Insurers Take Aim at Big Pharma. This Small-Cap Stock Stands to Win.

Fool.com | January 30, 2020

The premise of generic drugs was simple enough. Branded medicines protected by a patent tend to be overpriced, but the equivalent therapy made by other companies once a patent expires should lead to price-lowering competition. As it turns out, however, generic drugs have become overpriced as well. That's the stance the state of California has taken, anyway, with Governor Gavin Newsom announcing early this month the state is planning to launch its own prescription drug label. The Blue Cross Blue Shield Association doubled down on the idea with a more eyebrow-raising announcement just a few days ago, investing $55 million in pharmaceutical company Civica Rx to help it create a new subsidiary that will offer the health insurer access to self-supplied, cheaper generics for the people it insures. If this is the shape of things to come -and it appears to be -- a small drugmaker called Catalent (NYSE:CTLT) is quietly positioned to benefit in a big way.

Spotlight

Remember ebola? The rare but extremely contagious and fatal virus that threatened to wipe out the world in 2014-2016? Okay, maybe not the world…but the virus is very dangerous and is still a threat. With so much media surrounding the outbreak that plagued parts of Africa and spread to a handful of people around the world two years ago to radio silence to date, we find ourselves wondering, what happened to Ebola?

Spotlight

Remember ebola? The rare but extremely contagious and fatal virus that threatened to wipe out the world in 2014-2016? Okay, maybe not the world…but the virus is very dangerous and is still a threat. With so much media surrounding the outbreak that plagued parts of Africa and spread to a handful of people around the world two years ago to radio silence to date, we find ourselves wondering, what happened to Ebola?

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PHARMA TECH

Foresee Pharmaceuticals and TRPharm Announce License and Co-Development Agreement

Foresee Pharmaceuticals Co., Ltd | February 24, 2022

Foresee Pharmaceuticals Co., Ltd. a Taiwan and US-based biopharmaceutical company and TRPharm, a leading Turkish healthcare company, announced today that they have entered into an exclusive license agreement for the co-development and commercialisation in Turkey and certain MENA countries of Foresee's FP-045 program, an oral allosteric Aldehyde Dehydrogenase 2 (ALDH2) activator for the treatment of Fanconi Anemia and other rare and severe diseases. Under the terms of this partnership, Foresee and TRPharm will collaborate to initially expedite the development of FP-045 in Fanconi Anemia. Turkey and the surrounding region has a high prevalence Fanconi Anemia as well as other rare diseases. Foresee will own all development data which will be used as part of its global development and registration dossier. Upon approval and commercialization in the territory, Foresee will receive significant royalties from the revenue in the territory. TRPharm will have exclusive rights to register and commercialize in the territory and will cover all related costs. "We are very pleased to have established this collaboration with TRPharm, whose established track record of successful development, registrations and launches of rare disease products, including in hematology, makes us confident that they will make a remarkable partner for our FP-045 program. This is our second partnership with TRPharm and we look forward to continuing working together." Dr. Ben Chien, Founder, Chairman and CEO of Foresee İsmet Ince, General Manager of TRPharm, commented "Our purpose in TRPharm is to be the platform where health meets innovative solutions and I can think of no better example for it than this collaboration on FP-045 with Foresee. We are thrilled to have this opportunity to blaze a trail in Fanconi Anemia, which has a particularly high prevalence in our core regions, and provide relief to the patients with significant unmet need. It is an even greater pleasure to be doing this with Foresee, an esteemed international biopharmaceutical company with whom we share common views and a history of productive partnership. This collaboration also marks a step change in our R&D approach and is the culmination of a unique set of capabilities which we have developed over many years. We are confident that they will contribute materially to making this collaboration a rapid success." About Foresee Pharmaceuticals Co. Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late stage and early stage programs. CAMCEVI® 42 mg is now approved in the U.S. and under regulatory review in the EU. Additionally, U.S. and EU regulatory submissions are in preparation for CAMCEVI® 21 mg. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia. About TRPharm Conducting its activities with the vision of becoming a global and innovative healthcare company, TRPharm plays a leading role in Turkey & MENA and the neighboring regions thanks to its unique business model and emphasis on intellectual capital. Aiming at making its presence felt in every field with unmet healthcare needs, TRPharm focuses on enabling innovative healthcare solutions for the patients. It does so by leveraging its extensive experience at every stage, from development to commercialization, with extraordinary results. TRPharm has an extensive product portfolio in oncology/hematology, neurology, immunology and rare diseases.

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BUSINESS INSIGHTS

Halozyme Completes Antares Pharma Acquisition

Halozyme Therapeutics, Inc. | May 30, 2022

Halozyme Therapeutics, Inc. announced the successful completion of its acquisition of Antares Pharma, Inc. The tender offer for all of the outstanding shares of Antares common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, May 23, 2022. The minimum tender condition and all of the other conditions to the offer have been satisfied and on May 24, 2022, Halozyme accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Halozyme completed its acquisition of Antares through the merger of a wholly owned subsidiary of Halozyme with and into Antares, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of Halozyme. In connection with the merger, all Antares shares not validly tendered in the tender offer have been converted into the right to receive the same $5.60 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of May 24, 2022, Antares common stock will cease to be traded on the NASDAQ Global Select Stock Market. BofA Securities, Inc. and Wells Fargo Securities LLC acted as financial advisors to Halozyme and Weil, Gotshal & Manges LLP acted as legal advisor. Jefferies LLC acted as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor. About Halozyme Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has touched more than 600,000 patient lives in post-marketing use via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme derives revenues from these collaborations in the form of milestones and royalties as Halozyme's partners make progress developing and commercializing their products being developed using ENHANZE®. Halozyme is headquartered in San Diego.

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RESEARCH

Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Gilead | November 21, 2020

Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth. At clear odds with the FDA’s approval, the WHO has for now recommended against the use of remdesivir in any hospitalized patients—regardless of disease severity—after an expert panel said it had found no evidence that remdesivir has any meaningful effect on saving lives and other important outcomes for patients, the international body said Thursday. A “disappointed” Gilead immediately fought back. It pointed to remdesivir’s inclusion in several other organizations’ guidelines based on data from a phase 3 trial by the National Institute of Allergy and Infectious Diseases (NIAID), which showed the drug’s use could lead to faster recovery.

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