MONTH 2008
Volume 3, Issue X

Start-up companies working on male contraceptives

Every few years, academic researchers (and in the past, major pharma companies) have come together at the NIH's "Future of Male Contraception" conference to compare notes.  But what's going on outside academia, in the world of start-ups?  Surprisingly, more than half a dozen companies are trying to make it in the world of new male contraception!  Many are struggling, and we suspect that with the current economic troubles, that number will be halved by a year or two from now if there isn't fresh funding.  This creates an opening for government and foundation funders with deeper pockets: if they have savvy lawyers, they can get promises of affordable pricing for public clinics in exchange for saving the day with their investment.  This win-win arrangement would keep the companies alive long enough to reach market, while making sure their products benefit more than a select few.

Here’s a list of today’s male contraceptive start-ups, starting with those closest to market:

Product: Pro-Vas implantable clip
Company: Florida-based MenRx Surgical
Status: This company is well on its way to market with a new vasectomy tool, the Pro-Vas implantable vas-occlusive clip.  The clip would be used together with no-scalpel vasectomy to close the vas slightly more quickly and, it is hoped, with less tissue damage than standard cutting and tying. However, like the Vasclip before it, Pro-Vas has been approved under an FDA program that requires only equivalence to a device already on the market for another use in terms of safety, with little or no proof that it works as hoped.  The Vasclip, for example, seems to be off the market, after unacceptable failure rates were reported by physicians, users, and in the medical literature. The Pro-Vas has design improvements that may make it more effective than the Vasclip; the key change is that the device has a spring clip that should allow varying vas sizes to be effectively clamped while not damaging the underlying blood vessels. Product release is scheduled for November, and the company will look for physicians to participate in an efficacy trial then.

Product: SpermCheck home sperm count kit
Company: Virginia-based ContraVac
Status: The company’s SpermCheck Vasectomy is an over-the-counter test with a much lower threshold than the commonly-available sperm count tests.  It gained FDA approval last March, and the kit was to be available by the end of this summer but apears to be delayed.  In addition to allowing at-home confirmation of vasectomy success, the test will be useful for men using DIY heat-based methods of contraception. ContraVac is seeking additional financing in order to begin a sales and marketing campaign for the device.

Product: Intra Vas Device (IVD)
Company: Minnesota-based Shepherd Medical Company
Status: Presented promising Phase I clinical trial 6-month interim results at last year's Future of Male Contraception conference.  The company learned several lessons from the initial study of this removable vas deferens plug, and planned to run a new study with an improved insertion procedure to increase the 92% success rate.  However, the company did not win a second NIH grant, despite a high score on its application.  A company representative now says there is “nothing to report” clinically or structurally.

Product: HIFU non-surgical vasectomy
Company: California-based Vitality Medical Products, LLC
Status: High-intensity focused ultrasound (HIFU) has been tested as a way to nonsurgically close the vas deferens for permanent contraception.  For HIFU sterilization, a small ultrasound transducer is clamped around the vas deferens and the scrotal skin.  Proof-of-concept studies carried out at the Johns Hopkins Medical Institute with dogs have established the proper power level and length of time needed to permanently occlude the vas (about 40-60 seconds), using equipment supplied by a company that sells HIFU equipment for treating heart defects.  The developer of the technology founded the start-up company a few years ago to test and commercialize the sterilization method. He didn’t get funding, however, and the project has been dropped barring new investment.

Product: Vassonic device
Company: California-based Vassonic
Status: This company has taken advantage of advances in miniaturized energy storage and delivery to design an implantable ring-shaped device intended to kill sperm passing through the vas deferens.  The device, which circles the vas, is intended to zap sperm without blocking sperm flow, thus avoiding many of the potential side effects of blocking devices.  The device is designed to be activated or deactivated from outside by a healthcare professional, much like a pacemaker is adjusted.  The company is being tight-lipped about the technological details until hearing back on its patent applications.  In this era of shrinking government science budgets, a first NIH grant submission did not win funding, so the company will be looking for private funding sources as well as other grant submissions to finish feasibility studies on the device.

