Repros Therapeutics
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Repros Therapeutics Inc. was a US-based development stage
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
company headquartered in The Woodlands, Texas. Founded in 1987 as Zonagen, it focused on the development of oral small molecule drugs to address major unmet medical needs in male and female health. Joseph S. Podolski was the CEO of this company. The company attempted to develop a vaccine based contraceptive, but trails failed and project was later abandoned.


History

The company was organized on August 28, 1987 as Zonagen, to try to develop birth control methods based on modification of the
zona pellucida The ''zona pellucida'' (Latin meaning "transparent zone") is the specialized area surrounding mammalian oocytes (eggs). It is also known as an egg coat. The ''zona pellucida'' is essential for oocyte growth and fertilization. The ''zona pelluc ...
—a part of the
oocyte An oocyte (, oöcyte, or ovocyte) is a female gametocyte or germ cell involved in reproduction. In other words, it is an immature ovum, or egg cell. An oocyte is produced in a female fetus in the ovary during female gametogenesis. The female ger ...
. The company bought the rights to the research of Bonnie S. Dunbar, researcher and professor at the Baylor College of Medicine, and attempted to create a contraceptive vaccine. Zonagen, Inc. was formed in 1987 by Dunbar, Baylor and a group of investors, including
Ross Perot Henry Ross Perot ( ; June 27, 1930 – July 9, 2019) was an American businessman, politician, and philanthropist. He was the founder and chief executive officer of Electronic Data Systems and Perot Systems. He ran an Independent politician ...
and Lloyd Bentsen III, son of 69th United States Secretary of Treasury Lloyd Bentsen. The company hoped to market Dunbar's invention as a nonsurgical method of sterilizing dogs and cats. In the meantime, Zonagen would help Dunbar continue the pursuit of her life's work: the world's first contraceptive vaccine for humans. Her research, which had been progressing well, ground to a complete halt according to Brian Wallstin of the
Houston Press The ''Houston Press'' is an online newspaper published in Houston, Texas, United States. It is headquartered in the Midtown Houston, Midtown area. It was also a weekly print newspaper until November 2017. The publication is supported entirely ...
newspaper in his article “Biological Disaster.” The company, went public in 1993 with claims that a contraceptive vaccine was imminent. Bonnie Dunbar ended relations with the company and sued them. Zonagen would not develop any commercial product from research relating to the zona pellucida—despite naming itself after it. Its next project was to create an adjuvant. These products modify the effects of the active ingredient in a drug without having any direct effects of their own. However, Zonagen's attempt, ImmuMax, was merely an attempt to patent and cash in off a widely researched generic product: a structural element in the
exoskeleton An exoskeleton () . is a skeleton that is on the exterior of an animal in the form of hardened integument, which both supports the body's shape and protects the internal organs, in contrast to an internal endoskeleton (e.g. human skeleton, that ...
of
crustacean Crustaceans (from Latin meaning: "those with shells" or "crusted ones") are invertebrate animals that constitute one group of arthropods that are traditionally a part of the subphylum Crustacea (), a large, diverse group of mainly aquatic arthrop ...
s. The compound, chitosan, was indeed capable of causing some desirable effects within the immune system, but it also caused permanent scarring at injection point, which made it useless for the sort of medicinal purposes Zonagen hoped to use it for. After ceasing work on ImmuMax, Zonagen moved on to its third drug Vasomax, a disintegrating oral formulation of phentolamine. Realizing that
Pfizer Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...
's Viagra was going to be a hit product, Zonagen attempted to create a competing
erectile dysfunction Erectile dysfunction (ED), also referred to as impotence, is a form of sexual dysfunction in males characterized by the persistent or recurring inability to achieve or maintain a Human penis, penile erection with sufficient rigidity and durat ...
drug of its own. However, unlike Pfizer, Zonagen repeated its experience from ImmuMax; it got a forty-year-old generic drug, phentolamine, and attempted to use it as was a genuine Viagra competitor. While phentolamine was never proven to create erections by itself, Zonagen claimed that its formulation, simply phentolamine administered orally instead of in pill form, would work. Despite a failed Phase II trial in 1996 for Vasomax, the company proceeded to Phase III trials anyway. Once
Schering-Plough Schering-Plough Corporation was an American pharmaceutical company. It was originally the U.S. subsidiary of the German company Schering AG, which was founded in 1851 by Ernst Christian Friedrich Schering. As a result of nationalization, it becam ...
pulled out of its partnership with Zonagen for Vasomax, Zonagen abandoned its
New Drug Application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...
for Vasomax. The company was left with little more than a corporate shell and a bunch of lawsuits. Joseph S. Podolski served as Chief Executive Officer and as a director since 1992. He joined Zonagen in 1989 as Vice President of Operations. Previously, Podolski spent twelve years in various engineering, product development and manufacturing positions at G.D. Searle, a subsidiary of Monsanto Company. Before joining Monsanto, Podolski held positions in manufacturing, engineering, quality control and development of fine chemicals, antibiotics, pharmaceuticals and hospital products with
Abbott Laboratories Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, in the United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate k ...
, Dearborn Chemical Company and Baxter Pharmaceuticals. Joseph S. Podolski, the man who led Zonagen through two decades, decided it was time for a name change. In 2006, Zonagen changed its name to Repros Therapeutics, started to develop other pharmaceutical products for the reproductive system, and began work on its fourth lead drug, Proellex. Proellex is a very similar drug to asoprisnil. Asoprisnil was developed by
Germany Germany, officially the Federal Republic of Germany, is a country in Central Europe. It lies between the Baltic Sea and the North Sea to the north and the Alps to the south. Its sixteen States of Germany, constituent states have a total popu ...
-based Schering AG to treat
endometriosis Endometriosis is a disease in which Tissue (biology), tissue similar to the endometrium, the lining of the uterus, grows in other places in the body, outside the uterus. It occurs in women and a limited number of other female mammals. Endomet ...
. Development was discontinued because the drug was causing thickening of the
endometrium The endometrium is the inner epithelium, epithelial layer, along with its mucous membrane, of the mammalian uterus. It has a basal layer and a functional layer: the basal layer contains stem cells which regenerate the functional layer. The funct ...
. Repros claimed that its time on the drug/off the drug approach will make a big difference in safety versus asoprisnil. Currently, products under
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
are Proellex and Androxal. None have been approved by the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
as of mid-2010. Androxal consists of an isomer of Clomifene, which is already being used as a generic treatment for male hypogonadism. In December 2017, Allergan announced it was buying Repros Therapeutics. Repros now operates as a subsidiary of Allergan. Allergan was later acquired by Abbvie.


References


External links

* {{Pharmaceutical companies of the United States Companies formerly listed on the Nasdaq Pharmaceutical companies of the United States Health care companies based in Texas Companies based in The Woodlands, Texas 2018 mergers and acquisitions