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Around mid-March, Blainville, Quebec-based Duchesnay, a specialty pharma company with a long-standing commitment to women’s health, acquired exclusive U.S. and Canadian rights to market and distribute Osphena (ospemifene) from Osaka, Japan-based Shionogi Inc. Osphena is the only oral, non-hormonal prescription medication indicated for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy due to menopause. The acquisition is effective immediately.
The exclusive rights granted to Duchesnay enable the company to develop, manufacture and commercialize ospemifene-based products in the United States and Canada.
However, all that said, readers of DDNews know that we don’t focus much on post- approval news. So, let’s get to a few merger and acquisition deals announced since March that are a bit more up your alley—in the realm of therapeutic R&D.
Sucampo acquires Vtesse, increasing company focus on specialized diseases with high unmet need
ROCKVILLE, Md. & GAITHERSBURG, Md.—April 3 saw Sucampo Pharmaceuticals Inc., a global biopharmaceutical company, and Vtesse Inc., a privately-held rare disease company, announce that Sucampo had acquired Vtesse for upfront consideration of $200 million. Sucampo funded the acquisition through the issuance of 2,782,678 shares of Sucampo Class A common stock and $170 million of cash on hand; no external financing was utilized.
The acquisition provides Sucampo with VTS-270, which is in a pivotal study for the treatment of Niemann-Pick Disease Type C1 (NPC-1), and it builds on Sucampo’s capabilities, global development platform and focus on specialized areas of high, unmet medical need. There are currently no approved treatments for NPC-1 in the United States.
VTS-270 is a well-characterized mixture of 2-hydroxypropyl-ß-cyclodextrins (HPßCD) with a specific compositional fingerprint that distinguishes it from other HPßCD mixtures. It is administered by an intrathecal infusion to directly address the neurological manifestations of disease. Preclinical and early clinical studies suggest that the administration of VTS-270 may slow or stop certain indicators of NPC-1. VTS-270, which is currently in a pivotal Phase 2b/3 trial, has been granted Breakthrough Therapy designation in the U.S. and Orphan Drug designation in both the United States and the European Union.
Also, Vtesse and Sucampo intend to establish a foundation after the closing of the acquisition to support research related to NPC disease.
“At the time of Vtesse’s launch in January 2015, Vtesse’s original investors recognized the imperative of driving VTS-270 rapidly through clinical development to secure the data for regulatory approvals and to deliver the drug candidate to the NPC-1 community. Sucampo is a global partner that is fully behind the original mission of Vtesse and its investment group,” said David Mott, Vtesse’s board chair.
Agalimmune acquisition to accelerate expansion of immuno-oncology pipeline at BioLineRx
TEL AVIV, Israel—BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, has acquired Agalimmune Ltd., a private U.K.-based company with an innovative, anticancer immunotherapy platform. Acquisition consideration consisted of a $6-million upfront payment, of which $3 million is in cash and the remainder in BioLineRx shares. Additional future payments may be made based on development and commercial milestones.
Agalimmune’s lead compound is AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific antitumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response.
AGI-134 has completed numerous preclinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional preclinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types.
“Immuno- oncology is one of the most promising approaches for the treatment of cancer. Although a number of current immunotherapies are receiving widespread attention, many solid tumors are still able to evade the immune system’s surveillance,” said Philip Serlin, CEO of BioLineRx. “Most immunotherapies work best in highly mutated tumors that are infiltrated with immune cells, known as ‘hot’ tumors. Unfortunately, the overwhelming majority of tumors are ‘cold’ tumors, and thus transforming a ‘cold’ tumor into a ‘hot’ tumor is a major objective in cancer treatment.
“In this regard, Agalimmune’s lead asset, AGI-134, harnesses naturally occurring, pre-existing antibodies to elicit a tumor-specific immune response that is unique to the treated individual and provides a universal, small-molecule approach to personalized immunotherapy. The subsequent stimulation and recruitment of T cells, which recognize the patient’s own neo-antigens, to the tumor site, has the potential of transforming ‘cold’ tumors into ‘hot’ ones.”
Hitachi Chemical purchasing remaining interest in PCT
BASKING RIDGE, N.J.—Caladrius Biosciences Inc., a cell therapy company with a select therapeutic development pipeline focused on immune modulation, announced in March that the company has signed a definitive agreement in which its remaining 80.1-percent ownership interest in its PCT subsidiary will be purchased by Hitachi Chemical Co. America Ltd. for $75 million in cash—in addition, there is the potential for Caladrius to receive an additional cash payment of $5 million if PCT achieves a certain revenue-based milestone.
PCT is an industry-leading cell therapy development and manufacturing services provider and had been 19.9-percent owned by Hitachi Chemical. This transaction will redefine Caladrius as a cell therapeutics-only development company with multiple proprietary technology platforms and significant capital resources to fund future programs.
“Hitachi Chemical’s purchase of our remaining interest in PCT unlocks the value of this asset for our company both by transforming Caladrius into a well-capitalized pure play therapeutics development company and by eliminating our need to contribute the tens of millions of dollars of future capital investment in PCT needed for it to fully realize its cell therapy commercial manufacturing growth goals,” said Dr. David J. Mazzo, CEO of Caladrius.
“Hitachi Chemical intends to deploy the capital and engineering expertise needed to leverage PCT’s own engineering and cell therapy development and manufacturing expertise, thereby accelerating the creation of a global commercial manufacturing enterprise,” added Dr. Robert A. Preti, president of PCT.