Product: Non-occlusive vas device
Company: Canadian-based, but not yet named
Status: A team including Ron Weiss, a Canadian vasectomy expert who also participated in the WHO evaluation of RISUG facilities in 2002, is working on a non-occlusive, reversible vas-based device that is still under secrecy but is reportedly “redefining the field without re-inventing the wheel.”   Rodent tests are scheduled to begin this calendar year, and the startup is looking for funding.

Product: Modified testosterone
Company:  Tennessee-based GTx 
Status: SARMS are variants of testosterone designed in the lab to have as many of the benefits of testosterone as possible, while not affecting the prostate. A SARM could potentially be used as an oral male contraceptive, possibly with fewer side effects than testosterone itself. This company doing human studies of Ostarine™, its SARM, for the treatment of cancer wasting, the severe muscle loss associated with many cancers. GTx is concentrating on the profitable (and less politically tricky) cancer market, which is much more appealing from a business and legal standpoint than treating healthy young people needing contraception.  But if safe, this testosterone-like compound could be one of the first hormonal male contraceptives that can actually be taken as a pill instead of a shot or implant. GTx and Merck have formed a global strategic collaboration for SARMS, and GTx expects results from the 150-person trial later this autumn.

Product: Sperm-specific flagellar motility blockers
Company: Norwegian biotech Spermatech
Status: Spermatech recently partnered with a company that can do high-throughput screening (HTS) of drugs that might affect a sperm protein discovered by University of Massachusetts Medical School researcher Dr. George Witman.  If they can find a drug to block this protein, sperm won’t be able to swim.  The company has gathered all the intellectual property related to this sperm-specific protein under one roof, avoiding long patent fights and giving this approach its best chance at success. They will look for additional funding early next year.

Product: CatSper ion channel blockers
Company: Massachusetts-based Hydra Biosciences
Status: This company continues to look for larger partners interested in helping the company find a drug to block CatSper ion channels, using high-throughput screening to speed up the search.  The CatSper ion channels, discovered by company co-founder and Harvard researcher Dr. David Clapham and his team, play a crucial role in giving sperm their last big burst of energy that propels them into the egg.

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Press coverage: Time Magazine

Time Magazine focuses on hormonal research: what happened to Big Pharma’s  participation? Are men ready for a new contraceptive? “Just a few years ago, the new male contraceptive seemed like an inevitable reality. Major pharmaceutical companies like Wyeth, Schering and Organon were pumping millions into hormonal birth-control development programs for men, and researchers were breathlessly promising imminent production...”  IMCC director Kirsten Thompson and researcher Dr. David Handelsman are quoted about the demand and the progress that could be made; but “the lack of definitive results is a major problem, says Dr. John Amory, who has spearheaded much of the male contraceptive research at the University of Washington. He says the science needs to progress before researchers can blame Big Pharma for dragging its heels.”
The Long Wait for Male Birth Control
Time Magazine, 3 August

Finding Dulcinea, “the Internet's librarian,” summarizes the Time story and adds context, links, analysis, and resources.  “Scientifically speaking, birth control for men is an imminent possibility, but researchers and doctors involved in developing male contraceptive medications and devices say we’re a long way off from seeing these products on the market. Pharmaceutical companies aren’t making the necessary investments because of a widespread belief that men simply won’t take responsibility for birth control. ‘You can lead a horse to water, but you can't make it drink,’ researcher Dr. David Handelsman said, referring to the drug companies’ continued disinterest, and accusing the companies of being out of touch with what people actually want.”
Men’s Birth Control Faces Many Obstacles, 5 August

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Elaine Lissner, Director of the Male Contraception Information Project (MCIP)
MCIP is entirely nonprofit and works in three areas: raising public awareness of promising nonhormonal male contraceptives, advocating increased and expedited government research, and serving as a resource for journalists who wish to write about the subject.

Kirsten Thompson, Director of the Male Contraception Coalition (MCC)
The Coalition’s objectives are to speed the development of new male contraceptives through increased legislative and institutional support, to raise funds for applied male contraception research and development, and to educate the public about the work of the research community.