbuster potential to Generex. Revenues are already showing substantial gains with 9 month ending April 30, 2019 reported at $6,217,039 versus $2,218 for the same period in 2018. With expected high growth from the accumulated earning of all divisions, it would not be surprising to see shares trade over $12 in the next 12 months and there is also the potential for soaring prices if the news continues to be good on A37, and the new diabetes delivery system, and the new treatment for Type 1 diabetes and other indications.
Eric von Hofe, President of NuGenerex-ImmunoOncology commented, “This is an exciting milestone for NuGenerex Immuno-Oncology, as we have now revitalized our AE37 development program with a focus on combination therapy with checkpoint inhibitors, which are now becoming standard of care for a broad array of cancers. Combining our promising immunotherapeutic with Merck’s checkpoint inhibitor, KEYTRUDA for the treatment of triple negative breast cancer represents a novel treatment strategy for a cancer of high unmet need. Prior studies with each agent alone showed promising signs of efficacy. By combining the mechanisms of checkpoint inhibition by KEYTRUDA with the robust, long-lasting and tumor-specific T-cell activation by AE37, we hope to enhance the clinical effectiveness of the immunotherapy strategies.”
Jason Terrell, MD, Chief Scientific and Medical Officer of Generex Biotechnology commented, “The start of patient enrollment represents the culmination of a committed effort by the team at NuGenerex Immuno-Oncology (formerly Antigen Express) and our research partners at the NSABP Foundation and Merck. NuGenerex Immuno-Oncology has been a pioneer on the forefront of immunotherapy for over a decade with our Ii-Key platform that ensures CD4 T-cell activation against any tumor antigen to which the Ii-Key is attached. The Ii-Key platform holds great promise, and we plan to initiate additional trials using the combination of checkpoint inhibitors with AE37 immune system activation in the field of personalized immuno-oncology to help patients in need of treatment options.”
