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Repros Therapeutics Inc. (), was a US-based development stage biopharmaceutical company headquartered in
The Woodlands, Texas The Woodlands is a special-purpose district and census-designated place (CDP) in the U.S. state of Texas in the Houston–The Woodlands–Sugar Land metropolitan statistical area. The Woodlands is primarily located in Montgomery County, with por ...
. 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 A chief executive officer (CEO), also known as a central executive officer (CEO), chief administrator officer (CAO) or just chief executive (CE), is one of a number of corporate executives charged with the management of an organization especially ...
of this company.


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 (plural zonae pellucidae, also egg coat or pellucid zone) is a specialized extracellular matrix that surrounds the plasma membrane of mammalian oocytes. It is a vital constitutive part of the oocyte. The zona pellucida first ...
—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 ...
. The company bought the rights to the research of
Bonnie S. Dunbar Bonita Sue "Bonnie" Dunbar (born February 14, 1948) is a former professor in the department of molecular and cell biology at Baylor College of Medicine, a position she held from 1994 to 2004. Prior thereto she was an assistant professor in the s ...
, researcher and professor at the
Baylor College of Medicine Baylor College of Medicine (BCM) is a medical school and research center in Houston, Texas, within the Texas Medical Center, the world's largest medical center. BCM is composed of four academic components: the School of Medicine, the Graduate Sc ...
, 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 business magnate, billionaire, politician and philanthropist. He was the founder and chief executive officer of Electronic Data Systems and Perot Systems. He ran an inde ...
and Lloyd Bentsen III, son of 69th United States Secretary of Treasury
Lloyd Bentsen Lloyd Millard Bentsen Jr. (February 11, 1921 – May 23, 2006) was an American politician who was a four-term United States Senator (1971–1993) from Texas and the Democratic Party nominee for vice president in 1988 on the Michael Dukakis ti ...
. 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 area. It was also a weekly print newspaper until November 2017. The publication is supported entirely by advertising ...
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 In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesic ...
. 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 (from Greek ''éxō'' "outer" and ''skeletós'' "skeleton") is an external skeleton that supports and protects an animal's body, in contrast to an internal skeleton (endoskeleton) in for example, a human. In usage, some of the ...
of
crustacean Crustaceans (Crustacea, ) form a large, diverse arthropod taxon which includes such animals as decapods, seed shrimp, branchiopods, fish lice, krill, remipedes, isopods, barnacles, copepods, amphipods and mantis shrimp. The crustacean group ...
s. The compound,
chitosan Chitosan is a linear polysaccharide composed of randomly distributed β-(1→4)-linked Glucosamine, D-glucosamine (deacetylated unit) and N-Acetylglucosamine, ''N''-acetyl-D-glucosamine (acetylated unit). It is made by treating the chitin shell ...
, 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 Phentolamine, sold under the brand name Regitine among others, is a reversible nonselective α-adrenergic antagonist. Mechanism Its primary action is vasodilation due to α1 blockade. Non-selective α-blockers can cause a much more pronounced r ...
. Realizing that
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
's
Viagra Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by ...
was going to be a hit product, Zonagen hoped to ride its coattails with an
erectile dysfunction Erectile dysfunction (ED), also called impotence, is the type of sexual dysfunction in which the penis fails to become or stay erect during sexual activity. It is the most common sexual problem in men.Cunningham GR, Rosen RC. Overview of male ...
drug of its own. However, unlike Pfizer, Zonagen repeated its experience from ImmuMax; it got a forty-year-old generic drug, phentolamine, dressed it up as something new, and acted as if it 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 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 G.D. Searle, LLC is a wholly owned subsidiary of Pfizer. It is currently a trademark company and subsidiary of Pfizer, operating in more than 43 countries. It also operates as a distribution trademark for various pharmaceuticals that were devel ...
, a subsidiary of
Monsanto Company The Monsanto Company () was an American agrochemical and agricultural biotechnology corporation founded in 1901 and headquartered in Creve Coeur, Missouri. Monsanto's best known product is Roundup (herbicide), Roundup, a glyphosate-based herbic ...
. 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, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known dr ...
,
Dearborn Chemical Company Dearborn may refer to: People * Dearborn (surname) ** Henry Dearborn (1751–1829), U.S. Secretary of War under President Thomas Jefferson, Senior Officer of the U.S. Army during the War of 1812 Places in the United States Forts * Fort Dearborn, a ...
and
Baxter Pharmaceuticals Baxter International Inc. is an American multinational healthcare company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat kidney disease, and other chronic and acute medical conditions. The compa ...
. 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 ( INN; developmental code name J-867) is a synthetic, steroidal selective progesterone receptor modulator that was under development by Schering and TAP Pharmaceutical Products for the treatment of uterine fibroids. In 2005, phase ...
. Asoprisnil was developed by
Germany Germany,, officially the Federal Republic of Germany, is a country in Central Europe. It is the second most populous country in Europe after Russia, and the most populous member state of the European Union. Germany is situated betwe ...
-based
Schering AG Schering AG was a research-centered German multinational pharmaceutical company headquartered in Wedding, Berlin, which operated as an independent company from 1851 to 2006. In 2006, it was bought by Bayer AG and merged to form the Bayer subsi ...
to treat
endometriosis Endometriosis is a disease of the female reproductive system in which cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grow outside the uterus. Most often this is on the ovaries, f ...
. Development was discontinued because the drug was causing thickening of the
endometrium The endometrium is the inner 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 functional laye ...
. 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 participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
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 respon ...
as of mid-2010. Androxal consists of an isomer of
Clomifene Clomifene, also known as clomiphene, is a medication used to treat infertility in women who do not ovulate, including those with polycystic ovary syndrome. Use results in a greater chance of twins. It is taken by mouth once a day, with a course ...
, 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.


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